UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the date of November 28, 2023
Commission File Number 001-39124
Centogene N.V.
(Translation of registrant's name into English)
Am Strande
7
18055 Rostock
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F X Form
40-F
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Centogene N.V.
On November 20, 2023, and pursuant to the joint venture agreement (the
“Joint Venture Agreement”) that Centogene N.V. (“we” or the “Company”) entered into on June 26, 2023
with Pharmaceutical Investment Company (“PIC”), as amended by the variation agreement between the Company and PIC on October
23, 2023 (the “Variation Agreement”), Genomics Innovations Company Limited (the “JV”) was fully formed as a limited
liability company organized under the laws of the Kingdom of Saudi Arabia. The full text of the Joint Venture Agreement was attached as
Exhibit 99.2 to the Company’s Current Report on 6-K filed on June 27, 2023. The full text of the Variation Agreement to the Joint
Venture Agreement was attached as Exhibit 99.1 to the Company’s Current Report on 6-K filed on October 27, 2023.
On November 28, 2023, the Company issued a press release titled
“CENTOGENE and Lifera, a Public Investment Fund (PIF) Company, Complete Strategic Joint Venture Transaction” regarding the formation
of the JV. A copy of the press release is attached hereto as Exhibit 99.1.
Consultancy Agreement
On November 27, 2023, in connection with the formation of the
JV, the Company entered into a consultancy agreement with the JV (the “Consultancy Agreement”) pursuant to which the Company
will provide certain pre-agreed services, and other services which the parties reasonably determine are necessary from time to time, to
the JV to support the JV in the construction, management and operation of a facility in the Kingdom of Saudi Arabia that will serve as
a diagnostics center, laboratory and biodatabank. In consideration for the Company’s provision of the services to the JV, the JV
will pay the Company a project consultation fee as well as performance-based milestone payments and commercial milestone payments. The
JV can terminate the Consultancy Agreement two and a half years after the effective date of the agreement, upon nine months’ written
notice. So long as the Joint Venture Agreement is in effect, the Consultancy Agreement will remain in effect for ten years, unless earlier
terminated in accordance with its terms.
The foregoing summary of the Consultancy Agreement does not purport
to be complete and is subject to, and qualified in its entirety by, the full text of the Consultancy Agreement attached as Exhibit 99.2
to this Current Report on Form 6-K, which is incorporated herein by reference.
Laboratory Services Agreement
On November 27, 2023, in connection with the formation of the
JV, the Company entered into a laboratory services agreement with the JV (the “Laboratory Services Agreement”) pursuant to
which the Company will provide certain laboratory services to the JV in relation to patient samples collected in the Kingdom of Saudi
Arabia. Such laboratory services will include (i) certain testing services that the Company sells or makes available to its other customers,
as well as other testing services that may be agreed by the parties from time to time and (ii) certain dry-lab services, including analyzing
and interpreting data and providing clinical reports to clinicians. In consideration for the Company’s performance of the services
under the Laboratory Services Agreement, the JV will pay testing fees calculated based on an agreed methodology. The JV can terminate
the Laboratory Services Agreement two and a half years after the effective date of the agreement, upon nine months’ written notice.
The Laboratory Services Agreement will remain in effect until the expiration or termination of the Consultancy Agreement, unless earlier
terminated in accordance with its terms.
The foregoing summary of the Laboratory Services Agreement does not
purport to be complete and is subject to, and qualified in its entirety by, the full text of the Laboratory Services Agreement attached
as Exhibit 99.3 to this Current Report on Form 6-K, which is incorporated herein by reference.
Technology Transfer and Intellectual Property License Agreement
On November 27, 2023, in connection with the formation of the
JV, the Company entered into a technology transfer and intellectual property license agreement with the JV (the “IP License Agreement”)
pursuant to which the Company grants the JV an exclusive license to use certain know-how, patents and data in the Kingdom of Saudi Arabia
to (i) receive the benefits provided by the Company under the Consultancy Agreement and Laboratory Services Agreement, (ii) operate its
business, (iii) perform diagnostic testing services and (iv) access, view and manipulate certain data. In consideration for the license
granted by the Company, the JV will pay an upfront payment and, beginning on the sixth anniversary of the JV’s incorporation until
the 10th anniversary of the effective date of the IP License Agreement, the JV will pay a low-single digit royalty on the JV’s net
revenue. The JV can terminate the IP License Agreement two and a half years after the effective date of the agreement, upon nine months’
written notice. So long as the Joint Venture Agreement is in effect, the IP License Agreement will remain in effect for ten years and
automatically renew for successive one-year terms, unless earlier terminated in accordance with its terms.
The foregoing summary of the IP License Agreement does not purport
to be complete and is subject to, and qualified in its entirety by, the full text of the IP License Agreement attached as Exhibit 99.4
to this Current Report on Form 6-K, which is incorporated herein by reference.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: November 28, 2023
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CENTOGENE N.V. |
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By: |
/s/ Jose Miguel Coego Rios |
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Name: |
Jose Miguel Coego Rios |
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Title: |
Chief Financial Officer |
Exhibit Index
^ Certain exhibits and schedules to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K. The Company agrees
to furnish supplementally a copy of any omitted exhibit or schedule to the SEC upon its request.
† Portions
of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10).
Exhibit 99.1
Press
Release
CENTOGENE
and Lifera, a Public Investment Fund (PIF) Company, Complete Strategic Joint Venture Transaction
| · | Lifera
Omics, newly formed Joint Venture (JV) to be based in Riyadh, Saudi Arabia, provides state-of-the-art
genomic and multiomic testing services to patients, health systems, biopharma clients, and
research institutions across the Gulf Cooperation Council (GCC) region |
| · | CENTOGENE
to receive an additional $10 million upfront JV milestone payment, following an initial $30
million investment from Lifera. Company eligible for additional performance-related milestone
payments and revenue-based royalties until the year 2033 |
| · | CENTOGENE
and Lifera executive leadership to present on the collaborative vision at Global Healthspan
Summit on November 30 in Riyadh |
CAMBRIDGE,
Mass. and ROSTOCK, Germany, and BERLIN, November 28, 2023 (GLOBE NEWSWIRE) --
Centogene
N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced
that it has completed the transaction to form a new joint venture (JV) with Lifera, a biopharmaceutical company wholly-owned by the Public
Investment Fund (PIF). The JV has been formed to increase local and regional access as well as rapid delivery of world-class genomic
and multiomic testing to patients in Saudi Arabia and countries of the Gulf Cooperation Council (GCC). The new JV will be located in
Riyadh, Saudi Arabia, and operate under the name ‘Lifera Omics’.
“Completing
this transaction marks a significant milestone on our mission to deliver data-driven, life-changing answers to patients and paves a pathway
to achieving sustainable growth and profitability for CENTOGENE,” said Kim Stratton, Chief Executive Officer at CENTOGENE. “We
are now excited to leverage our leading diagnostics and multiomics expertise to build up Lifera Omics. This, together with Lifera’s
strong local presence and resources, will establish widespread access to local state-of-the-art genetic sequencing and multiomic testing
tailored to regional needs.”
”The
completion of the joint venture with CENTOGENE marks the beginning of the next phase of Lifera’s mission to grow Saudi Arabia’s
biopharma sector,” commented Dr. Ibrahim Aljufalli, Chairman of the Lifera Board. “By combining CENTOGENE’s expertise
of rare, metabolic, and neurodegenerative diseases with our deep understanding of the local healthcare landscape, this marks an important
moment for Saudi Arabia and the GCC – laying the foundation for our two companies to combine resources and bring superior healthcare
solutions to patients and their families.”
Strong
Synergy With Focus on Genetic Conditions
CENTOGENE
is the current market leader in outsourced genetic testing for patients in Saudi Arabia. Lifera Omics will build on this strength with
an advanced laboratory and bioinformatics infrastructure, also leveraging the CENTOGENE Biodatabank. This is the world’s largest
real-world integrated multiomic data repository in rare and neurodegenerative diseases, which has more than 70 million unique variants
and over 60,000 Saudi Arabian patient datasets. Lifera Omics will develop capabilities for genetic and multiomic testing and interpretation,
working collaboratively with CENTOGENE globally, and serving as a
vehicle
for large national screening and genomics programs. As such, patients in Saudi Arabia and the GCC, a rapidly growing region with over
56 million inhabitants, will have increased access to the world’s most advanced and effective diagnostic offerings, which is at
the core of Lifera’s strategic objectives to contribute to improving national resilience and health outcomes.
Additional
Information
Under
the terms of the transaction, both Lifera and CENTOGENE will make an investment into Lifera Omics, and the initial funding will reflect
an ownership structure of an 80%-20% split between Lifera and CENTOGENE, respectively. CENTOGENE is also eligible for performance-related
milestone payments, including a $10 million upfront JV milestone payment, as well as revenue-based royalties until the year 2033. Both
parties will be represented on the board of Lifera Omics, and two Lifera representatives will join CENTOGENE’s Supervisory Board.
In
addition, Lifera made an investment in CENTOGENE in the form of a mandatorily convertible loan with a total aggregate principal amount
of $30 million. The term of the convertible loan is six months, automatically converting into common stock no more than six months from
October 26, 2023, while providing CENTOGENE the ability to trigger earlier conversion.
Moelis
LLC acted as a financial advisor to CENTOGENE on the transaction. Davis Polk & Wardwell London LLP acted as legal advisor to CENTOGENE
on the transaction. Ernst & Young acted as financial advisor to Lifera on the transaction. Latham & Watkins acted as legal advisor
to Lifera on the transaction.
Additional
information regarding this announcement and the Companies’ Joint Venture can be found in the Current Report on Form 6-K that the
Company intends to file today with the U.S. Securities and Exchange Commission and Form 6-K filed by the Company on Oct 27, 2023.
Upcoming
Presentation Details
CENTOGENE
and Lifera management will be presenting at the Global Healthspan Summit at the Four Seasons Hotel in Riyadh on November 30, 2023. To
learn more about the event and their presentation on the impact of collaboration in accelerating precision medicine, visit: https://link.centogene.com/ghs
About
Lifera
Lifera
is a new biopharmaceutical company dedicated to advancing Saudi Arabia’s biopharmaceutical sector and building national health
resilience. By developing local manufacturing capacity for vaccines, insulin, plasma therapeutics and other biologics, as well as investing
in genetic testing and precision medicine, Lifera aims to ensure people in Saudi Arabia have access to reliable and affordable medicines.
Lifera
will do this through partnerships and investments with leading international and Saudi companies to transfer global expertise and technology
to Saudi Arabia. Wholly-owned by the Public Investment Fund (PIF), Lifera’s differentiated vision and mission make it an ideal
partner to build the biopharmaceutical sector in Saudi Arabia.
About
CENTOGENE
CENTOGENE’s
mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative
diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next
generation of precision
medicine.
Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states,
and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
Since
our founding in 2006, CENTOGENE has been offering rapid and reliable diagnosis – building a network of approximately 30,000 active
physicians. Our ISO, CAP, and CLIA certified multiomic reference laboratories in Germany utilize Phenomic, Genomic, Transcriptomic, Epigenomic,
Proteomic, and Metabolomic datasets. This data is captured in our CENTOGENE Biodatabank, with over 800,000 patients represented from
over 120 highly diverse countries, over 70% of whom are of non-European descent. To date, the CENTOGENE Biodatabank has contributed to
generating novel insights for more than 285 peer-reviewed publications.
By
translating our data and expertise into tangible insights, we have supported over 50 collaborations with pharma partners. Together, we
accelerate and de-risk drug discovery, development, and commercialization in target and drug screening, clinical development, market
access and expansion, as well as offering CENTOGENE Biodata Licenses and Insight Reports to enable a world healed of all rare and neurodegenerative
diseases.
To
discover more about our products, pipeline, and patient-driven purpose, visit www.centogene.com
and follow us on LinkedIn.
Forward-Looking
Statements
This
press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements contained
herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” “plan,”
“is designed to,” “potential,” “predict,” “objective” and similar expressions and future
or conditional verbs such as “will,” “would,” “should,” “could,” “might,”
“can,” and “may,” or the negative of these are generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause CENTOGENE’s
actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed
or implied by the forward- looking statements. Such risks and uncertainties include, among others, negative economic and geopolitical
conditions and instability and volatility in the worldwide financial markets, possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory
approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our
ability to manage growth, execute our business strategy and enter into new client relationships, our dependency on the rare disease industry,
our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations
of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our continued ongoing compliance
with covenants linked to financial instruments, our requirement for additional financing, and our ability to continue as a going concern,
or other factors. For further information on the risks and uncertainties that could cause actual results to differ from those expressed
in these forward-looking statements, as well as risks relating to CENTOGENE’s business in general, see CENTOGENE’s risk factors
set forth in CENTOGENE’s Form 20-F filed on May 16, 2023, with the Securities and Exchange Commission (the “SEC”) and
subsequent filings with the SEC. Any forward-looking statements contained in this press release speak
only
as of the date hereof, and CENTOGENE specifically disclaims any obligation to update any forward-looking statement, whether as a result
of new information, future events, or otherwise.
CONTACT
Lifera
Nisreen
Qaid
Communication
Director
nqaid@lifera.com.sa
CENTOGENE
Melissa
Hall
Corporate
Communications
Press@centogene.com
Lennart
Streibel
Investor
Relations
IR@centogene.com
Exhibit 99.2
Execution Version
GENOMICS
INNOVATIONS COMPANY LIMITED
(“Company”)
and
CENTOGENE
N.V.
(“NV”)
dated 27 November
2023
|
CONSULTANCY
AGREEMENT
related to
KSA FACILITY
|
CONTENTS
Clause |
|
Page |
1. |
Definitions; Interpretation; Conflicts |
1 |
2. |
Engagement and Scope of Authority |
1 |
3. |
NV’s Obligations and Responsibilities |
3 |
4. |
Company’s Obligations and Responsibilities |
4 |
5. |
FEES |
5 |
6. |
TAXES |
8 |
7. |
Standards |
10 |
8. |
COOPERATION |
11 |
9. |
NV Personnel |
11 |
10. |
Data Protection AND CYBERSECURITY |
11 |
11. |
Term |
12 |
12. |
Representations and Warranties |
13 |
13. |
Intellectual Property Rights |
13 |
14. |
Confidential information |
14 |
15. |
Indemnities |
16 |
16. |
Limitation of Liability |
18 |
17. |
Force Majeure |
19 |
18. |
Insurance |
20 |
19. |
Termination |
20 |
20. |
Notices |
23 |
21. |
Assignment and Subcontracting |
25 |
22. |
Costs |
25 |
23. |
Audit |
25 |
24. |
Language |
26 |
25. |
Cooperation with Regulators |
26 |
26. |
Anti-Bribery and Corruption |
26 |
27. |
Export Control and Sanctions |
26 |
28. |
Further Assurance |
27 |
29. |
Required Consents |
27 |
30. |
Rights of Third Parties |
27 |
31. |
Waiver and Variation |
27 |
32. |
Severability |
28 |
33. |
Governing Law; ARBITRATION AND JURISDICTION |
28 |
34. |
Entire Agreement |
28 |
35. |
Counterparts |
29 |
Schedule 1 DEFINED TERMS AND INTERPRETATION |
31 |
Part 1 - Defined Terms |
31 |
Part 2 - Interpretation |
39 |
Schedule 2 SCOPE OF NV SERVICES |
40 |
Schedule 3 PERSONAL DATA AND INFORMATION SECURITY |
51 |
Schedule 4 STAFFING AND SECONDMENT |
75 |
CONSULTANCY
AGREEMENT
This CONSULTANCY
AGREEMENT (the “Agreement”) is dated 27 November 2023 (the “Effective Date”), and is entered
into by and between:
| (1) | GENOMICS
INNOVATIONS COMPANY LIMITED, a company organized under the laws of the Kingdom of Saudi
Arabia with a registered office at Building No. 3936, 6651 Al Nakheel District, 12382 Riyadh,
Kingdom of Saudi Arabia (“Company”); and |
| (2) | CENTOGENE
N.V., a company organized under the laws of the Netherlands with a registered office
at Am Strande 7, 18055 Rostock, Germany (“NV”). |
Company and NV
shall be referred to herein either individually as a “Party” or together as the “Parties”.
WHEREAS:
| (A) | NV and its
Affiliates (as defined below) have developed and maintain certain laboratories and a biodatabank
relating to patient samples collected in the ordinary course of its diagnostics business
at a site located in Rostock, Germany (“NV Facility”); |
| (B) | Company and
NV have entered into a Joint Venture Agreement dated 26 June 2023 (the “Joint Venture
Agreement”) for the establishment of Company and the operation of the KSA Facility
in the Kingdom; |
| (C) | Company and
NV have entered into a Technology Transfer and Intellectual Property License Agreement dated
27 November 2023 (“Technology Transfer and Intellectual Property License Agreement”)
for the purposes of transferring and licensing certain technology and data from NV to Company
in relation to the establishment of the KSA Facility; |
| (D) | Company and
NV have entered into a Laboratory Services Agreement dated 27 November 2023 (“Laboratory
Services Agreement”) whereby NV or its Affiliates shall act as the exclusive provider
of certain laboratory and diagnostic services to Company; |
| (E) | Company desires
to receive the NV Services (as defined in clause 3.1) to support Company in the construction
and operation of the KSA Facility and NV desires to provide the NV Services pursuant to the
terms and conditions set forth herein; and |
| (F) | The Parties
now desire to enter into this Agreement to document such terms and conditions. |
NOW, THEREFORE,
in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows:
| 1. | Definitions;
Interpretation; Conflicts |
Capitalized
terms used in this Agreement shall have the meanings given in Part 1 (Defined Terms) of Schedule 1 (Defined Terms and Interpretation).
This Agreement shall be interpreted in accordance with Part 2 (Interpretation) of Schedule 1 (Defined Terms and Interpretation).
| 2. | Engagement
and Scope of Authority |
| 2.1.1 | Subject
to the terms and conditions of this Agreement, during the Term, Company hereby engages NV
and its Affiliates, and NV and its Affiliates hereby agree to be so engaged, as the exclusive
provider of the NV Services to support Company with its operation of the KSA Facility in
accordance with Applicable Law; provided that Company shall have the ability to obtain
related Third Party Services from the Third Party Service Providers, at Company’s sole
cost and expense, as needed to perform such Third Party Services at the KSA Facility in consultation
with NV. |
| 2.1.2 | NV shall
provide, or shall cause to be provided, the NV Services (as defined in clause 3.1): |
| (a) | in a professional
and workmanlike manner; and |
| (b) | by applying
Commercially Reasonable Efforts to provide levels of accuracy, quality, completeness, timeliness,
and care consistent with the levels provided by NV and its Affiliates at the NV Facility. |
| 2.1.3 | In the
event NV is unable to or materially fails to provide one or more of the NV Services to Company’s
reasonable satisfaction and such inability or failure continues for more than thirty (30)
days following written notice from Company adequately describing such inability or material
failure, then without prejudice to any other rights and remedies Company may have under this
Agreement, Company shall have the right to engage other third-party service providers at
Company’s discretion and NV’s sole cost and expense to provide such services;
provided that NV shall not be responsible for any acts or omissions by any such third-party
service provider that adversely affect NV’s provision of the NV Services. |
| 2.1.4 | In accordance
with the terms of this Agreement: |
| (a) | in consideration
of NV’s and its Affiliates’ performance of its obligations under this Agreement
(including with respect to Schedule 2 (Scope of Services)), Company shall pay to NV
the Fees due under this Agreement and shall comply with its other obligations under this
Agreement; and |
| (b) | in consideration
for the payment of the Fees due under this Agreement and Company performing its obligations
under this Agreement, NV shall provide (or subject to clause 21.1, cause to be provided)
the NV Services in accordance with the terms of this Agreement and comply with its other
obligations under this Agreement. |
NV and
its Affiliates at all times shall be deemed an independent contractor and neither it nor any of its Affiliates or any of their respective
employees, directors, contractors, subcontractors or outside consultants shall be considered to be an agent, servant, employee or representative
of Company.
| 2.3 | Retention of Control by Company
and Limitation on Authority |
Company
and NV expressly acknowledge and agree that this Agreement does not convey ownership or Control over all or any part of Company or the
KSA Facility to NV. Company owns and Controls all rights to the KSA Facility, subject to the terms of the Technology Transfer and Intellectual
Property License Agreement.
| 2.4 | NV shall not, pursuant to this
Agreement, take any actions: |
| 2.4.1 | that
require the prior approval of or are reserved to the Board of Directors, or the Shareholders,
without first ensuring that such actions have been approved by the applicable governing body,
or otherwise contravene any approval right under the Joint Venture Agreement; |
| 2.4.2 | that
contravene policies adopted by Company or any directives issued by the Board of Directors,
in each case that have been provided to NV in advance in writing; or |
| 2.4.3 | on behalf
of, or assume, create or incur liability or obligation, against, in the name of, or on behalf
of, any of Company, any Shareholder or the KSA Facility, except to the extent expressly permitted
under this Agreement or authorized in writing by or on behalf of Company. |
| 2.5 | Company shall not, pursuant to
this Agreement, take any actions: |
| 2.5.1 | that
contravene policies relating to the provision of NV Services adopted by NV that have been
provided to Company in advance in writing; or |
| 2.5.2 | on behalf
of, or assume, create or incur liability or obligation, against, in the name of, or on behalf
of, NV, its Affiliates or the NV Facility, except to the extent expressly authorized in writing
by or on behalf of NV or otherwise expressly permitted under this Agreement. |
| 3. | NV’s
Obligations and Responsibilities |
Subject
to the terms and conditions of this Agreement, NV shall (or shall cause its Affiliates to) make available and provide to Company the
services described in Schedule 2 (Scope of Services) and such other services as the Parties reasonably determine necessary to
pursue the goal of achieving performance of the KSA Facility as a diagnostics centre, laboratory and biodatabank, in accordance with
the same or substantially similar standards as the NV Facility, including Accreditation (collectively, “NV Services”).
| 3.2 | Cooperation
with Others |
NV shall
use Commercially Reasonable Efforts to cooperate with any Third Party Service Provider or other third party service providers engaged
by Company pursuant to clause 2.1.1 in connection with the provision of the NV Services. Company shall use Commercially Reasonable Efforts
to facilitate the cooperation of Third Party Service Providers or other third party service providers engaged by Company pursuant to
clause 2.1.1 in connection with the provision of the NV Services under this Agreement.
| 3.3.1 | NV shall
designate a representative (the “NV Representative”) who shall be NV’s
relationship manager for purposes of this Agreement and to facilitate NV’s provision
of the NV Services under, and the administration of, this Agreement. At all times, NV shall
designate a NV Representative who has the qualifications, expertise, industry experience
and prior relationship with NV to assure Company that such NV Representative would successfully
fulfil the role he or she is engaged to provide under this Agreement. The initial NV Representative
shall be Miguel Coego. In the event NV is intending to replace the NV Representative, NV
shall inform Company of such intent and provide a reasonable explanation for the replacement
need at least ten (10) Business Days prior to replacing the NV Representative to the extent |
reasonably
practicable. NV shall ensure that any such replacement shall meet all of Company’s requirements as provided herein.
| 3.3.2 | If Company
is not reasonably satisfied with the NV Representative, it shall provide detailed information
to NV regarding its reasons for dissatisfaction and NV shall use Commercially Reasonable
Efforts to address the reasons presented by Company. If after such Commercially Reasonable
Efforts have been made, Company still remains dissatisfied with the NV Representative, NV
shall remove and replace such NV Representative as soon as reasonably practicable, and such
replacement shall otherwise meet the qualifications as described in clause 3.3.1. |
NV shall
keep such business, financial and other records and other documentation as consistent with NV’s retention policies relating to
its activities undertaken in connection with the provision of the NV Services, in accordance with Applicable Law and shall, if required
pursuant to clause 23 of this Agreement, make such records available for inspection and/or provide copies thereof to an independent professional
firm chosen and/or appointed by Company, provided such auditor is reasonably acceptable to NV.
NV will
act in good faith to comply with its obligations under this Agreement.
| 4. | Company’s
Obligations and Responsibilities |
Company,
at its reasonable discretion shall provide, or cause to be provided, to NV and its Affiliates copies of business, financial and other
records or documentation relating to the KSA Facility that Company deems reasonably necessary for NV and its Affiliates to possess, or
NV reasonably requests, in order to provide the NV Services.
Company
shall provide, or cause to be provided, to NV and its Affiliates reasonable access to the KSA Facility to the extent required for NV
and its Affiliates to provide the NV Services. NV and its Affiliates will abide by all site health, safety and other procedures and policies
established at the KSA Facility of which Company has provided reasonable advance written notice to NV or NV Personnel.
| 4.3 | Project Information Systems |
Company
shall cause NV and its Affiliates to be provided with reasonable access to the KSA Facility’s:
| (b) | accounting
and management maintenance system; and |
| (c) | other information
systems, |
in each
case in clauses (a)-(c) above, solely to the extent required for NV to perform the NV Services hereunder.
Company
shall keep such business, financial and other records and other documentation as consistent with industry standards relating to its activities
undertaken in connection with the receipt of the NV Services, in accordance with Applicable Law.
Company
will act in good faith to comply with its obligations under this Agreement.
| 4.6 | Company Representative |
Company
shall designate a representative (the “Company Representative”) who shall be Company’s relationship manager
for purposes of this Agreement and to facilitate Company’s receipt of the NV Services under, and the administration of, this Agreement.
At all times, Company shall designate a Company Representative who has the qualifications, expertise and industry experience to assure
NV that such Company Representative would successfully fulfil the role he or she is engaged to provide under this Agreement. The initial
Company Representative shall be Jeremy Panacheril. In the event Company is intending to replace the Company Representative, Company shall
inform NV of such intent and provide an explanation for the replacement need at least ten (10) Business Days prior to replacing the Company
Representative. Company shall ensure that any such replacement shall meet all of the requirements as provided herein.
| 5.1.1 | In consideration
for NV’s provision of the NV Services and performance of its obligations under this
Agreement, Company shall pay to NV: |
| (a) | the Project
Consultation Fee as determined pursuant to clause 5.2 below; and |
| (b) | the Fixed
Performance Fee as determined pursuant to clause 5.3 below, |
(collectively,
the “Fees”).
| 5.1.2 | The Fees
are the only amounts payable by Company to NV in respect of NV’s provision of the NV
Services and performance of its other obligations in this Agreement. |
| 5.2 | Project Consultation Fee |
Company
shall pay to NV, for the services provided by any NV Personnel, a fee (the “Project Consultation Fee”) of an amount
equal to:
| 5.2.1 | for all
Seconded Personnel (including, for the avoidance of doubt, the Approved Seconded Personnel),
all reasonable costs and expenses incurred by NV in connection with the NV Services provided
by such Seconded Personnel as mutually agreed between the Parties in writing, in advance,
including, for the avoidance of doubt, the wages and benefits of such Seconded Personnel
during the period of secondment, and any federal, state, local or foreign Taxes owed by Company
in respect of the payment of such wages or benefits, including any employer and/or withholding
Taxes; |
| 5.2.2 | for Other
Personnel, all reasonable costs and expenses incurred by NV in connection with the NV Services
provided by such Other Personnel as mutually agreed between the Parties in writing, in advance,
including, for the avoidance of doubt, the wages |
and
benefits of such Other Personnel attributable to the period during which such Other Personnel provide the NV Services and any federal,
state, local or foreign Taxes owed by Company in respect of the payment of such wages or benefits, including any employer and/or withholding
Taxes; and
| 5.2.3 | any
and all costs and expenses (other than those covered by clauses 5.2.1 and 5.2.2) that are
directly related to the provision of the NV Services that are mutually agreed between the
Parties in advance and in writing, including reasonable expenses incurred in connection with
NV’s use of any consultants and permitted subcontractors (pursuant to clause 21.1),
such as reasonable travel, housing, logistics, daily allowances, project bonuses, expat packages
and other reasonable costs and expenses related to the preparation of the NV Services by
NV Personnel incurred prior to the Effective Date. |
| 5.3.1 | Upon
the achievement of each milestone event by NV set forth below (each, an “Operational
Milestone”), and subject to clause 5.3.2, Company shall pay to NV the corresponding
milestone-based fee (the “Operational Milestone Fee”) in accordance with
the payment schedule set out below: |
Operational
Milestone |
Operational
Milestone Fee |
Criteria
for demonstrating achievement of Operational Milestone |
Estimated
timeline for completion of Operational Milestone |
Build-up and transfer
of wet lab capable of conducting the wet-lab services described in Phase 4 of Schedule 2 (Scope of Services)
(“First Operational
Milestone”)
|
SAR
Twenty million (20,000,000.00) |
[***] |
[***] |
Accreditation of wet lab
and dry lab, with stand-alone Accreditation for Company
(“Second Operational
Milestone”)
|
SAR
Twenty million (20,000,000.00) |
[***] |
[***] |
| 5.3.2 | In the
event NV fails to achieve either Operational Milestone within the corresponding timeline
set forth above, and such failure is due to NV’s or NV’s Affiliates’ failure
to perform the applicable NV Services for a reason within NV’s control, Company shall
have the right to reduce the Operational Milestone Fee corresponding to such Operational
Milestone by: |
| (a) | fifteen percent (15%) if such
Operational Milestone is achieved more than three (3) months following the corresponding estimated timeline for completion set forth
above; and |
| (b) | an additional fifteen percent
(15%) if such Operational Milestone is achieved more than six (6) months following the corresponding estimated timeline for completion
set forth above. |
The
Parties agree that failure to meet any Operational Milestone for any of the following reasons shall not be deemed to be within NV’s
control:
| (i) | any negligent
acts or omissions taken by Company or any of its Affiliates in relation to the KSA Facility
under this Agreement; |
| (ii) | changes
to Applicable Law; |
| (iii) | any
actions by any Governmental Authority or Regulator in relation to the KSA Facility; or |
| (iv) | any Force
Majeure Event. |
| 5.3.3 | NV shall
only be entitled to submit an Invoice for the applicable Operational Milestone Fee for each
Operational Milestone after the corresponding criteria for achievement of such Operational
Milestone has been achieved. Any dispute as to the achievement of the relevant criteria shall
be dealt with in accordance with clause 33.2 of this Agreement. |
| 5.3.4 | Upon
the achievement by Company of each milestone event set forth below (each, a “Commercial
Milestone”), Company shall pay to NV the corresponding milestone-based fee (the
“Commercial Milestone Fee”, and together with the Operational Milestone
Fee, the “Fixed Performance Fee”) in accordance with the payment schedule
set out below: |
Commercial
Milestone |
Commercial
Milestone Fee |
Company achieving an annual
Net Revenue of SAR Two hundred million (200,000,000.00)
|
SAR
Forty million (40,000,000.00) |
Company achieving an annual
Net Revenue of SAR Three hundred million (300,000,000.00)
|
SAR
Forty million (40,000,000.00) |
Company achieving an annual
Net Revenue of SAR Four hundred and sixty million (460,000,000.00)
|
SAR
Forty million (40,000,000.00) |
Each Commercial
Milestone Fee will be payable only one time and upon the later of: (a) achievement of the applicable Commercial Milestone; and (b) achievement
of the Second Operational Milestone. The Commercial Milestone Fee will be paid within sixty (60) days of the achievement of the later
of clause (a) or (b).
| 5.3.5 | With
respect to any Commercial Milestone, NV shall only be entitled to submit an Invoice for the
applicable Commercial Milestone Fee for such Commercial Milestone after the corresponding
criteria for achievement of such Commercial Milestone has |
been
achieved in accordance with clause 5.3.4. Any dispute as to the achievement of the relevant criteria shall be resolved in accordance
with clause 33.2 of this Agreement.
| 5.3.6 | Subject
to any termination for cause by Company under clause 19.2, Company’s obligation to
pay the Commercial Milestone Fees shall survive the expiration or earlier termination of
this Agreement and shall be paid to Company when such Commercial Milestone has been achieved;
provided that if any Commercial Milestone is not achieved by the tenth (10th)
anniversary of the date of expiration or termination of this Agreement, NV shall no longer
be entitled to receive any such unpaid Commercial Milestone Fee and Company’s obligations
with respect to the payment thereof shall terminate. |
| 5.3.7 | NV shall
invoice Company on a monthly basis (each, an “Invoice”) for an amount
equal to: |
| (a) | the Project
Consultation Fee incurred by NV for the preceding month; and |
| (b) | any Fixed
Performance Fees payable to NV for the preceding month, |
together
with time sheets and details of actual costs and expenses incurred for the applicable NV Personnel to evidence that the amounts so invoiced
by NV are accurate. Each Invoice shall comply with local VAT requirements (either in KSA or Germany).
| 5.3.8 | Subject
to clause 5.3.10, Company shall pay to NV all undisputed amounts set forth in an Invoice
within thirty (30) days of Company’s receipt of the Invoice. |
| 5.3.9 | All payments
of the Project Consultation Fees from Company to NV shall be payable in Euros (EUR). All
payments of the Fixed Performance Fees from Company to NV shall be payable in Saudi Arabian
Riyals (SAR). The Fees shall be paid by wire transfer in immediately available funds into
such bank account nominated by NV to Company in writing prior to the relevant payment of
the Fees. Company shall be liable for all bank charges relating to such wire transfers for
the Fees. |
| 5.3.10 | Company
may withhold payment of any part of an Invoice that it disputes in good faith. Company and
NV will establish a working level committee and a process to address any dispute that Company
has about an Invoice. Company shall pay any undisputed portion of an Invoice as provided
in this clause 5. If a Dispute about an Invoice is not resolved within thirty (30) days of
Company’s receipt of the Invoice, then it will be resolved pursuant to the Dispute
resolution procedures set out in clause 33.2 of this Agreement. |
| 5.3.11 | Company
may set-off any amounts due from NV or its Affiliates to Company pursuant to any agreement
between Company and NV or its Affiliates, against any charges or expenses payable by Company
to NV or its Affiliates. For the avoidance of doubt, any set-off shall not impact the obligations
of a Party under clause 6. |
| 5.3.12 | If any
undisputed payment due to NV under this Agreement is not paid by the applicable due date,
NV may charge Company interest on any outstanding amount of such payment, accruing as of
the original due date, at an annual rate equal to the prime rate (as reported in The Wall
Street Journal (U.S. edition)) plus one percentage point (1%) or the maximum rate allowable
by Applicable Law, whichever is less. |
| 6.1 | Without prejudice
to the generality of clause 6.2 below, the Fees payable in accordance with this Agreement
shall be exclusive of any additional Taxes, levies or fees that may apply to the provision
of the NV Services. Any such Taxes, levies or fees shall be payable in addition to, and at
the same time and in the same manner as, the Fees against provision by NV to Company of an
invoice for the same; provided that Company shall only be responsible for withholding
taxes if NV does not have a permanent establishment in KSA. Any additional Taxes shall not
include any taxes, levies or fees applicable to NV for a taxable presence in KSA relating
to a permanent establishment for corporation income tax. Any Taxes relating to the permanent
establishment of NV shall be solely borne by NV and not Company. |
| 6.2 | All amounts,
monetary or otherwise, expressed under this Agreement which (in whole or in part) constitute
the consideration for any supply for VAT purposes by NV are deemed to be exclusive of any
VAT which is chargeable on that supply, and accordingly if VAT is or becomes chargeable on
any supply made by NV to any Party under this Agreement and NV is required to account to
the relevant tax authority for VAT on that supply, Company must pay to NV (in addition to
and at the same time as paying any other consideration for such supply, or at the point the
VAT becomes due to be paid or accounted for by NV if earlier) an amount equal to the amount
of that VAT (and NV must promptly provide an appropriate VAT invoice to Company where so
required to by Applicable Law). In this clause 6.2, references to “NV” shall
include reference to a relevant Affiliate of NV. NV shall provide a valid tax invoice to
Company. |
| 6.3 | In relation
to any supply made by NV (or a relevant Affiliate) to Company under this Agreement, if reasonably
requested by Company, NV must promptly provide Company with details of NV’s (or the
relevant Affiliate’s) VAT registration and such other information as is reasonably
requested in connection with Company’s VAT reporting requirements in relation to such
supply. |
| 6.4 | The following
provisions shall apply should any payment in respect of any Fees from Company to NV be subject
by Applicable Law to any deduction or withholding on account of Tax: |
| 6.4.1 | The Tax
Deduction will be made in the minimum amount permitted by Applicable Law and Company shall
account to the relevant tax authority for the same, in full and within all applicable time
limits; provided that any late payment fees or penalties associated with Company’s
failure to comply with this clause 6.4.1 shall be borne solely by Company. |
| 6.4.2 | Company
shall provide evidence, reasonably satisfactory to NV, of the Tax Deduction and any relevant
payment to a tax authority on written request from NV to Company. |
| 6.4.3 | NV shall
(or shall procure that a relevant Affiliate shall), on written request from Company, provide
a declaration of Tax residence on the prescribed forms and obtain certification by the relevant
taxation authority in order to confirm the applicability and availability of any reduced
rate of withholding on account of Tax, pursuant to the provisions of any relevant double
taxation treaties or otherwise. |
| 6.4.4 | If a
Tax Deduction is required by Applicable Law to be made by Company in relation to any payment
in respect of the Fees, the amount of the payment due from Company shall be increased to
an amount which (after making any Tax Deduction) leaves an amount equal to the payment which
would have been received if no Tax Deduction had been required. |
| 6.4.5 | If Company
has been obliged to make an increased payment under clause 6.4.4 in respect of a Tax Deduction
and NV determines that: |
| (a) | a Tax Credit
is attributable to that payment, or to the relevant Tax Deduction; and |
| (b) | that NV (or
a relevant Affiliate) has obtained and utilized that Tax Credit, |
then NV
shall pay to Company an amount (or procure the payment by the relevant Affiliate of an amount to Company) which NV determines will leave
it (or the relevant Affiliate), after that payment, in the same after-Tax position as it would have been had no increased payment under
clause 6.4.4 been required to be made by Company.
| 6.5 | Company shall
report and pay VAT directly to the relevant KSA tax authority to the extent that the amounts
charged by NV to Company under this Agreement are subject to VAT under the Applicable Laws
of KSA. Notwithstanding any other provision of this clause 6 or this Agreement, in relation
to any Taxes that NV may incur related to the registration of NV as a permanent establishment
in KSA, NV shall notify Company of such Taxes, comply with any requirements under Applicable
Law and follow all necessary compliance and registration requirements. NV shall bear any
associated costs including any Taxes, fines or penalties from a Governmental Authority, or
Regulatory Authority. |
NV shall
ensure that the NV Services are provided:
| 7.1.1 | as soon
as reasonably possible upon commencement of this Agreement in accordance with, and given
the nature and extent of the relevant NV Services as described in, Schedule 2 (Scope of
Services), with a goal of assisting Company to operate the KSA Facility in a manner that
achieves provision of services substantially similar to those provided at the NV Facility
and similar sized global biodatabanks; |
| 7.1.2 | using
substantially similar levels of skill and care used by NV and its Affiliates in the NV Facility
and in a professional manner, by properly trained and qualified NV Personnel; |
| (a) | the KSA Facility
License; |
| (b) | Good Laboratory
Practice with respect to NV Services relating to laboratory services; |
| (c) | Good Industry
Practice with respect to all other NV Services; |
| (d) | Schedule 3
(Personal Data and Information Security); |
| (e) | Schedule 4
(Staffing and Secondment); and |
| (f) | other reasonable
Company policies as notified by Company reasonably in advance from time to time in writing. |
| 7.2 | Observance of Islamic Tradition |
NV hereby:
| 7.2.1 | acknowledges
that society in KSA is based on Islamic beliefs, conventions, customs and traditions; and |
| 7.2.2 | to the
extent any NV Personnel are visiting the premises at the KSA Facility or any other Company
facility, NV will direct them to comply with reasonable policies regarding such beliefs,
conventions, customs and traditions, as accepted in writing by NV to be applicable hereunder. |
| 8.1.1 | cooperate
in good faith with the other Party and subject to clause 14 of this Agreement, make such
information available to the other Party so as to enable such Party to perform its obligations
under this Agreement, where such information is in its possession and is disclosable, within
the time periods specified herein or, where no time period is specified, within a reasonable
time period; and |
| 8.1.2 | act in
a cooperative manner in dealing with the other Party in connection with this Agreement. |
| 8.2 | With respect to Company’s
professional advisors, or other third parties engaged by or on behalf of Company: |
| 8.2.1 | NV shall
provide commercially reasonable cooperation required by Company’s professional advisors,
or other third parties engaged by or on behalf of Company, in connection with the performance
of the NV Services and shall use all Commercially Reasonable Efforts to perform its obligations
under this Agreement in a manner that does not materially obstruct, disrupt or delay the
performance of services or works by such professional advisors, or other third parties engaged
by or on behalf of Company. NV and any NV Personnel shall consult with any such professional
advisors and other third parties as necessary in connection with the provision of relevant
NV Services. |
| 8.2.2 | Company
shall require its professional advisors and other third parties engaged by or on behalf of
Company in connection with the operation of the KSA Facility to provide commercially reasonable
cooperation with NV and use all Commercially Reasonable Efforts to perform their obligations
in a manner that does not materially obstruct, disrupt or delay the provision of NV Services
by NV. Company shall use Commercially Reasonable Efforts to require such professional advisors
and other third parties to consult with NV as necessary in connection with the performance
of relevant NV Services. |
| 8.3 | Each Party shall promptly notify
the other Party in writing if it becomes aware of an act or omission of a professional advisor or third-party supplier engaged by Company
which may cause a material problem or delay in providing the NV Services. In such a case, each Party shall to the extent it is reasonably
able, work with the other Party and such professional advisor or third-party supplier to prevent, resolve or circumvent such problem
or delay, at Company’s sole cost and expense. |
NV
agrees to use Commercially Reasonable Efforts to make available certain categories of NV Personnel to Company in accordance with Schedule
4 (Staffing and Secondment).
| 10. | Data Protection
AND CYBERSECURITY |
| 10.1 | To the extent
NV or Company collects, stores, hosts or otherwise processes Personal Data in connection
with this Agreement, NV and Company shall comply with Applicable Data Protection Laws. |
| 10.2 | To the extent
NV collects, stores, hosts or otherwise processes Personal Data on behalf of Company in connection
with the performance of the NV Services set out in Schedule 2 (Scope of Services)
as a data processor (as defined in the GDPR), the data processing clauses set forth in Schedule
3 (Personal Data and Information Security) shall apply and Part B of Schedule 3 (Personal
Data and Information Security) shall also apply to the extent NV collects, stores, hosts
or otherwise processes Personal Data on behalf of Company as a data processor and such processing
is subject to the KSA PDPL. |
| 10.3 | To the extent
that the performance of the NV Services set out in Schedule 2 (Scope of Services)
entail data processing operations which do not qualify as a controller-to-processor relationship
under Article 28 of the GDPR, the Parties undertake to negotiate in good faith and enter
into any further data protection related agreement to the extent such an agreement is necessary
to comply with the GDPR and/or any other Applicable Data Protection Laws, such as the KSA
PDPL, prior to the commencement of the respective NV Services. |
| 10.4 | The Parties
further agree to negotiate in good faith modifications to this Agreement, including Schedule
3 (Personal Data and Information Security), if changes are required for the Parties
to continue to process Personal Data as contemplated by this Agreement in compliance with
Applicable Data Protection Laws or to address the legal interpretation of Applicable Data
Protection Laws, including: |
| 10.4.1 | to comply
with the KSA PDPL, including any guidance issued by a Regulatory Authority; |
| 10.4.2 | to comply
with applicable international Personal Data transfer requirements; and |
| 10.4.3 | to obtain
authorisation or approval from a Regulatory Authority prior to transferring Personal Data
outside of the relevant jurisdiction if such authorisation or approval is required. |
| 10.5 | To the extent
NV collects, stores, hosts or otherwise processes Personal Data on behalf of Company in connection
with the performance of the NV Services set out in Schedule 2 (Scope of Services),
NV shall comply with the cybersecurity requirements set forth below: |
| 10.5.1 | Notify
Company without undue delay and in any event within 48 hours of becoming aware of a breach
of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised
disclosure of, or access to, such Personal Data; |
| 10.5.2 | Reasonably
comply with Company organisational policies and procedures regarding cybersecurity, as provided
to NV in writing and in advance from time to time; and |
| 10.5.3 | Process
such Personal Data in accordance with laws relating to cybersecurity and cloud computing,
including as issued by Regulatory Authorities such as the National Cybersecurity Authority
and the Communications, Space and Technology Commission. |
| 11.1 | This Agreement
shall come into effect on the Effective Date, and, unless terminated earlier in accordance
with clause 19 of this Agreement, shall remain in full force and effect for a period of ten
(10) years so long as the Joint Venture Agreement has not been terminated (the “Term”)
or shall terminate simultaneously with the Joint Venture Agreement (it being understood that
each NV Service, and NV’s obligations with respect thereto, shall terminate upon the
earlier of: |
| 11.1.1 | the
expiration of the Term; |
| 11.1.2 | termination
of this Agreement; and |
| 11.1.3 | completion
of such NV Service based on objective criteria, including as applicable, with respect to
Accreditation, or the end of the applicable time periods set forth on Schedule 2 (Scope
of Services)). |
| 12. | Representations
and Warranties |
12.1
Each Party represents, warrants and undertakes to the other Party that:
| 12.1.1 | it has
the capacity, power and authority to enter into this Agreement; |
| 12.1.2 | the
persons executing this Agreement have been duly authorized to do so; |
| 12.1.3 | once
duly executed, this Agreement shall constitute its legal, valid and binding obligations and
shall not violate the terms of any other agreement or judgement or court order to which it
is bound; |
| 12.1.4 | it shall
comply in all material respects with all Applicable Laws in the course of performing its
obligations and exercising its rights under this Agreement; and |
| 12.1.5 | in the
performance of its obligations under this Agreement, it will not take any action that causes
either Party to violate or otherwise become exposed to penalties under any ABC Laws or Applicable
Export Control or Economic Sanctions Programs. |
| 12.2 | NV represents,
warrants and undertakes to Company that: |
| 12.2.1 | as of
the Effective Date, NV Personnel: |
| (a) | have not been
debarred or subject to debarment or, to NV’s knowledge, convicted of a crime for which
a person could be debarred before a Regulatory Authority under Applicable Law; or |
| (b) | to NV’s
knowledge, have not ever been under indictment for a crime for which a person could be debarred
under such Applicable Law. |
| 12.2.2 | to NV’s
knowledge, as of the Effective Date, there are no pending, and NV and/or its Affiliates have
not received written notice threatening any adverse Claims against NV or its Affiliates that
would have a material impact on NV’s ability to provide the NV Services; |
| 12.2.3 | as of
the Effective Date, NV has furnished or made available to Company or its agents or representatives
all material information that is responsive to diligence requests from Company and its agents
or representative and is in NV’s or any of its Affiliates’ possession concerning
the NV Services (including material information relating to |
the
safety or efficacy of such NV Services and all material regulatory filings, permits and approvals);
| 12.2.4 | as of
the Effective Date, NV and its Affiliates have conducted all research and development, clinical
and laboratory services in accordance in all material respects with all Applicable Laws;
and |
| 12.2.5 | any
regulatory filing filed by NV or its Affiliates with respect to the NV Services prior to
the Effective Date, such as with the NV Facility’s CAP/CLIA certification, and regulatory
permits and approvals obtained prior to the Effective Date were true and accurate in all
material respects. |
| 13. | Intellectual
Property Rights |
| 13.1 | Nothing in this Agreement shall
operate to transfer ownership of or grant a license to: |
| 13.1.1 | any
Intellectual Property Rights belonging to either Party or any of such Party’s Affiliates,
including, without limitation: |
| (a) | any Intellectual
Property Rights belonging to a Party or any of its Affiliates on or prior to the Effective
Date, including, without limitation, any Know-How that is included in the NV Services; |
| (b) | any Intellectual
Property Rights in any items which are developed or acquired by a Party or any of its Affiliates
independently of this Agreement; or |
| (c) | any Intellectual
Property Rights developed or acquired by a Party or any of its Affiliates in performing its
obligations under this Agreement, |
it being
understood that any license to any such Intellectual Property Rights required for the provision or receipt of the NV Services is addressed
in the Technology Transfer and Intellectual Property License Agreement.
| 14. | Confidential
information |
| 14.1 | Each Party
(the “Recipient”) acknowledges that it may receive Confidential Information
that has been created, discovered or developed by the other Party (the “Provider”). |
| 14.2 | The Recipient undertakes to the
Provider to: |
| 14.2.1 | hold
all Confidential Information which it obtains in relation to this Agreement in strict confidence
and will take all necessary measures to preserve the confidentiality of the Confidential
Information; |
| 14.2.2 | not
disclose, or authorize the disclosure of, Confidential Information to any third party other
than pursuant to clauses 14.4 or 14.6; |
| 14.2.3 | not
use, or authorize anyone to use, Confidential Information for any purpose other than the
performance of its obligations pursuant to this Agreement, or the exercise of its rights
or receipt of any benefits under this Agreement; and |
| 14.2.4 | promptly
notify the Provider of any suspected or actual unauthorized use or disclosure of Confidential
Information for which the Recipient is responsible and of which the Recipient becomes aware
and promptly take all Commercially Reasonable Efforts that Recipient may require in order
to prevent, stop or remedy the unauthorized use or disclosure. |
| 14.3 | To the extent NV is the Recipient
of Company Confidential Information, NV undertakes to: |
| 14.3.1 | Remove
such Confidential Information from NV systems at the end of the NV Services; provided
that such removal does not violate or otherwise conflict with Applicable Law; |
| 14.3.2 | Process
such Confidential Information in accordance with Company organisational policies and procedures
regarding cybersecurity, as provided to NV in writing and in advance from time to time; and |
| 14.3.3 | Process
such Confidential Information in accordance with KSA laws relating to cybersecurity and cloud
computing, including as issued by Regulatory Authorities such as the National Cybersecurity
Authority and the Communications, Space and Technology Commission, to the extent applicable. |
| 14.4 | The Recipient
may disclose Confidential Information to its Affiliates and its and their respective officers,
directors, employees, contractors, advisors and auditors, but only to the extent, and provided,
that such persons: |
| 14.4.1 | need
to know the Confidential Information disclosed to them; |
| 14.4.2 | have
been informed of the confidential nature of the Confidential Information and the purpose
for which it may be lawfully used; and |
| 14.4.3 | comply
with the terms of this clause 14 of this Agreement in respect of the Confidential Information
disclosed to them. |
| 14.5 | Clause 14.1 shall not apply to
Confidential Information to the extent that: |
| 14.5.1 | such
Confidential Information has been placed in the public domain other than through the fault
of the Recipient; |
| 14.5.2 | such
Confidential Information was at the time of receipt, publicly available; |
| 14.5.3 | such
Confidential Information has been independently developed without reference to the Confidential
Information, as established by independent evidence; or |
| 14.5.4 | the
Provider has approved in writing the particular use or disclosure of the Confidential Information. |
| 14.6 | The Recipient
also may disclose Confidential Information if, and solely to the extent that, it is required
to do so by any Governmental Authority or Regulator or otherwise as required by Applicable
Law. Where Recipient is required to disclose Confidential Information relating to itself
in accordance with this clause 14.6, it shall: |
| 14.6.1 | to the
extent that it is able to do so and is not prohibited by Applicable Law, notify the Provider
in writing as soon as practicable upon becoming aware of the obligation to disclose, prior
to such disclosure; and |
| 14.6.2 | to the
extent it is able to do so, cooperate with the Provider in avoiding or limiting the disclosure
to that portion of the Confidential Information which it is legally required to furnish and
obtaining assurances as to confidentiality from the body to whom the Confidential Information
is to be disclosed. |
| 14.7 | Where a Party collects, processes,
stores or hosts Company Data or NV Data, it shall comply with the provisions of Schedule 3 (Personal Data and Information Security). |
| 14.8 | Subject to
the express provision of this clause 14, each Party shall maintain and shall procure that
its Affiliates and contractors maintain the confidentiality of the existence and terms of
the negotiations between the Parties and of this Agreement and of the services provided pursuant
to this Agreement and any other Project Document. Each Party shall not and shall procure
that each of its Affiliates and contractors and subcontractors shall not, issue any press
release or other public statement relating to the existence or content of this Agreement
or any other Project Document without the prior written approval of the other Party. |
| 14.9 | Subject to requirements under
Applicable Law, the obligations with respect to Confidential Information shall survive the termination or expiry of this Agreement and
shall apply for five (5) years from such termination or expiration of this Agreement. |
| 14.10 | Subject to the requirements set
forth in clause 14.4, either Party shall be able to disclose any materials relating to the provision or receipt of the NV Services or
this Agreement to investors for the purpose of evaluation of such Party. |
| 15.1 | NV shall
defend, indemnify and hold harmless Company and its respective employees, personnel, consultants,
agents, contractors and subcontractors (each a “Company Indemnitee”),
during the Term and, solely to the extent arising within the applicable statute of limitations
period allowed under Applicable Law, thereafter in respect of any Indemnified Losses to the
extent the same are assessed against, or incurred by, a Company Indemnitee in respect of
the following: |
| 15.1.1 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a Company Indemnitee
to the extent directly caused by NV’s material breach of this Agreement; |
| 15.1.2 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a Company Indemnitee
related to the NV Services to the extent directly caused by NV’s gross negligence or
Wilful Misconduct; |
| 15.1.3 | any
Claims brought against a Company Indemnitee arising out of or in connection with a material
breach by NV in relation to the performance of the NV Services other than Claims directly
caused by Company’s or its Affiliates’ gross negligence, fraud or Wilful Misconduct; |
| 15.1.4 | any
Claims brought against a Company Indemnitee in respect of death or bodily injury occurring
in the performance of the NV Services for which it is finally determined by a court of competent
jurisdiction that NV is legally liable or responsible; |
| 15.1.5 | any
Claims brought against a Company Indemnitee in respect of any damage, loss or destruction
of any real or tangible property owned by Company occurring in the performance of the NV
Services for which it is finally determined by a court of competent jurisdiction that NV
is legally liable or responsible for that damage, loss or destruction; |
| 15.1.6 | any
Claims brought against a Company Indemnitee arising out of failure of NV to comply with its
obligations to provide payment or benefits to any NV Personnel; |
| 15.1.7 | any
Claims brought against a Company Indemnitee arising out of, or in connection with, any acts
of fraud, fraudulent misrepresentation or theft by NV; |
| 15.1.8 | any
Claims brought against a Company Indemnitee arising out of, or in connection with, any material
breach by NV of any ABC Laws in the performance of this Agreement; and |
| 15.1.9 | any
Claims brought against a Company Indemnitee arising out of a breach by NV of its obligations
under clause 14 of this Agreement. |
| 15.2 | For the purpose
of interpreting clause 15.1, any reference to an act or omission of NV shall also include
relevant acts or omissions of any NV Personnel, NV’s Affiliates, subcontractors of
NV (pursuant to clause 21.1 of this Agreement) and their relevant personnel. |
| 15.3 | Company shall
defend, indemnify and hold harmless NV and its respective employees, personnel, consultants,
agents, contractors and subcontractors (each a “NV Indemnitee”), during
the Term and, solely to the extent arising within the applicable statute of limitations period
allowed under Applicable Law, thereafter, in respect of any Indemnified Losses to the extent
the same are assessed against, or incurred by a NV Indemnitee in respect of the following: |
| 15.3.1 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a NV Indemnitee
to the extent directly caused by Company’s material breach of this Agreement; |
| 15.3.2 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a NV Indemnitee
to the extent directly caused by Company’s gross negligence or Wilful Misconduct; |
| 15.3.3 | any
Claims brought against an NV Indemnitee arising out of or in connection with a material breach
by Company of this Agreement other than Claims directly caused by NV’s or its Affiliates’
gross negligence, fraud or Wilful Misconduct; |
| 15.3.4 | any
Claims brought against a NV Indemnitee in respect of death or bodily injury occurring in
the context of this Agreement for which it is finally determined by a court of competent
jurisdiction that Company is legally liable or responsible; |
| 15.3.5 | any
Claims brought against a NV Indemnitee in respect of any damage, loss or destruction of any
real or tangible property occurring in the context of this Agreement for which it is finally
determined by a court of competent jurisdiction that Company is legally liable or responsible
for that damage, loss or destruction; |
| 15.3.6 | any
Claims brought against a NV Indemnitee arising out of, or in connection with, any acts of
fraud, fraudulent misrepresentation or theft by Company; |
| 15.3.7 | any
Claims brought against a NV Indemnitee arising out of, or in connection with, any material
breach by Company of any ABC Laws in the performance of this Agreement; and |
| 15.3.8 | any
Claims brought against a NV Indemnitee arising out of a breach by Company of its obligations
under clause 14 of this Agreement. |
| 15.4 | For the purpose of interpreting
clause 15.3, any reference to an act or omission of Company shall also include relevant acts or omissions of any Company Personnel, Company’s
Affiliates, subcontractors of Company and their relevant personnel. |
| 15.5 | Upon a third
party threatening or bringing a Claim in respect of which a Party has a legal obligation
to indemnify pursuant to this Agreement, the Indemnitee shall notify the Indemnitor as soon
as reasonably practicable upon becoming aware of the Claim (it being understood that any
failure to so notify the Indemnitor of such Claim shall not relieve the Indemnitor of its |
indemnification
obligations except to the extent the Indemnitor is adversely prejudiced by such failure) and:
| 15.5.1 | the
Indemnitor shall, at its own expense, defend the Claim and have sole control of the conduct
of the defence and settlement of the Claim; provided, that the Indemnitee shall have
the right to: |
| (a) | where appropriate,
participate in any defence and settlement, such participation to be at the Indemnitor’s
own cost and in any event the Indemnitor shall remain in control of the conduct of the defence; |
| (b) | review
the terms of any settlement and approve any wording which relates to an admission of liability
on the part of the Indemnitee, the payment of any consideration by Indemnitee or which the
Indemnitee reasonably believes may impact the Indemnitee’s reputation and may veto
any such proposed settlement in respect of the Indemnitee and any such settlement or admission
(including its terms) shall be subject to confidential treatment by both Parties; and |
| (c) | join the
Indemnitor as a defendant in legal proceedings arising out of the Claim. |
| 15.5.2 | the
Indemnitee shall: |
| (a) | not make
any admissions (except under compulsion of Applicable Law), agree to any settlement or otherwise
compromise the defence or settlement of the Claim without the prior written approval of the
Indemnitor; and |
| (b) | give, at
the Indemnitor’s request and cost, all reasonable assistance in connection with the
defence and settlement of the Claim. |
| 15.5.3 | If the
Indemnitor does not elect to defend the Claim or does not, following such election, actively
defend the Claim, then: |
| (a) | the Indemnitee
shall have the right to defend or settle the Claim in the manner it considers appropriate,
at the cost of the Indemnitor (including in respect of any Indemnified Losses for which the
Indemnitor is liable pursuant to the indemnity given under clause 15 and reasonable legal
costs); and |
| (b) | the Indemnitor
shall give, at Indemnitee’s request, all reasonable assistance in connection with the
conduct of the defence and settlement of the Claim at the cost of the Indemnitor. |
| 15.6 | This clause
15 shall remain in full force and effect notwithstanding any termination or expiry of this
Agreement. |
| 15.7 | Notwithstanding anything to the
contrary, in no event shall Company be entitled to recover from NV under both this Agreement and any other Project Document for the same
Losses. |
| 16. | Limitation
of Liability |
| 16.1 | Nothing in
this Agreement shall exclude or limit the liability of either NV Group or Company Group for: |
| 16.1.1 | fraud
(including fraudulent misrepresentation); |
| 16.1.2 | death
or personal injury due to gross negligence; |
| 16.1.3 | Wilful
Misconduct; or |
| 16.1.4 | any
other liability which cannot be excluded or limited by Applicable Law. |
| 16.2 | Subject to clauses 16.1, 16.3
and 16.4 each of NV Group and Company Group: |
| 16.2.1 | shall
only be liable for direct loss arising in relation to a breach of this Agreement; and |
| 16.2.2 | shall
not be liable for any loss of profits, loss of business opportunity, or any indirect or consequential
loss arising under or in relation to this Agreement whether as a result of breach of contract,
tort (including negligence), breach of statutory duty or otherwise. |
| 16.3 | Except for
a Claim for breach of an obligation to pay amounts due pursuant to this Agreement and subject
to clauses 16.1 and 16.2, each Party’s total aggregate liability to the other Party
and its Affiliates, whether based on an action or Claim in contract, tort (including negligence),
breach of statutory duty or otherwise arising out of, or in relation to, this Agreement shall
be limited to ten million Euros (€10,000,000.00). |
| 16.4 | Each Party
acknowledges its general duty to reasonably mitigate any Losses incurred in relation to this
Agreement and, in any case, each Party shall reasonably mitigate any Losses incurred by it
in relation to this Agreement. |
| 16.5 | Each Party
shall be relieved from liability for not performing its directly affected obligations (other
than payment obligations not under Dispute) pursuant to this Agreement if, and to the extent
a Force Majeure Event occurs, in which case relief shall be provided pursuant to clause 17. |
| 16.6 | This clause
16 shall remain in full force and effect notwithstanding any termination or expiry of this
Agreement. |
17.1
Neither Party shall be liable for failure or delay in performing any of its obligations (other than any payment obligations) under
or pursuant to this Agreement if such failure or delay is due to any cause whatsoever outside its reasonable control and which by the
exercise of due diligence such Party is unable to prevent or overcome, including:
| 17.1.2 | flood,
fire, earthquake or explosion; |
| 17.1.3 | war,
invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or
other civil unrest; |
| 17.1.5 | government
actions, embargoes, Sanctions or blockades in effect on or after the date of this Agreement; |
| 17.1.6 | action
by any Governmental Authority or Regulator (including regulatory changes); provided, that
the Party relying on the government act or omission as a reason for delay in performance
did not, directly or indirectly, procure or induce such government act or omission; |
| 17.1.7 | national
emergency; |
| 17.1.8 | pandemics
or epidemics; and |
| 17.1.9 | strikes,
labour stoppages, or other industrial disturbances, |
(each
a “Force Majeure Event”) and the affected Party shall be relieved from its liability hereunder during the period of
such Force Majeure Event and the other Party may terminate this Agreement in accordance with clause 19 if such Force Majeure Event continues
for more than one hundred and eighty (180) days. The affected Party shall, in any event, use reasonable endeavours to avoid or mitigate
the effect of such events so as to recommence performance of their obligations as soon as reasonably possible following the Force Majeure
Event no longer applying.
| 18.1 | Subject to
the last sentence of this clause 18.1, NV undertakes that NV will obtain, pay for, and maintain
during the Term, at its own expense, and to the extent the same is available on commercially
reasonable terms, a policy or policies of insurance in line with Applicable Law, Good Industry
Practice and standards applicable to an operator of laboratory services and a biodatabank
of similar size from reputable insurance providers in connection with the NV Services and
the NV Personnel. The requirements stated in this clause 18.1 shall not be construed in any
way as a limit to NV’s liability under this Agreement or as constituting any waiver
by Company of any of its rights or remedies under this Agreement. Company acknowledges that
NV may meet these obligations by self-insuring against such risks. |
| 18.2 | NV shall provide written notice
to Company prior to any material modification, cancellation or non-renewal of any such policies, as is consistent with the relevant policy
provisions. |
| 18.3 | If there is Loss, damage or other
event that requires notice or other action under the terms of any insurance coverage specified in clause 18.1, NV shall be solely responsible
for taking such action. |
| 18.4 | Subject to
the last sentence of this clause 18.4, Company undertakes to obtain, pay for, and maintain
during the Term, at its own expense, and to the extent the same is available on commercially
reasonable terms a policy or policies of insurance (including professional indemnity, third
party liability, property and cybersecurity insurance) from reputable insurance providers
in connection with the KSA Facility and Company Personnel pursuant to this Agreement. The
insurance shall cover Company against potential liabilities under or in relation to this
Agreement; provided, that the requirements stated in this clause 18.4 shall not be
construed in any way as a limit to Company’s liability under this Agreement or as constituting
any waiver by NV of any of its rights or remedies under this Agreement. NV acknowledges that
Company may meet these obligations by self-insuring against such risks. |
| 18.5 | Company shall provide written
notice to NV prior to any material modification, cancellation or non-renewal of any such policies, as is consistent with the relevant
policy provisions. |
| 18.6 | If there is Loss, damage or other
event that requires notice or other action under the terms of any insurance coverage specified in clause 18.4, Company shall be solely
responsible for taking such action. |
| 18.7 | Each of Company’s and NV’s
obligations specified in this clause 18 shall not limit or expand in any way the other liabilities and obligations assumed by Company
and NV, respectively, under this Agreement. |
| 19.1 | Termination for Convenience |
Company
may terminate this Agreement or any affected part of the NV Services for any reason by giving nine (9) months’ prior written notice
to NV; provided that Company may not send any notice terminating this Agreement pursuant to this clause 19.1 prior to two and
a half (2.5) years from the Effective Date.
| 19.2 | Termination
for Cause by Company |
Company
may terminate this Agreement with immediate effect by written notice to NV if:
| 19.2.1 | NV is
in material breach of any of its obligations under this Agreement and either that breach
is not capable of remedy or, if the breach is capable of remedy, NV has failed to remedy
such breach within sixty (60) days (unless a shorter remedy period applies hereunder) after
receiving written notice requiring it to remedy the relevant breach; provided that,
no event of default shall be deemed to have occurred hereunder if such breach cannot reasonably
be cured within such sixty (60) day period and NV has commenced and is diligently pursuing
such cure within such sixty (60) day period, in which case NV shall have an additional period
of time (not to exceed one hundred and twenty (120) days after receipt of written notice
of such default) to cure such default and Company may not terminate this Agreement during
such period; |
| 19.2.2 | NV Abandons
the provision of the NV Services and NV has failed to remedy such Abandonment within forty-five
(45) days after receiving written notice requiring it to remedy such Abandonment; |
| 19.2.3 | NV is
unable to pay its debts as they fall due or an order is made or a resolution passed for the
administration, winding-up or dissolution of NV (other than for the purposes of a solvent
amalgamation or reconstruction) or an administrative or other receiver, manager, liquidator,
administrator, trustee or similar officer is appointed over all or any substantial part of
the assets of NV; |
| 19.2.4 | NV or
any of its Affiliates providing NV Services hereunder is in material breach of clause 26
or 27; |
| 19.2.5 | NV enters
into or proposes any composition or arrangement with its creditors generally or anything
analogous to the foregoing occurs in the Netherlands; |
| 19.2.6 | NV ceases
to be authorized to exist as a legal entity under Applicable Law; or |
| 19.2.7 | there
is an NV Change of Control (as defined in the Joint Venture Agreement). |
| 19.3 | Termination for Cause by NV |
NV may
terminate this Agreement with immediate effect by written notice to Company if:
| 19.3.1 | Company
is in material breach of any of its obligations under this Agreement and either that breach
is not capable of remedy or, if the breach is capable of remedy, Company has failed to remedy
such breach within sixty (60) days (unless a shorter remedy period applies hereunder) after
receiving written notice requiring it to remedy the relevant breach; provided that,
no event of default shall be deemed to have occurred hereunder if such breach cannot reasonably
be cured within such sixty (60) day period and Company has commenced and is diligently pursuing
such cure within such sixty (60) day period, in which case Company shall have an additional
period |
of
time (not to exceed one hundred and twenty (120) days after receipt of written notice of such default) to cure such default and NV may
not terminate this Agreement during such period;
| 19.3.2 | notwithstanding
clause 19.3.1, Company fails to pay any undisputed amounts due under this Agreement within
thirty (30) Business Days of written demand by Formal Notice to Company for such payment
or Company fails to pay any Disputed amount within thirty (30) Business Days of such Disputed
payments being agreed; |
| 19.3.3 | Company
is unable to pay its debts as they fall due, or an order is made, or a resolution passed
for the administration, winding-up or dissolution of Company (otherwise than for the purposes
of a solvent amalgamation or reconstruction), or an administrative or other receiver, manager,
liquidator, administrator, trustee or similar officer is appointed over all or any substantial
part of the assets of Company; |
| 19.3.4 | Company
or any of its Affiliates is in material breach of clause 26 or 27; |
| 19.3.5 | Company
enters into or proposes any composition or arrangement with its creditors generally or anything
analogous to the foregoing occurs in KSA; or |
| 19.3.6 | Company
ceases to be authorized to exist as a legal entity under Applicable Law. |
This
Agreement will terminate automatically upon termination of the Joint Venture Agreement.
| 19.5 | Termination without need for Judicial
Order |
If a
Party terminates this Agreement pursuant to this clause 19, such Party shall be entitled to do so without first obtaining judgment from
the courts of KSA or any other competent authority.
| 19.6 | Consequence of Expiry or Termination |
| 19.6.1 | Upon
expiry or termination, as the case may be, of this Agreement, NV shall: |
| (a) | comply with its obligations under
clause 14; |
| (b) | promptly deliver to Company, upon
its request, any outstanding deliverables prepared by NV in the context of its provision of the NV Services under this Agreement and
that are in NV’s possession or under NV’s control; provided, that Company has paid to NV all outstanding Fees (except
to the extent Disputed in good faith) that are payable on or prior to the date of such expiry or termination; |
| (c) | subject to
the terms of the Technology Transfer and Intellectual Property License Agreement and licenses
granted thereunder, promptly return to Company, any Company Confidential Information and
any other assets or property of Company, in each case, then in possession of NV held or maintained
by NV as of the effective date of such termination or expiration; provided, however,
that NV may continue to retain a copy of Company Confidential Information and use it as permitted
under clause 14; and |
| (d) | subject to
the terms of the Technology Transfer and Intellectual Property License Agreement, stop using,
or allowing the use of, any of Company’s trademarks, logos, devices, symbols, brands
or other similar items (whether registered or unregistered) used by or licensed to NV. |
| 19.6.2 | Upon
expiry or termination, as the case may be, of this Agreement, Company shall: |
| (a) | immediately
pay to NV all outstanding Fees (except to the extent Disputed in good faith) payable prior
to the date of such expiry or termination; |
| (b) | subject to
the terms of the Technology Transfer and Intellectual Property License Agreement, promptly
return to NV, any NV Confidential Information and any other assets or property of NV, in
each case, then in possession of Company held or maintained by Company as of the effective
date of such termination or expiration; provided, however, that Company may continue
to retain a copy of Company Confidential Information and use it as permitted under clause
14; |
| (c) | subject to
the terms of the Technology Transfer and Intellectual Property License Agreement, stop using,
or allowing the use of, any of NV’s trademarks, logos, devices, symbols, brands or
other similar items (whether registered or unregistered) used by or licensed to Company;
and |
| (d) | comply with
its obligations under clause 14. |
| 19.7.1 | NV shall
ensure that, upon termination (other than any termination for cause by NV pursuant to clause
19.3) or expiry of this Agreement, a transfer of the NV Services to Company shall take place
in accordance with the Transition Plan. No later than twelve (12) months prior to the expiry
of this Agreement or as soon as reasonably practicable upon the issuance of a notice of termination
(other than as a result of the expiry of this Agreement), the Parties shall agree on a transition
plan (the “Transition Plan”) outlining the particulars of all responsibilities
and obligations of NV and Company in relation to the transition of the NV Services to Company
in accordance with Good Industry Practice, as applicable. |
| 19.7.2 | Company
shall pay reasonable costs and expenses in connection with the Transition Plan which shall
be mutually agreed by the Parties in advance, provided that NV shall be required to
pay all costs and expenses incurred by NV (including Project Consultation Fees) in connection
with the Transition Plan in the event Company terminates this Agreement pursuant to clauses
19.2.1-19.2.6. |
| 19.8.1 | Termination
or expiry of this Agreement (howsoever occasioned) shall not affect any accrued rights or
liabilities of either Party, nor shall it affect the coming into force or the continuance
in force of any provision of this Agreement which is expressly or by implication intended
to come into force or continue in force on or after termination. |
| 19.8.2 | The
following clauses, and provisions referred to by such clauses, shall survive termination
or expiry of this Agreement together with any other provisions which by their nature are
expressed to survive expiry or termination or are intended or required to give effect to
the expiration or termination of this Agreement: clauses 1 (Definitions; Interpretations;
Conflicts); 5.3.4-5.3.12 (Commercial Milestones and Payment Terms) (provided
that such clauses shall only survive with respect to any outstanding Fees and any other
amounts due from Company to NV under this Agreement that are payable for periods prior to
the date of such expiry or termination but have not been paid to NV yet or in connection
with NV’s performance of the Transition Plan and any outstanding unpaid Commercial
Milestones subject to clause |
5.3.6);
13 (Intellectual Property Rights), 14 (Confidential Information), 15 (Indemnity), 16 (Limitation of Liability),
19.6-19.8 (Termination), 20 (Notices) and 33 (Governing Law; Arbitration and Jurisdiction), and the applicable
provisions of Schedule 1 (Defined Terms and Interpretation).
| 20.1 | Any communication
to be given in connection with this Agreement shall be in writing and if such communication
is a Formal Notice shall either be delivered by hand or courier to a Party’s registered
office (or such other address as it may notify to the other Party for such purpose) or by
email as follows: |
to Company at: |
to NV at: |
GENOMICS INNOVATIONS
COMPANY LIMITED
Building No. 3936, 6651 Al Nakheel District, Postal Code 12382, RGNB3936, Riyadh, Kingdom of Saudi Arabia
|
CENTOGENE
N.V.
Am Strande 7,
18055
Rostock, Germany |
|
|
Marked for the attention of: |
Marked for the attention of: |
|
|
[***]
email:[***] |
Chief Legal
Officer
email: [***] |
|
|
|
With a copy,
which shall not constitute notice, to:
[***] |
|
|
|
And with a
copy, which shall not constitute notice, to:
Chief Financial
Officer
email: [***] |
| 20.2 | A communication sent according
to clause 20.1 shall be deemed to have been received: |
| 20.2.1 | if delivered
by hand, on written acknowledgment or receipt by an officer or an employee of the receiving
Party; |
| 20.2.2 | if delivered
by courier, on production of evidence from the relevant courier that the notice was successfully
delivered; or |
| 20.2.3 | if by
email, upon transmission to the correct email address as specified; provided, that
a hard copy is sent by post as soon as reasonably practicable thereafter to the address set
out in clause 20.1. |
If,
under the preceding provisions of this clause 20.2, a communication would otherwise be deemed to have been received outside normal business
hours in the place of receipt, being 9:00 a.m. to 4:00 p.m. on a Business Day, it shall be deemed to have been received at 9:00 a.m.
on the next Business Day.
| 20.3 | A Party may
notify the other Party of a change to its name or address or email address for the purposes
of clause 20.1; provided, that such notification shall only be effective on: |
| 20.3.1 | the
date specified in the notification as the date on which the change is to take place; or |
| 20.3.2 | if no
date is specified or the date specified is less than five (5) Business Days after the date
on which notice is deemed to have been served, the date falling five (5) Business Days after
notice of any such change is deemed to have been given. |
| 21. | Assignment
and Subcontracting |
| 21.1 | The Parties
acknowledge and agree that NV shall assume full responsibility to Company for the provision
of the NV Services under this Agreement, subject to the terms and conditions of this Agreement.
Accordingly, NV may not subcontract any of its obligations under this Agreement without prior
written consent from Company (not to be unreasonably withheld, conditioned or delayed); provided
that NV may subcontract all or any of its obligations under this Agreement to any Affiliate
of NV without Company’s prior written consent. NV shall assume full liability and responsibility
for any subcontractor’s compliance with the terms of this Agreement as if this Agreement
were made between Company and such subcontractor. For the avoidance of doubt, any and all
obligations of NV under this Agreement may be subcontracted to Centogene GmbH. |
| 21.2 | Neither Party is permitted to
assign, sub-license, create a charge over or otherwise dispose of any of its rights or transfer or otherwise dispose of any of its obligations
under this Agreement without the prior written consent of the other Party (not to be unreasonably withheld, conditioned or delayed);
provided that either Party is permitted to assign, sub-license, create a charge over or otherwise dispose of any of its rights
or transfer or otherwise dispose of any of its obligations under this Agreement: |
| 21.2.1 | to any
Affiliate; or |
| 21.2.2 | in relation
to its right to receive payment under this Agreement, as collateral to any financial institution
providing financing to such Party or any of such Party’s Affiliates, |
in
each case without the prior written consent of the other Party.
Except
as otherwise set forth in this Agreement, each Party shall pay the costs and expenses incurred by it in connection with preparation,
review, negotiation and execution of this Agreement.
| 23.1 | NV shall (and
shall procure that its subcontractors, vendors, Affiliates, and all NV Personnel) maintain
and keep accurate and complete reports, instructions, plans, receipts, drawings, accounts,
records and all other documents that relate to the NV Services or Fees, or that relate to
or are referred to in this Agreement (collectively, the “Records”), in
accordance with accounting practices consistent with Good Industry Practice and Applicable
Law, until the expiry of five (5) years after the expiry of the Term or termination of this
Agreement. |
| 23.2 | Company (and
any of Company’s Regulators, agents or professional advisors) shall have the right
to audit NV’s compliance with this Agreement on giving at least ten (10) days’
written notice to NV, unless such audit is required: |
| 23.2.1 | for
reasons of actual or suspected fraud, criminal activity or failure to comply with Applicable
Law; |
| 23.2.3 | for
reasons of actual or suspected non-compliance by NV with any material data security obligations
under Schedule 3 (Personal Data and Information Security), |
in which
case such audits may be at any time.
| 23.3 | Any audit conducted
pursuant to this clause 23 must be made by an independent professional firm chosen or appointed
by Company and reasonably acceptable to NV who enters into a reasonable non-disclosure agreement
with NV. All audit activities must be conducted during normal business hours, without disruption
to normal business activities and the materials to be reviewed may be redacted to protect
privacy, legally privileged information and otherwise as is reasonable in light of Applicable
Law and contractual obligations. Company shall be responsible for costs and expenses related
to the audit. No Record may be audited more than one time. |
| 24.1 | This Agreement
shall be executed in English. |
| 24.2 | Any notice
(including, without limitation, a Formal Notice) given in connection with this Agreement
shall be in English. |
| 24.3 | Any other document
provided by a Party in connection with this Agreement shall be in English. |
| 25. | Cooperation
with Regulators |
Each
Party shall at all times provide reasonable cooperation with any Regulatory Authority in connection with the NV Services and provide
all such reasonable assistance as such other Party may require in dealing with Regulatory Authorities as is relevant to the NV Services.
| 26. | Anti-Bribery
and Corruption |
| 26.1 | Neither Party,
nor any of its Affiliates shall accept or give any commission or gift or other financial
benefit or inducement from or to any person or party in connection with its rights and obligations
under this Agreement and shall ensure that its employees, agents and subcontractors shall
not accept or give any such commission, gift, benefit or inducement, and shall immediately
notify the other Party of any such commission, gift, benefit or inducement which may be offered. |
| 26.2 | Each Party, its Affiliates and
their Affiliated Persons shall be solely responsible for complying, have to their best knowledge complied, and shall comply, with ABC
Laws and have to their best knowledge not taken and shall not take or fail to take any actions, which act or omission would subject the
other Party or its Affiliates to liability under ABC Laws. |
| 26.3 | Each Party and its Affiliates
shall implement and maintain an effective and appropriate internal control system and a compliance program for the prevention of bribery
and corruption, money laundering and other crimes. |
| 26.4 | In the event
that a Party (a “Notified Party”) reasonably believes that it has (or
any of its Affiliates have) violated, or is in violation of, any ABC Laws, including without
limitation if the Notified Party has received any correspondence or notice from a Regulator
that the Notified Party has breached, may potentially breach or is in breach of, any ABC
Laws, then the Notified |
Party
is required to promptly notify the other Party of such breach. The Notified Party agrees to provide all reasonable assistance with respect
to any audit or investigation by a Regulator (or any similar body) into whether a violation of any ABC Law has occurred by the Notified
Party and the nature and extent of such violation.
| 27. | Export Control
and Sanctions |
The
Parties agree not to use or otherwise export or re-export anything exchanged or transferred between them pursuant to this Agreement except
as authorized by Applicable Laws and the laws of the jurisdiction in which it was obtained. In particular, but without limitation, items
and services exchanged may not be exported or re-exported into any Sanctioned Countries. By entering into this Agreement, each Party
represents and warrants that they are not located in a Sanctioned Country or on any sanctioned persons list. Each Party also agrees that
they will not use any item or service exchanged for any purposes prohibited by Applicable Law, including, without limitation, the development,
design, manufacture or production of missiles, or nuclear, chemical or biological weapons. In the event either Party becomes aware of
any suspected violations of this clause 27 that Party will promptly inform the other Party of such suspected violations, and the Parties
shall cooperate with one another in any subsequent investigation and defence, be they civil or criminal.
Each
Party shall do and execute, or arrange for the doing and executing of, each necessary act, document and thing reasonably within its power
to implement and give effect to this Agreement.
29.1
NV will provide Company with commercially reasonable assistance as is reasonably requested by Company in order for Company to
obtain and maintain the relevant approvals, licenses and consents with respect to the provision of NV Services and the KSA Facility.
| 29.2 | Each Party
shall obtain and maintain during the Term of this Agreement any permits, licenses or registrations,
approvals and no-objections, required for the provision or receipt, as applicable, of the
NV Services and the performance of its other obligations under this Agreement; provided,
however, that notwithstanding any other provision to the contrary in this Agreement, Company
acknowledges that NV will be providing the NV Services without establishing any licensed
presence in KSA. Company acknowledges it is not a breach of this Agreement that NV does not
establish any such presence or obtain any license in KSA. |
| 30. | Rights of
Third Parties |
30.1
A person who is not a party to this Agreement shall not have any right to enforce any term of this Agreement.
| 30.2 | The rights
of the Parties to terminate, rescind or agree to any variation, waiver or settlement under
this Agreement is not subject to the consent of any person that is not a party to this Agreement. |
| 31.1 | A failure or
delay by a Party to exercise any right or remedy provided under this Agreement, whether by
conduct or otherwise, shall not constitute a waiver of that or any other right or remedy,
nor shall it preclude or restrict any further exercise of that or any other right or remedy.
No single or partial exercise of any right or remedy provided under this Agreement, whether |
by
conduct or otherwise, shall preclude or restrict the further exercise of that or any other right or remedy.
| 31.2 | A waiver of
any right or remedy under this Agreement shall only be effective if given in writing and
signed by the Party against whom the waiver would be enforced and shall not be deemed a waiver
of any subsequent breach or default. |
| 31.3 | No variation
or amendment of this Agreement shall be valid unless it is in writing and duly executed by
or on behalf of all of the Parties to this Agreement. Unless expressly agreed in writing,
no variation or amendment shall constitute a general waiver of any other provision of this
Agreement, nor shall it affect any rights or obligations under or pursuant to this Agreement
which have already accrued up to the date of variation or amendment, and the rights and obligations
under or pursuant to this Agreement shall remain in full force and effect, except and only
to the extent that they are varied or amended in accordance with this clause 31. |
Where
any provision of this Agreement is or becomes illegal, invalid or unenforceable in any respect, then such provision shall be deemed to
be severed from this Agreement and, if possible, replaced with a lawful provision which, as closely as possible, gives effect to the
intention of the Parties under this Agreement and, where permissible, that shall not affect or impair the legality, validity or enforceability
in that, or any other, jurisdiction of any other provision of this Agreement.
| 33. | Governing
Law; ARBITRATION AND JURISDICTION |
This
Agreement shall be governed and construed in accordance with the laws of the Kingdom.
| 33.2.1 | In the
event of any dispute, difference, claim, controversy or question between Company and NV,
directly or indirectly arising at any time under, out of, in connection with or in relation
to this Agreement (or the subject matter of this Agreement) or any term, condition or provision
hereof, including any of the same relating to the existence, validity, interpretation, construction,
performance, enforcement and termination of this Agreement (a “Dispute”),
Company and NV shall first endeavor to settle such Dispute by good faith negotiation. The
Parties agree, save as otherwise agreed in writing by Company and NV, that the negotiations
shall not exceed three (3) months from the date of the start of such negotiations. |
| 33.2.2 | Notwithstanding
the provisions of clause 33.2.1 above, any Dispute arising out of, or in connection with,
this Agreement shall be finally administered by the Saudi Centre for Commercial Arbitration
(“SCCA”) in accordance with its Arbitration Rules. The arbitration shall
be conducted by an arbitration tribunal consisting of three (3) independent arbitrators,
none of whom shall have any relationship or competitive interests with any of the Parties
or any of their Affiliates. Company shall appoint one (1) arbitrator, NV shall appoint
one (1) arbitrator and the SCCA shall appoint one (1) arbitrator. The arbitration shall
take place in the English language and the seat shall be at the SCCA, in Riyadh, the Kingdom.
Judgment for any award rendered may be entered in any court having jurisdiction or an application
may be made to such court for a judicial recognition of the award or an order of enforcement
thereof, as the case may be. Nothing in this clause shall preclude any Party from seeking
provisional measures to secure its rights from any court having jurisdiction or where |
any
assets of the other Party may be found. The arbitration proceedings contemplated by this clause and the content of any award rendered
in connection with such proceeding shall be kept confidential by the Parties.
| 34.1 | This Agreement
and the Project Documents set out the entire agreement and understanding between the Parties
in respect of the subject matter of this Agreement and supersede all prior agreements and
understandings, both oral and written, between the Parties with respect to the subject matter
hereof and thereof. |
| 34.2 | Each Party
acknowledges that it is not relying on, and shall have no remedies in respect of, any undertakings,
representations, warranties, promises or assurances (whether made innocently or negligently)
that are not set forth in this Agreement. |
| 34.3 | Nothing in
the preceding sub clause limits or excludes any liability for fraud or fraudulent concealment. |
This
Agreement or any amendment agreed to pursuant to clause 31.3 may be executed in any number of counterparts, each of which shall be deemed
to be an original, and all of which, when taken together, shall constitute one and the same instrument.
[Signature
Page Follows]
IN WITNESS WHEREOF,
this Agreement has been executed by the Parties by their duly authorized representatives on the Effective Date.
Signed by Kim Stratton for and on behalf of
CENTOGENE N.V. |
)
)
)
)
) |
/s/ Kim Stratton |
|
|
|
Signed by Miguel Coego for and on behalf of
CENTOGENE N.V. |
)
)
)
)
) |
/s/ Miguel Coego |
|
|
|
Signed by Jeremy Panacheril for and on behalf of
GENOMICS INNOVATIONS COMPANY LIMITED |
)
)
)
)
) |
/s/ Jeremy Panacheril |
Schedule
1
DEFINED TERMS AND INTERPRETATION
Part
1 – Defined Terms
In this Agreement:
“Abandon”
or “Abandonment” means the material failure of NV to provide all or a material part of the NV Services for a continuous
and consecutive period of forty-five (45) Business Days or more, other than any material non-performance due to:
| (a) | non-payment
by Company of the Fees that are due in accordance with the terms of this Agreement; or |
| (b) | occurrence
of a Force Majeure Event; |
“ABC
Laws” means all laws and regulations applicable to the Parties and this Agreement, that relates to bribery or corruption or
money laundering, including (without limitation):
| (a) | the
Saudi Arabian Anti-Bribery Law promulgated by royal decree number M/36 dated 26/12/1412H
(corresponding to 27 June 1992) and the Saudi Arabian Anti-Money Laundering Law promulgated
by royal decree number M/20 dated 5/2/1439H (corresponding to 25 October 2017); |
| (b) | the
US Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations issued
thereunder; and |
| (c) | the
UK Bribery Act 2010, as each may be amended or re-enacted from time to time. |
“Accreditation”
means the CAP Laboratory Accreditation from the College of American Pathologists (“CAP”) and the Clinical Laboratory
Improvement Amendments (“CLIA”) certification, or, in the event Company is unable to obtain such accreditation or
certification, as applicable, due to regulatory changes arising after the Effective Date, an equivalent internationally recognized accreditation
or certification, as applicable, as mutually agreed by the Board of Directors, and “Accredited” shall be construed
accordingly;
“Affiliate”
means any person, now or in the future, directly Controlling, Controlled by or under direct or indirect Common Control of a Party. For
the avoidance of doubt, for purposes of this Agreement, when used in connection with Company, the term “Affiliate” will not
include NV, and when used in connection with NV, the term “Affiliate” will not include Company;
“Affiliated
Persons” means a relevant Party and its Affiliates’ officers, directors, employees, agents or representatives, or any
of its stockholders, principals or owners (including ultimate beneficial owners) acting on its behalf or in its interests;
“Agreement”
has the meaning set out in the preamble of this Agreement;
“Applicable
Data Protection Laws” means any and all laws, statutes, rules and regulations relating to the privacy, security, protection,
access, collection, storage, transmission, disclosure, exchange or other processing of Personal Data, including, but not limited to,
the General Data Protection Regulation (EU) 2016/679 (“GDPR”), the German Federal Data Protection Act (Bundesdatenschutzgesetz),
the provisions of the German Genetic Diagnostics Act (Gendiagnostikgesetz), the Kingdom National Data Management Office’s
Interim Regulations on Personal Data Protection, the Kingdom Ministry of Health’s Guidelines for Informed Consent, and the Kingdom
Personal Data Protection Law (issued pursuant to Royal Decree M/19 of 9/2/1443H (corresponding to 16 September 2021) and any relevant
implementing
regulations issued pursuant to the Kingdom Personal Data Protection Law (“KSA PDPL”)), in each case as amended or
updated from time to time;
“Applicable
Export Control” or “Economic Sanctions Programs” means all applicable national and international export
controls, Sanctions laws, regulations and programs;
“Applicable
Law” means any of the following, to the extent that it applies to a Party:
| (a) | any
laws, statute, directive, order, enactment, regulation, bylaw, ordinance or subordinate legislation
in force from time to time; but subject to any written waivers granted by any Governmental
Authority; |
| (b) | any
binding court order, judgment or decree; |
| (c) | any
applicable industry code, policy or standard enforceable by law; |
| (d) | any
applicable direction, statement of practice, policy, rule or order that is set out by a Regulatory
Authority that is binding on the Parties; and |
| (e) | the
ABC Laws, Applicable Data Protection Laws and the Applicable Export Control or Economic Sanctions
Programs; |
“Approved
Employment Contract” has the meaning set out in Schedule 4 (Staffing and Secondment) clause 3.2 of this Agreement;
“Approved
Policy” means a policy of Company approved in accordance with the terms of the Joint Venture Agreement;
“Approved
Seconded Personnel” has the meaning set out in Schedule 4 (Staffing and Secondment) clause 3.2 of this Agreement;
“Board
of Directors” means the Board of Directors of Company from time to time;
“Business
Day” means any day other than a Friday, Saturday or public holiday in KSA or Germany;
“Business
Plan” means the Initial Business Plan set out in Schedule 7 of the Joint Venture Agreement;
“Claim”
means any claims, demands, suits, proceedings or actions by any Governmental Authority, Regulatory Authority or a third party (in either
case, not being connected to or related to the relevant Indemnitee);
“Clauses”
has the meaning set out in Schedule 3 (Personal Data and Information Security) Part A clause 1.1 of this Agreement;
“Commercial
Milestone” has the meaning set out in clause 5.3.4 of this Agreement;
“Commercial
Milestone Fee” has the meaning set out in clause 5.3.4 of this Agreement;
“Commercially
Reasonable Efforts” means taking such steps and performing in such a manner as a similarly situated company would undertake
where such company was acting in a determined, prudent and reasonable manner to achieve the particular result for its own benefit;
“Company”
has the meaning set out in the preamble of this Agreement;
“Company
Confidential Information” means Confidential Information of Company;
“Company
Data” means all Personal Data which relates to Company Personnel;
“Company
Group” means Company and its Affiliates;
“Company
Indemnitee” has the meaning set out in clause 15.1 of this Agreement;
“Company
Personnel” means any employees, officers, directors, consultants, contractors or agents employed or engaged by Company or its
Affiliates, but excluding any NV Personnel seconded to Company;
“Company
Representative” has the meaning set out in clause 4.6 of this Agreement;
“Confidential
Information” means information that is marked, designated or otherwise identified as ‘confidential’ or which by
its nature is clearly confidential. Confidential Information includes (without limitation) any information concerning the technology,
technical processes, samples, studies, findings, inventions, ideas, business processes, procedures, business affairs, financial affairs
and finance of Company Group or NV Group, as the case may be; provided that Confidential Information shall not include any Personal
Data which is addressed separately in Schedule 3 (Personal Data and Information Security) of this Agreement. Company’s or
NV’s security procedures are also included within the definition of Confidential Information. Confidential Information may take
the form of documents, technical specifications, unpublished patent specifications, data, drawings, plans, processes, photographs, databases,
computer software in disk, cassette, tape or electronic form and data storage or memory in, and items of, computer hardware; or oral
descriptions, demonstrations or observations, and Confidential Information includes (without limitation) information which is supplied
to, stored by, processed or marked for destruction by, NV Group to Company Group, or by Company Group to NV Group;
“Construction
Completion” has the meaning set out in clause 1.1.3(b)(ii) of Schedule 2 of this Agreement;
“Control”
(including the terms “Controlling”, “Controlled by” and “under Common Control”),
means in relation to any person (being the “Controlled Person”), being:
| (a) | entitled
to exercise, or control the exercise of (directly or indirectly) more than fifty percent
(50%) of the voting power at any general meeting of the shareholders, members or partners
or other equity holders (and including, in the case of a limited partnership, of the limited
partners of) in respect of all or substantially all matters falling to be decided by resolution
or meeting of such persons; |
| (b) | entitled
to appoint or remove: |
| (i) | directors
on the Controlled Person’s board of directors or its other governing body (or, in the
case of a limited partnership, of the board or other governing body of its general partner)
who are able (in the aggregate) to exercise more than fifty percent (50%) of the voting power
at meetings of that board or governing body in respect of all or substantially all matters; |
| (ii) | any
managing member of such Controlled Person; and/or |
| (iii) | in
the case of a limited partnership, its general partner; or |
| (c) | entitled to exercise a dominant
influence over the Controlled Person (otherwise than solely as a fiduciary) by virtue of the provisions contained in its constitutional
documents or pursuant to an agreement with other shareholders, partners or members of the Controlled Person; |
“Data
Protection Impact Assessment” has the meaning set out in clause 7.3.1 of Schedule 3 (Personal Data and Information Security)
of this Agreement;
“Dispute”
has the meaning set out in clause 33.2.1 of this Agreement;
“Effective
Date” has the meaning set out in the preamble of this Agreement;
“Fees”
has the meaning set out in clause 5.1.1 of this Agreement;
“First
Operational Milestone” has the meaning set out in clause 5.3.1 of this Agreement;
“Fixed
Performance Fee” has the meaning set out in clause 5.3.4 of this Agreement;
“Force
Majeure Event” has the meaning set out in clause 17 of this Agreement;
“Formal
Notices” means:
| (a) | notices
invoking, or relating to, Dispute resolution or any litigation between the Parties; |
| (b) | notices
given in connection with a Force Majeure Event pursuant to clause 17 of this Agreement; |
| (c) | a change
to the contact details specified in clause 20.1 of this Agreement; or |
| (d) | any
other notices stated in this Agreement to be a Formal Notice; |
“Good
Industry Practice” means the degree of skill, diligence, prudence and foresight and standard of care which would ordinarily
be expected to be observed by a duly qualified, skilled and experienced professional engaged in the same or similar type of undertaking
as that of NV in providing the NV Services;
“Good
Laboratory Practice” means international ethical and scientific quality standards, practices, methods and procedures conforming
to Applicable Law and international health industry practice and exercising that degree of skill, care, diligence, prudence and foresight
which would reasonably and ordinarily be expected from a duly qualified, skilled, efficient and experienced laboratory service provider
providing laboratory services in connection with a facility of a size and capacity comparable to the KSA Facility;
“Governmental
Authority” means any federal, emirate, state, provincial or municipal government or political subdivision thereof, a governmental
or quasi-governmental ministry, legislative body, agency, authority, board, bureau, commission, government-controlled corporation or
entity, department, instrumentality or public body, or any court, administrative tribunal or public utility that has jurisdiction over
the Party or matter in question;
“Indemnified
Losses” means:
| (a) | any
amounts awarded by a court or tribunal of competent jurisdiction or arbitrator to a third
party; |
| (b) | any
amounts paid in settlement to a third party; |
| (c) | any
interest awarded by a court of competent jurisdiction or arbitrator in respect of the above;
and |
| (d) | reasonable
costs of investigation, litigation, settlement and external legal fees (on a solicitor-client
basis) and disbursements and administrative costs directly incurred by the Indemnitee in
respect of a Claim; |
“Indemnitee”
means a Party relying on an indemnity pursuant to this Agreement;
“Indemnitor”
means a Party providing an indemnity pursuant to this Agreement;
“Intellectual
Property Rights” means any and all rights available under patent, copyright, industrial design, trade secret law or any trademarks,
service marks, trade names or other statutory provision or common law doctrine with respect to designs, formulas, algorithms, procedures,
methods, techniques, ideas, Know-How, programs, subroutines, tools, inventions, creations, improvements, works of authorship, other similar
materials, and all recordings, graphs, drawings, reports, analyses, other writings, and any other embodiment of the foregoing, in any
form, whether or not specifically listed herein, which may subsist in any part of the world, in each case whether registered or unregistered
and including all applications for, and renewals or extensions of, such rights for their full term;
“Invoice”
has the meaning set out in clause 5.3.7 of this Agreement;
“Joint
Venture Agreement” has the meaning set out in the preamble to this Agreement;
“Kingdom”
or “KSA” means the Kingdom of Saudi Arabia;
“Know-How”
has the meaning set out in the Technology Transfer and Intellectual Property License Agreement;
“KSA
Biodatabank” means national KSA data registries, biodatabank and genetic data including in relation to rare and neurodegenerative
diseases that is Controlled by Company;
“KSA
Facility” means the facility for the establishment and maintenance of the KSA Lab and the KSA Biodatabank;
“KSA
Facility License” means the license issued by the Saudi Food and Drug Authority authorizing the KSA Facility to provide services
in Riyadh, KSA;
“KSA
Lab” means a laboratory facility to be located in Riyadh, the Kingdom, and operated in accordance with Applicable Law with
the intention that it becomes an Accredited, globally recognized, commercially driven genomics wet and dry lab;
“Laboratory
Services Agreement” has the meaning set out in the preamble of this Agreement;
“Lawful
Export Measures” has the meaning set out in Schedule 3 (Personal Data and Information Security) Part B clause 2.3 of
this Agreement;
“Licensed
Other Personnel” has the meaning set out in clause 1.1.2 of Schedule 4 (Staffing and Secondment) of this Agreement;
“Licensed
Personnel” means laboratory or clinical professionals that are employees of NV or parties contracted by NV;
“Licensed
Seconded Personnel” has the meaning set out in clause 1.1.1 of Schedule 4 (Staffing and Secondment) of this Agreement;
“Losses”
means all Claims (whether or not successful, compromised or settled), actions, proceedings, liabilities, demands, judgments (asserted
or established in any jurisdiction) and any and all losses, damages (including interest), any amounts paid in settlement (including interest)
of a Claim, costs, expenses (including reasonable legal, investigative, administrative or professional costs and expenses incurred in
disputing or defending any of the foregoing), Taxes, fines or penalties;
“Net
Revenue” means the revenue of Company less any customer discounts or allowances including:
| (a) | credits
or allowances given to customers for rejections or returns of a product or service; |
| (b) | sales taxes,
excise taxes and use taxes, on the production, importation, use or sale of such product or
service; |
| (c) | freight,
postage, shipping and insurance charges allowed or paid for delivery of the products or service,
to the extent included in the gross sales price; |
| (d) | cash discounts
given by Company or any of its Affiliates or its or their permitted sublicensees in the ordinary
course of the business; |
| (e) | chargebacks,
rebates, administrative fee arrangements, reimbursements, and similar payments to wholesalers
and other distributors, buying groups, health care insurance carriers, pharmacy benefit management
companies, health maintenance organizations, other institutions or health care organizations
or other customers; |
| (f) | amounts
due to third parties on account of rebate payments or other price reductions provided, based
on sales by Company or its Affiliates or sublicensees to any Governmental Authorities or
Regulators; |
| (g) | other specifically
identifiable amounts that have been credited against or deducted from gross sales of products
and services, and which are substantially similar to those credits and deductions listed
above; and |
any
other permitted deductions in accordance with International Financial Reporting Standards (“IFRS”) not set out in
(a)-(g) above;
“Non-Licensed
Other Personnel” has the meaning set out in clause 1.1.4 of Schedule 4 (Staffing and Secondment) of this Agreement;
“Non-Licensed
Personnel” means employees of NV or parties contracted by NV other than Licensed Personnel;
“Non-Licensed
Seconded Personnel” has the meaning set out in clause 1.1.3 of Schedule 4 (Staffing and Secondment) of this Agreement;
“Notified
Party” has the meaning set out in clause 26.4 of this Agreement;
“NV”
has the meaning set out in the preamble of this Agreement;
“NV
Confidential Information” means Confidential Information of NV;
“NV
Data” means all Personal Data which relates to NV Personnel;
“NV
Facility” has the meaning set out in the preamble of this Agreement;
“NV
Group” means NV and its Affiliates;
“NV
Indemnitee” has the meaning set out in clause 15.3 of this Agreement;
“NV
Personnel” means employees, officers, directors, consultants, contractors and agents engaged wholly or partly by NV (or any
of its Affiliates), including Licensed Seconded Personnel, Licensed Other Personnel, Non-Licensed Seconded Personnel, Non-Licensed Other
Personnel, from time to time, including the NV Representative and any Approved Seconded Personnel, to provide the NV Services;
“NV
Representative” has the meaning set out in clause 3.3.1 of this Agreement;
“NV
Services” has the meaning set out in clause 3.1 of this Agreement;
“OFAC”
means the U.S. Department of the Treasury’s Office of Foreign Assets Control;
“Operational
Milestone” has the meaning set out in clause 5.3.1 of this Agreement;
“Operational
Milestone Fee” has the meaning set out in clause 5.3.1 of this Agreement;
“Other
Personnel” means those Licensed Personnel and Non-Licensed Personnel that perform NV Services for Company other than Seconded
Personnel;
“Party”
or “Parties” have the meaning set out in the preamble of this Agreement;
“Personal
Data” has the meaning given to it in Applicable Data Protection Laws;
“Personal
Data Breach” has the meaning set out in clause 6.4.1 of Schedule 3 (Personal Data and Information Security) of this
Agreement;
“Project
Consultation Fee” has the meaning set out in clause 5.2 of this Agreement;
“Project
Documents” means, collectively, this Agreement, the Joint Venture Agreement, the Technology Transfer and Intellectual Property
License Agreement and the Laboratory Services Agreement;
“Provider”
has the meaning set out in clause 14.1 of this Agreement;
“Recipient”
has the meaning set out in clause 14.1 of this Agreement;
“Records”
has the meaning set out in clause 23.1 of this Agreement;
“Regulator”
or “Regulatory Authority” means any national, regional, state or local regulatory agency, department, bureau, commission,
council or other Governmental Authority whose review and/or approval is necessary for performing clinical and/or laboratory services
in the applicable regulatory jurisdiction and granting regulatory approvals or having regulatory or supervisory authority over a Party
or a Party’s assets, resources or business, or over the NV Services;
"SAR”
means Saudi Arabian Riyals;
“Sanctioned
Countries” means, at any time, a country or territory that is itself the target of comprehensive Sanctions (as of the date
of this Agreement, Cuba, Iran, North Korea, Syria, the Crimea region of Ukraine, the so-called Donetsk People’s Republic, and the
so-called Luhansk People’s Republic);
“Sanctions”
means economic or financial sanctions or trade embargoes imposed, administered or enforced from time to time by the United States, the
European Union or any member state thereof, the United Kingdom, the United Nations or any governmental institution or agency of any of
the foregoing, including OFAC or the United States Department of State, the United Kingdom’s Office of Financial Sanctions Implementation
or His Majesty’s Treasury or the United Nations Security Council;
“SCCA”
has the meaning given in clause 33.2.2 of this Agreement;
“Second
Operational Milestone” has the meaning set out in clause 5.3.1 of this Agreement;
“Seconded
Personnel” means those Licensed Personnel or Non-Licensed Personnel that are seconded to Company from time to time, including
any Approved Seconded Personnel;
“Shareholders”
means any person to whom one or more shares may be transferred or issued from time to time in accordance with the Joint Venture Agreement,
and “Shareholder” means any of them;
“Staffing
Plan” has the meaning set out in clause 1.2 of Schedule 4 (Staffing and Secondment) of this Agreement;
“Tax”
means all forms of taxation and statutory, governmental, state, federal, provincial, local, government or municipal charges, duties,
imposts, contributions, levies, VAT, withholdings or other liabilities in the nature of taxation wherever chargeable and whether of KSA
or any other jurisdiction (including, for the avoidance of doubt, social security contributions in KSA and Germany and corresponding
obligations elsewhere) and any penalty, fine, surcharge, interest, charges or costs relating to it or them;
“Tax
Credit” means a credit against, relief or remission for, or repayment of, any Tax;
“Tax
Deduction” means any amount which Company is required by Applicable Law to deduct or withhold on account of Tax from any payment
by Company to NV (or a relevant Affiliate) in respect of any Fees;
“Technology
Transfer and Intellectual Property License Agreement” has the meaning set out in the recitals of this Agreement;
“Term”
has the meaning set out in clause 11 of this Agreement;
“Third
Party Service Provider” means a third-party entity engaged by Company (other than NV, any of its Affiliates or any NV Personnel)
to provide Third Party Services;
“Third
Party Services” means any services which NV and Company agree in advance in writing are Third Party Services for the purposes
of this Agreement;
“Transition
Plan” has the meaning set out in clause 19.7.1 of this Agreement;
“VAT”
means:
| (a) | any
Tax imposed in relation to the Unified Agreement for Value Added Tax for the Co-operation
Council for the Arab States of the Gulf; |
| (b) | any
other Tax of a similar nature, imposed in a member state of the Co-operation Council for
the Arab States of the Gulf; or |
| (c) | any
other similar Taxes imposed anywhere in the world; and |
“Wilful
Misconduct” means conduct that is unreasonable, deliberate and carried out by a Party in the knowledge that it will result
in significant injury or damage to the other Party.
Part
2 - Interpretation
In this
Agreement:
| (a) | any
reference to “Schedule” or “Annex”, unless the context otherwise
requires, is a reference to the relevant schedule or annex of and to this Agreement, and
any reference to a “clause”, “section” or “paragraph”,
unless the context otherwise requires, is a reference to a clause in this Agreement, a section
or paragraph in the relevant Schedule and a paragraph in the relevant Annex, respectively; |
| (b) | the
clause, section and paragraph headings and the contents page in this Agreement are included
for convenience purposes only and shall not affect the interpretation of this Agreement; |
| (c) | use
of the singular in this Agreement includes the plural and vice versa; |
| (d) | any
reference to a Party or the Parties means a party or the parties to this Agreement, including
their successors in interest and permitted assigns; |
| (e) | any
reference to “persons” includes natural persons, companies, corporations, partnerships,
limited liability companies, firms, associations, organisations, Governmental Authorities,
foundations and trusts (in each case, whether or not having separate legal personality); |
| (f) | any
reference to a date refers to the Gregorian calendar; |
| (g) | any
reference to a statute, statutory provision or subordinate legislation shall, except where
the context otherwise requires, be construed as referring to such legislation as amended
and in force from time to time and to any legislation which re-enacts or consolidates (with
or without modification) any such legislation; |
| (h) | unless
otherwise defined, terms used in the healthcare industry or other relevant business context
shall be interpreted in accordance with their generally understood meaning in that industry
or business context; |
| (i) | any
phrase introduced by the terms “including”, “include”, “in
particular” or any similar expression shall be construed as illustrative and shall
not limit the sense of the words preceding those terms; |
| (j) | any
reference to “writing” or “written” includes email (but not faxes),
save with respect to Formal Notices, where service in accordance with clause 20 of this Agreement
is required; and |
| (k) | any
reference to any agreement or other instrument shall, except where expressly provided to
the contrary, include any amendment, restatement, amendment and restatement, modification,
variation or novation (in whole or in part) to such agreement or other instrument. |
Schedule
2
[***]
Schedule
3
PERSONAL DATA AND INFORMATION SECURITY
PART
A - GDPR Data Processing Clauses
| 1.1 | The purpose
of these Data Processing Clauses (the “Clauses”) is to ensure compliance
with Article 28(3) and (4) of Regulation (EU) 2016/679 of the European Parliament and of
the Council of 27 April 2016 on the protection of natural persons with regard to the processing
of Personal Data and on the free movement of such data. |
| 1.2 | The controllers
and processors listed in Annex I have agreed to these Clauses in order to ensure compliance
with Article 28(3) and (4) of Regulation (EU) 2016/679. |
| 1.3 | These Clauses
apply to the processing of Personal Data as specified in Annex II. |
| 1.4 | Annexes I to
V are an integral part of the Clauses. |
| 1.5 | These Clauses
are without prejudice to obligations to which the controller is subject by virtue of Regulation
(EU) 2016/679. |
| 1.6 | These Clauses
do not by themselves ensure compliance with obligations related to international transfers
in accordance with Chapter V of Regulation (EU) 2016/679. |
| 2.1 | Where these
Clauses use the terms defined in Regulation (EU) 2016/679, those terms shall have the same
meaning as in that Regulation. |
| 2.2 | These Clauses
shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. |
| 2.3 | These Clauses
shall not be interpreted in a way that runs counter to the rights and obligations provided
for in Regulation (EU) 2016/679 or in a way that prejudices the fundamental rights or freedoms
of the data subjects. |
| 3.1 | In
the event of a contradiction between these Clauses and the provisions of the Project Documents,
these Clauses shall prevail. In the event of a contradiction between these Clauses, the provisions
of the Project Documents and the standard contractual clauses attached to this Schedule with
respect to the transfer of Personal Data to a third country, the standard contractual clauses
shall prevail. |
| 4.1 | Any entity
that is not a Party to these Clauses may, with the written agreement of all the Parties,
accede to these Clauses at any time as a controller or a processor by completing the Annexes
and signing Annex I. |
| 4.2 | Once Annex
I has been completed and signed as set forth in clause 4.1, the acceding entity shall be
treated as a Party to these Clauses and have the rights and obligations of a controller or
a processor, in accordance with its designation in Annex I. |
| 4.3 | The acceding
entity shall have no rights or obligations resulting from these Clauses from the period prior
to becoming a Party. |
| 5. | DESCRIPTION
OF PROCESSING |
| 5.1 | The details
of the processing operations, in particular the categories of Personal Data and the purposes
of processing for which the Personal Data is processed on behalf of the controller, are specified
in Annex II. |
| 6. | OBLIGATIONS
OF THE PARTIES |
| 6.1.1 | The
processor shall process Personal Data only on documented instructions from the controller,
unless required to do so by Union or Member State law to which the processor is subject.
In this case, the processor shall inform the controller of that legal requirement before
processing, unless the law prohibits this on important grounds of public interest. Subsequent
instructions may also be given by the controller throughout the duration of the processing
of Personal Data. These instructions shall always be documented. |
| 6.1.2 | The
processor shall immediately inform the controller if, in the processor’s opinion, instructions
given by the controller infringe Regulation (EU) 2016/679 or the applicable Union or Member
State data protection provisions. |
The
processor shall process the Personal Data only for the specific purpose(s) of the processing, as set out in Annex II, unless it receives
further instructions from the controller.
| 6.3 | Duration
of the Processing of Personal Data |
Processing
by the processor shall only take place for the duration specified in Annex II.
| 6.4 | Security
of Processing |
| 6.4.1 | The
processor shall at least implement the technical and organisational measures specified in
Annex III to ensure the security of the Personal Data. This includes protecting the data
against a breach of security leading to accidental or unlawful destruction, loss, alteration,
unauthorised disclosure or access to the data (a “Personal Data Breach”).
In assessing the appropriate level of security, the Parties shall take due account of the
state of the art, the costs of implementation, the nature, scope, context and purposes of
processing and the risks involved for the data subjects. |
| 6.4.2 | The
processor shall grant access to the Personal Data undergoing processing to members of its
personnel only to the extent strictly necessary for implementing, managing and monitoring
of this Agreement. The processor shall ensure that persons authorized to process the Personal
Data received have committed themselves to confidentiality or are under an appropriate statutory
obligation of confidentiality. |
If the
processing involves Personal Data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade
union membership, genetic data or biometric data for the purpose of uniquely identifying a natural person, data concerning health or
a person’s sex
life
or sexual orientation, or data relating to criminal convictions and offences (sensitive data), the processor shall apply specific restrictions
and/or additional safeguards.
| 6.6 | Documentation
and Compliance |
| 6.6.1 | The
Parties shall be able to demonstrate compliance with these Clauses. |
| 6.6.2 | The
processor shall deal promptly and adequately with inquiries from the controller about the
processing of data in accordance with these Clauses. |
| 6.6.3 | The
processor shall make available to the controller all information necessary to demonstrate
compliance with the obligations that are set out in these Clauses and stem directly from
Regulation (EU) 2016/679. At the controller’s request, the processor shall also permit
and contribute to audits of the processing activities covered by these Clauses, at reasonable
intervals or if there are indications of non-compliance. In deciding on a review or an audit,
the controller may take into account relevant certifications held by the processor. |
| 6.6.4 | The
controller may choose to conduct the audit by itself or mandate an independent auditor. Audits
may also include inspections at the premises or physical facilities of the processor and
shall, where appropriate, be carried out with reasonable notice. |
| 6.6.5 | The
Parties shall make the information referred to in this Clause, including the results of any
audits, available to the competent supervisory authority/ies on request. |
| 6.7.1 | The
processor has the controller’s general authorisation for the engagement of sub-processors
from an agreed list which is set forth in Annex IV. The processor shall specifically inform
in writing the controller of any intended changes of Annex IV through the addition or replacement
of sub-processors at least 20 Business Days in advance, thereby giving the controller sufficient
time to be able to object to such changes prior to the engagement of the concerned sub-processor(s).
The processor shall provide the controller with the information necessary to enable the controller
to exercise the right to object. |
| 6.7.2 | Where
the processor engages a sub-processor for carrying out specific processing activities (on
behalf of the controller), it shall do so by way of a contract which imposes on the sub-processor,
in substance, the same data protection obligations as the ones imposed on the data processor
in accordance with these Clauses. The processor shall ensure that the sub-processor complies
with the obligations to which the processor is subject pursuant to these Clauses and to Regulation
(EU) 2016/679. |
| 6.7.3 | At
the controller’s request, the processor shall provide a copy of such a sub-processor
agreement and any subsequent amendments to the controller. To the extent necessary to protect
business secrets or other Confidential Information, including Personal Data, the processor
may redact the text of the agreement prior to sharing the copy. |
| 6.7.4 | The
processor shall remain fully responsible to the controller for the performance of the sub-processor’s
obligations in accordance with its contract with the processor. The processor shall notify
the controller of any failure by the sub-processor to fulfil its contractual obligations. |
| 6.7.5 | The
processor shall agree to a third-party beneficiary clause with the sub-processor whereby
- in the event the processor has factually disappeared, ceased to exist in law or |
has
become insolvent - the controller shall have the right to terminate the sub-processor contract and to instruct the sub-processor to erase
or return the Personal Data.
| 6.8 | International
Transfers |
| 6.8.1 | Any
transfer of data to a third country or an international organization by the processor shall
be done only on the basis of documented instructions from the controller or in order to fulfil
a specific requirement under Union or Member State law to which the processor is subject
and shall take place in compliance with Chapter V of Regulation (EU) 2016/679. |
| 6.8.2 | To
the extent that the services provided by processor entail a transfer of Personal Data from
NV to Company, the standard contractual clauses attached to this Schedule as Annex V apply. |
| 6.8.3 | The
controller agrees that where the processor engages a sub-processor in accordance with Clause
6.7 for carrying out specific processing activities (on behalf of the controller) and those
processing activities involve a transfer of Personal Data within the meaning of Chapter V
of Regulation (EU) 2016/679, the processor and the sub-processor can ensure compliance with
Chapter V of Regulation (EU) 2016/679 by using standard contractual clauses adopted by the
Commission in accordance with of Article 46(2) of Regulation (EU) 2016/679, provided the
conditions for the use of those standard contractual clauses are met. |
| 7. | ASSISTANCE
TO THE CONTROLLER |
| 7.1 | The processor
shall promptly notify the controller of any request it has received from the data subject.
It shall not respond to the request itself, unless authorized to do so by the controller. |
| 7.2 | The processor
shall assist the controller in fulfilling its obligations to respond to data subjects’
requests to exercise their rights, taking into account the nature of the processing. In fulfilling
its obligations in accordance with 7.1 and 7.2, the processor shall comply with the controller’s
instructions. |
| 7.3 | In addition
to the processor’s obligation to assist the controller pursuant to Clause 7.2, the
processor shall furthermore assist the controller in ensuring compliance with the following
obligations, taking into account the nature of the data processing and the information available
to the processor: |
| 7.3.1 | the
obligation to carry out an assessment of the impact of the envisaged processing operations
on the protection of Personal Data (a “Data Protection Impact Assessment”)
where a type of processing is likely to result in a high risk to the rights and freedoms
of natural persons; |
| 7.3.2 | the
obligation to consult the competent supervisory authority/ies prior to processing where a
Data Protection Impact Assessment indicates that the processing would result in a high risk
in the absence of measures taken by the controller to mitigate the risk; |
| 7.3.3 | the
obligation to ensure that Personal Data is accurate and up to date, by informing the controller
without delay if the processor becomes aware that the Personal Data it is processing is inaccurate
or has become outdated; and |
| 7.3.4 | the
obligations in Article 32 Regulation (EU) 2016/679. |
| 8. | NOTIFICATION
OF PERSONAL DATA BREACH |
| 8.1 | In the event
of a Personal Data Breach, the processor shall cooperate with and assist the controller for
the controller to comply with its obligations to notify competent supervisory authorities
or affected individuals under Applicable Data Protection Laws. |
| 8.2 | Data
Breach Concerning Data Processed by the Controller |
In the
event of a Personal Data Breach concerning data processed by the controller, the processor shall assist the controller:
| 8.2.1 | in
notifying the Personal Data Breach to the competent supervisory authority/ies, without undue
delay after the controller has become aware of it, where relevant (unless the Personal Data
Breach is unlikely to result in a risk to the rights and freedoms of natural persons); |
| 8.2.2 | in
obtaining the following information which, pursuant to Article 33(3) Regulation (EU) 2016/679,
shall be stated in the controller’s notification, and must at least include: |
| (i) | the nature
of the Personal Data including where possible, the categories and approximate number of data
subjects concerned and the categories and approximate number of Personal Data records concerned; |
| (ii) | the likely
consequences of the Personal Data Breach; and |
| (iii) | the
measures taken or proposed to be taken by the controller to address the Personal Data Breach,
including, where appropriate, measures to mitigate its possible adverse effects. |
Where,
and insofar as, it is not possible to provide all this information at the same time, the initial notification shall contain the information
then available and further information shall, as it becomes available, subsequently be provided without undue delay.
| 8.2.3 | in
complying, pursuant to Article 34 Regulation (EU) 2016/679, with the obligation to communicate
without undue delay the Personal Data Breach to the data subject, when the Personal Data
Breach is likely to result in a high risk to the rights and freedoms of natural persons. |
| 8.3 | Data Breach
Concerning Data Processed by the Processor |
In the
event of a Personal Data Breach concerning data processed by the processor, the processor shall notify the controller without undue delay
after the processor has become aware of the breach. Such notification shall contain, at least:
| 8.3.1 | a description
of the nature of the breach (including, where possible, the categories and approximate number
of data subjects and data records concerned); |
| 8.3.2 | the
details of a contact point where more information concerning the Personal Data Breach can
be obtained; and |
| 8.3.3 | its
likely consequences and the measures taken or proposed to be taken to address the breach,
including to mitigate its possible adverse effects. |
Where,
and insofar as, it is not possible to provide all this information at the same time, the initial notification shall contain the information
then available and further information shall, as it becomes available, subsequently be provided without undue delay.
The
Parties shall set out in Annex III all other elements to be provided by the processor when assisting the controller in the compliance
with the controller’s obligations under Articles 33 and 34 of Regulation (EU) 2016/679.
| 9. | NON-COMPLIANCE
WITH THE CLAUSES AND TERMINATION |
| 9.1 | Without prejudice
to any provisions of Regulation (EU) 2016/679, in the event that the processor is in breach
of its obligations under these Clauses, the controller may instruct the processor to suspend
the processing of Personal Data until the latter complies with these Clauses or this Agreement
is terminated. The processor shall promptly inform the controller in case it is unable to
comply with these Clauses, for whatever reason. |
| 9.2 | The controller
shall be entitled to terminate this Agreement insofar as it concerns processing of Personal
Data in accordance with these Clauses if: |
| 9.2.1 | the
processing of Personal Data by the processor has been suspended by the controller pursuant
to Clause 9.1 and if compliance with these Clauses is not restored within a reasonable time
and in any event within one month following suspension; |
| 9.2.2 | the
processor is in substantial or persistent breach of these Clauses or its obligations under
Regulation (EU) 2016/679; or |
| 9.2.3 | the
processor fails to comply with a binding decision of a competent court or the competent supervisory
authority/ies regarding its obligations pursuant to these Clauses or to Regulation (EU) 2016/679. |
| 9.3 | The processor
shall be entitled to terminate this Agreement insofar as it concerns processing of Personal
Data under these Clauses where, after having informed the controller that its instructions
infringe applicable legal requirements in accordance with Clause 7.1, the controller insists
on compliance with the instructions. |
| 9.4 | Following termination
of this Agreement, the processor shall, at the choice of the controller, delete all Personal
Data processed on behalf of the controller and certify to the controller that it has done
so, or return all the Personal Data to the controller and delete existing copies unless Union
or Member State law requires storage of the Personal Data. Until the Personal Data is deleted
or returned, the processor shall continue to ensure compliance with these Clauses. |
PART
B - KSA PDPL DATA PROCESSING CLAUSES
| 1. | APPLICATION
OF THE CLAUSES |
| 1.1 | Where the processing
of Personal Data is subject to the KSA PDPL, the Clauses shall apply to such processing and
where applicable, references to Regulation (EU) 2016/679 and to relevant Articles of Regulation
(EU) 2016/679 in the Clauses shall be interpreted as references to the relevant article of
the KSA PDPL and relevant implementing regulations, and references to Union or Member State
laws and supervisory authorities or similar terms in the Clauses shall be interpreted as
references to Kingdom laws and Kingdom Regulatory Authorities, or similar Kingdom related
terms. |
| 1.2 | The application
of the KSA PDPL and extension of the Clauses to apply to processing of Personal Data subject
to the KSA PDPL is supplementary to and in no way replaces or supersedes the processor’s
or controller’s rights or obligations under the Clauses. |
| 1.3 | When processing
Personal Data subject to the KSA PDPL, the processor shall notify the controller and follow
the instructions of the controller if it receives a legally binding request from Kingdom
authorities, including judicial authorities, for the disclosure of such Personal Data, or
is otherwise obliged to disclose such data or becomes aware of any direct access by Kingdom
authorities. The processor shall not require the prior consent of a data subject in relation
to disclosing Personal Data in accordance with legally binding requests from Kingdom public
authorities. |
| 1.4 | When processing
Personal Data subject to the KSA PDPL, the processor shall notify the controller in writing
without undue delay if it becomes aware of any violation of the controller’s instructions
or Kingdom laws. |
| 2. | TRANSFERS
OF PERSONAL DATA |
| 2.1 | To the extent
that the processor receives, accesses or otherwise transfers Personal Data outside of the
Kingdom, the transfer shall comply with Article 29 of the KSA PDPL, including the Regulation
on Personal Data Transfers outside the Kingdom, issued pursuant to the KSA PDPL, and in relation
to any onward transfer of the Personal Data by the processor to another person, the other
person shall comply with the same obligations. |
| 2.2 | In particular,
the processor shall ensure that: |
| 2.2.1 | The
transfer shall take place to a jurisdiction which maintains an appropriate level of Personal
Data protection (commonly referred to as “adequacy”) as determined by the relevant
Regulatory Authority in accordance with Article 29(2)(b) of the KSA PDPL; |
| 2.2.2 | The
transfer shall not prejudice Kingdom national security or the interests of the Kingdom or
violate Kingdom laws; |
| 2.2.3 | The
transfer shall be limited to the minimum amount of Personal Data necessary; and |
| 2.2.4 | The
processor shall assist the controller in ensuring compliance with an obligation to carry
out a risk assessment of the impact of the envisaged transfer or disclosure of Personal Data
outside the Kingdom. |
| 2.3 | To the extent
the recipient jurisdiction is not considered as adequate under Article 29(2)(b) of the KSA
PDPL, the processor shall seek prior approval from the controller prior to transferring the
Personal Data outside of the Kingdom and the Parties shall negotiate in good faith modifications
to this Schedule 3 in order to put in place a method for allowing the lawful |
transfer
of Personal Data, which may include the provisions under model transfer terms, or prior registration, licensing or permission from a
Regulatory Authority (“Lawful Export Measure”).
| 2.4 | To the extent
such Lawful Export Measure requires: |
| 2.4.1 | a contract
imposing appropriate safeguards on the transfer and processing of such Personal Data (which
is not otherwise satisfied by this Schedule); |
| 2.4.2 | a description
of the processing of Personal Data contemplated under this Schedule; and |
| 2.4.3 | a description
of technical and organisational measures to be implemented by the data importer, |
the
Parties agree that Annex V – Standard Contractual Clauses, Annex II - the description of processing activities, and Annex III -
the description of technical and organisational measures, shall apply mutatis mutandis for the benefit of such transfer, and in
relation to any onward transfer of the Personal Data by that data importer to another person, the other person shall comply with the
same importer obligations.
| 2.5 | The controller
may in its absolute discretion refuse to give approval to transfer Personal Data outside
of the Kingdom where the recipient of Personal Data is not located in the European Union. |
ANNEX
I OF THE CLAUSES - LIST OF PARTIES
Controller:
Name:
Genomics Innovations
Company Limited, a limited liability company organized uder the laws of the Kingdom of Saudi Arabia.
Address / registered
office:
Building No. 3936,
6651 Al Nakheel District, 12382 Riyadh, Kingdom of Saudi Arabia
Contact person’s
name, position and contact details:
[***]
[***]
Name and contact
details of the data protection officer:
[***]
[***]
Signature and accession
date: See following Signature Page.
Processor:
Name:
Centogene N.V.,
a company organized under the laws of the Netherlands.
Address / registered
office:
Amsterdam and registered
with the Kamer von Koophandel (Netherlands) under 72822872
Contact person’s
name, position and contact details:
[***], General
Counsel,
[***]
Name and contact
details of the data protection officer:
[***],
datenschutz nord GmbH, Konsul-Schmidt-Str. 88, 28217 Bremen
Signature and accession
date: See following Signature Page.
These Data Processing Clauses have
been executed by the Parties on 27 November 2023.
Signed by Kim Stratton for and on
behalf of Processor
|
/s/ Kim Stratton |
|
|
Signed by Miguel Coego for and on
behalf of Processor
|
/s/ Miguel Coego |
|
|
Signed by Jeremy Panacheril for
and on behalf of Controller
|
/s/ Jeremy Panacheril |
ANNEX
II OF THE CLAUSES: DESCRIPTION OF THE PROCESSING
Categories of
data subjects whose personal data is processed
- Employees (permanent staff, trainees,
temporary workers, freelancers)
- Patients
- Health care professionals
- Suppliers / subcontractors
/ contact persons
Categories of
personal data processed
- Personal master data (name, title,
academic degree, date of birth)
- Contact details (email address, phone
number, postal address)
- Contract data (contract details, services,
customer number)
- Health Data
- Genetic Data
- Biometrical Data
- Billing data and payment information
(invoice details, bank details, credit card information)
- Employee data
- Electronic communications
data (IP address, internet pages accessed, information on the terminal device, operating system and browser used)
Sensitive data
processed (if applicable) and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks
involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised
training), keeping a record of access to the data, restrictions for onward transfers or additional security measures.
- Genetic Data
- Health Data
- Biometrical Data
All Personal Data, including sensitive
data, is generally processed with a high level of restriction and safeguards to protect the data, including strict purpose limitation,
access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions
for onward transfers and additional security measures.
Nature of the
processing
Performance of
the services set out in SCHEDULE 2 of this Agreement.
Purpose(s) for
which the personal data is processed on behalf of the controller
Performance of
the services set out in SCHEDULE 2 of this Agreement.
Duration of
the processing
The duration of
the processing is limited to the term of this Agreement (c.f. clause 11 of this Agreement)
For processing
by (sub-) processors, also specify subject matter, nature and duration of the processing
Sub-processor:
Centogene GmbH
Subject matter:
Provision of NV Services as set out in Schedule 2 (Scope of Services).
Nature of processing:
Collection, storage, consultation, use, disclosure by transmission, restriction, deletion and destruction (as applicable).
Duration of processing:
Duration of processing is limited to the term of this Agreement
ANNEX III
OF THE CLAUSES - TECHNICAL AND ORGANISATIONAL MEASURES INCLUDING TECHNICAL AND ORGANISATIONAL MEASURES TO ENSURE THE SECURITY OF THE
DATA
See attached.
ANNEX
IV OF THE CLAUSES: LIST OF SUB-PROCESSORS
The controller
has authorised the use of the following sub-processors:
Name |
Address |
Contact
person’s name, position and cotact details |
Description
of the processing |
Centogene
GmbH |
Am Strande
7, 18055 Rostock, Germany |
[***], CFO
[***]
|
Provision
of NV Services as described in this Agreement on Schedule 2 (Scope of Services) |
|
|
|
|
ANNEX
V OF THE CLAUSES:
STANDARD CONTRACTUAL
CLAUSES
for the transfer
of personal data to third countries pursuant to Regulation (EU) 2016/679, and in accordance with Commission Implementing Decision (EU)
2021/914 of 4 June 2021
MODULE 4: PROCESSOR
TO CONTROLLER TRANSFER
SECTION I
Clause 1
Purpose and
scope
| (a) | The purpose
of these standard contractual clauses is to ensure compliance with the requirements of Regulation
(EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection
of natural persons with regard to the processing of personal data and on the free movement
of such data (General Data Protection Regulation) for the transfer of personal data to a
third country. |
| (i) | the natural
or legal person(s), public authority/ies, agency/ies or other body/ies (hereinafter “entity/ies”)
transferring the personal data, as listed in Annex I.A. (hereinafter each “data exporter”),
and |
| (ii) | the
entity/ies in a third country receiving the personal data from the data exporter, directly
or indirectly via another entity also Party to these Clauses, as listed in Annex I.A. (hereinafter
each “data importer”) |
have
agreed to these standard contractual clauses (hereinafter: “Clauses”).
| (c) | These Clauses
apply with respect to the transfer of personal data as specified in Annex I.B. |
| (d) | The Appendix
to these Clauses containing the Annexes referred to therein forms an integral part of these
Clauses. |
Clause 2
Effect
and invariability of the Clauses
| (a) | These
Clauses set out appropriate safeguards, including enforceable data subject rights and effective
legal remedies, pursuant to Article 46(1) and Article 46 (2)(c) of Regulation (EU) 2016/679
and, with respect to data transfers from controllers to processors and/or processors to processors,
standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679, provided
they are not modified, except to select the appropriate Module(s) or to add or update information
in the Appendix. This does not prevent the Parties from including the standard contractual
clauses laid down in these Clauses in a wider contract and/or to add other clauses or additional
safeguards, provided that they do not contradict, directly or indirectly, these Clauses or
prejudice the fundamental rights or freedoms of data subjects. |
| (b) | These
Clauses are without prejudice to obligations to which the data exporter is subject by virtue
of Regulation (EU) 2016/679. |
Clause 3
Third-party
beneficiaries
| (a) | Data
subjects may invoke and enforce these Clauses, as third-party beneficiaries, against the
data exporter and/or data importer, with the following exceptions: |
| (i) | Clause
1, Clause 2, Clause 3, Clause 6, Clause 7; |
| (ii) | Clause
8 - Clause 8.1 (b) and Clause 8.3(b); |
| (iii) | Clause
15.1(c), (d) and (e); |
| (b) | Paragraph (a)
is without prejudice to rights of data subjects under Regulation (EU) 2016/679. |
Clause 4
Interpretation
| (a) | Where
these Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have
the same meaning as in that Regulation. |
| (b) | These Clauses
shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. |
| (c) | These Clauses
shall not be interpreted in a way that conflicts with rights and obligations provided for
in Regulation (EU) 2016/679. |
Clause 5
Hierarchy
In the event of
a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses
are agreed or entered into thereafter, these Clauses shall prevail.
Clause 6
Description
of the transfer(s)
The details of
the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred,
are specified in Annex I.B.
Clause 7 - Optional
Docking clause
[Not applicable]
SECTION II
– OBLIGATIONS OF THE PARTIES
Clause 8
Data protection
safeguards
The data exporter
warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical
and organisational measures, to satisfy its obligations under these Clauses.
| (a) | The
data exporter shall process the personal data only on documented instructions from the data
importer acting as its controller. |
| (b) | The data exporter
shall immediately inform the data importer if it is unable to follow those instructions,
including if such instructions infringe Regulation (EU) 2016/679 or other Union or Member
State data protection law. |
| (c) | The data importer
shall refrain from any action that would prevent the data exporter from fulfilling its obligations
under Regulation (EU) 2016/679, including in the context of sub-processing or as regards
cooperation with competent supervisory authorities. |
| (d) | After the end
of the provision of the processing services, the data exporter shall, at the choice of the
data importer, delete all personal data processed on behalf of the data importer and certify
to the data importer that it has done so, or return to the data importer all personal data
processed on its behalf and delete existing copies. |
| 8.2 | Security
of processing |
| (a) | The
Parties shall implement appropriate technical and organisational measures to ensure the security
of the data, including during transmission, and protection against a breach of security leading
to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access
(hereinafter “personal data breach”). In assessing the appropriate level of security,
they shall take due account of the state of the art, the costs of implementation, the nature
of the personal data, the nature, scope, context and purpose(s) of processing and the risks
involved in the processing for the data subjects, and in particular consider having recourse
to encryption or pseudonymisation, including during transmission, where the purpose of processing
can be fulfilled in that manner. |
| (b) | The data exporter
shall assist the data importer in ensuring appropriate security of the data in accordance
with paragraph (a). In case of a personal data breach concerning the personal data processed
by the data exporter under these Clauses, the data exporter shall notify the data importer
without undue delay after becoming aware of it and assist the data importer in addressing
the breach. |
| (c) | The data exporter
shall ensure that persons authorised to process the personal data have committed themselves
to confidentiality or are under an appropriate statutory obligation of confidentiality. |
| 8.3 | Documentation
and compliance |
| (a) | The
Parties shall be able to demonstrate compliance with these Clauses. |
| (b) | The data exporter
shall make available to the data importer all information necessary to demonstrate compliance
with its obligations under these Clauses and allow for and contribute to audits. |
Clause 9
Use of sub-processors
[Intentionally
Omitted]
Clause 10
Data subject
rights
The Parties shall
assist each other in responding to enquiries and requests made by data subjects under the local law applicable to the data importer or,
for data processing by the data exporter in the EU, under Regulation (EU) 2016/679.
Clause 11
Redress
| (a) | The
data importer shall inform data subjects in a transparent and easily accessible format, through
individual notice or on its website, of a contact point authorised to handle complaints.
It shall deal promptly with any complaints it receives from a data subject. |
Clause 12
Liability
| (a) | Each
Party shall be liable to the other Party/ies for any damages it causes the other Party/ies
by any breach of these Clauses. |
| (b) | Each Party
shall be liable to the data subject, and the data subject shall be entitled to receive compensation,
for any material or non-material damages that the Party causes the data subject by breaching
the third-party beneficiary rights under these Clauses. This is without prejudice to the
liability of the data exporter under Regulation (EU) 2016/679. |
| (c) | Where more
than one Party is responsible for any damage caused to the data subject as a result of a
breach of these Clauses, all responsible Parties shall be jointly and severally liable and
the data subject is entitled to bring an action in court against any of these Parties. |
| (d) | The Parties
agree that if one Party is held liable under paragraph (c), it shall be entitled to claim
back from the other Party/ies that part of the compensation corresponding to its / their
responsibility for the damage. |
| (e) | The data importer
may not invoke the conduct of a processor or sub-processor to avoid its own liability. |
Clause 13
Supervision
[Not applicable]
SECTION III
– LOCAL LAWS AND OBLIGATIONS IN CASE OF ACCESS BY PUBLIC AUTHORITIES
Clause 14
Local laws
and practices affecting compliance with the Clauses
| (a) | The
Parties warrant that they have no reason to believe that the laws and practices in the third
country of destination applicable to the processing of the personal data by the data importer,
including any requirements to disclose personal data or measures authorising access by public
authorities, prevent the data importer from fulfilling its obligations under these Clauses.
This is based on the understanding that laws and practices that respect the essence of the
fundamental rights and freedoms and do not exceed what is necessary and proportionate in
a democratic society to safeguard one of the objectives listed in Article 23(1) of Regulation
(EU) 2016/679, are not in contradiction with these Clauses. |
| (b) | The Parties
declare that in providing the warranty in paragraph (a), they have taken due account in particular
of the following elements: |
| (i) | the specific
circumstances of the transfer, including the length of the processing chain, the number of
actors involved and the transmission channels used; intended onward transfers; the type of
recipient; the purpose of processing; the categories and format of the transferred personal
data; the economic sector in which the transfer occurs; the storage location of the data
transferred; |
| (ii) | the
laws and practices of the third country of destination– including those requiring the
disclosure of data to public authorities or authorising access by such authorities –
relevant in light of the specific circumstances of the transfer, and the applicable limitations
and safeguards; |
| (iii) | any
relevant contractual, technical or organisational safeguards put in place to supplement the
safeguards under these Clauses, including measures applied during transmission and to the
processing of the personal data in the country of destination. |
| (c) | The data importer
warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts
to provide the data exporter with relevant information and agrees that it will continue to
cooperate with the data exporter in ensuring compliance with these Clauses. |
| (d) | The Parties
agree to document the assessment under paragraph (b) and make it available to the competent
supervisory authority on request. |
| (e) | The data importer
agrees to notify the data exporter promptly if, after having agreed to these Clauses and
for the duration of the contract, it has reason to believe that it is or has become subject
to laws or practices not in line with the requirements under paragraph (a), including following
a change in the laws of the third country or a measure (such as a disclosure request) indicating
an application of such laws in practice that is not in line with the requirements in paragraph
(a). |
| (f) | Following a
notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe
that the data importer can no longer fulfil its obligations under these Clauses, the data
exporter shall promptly identify appropriate measures (e.g. technical or organisational measures
to ensure security and confidentiality) to be adopted by the data exporter and/or data importer
to address the situation. The data exporter shall suspend the data transfer if it considers
that no appropriate safeguards for such transfer can be ensured, or if instructed by the
competent supervisory authority to do so. In this case, the data exporter shall be entitled
to terminate the contract, insofar as it concerns the processing of personal data under these
Clauses. If the contract involves more than two Parties, the data exporter may exercise this
right to termination only with respect to the relevant Party, unless the Parties have agreed |
otherwise.
Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e) shall apply.
Clause 15
Obligations
of the data importer in case of access by public authorities
| (a) | The
data importer agrees to notify the data exporter and, where possible, the data subject promptly
(if necessary with the help of the data exporter) if it: |
| (i) | receives
a legally binding request from a public authority, including judicial authorities, under
the laws of the country of destination for the disclosure of personal data transferred pursuant
to these Clauses; such notification shall include information about the personal data requested,
the requesting authority, the legal basis for the request and the response provided; or |
| (ii) | becomes
aware of any direct access by public authorities to personal data transferred pursuant to
these Clauses in accordance with the laws of the country of destination; such notification
shall include all information available to the importer. |
| (b) | If the data
importer is prohibited from notifying the data exporter and/or the data subject under the
laws of the country of destination, the data importer agrees to use its best efforts to obtain
a waiver of the prohibition, with a view to communicating as much information as possible,
as soon as possible. The data importer agrees to document its best efforts in order to be
able to demonstrate them on request of the data exporter. |
| (c) | Where permissible
under the laws of the country of destination, the data importer agrees to provide the data
exporter, at regular intervals for the duration of the contract, with as much relevant information
as possible on the requests received (in particular, number of requests, type of data requested,
requesting authority/ies, whether requests have been challenged and the outcome of such challenges,
etc.). |
| (d) | The data importer
agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of
the contract and make it available to the competent supervisory authority on request. |
| (e) | Paragraphs
(a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause
14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with
these Clauses. |
| 15.2 | Review
of legality and data minimisation |
| (a) | The
data importer agrees to review the legality of the request for disclosure, in particular
whether it remains within the powers granted to the requesting public authority, and to challenge
the request if, after careful assessment, it concludes that there are reasonable grounds
to consider that the request is unlawful under the laws of the country of destination, applicable
obligations under international law and principles of international comity. The data importer
shall, under the same conditions, pursue possibilities of appeal. When challenging a request,
the data importer shall seek interim measures with a view to suspending the effects of the
request until the competent judicial authority has decided on its merits. It shall not disclose
the personal data requested until required to do so under the applicable procedural rules.
These requirements are without prejudice to the obligations of the data importer under Clause
14(e). |
| (b) | The data importer
agrees to document its legal assessment and any challenge to the request for disclosure and,
to the extent permissible under the laws of the country of destination, make the documentation
available to the data exporter. It shall also make it available to the competent supervisory
authority on request. |
| (c) | The data importer
agrees to provide the minimum amount of information permissible when responding to a request
for disclosure, based on a reasonable interpretation of the request. |
SECTION IV
– FINAL PROVISIONS
Clause 16
Non-compliance
with the Clauses and termination
| (a) | The
data importer shall promptly inform the data exporter if it is unable to comply with these
Clauses, for whatever reason. |
| (b) | In the event
that the data importer is in breach of these Clauses or unable to comply with these Clauses,
the data exporter shall suspend the transfer of personal data to the data importer until
compliance is again ensured or the contract is terminated. This is without prejudice to Clause
14(f). |
| (c) | The data exporter
shall be entitled to terminate the contract, insofar as it concerns the processing of personal
data under these Clauses, where: |
| (i) | the data
exporter has suspended the transfer of personal data to the data importer pursuant to paragraph
(b) and compliance with these Clauses is not restored within a reasonable time and in any
event within one month of suspension; |
| (ii) | the
data importer is in substantial or persistent breach of these Clauses; or |
| (iii) | the
data importer fails to comply with a binding decision of a competent court or supervisory
authority regarding its obligations under these Clauses. |
In these
cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties,
the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise.
| (d) | Personal data
collected by the data exporter in the EU that has been transferred prior to the termination
of the contract pursuant to paragraph (c) shall immediately be deleted in its entirety, including
any copy thereof. The data importer shall certify the deletion of the data to the data exporter.
Until the data is deleted or returned, the data importer shall continue to ensure compliance
with these Clauses. In case of local laws applicable to the data importer that prohibit the
return or deletion of the transferred personal data, the data importer warrants that it will
continue to ensure compliance with these Clauses and will only process the data to the extent
and for as long as required under that local law. |
| (e) | Either Party
may revoke its agreement to be bound by these Clauses where (i) the European Commission adopts
a decision pursuant to Article 45(3) of Regulation (EU) 2016/679 that covers the transfer
of personal data to which these Clauses apply; or (ii) Regulation (EU) 2016/679 becomes part
of the legal framework of the country to which the personal data is transferred. This is
without prejudice to other obligations applying to the processing in question under Regulation
(EU) 2016/679. |
Clause 17
Governing
law
These Clauses shall
be governed by the law of a country allowing for third-party beneficiary rights. The Parties agree that this shall be the law of Germany.
Clause 18
Choice of
forum and jurisdiction
Any dispute arising
from these Clauses shall be resolved by the courts of Germany.
APPENDIX
ANNEX I
A.
LIST OF PARTIES
Data exporter:
Processor, as defined in SCHEDULE 3 ANNEX I to this Agreement
Data importer:
Controller, as defined in SCHEDULE 3 ANNEX I to this Agreement
B. DESCRIPTION OF TRANSFER
- access via IT
systems
- via email (not
sensitive data)
C.
COMPETENT SUPERVISORY AUTHORITY
The competent supervisory authority
in the EU Member State where the data exporter is established.
Schedule
4
STAFFING AND SECONDMENT
| 1.1 | Staffing under
this Agreement shall consist of the following groups: |
| 1.1.1 | Licensed
Personnel who are Seconded Personnel (“Licensed Seconded Personnel”); |
| 1.1.2 | Licensed
Personnel who are Other Personnel (“Licensed Other Personnel”); |
| 1.1.3 | Non-Licensed
Personnel who are Seconded Personnel (“Non-Licensed Seconded Personnel”);
and |
| 1.1.4 | Non-Licensed
Personnel who are Other Personnel (“Non-Licensed Other Personnel”), |
provided
that NV Personnel may alternate between such categories.
| 1.2 | Company and
NV will develop, and as needed from time to time, and agreed on by the Parties in writing,
adjust, staffing plans for NV Personnel that is in compliance with all Applicable Laws (each
a “Staffing Plan”), subject to the budgetary approval requirements set
forth in the Joint Venture Agreement and in accordance with the Business Plan. A preliminary
Staffing Plan is set forth in Exhibit A to this Schedule 4. The Staffing Plan shall be negotiated
in good faith following the Effective Date between the Parties and amended as necessary in
NV’s reasonable discretion. The Staffing Plan shall include arrangements with respect
to the payment of wages, benefits and Taxes (including VAT), in compliance with Applicable
Law and in accordance with applicable industry standards, if applicable. |
| 1.3 | Company shall
cooperate with the NV Personnel to permit them to render the NV Services in accordance with
this Agreement and the Staffing Plan. |
| 1.4 | Company shall
inform NV as soon as reasonably practicable of any action, omission, event or occurrence
of which Company becomes aware that may constitute: |
| 1.4.1 | a material
breach by any NV Personnel of any Approved Policy; or |
| 1.4.2 | a clinical
or laboratory error attributable to or exacerbated by a NV Personnel. |
Failure
by Company to so inform NV of any of the matters described above shall not be deemed as a waiver by Company of any of its rights and
remedies in connection therewith under this Agreement.
| 2. | Except
as expressly set forth herein, none of the provisions of this Agreement shall be construed
to have the effect of forming any employment relationship by and between any of the NV Personnel
and Company, and each of the NV Personnel shall remain an employee, officer, director, consultant,
contractor or agent, as applicable, of NV (or its relevant Affiliate) for all purposes, including
remuneration, promotion and career planning. |
| 2.1.1 | To
the extent any NV Personnel are on the premises of the KSA Facility or access Company’s
systems, NV shall ensure that such NV Personnel observe and comply with any requirements
under Schedule 3 (Personal Data and Information Security) and any Company policies
provided by Company to NV reasonably in advance and in writing |
and
applicable to Company contractors or staff on Company premises or accessing Company systems.
| 2.1.2 | NV
shall ensure all NV Personnel are suitably qualified and have the relevant management and
experience level required to provide the NV Services. Where NV Personnel are required to
have specific qualifications, certifications or levels of experience in accordance with the
Staffing Plan and/or Exhibit A to this Schedule 4 (Staffing and Secondment) NV shall
use Commercially Reasonable Efforts to ensure that the relevant NV Personnel involved in
providing the relevant NV Services to Company comply with such qualifications, certifications
or levels of experience. |
| 2.1.3 | Subject
to the terms of this Schedule 4 (Staffing and Secondment), NV Personnel shall remain
under the overall control and supervision of NV at all times during the Term and NV shall
be fully responsible for them. |
| 3.1 | If Company
is not reasonably satisfied with any NV Personnel for any reason, NV shall remove and replace
such NV Personnel as soon as reasonably practicable at Company’s reasonable request
and such replacement personnel shall otherwise meet the required qualifications, certifications
and levels of experience as described in clause 2.1.2 and to the reasonable satisfaction
of Company. |
| 3.2 | Notwithstanding
anything to the contrary herein, no provisions of this Agreement will be construed to have
the effect of forming any relationship of employer and employee between Company and any NV
Personnel, each of whom shall remain an employee of NV (or its relevant Affiliate) for all
purposes, including remuneration, promotion and career planning. Company shall employ Seconded
Personnel who the Parties agree in writing from time to time will be employed by Company
(the “Approved Seconded Personnel”) pursuant to a KSA employment contract
approved by the Parties in writing (each, an “Approved Employment Contract”).
Company shall supervise and control the activities of such Approved Seconded Personnel who
are employees of Company in a manner consistent with this Agreement. |
| 3.3 | NV shall permit
Company to employ such Approved Seconded Personnel, and shall permit such Approved Seconded
Personnel to perform NV Services also while they are outside the KSA. While in the KSA during
each secondment, such Approved Seconded Personnel shall devote substantially all of his or
her working time to Company. |
| 3.4 | Company will
be the sponsor and employer of such Approved Seconded Personnel for KSA immigration and labour
law purposes, and will assist such Approved Seconded Personnel in obtaining and maintaining
immigration and labour sponsorship as well as any other licenses or authorizations required
for their work in connection with this Agreement. It is understood and agreed that Company
shall have no liability whatsoever to any person if any Approved Seconded Personnel is unable
to obtain a residence visa, work permit, or other license or sponsorship. |
| 3.5 | Company shall
not enter into any amendments to an Approved Employment Contract or enter into any other
agreements with such Approved Seconded Personnel, without the advance written approval of
NV, such approval not to be unreasonably withheld or delayed. |
| 3.6 | The salary,
normal working hours and benefits of any Approved Seconded Personnel shall be as defined
and set out in the Approved Employment Contract, except as otherwise agreed between Company
and the affected Approved Seconded Personnel. |
| 3.7 | Company shall
comply with the Approved Employment Contracts, the Approved Policies and applicable KSA laws
and regulations that apply to the relevant Approved Seconded Personnel. Company shall not,
and shall not require the Approved Seconded Personnel to do anything that shall, breach any
provisions of the Approved Employment Contract or the Approved Policies. NV shall direct
each Approved Seconded Personnel that the Parties agree will be employed by Company from
time to time to comply with such individual’s Approved Employment Contract and the
Approved Policies. |
| 4. | Compensation
of NV Personnel |
Except
for the Project Consultation Fees directly payable by Company to NV Personnel (as applicable) pursuant to this Agreement, NV shall pay,
or cause the appropriate person to pay, all wages and benefits to which the NV Personnel may be entitled.
| 5.1 | Company shall
maintain a safe and secure premises for all NV Personnel providing the NV Services in KSA
and shall not knowingly direct any NV Personnel to engage in conduct or duties that may endanger
their safety or security or the safety or security of others. In addition, Company shall
take all reasonable steps to ensure a safe and harassment free working environment for NV
Personnel. Should Company learn of any safety, security, or harassment related issue, Company
shall promptly report such issue to NV and respond timely to correct the issue. |
| 5.2 | If at any time
NV reasonably determines the safety or security of any NV Personnel is endangered or they
are being asked to act contrary to Approved Policies, including NV Personnel being subjected
to a harassing environment, NV shall have the right upon reasonable written notice to Company
to require that appropriate action be taken to remedy the situation in a timely manner. |
EXHIBIT
A
[***]
Exhibit 99.3
Execution
Version
GENOMICS
INNOVATIONS COMPANY LIMITED
(“Company”)
and
CENTOGENE
N.V.
(“NV”)
dated
27 November 2023
|
LABORATORY SERVICES AGREEMENT
|
TABLE OF CONTENTS
Clause |
|
Page |
1. |
Definitions; Interpretation; Conflicts |
1 |
2. |
Engagement and Scope of Authority |
1 |
3. |
NV’s Obligations and Responsibilities |
4 |
4. |
Company’s Responsibilities |
8 |
5. |
Charges for the testing services |
9 |
6. |
TAXES |
10 |
7. |
REGULATORY |
11 |
8. |
COOPERATION |
15 |
9. |
Term |
15 |
10. |
Representations and Warranties |
15 |
11. |
Intellectual Property Rights |
17 |
12. |
Confidential information |
18 |
13. |
Indemnities |
19 |
14. |
LIMITATION ON Liability |
22 |
15. |
Force Majeure |
22 |
16. |
Insurance |
23 |
17. |
Termination |
24 |
18. |
Notices |
27 |
19. |
Assignment and Subcontracting |
28 |
20. |
Costs |
29 |
21. |
Audit |
29 |
22. |
Language |
29 |
23. |
Anti-Bribery and Corruption |
29 |
24. |
Export Control and Sanctions |
30 |
25. |
Further Assurance |
30 |
26. |
Waiver and Variation |
30 |
27. |
Severability |
31 |
28. |
Rights of Third Parties |
31 |
29. |
Governing Law; ARBITRATION and Jurisdiction |
31 |
30. |
Entire Agreement |
32 |
31. |
Counterparts |
32 |
Schedule 1 DEFINED TERMS AND INTERPRETATION |
34 |
Part 1 - Defined Terms |
34 |
Part 2 - Interpretation |
41 |
Schedule 3 DATA Sharing Agreement |
46 |
Schedule 2 SCOPE OF TESTING SERVICES |
42 |
Schedule 4 PRICING METHODOLOGY |
67 |
Schedule 5 t&Cs |
68 |
LABORATORY
SERVICES AGREEMENT
This LABORATORY
SERVICES AGREEMENT (the “Agreement”) is dated 27 November 2023 (the “Effective Date”), and
is entered into by and between:
| (2) | CENTOGENE
N.V., a company organized under the laws of the Netherlands with a registered office
at Am Strande 7, 18055 Rostock, Germany (“NV”). |
Company and NV
shall be referred to herein either individually as a “Party” or together as the “Parties”.
WHEREAS:
| (A) | NV and its
Affiliates (as defined below) have developed and maintain certain laboratories and a biodatabank
relating to patient samples collected in the ordinary course of its diagnostics business
at a site located in Rostock, Germany (“NV Facility”); |
| (B) | Company and
NV have entered into a Joint Venture Agreement dated 26 June 2023 (the “Joint Venture
Agreement”) for the establishment of Company and the operation of the KSA Facility
in the Kingdom; |
| (C) | Company and
NV have entered into a Technology Transfer and Intellectual Property License Agreement dated
27 November 2023 (“Technology Transfer and Intellectual Property License Agreement”)
for the purposes of transferring and licensing certain technology and data from NV to Company
in relation to the establishment of the KSA Facility; |
| (D) | Company and
NV have entered into a Consultancy Agreement dated 27 November 2023 (“Consultancy
Agreement”) for the provision by NV and its Affiliates of certain consultancy services
related to the construction and operation of the KSA Facility; |
| (E) | Company desires
to receive, and NV and its Affiliates have agreed to provide, certain laboratory services
in relation to patient samples collected in KSA; |
| (F) | NV and
its Affiliates have the facilities, rights, licenses, and expertise to conduct the Testing
Services (as defined below in clause 2.1.1) at the NV Facility, in accordance with all Applicable
Laws and the terms of this Agreement; and |
| (G) | The Parties
now desire to enter into this Agreement to document such terms and conditions. |
NOW, THEREFORE,
in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows:
| 1. | Definitions;
Interpretation; Conflicts |
Capitalized
terms used in this Agreement shall have the meanings given in Part 1 (Defined Terms) of Schedule 1 (Defined Terms and Interpretation).
This Agreement shall be interpreted in accordance with Part 2 (Interpretation) of Schedule 1 (Defined Terms and Interpretation).
| 2. | Engagement
and Scope of Authority |
| 2.1.1 | Subject
to the terms and conditions of this Agreement (including, for the avoidance of doubt, the
terms and conditions set forth in Schedule 5 (T&Cs)), during the Term, Company
hereby engages NV and its Affiliates, and NV and its Affiliates hereby agree to be so engaged,
as the exclusive provider of the products and services which NV and its Affiliates now or
in the future sell or otherwise make available to their other customers, and which, as of
the Effective Date, are described in Schedule 2 (Scope of Testing Services) (the “Testing
Services”). The Parties may amend Schedule 2 (Scope of Testing Services)
by mutual written agreement from time to time during the Term to reflect changes in the products
and services provided by NV and its Affiliates to its customers. In the event that, at any
time during the Term, Company requires a service that neither NV nor any of its Affiliates
is at such time providing to other customers (a “New Service”), Company
shall first discuss such New Service with NV before seeking to obtain such New Service from
a third party. NV shall, as promptly as reasonably practicable (and in any event within fourteen
(14) days) and in its sole discretion, determine whether it is able to provide such New Service
to Company, and if NV determines that it is able to provide such New Service and notifies
Company of the same, such New Service shall be deemed a Testing Service for purposes of this
Agreement and the terms and conditions set forth herein relating to Testing Services shall
apply to such New Service. If NV does not respond to Company within the foregoing fourteen
(14)-day period or if NV notifies Company in writing within such period that it is not able
to provide such New Service, Company may obtain such New Service from a third party at Company’s
sole cost and expense. NV may subcontract any of the Testing Services as set forth in clause 19.1. |
| (a) | In the
event that the Parties reach an agreement with respect to a set of Testing Services for a
particular project that is outside the scope of the performance of the Testing Services existing
as of such time (including, for the avoidance of doubt, with respect to Company Customer
Contracts), a new sequentially numbered project addendum for said Testing Services shall
be attached to this Agreement (each, a “Project Addendum”), and such Project
Addendum together with this Agreement shall collectively, independent from other Project
Addenda, constitute the entire agreement for the specific project. |
| (b) | NV acknowledges
and agrees that Company shall have no obligation to enter into any Project Addendum under
this Agreement, and any Project Addendum entered into hereunder shall be subject to NV complying
with the terms and conditions set forth in this Agreement. |
| (c) | No Project
Addendum shall be attached to this Agreement without first being executed by the Parties.
To the extent any terms set forth in a Project Addendum conflict with the terms set forth
in this Agreement, the terms of this Agreement shall control, unless otherwise mutually agreed
in writing by the Parties. |
The
Testing Services performed by NV or its Affiliates shall adhere to NV’s requirements for collection of biological samples (each
a “Sample,” and collectively, the “Samples”) where such Samples are provided by or on behalf of
the applicable Customer using kits for collection of such Samples (“Collection Kits”) in accordance with clause 3.2.
During
Phases 1 and 2 as described in Schedule 2 (Scope of Testing Services), dry-lab services, including analysing and interpreting
data and providing clinical reports to clinicians, shall be performed by NV and its Affiliates at the NV Facility. Beginning in Phase
3 as described in Schedule 2 (Scope of Testing Services), all dry-lab services shall be provided by Company and neither NV nor
any of its Affiliates shall have any further obligation to provide any dry-lab services to Company. If additional support for dry-lab
services is requested by Company following the conclusion of Phase 2, the Parties shall discuss the provision of such services in good
faith, including the payment of additional fees to NV.
NV and
its Affiliates at all times shall be deemed an independent contractor and neither it nor any of its Affiliates or any of their respective
employees, directors, contractors, permitted subcontractors or outside consultants shall be considered to be an agent, servant, employee
or representative of Company.
In the
event NV or its Affiliates notifies Company in writing that it is unable to provide a particular Testing Service, Company shall have
the right to engage related third-party service providers, at its sole discretion, to provide such Testing Service, at Company’s
sole cost and expense and solely for the period in which NV or its Affiliates is unable to provide such Testing Service. Notwithstanding
anything to the contrary herein, the Parties hereby agree that the provisions set out in clause 10.2 (Restrictive Covenants) of
the Joint Venture Agreement shall apply to this Agreement mutatis mutandis.
| 2.4 | Retention
of Control by Company and Limitation on Authority |
Company
and NV expressly acknowledge and agree that this Agreement does not convey ownership or Control over all or any part of Company or the
KSA Facility to NV. Company owns and controls all rights to the KSA Facility, subject to the terms of the Technology Transfer and Intellectual
Property License Agreement.
| 2.5 | NV shall not,
pursuant to this Agreement, take any actions: |
| 2.5.1 | that
require the prior approval of or are reserved to the Board of Directors, or the Shareholders,
without first ensuring that such actions have been approved by the applicable governing body,
or otherwise contravene any approval right under the Joint Venture Agreement; |
| 2.5.2 | that
contravene policies adopted by Company or any directives issued by the Board of Directors,
in each case that have been provided to NV in advance in writing; or |
| 2.5.3 | on
behalf of, or assume, create or incur liability or obligation, against, in the name of, or
on behalf of, any of Company, any Shareholder or the KSA Facility, except to the extent expressly
permitted under this Agreement or authorized in writing by or on behalf of Company. |
| 2.6 | Company shall
not, pursuant to this Agreement, take any actions: |
| 2.6.1 | that
contravene policies adopted by NV that have been provided to Company in advance in writing
in connection with the provision of Testing Services at the KSA Facility; or |
| 2.6.2 | on
behalf of, or assume, create or incur liability or obligation, against, in the name of, or
on behalf of, NV, its Affiliates or the NV Facility, except to the extent expressly authorized
in writing by or on behalf of NV. |
| 3. | NV’s
Obligations and Responsibilities |
| 3.1.1 | NV
shall (or shall cause its Affiliates to) perform Testing Services in Schedule 2 (Scope
of Testing Services) using Samples collected from the Collection Kit (unless otherwise
set forth in any applicable Project Addendum), as ordered from time to time by Customers
pursuant to their respective agreements with Company, or as otherwise specified by Company
on a per test basis in accordance with clause 3.2, in a timely and professional manner by
applying Commercially Reasonable Efforts to provide levels of accuracy, quality, safety,
completeness, timeliness and care consistent with the levels provided by NV and its Affiliates
with respect to Testing Services at the NV Facility, industry standards as of the date hereof
and in accordance with: |
| (a) | the terms
and conditions of this Agreement and all Schedules, any applicable Project Addendum and all
attachments thereto; |
| (b) | NV’s
policies and guidelines with respect to Testing Services; |
| (c) | applicable
policies and guidelines provided by or on behalf of Company to NV in writing from time to
time (including confidentiality and data protection) in respect of the Testing Services;
provided that such policies and guidelines do not conflict with any policies and guidelines
of NV; |
| (e) | general
standards of Good Laboratory Practice as appropriate; and |
| (f) | all relevant
consents. |
| 3.1.2 | With
respect to each Testing Service, NV shall ensure that any applicable equipment, medical gases,
medical equipment and supplies, consumables and other items supplied or used in the performance
of such Testing Service comply with Applicable Law, regulatory guidance, and any relevant
consents. |
| (a) | ensure
its staff undertaking the tests are suitably skilled, experienced and qualified to carry
out such tests; |
| (b) | nominate
an infection prevention lead; |
| (c) | comply
with all Applicable Laws in relation to infection prevention; |
| (d) | nominate
a member of the NV Personnel to be responsible for ensuring compliance with the KSA PDPL;
and |
| (e) | ensure
staff are covered by commercially reasonable insurance or indemnity arrangements appropriate
for the performance of this Agreement. |
| 3.2.1 | Until
Company’s ordering portal is operational, Customers shall request Collection Kits using
NV’s ordering portal, CentoPortal (the “CentoPortal”) or other established
communication channels (e.g., directly via regional sales manager) pursuant to their
respective agreements with Company, and NV shall confirm such request, in each case, in accordance
with the terms and conditions in Schedule 5 (T&Cs). |
| 3.2.2 | Unless
otherwise agreed by the Parties in writing, NV or its Affiliates shall ship the Collection
Kits (or shall cause such Collection Kits to be shipped) to Company, at Company’s sole
cost and expense (including all shipping costs), for Company to distribute to Customers. |
| 3.2.3 | Unless
otherwise agreed by the Parties in writing, Company shall arrange for Customer to ship each
Sample to NV, or its Affiliate, at Company’s sole cost and expense (including all shipping
costs) and in compliance with Applicable Law. Company shall ensure that the applicable Customer
provides NV with an order for Testing Services for a corresponding Sample. |
| 3.2.4 | NV
shall report results from the performance of Testing Services on such Sample in accordance
with the consent provided to NV or its Affiliate in connection with providing the Testing
Services, to Company in accordance with clause 3.3. NV shall be responsible for fulfilling
any results reporting requirements to appropriate health authorities as may be required by
Applicable Law. |
| 3.2.5 | Subject
to clause 26.3, the Parties hereby acknowledge and agree that the provisions set out in this
clause 3.2 may change as the phases set forth in Schedule 2 (Scope of Services) of
the Consultancy Agreement progress and the KSA Facility is operational. The Parties shall
use Commercially Reasonable Efforts to amend the provisions of this clause 3.2 as necessary
to reflect Company’s capabilities to conduct testing services in accordance with clause
26.3. |
| 3.3.1 | NV
shall provide Company with report results and conclusions from the Testing Services in a
timely manner in accordance with the applicable patient consent form and Applicable Law. |
| 3.3.2 | Company
may provide the report results and conclusions from the Testing Services to the Customer
in accordance with the applicable patient consent form and Applicable Law (it being understood
that NV shall provide results directly to the Customer until Company is able to do so). |
| 3.3.3 | NV
shall provide Company with conclusions, insights and analysis in relation to the report results
generated by NV or its Affiliates during the performance of the Testing Services in a timely
manner. |
| 3.4 | Notice of
Factors Affecting Performance |
Without
limitation to its other obligations under this Agreement, NV shall promptly, but no more than ninety-six (96) hours from discovery, advise
Company in writing of the occurrence of any event or other issue that may materially delay or affect the performance of any Testing
Services
under this Agreement. Without limiting the foregoing, in the event that NV receives any written notice from any Regulatory Authority,
Governmental Authority, licensing agency or other compliance organization that NV is not or may not be in compliance with any Applicable
Laws relating to the Testing Services, NV shall as promptly as reasonably practicable notify Company of the receipt of such correspondence
and provide a copy thereof to Company with a response of denial or remediation plan, as the case may be, in each case, subject to Applicable
Law. Following receipt of notice of any of the foregoing, Company shall have:
| 3.4.1 | no
obligation to send any Samples for Testing Services until the issue has been fully investigated
and resolved to Company’s reasonable satisfaction; |
| 3.4.2 | the
right to obtain the Testing Services from other sources (including by performing the Testing
Services itself or through Company’s Affiliates) without liability to NV and at NV’s
cost and expense for re-testing of any affected tests; provided that Company may only
obtain Testing Services from other sources if NV has failed to remediate any such issues
in accordance with its remediation plan, as mutually agreed between the Parties; |
| 3.4.3 | the
right to request NV to take reasonable remedial actions, at NV’s sole cost and expense;
provided that if such event or issue is due to Company’s failure to perform or material
error in performing the Company Obligations, such remedial actions shall be at Company’s
sole cost and expense. |
NV
is and remains responsible for the cost of any Collection Kit (including all shipping and other associated costs for the replacement)
that requires replacement due to laboratory delays by NV, errors by NV in handling the Collection Kit or in performing the Testing Services
using the Samples generated from the Collection Kit; provided that for the avoidance of doubt, NV shall not be responsible for
the cost of replacing any Collection Kit if such replacement is needed due to any error made solely by Company, or any of its Affiliates,
in the performance of the Company Obligations.
| 3.6 | Insufficient
or Inadequate Samples |
For
tests not performed due to patient error or inadequate Samples, NV shall notify Company via the CentoPortal within four (4) Business
Days of receipt of the Collection Kit and state the reason the Testing Services could not be performed using the Sample generated from
such Collection Kit. Sample disposal shall follow NV’s established processes in compliance with the applicable patient consents
and Applicable Law and Company may request a new Sample for Testing Services at Company’s sole cost and expense.
Company
acknowledges and agrees that NV and its Affiliates shall have no obligation to return to Company any Samples; provided that NV
and its Affiliates agree to dispose of any such Samples in compliance with the applicable patient consents and Applicable Law.
| 3.8 | Errors in
Commercial Testing Services |
| 3.8.1 | Subject
to clause 3.8.2, in the event NV commits an error in the performance of Testing Services
hereunder that renders the results of the Testing Services partially or wholly inaccurate
or invalid, then NV shall promptly notify Company and undertake Commercially Reasonable Efforts
to promptly cure such error and/or repeat such Testing Services without additional costs
to Company. |
| 3.8.2 | If
an error in the performance of Testing Services cannot be reasonably corrected by NV, then
NV shall return to Company any and all fees paid to NV hereunder in connection with those
defective or erroneous Testing Services and at Company’s option, shall be responsible
for the cost of replacement Collection Kits (including shipping costs); provided that
NV shall not be responsible for returning any fees paid hereunder or payment of any costs
due to: (a) errors made solely by Company or any of its Affiliates in Company’s performance
of the Company Obligations; or (b) Company’s performance of wet laboratory services
during Phase 2 of the Testing Services (as set forth in Schedule 2 (Scope of Testing Services)),
in which case, all costs related to wet laboratory services errors, including with respect
to NV’s re-performance of such services, shall be borne solely and exclusively by Company. |
The
remedy under this clause 3.8 is not exclusive and is in addition to Company’s other rights and remedies under this Agreement, at
law, or in equity.
| 3.9.1 | NV
shall maintain sufficient capacity to perform the Testing Services set forth in the initial
forecast in the Business Plan. |
| 3.9.2 | By
no later than Monday of each calendar quarter during the Term, Company shall notify NV in
writing of its good faith forecast (the “Annual Forecast”) for the next
fifty-two (52) weeks with respect to Company’s requirements for the Testing Services.
NV shall use Commercially Reasonable Efforts to meet the requirements set forth in the Annual
Forecast; provided that such forecasts are consistent with the Business Plan or ten
percent (10%) above the levels provided in the Business Plan. In the event Company requires
Testing Services in excess of ten percent (10%) above the levels set forth in the Business
Plan (“Excess Services”), Company shall first discuss such additional
requirements with NV. NV shall, as promptly as reasonably practicable (and in any event within
fourteen (14) days) and in its sole discretion, determine whether it is able to provide such
Excess Services to Company or sub-contract such Excess Services from a third party that is
reasonably acceptable to Company on substantially the same terms as this Agreement, and if
NV determines that it is able to provide or outsource such Excess Services, NV shall notify
Company of the same, such Excess Services shall be deemed a Testing Service for purposes
of this Agreement and the terms and conditions set forth herein relating to Testing Services
shall apply to such Excess Service. If NV does not respond to Company within the foregoing
fourteen (14)-day period or if NV notifies Company in writing within such period that it
is not able to provide (or cause to be provided) such Excess Services, Company may obtain
such Excess Services from any third party at Company’s sole cost and expense provided
that, in the event such Excess Services relate to wet lab services and such third party
offers to provide dry lab services in addition to such Excess Services, Company shall use
Commercially Reasonable Efforts for such third party to only provide wet lab services and
to continue to have NV provide dry lab services. |
| 3.10.1 | NV
shall designate a representative (the “NV Representative”) who shall be
NV’s relationship manager for purposes of this Agreement and to facilitate NV’s
provision of the Testing Services under, and the administration of, this Agreement. At all
times, NV shall designate a NV Representative who has the qualifications, expertise, industry
experience and prior relationship with NV to assure Company that such NV Representative would
successfully fulfil the role he or she is engaged to provide under this Agreement. The initial
NV Representative shall be Miguel Coego. In the event NV is intending to replace the NV Representative,
NV shall inform Company of such intent |
and
provide a reasonable explanation for the replacement need at least ten (10) Business Days prior to replacing the NV Representative to
the extent reasonably practicable. NV shall ensure that any such. replacement shall meet all of Company’s requirements as provided
herein.
| 3.10.2 | If
Company is not reasonably satisfied with the NV Representative, it shall provide detailed
information to NV regarding its reasons for dissatisfaction and NV shall use Commercially
Reasonable Efforts to address the reasons presented by Company. If after such Commercially
Reasonable Efforts have been made, Company still remains dissatisfied with the NV Representative,
NV shall remove and replace such NV Representative as soon as reasonably practicable, and
such replacement shall otherwise meet the qualifications as described in clause 3.10.1. |
NV shall
keep such business, financial and other records and other documentation as consistent with NV’s retention policies relating to
its activities undertaken in connection with the provision of the Testing Services, in accordance with Applicable Laws including records
relating to:
| 3.11.1 | its
compliance with Applicable Laws; |
| 3.11.2 | its
performance of the Testing Services; and |
| 3.11.3 | any
data generated in the performance of the Testing Services, |
and
shall, if required pursuant to clause 21 of this Agreement and subject to Applicable Law (including, for the avoidance of doubt, any
and all Applicable Law and applicable patient consents relating to the disclosure and other processing of protected health information),
make such records available for inspection and/or provide copies thereof to an independent professional firm appointed by Company that
is reasonably acceptable to NV.
NV will
act in good faith to comply with its obligations under this Agreement.
| 4. | Company’s
Responsibilities |
| 4.1 | As between
the Parties (except as otherwise explicitly required by Applicable Law or as otherwise agreed
between the Parties in writing), Company or a Company Affiliate shall be solely responsible
for: |
| 4.1.1 | communicating with Customers,
including with respect to providing instructions for collection of Samples using the Collection Kit (it being understood that any communications
by Company with Customers with respect to such Customer’s use of the Collection Kits or NV’s performance of the Testing Services
shall be made in accordance with any instructions provided by NV) and provided Company shall not be liable for costs of any replacement
kits or Claims resulting from communications with Customers if such Claims are based solely on instructions provided by NV; |
| 4.1.2 | delivery
of Collection Kits to Customers; and |
| 4.1.3 | delivery
of Samples to NV for Testing Services (collectively, “Company Obligations”). |
Company
is solely responsible for any and all costs and expenses incurred in connection with the Company Obligations, including any shipping
costs. NV shall not be liable for any failure
in performing
the Testing Services if such failure is due to Company’s failure to perform or error in performing the Company Obligations. The
Parties hereby acknowledge and agree that the provisions set out in this clause 4.1 will change as the phases set forth in Schedule 2
of the Consultancy Agreement progress. The Parties shall use Commercially Reasonable Efforts to amend the provisions of this clause 4.1
as necessary.
| 4.2 | Company shall
use Commercially Reasonable Efforts to perform Company Obligations in a professional manner
consistent with industry standards and act in accordance with: |
| 4.2.1 | the
terms and conditions of this Agreement and all Schedules, and any applicable Project Addendum; |
| 4.2.2 | applicable
policies and guidelines provided by or on behalf of NV to Company relating to the provision
of the Testing Services in writing from time to time (including confidentiality and data
protection) provided that such policies and guidelines do not conflict with any policies
and guidelines of Company; |
| 4.2.3 | Applicable
Laws (including nominating a member of the Company Personnel to be responsible for ensuring
compliance with the KSA PDPL); and |
| 4.2.4 | all
relevant patient consents. |
| 4.3 | Company Representative |
Company
shall designate a representative (the “Company Representative”) who shall be Company’s relationship manager
for purposes of this Agreement and to facilitate Company’s receipt of the Testing Services under, and the administration of, this
Agreement. At all times, Company shall designate a Company Representative who has the qualifications, expertise and industry experience
to assure NV that such Company Representative would successfully fulfil the role he or she is engaged to provide under this Agreement.
The initial Company Representative shall be Jeremy Panacheril. In the event Company is intending to replace the Company Representative,
Company shall inform NV of such intent and provide an explanation for the replacement need at least ten (10) Business Days prior to replacing
the Company Representative. Company shall ensure that any such replacement shall meet all of the requirements as provided herein.
Company
shall keep such business, financial and other records and other documentation as consistent with industry standards relating to its activities
undertaken in connection with this Agreement, in accordance with Applicable Laws including:
| 4.4.1 | its
compliance with Applicable Laws; and |
| 4.4.2 | its
performance of the Company Obligations. |
Company
will act in good faith to comply with its obligations under this Agreement.
| 5. | Charges for
the testing services |
| 5.1 | In consideration
for NV’s performance of its obligations under this Agreement (including Schedule 2
(Scope of Testing Services)), except as otherwise set forth in any Project Addendum, |
the
fees payable for the Testing Services (“Testing Fees”) shall be calculated in accordance with the methodology set
forth in Schedule 4 (Pricing Methodology).
| 5.2 | NV shall invoice
Company on a monthly basis for the Testing Services (each, an “Invoice”)
in Euros (EUR). Subject to clause 5.4, Company shall pay to NV all undisputed amounts set
forth in an Invoice within sixty (60) days of Company’s receipt of the Invoice. |
| 5.3 | All payments
of the Testing Fees from Company to NV shall be payable in Euros (EUR). The Testing Fee shall
be paid by wire transfer in immediately available funds into such bank account nominated
by NV to Company in writing prior to the relevant payment of the Testing Fee. Company shall
be liable for all bank charges relating to such wire transfers for the Testing Fee. |
| 5.4 | Company may
withhold payment of any part of an Invoice that it disputes in good faith. Company and NV
will establish a working level committee and a process to address any dispute that Company
has about an Invoice. Company shall pay any undisputed portion of an Invoice as provided
in this clause 5. If a Dispute about an Invoice is not resolved within thirty (30) days of
Company’s receipt of the Invoice, then it will be resolved pursuant to the Dispute
resolution procedures set out in clause 29.2 of this Agreement. |
| 6.1 | Without prejudice
to the generality of clause 6.2 below, the Testing Fee payable in accordance with this Agreement
shall be exclusive of any additional Taxes, levies or fees that may apply to the provision
of the Testing Services. Any such Taxes, levies or fees shall be payable in addition to,
and at the same time and in the same manner as, the Testing Fee against provision by NV to
Company of an invoice for the same; provided that Company shall only be responsible
for withholding taxes if NV does not have a permanent establishment in KSA. Any additional
Taxes shall not include any taxes, levies or fees applicable to NV for a taxable presence
in KSA relating to a permanent establishment for corporation income tax. Any Taxes relating
to the permanent establishment of NV shall be solely borne by NV and not Company. |
| 6.2 | All amounts,
monetary or otherwise, expressed under this Agreement which (in whole or in part) constitute
the consideration for any supply for VAT purposes by NV are deemed to be exclusive of any
VAT which is chargeable on that supply, and accordingly if VAT is or becomes chargeable on
any supply made by NV to any Party under this Agreement and NV is required to account to
the relevant tax authority for VAT on that supply, Company must pay to NV (in addition to
and at the same time as paying any other consideration for such supply, or at the point the
VAT becomes due to be paid or accounted for by NV if earlier) an amount equal to the amount
of that VAT (and NV must promptly provide an appropriate VAT invoice to Company where so
required to by Applicable Law). In this clause 6.2, references to “NV” shall
include reference to a relevant Affiliate of NV. NV shall provide a valid tax invoice to
Company. |
| 6.3 | In relation
to any supply made by NV (or a relevant Affiliate) to Company under this Agreement, if reasonably
requested by Company, NV must promptly provide Company with details of NV’s (or the
relevant Affiliate’s) VAT registration and such other information as is reasonably
requested in connection with Company’s VAT reporting requirements in relation to such
supply. |
| 6.4 | The following
provisions shall apply should any payment in respect of any Testing Fee from Company to NV
be subject by Applicable Law to any deduction or withholding on account of Tax: |
| 6.4.1 | The
Tax Deduction will be made in the minimum amount permitted by Applicable Law and Company
shall account to the relevant tax authority for the same, in full and within |
all
applicable time limits; provided that any late payment fees or penalties associated with Company’s failure to comply with
this clause 6.4.1 shall be borne solely by Company.
| 6.4.2 | Company
shall provide evidence, reasonably satisfactory to NV, of the Tax Deduction and any relevant
payment to a tax authority on written request from NV to Company. |
| 6.4.3 | NV
shall (or shall procure that a relevant Affiliate shall), on written request from Company,
provide a declaration of Tax residence on the prescribed forms and obtain certification by
the relevant taxation authority in order to confirm the applicability and availability of
any reduced rate of withholding on account of Tax, pursuant to the provisions of any relevant
double taxation treaties or otherwise. |
| 6.4.4 | If
a Tax Deduction is required by Applicable Law to be made by Company in relation to any payment
in respect of the Testing Fee, the amount of the payment due from Company shall be increased
to an amount which (after making any Tax Deduction) leaves an amount equal to the payment
which would have been received if no Tax Deduction had been required. |
| 6.4.5 | If
Company has been obliged to make an increased payment under clause 6.4.4 in respect of a
Tax Deduction and NV determines that: |
| (a) | a Tax Credit
is attributable to that payment, or to the relevant Tax Deduction; and |
| (b) | that NV
(or a relevant Affiliate) has obtained and utilised that Tax Credit, |
then
NV shall pay to Company an amount (or procure the payment by the relevant Affiliate of an amount to Company) which NV determines will
leave it (or the relevant Affiliate), after that payment, in the same after-Tax position as it would have been had no increased payment
under clause 6.4.4 been required to be made by Company.
| 6.5 | Company shall
report and pay VAT directly to the relevant KSA tax authority to the extent that the amounts
charged by NV to Company under this Agreement are subject to VAT under the Applicable Laws
of KSA. Notwithstanding any other provision of clause 6 or this Agreement, in relation to
any Taxes that NV may incur related to the registration of NV as a permanent establishment
in KSA, NV shall notify Company of such Taxes, comply with any requirements under Applicable
Law and follow all necessary compliance and registration requirements. NV shall bear any
associated costs including any Taxes, fines or penalties from a Governmental Authority, or
Regulatory Authority. |
| 7.1 | Regulatory
Compliance and Approvals |
| 7.1.1 | Except
as otherwise set forth in any applicable Project Addendum, NV shall be solely responsible
for ensuring and maintaining compliance of the tests for the uses contemplated in this Agreement,
including in performing the Testing Services to be performed by NV and shall at all times
comply with all Applicable Laws. |
| 7.1.2 | NV
shall hold CLIA and CAP accreditation and any other regulatory approvals and permits necessary
to perform Testing Services at the NV Facility during the Term. |
| 7.2 | Complaints;
Cooperation; Recalls |
| 7.2.1 | NV
shall report to Company in writing promptly upon NV’s receipt of any complaints, or
upon becoming aware of problems or potential issues, concerning the Testing Services. NV
shall have a system in place to document such complaints, and to conduct investigations when
appropriate. |
| 7.2.2 | Company shall report to NV in
writing promptly upon Company’s receipt of any complaints from Customers regarding the performance of Phase 1 and, to the extent
applicable to NV, Phase 2 of the Testing Services. Company shall have a system in place to document such complaints, and to conduct investigations
when appropriate. |
| 7.2.3 | Each
Party shall at all times provide reasonable cooperation with any Governmental Authority or
Regulator in connection with the Testing Services and provide all such reasonable assistance
as such other Party may require in dealing with Governmental Authorities or Regulators as
is relevant to the Testing Services. In the event: |
| (a) | any Governmental
Authority or Regulator issues a request, directive or governmental order that the test should
or must be recalled, or that it cannot be marketed; or |
| (b) | Company
or NV determines that any test should or must be recalled, or cannot be marketed (it being
understood that Company may only be permitted to make such determination following Phase
1 as set forth in Schedule 2 (Scope of Testing Services) of this Agreement and only
upon mutual agreement with NV), |
each
Party, at its own sole cost and expense (subject to clause 7.2.4), shall reasonably co-operate in any investigations and take appropriate
corrective actions.
| 7.2.4 | In
the event that such recall or Governmental Authority or Regulator assertion in clauses 7.2.1.
7.2.2 or 7.2.3 results from the gross negligence, intentional misconduct, or material breach
of the terms of this Agreement or any applicable Project Addendum by NV or design defect
for any tests developed by NV, NV shall be responsible to Company for any Testing Fees paid
or payable, and any and all costs incurred by or on behalf of Company related to the recall
or Governmental Authority or Regulator assertion, including in connection with the Collection
Kits, testing results and communications with Customers regarding the recall. For the avoidance
of doubt, the remedies under this clause 7.2.4 are not exclusive. |
| 7.3 | Communication
with Company Customers and End-Users |
| 7.3.1 | Subject
to clause 7.3.2, Company or a Company Affiliate shall be solely responsible for communicating
with Customers and/or patients, including with respect to providing instructions for collection
of Samples and Collection Kits provided that such instructions shall comply with reasonable
written instructions provided by NV or its Affiliate to Company; unless otherwise agreed
in writing between the Parties. |
| 7.3.2 | NV
may communicate with Customers on Company’s request, solely to the extent required
with respect to its performance of the Testing Services or under Applicable Law (including
for the avoidance of doubt, providing results of such Testing Services to the Customer until
Company is able to do so), at all times in proper coordination with Company, and NV shall
promptly provide copies of any and all such communication with its Customers and/or patients
to Company. |
| 7.4 | Regulatory
Visit, Investigation or Audit; Correspondence with Governmental Authorities |
| 7.4.1 | In
the event NV receives notice of a visit, investigation or audit by any Governmental Authority
or Regulator relating to, or that has the potential to materially affect or impact the Testing
Services, NV will notify Company promptly, and in no event later than forty-eight (48) hours
after receipt of such notice (or in the event NV does not receive prior notice of said visit,
investigation or audit, in no event later than seventy-two (72) hours from the initiation
of the visit, investigation or audit). NV will ensure that NV and its agents and employees
cooperate with any visits, investigations or audits by Governmental Authorities or Regulators
related to or that have the potential to materially affect the Testing Services. NV agrees
that Company or its designee may be present during any such visit, investigation or audit
unless prohibited by Applicable Law. NV shall provide Company a copy of any correspondence
proposed to be submitted to or received from a Governmental Authority or Regulator and shall
provide Company a reasonable opportunity to review and comment on any such proposed correspondence
or proposed response prior to its submission to the Governmental Authority to the extent
such correspondence involves the Testing Services, and NV shall incorporate such reasonable
comments of Company; provided that Company must provide any such comments within five
(5) Business Days of receipt of NV’s proposed response. |
| 7.4.2 | In
the event Company receives notice of a visit, investigation or audit by any Governmental
Authority or Regulator relating to or that has the potential to materially affect or impact
Phase 1 or NV’s dry lab analysis under Phase 2 of the Testing Services as set forth
in Schedule 2 (Scope of Testing Services), Company will notify NV promptly, and in
no event later than forty-eight (48) hours after receipt of such notice (or in the event
Company does not receive prior notice of said visit, investigation or audit, in no event
later than seventy-two (72) hours from the initiation of the visit, investigation or audit).
Company will ensure that Company and its agents and employees cooperate with any visits,
investigations or audits by Governmental Authorities or Regulators related to or that have
the potential to materially affect the Testing Services. Company agrees that NV or its designee
may be present during any such visit, investigation or audit unless prohibited by Applicable
Law. Company shall provide NV a copy of any correspondence proposed to be submitted to or
received from a Governmental Authority or Regulator. |
| 7.5 | Data Privacy
and Cybersecurity Requirements |
| 7.5.1 | Each
Party agrees to comply with Applicable Data Protection Laws and the provisions of Schedule
3 (Data Sharing Agreement) to the extent applicable to each Party’s performance
of its obligations under this Agreement. |
| 7.5.2 | To
the extent that the performance of the Testing Services set out in Schedule 2 (Scope
of Testing Services) entail data processing operations whereunder the Parties do not
qualify as independent controllers under the GDPR and/or KSA PDPL, the Parties undertake
to negotiate in good faith and enter into any data protection related agreement to the extent
such an agreement is necessary to comply with the GDPR and/or KSA PDPL prior to the commencement
of the respective Testing Services. |
| 7.5.3 | The
Parties further agree to negotiate in good faith modifications to this Agreement, including
Schedule 3 (Data Sharing Agreement), if changes are required for the Parties to continue
to process Personal Data as contemplated by this Agreement in compliance with Applicable
Data Protection Laws or to address the legal interpretation of Applicable Data Protection
Laws, including: |
| (a) | to comply
with the KSA PDPL, including any guidance issued by a Regulatory Authority; |
| (b) | to comply
with applicable international Personal Data transfer requirements; and |
| (c) | to obtain
authorisation or approval from a Regulatory Authority prior to transferring Personal Data
outside of the relevant jurisdiction if such authorisation or approval is required. |
| 7.5.4 | To
the extent NV collects, stores, hosts or otherwise processes Personal Data on behalf of Company
in connection with the performance of the Testing Services, NV shall: |
| (a) | Notify
Company as promptly as practicable, and in any event within forty-eight (48) hours, of becoming
aware of a breach of security leading to the accidental or unlawful destruction, loss, alteration,
unauthorised disclosure of, or access to, such Personal Data; |
| (b) | Reasonably
comply with Company organisational policies and procedures regarding cybersecurity, as provided
in advance to NV in writing from time to time; and |
| (c) | Process
such Personal Data in accordance with Kingdom laws relating to cybersecurity and cloud computing,
including as issued by Regulatory Authorities such as the National Cybersecurity Authority
and the Communications, Space and Technology Commission. |
| 7.5.5 | To
the extent Company collects, processes, stores or hosts Personal Data on behalf of NV in
connection with the receipt of the Testing Services, Company shall notify NV as promptly
as practicable, and in any event within 48 hours, of becoming aware of a breach of security
leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure
of, or access to, such Personal Data. |
| 7.6.1 | NV
represents and warrants that neither it nor any NV Personnel providing Testing Services hereunder
is an Ineligible Person or, to the knowledge of NV, currently subject to or under investigation
for debarment, exclusion, suspension or any other event that may make NV or such person an
Ineligible Person. As used herein “Ineligible Person” shall mean an individual
or other person who: |
| (a) | is currently
excluded, debarred, suspended or otherwise ineligible to participate in health care programs
or state procurement or non-procurement programs; or |
| (b) | has been
convicted of a criminal offense. |
| 7.6.2 | During
the Term of this Agreement, NV shall notify Company in writing within twenty-four (24) hours
of discovery of NV or any NV Personnel providing Testing Services hereunder becoming an Ineligible
Person or becoming subject to or under investigation for debarment, exclusion, suspension
or any other event that may make NV or such person an Ineligible Person. Any such occurrence
or breach by NV of this clause 7.6.2 shall constitute a material breach of this Agreement
by NV and grounds for termination of this Agreement by Company under clause 17.2 and Company
shall be entitled to any and all remedies arising out of or otherwise relating to such material
breach. |
| 8.1.1 | cooperate
in good faith with the other Party and subject to clause 12 of this Agreement, make such
information available to the other Party so as to enable such Party to perform its obligations
under this Agreement, where such information is in its possession and is disclosable, within
the time periods specified herein or, where no time period is specified, within a reasonable
time period; and |
| 8.1.2 | act
in a cooperative manner in dealing with the other Party in connection with this Agreement. |
This
Agreement shall come into effect on the Effective Date, and shall remain in full force and effect until the expiration or earlier termination
of the Consultancy Agreement, unless terminated earlier in accordance with clause 17 of this Agreement (the “Term”).
| 10. | Representations
and Warranties |
| 10.1 | Each Party
represents, warrants and undertakes to the other Party that: |
| 10.1.1 | it
has the full capacity, power and authority to enter into this Agreement and to perform its
obligations under this Agreement without the need for any consents or approvals not yet obtained; |
| 10.1.2 | it
has taken all corporate action to authorize, execute and deliver this Agreement and that
it is not precluded from entering into this Agreement by any other agreement; and |
| 10.1.3 | its
execution and performance under this Agreement shall not breach any oral or written agreement
with any third party or any obligation owed by such Party to any third party to keep any
information or materials in confidence or in trust. |
| 10.2 | NV represents,
warrants and undertakes to Company that: |
| 10.2.1 | the
Collection Kits and Testing Services shall meet all standards, specifications, operating
conditions, and quality, service level, and performance requirements set forth herein in
all material respects; |
| 10.2.2 | the
Testing Services shall be materially complete, accurate and free from errors, and comply
in all material respects with the standards and requirements set forth herein; |
| 10.2.3 | it
shall perform the Testing Services in a professional and workmanlike manner and in a manner
consistent with the degree of care, skill, and diligence as is ordinarily exercised by a
professional laboratory under similar conditions and circumstances, and each individual performing
the Testing Services on behalf of NV will possess the qualifications, licenses, skills, and
experience needed to perform such Testing Services; |
| 10.2.4 | it
holds and maintains a current CLIA and CAP accreditation with the applicable Regulatory Authority
or Governmental Authority and all applicable regulatory approvals including laboratory permits
and licenses as required by any region in which NV provides any services, in which Testing
Services will be received by Company, or in which Customers or patients reside; and such
CLIA and CAP accreditation and regulatory approvals and permits shall not expire within the
next twelve (12) months; |
| 10.2.5 | it
is not currently in violation of any regulatory approvals and permits or CLIA and CAP accreditation
and it has filed or maintained with any Regulatory Authority or Governmental Authority in
the jurisdictions that it operates, any required filings, declarations, listings, registrations,
certifications, reports, claims, applications, amendments, notices, information and other
documents and statistics in relation to such regulatory approvals, permits or CLIA and CAP
accreditation; |
| 10.2.6 | any
healthcare submissions it has made to any Regulatory Authority or Governmental Authority
in respect of its services or products, regulatory approvals, permits or CLIA and CAP accreditation
during the last five (5) years are true complete and accurate and any tests or studies (including
involving any NV technology or data) have been conducted in compliance with Applicable Law; |
| 10.2.7 | NV
(or its Affiliates) have not received: |
| (a) | any written
notice of failing to comply with any Applicable Law in respect of its services (including
that could lead to the removal of its CLIA and CAP accreditation); |
| (b) | any other
written notice of violations, inspectional observations or failure to observe Good Laboratory
Practice; or |
| (c) | written
notice of any regulatory enforcement from any Regulatory Authority or Governmental Authority; |
| 10.2.8 | no
product manufactured, tested or distributed by Company in relation to the provision of its
services or the Testing Services has been subject to any recall, removal, market withdrawal
or replacement, corrective action, or any other safety notice alleging a lack of safety or
efficacy or regulatory compliance and, to NV’s knowledge, there are no facts that would
likely result in a material safety notice in respect of its products relating to the Testing
Services or a termination or suspension of any such product or service; |
| 10.2.9 | during
the past three (3) years, NV has maintained policies and procedures designed to ensure the
integrity of data generated or used in any studies, test, related to the handling, safety,
efficacy, reliability, reporting, testing or manufacturing of any products used in relation
to the Testing Services in accordance with Applicable Law; |
| 10.2.10 | NV
will be in compliance in all material respects with, and shall perform the Testing Services
in compliance in all material respects with, all Applicable Laws, including Good Laboratory
Practice standards and requirements, and any other Applicable Laws with respect to the transport,
storage and disposal of Samples and all items used to collect and store the Samples, and
the terms of this Agreement including Schedules; |
| 10.2.11 | NV
is not aware of any hindrance under any Applicable Data Protection Laws or binding case law
or binding guidance from competent supervisory authorities which could reasonably be expected
to obstruct or prohibit performance of the Testing Services or any other obligation of NV
under this Agreement; |
| 10.2.12 | as
of the Effective Date, to the knowledge of NV: |
| (a) | the provision
of any laboratory and diagnostic testing services, products and results by NV at the NV Facility
have not infringed, violated, or misappropriated any valid and enforceable Intellectual Property
Rights or any other proprietary rights of any third party in the last three (3) years; |
| (b) | the tests
provided by NV, results of any Testing Services and use or other exercise of rights in connection
therewith as contemplated by this Agreement, do not infringe, violate, or misappropriate
any valid and enforceable Intellectual Property Rights or any other proprietary rights of
any third party; |
| (c) | there are
no investigations pending or threatened in writing against NV in relation to the provision
of NV’s services or any products at the NV Facility, or the Testing Services; including
but not limited to investigations relating to the recall, withdrawal or suspension of any
of its products or services; |
| 10.2.13 | NV
shall not do any acts that infringe, violate, or misappropriate any Intellectual Property
Rights or other proprietary rights of any third party in the provision of the Testing Services; |
| 10.2.14 | it
will notify Company as soon as reasonably practicable if it becomes aware of any actual or
potential claims that could materially affect either Party’s ability to fully perform
its duties or to exercise its rights under this Agreement, including any claims arising out
of or in connection with any Testing Services provided hereunder; as of the Effective Date,
to the knowledge of NV, its provision of Testing Services hereunder will not contain or require
the use of any third party technology that requires payment of a royalty unless agreed to
by the Parties; and |
| 10.2.15 | NV
will be responsible for the professional quality, technical accuracy, completeness, and timeliness
of all test results and other Testing Services provided under this Agreement. |
| 10.3 | Company represents,
warrants and undertakes to NV that: |
| 10.3.1 | its
performance of the Company Obligations shall comply in all material respects with the standards
and requirements set forth herein; |
| 10.3.2 | it
shall perform the Company Obligations in a professional and workmanlike manner; and any employees
of Company performing the Company Obligations will possess the qualifications, licenses,
skills, and experience needed to perform such Company Obligations; |
| 10.3.3 | Company
will be in compliance in all material respects with, and shall perform the Company Obligations
in compliance in all material respects with all Applicable Laws, including with respect to
the transport of Samples and all items used to collect and store the Samples, and the terms
of this Agreement including Schedules; and |
| 10.3.4 | it
will notify NV as soon as reasonably practicable if it becomes aware of any actual or potential
claims that could materially affect either Party’s ability to fully perform its duties
or to exercise its rights under this Agreement, including any claims arising out of or in
connection with any Company Obligations. |
| 11. | Intellectual Property Rights |
| 11.1.1 | Nothing
in this Agreement shall operate to transfer ownership of or grant a license to any Intellectual
Property Rights belonging to either Party or any of such Party’s Affiliates, including,
without limitation: |
| (a) | any Intellectual
Property Rights belonging to a Party or any of its Affiliates on or prior to the Effective
Date, including, without limitation, any Know-How that is included in NV’s provision
of the Testing Services; |
| (b) | any Intellectual
Property Rights in any items which are developed or acquired by a Party or any of its Affiliates
independently of this Agreement; or |
| (c) | any Intellectual
Property Rights developed or acquired by a Party or any of its Affiliates in performing its
obligations under this Agreement, |
it being
understood that any license to any such Intellectual Property Rights required for the provision or receipt of the Testing Services is
addressed in the Technology Transfer and Intellectual Property License Agreement.
| 12. | Confidential
information |
| 12.1 | Each Party
(the “Recipient”) acknowledges that it may receive Confidential Information
that has been created, discovered or developed by the other Party (the “Provider”). |
| 12.2 | The Recipient
undertakes to the Provider to: |
| 12.2.1 | hold
all Confidential Information which it obtains in relation to this Agreement in strict confidence
and will take all necessary measures to preserve the confidentiality of the Confidential
Information; |
| 12.2.2 | not
disclose, or authorize the disclosure of, Confidential Information to any third party other
than pursuant to clauses 12.4 or 12.6; |
| 12.2.3 | not
use, or authorize anyone to use, Confidential Information for any purpose other than the
performance of its obligations pursuant to this Agreement, or the exercise of its rights
or receipt of any benefits under this Agreement; and |
| 12.2.4 | promptly
notify the Provider of any suspected or actual unauthorized use or disclosure of Confidential
Information for which the Recipient is responsible and of which the Recipient becomes aware
and promptly take all Commercially Reasonable Efforts that Recipient may require in order
to prevent, stop or remedy the unauthorized use or disclosure. |
| 12.3 | To the extent
NV is the Recipient of Company Confidential Information, NV undertakes to: |
| 12.3.1 | remove
such Confidential Information from NV systems at the end of the Testing Services; provided
that such removal does not violate or otherwise conflict with Applicable Law; |
| 12.3.2 | process
such Confidential Information in accordance with Company organisational policies and procedures
regarding cybersecurity, as provided to NV in writing and in advance from time to time; and |
| 12.3.3 | process
such Confidential Information in accordance with KSA laws relating to cybersecurity and cloud
computing, including as issued by Regulatory Authorities such as the National Cybersecurity
Authority and the Communications, Space and Technology Commission, to the extent applicable. |
| 12.4 | The Recipient
may disclose Confidential Information to its Affiliates and its and their respective officers,
directors, employees, contractors, advisors and auditors, but only to the extent, and provided,
that such persons: |
| 12.4.1 | need
to know the Confidential Information disclosed to them; |
| 12.4.2 | have
been informed of the confidential nature of the Confidential Information and the purpose
for which it may be lawfully used; and |
| 12.4.3 | comply
with the terms of this clause 12 of this Agreement in respect of the Confidential Information
disclosed to them. |
| 12.5 | Clause 12.1
shall not apply to Confidential Information to the extent that: |
| 12.5.1 | such
Confidential Information has been placed in the public domain other than through the fault
of the Recipient; |
| 12.5.2 | such
Confidential Information was at the time of receipt, publicly available; |
| 12.5.3 | such
Confidential Information has been independently developed without reference to the Confidential
Information, as established by independent evidence; or |
| 12.5.4 | the
Provider has approved in writing the particular use or disclosure of the Confidential Information. |
| 12.6 | The Recipient
also may disclose Confidential Information if, and solely to the extent that, it is required
to do so by any Governmental Authority or Regulator or otherwise as required by Applicable
Law. Where Recipient is required to disclose Confidential Information relating to itself
in accordance with this clause 12.6, it shall: |
| 12.6.1 | to
the extent that it is able to do so and is not prohibited by Applicable Law, notify the Provider
in writing as soon as practicable upon becoming aware of the obligation to disclose, prior
to such disclosure; and |
| 12.6.2 | to
the extent it is able to do so, cooperate with the Provider in avoiding or limiting the disclosure
to that portion of the Confidential Information which it is legally required to furnish and
obtaining assurances as to confidentiality from the body to whom the Confidential Information
is to be disclosed. |
| 12.7 | Subject to
the express provision of this clause 12, each Party shall maintain and shall procure that
its Affiliates and contractors maintain the confidentiality of the existence and terms of
the negotiations between the Parties and of this Agreement and of the services provided pursuant
to this Agreement and any other Project Document. Each Party shall not, and shall procure
that each of its Affiliates and contractors and permitted subcontractors shall not, issue
any press release or other public statement relating to the existence or content of this
Agreement or any other Project Document without the prior written approval of the other Party. |
| 12.8 | Subject to
requirements under Applicable Law, the obligations with respect to Confidential Information
shall survive the termination or expiry of this Agreement and shall apply for five (5) years
from such termination or expiration of this Agreement. |
| 12.9 | Subject to
the requirements set forth in clause 12.4, either Party shall be able to disclose any materials
relating to the provision or receipt of the Testing Services or this Agreement to investors
for the purpose of evaluation of such Party. |
| 13.1 | NV shall defend,
indemnify and hold harmless Company and its respective employees, personnel, consultants,
agents, contractors and subcontractors (each a “Company Indemnitee”),
during the Term and, solely to the extent arising within the applicable statute of limitations
period allowed under Applicable Law, thereafter, in respect of any Indemnified |
Losses
to the extent the same are assessed against, or incurred by a Company Indemnitee in respect of the following:
| 13.1.1 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a Company Indemnitee
to the extent directly caused by NV’s material breach of this Agreement; |
| 13.1.2 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a Company Indemnitee
related to the Testing Services to the extent directly caused by NV’s gross negligence
or Wilful Misconduct; |
| 13.1.3 | any Claims brought by a patient
or Customer on a Company Indemnitee in relation to the Testing Services during Phase 1 (wet laboratory services) and Phase 2 (dry laboratory
services), other than Claims directly caused by Company’s or its Affiliates’ gross negligence, fraud or Wilful Misconduct; |
| 13.1.4 | any Claims brought against a Company
Indemnitee in respect of death or bodily injury occurring in the performance of the Testing Services for which it is finally determined
by a court of competent jurisdiction that NV is legally liable or responsible; |
| 13.1.5 | any Claims brought against a Company
Indemnitee in respect of any damage, loss or destruction of any real or tangible property owned by Company occurring in the performance
of the Testing Services for which it is finally determined by a court of competent jurisdiction that NV is legally liable or responsible
for that damage, loss or destruction; |
| 13.1.6 | any
Claims brought against a Company Indemnitee arising out of, or in connection with, any acts
of fraud, fraudulent misrepresentation or theft by NV; |
| 13.1.7 | any
Claims brought against a Company Indemnitee arising out of, or in connection with, any material
breach by NV of any ABC Laws in the performance of this Agreement; and |
| 13.1.8 | any Claims brought against a Company
Indemnitee arising out of a breach by NV of its obligations under clause 12 of this Agreement. |
| 13.2 | For the purpose
of interpreting clause 13, reference to an act or omission of NV shall also include relevant
acts or omissions of any NV Personnel, NV’s Affiliates, subcontractors of NV (pursuant
to clause 19.1 of this Agreement) and their relevant personnel. |
| 13.3 | Company shall
defend, indemnify and hold harmless NV and its respective employees, personnel, consultants,
agents, contractors and subcontractors (each a “NV Indemnitee”), during
the Term and, solely to the extent arising within the applicable statute of limitations period
allowed under Applicable Law, thereafter, in respect of any Indemnified Losses to the extent
the same are assessed against, or incurred by a NV Indemnitee in respect of the following: |
| 13.3.1 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a NV Indemnitee
to the extent directly caused by Company’s material breach of this Agreement; |
| 13.3.2 | any
Claims, fines or other penalty imposed by a court or Regulatory Authority on a NV Indemnitee
to the extent directly caused by Company’s gross negligence or Wilful Misconduct; |
| 13.3.3 | any Claims brought by any patient
or Customer on a NV Indemnitee during Phase 2 solely to the extent caused by wet laboratory services provided by Company other than Claims
directly caused by NV’s or its Affiliates’ gross negligence, fraud or Wilful Misconduct; |
| 13.3.4 | any Claims brought against a NV
Indemnitee in respect of death or bodily injury occurring in the context of this Agreement for which it is finally determined by a court
of competent jurisdiction that Company is legally liable or responsible; |
| 13.3.5 | any Claims brought against a NV
Indemnitee in respect of any damage, loss or destruction of any real or tangible property occurring in the context of this Agreement
for which it is finally determined by a court of competent jurisdiction that Company is legally liable or responsible for that damage,
loss or destruction; |
| 13.3.6 | any Claims brought against a NV
Indemnitee arising out of, or in connection with, any acts of fraud, fraudulent misrepresentation or theft by Company; |
| 13.3.7 | any Claims brought against a NV
Indemnitee arising out of, or in connection with, any material breach by Company of any ABC Laws in the performance of this Agreement;
and |
| 13.3.8 | any Claims brought against a NV
Indemnitee arising out of a breach by Company of its obligations under clause 12 of this Agreement. |
| 13.4 | For the purpose
of interpreting clause 13.3, reference to an act or omission of Company shall also include
relevant acts or omissions of any Company Personnel, Company’s Affiliates, subcontractors
of Company and their relevant personnel. |
| 13.5 | Upon a third
party threatening or bringing a Claim in respect of which a Party has a legal obligation
to indemnify pursuant to this Agreement, the Indemnitee shall notify the Indemnitor as soon
as reasonably practicable upon becoming aware of the Claim (it being understood that any
failure to so notify the Indemnitor of such Claim shall not relieve the Indemnitor of its
indemnification obligations except to the extent the Indemnitor is adversely prejudiced by
such failure) and: |
| 13.5.1 | the Indemnitor shall, at its own
expense, defend the Claim and have sole control of the conduct of the defence and settlement of the Claim; provided, that the
Indemnitee shall have the right to: |
| (a) | where appropriate, participate
in any defence and settlement, such participation to be at the Indemnitor’s own cost and in any event the Indemnitor shall remain
in control of the conduct of the defence; |
| (b) | review the terms of any settlement
and approve any wording which relates to an admission of liability on the part of the Indemnitee, the payment of any consideration by
Indemnitee or which the Indemnitee reasonably believes may impact the Indemnitee’s reputation and may veto any such proposed settlement
in respect of the Indemnitee and any such settlement or admission (including its terms) shall be subject to confidential treatment by
both Parties; and |
| (c) | join the Indemnitor as a defendant
in legal proceedings arising out of the Claim. |
| 13.5.2 | the Indemnitee shall: |
| (a) | not make
any admissions (except under compulsion of Applicable Law), agree to any settlement or otherwise
compromise the defence or settlement of the Claim without the prior written approval of the
Indemnitor; and |
| (b) | give, at
the Indemnitor’s request and cost, all reasonable assistance in connection with the
defence and settlement of the Claim. |
| 13.5.3 | if the Indemnitor does not elect
to defend the Claim or does not, following such election, actively defend the Claim, then: |
| (a) | the Indemnitee
shall have the right to defend or settle the Claim in the manner it considers appropriate,
at the cost of the Indemnitor (including in respect of any Indemnified Losses for which the
Indemnitor is liable pursuant to the indemnity given under clause 13 and reasonable legal
costs); and |
| (b) | the Indemnitor
shall give, at Indemnitee’s request, all reasonable assistance in connection with the
conduct of the defence and settlement of the Claim at the cost of the Indemnitor. |
| 13.6 | This clause
13 shall remain in full force and effect notwithstanding any termination or expiry of this
Agreement. |
| 13.7 | Notwithstanding
anything to the contrary, in no event shall Company be entitled to recover from NV under
both this Agreement and any other Project Document for the same Losses. |
| 14. | LIMITATION
ON Liability |
| 14.1 | Nothing in
this Agreement shall exclude or limit the liability of either NV or its Affiliates or Company
or its Affiliates for: |
| 14.1.1 | fraud
(including fraudulent misrepresentation); |
| 14.1.2 | death
or personal injury due to gross negligence; |
| 14.1.3 | Wilful
Misconduct; or |
| 14.1.4 | any
other liability which cannot be excluded or limited by Applicable Law. |
| 14.2 | Subject to
clauses 14.1 and 14.3, each of NV and its Affiliates and Company and its Affiliates: |
| 14.2.1 | shall
only be liable for direct loss arising in relation to a breach of this Agreement; and |
| 14.2.2 | shall
not be liable for any loss of profits, loss of business opportunity, or any indirect or consequential
loss arising under or in relation to this Agreement whether as a result of breach of contract,
tort (including negligence), breach of statutory duty or otherwise. |
| 14.3 | Except for
a Claim for breach of an obligation to pay amounts due pursuant to this Agreement, and subject
to clauses 14.1 and 14.2, each Party’s total aggregate liability to the other Party
and its Affiliates, whether based on an action or Claim in contract, tort (including negligence),
breach of statutory duty or otherwise arising out of, or in relation to, this Agreement shall
be limited to ten million Euros (€10,000,000.00). |
| 14.4 | Each Party
acknowledges its general duty to reasonably mitigate any Losses incurred in relation to this
Agreement and, in any case, each Party shall reasonably mitigate any Losses incurred by it
in relation to this Agreement. |
| 14.5 | Each Party
shall be relieved from liability for not performing its directly affected obligations (other
than payment obligations not under Dispute) pursuant to this Agreement if, and to the extent
a Force Majeure Event occurs, in which case relief shall be provided pursuant to clause 15. |
| 14.6 | This clause
14 shall remain in full force and effect notwithstanding any termination or expiry of this
Agreement. |
| 15.1 | Neither Party
shall be liable for failure or delay in performing any of its obligations (other than any
payment obligations) under or pursuant to this Agreement if such failure or delay is due
to any cause whatsoever outside its reasonable control and which by the exercise of due diligence
such Party is unable to prevent or overcome, including: |
| 15.1.2 | flood,
fire, earthquake or explosion; |
| 15.1.3 | war,
invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or
other civil unrest; |
| 15.1.5 | government
actions, embargoes, Sanctions or blockades in effect on or after the date of this Agreement; |
| 15.1.6 | action
by any Governmental Authority or Regulator (including regulatory changes); provided,
that the Party relying on the government act or omission as a reason for delay in performance
did not, directly or indirectly, procure or induce such government act or omission; |
| 15.1.7 | national
emergency; |
| 15.1.8 | pandemics
or epidemics; and |
| 15.1.9 | strikes,
labour stoppages, or other industrial disturbances |
(each
a “Force Majeure Event”) and the affected Party shall be relieved from its liability hereunder during the period of
such Force Majeure Event and the other Party may terminate this Agreement in accordance with clause 17 if such Force Majeure Event continues
for more than one hundred and eighty (180) days. The affected Party shall, in any event, use reasonable endeavours to avoid or mitigate
the effect of such events so as to recommence performance of their obligations as soon as reasonably possible following the Force Majeure
Event no longer applying.
| 16.1 | Subject to
the last sentence of this clause 16.1, NV undertakes that NV will obtain, pay for, and maintain
during the Term, at its own expense, and to the extent the same is available on commercially
reasonable terms, a policy or policies of insurance in line with Applicable Law, good industry
practice and standards applicable to an operator of laboratory testing services and a biodatabank
of similar size from reputable insurance providers in connection with the provision of the
Testing Services. The requirements in this clause 16.1 shall not be construed in any way
as a limit to NV’s liability under this Agreement or as constituting any waiver by |
Company
of any of its rights or remedies under this Agreement. Company acknowledges that NV may meet these obligations by self-insuring against
such risks.
| 16.2 | NV shall
provide written notice to Company prior to any material modification, cancellation or non-renewal
of any such policies, as is consistent with the relevant policy provisions. |
| 16.3 | If there
is Loss, damage or other event that requires notice or other action under the terms of any
insurance coverage specified in clause 16.1, NV shall be solely responsible for taking such
action. |
| 16.4 | Subject to
the last sentence of this clause 16.4, Company undertakes to obtain, pay for, and maintain
during the Term, at its own expense, and to the extent the same is available on commercially
reasonable terms a policy or policies of insurance in line with Applicable Law and industry
standards from reputable insurance providers in connection with the KSA Facility and Company
Personnel pursuant to this Agreement. The requirements in this clause 16.4 shall not be construed
in any way as a limit to Company’s liability under this Agreement or as constituting
any waiver by NV of any of its rights or remedies under this Agreement. NV acknowledges that
Company may meet these obligations by self-insuring against such risks. |
| 16.5 | Company shall
provide written notice to NV prior to any material modification, cancellation or non-renewal
of any such policies, as is consistent with the relevant policy provisions. |
| 16.6 | If there is
Loss, damage or other event that requires notice or other action under the terms of any insurance
coverage specified in clause 16.4, Company shall be solely responsible for taking such action. |
| 16.7 | Each of Company’s
and NV’s obligations specified in this clause 16 shall not limit or expand in any way
the other liabilities and obligations assumed by Company and NV, respectively, under this
Agreement. |
| 17.1 | Termination
for Convenience |
Company
may terminate this Agreement, any affected part of the Testing Services for any reason by giving nine (9) months’ prior written
notice to NV; provided that Company may not send any notice terminating this Agreement pursuant to this clause 17.1 prior
to two and a half (2.5) years from the Effective Date.
| 17.2 | Termination
for Cause by Company |
Company
may terminate this Agreement with immediate effect by written notice to NV if:
NV is
in material breach of any of its obligations under this Agreement and either that breach is not capable of remedy or, if the breach is
capable of remedy, NV has failed to remedy such breach within sixty (60) days (unless a shorter remedy period applies hereunder) after
receiving written notice requiring it to remedy the relevant breach; provided that, no event of default shall be deemed to have
occurred hereunder if such breach cannot reasonably be cured within such sixty (60) day period and NV has commenced and is diligently
pursuing such cure within such sixty (60) day period, in which case NV shall have an additional period of time (not to exceed one hundred
and twenty (120) days after receipt of written notice of such default) to cure such default and Company may not terminate this Agreement
during such period;
| 17.2.1 | NV
Abandons the provision of the Testing Services and NV has failed to remedy such Abandonment
within forty-five (45) days after receiving written notice requiring it to remedy such Abandonment; |
| 17.2.2 | NV
is unable to pay its debts as they fall due or an order is made or a resolution passed for
the administration, winding-up or dissolution of NV (other than for the purposes of a solvent
amalgamation or reconstruction) or an administrative or other receiver, manager, liquidator,
administrator, trustee or similar officer is appointed over all or any substantial part of
the assets of NV; |
| 17.2.3 | NV
or any of its Affiliates providing Testing Services hereunder is in material breach of clause
23; |
| 17.2.4 | NV
enters into or proposes any composition or arrangement with its creditors generally or anything
analogous to the foregoing occurs in the Netherlands; |
| 17.2.5 | (a)
NV is subject to an enforcement action by any Regulatory Authority so long as such action
was not directly or indirectly caused or induced by Company; or |
(b)
NV ceases to be authorized to exist as a legal entity under Applicable Law,
and,
the occurrence of either sub clause (a) or (b) results in NV being prevented from performing any of its material obligations under this
Agreement and such event is not cured within sixty (60) days from its occurrence; or
| 17.2.6 | there
is an NV Change of Control (as defined in the Joint Venture Agreement). |
| 17.3 | Termination
for Cause by NV |
As a
non-exclusive remedy, NV may terminate this Agreement with immediate effect by written notice to Company if:
| 17.3.1 | Company
is in material breach of any of its obligations under this Agreement and either that breach
is not capable of remedy or, if the breach is capable of remedy, Company has failed to remedy
such breach within sixty (60) days (unless a shorter remedy period applies hereunder) after
receiving written notice requiring it to remedy the relevant breach; provided that,
no event of default shall be deemed to have occurred hereunder if such breach cannot reasonably
be cured within such sixty (60) day period and Company has commenced and is diligently pursuing
such cure within such sixty (60) day period, in which case Company shall have an additional
period of time (not to exceed one hundred and twenty (120) days after receipt of written
notice of such default) to cure such default and NV may not terminate this Agreement during
such period; |
| 17.3.2 | Notwithstanding
clause 17.3.1, Company fails to pay any undisputed amounts it is obligated to pay NV under
this Agreement within thirty (30) Business Days of written demand by Formal Notice to Company
for such payment or Company fails to pay any Disputed amount (once the amount to be paid
is agreed or determined pursuant to the dispute resolution process set forth in clause 29.2)
within thirty (30) Business Days of such Disputed payments being agreed; |
| 17.3.3 | Company
is unable to pay its debts as they fall due or an order is made or a resolution passed for
the administration, winding-up or dissolution of Company (otherwise than for the purposes
of a solvent amalgamation or reconstruction) or an administrative or |
other
receiver, manager, liquidator, administrator, trustee or similar officer is appointed over all or any substantial part of the assets
of Company;
| 17.3.4 | Company
or any of its Affiliates is in material breach of clause 23; |
| 17.3.5 | Company
enters into or proposes any composition or arrangement with its creditors generally or anything
analogous to the foregoing occurs in KSA; or |
| (a) | Company
is subject to an enforcement action by any Regulatory Authority, so long as such action was
not directly or indirectly caused or induced by NV; or |
| (b) | Company
ceases to be authorized to exist as a legal entity under Applicable Law, |
and
the occurrence of either sub clause (a) or (b) results in Company being prevented from performing any of its material obligations
under this Agreement and such event is not cured within sixty (60) days from its occurrence.
This
Agreement will terminate automatically upon termination of the Consultancy Agreement or the Joint Venture Agreement.
| 17.5 | Termination
without need for Judicial Order |
If a
Party terminates this Agreement pursuant to this clause 17, such Party shall be entitled to do so without first obtaining judgment from
the courts of KSA or any other competent authority.
| 17.6 | Consequence of Expiry or Termination |
| 17.6.1 | Upon
expiry or termination, as the case may be, of this Agreement, NV shall: |
| (a) | comply
with its obligations under clause 12; |
| (b) | promptly
deliver to Company, upon its request, any outstanding deliverables prepared by NV in the
context of its provision of the Testing Services under this Agreement and that are in NV’s
possession or under NV’s control; provided, that Company has paid to NV all
outstanding Testing Fees (except to the extent Disputed in good faith) that are payable on
or prior to the date of such expiry or termination; |
| (c) | subject
to the terms of the Technology Transfer and Intellectual Property License Agreement, promptly
return to Company, any Company Confidential Information and any other assets or property
of Company, in each case, then in possession of NV held or maintained by NV as of the effective
date of such termination or expiration; provided, that NV may continue to retain a
copy of Company Confidential Information and use it as permitted under clause 12; |
| (d) | subject
to the terms of the Technology Transfer and Intellectual Property License Agreement, stop
using, or allowing the use of, any of Company’s trademarks, logos, devices, symbols,
brands or other similar items (whether registered or unregistered) used by or licensed to
NV; and |
| (e) | cease any
further Testing Services. |
| 17.6.2 | Upon
expiry or termination, as the case may be, of this Agreement, Company shall: |
| (a) | immediately
pay to NV all outstanding Testing Fees (except to the extent Disputed in good faith) payable
prior to the date of such expiry or termination; |
| (b) | subject
to the terms of the Technology Transfer and Intellectual Property License Agreement promptly
return to NV, any NV Confidential Information and any other assets or property of NV, in
each case, then in possession of Company held or maintained by Company as of the effective
date of such termination or expiration; provided, that Company may continue to retain
a copy of Company Confidential Information and use it as permitted under clause 12; |
| (c) | subject
to the terms of the Technology Transfer and Intellectual Property License Agreement, stop
using, or allowing the use of, any of NV’s trademarks, logos, devices, symbols, brands
or other similar items (whether registered or unregistered) used by or licensed to Company;
and |
| (d) | comply
with its obligations under clause 12. |
| 17.7.1 | Termination
or expiry of this Agreement (howsoever occasioned) shall not affect any accrued rights or
liabilities of either Party, nor shall it affect the coming into force or the continuance
in force of any provision of this Agreement which is expressly or by implication intended
to come into force or continue in force on or after termination. |
| 17.7.2 | The
following clauses, and provisions referred to by such clauses, shall survive termination
or expiry of this Agreement together with any other provisions which by their nature are
expressed to survive expiry or termination or are intended or required to give effect to
the expiration or termination of this Agreement: clauses 1 (Definitions; Interpretations;
Conflicts), 5 (Charges for the Testing Services) (but solely with respect to any
payment terms governing the payment of any outstanding Testing Fee and any other amounts
due from Company to NV under this Agreement that are payable for periods prior to the date
of such expiry or termination but have not been paid to NV yet), 11 (Intellectual Property
Rights), 12 (Confidential Information), 13 (Indemnities), 14 (Limitation
on Liability), 17.6-17.7 (Termination), 18 (Notices), 29 (Governing
Law; Arbitration and Jurisdiction), and the applicable provisions of Schedule 1 (Defined
Terms and Interpretation). |
| 18.1 | Any communication
to be given in connection with this Agreement shall be in writing and if such communication
is a Formal Notice shall either be delivered by hand or courier to a Party’s registered
office (or such other address as it may notify to the other Party for such purpose) or by
email as follows: |
to Company at: |
to NV at: |
GENOMICS INNOVATIONS COMPANY LIMITED
Building No. 3936, 6651 Al Nakheel District, Postal Code 12382, RGNB3936, Riyadh, Kingdom of Saudi Arabia |
CENTOGENE
N.V.
Am Strande 7,
18055
Rostock, Germany |
|
|
|
Marked for the attention of: |
Marked for the attention of: |
|
|
|
[***]
email: [***] |
Chief Legal
Officer
email: [***] |
|
|
|
With a copy,
which shall not constitute notice, to:
[***] |
|
|
|
And with a
copy, which shall not constitute notice, to:
Chief Financial
Officer
email: [***] |
| 18.2 | A communication
sent according to clause 18.1 shall be deemed to have been received: |
| 18.2.1 | if
delivered by hand, on written acknowledgment or receipt by an officer or an employee of the
receiving Party; |
| 18.2.2 | if
delivered by courier, on production of evidence from the relevant courier that the notice
was successfully delivered; or |
| 18.2.3 | if
by email, upon transmission to the correct email address as specified; provided, that
a hard copy is sent by post as soon as reasonably practicable thereafter to the address set
out in clause 18.1. |
If,
under the preceding provisions of this clause 18.2, a communication would otherwise be deemed to have been received outside normal business
hours in the place of receipt, being 9:00 a.m. to 4:00 p.m. on a Business Day, it shall be deemed to have been received at 9:00 a.m.
on the next Business Day.
| 18.3 | A Party may
notify the other Party of a change to its name or address or email address for the purposes
of clause 18.1; provided, that such notification shall only be effective on: |
| 18.3.1 | the
date specified in the notification as the date on which the change is to take place; or |
| 18.3.2 | if
no date is specified or the date specified is less than five (5) Business Days after the
date on which notice is deemed to have been served, the date falling five (5) Business Days
after notice of any such change is deemed to have been given. |
| 19. | Assignment
and Subcontracting |
| 19.1 | The Parties
acknowledge and agree that NV shall assume full responsibility to Company for the provision
of the Testing Services under this Agreement, subject to the terms and conditions of this
Agreement. NV may subcontract any of its obligations under this Agreement; provided,
that NV shall: |
| 19.1.1 | in
no event subcontract all or substantially all of its obligations under this Agreement without
the prior consent of Company (not to be unreasonably withheld, conditioned or delayed); provided
that NV may subcontract all or substantially all of its obligations under this Agreement
to any Affiliate of NV without Company’s prior consent; and |
| 19.1.2 | assume
full liability and responsibility for such subcontractor’s compliance with the terms
of this Agreement as if this Agreement were made between Company and such |
subcontractor,
whether or not such terms are reflected in an agreement between NV and such subcontractor.
For
the avoidance of doubt, any and all obligations of NV under this Agreement may be subcontracted to Centogene GmbH.
| 19.2 | Neither Party
is permitted to assign, sub-license, create a charge over or otherwise dispose of any of
its rights or transfer or otherwise dispose of any of its obligations under this Agreement
without the prior written consent of the other Party (not to be unreasonably withheld, conditioned
or delayed); provided, that either Party is permitted to assign, sub-license, create
a charge over or otherwise dispose of any of its rights or transfer or otherwise dispose
of any of its obligations under this Agreement: |
| 19.2.1 | to
any Affiliate; or |
| 19.2.2 | in
relation to its right to receive payment under this Agreement, as collateral to any financial
institution providing financing to such Party or any of such Party’s Affiliates, |
in
each case without the prior written consent of the other Party.
Except
as otherwise set forth in this Agreement, each Party shall pay the costs and expenses incurred by it in connection with preparation,
review, negotiation and execution of this Agreement.
| 21.1 | Neither Party
shall have the right to audit the other Party’s (the “Defaulting Party”)
compliance with this Agreement, unless such audit is required by a Party (the “Requesting
Party”): |
| 21.1.1 | for
reasons of actual or suspected fraud, criminal activity or failure to comply with Applicable
Law; |
| 21.1.2 | by
a Regulatory Authority; or |
| 21.1.3 | for
reasons of actual or suspected non-compliance with any material obligations under this Agreement
in which case: |
| (a) | such audit
must be made by an independent professional firm who enters into a reasonable non-disclosure
agreement with the Defaulting Party: |
| (b) | such audit
must be conducted during normal business hours, without disruption to normal business activities;
and |
| (c) | the materials
to be reviewed may be redacted to protect privacy, legally privileged information and otherwise
as is reasonable in light of Applicable Law and contractual obligations. The Requesting Party
shall be responsible for any and all costs and expenses related to the audit. No record may
be audited more than one time and no audit shall take place more than once per year. |
| 22.1 | This Agreement
shall be executed in English. |
| 22.2 | Any notice
(including, without limitation, a Formal Notice) given in connection with this Agreement
shall be in English. |
| 22.3 | Any other
document provided by a Party in connection with this Agreement shall be in English. |
| 23. | Anti-Bribery
and Corruption |
| 23.1 | Neither Party, nor any of its
Affiliates shall accept or give any commission or gift or other financial benefit or inducement from or to any person or party in connection
with its rights and obligations under this Agreement and shall ensure that its employees, agents and subcontractors shall not accept
or give any such commission, gift, benefit or inducement, and shall immediately notify the other Party of any such commission, gift,
benefit or inducement which may be offered. |
| 23.2 | Each Party,
its Affiliates and their Affiliated Persons shall be solely responsible for complying, have
to their best knowledge complied, and shall comply, with ABC Laws and have to their best
knowledge not taken and shall not take or fail to take any actions, which act or omission
would subject the other Party or its Affiliates to liability under ABC Laws. |
| 23.3 | Each Party
and its Affiliates shall implement and maintain an effective and appropriate internal control
system and a compliance program for the prevention of bribery and corruption, money laundering
and other crimes. |
| 23.4 | In the event
that a Party (a “Notified Party”) reasonably believes that it has (or
any of its Affiliates have) violated, or is in violation of, any ABC Laws, including without
limitation if the Notified Party has received any correspondence or notice from a Regulator
that the Notified Party has breached, may potentially breach or is in breach of, any ABC
Laws, then the Notified Party is required to promptly notify the other Party of such breach.
The Notified Party agrees to provide all reasonable assistance with respect to any audit
or investigation by a Regulator (or any similar body) into whether a violation of any ABC
Law has occurred by the Notified Party and the nature and extent of such violation. |
| 24. | Export Control
and Sanctions |
The
Parties agree not to use or otherwise export or re-export anything exchanged or transferred between them pursuant to this Agreement except
as authorized by Applicable Laws and the laws of the jurisdiction in which it was obtained. In particular, but without limitation, items
and services exchanged may not be exported or re-exported into any Sanctioned Countries. By entering into this Agreement, each Party
represents and warrants that they are not located in a Sanctioned Country or on any sanctioned persons list. Each Party also agrees that
they will not use any item or service exchanged for any purposes prohibited by Applicable Law, including, without limitation, the development,
design, manufacture or production of missiles, or nuclear, chemical or biological weapons. In the event either Party becomes aware of
any suspected violations of this clause 24 that Party will promptly inform the other Party of such suspected violations, and the Parties
shall cooperate with one another in any subsequent investigation and defence, be they civil or criminal.
Each
Party shall do and execute, or arrange for the doing and executing of, each necessary act, document and thing reasonably within its power
to implement and give effect to this Agreement.
| 26.1 | A failure
or delay by a Party to exercise any right or remedy provided under this Agreement, whether
by conduct or otherwise, shall not constitute a waiver of that or any other right or remedy,
nor shall it preclude or restrict any further exercise of that or any other right or remedy.
No single or partial exercise of any right or remedy provided under this Agreement, whether
by conduct or otherwise, shall preclude or restrict the further exercise of that or any other
right or remedy. |
| 26.2 | A waiver
of any right or remedy under this Agreement shall only be effective if given in writing and
signed by the Party against whom the waiver would be enforced and shall not be deemed a waiver
of any subsequent breach or default. |
| 26.3 | No variation
or amendment of this Agreement shall be valid unless it is in writing and duly executed by
or on behalf of all of the Parties to this Agreement. Unless expressly agreed in writing,
no variation or amendment shall constitute a general waiver of any other provision of this
Agreement, nor shall it affect any rights or obligations under or pursuant to this Agreement
which have already accrued up to the date of variation or amendment, and the rights and obligations
under or pursuant to this Agreement shall remain in full force and effect, except and only
to the extent that they are varied or amended in accordance with this clause 26. |
Where
any provision of this Agreement is or becomes illegal, invalid or unenforceable in any respect, then such provision shall be deemed to
be severed from this Agreement and, if possible, replaced with a lawful provision which, as closely as possible, gives effect to the
intention of the Parties under this Agreement and, where permissible, that shall not affect or impair the legality, validity or enforceability
in that, or any other, jurisdiction of any other provision of this Agreement.
| 28. | Rights of
Third Parties |
| 28.1.1 | A
person who is not a party to this Agreement shall not have any right to enforce any term
of this Agreement. |
| 28.1.2 | The
rights of the Parties to terminate, rescind or agree to any variation, waiver or settlement
under this Agreement is not subject to the consent of any person that is not a party to this
Agreement. |
| 29. | Governing
Law; ARBITRATION and Jurisdiction |
This
Agreement shall be governed and construed in accordance with the laws of the Kingdom.
| 29.2.1 | In
the event of any dispute, difference, claim, controversy or question between Company and
NV, directly or indirectly arising at any time under, out of, in connection with or in relation
to this Agreement (or the subject matter of this Agreement) or any term, condition or provision
hereof, including any of the same relating to the existence, validity, interpretation, construction,
performance, enforcement and termination of this Agreement (a “Dispute”),
Company and NV shall first endeavour to settle such Dispute by good faith negotiation. The
Parties agree, save as otherwise agreed in writing by |
Company
and NV, that the negotiations shall not exceed three (3) months from the date of the start of such negotiations.
| 29.2.2 | Notwithstanding
the provisions of clause 29.2.1 above, any Dispute arising out of, or in connection with,
this Agreement shall be finally administered by the Saudi Centre for Commercial Arbitration
(“SCCA”) in accordance with its Arbitration Rules. The arbitration shall
be conducted by an arbitration tribunal consisting of three (3) independent arbitrators,
none of whom shall have any relationship or competitive interests with any of the Parties
or any of their Affiliates. Company shall appoint one (1) arbitrator, NV shall appoint one
(1) arbitrator and the SCCA shall appoint one (1) arbitrator. The arbitration shall take
place in the English language and the seat shall be at the SCCA, in Riyadh, the Kingdom.
Judgment for any award rendered may be entered in any court having jurisdiction or an application
may be made to such court for a judicial recognition of the award or an order of enforcement
thereof, as the case may be. Nothing in this clause shall preclude any Party from seeking
provisional measures to secure its rights from any court having jurisdiction or where any
assets of the other Party may be found. The arbitration proceedings contemplated by this
clause and the content of any award rendered in connection with such proceeding shall be
kept confidential by the Parties. |
| 30.1 | This Agreement
and the Project Documents set out the entire agreement and understanding between the Parties
in respect of the subject matter of this Agreement and supersede all prior agreements and
understandings, both oral and written between the Parties with respect to the subject matter
hereof and thereof. For the avoidance of doubt, the provisions of Schedule 5 (T&Cs)
shall be excluded from this Agreement except for Articles 4.1-4.3 of the T&Cs and in
the event of any conflict between the terms of this Agreement (including any Project Addendum)
and any Schedule, the terms of this Agreement shall govern. |
| 30.2 | Each Party
acknowledges that it is not relying on, and shall have no remedies in respect of, any undertakings,
representations, warranties, promises or assurances (whether made innocently or negligently)
that are not set forth in this Agreement. |
| 30.3 | Nothing in
the preceding sub clause limits or excludes any liability for fraud or fraudulent concealment. |
This
Agreement or any amendment agreed to pursuant to clause 26.3 may be executed in any number of counterparts, each of which shall be deemed
to be an original, and all of which, when taken together, shall constitute one and the same instrument.
[Signature
Page Follows]
IN WITNESS WHEREOF,
this Agreement has been executed by the Parties by their duly authorized representatives on the Effective Date.
Signed by Kim Stratton for and on behalf of
CENTOGENE N.V. |
)
)
)
)
) |
/s/ Kim Stratton |
|
|
|
Signed by Miguel Coego for and on behalf of
CENTOGENE N.V. |
)
)
)
)
) |
/s/ Miguel Coego |
|
|
|
Signed by Jeremy Panacheril for and on behalf of
GENOMICS INNOVATIONS COMPANY LIMITED |
)
)
)
)
) |
/s/ Jeremy Panacheril |
Schedule
1
DEFINED TERMS AND INTERPRETATION
Part 1 - Defined
Terms
In this Agreement:
“Abandon”
or “Abandonment” means the material failure of NV or any Affiliate thereof to provide all or a material part of the
Testing Services for a continuous and consecutive period of forty-five (45) Business Days or more, other than any material non-performance
due to:
| (a) | non-payment by Company of the
Testing Fees that are due in accordance with the terms of this Agreement; or |
| (b) | occurrence of a Force Majeure
Event; |
“ABC Laws”
means all laws and regulations applicable to the Parties and this Agreement, that relates to bribery or corruption or money laundering,
including (without limitation):
| (a) | the Saudi Arabian Anti-Bribery
Law promulgated by royal decree number M/36 dated 26/12/1412H (corresponding to 27 June 1992) and the Saudi Arabian Anti-Money
Laundering Law promulgated by royal decree number M/20 dated 5/2/1439H (corresponding to 25 October 2017); |
| (b) | the US Foreign Corrupt Practices
Act of 1977, as amended, and the rules and regulations issued thereunder, and |
| (c) | the UK Bribery Act 2010, as each
may be amended or re-enacted from time to time; |
“Accreditation”
means the CAP Laboratory Accreditation from the College of American Pathologists (“CAP”) and the Clinical Laboratory
Improvement Amendments (“CLIA”) certification or, in the event Company is unable to obtain such accreditation or certification,
as applicable, due to regulatory changes arising after the Effective Date, an equivalent internationally recognized accreditation or
certification, as applicable, as mutually agreed by the Board of Directors, and “Accredited” shall be construed accordingly;
“Affiliate”
means any person, now or in the future, directly Controlling, Controlled by or under direct or indirect Common Control of a Party. For
the avoidance of doubt, for purposes of this Agreement, when used in connection with Company, the term “Affiliate” will not
include NV, and when used in connection with NV, the term “Affiliate” will not include Company;
“Affiliated
Persons” means a relevant Party and its Affiliates’ officers, directors, employees, agents or representatives, or any
of its stockholders, principals or owners (including ultimate beneficial owners) acting on its behalf or in its interests;
“Agreement”
has the meaning set out in the preamble of this Agreement;
“Annual
Forecast” has the meaning set out in clause 3.9.2 of this Agreement;
“Applicable
Data Protection Laws” means any and all laws, statutes, rules and regulations relating to the privacy, security, protection,
access, collection, storage, transmission, disclosure, exchange or other processing of Personal Data, including, but not limited to,
the General Data Protection Regulation (EU) 2016/679 (“GDPR”), the German Federal Data Protection Act (Bundesdatenschutzgesetz),
the provisions of the German Genetic Diagnostics Act (Gendiagnostikgesetz), the Kingdom National Data
Management
Office’s Interim Regulations on Personal Data Protection, the Kingdom Ministry of Health’s Guidelines for Informed Consent,
and the Kingdom Personal Data Protection Law (issued pursuant to Royal Decree M/19 of 9/2/1443H (corresponding to 16 September 2021)
and any relevant implementing regulations issued pursuant to the Kingdom Personal Data Protection Law (“KSA PDPL”)),
in each case as amended or updated from time to time;
“Applicable
Export Control” or “Economic Sanctions Programs” means all applicable national and international
export controls, Sanctions laws, regulations and programs;
“Applicable
Law” means any of the following, to the extent that it applies to a Party:
| (a) | any laws, statute, directive,
order, enactment, regulation, bylaw, ordinance or subordinate legislation in force from time to time, but subject to any written waivers
granted by any Governmental Authority; |
| (b) | any binding court order, judgment
or decree; |
| (c) | any applicable industry code,
policy or standard enforceable by law; |
| (d) | any applicable direction, statement
of practice, policy, rule or order that is set out by a Regulatory Authority, that is binding on the Parties; |
| (e) | the ABC Laws and the Applicable
Export Control or Economic Sanctions Programs; and |
| (f) | Applicable Data Protection Laws; |
“Board
of Directors” means the Board of Directors of Company from time to time;
“Business
Day” means any day other than a Friday, Saturday or public holiday in KSA or Germany;
“Business
Plan” means the Initial Business Plan set out in Schedule 7 of the Joint Venture Agreement;
“CentoPortal”
has the meaning set out in clause 3.2.1 of this Agreement;
“Claim”
means any claims, demands, suits, proceedings or actions by any Governmental Authority, Regulatory Authority or a third party (in either
case, not being connected to or related to the relevant Indemnitee);
“Clause”
has the meaning set out in Schedule 3 (Data Sharing Agreement) Part II of this Agreement;
“Collection
Kits” has the meaning set out in clause 2.1.3 of this Agreement;
“Commercially
Reasonable Efforts” means taking such steps and performing in such a manner as a similarly situated company would undertake
where such company was acting in a determined, prudent and reasonable manner to achieve the particular result for its own benefit;
“Company”
has the meaning set out in the preamble of this Agreement;
“Company
Confidential Information” means Confidential Information of Company;
“Company
Customer Contracts” means an agreement entered into in relation to the provision of bulk Testing Services between Company and
a customer of Company in which the annual revenue earned from such agreement is over two million, five hundred thousand Euros (€2,500,000.00);
“Company
Data” means information (including Personal Data) that NV either receives from Company or to which NV receives access in connection
with the performance of this Agreement;
“Company
Indemnitee” has the meaning set out in clause 13.1 of this Agreement;
“Company
Obligations” has the meaning set out in clause 4.1.3 of this Agreement;
“Company
Personnel” means any employees, officers, directors, consultants, contractors or agents employed or engaged by Company or its
Affiliates, but excluding any NV Personnel seconded to Company;
“Company
Representative” has the meaning set out in clause 4.3 of this Agreement;
“Confidential
Information” means information that is marked, designated, or otherwise identified as ‘confidential’ or which by
its nature is clearly confidential. Confidential Information includes (without limitation) any information concerning the technology,
technical processes, samples, studies, findings, inventions, ideas, business processes, procedures, business affairs, financial affairs
and finance of Company and its Affiliates or NV and its Affiliates, as the case may be; provided that Confidential Information
shall not include any Personal Data which is addressed separately in Schedule 3 (Data Sharing Agreement) of this Agreement. Company’s
or NV’s security procedures are also included within the definition of Confidential Information. Confidential Information may take
the form of documents, technical specifications, unpublished patent specifications, data, drawings, plans, processes, photographs, databases,
computer software in disk, cassette, tape or electronic form and data storage or memory in, and items of, computer hardware; or oral
descriptions, demonstrations or observations, and Confidential Information includes (without limitation) information which is supplied
to, stored by, processed or marked for destruction by, NV to Company, or by Company to NV;
“Consent
Form” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 7.4 of this Agreement;
“Consultancy
Agreement” has the meaning set out in the preamble of this Agreement;
“Control”
(including the terms “Controlling”, “Controlled by” and “under Common Control”),
means in relation to any person (being the “Controlled Person”), being:
| (a) | entitled
to exercise, or control the exercise of (directly or indirectly) more than fifty percent
(50%) of the voting power at any general meeting of the shareholders, members or partners
or other equity holders (and including, in the case of a limited partnership, of the limited
partners of) in respect of all or substantially all matters falling to be decided by resolution
or meeting of such persons; |
| (b) | entitled
to appoint or remove: |
| (i) | directors
on the Controlled Person’s board of directors or its other governing body (or, in the
case of a limited partnership, of the board or other governing body of its general partner)
who are able (in the aggregate) to exercise more than fifty percent (50%) of the voting power
at meetings of that board or governing body in respect of all or substantially all matters; |
| (ii) | any
managing member of such Controlled Person; and/or |
| (iii) | in
the case of a limited partnership, its general partner; or |
| (c) | entitled
to exercise a dominant influence over the Controlled Person (otherwise than solely as a fiduciary)
by virtue of the provisions contained in its constitutional documents or pursuant to an agreement
with other shareholders, partners or members of the Controlled Person; |
“Customer”
means a physician or other healthcare professional licensed to receive the results of the Testing Services in accordance with Applicable
Laws for specific patients pursuant to an agreement between Company and such healthcare professional;
“Data
Sharing Agreement” means the data use agreement entered into by and between Company and NV on or around the date of this Agreement;
“Defaulting
Party” has the meaning set out in clause 21.1 of this Agreement;
“Dispute”
has the meaning set out in clause 29.2.1 of this Agreement;
“Dual
Consent” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 7.3 of this Agreement;
“Effective
Date” has the meaning set out in the preamble of this Agreement;
“Excess
Services” has the meaning set out in clause 3.9.2 of this Agreement;
“Force
Majeure Event” has the meaning set out in clause 15 of this Agreement;
“Formal
Notices” means:
| (a) | notices invoking, or relating
to, Dispute resolution or any litigation between the Parties; |
| (b) | notices given in connection with
a Force Majeure Event pursuant to clause 15 of this Agreement; |
| (c) | a change to the contact details
specified in clause 18.1 of this Agreement; or |
| (d) | any other notices stated in this
Agreement to be a Formal Notice; |
“Good
Laboratory Practice” means international ethical and scientific quality standards, practices, methods and procedures conforming
to Applicable Law and international health industry practice and exercising that degree of skill, care, diligence, prudence and foresight
which would reasonably and ordinarily be expected from a duly qualified, skilled, efficient and experienced laboratory service provider
providing laboratory services in connection with a facility of a size and capacity comparable to the KSA Facility;
“Governmental
Authority” means any federal, emirate, state, provincial or municipal government or political subdivision thereof, a governmental
or quasi-governmental ministry, legislative body, agency, authority, board, bureau, commission, government-controlled corporation or
entity, department, instrumentality or public body, or any court, administrative tribunal or public utility that has jurisdiction over
the Party or matter in question;
“Indemnified
Losses” means:
| (a) | any amounts awarded by a court
or tribunal of competent jurisdiction or arbitrator to a third party; |
| (b) | any amounts paid in settlement
to a third party; |
| (c) | any interest awarded by a court
of competent jurisdiction or arbitrator in respect of the above; and |
| (d) | reasonable costs of investigation,
litigation, settlement and external legal fees (on a solicitor-client basis) and disbursements and administrative costs directly incurred
by the Indemnitee in respect of a Claim; |
“Indemnitee”
means a Party relying on an indemnity pursuant to this Agreement;
“Indemnitor”
means a Party providing an indemnity pursuant to this Agreement;
“Ineligible
Person” has the meaning set out in clause 7.6.1 of this Agreement;
“Intellectual
Property Rights” means any and all rights available under patent, copyright, industrial design, trade secret law or any trademarks,
service marks, trade names or other statutory provision or common law doctrine with respect to designs, formulas, algorithms, procedures,
methods, techniques, ideas, Know-How, programs, subroutines, tools, inventions, creations, improvements, works of authorship, other similar
materials, and all recordings, graphs, drawings, reports, analyses, other writings, and any other embodiment of the foregoing, in any
form, whether or not specifically listed herein, which may subsist in any part of the world, in each case whether registered or unregistered
and including all applications for, and renewals or extensions of, such rights for their full term;
“Invoice”
has the meaning set out in clause 5.2 of this Agreement;
“Joint
Venture Agreement” has the meaning set out in the preamble to this Agreement;
“Kingdom”
or “KSA” means the Kingdom of Saudi Arabia;
“Know-How”
has the meaning set out in the Technology Transfer and Intellectual Property License Agreement;
“KSA Biodatabank”
means national KSA data registries, biodatabank and genetic data including in relation to rare and neurodegenerative diseases that is
Controlled by Company;
“KSA Facility”
means the facility for the establishment and maintenance of the KSA Lab and the KSA Biodatabank;
“KSA Lab”
means a laboratory facility to be located in Riyadh, the Kingdom, and operated in accordance with Applicable Law with the intention that
it becomes an Accredited, globally recognized, commercially driven genomics wet and dry lab;
“Lawful
Export Measures” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 8.3 of this Agreement;
“Losses”
means all Claims (whether or not successful, compromised or settled), actions, proceedings, liabilities, demands, judgments (asserted
or established in any jurisdiction) and any and all losses, damages (including interest), any amounts paid in settlement (including interest)
of a Claim, costs, expenses (including reasonable legal, investigative, administrative or professional costs and expenses incurred in
disputing or defending any of the foregoing), Taxes, fines or penalties;
“New Service”
has the meaning set out in clause 2.1.1 of this Agreement;
“Notified
Party” has the meaning set out in clause 23.4 of this Agreement;
“NV”
has the meaning set out in the preamble of this Agreement;
“NV Clinical
Personnel” means any NV clinical or laboratory technician, clinical administrator and other allied health professionals as
determined by NV who has any applicable local licenses and are qualified to provide the Testing Services contemplated hereunder;
“NV Confidential
Information” means Confidential Information of NV;
“NV Data”
means information (including Personal Data) that Company either receives from NV or to which Company receives access in connection with
the performance of this Agreement;
“NV Facility”
has the meaning set out in the preamble of this Agreement;
“NV Indemnitee”
has the meaning set out in clause 13.3 of this Agreement;
“NV Personnel”
means employees, officers, directors, consultants, contractors and agents engaged wholly or partly by NV (or any of its Affiliates),
including NV Representatives, to provide the Testing Services other than NV Clinical Personnel;
“NV Representative”
has the meaning set out in clause 3.10.1;
“OFAC”
means the U.S. Department of the Treasury’s Office of Foreign Assets Control;
“Party”
or “Parties” have the meaning set out in the preamble of this Agreement;
“Patient
Data” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 7.1 of this Agreement;
“Patients”
has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 2.1.2 of this Agreement;
“Personal
Data” has the meaning given to it in Applicable Data Protection Laws;
“Project
Addendum” has the meaning set out in clause 2.1.2(a) of this Agreement;
“Project
Documents” means, collectively, this Agreement, the Joint Venture Agreement, the Technology Transfer and Intellectual Property
License Agreement and the Consultancy Agreement;
“Provider”
has the meaning set out in clause 12.1 of this Agreement;
“Recipient”
has the meaning set out in clause 12.1 of this Agreement;
“Regulator”
or “Regulatory Authority” means any national, regional, state or local regulatory agency, department, bureau, commission,
council or other Governmental Authority whose review and/or approval is necessary for performing clinical and/or laboratory services
in the applicable regulatory jurisdiction and granting regulatory approvals or having regulatory or supervisory authority over a Party
or a Party’s assets, resources or business, or over the Testing Services;
“Requesting
Party” has the meaning set out in clause 21.1 of this Agreement;
“Sample”
has the meaning set out in clause 2.1.3 of this Agreement;
“Sanctioned
Countries” means, at any time, a country or territory that is itself the target of comprehensive Sanctions (as of the date
of this Agreement, Cuba, Iran, North Korea, Syria, the Crimea region of Ukraine, the so-called Donetsk People’s Republic, and the
so-called Luhansk People’s Republic);
“Sanctions”
means economic or financial sanctions or trade embargoes imposed, administered or enforced from time to time by the United States, the
European Union or any member state thereof, the United Kingdom, the United Nations or any governmental institution or agency of any of
the foregoing, including OFAC or the United States Department of State, the United Kingdom’s Office of Financial Sanctions Implementation
or His Majesty’s Treasury or the United Nations Security Council;
“SCCA”
has the meaning set out in clause 29.2.2;
“Security
Breaches” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 2.1.5(e) of this Agreement;
“Shareholders”
means any person to whom one or more shares may be transferred or issued from time to time in accordance with the Joint Venture Agreement,
and “Shareholder” means any of them;
“Tax”
means all forms of taxation and statutory, governmental, state, federal, provincial, local, government or municipal charges, duties,
imposts, contributions, levies, VAT, withholdings or other liabilities in the nature of taxation wherever chargeable and whether of KSA
or any other jurisdiction (including, for the avoidance of doubt, social security contributions in KSA and Germany and corresponding
obligations elsewhere) and any penalty, fine, surcharge, interest, charges or costs relating to it or them;
“Tax Credit”
means a credit against, relief or remission for, or repayment of, any Tax;
“Tax Deduction”
means any amount which Company is required by Applicable Law to deduct or withhold on account of Tax from any payment by Company to NV
(or a relevant Affiliate) in respect of any Testing Fees;
“Technology
Transfer and Intellectual Property License Agreement” has the meaning set out in the preamble of this Agreement;
“Term”
has the meaning set out in clause 9 of this Agreement;
“Testing
Fee” has the meaning set out in clause 5.1 of this Agreement;
“Testing
Services” has the meaning set out in clause 2.1.1 of this Agreement;
“Third
Countries” has the meaning set out in Schedule 3 (Data Sharing Agreement) Part I clause 2.1.4 of this Agreement;
“VAT”
means:
| (a) | any Tax imposed in relation to
the Unified Agreement for Value Added Tax for the Co-operation Council for the Arab States of the Gulf; |
| (b) | any other Tax of a similar nature,
imposed in a member state of the Co-operation Council for the Arab States of the Gulf; or |
| (c) | any other similar Taxes imposed
anywhere in the world; and |
“Wilful
Misconduct” means conduct that is unreasonable, deliberate and carried out by a Party in the knowledge that it will result
in significant injury or damage to the other Party.
Part 2 –
Interpretation
In this Agreement:
| (a) | any
reference to “Schedule” or “Annex”, unless the context otherwise
requires, is a reference to the relevant schedule or annex of and to this Agreement, and
any reference to a “clause”, “section” or “paragraph”,
unless the context otherwise requires, is a reference to a clause in this Agreement, a section or
paragraph in the relevant Schedule and a paragraph in the relevant Annex, respectively; |
| (b) | the
clause, section and paragraph headings and the contents page in this Agreement are included
for convenience purposes only and shall not affect the interpretation of this Agreement; |
| (c) | use
of the singular in this Agreement includes the plural and vice versa; |
| (d) | any
reference to a Party or the Parties means a party or the parties to this Agreement, including
their successors in interest and permitted assigns; |
| (e) | any
reference to “persons” includes natural persons, companies, corporations, partnerships,
limited liability companies, firms, associations, organisations, Governmental Authorities,
foundations and trusts (in each case, whether or not having separate legal personality); |
| (f) | any
reference to a date refers to the Gregorian calendar; |
| (g) | any
reference to a statute, statutory provision or subordinate legislation shall, except where
the context otherwise requires, be construed as referring to such legislation as amended
and in force from time to time and to any legislation which re-enacts or consolidates (with
or without modification) any such legislation; |
| (h) | unless
otherwise defined, terms used in the healthcare industry or other relevant business context
shall be interpreted in accordance with their generally understood meaning in that industry
or business context; |
| (i) | any
phrase introduced by the terms “including”, “include”, “in
particular” or any similar expression shall be construed as illustrative and shall
not limit the sense of the words preceding those terms; |
| (j) | any
reference to “writing” or “written” includes email (but not faxes),
save with respect to Formal Notices, where service in accordance with clause 18 of this Agreement
is required; and |
| (k) | any
reference to any agreement or other instrument shall, except where expressly provided to
the contrary, include any amendment, restatement, amendment and restatement, modification,
variation or novation (in whole or in part) to such agreement or other instrument. |
Schedule
2
[***]
Schedule
3
DATA SHARING AGREEMENT
PART
I – OBLIGATIONS AND SAFEGUARDS
| 1. | Purpose of Data
Sharing |
| 1.1 | This Schedule 3
sets out the framework for the sharing of Personal Data between the Parties both acting as
independent data controllers within the meaning of Art. 4 (7) GDPR and under the KSA
PDPL. It defines the principles and procedures that the Parties shall adhere to and the responsibilities
the Parties owe to each other under the GDPR and KSA PDPL and other Applicable Data Protection
Laws. |
| 1.2 | The Parties
consider this data sharing initiative necessary to enable the provision of the Testing Services
under this Agreement. NV agrees to only process Company Data (as defined in Schedule 1 (Defined
Terms) above) for the purpose of fulfilling its obligations under this Schedule 3
and this Agreement and as set out in the applicable Consent Form. |
| 2. | Protection of
Personal Data |
| 2.1 | To the extent
that Company Data includes Personal Data (as defined in Schedule 1 above), NV shall, and
shall procure that its representatives shall: |
| 2.1.1 | use
or disclose the Company Data solely for the purposes of this Agreement or as otherwise authorized
by Company in writing from time to time. In particular, Company shall not sell, assign, lease
or commercially exploit Company Data; |
| 2.1.2 | store,
use and process Company Data referring to patients or related individuals of Company (“Patients”)
only on the basis of explicit consent given by respective Patients as set out in clause 7
of this Schedule 3 Part I below; |
| 2.1.3 | store,
use or process Company Data for no longer than is necessary to fulfil its obligations under
this Agreement and in any event not longer than any statutory or professional retention periods
applicable under any Applicable Laws or as set out in the applicable Consent Form; |
| 2.1.4 | not
store in or transfer Company Data to countries outside the European Economic Area (“Third
Countries”), nor allow processing or access to the Company Data from a Third Country
other than (a) data transfers from NV to Company, or (b) as authorized by Company in writing
from time to time; provided that Company agrees that NV may store, transfer or otherwise
provide access to Company Data to NV’s office in Belgrade, Serbia, provided
that such storage, transfer, or access is made in compliance with Applicable Data Protection
Law; and |
| 2.1.5 | to
the extent necessary to allow Company to comply with Applicable Data Protection Laws: |
| (a) | assist
Company with any subject access requests which it may receive from individuals to whom any
Company Data relates; |
| (b) | carry
out any reasonable request from Company to amend, transfer or delete any Company Data; provided
that such requests do not conflict with Applicable Data Protection Laws or the applicable
Consent Form; |
| (c) | notify
Company without undue delay about any enquiries from the relevant data protection authority
in relation to the Company Data and cooperate promptly and thoroughly with such data protection
authority, to the extent required under the Applicable Data Protection Laws; |
| (d) | take adequate
technical and organisational measures against unauthorised or unlawful processing of, accidental
loss or destruction of, or damage to, the Company Data; |
| (e) | notify
Company without undue delay after NV learns of any misappropriation or unauthorized access
to, or disclosure or use of, the Company Data (collectively, “Security Breaches”); |
| (f) | investigate
each Security Breach that it becomes aware of or has reason to suspect may have occurred
without undue delay after becoming aware or having reason to suspect such Security Breach
has occurred, and, in the case of an actual Security Breach, provide assistance to Company
in connection with any reasonable investigation that Company may desire to conduct with respect
to such Security Breach; and |
| (g) | implement
any steps reasonably requested by Company to limit, stop or otherwise remedy any actual or
suspected Security Breach; provided that such steps do not conflict with Applicable
Data Protection Laws. |
| 3. | Transparency
Obligations |
| 3.1 | Each Party
shall be solely and separately responsible to fulfill its own information obligations and/or
transparency obligations towards affected individuals under Applicable Data Protection Law
in connection with the performance of this Agreement. |
| 3.2 | The Parties
shall provide each other reasonable assistance required to fulfill their respective obligations
set out under clause 3.1 above. |
| 3.3 | Each Party
shall provide the other Party with templates and respective documentation necessary to fulfill
such Party’s information obligation and/or transparency obligation under the Applicable
Data Protection Laws towards individuals in connection with the performance of Testing Services. |
| 4.1 | NV may not
subcontract any of its processing activities permitted by this Agreement without the prior
written consent of Company; provided that NV shall be permitted to subcontract any
of its processing activities to Centogene GmbH without Company’s consent. |
| 5.1 | At the end
of the Term, NV shall, and shall ensure that the NV Personnel and any permitted subcontractors
shall: |
| 5.1.1 | if
so requested by Company promptly provide to Company copies of any Company Data that NV or
a permitted subcontractor (including any NV Personnel) has in its possession in a format
and on media reasonably requested by Company; and |
| 5.1.2 | if
so requested by Company, destroy or delete permanently any copies of Company Data in NV’s
or the subcontractor’s (including NV Personnel’s) possession (including backup
copies) and certify in writing to Company that it has done so; provided that such |
destruction
or deletion does not violate Applicable Law (it being understood that nothing in this clause 5.1.2 shall require NV to destroy or delete
any NV Derived Data (as defined under the Technology Transfer and Intellectual Property License Agreement)).
| 6. | Transfer of
Company Data |
| 6.1 | The Parties
agree to establish channels for any transfer and re-transfer of Company Data and NV Data
which are secured by appropriate technical and organisational measures including transport
encryption following the state of the art. |
| 6.2 | To the extent
that the provision of Testing Services entails any transfer of Personal Data by NV to the
Kingdom, Part II of this Schedule 3 applies. |
| 7. | Legal Bases
for the Processing Of Personal Data |
| 7.1 | NV and Company
acknowledge and agree that the Company Data includes Personal Data referring to Patients
(“Patient Data”). |
| 7.2 | NV shall store,
use and process Patient Data solely on the basis of explicit and unambiguous consent given
by respective patients which enables Company and NV to process and share Patient Data in
the context of the Testing Services and as required under (a) Applicable Laws of the Kingdom
(including, but not limited to the KSA PDPL), (b) Applicable Laws in Germany and the Netherlands
(including, but not limited to data protection laws applicable in Germany and the Netherlands),
and (c) all other laws applicable to the performance of the Testing Services (“Dual
Consent”). |
| 7.3 | Company shall
implement a suitable process to ensure that each Patient has provided Dual Consent prior
to the performance of Testing Services for a Sample of the respective Patient. |
| 7.4 | The Parties
will cooperate in good faith to (a) prepare a form to obtain Dual Consent from Patients (“Consent
Form”), and (b) continuously revise the Consent Form, if needed, in particular
to ensure compliance with Applicable Law and to reflect changes in the processing of Patient
Data. |
| 7.5 | Company shall
store and hold available Consent Forms provided by Patients. Upon request by NV and to the
extent required to demonstrate compliance with Applicable Law, Company shall provide access
to these Consent Forms to NV. |
| 7.6 | The Parties
agree to cooperate in good faith in case Patients revoke their respective Dual Consent. The
Parties agree to inform each other about any withdrawal of Dual Consent without undue delay.
Upon notification of a withdrawal of Dual Consent, both Parties (a) will cease to perform
any Testing Services involving the respective Patient, and (b) delete all respective Patient
Data without undue delay, provided that no statutory requirements require a longer retention
period. |
| 8. | KSA PERSONAL
DATA TRANSFER TERMS |
| 8.1 | To the extent
that NV receives, accesses or otherwise transfers Personal Data outside of the Kingdom, the
transfer shall comply with Article 29 of the KSA PDPL, including the Regulation on Personal
Data Transfers outside the Kingdom, issued pursuant to the KSA PDPL, and in relation to any
onward transfer of the Personal Data by NV to another person, the other person shall comply
with the same obligations. |
| 8.2 | In particular,
NV shall ensure that: |
| 8.2.1 | The
transfer shall take place to a jurisdiction which maintains an appropriate level of Personal
Data protection (commonly referred to as “adequacy”) as determined by the relevant
Regulatory Authority in accordance with Article 29(2)(b) of the KSA PDPL; |
| 8.2.2 | The
transfer shall not prejudice Kingdom national security or the interests of the Kingdom or
violate Kingdom laws; and |
| 8.2.3 | The
transfer shall be limited to the minimum amount of Personal Data necessary. |
| 8.3 | To the extent
the recipient jurisdiction is not considered as adequate under Article 29(2)(b) of the
KSA PDPL, NV shall seek prior approval from Company prior to transferring the Personal Data
outside of the Kingdom and the Parties shall negotiate in good faith modifications to this
Schedule 3 in order to put in place a method for allowing the lawful transfer of Personal
Data, which may include the provisions under model transfer terms, or prior registration,
licensing or permission from a Regulatory Authority (“Lawful Export Measure”);
provided that Company agrees that NV may transfer Personal Data to NV’s office
in Belgrade, Serbia, provided that such storage, transfer, or access is made in compliance
with Applicable Data Protection Law. |
| 8.4 | To the extent
such Lawful Export Measure requires: |
| 8.4.1 | a contract
imposing appropriate safeguards on the transfer and processing of such Personal Data (which
is not otherwise satisfied by this Schedule); |
| 8.4.2 | a description
of the processing of Personal Data contemplated under this Schedule; and |
| 8.4.3 | a description
of technical and organisational measures to be implemented by the data importer, |
the
Parties agree that Part II – EU Standard Contractual Clauses Model 1, Annex I - the list of Parties and description of transfer,
and Annex III - the description of technical and organisational measures, shall apply mutatis mutandis for the benefit of such
transfer, and in relation to any onward transfer of the Personal Data by that data importer to another person, the other person shall
comply with the same importer obligations.
| 8.5 | Company may
in its absolute discretion refuse to give approval to transfer Personal Data outside of the
Kingdom where the recipient of Personal Data is not located in the European Union; provided
that Company agrees that NV may transfer Personal Data to NV’s office in Belgrade,
Serbia, provided that such storage, transfer, or access is made in compliance with
Applicable Data Protection Law. |
PART
II – EU STANDARD CONTRACTUAL CLAUSES – MODULE 1
STANDARD CONTRACTUAL
CLAUSES
for the transfer
of personal data to third countries pursuant to Regulation (EU) 2016/679, and in accordance with Commission Implementing Decision (EU)
2021/914 of 4 June 2021
MODULE 1: CONTROLLER
TO CONTROLLER TRANSFER
SECTION I
Clause 1
Purpose and
scope
| (a) | The purpose
of these standard contractual clauses is to ensure compliance with the requirements of Regulation
(EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on
the protection of natural persons with regard to the processing of personal data and on the
free movement of such data (General Data Protection Regulation) for the transfer of personal
data to a third country. |
| (i) | the natural
or legal person(s), public authority/ies, agency/ies or other body/ies (hereinafter “entity/ies”)
transferring the personal data, as listed in Annex I.A. (hereinafter each “data exporter”),
and |
| (ii) | the
entity/ies in a third country receiving the personal data from the data exporter, directly
or indirectly via another entity also Party to these Clauses, as listed in Annex I.A. (hereinafter
each “data importer”) |
have
agreed to these standard contractual clauses (hereinafter: “Clauses”).
| (c) | These Clauses
apply with respect to the transfer of personal data as specified in Annex I.B. |
| (d) | The Appendix
to these Clauses containing the Annexes referred to therein forms an integral part of these
Clauses. |
Clause 2
Effect and
invariability of the Clauses
| (a) | These Clauses
set out appropriate safeguards, including enforceable data subject rights and effective legal
remedies, pursuant to Article 46(1) and Article 46 (2)(c) of Regulation (EU) 2016/679
and, with respect to data transfers from controllers to processors and/or processors to processors,
standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679,
provided they are not modified, except to select the appropriate Module(s) or to add or update
information in the Appendix. This does not prevent the Parties from including the standard
contractual clauses laid down in these Clauses in a wider contract and/or to add other clauses
or additional safeguards, provided that they do not contradict, directly or indirectly, these
Clauses or prejudice the fundamental rights or freedoms of data subjects. |
| (b) | These Clauses
are without prejudice to obligations to which the data exporter is subject by virtue of Regulation
(EU) 2016/679. |
Clause 3
Third-party
beneficiaries
| (a) | Data subjects
may invoke and enforce these Clauses, as third-party beneficiaries, against the data exporter
and/or data importer, with the following exceptions: |
| (i) | Clause
1, Clause 2, Clause 3, Clause 6, Clause 7; |
| (ii) | Clause
8 - Clause 8.5 (e) and Clause 8.9(b); |
| (iii) | Clause
12 - Clause 12(a) and (d); |
| (v) | Clause
15.1(c), (d) and (e); |
| (vii) | Clause
18 - Clause 18(a) and (b). |
| (b) | Paragraph (a)
is without prejudice to rights of data subjects under Regulation (EU) 2016/679. |
Clause 4
Interpretation
| (a) | Where these
Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have the
same meaning as in that Regulation. |
| (b) | These Clauses
shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. |
| (c) | These Clauses
shall not be interpreted in a way that conflicts with rights and obligations provided for
in Regulation (EU) 2016/679. |
Clause 5
Hierarchy
In the event of
a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses
are agreed or entered into thereafter, these Clauses shall prevail.
Clause 6
Description
of the transfer(s)
The details of
the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred,
are specified in Annex I.B.
Clause 7 - Optional
Docking clause
| (a) | An entity that
is not a Party to these Clauses may, with the agreement of the Parties, accede to these Clauses
at any time, either as a data exporter or as a data importer, by completing the Appendix
and signing Annex I.A. |
| (b) | Once it has
completed the Appendix and signed Annex I.A, the acceding entity shall become a Party to
these Clauses and have the rights and obligations of a data exporter or data importer in
accordance with its designation in Annex I.A. |
| (c) | The acceding
entity shall have no rights or obligations arising under these Clauses from the period prior
to becoming a Party. |
SECTION II
– OBLIGATIONS OF THE PARTIES
Clause 8
Data protection
safeguards
The data exporter
warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical
and organisational measures, to satisfy its obligations under these Clauses.
The data importer
shall process the personal data only for the specific purpose(s) of the transfer, as set out in Annex I.B. It may only process the personal
data for another purpose:
| (i) | where
it has obtained the data subject’s prior consent; |
| (ii) | where
necessary for the establishment, exercise or defence of legal claims in the context of specific
administrative, regulatory or judicial proceedings; or |
| (iii) | where
necessary in order to protect the vital interests of the data subject or of another natural
person. |
| (a) | In order to
enable data subjects to effectively exercise their rights pursuant to Clause 10, the
data importer shall inform them, either directly or through the data exporter: |
| (i) | of its
identity and contact details; |
| (ii) | of the
categories of personal data processed; |
| (iii) | of the
right to obtain a copy of these Clauses; |
| (iv) | where
it intends to onward transfer the personal data to any third party/ies, of the recipient
or categories of recipients (as appropriate with a view to providing meaningful information),
the purpose of such onward transfer and the ground therefore pursuant to Clause 8.7. |
| (b) | Paragraph (a)
shall not apply where the data subject already has the information, including when such information
has already been provided by the data exporter, or providing the information proves impossible
or would involve a disproportionate effort for the data importer. In the latter case, the
data importer shall, to the extent possible, make the information publicly available. |
| (c) | On request,
the Parties shall make a copy of these Clauses, including the Appendix as completed by them,
available to the data subject free of charge. To the extent necessary to protect business
secrets or other confidential information, including personal data, the Parties may redact
part of the text of the Appendix prior to sharing a copy, but shall provide a meaningful
summary where the data subject would otherwise not be able to understand its content or exercise
his/her rights. On request, the Parties shall provide the data subject with the reasons for
the redactions, to the extent possible without revealing the redacted information. |
| (d) | Paragraphs
(a) to (c) are without prejudice to the obligations of the data exporter under Articles 13
and 14 of Regulation (EU) 2016/679. |
| 8.3 | Accuracy
and data minimisation |
| (a) | Each Party
shall ensure that the personal data is accurate and, where necessary, kept up to date. The
data importer shall take every reasonable step to ensure that personal data that is inaccurate,
having regard to the purpose(s) of processing, is erased or rectified without delay. |
| (b) | If one of the
Parties becomes aware that the personal data it has transferred or received is inaccurate,
or has become outdated, it shall inform the other Party without undue delay. |
| (c) | The data importer
shall ensure that the personal data is adequate, relevant and limited to what is necessary
in relation to the purpose(s) of processing. |
The data importer
shall retain the personal data for no longer than necessary for the purpose(s) for which it is processed. It shall put in place appropriate
technical or organisational measures to ensure compliance with this obligation, including erasure or anonymisation of the data and all
back-ups at the end of the retention period.
| 8.5 | Security
of processing |
| (a) | The data importer
and, during transmission, also the data exporter shall implement appropriate technical and
organisational measures to ensure the security of the personal data, including protection
against a breach of security leading to accidental or unlawful destruction, loss, alteration,
unauthorised disclosure or access (hereinafter “personal data breach”). In assessing
the appropriate level of security, they shall take due account of the state of the art, the
costs of implementation, the nature, scope, context and purpose(s) of processing and the
risks involved in the processing for the data subject. The Parties shall in particular consider
having recourse to encryption or pseudonymisation, including during transmission, where the
purpose of processing can be fulfilled in that manner. |
| (b) | The Parties
have agreed on the technical and organisational measures set out in Annex II. The data importer
shall carry out regular checks to ensure that these measures continue to provide an appropriate
level of security. |
| (e) | The data importer
shall ensure that persons authorised to process the personal data have committed themselves
to confidentiality or are under an appropriate statutory obligation of confidentiality. |
| (f) | In the event
of a personal data breach concerning personal data processed by the data importer under these
Clauses, the data importer shall take appropriate measures to address the personal data breach,
including measures to mitigate its possible adverse effects. |
| (g) | In case of
a personal data breach that is likely to result in a risk to the rights and freedoms of natural
persons, the data importer shall without undue delay notify both the data exporter and the
competent supervisory authority pursuant to Clause 13. Such notification shall contain i)
a description of the nature of the breach (including, where possible, categories and approximate
number of data subjects and personal data records concerned), ii) its likely consequences,
iii) the measures taken or proposed to address the breach, and iv) the details of a contact
point from whom more information can be obtained. To the extent it is not possible for the
data importer to provide all the information at the same time, it may do so in phases without
undue further delay. |
| (h) | In case of
a personal data breach that is likely to result in a high risk to the rights and freedoms
of natural persons, the data importer shall also notify without undue delay the data subjects
concerned of the personal data breach and its nature, if necessary in cooperation with the
data |
exporter,
together with the information referred to in paragraph (e), points ii) to iv), unless the data importer has implemented measures to significantly
reduce the risk to the rights or freedoms of natural persons, or notification would involve disproportionate efforts. In the latter case,
the data importer shall instead issue a public communication or take a similar measure to inform the public of the personal data breach.
| (i) | The data importer
shall document all relevant facts relating to the personal data breach, including its effects
and any remedial action taken, and keep a record thereof. |
Where the transfer involves personal
data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data,
or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual
orientation, or data relating to criminal convictions or offences (hereinafter “sensitive data”), the data importer shall
apply specific restrictions and/or additional safeguards adapted to the specific nature of the data and the risks involved. This may
include restricting the personnel permitted to access the personal data, additional security measures (such as pseudonymisation) and/or
additional restrictions with respect to further disclosure.
The data importer
shall not disclose the personal data to a third party located outside the European Union (in the same country as the data importer or
in another third country, hereinafter “onward transfer”) unless the third party is or agrees to be bound by these Clauses,
under the appropriate Module. Otherwise, an onward transfer by the data importer may only take place if:
| (a) | it is to a
country benefitting from an adequacy decision pursuant to Article 45 of Regulation (EU)
2016/679 that covers the onward transfer; |
| (b) | the third party
otherwise ensures appropriate safeguards pursuant to Articles 46 or 47 of Regulation (EU)
2016/679 with respect to the processing in question; |
| (c) | the third party
enters into a binding instrument with the data importer ensuring the same level of data protection
as under these Clauses, and the data importer provides a copy of these safeguards to the
data exporter; |
| (d) | it is necessary
for the establishment, exercise or defence of legal claims in the context of specific administrative,
regulatory or judicial proceedings; |
| (e) | it is necessary
in order to protect the vital interests of the data subject or of another natural person;
or |
| (f) | where none
of the other conditions apply, the data importer has obtained the explicit consent of the
data subject for an onward transfer in a specific situation, after having informed him/her
of its purpose(s), the identity of the recipient and the possible risks of such transfer
to him/her due to the lack of appropriate data protection safeguards. In this case, the data
importer shall inform the data exporter and, at the request of the latter, shall transmit
to it a copy of the information provided to the data subject. |
Any onward transfer
is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.
| 8.8 | Processing
under the authority of the data importer |
The data importer
shall ensure that any person acting under its authority, including a processor, processes the data only on its instructions.
| 8.9 | Documentation
and compliance |
| (a) | Each Party
shall be able to demonstrate compliance with its obligations under these Clauses. In particular,
the data importer shall keep appropriate documentation of the processing activities carried
out under its responsibility. |
| (b) | The data importer
shall make such documentation available to the competent supervisory authority on request. |
Clause 9
Use of sub-processors
[Intentionally
Omitted.]
Clause 10
Data subject
rights
| (a) | The data importer,
where relevant with the assistance of the data exporter, shall deal with any enquiries and
requests it receives from a data subject relating to the processing of his/her personal data
and the exercise of his/her rights under these Clauses without undue delay and at the latest
within one month of the receipt of the enquiry or request. The data importer shall take appropriate
measures to facilitate such enquiries, requests and the exercise of data subject rights.
Any information provided to the data subject shall be in an intelligible and easily accessible
form, using clear and plain language. |
| (b) | In particular,
upon request by the data subject the data importer shall, free of charge: |
| (i) | provide
confirmation to the data subject as to whether personal data concerning him/her is being
processed and, where this is the case, a copy of the data relating to him/her and the information
in Annex I; if personal data has been or will be onward transferred, provide information
on recipients or categories of recipients (as appropriate with a view to providing meaningful
information) to which the personal data has been or will be onward transferred, the purpose
of such onward transfers and their ground pursuant to Clause 8.7; and provide information
on the right to lodge a complaint with a supervisory authority in accordance with Clause
12(c)(i); |
| (ii) | rectify
inaccurate or incomplete data concerning the data subject; |
| (iii) | erase
personal data concerning the data subject if such data is being or has been processed in
violation of any of these Clauses ensuring third-party beneficiary rights, or if the data
subject withdraws the consent on which the processing is based. |
| (c) | Where the data
importer processes the personal data for direct marketing purposes, it shall cease processing
for such purposes if the data subject objects to it. |
| (d) | The data importer
shall not make a decision based solely on the automated processing of the personal data transferred
(hereinafter “automated decision”), which would produce legal effects concerning
the data subject or similarly significantly affect him / her, unless with the explicit consent
of the data subject or if authorised to do so under the laws of the country of destination,
provided that such laws lays down suitable measures to safeguard the data subject’s
rights and legitimate interests. In this case, the data importer shall, where necessary in
cooperation with the data exporter: |
| (i) | inform
the data subject about the envisaged automated decision, the envisaged consequences and the
logic involved; and |
| (ii) | implement
suitable safeguards, at least by enabling the data subject to contest the decision, express
his/her point of view and obtain review by a human being. |
| (e) | Where requests
from a data subject are excessive, in particular because of their repetitive character, the
data importer may either charge a reasonable fee taking into account the administrative costs
of granting the request or refuse to act on the request. |
| (f) | The data importer
may refuse a data subject’s request if such refusal is allowed under the laws of the
country of destination and is necessary and proportionate in a democratic society to protect
one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679. |
| (g) | If the data
importer intends to refuse a data subject’s request, it shall inform the data subject
of the reasons for the refusal and the possibility of lodging a complaint with the competent
supervisory authority and/or seeking judicial redress. |
Clause 11
Redress
| (a) | The data importer
shall inform data subjects in a transparent and easily accessible format, through individual
notice or on its website, of a contact point authorised to handle complaints. It shall deal
promptly with any complaints it receives from a data subject. |
| (b) | In case of
a dispute between a data subject and one of the Parties. as regards compliance with these
Clauses, that Party shall use its best efforts to resolve the issue amicably in a timely
fashion. The Parties shall keep each other informed about such disputes and, where appropriate,
cooperate in resolving them. |
| (c) | Where the data
subject invokes a third-party beneficiary right pursuant to Clause 3, the data importer shall
accept the decision of the data subject to: |
| (i) | lodge
a complaint with the supervisory authority in the Member State of his/her habitual residence
or place of work, or the competent supervisory authority pursuant to Clause 13; |
| (ii) | refer
the dispute to the competent courts within the meaning of Clause 18. |
| (d) | The Parties
accept that the data subject may be represented by a not-for-profit body, organisation or
association under the conditions set out in Article 80(1) of Regulation (EU) 2016/679. |
| (e) | The data importer
shall abide by a decision that is binding under the applicable EU or Member State law. |
| (f) | The data importer
agrees that the choice made by the data subject will not prejudice his/her substantive and
procedural rights to seek remedies in accordance with applicable laws. |
Clause
12
Liability
| (a) | Each Party
shall be liable to the other Party/ies for any damages it causes the other Party/ies by any
breach of these Clauses. |
| (b) | Each Party
shall be liable to the data subject, and the data subject shall be entitled to receive compensation,
for any material or non-material damages that the Party causes the data subject by breaching
the third-party beneficiary rights under these Clauses. This is without prejudice to the
liability of the data exporter under Regulation (EU) 2016/67 9. |
| (c) | Where more
than one Party is responsible for any damage caused to the data subject as a result of a
breach of these Clauses, al l responsible Parties shall be jointly and severally liable and
the data subject is entitled to bring an action in court against any of these Parties. |
| (d) | The Parties
agree that if one Party is held liable under paragraph (c), it shall be entitled to claim
back from the other Party/ies that part of the compensation corresponding to its / their
responsibility for the damage. |
| (e) | The data importer
may not invoke the conduct of a processor or sub-processor to avoid its own liability. |
Clause 13
Supervision
| (a) | The supervisory
authority with responsibility for ensuring compliance by the data exporter with Regulation
(EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent
supervisory authority. |
| (b) | The data importer
agrees to submit itself to the jurisdiction of and cooperate with the competent supervisory
authority in any procedures aimed at ensuring compliance with these Clauses. In particular,
the data importer agrees to respond to enquiries, submit to audits and comply y with the
measures adopted by the supervisory authority, including remedial and compensatory measures.
It shall provide the supervisory authority with written confirmation that the necessary actions
have been taken. |
SECTION III
– LOCAL LAWS AND OBLIGATIONS IN CASE OF ACCESS BY PUBLIC AUTHORITIES
Clause 14
Local laws
and practices affecting compliance with the Clauses
| (a) | The Parties
warrant that they have no reason to believe that the laws and practices in the third country
of destination applicable to the processing of the personal data by the data importer, including
any requirements to disclose personal data or measures authorising access by public authorities,
prevent the data importer from fulfilling its obligations under these Clauses. This is based
on the understanding that laws and practices that respect the essence of the fundamental
rights and freedoms and do not exceed what is necessary and proportionate in a democratic
society to safeguard one of the objectives listed in Article 23(1) of Regulation (EU)
2016/679, are not in contradiction with these Clauses. |
| (b) | The Parties
declare that in providing the warranty in paragraph (a), they have taken due account in particular
of the following elements: |
| (i) | the specific
circumstances of the transfer, including the length of the processing chain, the number of
actors involved and the transmission channels used; intended onward transfers; the type of
recipient; the purpose of processing; the categories and format of the transferred personal
data; the economic sector in which the transfer occurs; the storage location of the data
transferred; |
| (ii) | the
laws and practices of the third country of destination – including those requiring
the disclosure of data to public authorities or authorising access by such authorities –
relevant in light of the specific circumstances of the transfer, and the applicable limitations
and safeguards; |
| (iii) | any
relevant contractual, technical or organisational safeguards put in place to supplement the
safeguards under these Clauses, including measures applied during transmission and to the
processing of the personal data in the country of destination. |
| (c) | The data importer
warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts
to provide the data exporter with relevant information and agrees that it will continue to
cooperate with the data exporter in ensuring compliance with these Clauses. |
| (d) | The Parties
agree to document the assessment under paragraph (b) and make it available to the competent
supervisory authority on request. |
| (e) | The data importer
agrees to notify the data exporter promptly if, after having agreed to these Clauses and
for the duration of the contract, it has reason to believe that it is or has become subject
to laws or practices not in line with the requirements under paragraph (a), including following
a change in the laws of the third country or a measure (such as a disclosure request) indicating
an application of such laws in practice that is not in line with the requirements in paragraph
(a). |
| (f) | Following a
notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe
that the data importer can no longer fulfil its obligations under these Clauses, the data
exporter shall promptly identify appropriate measures (e.g. technical or organisational measures
to ensure security and confidentiality) to be adopted by the data exporter and/or data importer
to address the situation. The data exporter shall suspend the data transfer if it considers
that no appropriate safeguards for such transfer can be ensured, or if instructed by the
competent supervisory authority to do so. In this case, the data exporter shall be entitled
to terminate the contract, insofar as it concerns the processing of personal data under these
Clauses. If the contract involves more than two Parties, the data exporter may exercise this
right to termination only with respect to the relevant Party, unless the Parties have agreed
otherwise. Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e)
shall apply. |
Clause 15
Obligations
of the data importer in case of access by public authorities
| (a) | The data importer
agrees to notify the data exporter and, where possible, the data subject promptly (if necessary
with the help of the data exporter) if it: |
| (i) | receives
a legally binding request from a public authority, including judicial authorities, under
the laws of the country of destination for the disclosure of personal data transferred pursuant
to these Clauses; such notification shall include information about the personal data requested,
the requesting authority, the legal basis for the request and the response provided; or |
| (ii) | becomes
aware of any direct access by public authorities to personal data transferred pursuant to
these Clauses in accordance with the laws of the country of destination; such notification
shall include all information available to the importer. |
| (g) | If the data
importer is prohibited from notifying the data exporter and/or the data subject under the
laws of the country of destination, the data importer agrees to use its best efforts to obtain
a waiver of the prohibition, with a view to communicating as much information as possible,
as soon as possible. The data importer agrees to document its best efforts in order to be
able to demonstrate them on request of the data exporter. |
| (h) | Where permissible
under the laws of the country of destination, the data importer agrees to provide the data
exporter, at regular intervals for the duration of the contract, with as much relevant information
as possible on the requests received (in particular, number of requests, type of data requested,
requesting authority/ies, whether requests have been challenged and the outcome of such challenges,
etc.). |
| (i) | The data importer
agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of
the contract and make it available to the competent supervisory authority on request. |
| (j) | Paragraphs
(a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause
14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with
these Clauses. |
| 15.2 | Review
of legality and data minimisation |
| (a) | The data importer
agrees to review the legality of the request for disclosure, in particular whether it remains
within the powers granted to the requesting public authority, and to challenge the request
if, after careful assessment, it concludes that there are reasonable grounds to consider
that the request is unlawful under the laws of the country of destination, applicable obligations
under international law and principles of international comity. The data importer shall,
under the same conditions, pursue possibilities of appeal. When challenging a request, the
data importer shall seek interim measures with a view to suspending the effects of the request
until the competent judicial authority has decided on its merits. It shall not disclose the
personal data requested until required to do so under the applicable procedural rules. These
requirements are without prejudice to the obligations of the data importer under Clause 14(e). |
| (k) | The data importer
agrees to document its legal assessment and any challenge to the request for disclosure and,
to the extent permissible under the laws of the country of destination, make the documentation
available to the data exporter. It shall also make it available to the competent supervisory
authority on request. |
| (l) | The data importer
agrees to provide the minimum amount of information permissible when responding to a request
for disclosure, based on a reasonable interpretation of the request. |
SECTION
IV – FINAL PROVISIONS
Clause
16
Non-compliance
with the Clauses and termination
| (a) | The data importer
shall promptly inform the data exporter if it is unable to comply with these Clauses, for
whatever reason. |
| (b) | In the event
that the data importer is in breach of these Clauses or unable to comply with these Clauses,
the data exporter shall suspend the transfer of personal data to the data importer until
compliance is again ensured or the contract is terminated. This is without prejudice to Clause
14(f). |
| (c) | The data exporter
shall be entitled to terminate the contract, insofar as it concerns the processing of personal
data under these Clauses, where: |
| (i) | the data
exporter has suspended the transfer of personal data to the data importer pursuant to paragraph
(b) and compliance with these Clauses is not restored within a reasonable time and in any
event within one month of suspension; |
| (ii) | the
data importer is in substantial or persistent breach of these Clauses; or |
| (iii) | the
data importer fails to comply with a binding decision of a competent court or supervisory
authority regarding its obligations under these Clauses. |
In these
cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties,
the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise.
| (b) | Personal data
that has been transferred prior to the termination of the contract pursuant to paragraph
(c) shall at the choice of the data exporter immediately be returned to the data exporter
or deleted in its entirety. The same shall apply to any copies of the data. The data importer
shall certify the deletion of the data to the data exporter. Until the data is deleted or
returned, the data importer shall continue to ensure compliance with these Clauses. In case
of local laws applicable to the data importer that prohibit the return or deletion of the
transferred personal data, the data importer warrants. that it will continue to ensure compliance
with these Clauses and will only process the data to the extent and for as long as required
under that local law. |
| (c) | Either Party
may revoke its agreement to be bound by these Clauses where (i) the European Commission adopts
a decision pursuant to Article 45(3) of Regulation (EU) 2016/679 that covers the transfer
of personal data to which these Clauses apply; or (ii) Regulation (EU) 2016/679 becomes part
of the legal framework of the country to which the personal data is transferred. This is
without prejudice to other obligations applying to the processing in question under Regulation
(EU) 2016/679. |
Clause 17
Governing
law
These Clauses shall
be governed by the law of one of the EU Member States, provided such law allows for third-party beneficiary rights. The Parties agree
that this shall be the law of Germany.
Clause 18
Choice of
forum and jurisdiction
| (a) | Any dispute
arising from these Clauses shall be resolved by the courts of an EU Member State. |
| (b) | The Parties
agree that those shall be the courts of Germany. |
| (c) | A data subject
may also bring legal proceedings against the data exporter and/or data importer before the
courts of the Member State in which he/she has his/her habitual residence. |
| (d) | The Parties
agree to submit themselves to the jurisdiction of such courts. |
APPENDIX
ANNEX I
A.
LIST OF PARTIES
Data exporter:
Name:
Centogene N.V.
a company organized under the laws of the Netherlands.
Address / registered
office:
Amsterdam and registered
with the Kamer von Koophandel (Netherlands) under 72822872
Contact person’s
name, position and contact details:
[***], General
Counsel, [***]
Name and contact
details of the data protection officer:
[***],
datenschutz nord GmbH, Konsul-Schmidt-Str. 88, 28217 Bremen
Signature and
date:
See signature
page below
Role (controller/processor):
Controller.
Data importer(s):
Name:
Genomics Innovations
Company Limited, a limited liability company organized uder the laws of the Kingdom of Saudi Arabia.
Address. / registered
office:
Building No. 3936,
6651 Al Nakheel District, 12382 Riyadh, Kingdom of Saudi Arabia
Contact person’s
name, position and c ontact details:
[***]
[***]
Name and contact
details of the data protection officer:
[***]
[***]
Signature and
date:
See signature
page. below
Role (controller/processor):
Controller.
B.
DESCRIPTION OF TRANSFER
- access via IT systems
- via email (not
sensitive data)
C.
COMPETENT SUPERVISORY AUTHORITY
Der Landesbeauftragte für Datenschutz
und Informationsfreiheit Mecklenburg-Vorpommern, Werderstraße 74a, 19055 Schwerin, Germany, https://www.datenschutz-mv.de
This Schedule 3
(Data Sharing Agreement) has been executed by the Parties on 27 November 2023.
Signed by Kim Stratton for and on
behalf of NV
|
/s/ Kim Stratton |
|
|
Signed by Miguel Coego for and on
behalf of NV
|
/s/ Miguel Coego |
|
|
Signed by Jeremy Panacheril for
and on behalf of Company
|
/s/ Jeremy Panacheril |
ANNEX II
- TECHNICAL AND ORGANISATIONAL MEASURES INCLUDING TECHNICAL AND ORGANISATIONAL MEASURES TO ENSURE THE SECURITY OF THE DATA
See attached.
Schedule
4
[***]
Schedule
5
[***]
Exhibit 99.4
Execution
Version
GENOMICS
INNOVATIONS COMPANY LIMITED
(“Company”)
and
CENTOGENE
N.V.
(“NV”)
dated
27 November 2023
|
TECHNOLOGY
TRANSFER AND INTELLECTUAL PROPERTY LICENSE AGREEMENT
|
TABLE
OF CONTENTS
Clause |
|
Page |
|
|
|
1. |
DEFINITIONS; INTERPRETATION |
1 |
2. |
LICENSE GRANTS AND ASSOCIATED RIGHTS AND RESTRICTIONS |
1 |
3. |
TECHNOLOGY TRANSFER AND USE OF DATA |
4 |
4. |
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND ENFORCEMENT |
5 |
5. |
PAYMENTS |
7 |
6. |
TAXES |
8 |
7. |
CONFIDENTIAL INFORMATION |
10 |
8. |
REPRESENTATIONS, WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY |
11 |
9. |
TERM AND TERMINATION |
15 |
10. |
GOVERNMENTAL COMPLIANCE |
18 |
11. |
NOTICES |
19 |
12. |
FURTHER ASSURANCES |
20 |
13. |
ANNOUNCEMENTS |
20 |
14. |
LANGUAGE |
20 |
15. |
ASSIGNMENT AND SUBCONTRACTING |
20 |
16. |
NO PARTNERSHIP OR AGENCY |
21 |
17. |
COSTS AND TAXES |
21 |
18. |
WAIVER AND VARIATION |
21 |
19. |
SEVERABILITY |
21 |
20. |
THIRD PARTY RIGHTS |
22 |
21. |
SPECIFIC PERFORMANCE |
22 |
22. |
GOVERNING LAW AND JURISDICTION |
22 |
23. |
FORCE MAJEURE |
23 |
24. |
ENTIRE AGREEMENT |
23 |
25. |
COUNTERPARTS |
24 |
SCHEDULE 1 |
26 |
PART 1 - DEFINITIONS |
26 |
PART 2 - INTERPRETATION |
36 |
SCHEDULE 2 NV TRADEMARKS |
37 |
SCHEDULE 3 PERMITTED ENCUMBRANCES |
40 |
SCHEDULE 4 NV IPR CLAIMS |
41 |
SCHEDULE 5 ACKNOWLEDGEMENT AND UNDERTAKING |
42 |
TECHNOLOGY
TRANSFER AND INTELLECTUAL PROPERTY LICENSE AGREEMENT
THIS
TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY LICENSE AGREEMENT (this “IP Agreement”) is dated 27 November 2023
(the “Effective Date”) and is entered into by and between:
| (1) | GENOMICS
INNOVATIONS COMPANY LIMITED, a company organized under the laws of the Kingdom of Saudi
Arabia with a registered office at Building No. 3936, 6651 Al Nakheel District, 12382 Riyadh,
Kingdom of Saudi Arabia (“Company”); and |
| (2) | CENTOGENE
N.V., a company organized under the laws of the Netherlands with a registered office
at Am Strande 7, 18055 Rostock, Germany (“NV”). |
Company
and NV shall be referred to herein either individually as a “Party” or together as the “Parties”.
| (A) | NV
and its Affiliates (as defined below) have developed and maintain certain laboratories and
a biodatabank relating to patient samples collected in the ordinary course of its diagnostics
business at a site located in Rostock, Germany (“NV Facility”); |
| (B) | Company
and NV have entered into a Joint Venture Agreement dated 26 June 2023 (“Joint Venture
Agreement”) for the establishment of Company and the operation of the KSA Facility
in the Kingdom; |
| (C) | Company and
NV have entered into a Laboratory Services Agreement dated 27 November 2023 (“Laboratory
Services Agreement”) whereby NV or its Affiliates shall act as the exclusive provider
of certain laboratory and diagnostic services to Company; |
| (D) | Company and
NV have entered into a Consultancy Agreement dated 27 November 2023 (“Consultancy
Agreement”) for the provision by NV and its Affiliates of certain consultancy services
related to the construction and operation of the KSA Facility; |
| (E) | The
Parties wish to enter into this IP Agreement to address the Parties’ respective rights
with respect to certain Intellectual Property Rights that will be used in connection with
the activities contemplated by the Consultancy Agreement and Laboratory Services Agreement;
and |
| (F) | Company
wishes to obtain from NV, and NV wishes to grant to Company, an exclusive license in the
KSA to certain NV IPR (as defined below) for Company’s operation of the Business (as
defined below) and establishment of the KSA Facility, on the terms and conditions set forth
herein. |
NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, the Parties hereby agree
as follows:
| 1. | DEFINITIONS;
INTERPRETATION |
Capitalized
terms used in this IP Agreement shall have the meanings given in Part 1 (Definitions) of Schedule 1 (Defined Terms and Interpretation).
This IP Agreement shall be interpreted in accordance with Part 2 (Interpretation) of Schedule 1 (Defined Terms and Interpretation).
| 2. | LICENSE
GRANTs and associated rights and restrictions |
| 2.1.1 | Subject
to the terms and conditions of this IP Agreement, NV hereby grants (and shall cause its Affiliates
to grant) to Company: |
| (a) | an
exclusive, perpetual (in accordance with the terms set forth in clause 9.3.2), non-sublicensable
(other than as set forth in clause 2.3), non-transferable (other than as set forth in clause
15), royalty-bearing license to use the NV Technology, NV Know-How, NV Patents, in KSA, and
solely for the purposes of: |
| (i) | receiving
the full benefit of services provided by NV under any Project Documents; |
| (ii) | operating
the KSA Facility and the Business (including in connection with any and all services and/or
products marketed, promoted or provided by Company to its customers); |
| (iii) | performing
diagnostic testing services by Company in KSA by accessing and utilizing the NV Technology;
and |
| (iv) | accessing,
viewing and Manipulating the NV Data and creating Company Derived Data, |
collectively
(i)-(iv) (the “Purpose”);
| (b) | an
exclusive, perpetual (in accordance with the terms set forth in clause 9.3.2), irrevocable
(other than as set forth in clause 9.3), non-sublicensable (other than as set forth in clause
2.3), non-transferable (other than as set forth in clause 15) license to use the NV Variant
List as of the date that the KSA Facility is operational and updated thereafter during the
Term solely in KSA and solely for the Purpose; |
| (c) | an
exclusive, perpetual (in accordance with the terms set forth in clause 9.3.2), irrevocable
(other than as set forth in clause 9.3), non-sublicensable (other than as set forth in clause
2.3), non-transferable (other than as set forth in clause 15) license to use the NV KSA Data
solely in KSA and solely for the Purpose; |
| (d) | an
exclusive, perpetual, irrevocable, royalty-free, fully paid-up, fully sublicensable (through
multiple tiers of sublicenses), fully transferable, license to use the New NV IPR, solely
in KSA and solely for the Purpose; and |
| (e) | an
exclusive, limited, royalty-free, non-transferable, non-sublicensable (except as set forth
in clause 2.3) and license to use the NV Trademarks solely in KSA and solely in connection
with the Business for use on Business Materials and Promotional Materials for the duration
of the Initial Term (unless earlier terminated in accordance with clause 9.2). |
| 2.1.2 | The
license grants from NV in clause 2.1.1 shall be exclusive to Company in KSA and NV shall
not grant to any Third Party a right to use the NV IPR in KSA. The Parties hereby acknowledge
and agree that clause 10 (Restrictive Covenants) of the Joint Venture Agreement shall apply
to this IP Agreement mutatis mutandis. In the event that Company is successful in
securing any Material Opportunity, the Parties shall discuss in good faith, |
for
up to forty (40) Business Days, the terms of an agreement pursuant to which Company would obtain an exclusive license to use NV IPR in
the Other GCC Member State that is the subject of such Material Opportunity in compliance with the terms set forth in the Joint Venture
Agreement.
| 2.1.3 | For
the avoidance of doubt, Company’s license to the NV Data under clauses 2.1.1(b) and
2.1.1(c) shall at all times be subject to any restrictions provided by Applicable Law, including,
but not limited to, the informed consent form of each applicable data subject pursuant to
Applicable Data Protection Laws. Company shall not be in breach of the license grant in clause
2.1.1(e) where it uses such NV Trademarks on any websites or digital materials outside of
KSA so long as such use complies with Company’s obligations under clause 10 (Restrictive
Covenants) of the Joint Venture Agreement. |
| 2.2.1 | Subject
to the terms and conditions of this IP Agreement, Company hereby grants (and shall cause
its Affiliates to grant) to NV and its Affiliates a non-exclusive, royalty-free, fully paid-up,
non-sublicensable (other than as set forth in clause 2.3) and non-transferable (other than
as set forth in clause 15) license to use the Company IPR (other than Company Data) in Germany
and KSA, solely for the purposes of performing its obligations under the Laboratory Services
Agreement and Consultancy Agreement, for the duration of the Term (unless earlier terminated
in accordance with clause 9.2). |
| 2.2.2 | Company
has collected, or will collect, Company Data and shall make such Company Data available to
NV in order for NV to fulfil its obligations under the Laboratory Services Agreement. Subject
to the terms and conditions of this IP Agreement, Company hereby grants (and shall cause
its Affiliates to grant) to NV and its Affiliates a non-exclusive, royalty-free, fully paid-up,
non-sublicensable (other than as set forth in clause 2.3), non-transferable (other than as
set forth in clause 15) license to use the Company Data in Germany and KSA, for the duration
of the Term (unless earlier terminated in accordance with clause 9.2) for the purposes of: |
| (a) | providing
the Testing Services (as defined in the Laboratory Services Agreement) to Company under the
Laboratory Services Agreement; |
| (b) | conducting
internal research and development at the NV Facility; and |
| (c) | accessing,
viewing and analyzing the Company Data and creating NV Derived Data |
| 2.2.3 | For
the avoidance of doubt, NV’s license to the Company Data under clause 2.2.2 shall at
all times be subject to any restrictions provided by Applicable Law including, but not limited
to, the informed consent form of each applicable data subject pursuant to Applicable Data
Protection Laws. |
| 2.3.1 | The
Licensed Party may not sublicense any licenses granted to it under clauses 2.1.1(a), 2.1.1(b),
2.1.1(c), 2.1.1(e), 2.2.1 or 2.2.2, as applicable, to any Third Party without the prior written
consent of the Licensing Party; provided that, Company may sublicense the NV IPR to
Third Party service providers engaged pursuant to the terms of the Consultancy Agreement
or Laboratory Services Agreement without prior written consent, solely to |
allow
such service providers to provide the services permitted under such agreement to Company.
| 2.3.2 | In
the event that the Licensing Party consents to the Licensed Party granting any such sublicense,
the sublicense agreement shall be consistent with, and expressly made subject to, the terms
and conditions of this IP Agreement. The Licensed Party shall be liable for any acts or omissions
of its subcontractor or failure of any of its sublicensees to comply with this IP Agreement
and the grant of any such sublicense shall not relieve such Licensed Party of its obligations
under this IP Agreement. Except for any sublicenses granted by Company under clause 2.1.1(d),
upon the expiration or earlier termination of this IP Agreement, any such sublicense agreements
shall automatically terminate (and each sublicense agreement shall include terms notifying
the sublicensee of and automatically effecting such termination). Any sublicense granted
or attempted to be granted in contravention of the terms and conditions of this clause 2.3
shall be null and void. |
NV
shall not incorporate into any NV deliverable under the Consultancy Agreement or Laboratory Services Agreement or otherwise provide Company
with, any Intellectual Property Rights owned by a Third Party (the “Third Party IPR”) necessary for Company to receive
the benefit of any Project Documents without first:
| 2.4.1 | obtaining
Company’s prior written consent; and |
| 2.4.2 | informing
Company of the details and required uses for such Third Party IPR. |
In
the event Company requires a license to continue to use such Third Party IPR, NV shall use commercially reasonable efforts to assist
Company in obtaining a license to such Third Party IPR, at Company’s sole cost and expense (including the payments of any royalties,
fees or other amounts under such license).
Except
as otherwise expressly set forth in this IP Agreement, none of the Parties or their Affiliates shall acquire under this IP Agreement
any license or other right, title or interest, by implication, estoppel or otherwise, under any Intellectual Property Rights of the other
Party or such other Party’s Affiliates.
| 3. | TECHNOLOGY
TRANSFER AND USE OF DATA |
| 3.1 | NV
shall provide Company with copies of the NV Technology, NV Data and NV Know-How in accordance
with the timelines set forth on Schedule 2 (Scope of Services) of the Consultancy
Agreement (and any other Project Documents) unless otherwise mutually agreed by the Parties
in writing. |
| 3.2 | For
the avoidance of doubt, any transfer of NV Data to Company or Company Data to NV under any
Project Documents shall only be performed to the extent permissible under all Applicable
Laws and any applicable consents from data subjects pursuant to Applicable Data Protection
Laws including, but not limited to, the Data Sharing Agreement in the Laboratory Services
Agreement. |
| 3.3 | Company
shall accept such transfer of the copies of NV Technology, NV Data and NV Know-How as soon
as practicable, including by designating representatives to serve as recipients of such NV
Technology and NV Know-How. |
| 3.4 | During
the Term, NV shall notify Company of any new, or Improvements to, NV Technology or NV Know-How
(including any New NV IPR), or any NV Technology or NV Know-How not previously transferred
to Company, which, in each case, are necessary to provide the services under the Project
Documents and, at Company’s written request, NV shall either promptly transfer copies
of such NV Technology or NV Know-How to Company and/or update Schedule 2 (Scope of Services)
of the Consultancy Agreement or the relevant Project Documents to reflect the reasonable
timeline for such transfer, which shall be mutually agreed by the Parties in writing. |
| 3.5 | NV
shall provide reasonable training and assistance to Company in relation to the technology
transfer as set forth in the Laboratory Services Agreement and Consultancy Agreement or,
if not set forth therein, only as mutually agreed to by the Parties in writing. |
| 4. | INTELLECTUAL
PROPERTY OWNERSHIP, PROTECTION AND ENFORCEMENT |
| 4.1 | Intellectual
Property Ownership |
| 4.1.1 | Company
Background IPR and NV Background IPR |
As
between the Parties, and subject to the licenses granted under this IP Agreement, NV solely and exclusively owns, and shall continue
to solely and exclusively own, the entire right, title, and interest in and to any and all NV Background IPR, and Company shall solely
and exclusively own the entire right, title, and interest in and to any and all Company Background IPR.
Subject
to the license grants and other rights herein, as between the Parties:
| (a) | NV
shall solely and exclusively own and retain all right, title and interest in and to any and
all New IPR that is conceived, discovered, developed, reduced to practice or otherwise made
solely by or on behalf of NV (or its Affiliates or its or their sublicensees or personnel)
under any of the Project Documents, including any NV Derived Data (the “New NV IPR”); |
| (b) | Company
shall solely and exclusively own and retain all right, title and interest in and to any and
all New IPR that is conceived, discovered, developed, reduced to practice or otherwise made
solely by or on behalf of Company (or its Affiliates or its or their sublicensees or personnel
and any NV secondees during the course of their secondment from NV at the KSA Facility (the
“NV Secondees”)) under any of the Project Documents, including any Company
Derived Data and Company Data (“New Company IPR”); |
| (c) | After
Company and NV have notified each other in relation to the selection of any NV Secondees
as a condition precedent to the start of any secondment under the Consultancy Agreement,
the relevant NV Secondee shall execute, and NV shall use commercially reasonable efforts
to secure such execution of, an Acknowledgment and Undertaking materially in the form of
Schedule 5 (Acknowledgement and Undertaking). In the event of any conflict between
the provisions of this IP Agreement and the provisions of any Acknowledgment and Undertaking,
the provisions of the Acknowledgment and Undertaking shall prevail; and |
| (d) | While
the Parties do not anticipate the creation of New IPR that is jointly created under the Project
Documents, the Parties shall jointly own all right, title and interest in and to any and
all New IPR that is conceived, discovered, developed, reduced to practice or otherwise made
jointly by or on behalf of both Parties (or its Affiliates or its or their permitted sublicensees
or personnel) under the Project Documents during the Term; that does not constitute New NV
IPR or New Company IPR and is not related to any further commercial or non-operational activities
of the KSA Facility (“Joint IPR”). Each Party shall have an equal and
undivided joint ownership interest in and to the Joint IPR. Each Party will exercise its
ownership rights in and to such Joint IPR, including the right to license and sublicense
or otherwise to exploit, transfer or Encumber its ownership interest, without an accounting
or obligation to, or consent required from, the other Party. |
| 4.2.1 | NV,
on behalf of itself and its Affiliates, and together with their respective officers, directors,
employees, contractors, advisors and agents, hereby assigns to Company, any and all rights
that it or they may have or acquire with respect to all Company IPR and take any such action
as is reasonably required by Company to effect such assignment. |
| 4.2.2 | Company,
on behalf of itself and its Affiliates, and together with their respective officers, directors,
employees, contractors, advisors and agents, hereby assigns to NV, any and all rights that
it or they may have or acquire with respect to all NV IPR and take any such action as is
reasonably required by NV to effect such assignment. For the avoidance of doubt, Company
shall own all Intellectual Property Rights created or developed solely by an NV Secondee
during the course of such NV Secondee’s secondment under the Consultancy Agreement. |
| 4.2.3 | NV
hereby assigns to Company all Intellectual Property Rights created or developed solely by
the NV Secondees in the course of their secondment and all materials embodying such rights
to the fullest extent permitted by Applicable Law, and will at Company’s reasonable
request and at Company’s sole cost and expense provide those materials and execute
all further documentation necessary to effect and confirm Company’s ownership of those
rights. |
| 4.2.4 | NV
shall use commercially reasonable efforts to cause the NV Secondees to assign to NV in writing
all Intellectual Property Rights that will be created by NV Secondees during the course of
their secondment under the Consultancy Agreement to the fullest extent permissible by Applicable
Law by executing the Acknowledgement and Undertaking set forth in Schedule 5 (Acknowledgement
and Undertaking) and NV shall provide to Company promptly such document. |
| 4.2.5 | Each
Party, for itself and on behalf of its Affiliates, and together with their respective officers,
directors, employees, contractors, advisors and agents, hereby assigns to the other Party
an equal and undivided joint ownership interest in and to all Joint IPR to be held in accordance
with clause 4.1.2(d). |
| 4.3 | Protection,
Maintenance and Enforcement |
| 4.3.1 | NV
shall not assign or grant any rights under any NV Technology in a manner inconsistent with the licenses granted in this IP Agreement. |
| 4.3.2 | NV
shall determine in its sole discretion how to, and shall have the sole right (but not the
obligation) to, protect, register, maintain, enforce and defend the NV IPR. |
| 4.3.3 | Company
shall determine in its sole discretion how to, and shall have the sole right (but not the
obligation) to, protect, register, maintain, enforce and defend the Company IPR. |
| 4.3.4 | The
Parties shall jointly determine how to protect, register, maintain, enforce and defend the
Joint IPR. The Parties will work together in good faith to develop an agreement regarding
the protection, maintenance, enforcement and prosecution of any Joint IPR and will take any
and all other reasonable and necessary actions related to the protection, maintenance, enforcement
and prosecution of the Joint IPR. However, in the event that NV and Company are unable to
agree on such prosecution strategy within six (6) months of such Joint IPR being developed,
Company shall have the final decision-making authority with respect to the prosecution strategy
and NV waives any claims that it may have against Company or otherwise with respect to Company’s
decision(s) or the result(s) thereof. |
| 4.4 | Notice
of Infringement |
The
Licensed Party shall give the Licensing Party prompt written notice of:
| 4.4.1 | any
actual or suspected infringement, misappropriation or other violation of the Intellectual
Property Rights licensed to the Licensed Party under clause 2.1 or 2.2; or |
| 4.4.2 | any
assertion by a Third Party that the use of any Intellectual Property Rights licensed to the
Licensed Party under clause 2.1 or 2.2 infringes, misappropriates or otherwise violates such
Third Party’s Intellectual Property Rights, together with a summary of any relevant
evidence or additional information relating to the alleged infringement, misappropriation
or other violation. In the event either Party brings a suit or takes any other action in
accordance with clause 4.3 , the other Party shall cooperate fully, including, if required
to bring and maintain such action, being named as a party to such action. |
| 5.1 | In
consideration for NV’s grant of the rights and licenses to Company hereunder, Company
shall pay a one-time, non-refundable and non-creditable payment of forty million Saudi Arabian
Riyals (SAR 40,000,000.00) to NV upon the Effective Date. |
| 5.2 | During
the Royalty Term, in consideration for NV’s grant of the rights and licenses to Company
hereunder, Company shall make non-refundable, non-creditable royalty payments to NV in an
amount equal to two and a half percent (2.5%) of Company’s Net Revenue (the “Royalty
Fee”). |
The
Royalty Fee shall be payable for a period commencing as of the sixth (6th) anniversary of the date of incorporation of Company
and expiring on the tenth (10th) anniversary of the Effective Date (“Royalty Term”) (it being understood
that, notwithstanding anything in this IP Agreement to the contrary, Company’s obligation to pay the Royalty Fee pursuant to this
clause 5.3 shall survive the expiration or earlier termination of this IP Agreement). Upon the expiration of the Royalty Term, the license
grants to Company under clause 2.1 will become fully-paid and royalty-free with respect to KSA during the Term.
| 5.4.1 | Within
thirty (30) Business Days after the end of each Calendar Quarter, commencing with the sixth
anniversary of the date of incorporation of Company, Company shall: |
| (a) | provide
NV with a report that states Company’s Net Revenue for such Calendar Quarter; and |
| (b) | remit
payment to NV of the applicable royalty payment shown to be due in such report. |
| 5.4.2 | All
payments from Company to NV under this IP Agreement shall be payable in Saudi Arabian Riyals
(SAR), which shall be paid by wire transfer in immediately available funds into such bank
account nominated by NV to Company in writing prior to the relevant payment within sixty
(60) Business Days of the end of the Calendar Quarter. Company shall be liable for all bank
charges relating to such wire transfers. |
| 5.4.3 | If
any undisputed payment due to NV under this IP Agreement is not paid by the applicable due
date, NV may charge Company interest on any outstanding amount of such payment, accruing
as of the original due date, at an annual rate equal to the prime rate (as reported in The
Wall Street Journal (U.S. edition)) plus one percentage point (1%) or the maximum rate allowable
by Applicable Law, whichever is less. |
| 5.5.1 | Company
shall maintain complete and accurate records in sufficient detail to permit NV to confirm
the accuracy of any and all royalty payments payable by Company hereunder. |
| 5.5.2 | For
a period of three (3) years from the end of the calendar year to which such records
pertain, such records shall be open for examination upon NV’s provision of at least
thirty (30) days’ prior notice, such examination to be conducted during regular
business hours, and not more often than once each calendar year, by a nationally recognized
independent certified public accountant selected by Company and reasonably acceptable to
NV, for the sole purpose of verifying for NV the accuracy of the royalty reports provided
by Company under this IP Agreement. |
| 5.5.3 | Such
independent certified public accountant shall be bound by confidentiality and non-use obligations
to reasonable satisfaction of Company that limit disclosure to whether an underpayment or
overpayment has occurred, and, if so, the value of such underpayment or overpayment. Company
and NV will be entitled to receive a full written report of such independent certified public
accountant with respect to its findings and NV will provide, without condition or qualification,
Company with a copy of the report, or other summary of findings, prepared by such independent
certified public accountant promptly following NV’s receipt of same. |
| 5.5.4 | NV
shall bear the cost of such audit unless such audit reveals an underpayment by Company of
more than five percent (5%) of the amount actually due for the time period being audited,
in which case Company shall reimburse NV for the costs of such audit. Company shall pay to
NV any underpayment discovered by such audit within thirty (30) days after the independent
certified public accountant’s report, plus interest (as set forth in clause 5.4.3)
from the original due date. If the audit reveals an overpayment by Company, then Company
may take a credit for such overpayment or offset against any future payments due to NV (it
being understood that if there will be no future payment |
due,
then NV shall refund such amount to Company within thirty (30) days after the date of the audit). For the avoidance of doubt, any
set-off shall not impact the obligations of a Party under clause 6.
| 6.1 | Without
prejudice to the generality of clause 6.2 below, the amounts payable in accordance with this IP Agreement shall be exclusive of
any additional Taxes, levies or fees that may apply. Any such Taxes, levies or fees shall be payable in addition to, and at the same
time and in the same manner as, the payments against provision by NV to Company of an invoice for the same provided, that Company
shall only be responsible for withholding taxes if NV does not have a permanent establishment in KSA. Any additional Taxes shall not
include any taxes, levies or fees applicable to NV for a taxable presence in KSA relating to a permanent establishment for corporation
income tax. Any Taxes relating to the permanent establishment of NV shall be solely borne by NV and not Company. |
| 6.2 | All
amounts, monetary or otherwise, expressed under this IP Agreement which (in whole or in part)
constitute the consideration for any supply for VAT purposes by NV are deemed to be exclusive
of any VAT which is chargeable on that supply, and accordingly if VAT is or becomes chargeable
on any supply made by NV to any Party under this IP Agreement and NV is required to account
to the relevant tax authority for VAT on that supply, Company must pay to NV (in addition
to and at the same time as paying any other consideration, or at the point the VAT becomes
due to be paid or accounted for by NV if earlier) an amount equal to the amount of that VAT
(and NV must promptly provide an appropriate VAT invoice to Company where so required to
by Applicable Law). In this clause 6.2, references to “NV” shall include
reference to a relevant Affiliate of NV. |
| 6.3 | In
relation to any supply made by NV (or a relevant Affiliate) to Company under this IP Agreement, if reasonably requested by Company, NV
must promptly provide Company with details of NV’s (or the relevant Affiliate’s) VAT registration and such other information
as is reasonably requested in connection with Company’s VAT reporting requirements in relation to such supply. |
| 6.4 | The
following provisions shall apply should any payment from Company to NV be subject by Applicable Law to any deduction or withholding on
account of Tax: |
| 6.4.1 | The
Tax Deduction will be made in the minimum amount permitted by Applicable Law and Company
shall account to the relevant tax authority for the same, in full and within all applicable
time limits; provided that any late payment fees or penalties associated with Company’s
failure to comply with this clause 6.4.1 shall be borne solely by Company. |
| 6.4.2 | Company
shall provide evidence, reasonably satisfactory to NV, of the Tax Deduction and any relevant payment to a tax authority on written request
from NV to Company. |
| 6.4.3 | NV
shall (or shall procure that a relevant Affiliate shall), on written request from Company, provide a declaration of Tax residence on
the prescribed forms and obtain certification by the relevant taxation authority in order to confirm the applicability and availability
of any reduced rate of withholding on account of Tax, pursuant to the provisions of any relevant double taxation treaties or otherwise. |
| 6.4.4 | If
a Tax Deduction is required by Applicable Law to be made by Company in relation to any payment
under this IP Agreement, the amount of the payment due from Company shall be increased to
an amount which (after making any Tax Deduction) leaves an |
amount
equal to the payment which would have been received if no Tax Deduction had been required.
| 6.4.5 | If
Company has been obliged to make an increased payment under clause 6.4.4 in respect of a Tax Deduction and NV determines that: |
| (a) | a
Tax Credit is attributable to that payment, or to the relevant Tax Deduction; and |
| (b) | that
NV (or a relevant Affiliate) has obtained and utilized that Tax Credit, |
then
NV shall pay to Company an amount (or procure the payment by the relevant Affiliate of an amount to Company) which NV determines will
leave it (or the relevant Affiliate), after that payment, in the same after-Tax position as it would have been had no increased payment
under clause 6.4.4 been required to be made by Company.
| 6.4.6 | Company
shall report and pay VAT directly to the relevant KSA tax authority to the extent that the
amounts charged by NV to Company under this IP Agreement are subject to VAT under the Applicable
Laws of KSA. Notwithstanding any other provision of this clause 6 or this IP Agreement, in
relation to any Taxes that NV may incur related to the registration of NV as a permanent
establishment in KSA, NV shall notify Company of such Taxes, comply with any requirements
under Applicable Law and follow all necessary compliance and registration requirements. NV
shall bear any associated costs including any Taxes, fines or penalties from a Governmental
Authority, or Regulatory Authority. |
| 7. | Confidential
information |
| 7.1 | Each
Party (the “Recipient”) acknowledges that it may receive Confidential
Information that has been created, discovered or developed by the other Party (the “Provider”). |
| 7.2 | The
Recipient undertakes to the Provider to: |
| 7.2.1 | hold
all Confidential Information which it obtains in relation to this IP Agreement in strict
confidence and will take all necessary measures to preserve the confidentiality of the Confidential
Information; |
| 7.2.2 | not
disclose, or authorize the disclosure of, Confidential Information to any Third Party other
than pursuant to clauses 7.3 or 7.5; |
| 7.2.3 | not
use, or authorize anyone to use, Confidential Information for any purpose other than the
performance of its obligations pursuant to this IP Agreement, or the exercise of its rights
or receipt of any benefits under this IP Agreement; and |
| 7.2.4 | promptly
notify the Provider of any suspected or actual unauthorized use or disclosure of Confidential
Information for which the Recipient is responsible and of which the Recipient becomes aware
and promptly take all commercially reasonable efforts that Recipient may require in order
to prevent, stop or remedy the unauthorized use or disclosure. |
| 7.3 | The
Recipient may disclose Confidential Information to its Affiliates and its and their respective
officers, directors, employees, contractors, advisors and auditors, but only to the extent,
and provided, that such persons: |
| 7.3.1 | need
to know the Confidential Information disclosed to them; |
| 7.3.2 | have
been informed of the confidential nature of the Confidential Information and the purpose
for which it may be lawfully used; and |
| 7.3.3 | comply
with the terms of this clause 7 of this IP Agreement in respect of the Confidential Information
disclosed to them. |
| 7.4 | Clause
7.1 shall not apply to Confidential Information to the extent that: |
| 7.4.1 | such
Confidential Information has been placed in the public domain other than through the fault
of the Recipient; |
| 7.4.2 | such
Confidential Information was at the time of receipt, publicly available; |
| 7.4.3 | such
Confidential Information has been independently developed without reference to the Confidential
Information, as established by independent evidence; or |
| 7.4.4 | the
Provider has approved in writing the particular use or disclosure of the Confidential Information. |
| 7.5 | The
Recipient also may disclose Confidential Information if, and solely to the extent that, it
is required to do so by any Governmental Authority or Regulator or otherwise as required
by Applicable Law. Where Recipient is required to disclose Confidential Information relating
to itself in accordance with this clause 7.5, it shall: |
| 7.5.1 | to
the extent that it is able to do so and is not prohibited by Applicable Law, notify the Provider
in writing as soon as practicable upon becoming aware of the obligation to disclose, prior
to such disclosure; and |
| 7.5.2 | to
the extent it is able to do so, cooperate with the Provider in avoiding or limiting the disclosure
to that portion of the Confidential Information which it is legally required to furnish and
obtaining assurances as to confidentiality from the body to whom the Confidential Information
is to be disclosed. |
| 7.6 | Subject
to the express provision of this clause 7, each Party shall maintain and shall procure that
its Affiliates and contractors maintain the confidentiality of the existence, terms of the
negotiations between the Parties and of this IP Agreement, and of the services provided pursuant
to this IP Agreement and any other Project Document. Each Party shall not, and shall procure
that each of its Affiliates and contractors and subcontractors shall not, issue any press
release or other public statement relating to the existence or content of this IP Agreement
or any other Project Document without the prior written approval of the other Party. |
| 7.7 | Subject
to requirements under Applicable Law, the obligations with respect to Confidential Information
shall survive the termination or expiry of this IP Agreement. |
| 8. | REPRESENTATIONS,
WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY |
| 8.1 | Mutual
Representations and Warranties |
Each
of Company and NV represent and warrant that:
| 8.1.1 | it
has the full power and authority to enter into this IP Agreement and to carry out its obligations
hereunder; |
| 8.1.2 | it
is duly organized, validly existing, and in good standing as a corporation or other entity
as represented herein under the Applicable Laws of its jurisdiction of incorporation or organization; |
| 8.1.3 | it
shall comply in all material aspects with all Applicable Laws in the course of performing
its obligations and exercising its rights under this IP Agreement; |
| 8.1.4 | the
execution of this IP Agreement by its representative whose signature is set forth at the
end hereof has been duly authorized by all necessary action of the Party; and |
| 8.1.5 | when
executed and delivered by such Party, this IP Agreement shall constitute the legal, valid,
and binding obligation of such Party, enforceable against such Party in accordance with its
terms. |
| 8.2 | Additional
Representations, Warranties and Undertakings of NV |
NV
represents, warrants, and undertakes (as applicable) to Company that, as of the Effective Date:
| 8.2.1 | NV
and its Affiliates solely own the entire right, title and interest in and to the NV Technology,
NV Patents, NV Know-How and NV Trademarks or NV Data to the extent such data is owned by
NV; |
| 8.2.2 | other
than as disclosed on Schedule 3 (Permitted Encumbrances), NV and its Affiliates
have not previously assigned, transferred, conveyed or otherwise Encumbered its right, title
and interest in such NV IPR in a manner that would prevent NV from granting Company the rights
granted under this IP Agreement; |
| 8.2.3 | NV
and its Affiliates have not granted and will not grant any license or right in the NV IPR
that is inconsistent with the licenses and rights granted to Company and its Affiliates under
this IP Agreement in any material respect; |
| 8.2.4 | NV
is not a party to any agreement that would materially prevent it from granting the rights
granted to Company under this IP Agreement or performing its obligations under this IP Agreement; |
| 8.2.5 | NV
and its Affiliates have not received any written notice from any Third Party asserting or
alleging that any NV IPR or the exploitation thereof infringes or misappropriates the Intellectual
Property Rights of such Third Party, and to NV’s actual knowledge, without any duty
of inquiry, the permitted use of the NV IPR pursuant to this IP Agreement has not infringed
or misappropriated and will not infringe or misappropriate the Intellectual Property Rights
of any Third Party; |
| 8.2.6 | Other
than as disclosed on Schedule 4 (NV IPR Claims), as of the Effective Date, there are
no pending, and NV and its Affiliates have not received written notice threatening, adverse
actions, suits, proceedings, or claims against NV or its Affiliates involving any NV IPR; |
| 8.2.7 | to
NV’s knowledge, no Third Party has or is engaged in any unauthorized use, infringement
or misappropriation of any NV IPR; |
| 8.2.8 | to
NV’s knowledge, all NV Patents are subsisting and in good standing; being diligently
prosecuted in applicable patent offices in accordance with Applicable Law; have been filed
and maintained properly and correctly and all issued NV Patents are valid and enforceable; |
| 8.2.9 | all
material regulatory filings, regulatory approvals and other material correspondence with
Regulatory Authorities in the KSA relating to any NV IPR is accurate, complete and true in
all material respects; |
| 8.2.10 | NV
and its Affiliates have conducted all research and development of NV Technology in accordance
with all Applicable Laws; and |
| 8.2.11 | all
regulatory filings or regulatory approvals filed by NV or its Affiliates with respect to
NV Technology have been true and accurate in all material respects; |
| 8.3.1 | NV
shall defend, indemnify and hold harmless Company and its respective employees, personnel,
consultants, agents, contractors and subcontractors (each a “Company Indemnitee”)
during the Term and, solely to the extent arising within the applicable statute of limitations
period allowed under Applicable Law, thereafter, in respect of any Indemnified Losses to
the extent the same are assessed against, or incurred by, a Company Indemnitee in respect
of, the following: |
| (a) | NV’s
gross negligence, fraud or Willful Misconduct; |
| (b) | any
allegation that Company’s use of NV IPR in accordance with the terms and conditions
of this IP Agreement infringe any Third Party IPR; provided that in no event shall
NV be obligated to indemnify any Company Indemnitee for any Indemnified Losses to the extent
relating to any alteration or modification of the NV IPR by or on behalf of any Company Indemnitee
or any combination of any NV IPR with any other products, technology or other Intellectual
Property Rights; provided further that NV has not provided written instructions to
Company to make such alterations or modifications; |
| (c) | use
of any Company Data in violation of the terms of this IP Agreement or Applicable Law; |
| (d) | material
breach of this IP Agreement; or |
| (e) | the
violation of Applicable Law. |
| 8.3.2 | Company
shall defend, indemnify and hold harmless NV and its respective employees, personnel, consultants,
agents, contractors and subcontractors (each a “NV Indemnitee”) during
the Term and, solely to the extent arising within the applicable statute of limitations period
allowed under Applicable Law, thereafter, in respect of any Indemnified Losses to the extent
the same are assessed against, or incurred by, a NV Indemnitee in respect of the following: |
| (a) | Company’s
gross negligence, fraud or Willful Misconduct; |
| (b) | any
allegation that NV’s use of Company IPR in accordance with the terms and conditions
of this IP Agreement infringe any Third Party Intellectual Property Rights; provided
that in no event shall Company be obligated to indemnify any NV Indemnitee for any Indemnified
Losses to the extent relating to any alteration or modification of the Company IPR by or
on behalf of any NV Indemnitee or any combination of any Company IPR with any other products,
technology or other |
| (c) | Intellectual
Property Rights; provided further that Company has not provided written instructions to NV to make such alterations or modifications; |
| (d) | use
of any NV Data in violation of the terms of this IP Agreement or Applicable Law; |
| (e) | material
breach of this IP Agreement; or |
| (f) | the
violation of Applicable Law. |
| 8.3.3 | For
the purpose of interpreting clause 8.3, reference to an act or omission of a Party shall
also include relevant acts or omissions of the applicable Party’s personnel, Affiliates,
subcontractors and their relevant personnel. |
| 8.3.4 | The
provisions of clause 13.5 of the Laboratory Services Agreement shall govern the procedure
for indemnification claims under this IP Agreement. |
| 8.3.5 | This
clause 8.3 shall remain in full force and effect notwithstanding any termination or expiry
of this IP Agreement. |
| 8.3.6 | Notwithstanding
anything to the contrary, in no event shall Company be entitled to recover from NV under
both this IP Agreement and any other Project Document for the same Losses. |
| 8.4 | Limitation
on Liability |
| 8.4.1 | In
no event shall either Party have any liability under this IP Agreement for any Losses, whether
based on an action or claim in contract, tort (including negligence), breach of statutory
duty or otherwise that exceed in the aggregate ten million Euros (€10,000,000.00). |
| 8.4.2 | Subject
to clause 8.4.3, in no event shall either Party have any liability under this IP Agreement
for: |
| (a) | any
punitive, exemplary, incidental, special, indirect or consequential loss or damages; or |
| (b) | any
direct or indirect: |
| (i) | loss
of profits, contract, income, or revenue; |
| (iii) | business
interruption or downtime; |
| (iv) | loss
of the use of money or failure to realize anticipated savings; or |
| (v) | loss
of opportunity, goodwill or reputation. |
| 8.4.3 | Nothing
in this IP Agreement shall exclude or limit the liability of any Party for: |
| (a) | fraud
(including fraudulent misrepresentation); |
| (b) | death
or personal injury caused by a Party’s gross negligence; |
| (c) | a
Party’s Willful Misconduct or gross negligence; |
| (e) | the
indemnity in clause 8.3 (other than any Losses arising out of any breach by either Party
of the representations and warranties contained in clauses (i) 8.1 and 8.2; or (ii) 8.3.1(b)
or 8.3.2(b), in each case, which Losses shall be subject to the limitation of liability set
forth in clause 8.4); or |
| (f) | any
other liability which cannot be excluded or limited by Applicable Law. |
| 8.4.4 | Each
Party acknowledges its general duty to reasonably mitigate any Losses incurred in relation
to this IP Agreement and, in any case, each Party shall reasonably mitigate any Losses incurred
by it in relation to this IP Agreement. |
| 8.4.5 | Except
as expressly stated in clause 8.1 and 8.2, no Party has made and nor makes any promises,
covenants, guarantees, representations or warranties of any nature, directly or indirectly,
express, statutory or implied, including without limitation, merchantability or fitness for
a particular purpose, suitability, durability, condition, quality or any other characteristic
of any Technology, Intellectual Property Rights or data licensed pursuant to this IP Agreement. |
This
IP Agreement shall be in full force and effect beginning on the Effective Date and continue for a period of ten (10) years unless terminated
in the manner set forth in clause 9.2 below (such period, the “Initial Term”). The Initial Term shall automatically
renew for successive one-year terms (each a “Renewal Term”) unless or until either Party notifies the other Party
in writing of its intention not to renew no less than ninety (90) calendar days prior the expiration of the Initial Term or then-current
Renewal Term or this IP Agreement is otherwise terminated pursuant to clause 9.2 below (the Initial Term and any Renewal Terms, the “Term”).
This
IP Agreement may be terminated upon the occurrence of any of the following events:
| 9.2.1 | Company
may terminate this IP Agreement for any reason by giving nine (9) months’ prior written
notice to NV; provided that Company may not send any notice terminating this IP Agreement
pursuant to this clause 9.2.1 prior to two and a half (2.5) years from the Effective Date,
it being understood that Company’s obligations to pay the Royalty Fees set forth in
clause 5.2 shall survive any such termination for convenience in accordance with clause 5.3). |
| 9.2.2 | This
IP Agreement shall terminate automatically upon termination of the Joint Venture Agreement. |
| 9.2.3 | Either
Party may terminate this IP Agreement in the event the other Party is in material breach
of any of its obligations under this IP Agreement and either that breach is not capable of
remedy or, if the breach is capable of remedy, the breaching Party has failed to remedy such
breach within sixty (60) days (unless a shorter remedy period applies hereunder) after receiving
written notice requiring it to remedy the relevant breach; provided that, no event
of default shall be deemed to have occurred hereunder if such |
breach
cannot reasonably be remedied within such sixty (60) day period and the breaching Party has commenced and is diligently pursuing such
remedy within such sixty (60) day period, in which case the breaching Party shall have an additional period of time (not to exceed one
hundred and twenty (120) days after receipt of written notice of such default) to remedy such default and the non-breaching Party may
not terminate this IP Agreement during such period.
| 9.2.4 | Notwithstanding
clause 9.2.3, NV may terminate this IP Agreement if Company fails to pay any undisputed amounts
due under this IP Agreement within thirty (30) Business Days of written demand by Formal
Notice to Company for such payment or Company fails to pay any disputed amount within thirty
(30) Business Days of such disputed payments being agreed. |
| 9.2.5 | NV
may terminate this IP Agreement if NV Abandons (as defined in the relevant Project Document)
the provision of services under the Project Documents and NV has failed to remedy such Abandonment
within forty-five (45) days after receiving written notice requiring it to remedy such Abandonment. |
| 9.2.6 | Company
may terminate this IP Agreement if there is an NV Change of Control (as defined in the Joint
Venture Agreement). |
| 9.2.7 | Either
Party may terminate this IP Agreement with immediate effect by written notice to the defaulting
Party if: |
| (a) | the
defaulting Party is unable to pay its debts as they fall due or an order is made or a resolution
passed for the administration, winding-up or dissolution of the defaulting Party (other than
for the purposes of a solvent amalgamation or reconstruction) or an administrative or other
receiver, manager, liquidator, administrator, trustee or similar officer is appointed over
all or any substantial part of the assets of the defaulting Party; or |
| (b) | the
defaulting Party enters into or into or proposes any composition or arrangement with its
creditors generally or anything analogous to the foregoing occurs. |
| 9.3.1 | Upon
termination or expiration of this IP Agreement, all rights and obligations of the Parties
under this IP Agreement immediately cease (including, for the avoidance of doubt, any license
grants, including the licenses granted under clauses 2.1 and 2.2); provided that: |
| (a) | the
provisions surviving pursuant to clause 9.5 shall continue; and |
| (b) | Company
may continue to use the NV Trademarks for the Transition Period set forth in and otherwise
in accordance with clause 9.3.6. |
| 9.3.2 | Notwithstanding
anything to the contrary herein, other than in the event of termination by NV pursuant to
clause 9.2.3, 9.2.4 or 9.2.7 whereby the Parties shall meet in good faith to discuss the
terms of a separate license agreement, Company will retain a non-exclusive, non-sublicensable,
non-transferable, royalty-bearing (for so long as the Royalty Term is still in effect, after
which such license shall become royalty-free and fully paid-up) license to the NV Technology,
NV Patents, NV Know-How and NV Data then existing at the effective date of termination of
this IP Agreement for the Purpose; provided that the |
foregoing
license shall automatically terminate immediately in the event Company uses the NV Patents, NV Technology, NV Know-How and NV Data in
any manner that:
| (a) | materially
breaches the terms and conditions of the license set forth in this clause 9.3.2 and either
that breach is not capable of remedy or, if the breach is capable of remedy, Company has
failed to remedy such breach within sixty (60) days (unless a shorter remedy period applies
hereunder) after receiving written notice requiring it to remedy the relevant breach; provided
that, no event of default shall be deemed to have occurred hereunder if such breach cannot
reasonably be remedied within such sixty (60) day period and Company has commenced and is
diligently pursuing such remedy within such sixty (60) day period, in which case Company
shall have an additional period of time (not to exceed one hundred and twenty (120) days
after receipt of written notice of such default) to remedy such default and NV may not terminate
this IP Agreement during such period; |
| (b) | violates
Applicable Law or violates any applicable consents from any data subjects. |
| 9.3.3 | Following
expiration or earlier termination of this IP Agreement, the Parties shall discuss in good
faith the terms of an agreement pursuant to which Company shall obtain a license grant to
the NV Variant List following the Term. |
| 9.3.4 | On
any termination of this IP Agreement for any reason by Company or expiration of the Term: |
| (a) | NV
shall as soon as reasonably practicable return, delete or destroy (as directed in writing by the other Company) all Company Data and
other materials or information provided to NV by Company in connection with this IP Agreement or under any Project Document including
materials containing or based on Company’s Confidential Information, subject to the confidentiality obligations in clause 7; and |
| (b) | NV
shall as soon as reasonably practicable ensure that all Company Data and that has been used or accessed by NV (excluding any NV Derived
Data) is deleted from any IT system of NV or its Affiliates. and any electronic data shall be considered deleted, for the purpose of
this clause 9.3.4 where it has been put beyond use by NV or its Affiliates; |
provided
that if NV is required by any Applicable Law or Governmental Authority or Regulatory Authority to retain any data, documents or materials
that it would otherwise be required to return or destroy under clause 9.3.4, it shall notify Company in writing of that retention, giving
details of the documents or materials that it must retain and NV shall not be in breach of clause 9.3.4 with respect to the retained
data, documents or materials, however, clause 7 shall continue to apply to such data, documents and materials.
In
the event the Parties wish to enter into any further research and/or collaborations in respect of Company Data that has been retained
by NV pursuant to this clause 9.3.4, the Parties shall enter into good faith discussions with respect to a separate license agreement.
| 9.3.5 | Where
there is a termination of only certain services under a Project Document (and not the IP Agreement as a whole) clause 9.3.4 shall still
apply but only to the extent applicable to the terminated service. |
| 9.3.6 | Upon
expiration or termination of the Initial Term, Company shall, and shall cause its Affiliates
and any sublicensees to, as soon as practicable (but in no event more than six (6) months)
following expiration or termination of the Initial Term (the “Transition Period”)
cease any and all use of the NV Trademarks or any derivation thereof in any form, including
by removing the NV Trademarks from any and all assets, inventories, advertisements, communications,
website content, other internet or electronic communication vehicles and other documents
and materials of Company, its Affiliates and its sublicensees and making any and all filings
necessary to remove any NV Trademarks (including any Composite Marks) from Company’s
Corporate Identity (it being understood that Company shall promptly change its Corporate
Identity to not use any Composite Marks or any other NV Trademarks). |
| 9.3.7 | Company
agrees and hereby specifically consents to NV obtaining a decree of a court having jurisdiction
over Company, its Affiliates or any of its sublicensees to enforce the provisions of this
clause 9.3, in addition to any other remedy to which it may be entitled by Applicable Law. |
The
Parties agree that Company, as a licensee of such rights under this IP Agreement, will retain and may fully exercise all of its rights
and elections under Applicable Law, including the right to preserve and enforce the licensee benefits set forth in this IP Agreement.
NV agrees to notify Company in the event of any insolvency or bankruptcy event that might affect the rights granted to Company’s
rights hereunder, with the intent to provide notice so that Company would have an opportunity to object to any transfer in bankruptcy
that might lead to the rejection of any pre-existing licenses. Without limiting the foregoing, the Parties agree that Company may assert
without objection from NV that this IP Agreement is not vulnerable to rejection under bankruptcy laws and that, if rejected, such rejection
shall not result in termination of the IP Agreement or a similar result or effect. All rights, powers and remedies of Company, as a licensee
hereunder, provided herein by NV are in addition to and not in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity in the event of the commencement of a bankruptcy case by or against NV.
Upon
expiration or termination of this IP Agreement, the terms of clauses 2.5, 4.1, 4.2, 4.3, 5.2, 5.3, 5.4 (solely to the extent the Royalty
Term has not yet expired), 5.5, 7, 8.3, 8.4, 9.3, 9.4, 9.5, 11-22 and 24 and any definitions necessary to construe any of the forgoing
provisions, shall survive the termination of this IP Agreement.
| 10. | GOVERNMENTAL
COMPLIANCE |
| 10.1 | Compliance
with Applicable Laws |
Each
Party warrants that it shall comply with any Applicable Law related to the subject matter of this IP Agreement that are applicable to
such Party.
| 10.2 | Responsibility
for Compliance |
Each
Party shall (except as otherwise set forth in other written agreements entered into between the Parties) be, as to its own activities,
responsible for compliance with Applicable Law with respect to any sale, manufacture or other use involving any Technology, including
any NV Technology,
and
any associated Intellectual Property Rights therein, including, without limitation, any Applicable Export Control or Economic Sanctions
Programs.
Except
as otherwise provided in this IP Agreement, each Party shall be responsible for any and all of its expenses, costs, fees, duties and/or
Taxes necessary to comply with Applicable Law in connection with the subject matter of this IP Agreement.
| 11.1 | Any
communication to be given in connection with this IP Agreement shall be in writing and, if
such communication is a Formal Notice, shall either be delivered by hand or courier to a
Party’s registered office (or such other address as a Party may notify the other Party
for such purpose) or by e-mail as follows: |
to
NV at:
CENTOGENE
N.V.
Am
Strande 7, 18055
Rostock,
Germany |
to
Company at:
GENOMICS
INNOVATIONS COMPANY LIMITED
Building
No. 3936, 6651 Al Nakheel District, Postal Code 12382, RGNB3936, Riyadh, Kingdom of Saudi Arabia
|
|
|
Marked
for the attention of:
Chief
Legal Officer
email:
[***] |
Marked
for the attention of:
[***]
email:
[***]
|
|
|
With
a copy, which shall not constitute notice, to:
[***] |
|
|
|
And
with a copy, which shall not constitute notice, to:
Chief
Financial Officer
email:
[***] |
|
| 11.2 | A
communication sent according to clause 11.1 shall be deemed to have been received: |
| 11.2.1 | if
delivered by hand, on written acknowledgment or receipt by an officer or an employee of the
receiving Party; |
| 11.2.2 | if
delivered by courier, on production of evidence from the relevant courier that the notice
was successfully delivered; or |
| 11.2.3 | if
by e-mail, upon transmission to the correct e-mail address as specified, provided that a
hard copy is sent by post as soon as reasonably practicable thereafter to the address set
out in clause 11.1. |
| 11.3 | If,
under the preceding provisions of clause 11.2, a communication would otherwise be deemed
to have been received outside normal business hours in the place of receipt, being 9:00 a.m.
to 4:00 p.m. on a Business Day, it shall be deemed to have been received at 9:00 a.m.
on the next Business Day. |
| 11.4 | A
Party may notify the other Party of a change to its name or address or e-mail address for
the purposes of clause 11.1; provided that such notification shall only be effective
on: |
| 11.4.1 | the
date specified in the notification as the date on which the change is to take place; or |
| 11.4.2 | if
no date is specified or the date specified is less than five (5) Business Days after the
date on which notice is deemed to have been served, the date falling five (5) Business Days
after notice of any such change is deemed to have been given. |
| 12.1 | Each
Party agrees that it shall execute and perform all such deeds, documents, assurances, acts
and things and exercise all powers and rights available to it, reasonably required to implement
the terms of this IP Agreement. |
| 12.2 | Save
as otherwise provided in this IP Agreement, nothing in this clause 12 shall require, or be
construed to require, any Party to agree to: |
| 12.2.1 | sell,
hold, divest, discontinue or limit any assets, businesses or interests; |
| 12.2.2 | any
conditions relating to, or changes or restrictions in, the operations of their assets, businesses
or interests; |
| 12.2.3 | any
conditions relating to, or changes or restrictions in, the operations of the assets, businesses
or interests of either Party which could reasonably be expected to materially and adversely
impact the economic or business benefits to such Party of the transactions contemplated by
this IP Agreement; or |
| 12.2.4 | any
material modification or waiver of the terms and conditions of this IP Agreement. |
Other
than as required under Applicable Law, neither Party shall issue any announcement or communication concerning the rights and obligations
contemplated by this IP Agreement without the prior consent in writing of the other Party.
| 14.1 | This
IP Agreement shall be executed in English. |
| 14.2 | Any
notice (including a Formal Notice) given in connection with this IP Agreement must be in
English. |
| 14.3 | Any
other document provided by a Party in connection with this IP Agreement must be in English. |
| 15. | Assignment
and Subcontracting |
| 15.1 | Neither
Party is permitted to assign, sub-license, create a charge over or otherwise Dispose of any
of its rights or subcontract, transfer or otherwise Dispose of any of its obligations under
this IP |
Agreement
without the prior written consent of the other Party (not to be unreasonably withheld, conditioned or delayed); provided that
either Party is permitted to assign, sub-license, create a charge over or otherwise Dispose of any of its rights or transfer or otherwise
Dispose of any of its obligations under this IP Agreement:
| 15.1.1 | to
any Affiliate; or |
| 15.1.2 | in
relation to its right to receive payment under this IP Agreement, as collateral to any financial
institution providing financing to such Party or any of such Party’s Affiliates, |
in
each case without the prior written consent of the other Party.
| 16. | No
Partnership or Agency |
| 16.1 | Nothing
in this IP Agreement shall be deemed to constitute a partnership between or among any of
the Parties, nor constitute any Party constituting or becoming in any way the agent of any
other Party for any purpose. |
| 16.2 | Unless
specifically authorized in writing by a Party or as otherwise set forth herein, no other
Party shall have any authority to incur an expenditure in the name or for the account of
such Party or hold itself out in any way as having authority to bind such Party. |
Except
as otherwise set forth in this IP Agreement, each Party shall pay the costs and expenses, including any Tax, incurred by it in connection
with the preparation, review, negotiation and execution of this IP Agreement.
| 18.1 | A
failure or delay by a Party to exercise any right or remedy provided under this IP Agreement,
whether by conduct or otherwise, shall not constitute a waiver of that or any other right
or remedy, nor shall it preclude or restrict any further exercise of that or any other right
or remedy. No single or partial exercise of any right or remedy provided under this IP Agreement,
whether by conduct or otherwise, shall preclude or restrict the further exercise of that
or any other right or remedy. |
| 18.2 | A
waiver of any right or remedy under this IP Agreement shall only be effective if given in
writing and signed by the Party against whom the waiver would be enforced and shall not be
deemed a waiver of any subsequent breach or default. |
| 18.3 | No
variation or amendment of this IP Agreement shall be valid unless it is in writing and duly
executed by or on behalf of all of the Parties to this IP Agreement. Unless expressly agreed
in writing, no variation or amendment shall constitute a general waiver of any other provision
of this IP Agreement, nor shall it affect any rights or obligations under or pursuant to
this IP Agreement which have already accrued up to the date of variation or amendment, and
the rights and obligations under or pursuant to this IP Agreement shall remain in full force
and effect, except and only to the extent that they are varied or amended in accordance with
this clause 18. |
Where
any provision of this IP Agreement is or becomes illegal, invalid or unenforceable in any respect, then such provision shall be deemed
to be severed from this IP Agreement and, if possible, replaced with a lawful provision which, as closely as possible, gives effect to
the intention of the Parties under this IP Agreement and, where permissible, that shall not affect or impair the legality,
validity
or enforceability in that, or any other, jurisdiction of any other provision of this IP Agreement.
| 20.1 | A
person who is not a party to this IP Agreement shall not have any right to enforce any term
of this IP Agreement. |
| 20.2 | The
rights of the Parties to terminate, rescind or agree to any variation, waiver or settlement
under this IP Agreement is not subject to the consent of any person that is not a party to
this IP Agreement. |
Each
Party acknowledges that a breach or threatened breach by such Party of its obligations under this IP Agreement would give rise to irreparable
harm to the other Party for which monetary damages would not be an adequate remedy and hereby agrees that in the event of a breach or
a threatened breach by such Party of any such obligations, the other Party shall, in addition to any and all other rights and remedies
that may be available to it in respect of such breach or threatened breach, be entitled to equitable relief, including a temporary restraining
order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction (without
any requirement to post bond) to prevent such breach or to enforce specifically the performance of the terms of this IP Agreement.
| 22. | Governing
Law and Jurisdiction |
This
IP Agreement shall be governed and construed in accordance with the laws of the Kingdom.
| 22.2.1 | In
the event of any dispute, difference, claim, controversy or question between Company and
NV, directly or indirectly arising at any time under, out of, in connection with or in relation
to this IP Agreement (or the subject matter of this IP Agreement) or any term, condition
or provision hereof, including any of the same relating to the existence, validity, interpretation,
construction, performance, enforcement and termination of this IP Agreement (a “Dispute”),
Company and NV shall first endeavor to settle such Dispute by good faith negotiation. The
Parties agree, save as otherwise agreed in writing by Company and NV, that the negotiations
shall not exceed three (3) months from the date of the start of such negotiations. |
| 22.2.2 | Notwithstanding
the provisions of clause 22.2.1 above, any Dispute arising out of, or in connection with,
this IP Agreement shall be finally administered by the Saudi Centre for Commercial Arbitration
(“SCCA”) in accordance with its Arbitration Rules. The arbitration shall
be conducted by an arbitration tribunal consisting of three (3) independent arbitrators,
none of whom shall have any relationship or competitive interests with any of the Parties
or any of their Affiliates. Company shall appoint one (1) arbitrator, NV shall appoint one
(1) arbitrator and the SCCA shall appoint one (1) arbitrator. The arbitration shall take
place in the English language and the seat shall be at the SCCA, in Riyadh, the Kingdom.
Judgment for any award rendered may be entered in any court having jurisdiction or an application
may be made to such court for a judicial recognition of the award or an order of enforcement
thereof, as the case may be. Nothing in this clause shall preclude any Party from seeking
provisional measures to secure its rights from any court |
having
jurisdiction or where any assets of the other Party may be found. The arbitration proceedings contemplated by this clause and the content
of any award rendered in connection with such proceeding shall be kept confidential by the Parties.
| 23.1 | Neither
Party shall be liable for failure or delay in performing any of its obligations (other than
any payment obligations) under or pursuant to this IP Agreement if such failure or delay
is due to any cause whatsoever outside its reasonable control and which by the exercise of
due diligence such Party is unable to prevent or overcome, including: |
| 23.1.2 | flood,
fire, earthquake or explosion; |
| 23.1.3 | war,
invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or
other civil unrest; |
| 23.1.5 | government
actions, embargoes, sanctions or blockades in effect on or after the date of this IP Agreement; |
| 23.1.6 | action
by any Governmental Authority or Regulator (including regulatory changes); provided
that the Party relying on the government act or omission as a reason for delay in performance
did not, directly or indirectly, procure or induce such government act or omission; |
| 23.1.7 | national
emergency; |
| 23.1.8 | pandemics
or epidemics; and |
| 23.1.9 | strikes,
labour stoppages, or other industrial disturbances |
(each
a “Force Majeure Event”) and the affected Party shall be relieved from its liability hereunder during the period of
such Force Majeure Event and the other Party may terminate this IP Agreement in accordance with clause 9.2 if such Force Majeure Event
continues for more than one hundred and eighty (180) days.
| 23.2 | The
affected Party shall, in any event, use reasonable endeavours to avoid or mitigate the effect
of such events so as to recommence performance of their obligations as soon as reasonably
possible following the Force Majeure Event no longer applying. |
| 24.1 | This
IP Agreement and the Project Documents set out the entire agreement and understanding between
the Parties in respect of the subject matter of this IP Agreement and supersede all prior
agreements and understandings, both oral and written, between the Parties with respect to
the subject matter hereof and thereof. |
| 24.2 | Each
Party acknowledges that it is not relying on, and shall have no remedies in respect of, any
undertakings, representations, warranties, promises or assurances (whether made innocently
or negligently) that are not set forth in this IP Agreement. |
This
IP Agreement (and any amendment agreed to pursuant to clause 18.3) may be executed in any number of counterparts, each of which shall
be deemed to be an original, and all of which, when taken together, shall constitute one and the same instrument.
IN
WITNESS WHEREOF, this IP Agreement has been executed by the Parties by their duly authorized representatives on the Effective Date.
Signed
by
Kim
Stratton for and on behalf of CENTOGENE N.V.
|
)
)
) |
/s/ Kim Stratton |
Signed
by
Miguel
Coego for and on behalf of CENTOGENE N.V.
|
)
)
)
)
)
) |
/s/ Miguel Coego |
Signed
by
Jeremy
Panacheril for and on behalf of GENOMICS INNOVATIONS COMPANY LIMITED
|
)
)
)
)
) |
/s/ Jeremy Panacheril |
SCHEDULE
1
PART
1 - DEFINITIONS
In
this IP Agreement:
“ABC
Laws” means all laws and regulations applicable to the Parties and this IP Agreement, that relates to bribery or corruption
or money laundering, including (without limitation):
| (a) | the
Saudi Arabian Anti-Bribery Law promulgated by royal decree number M/36 dated 26/12/1412H
(corresponding to 27 June 1992) and the Saudi Arabian Anti-Money Laundering Law promulgated
by royal decree number M/20 dated 5/2/1439H (corresponding to 25 October 2017); |
| (b) | the
US Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations issued
thereunder; and |
| (c) | the
UK Bribery Act 2010, as each may be amended or re-enacted from time to time; |
“Accredited”
means the CAP Laboratory Accreditation from the College of American Pathologists and the Clinical Laboratory Improvement Amendments certification
or, in the event Company is unable to obtain such accreditation or certification, as applicable, due to regulatory changes arising after
the Effective Date, an equivalent internationally recognized accreditation or certification, as applicable, as mutually agreed by the
Board of Directors, and “Accredited” shall be construed accordingly;
“Acknowledgment
and Undertaking” means the acknowledgment and undertaking attached hereto as Schedule 5 (Acknowledgement and Undertaking)
that shall be executed by a NV Secondee prior to the commencement of any secondment pursuant to the Consultancy Agreement;
“Affiliate”
means any person, now or in the future, directly controlling, controlled by or under direct or indirect common control of a Party. For
the avoidance of doubt, for purposes of this IP Agreement when used in connection with Company, the term “Affiliate” will
not include NV and when used in connection with NV, the term “Affiliate” will not include Company. For the purposes of this
definition, “control” (including the terms “controlling”, “controlled by” and
“under common control”), means in relation to any Person (being the “Controlled Person”), being:
| (a) | entitled
to exercise, or control the exercise of (directly or indirectly) more than fifty percent
(50%) of the voting power at any general meeting of the shareholders, members or partners
or other equity holders (and including, in the case of a limited partnership, of the limited
partners of) in respect of all or substantially all matters falling to be decided by resolution
or meeting of such Persons; |
| (b) | entitled
to appoint or remove: |
| (i) | directors
on the Controlled Person’s board of directors or its other governing body (or, in the
case of a limited partnership, of the board or other governing body of its general partner)
who are able (in the aggregate) to exercise more than fifty percent (50%) of the voting power
at meetings of that board or governing body in respect of all or substantially all matters; |
| (ii) | any
managing member of such Controlled Person; and/or |
| (iii) | in
the case of a limited partnership, its general partner; or |
| (c) | entitled
to exercise a dominant influence over the Controlled Person (otherwise than solely as a fiduciary)
by virtue of the provisions contained in its constitutional documents or pursuant to an agreement
with other shareholders, partners or members of the Controlled Person; |
“Applicable
Data Protection Laws” means any and all laws, statutes, rules and regulations r the privacy, security, protection, access,
collection, storage, transmission, disclosure, exchange or other processing of Personal Data, including, but not limited to: the General
Data Protection Regulation (EU) 2016/679 (“GDPR”), the German Federal Data Protection Act (Bundesdatenschutzgesetz),
the provisions of the German Genetic Diagnostics Act (Gendiagnostikgesetz), the Kingdom National Data Management Office’s
Interim Regulations on Personal Data Protection, the Kingdom Ministry of Health’s Guidelines for Informed Consent, and the Kingdom
Personal Data Protection Law (issued pursuant to Royal Decree M/19 of 9/2/1443H (corresponding to 16 September 2021), and any relevant
implementing regulations issued pursuant to the Kingdom Personal Data Protection Law (“KSA PDPL”)), in each case as
amended or updated from time to time;
“Applicable
Export Control” or “Economic Sanctions Programs” means all applicable national and international export
controls, sanctions laws, regulations and programs;
“Applicable
Law” means any of the following, to the extent that it applies to a Party:
| (a) | any
laws, statute, directive, order, enactment, regulation, bylaw, ordinance or subordinate legislation
in force from time to time, but subject to any written waivers granted by any Governmental
Authority; |
| (b) | any
binding court order, judgment or decree; |
| (c) | any
applicable industry code, policy or standard enforceable by law; |
| (d) | any
applicable direction, statement of practice, policy, rule or order that is set out by a Regulatory
Authority, that is binding on the Parties; and |
| (e) | the
ABC Laws, Applicable Data Protection Laws and the Applicable Export Control or Economic Sanctions
Programs; |
“Board
of Directors” means the Board of Directors of Company from time to time;
“Business”
has the meaning given to this term in the Joint Venture Agreement;
“Business
Day” means any day other than a Friday, Saturday or public holiday in KSA or Germany;
“Business
Materials” means signs, business cards, invoices, letterhead, agreements and other commercial documents;
“Calendar
Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1;
provided, however, that the last Calendar Quarter of the Term shall end upon the expiration or termination of this IP Agreement;
“Claim”
means any claims, demands, suits, proceedings or actions by any Governmental Authority, Regulatory Authority or a Third Party (in either
case, not being connected to or related to the relevant Indemnitee);
“Company”
has the meaning given to this term in the preamble of this IP Agreement;
“Company
Background IPR” means any and all Intellectual Property Rights, Technology and data owned or Controlled by Company or any of
its Affiliates:
| (a) | in
existence as of immediately prior to the Effective Date; or |
| (b) | arising
during the Term but independently from this IP Agreement and the other Project Documents; |
“Company
Data” means all rights, title and interest in and to any samples, data or information that is:
| (a) | exclusively
related to the Business or Company’s customers that is provided to, held or obtained
by NV or any of its Affiliates pursuant to the Consultancy Agreement or Laboratory Services
Agreement during the term of such agreements; |
| (b) | created,
generated, collected or processed by NV or its Affiliates for Company in the performance
of its services under the Consultancy Agreement and Laboratory Services Agreement during
the term of such agreements subject to and in accordance with patient consents and Applicable
Law, including reports and other results and output of such services; or |
| (c) | material
findings, results and derivatives (excluding any NV Derived Data) from any of the items described
in clause (a) and (b) above; |
“Company
Derived Data” means Derived Data that is Manipulated by Company or its Affiliates;
“Company
Indemnitee” has the meaning given to this term in clause 8.3.1 of this IP Agreement;
“Company
IPR” means all Intellectual Property Rights that are owned or Controlled by Company or to which Company otherwise has legal
rights, including, but not limited to, Company Background IPR, Company Data and New Company IPR;
“Composite
Mark” has the meaning in clause 2.7 of Schedule 2 (NV Trademarks);
“Confidential
Information” means information that is marked, designated, or otherwise identified as ‘confidential’ or which by
its nature is clearly confidential. Confidential Information includes any Personal Data and information concerning the technology, technical
processes, samples, studies, findings, inventions, ideas, business processes, procedures, business affairs, financial affairs and finance
of Company and its Affiliates or NV and its Affiliates, as the case may be; provided, that Company’s or NV’s security
procedures are also included within the definition of Confidential Information. Confidential Information may take the form of documents,
technical specifications, unpublished Patent specifications, data, drawings, plans, processes, photographs,
databases,
computer software in disk, cassette, tape or electronic form and data storage or memory in, and items of, computer hardware; or oral
descriptions, demonstrations or observations, and Confidential Information includes (without limitation) information which is supplied
to, stored by, processed or marked for destruction by, NV to Company, or by Company to NV under this IP Agreement, including all Company
IPR and NV IPR;
“Consultancy
Agreement” has the meaning given to this term in the preamble of this IP Agreement;
“Control”
or “Controlled” means with respect to any Patents, Know-How, materials, information or any other Intellectual Property
Rights, the legal authority or right (whether by ownership, license or otherwise but without taking into account any rights granted by
one Party to the other Party pursuant to this IP Agreement) of a Party to grant access, a license or a sublicense of or under such, Patents,
Know-How, materials, information or other Intellectual Property Rights to the other Party, or to otherwise disclose proprietary or trade
secret information to such other Party without:
| (a) | violating
the terms of any agreement or other arrangement with any Third Party in existence as of the
time such Party or its Affiliate would be required hereunder to grant such license, sublicense,
or right of access and use; or |
| (b) | incurring
any additional payment obligations to any Third Party for which such other Party has not
agreed to reimburse such Party pursuant to the Project Document; |
“Corporate
Identity” means any business or corporate entity name, trade name or other business or corporate identifier (e.g., “d/b/a”);
“Derived
Data” means any data (wholly or in part) Manipulated to such a degree that:
| (a) | is
anonymized and cannot be identified as originating or deriving directly from the data or
services provided pursuant to any Project Documents; |
| (b) | cannot
be used to identify a natural person; |
| (c) | cannot
be reverse-engineered such that it can be so identified; and |
| (d) | is
not capable of use substantially as a substitute for the data or the results of the Testing
Services (as defined in the Laboratory Services Agreement); |
“Dispose”
means to:
| (a) | sell,
assign, transfer or otherwise dispose of it |
| (b) | create
or permit to subsist any Encumbrance over it; |
| (c) | direct
(by way of renunciation or otherwise) that another person should, or assign any right to,
receive it; |
| (d) | enter
into any agreement in respect of the votes or any economic or other rights attached to it;
or |
| (e) | agree,
whether or not subject to any condition precedent or subsequent, to do any of the foregoing; |
“Dispute”
has the meaning given to this term in clause 22.2.1 of this IP Agreement;
“Effective
Date” has the meaning given to this term in the preamble of this IP Agreement;
“Encumber”
means creating or allowing to exist or agreeing to create or agreeing to allow to exist any mortgage, charge (fixed or floating), pledge,
lien, option, right to acquire, assignment by way of security, trust arrangement for the purpose of providing security or any other security
interest of any kind, including title retention arrangements;
“Encumbrance”
has the meaning correlative to Encumber herein;
“Force
Majeure Event” has the meaning given to this term in clause 23.1 of this IP Agreement;
“Formal
Notices” means:
| (a) | notices
invoking, or relating to, Dispute resolution or any litigation between the Parties; |
| (b) | notices
given in connection with a Force Majeure Event pursuant to clause 23 of this IP Agreement; |
| (c) | a
change to the contact details specified in clause 11.1 of this IP Agreement; or |
| (d) | any
other notices stated in this IP Agreement to be a Formal Notice; |
“GCC”
means the Cooperation Council for the Arab States of the Gulf, consisting of the Kingdom, the Kingdom of Bahrain, State of Kuwait, State
of Qatar, The United Arab Emirates and the Sultanate of Oman;
“Governmental
Authority” means any federal, emirate, state, provincial or municipal government or political subdivision thereof, a governmental
or quasi-governmental ministry, legislative body, agency, authority, board, bureau, commission, government-controlled corporation or
entity, department, instrumentality or public body, or any court, administrative tribunal or public utility that has jurisdiction over
the Party or matter in question;
“Improvement”
means any update, upgrade, modification, enhancement, variation or improvement to Technology, including any and all manufacturing
and engineering developments;
“Indemnified
Losses” means:
| (a) | any
amounts awarded by a court or tribunal of competent jurisdiction or arbitrator to a Third
Party; |
| (b) | any
amounts paid in settlement to a Third Party; |
| (b) | any
interest awarded by a court of competent jurisdiction or arbitrator in respect of the above;
and |
| (c) | reasonable
costs of investigation, litigation, settlement and external legal fees (on a solicitor-client
basis) and disbursements and administrative costs directly incurred by the Indemnitee in
respect of a Claim; |
“Indemnitee”
means a Party relying on an indemnity pursuant to this IP Agreement;
“Initial
Term” has the meaning given to this term in clause 9.1 of this IP Agreement;
“Intellectual
Property Rights” or “IPR” means all past, present, and future rights of the following types, which may exist
or be created under the laws of any jurisdiction in the world:
| (a) | rights
associated with works of authorship, including exclusive exploitation rights, copyrights,
moral rights, and other similar works; |
| (b) | trade
secret rights and Know-How; |
| (c) | Patents,
Technology, and other industrial property rights; |
| (d) | other
proprietary rights in intellectual property; and |
| (e) | rights
in or relating to registrations, renewals, extensions, combinations, divisions, and reissues
of, and applications for, any of the rights referred to in clauses (a) through (d) above; |
“IP
Agreement” has the meaning given to this term in the preamble of this IP Agreement;
“Joint
IPR” has the meaning given to this term in clause 4.1.2(d) of this IP Agreement;
“Joint
Venture Agreement” or “JV Agreement” has the meaning given to this term in the preamble of this IP Agreement;
“Kingdom”
or “KSA” means the Kingdom of Saudi Arabia;
“Know-How”
means know-how, trade secrets, technical data, unpatented inventions, and commercial information and techniques in any form (including
paper, electronically stored data, magnetic media, film and microfilm) including, without limitation, drawings, formulae, test results,
reports, project reports and testing procedures, instruction and training manuals, tables of operating conditions and lists and particulars
of suppliers;
“KSA
Biodatabank” means national KSA data registries, biodatabank, and genetic data including in relation to rare and neurodegenerative
diseases that is Controlled by Company;
“KSA
Facility” means the facility for the establishment and maintenance of the KSA Lab and the KSA Biodatabank;
“KSA
Lab” means a laboratory facility to be located in Riyadh, the Kingdom, and operated in accordance with Applicable Law with
the intention that it becomes an Accredited, globally recognized, commercially driven genomics wet and dry lab;
“Laboratory
Services Agreement” has the meaning given to this term in the preamble of this IP Agreement;
“Licensed
Party” means a Party in its capacity as licensee under the licenses granted under clause 2.1 or clause 2.2;
“Licensing
Party” means a Party in its capacity as licensor under the licenses granted under clause 2.1 or clause 2.2;
“Losses”
means all Claims (whether or not successful, compromised or settled), actions, proceedings, liabilities, demands, judgments (asserted
or established in any jurisdiction) and any and all losses, damages (including interest), any amounts paid in settlement (including interest)
of a Claim, costs, expenses (including reasonable legal, investigative, administrative or professional costs and expenses incurred in
disputing or defending any of the foregoing), Taxes, fines or penalties;
“Manipulate”
means to combine or aggregate the data (wholly or in part) with other data or information or to adapt the data (wholly or in part);
“Material
Opportunity” means the opportunity to enter into any agreement in any Other GCC Member State for the provision of services
related to the Business with prospective clients or government entities, the value of which exceeds five million Saudi Arabian Riyals
(SAR 5,000,000.00);
“Net
Revenue” means the net revenue of Company, after deduction of reasonable and customary customer discounts or allowances, as
calculated in accordance with generally accepted accounting principles consistently applied;
“New
Company IPR” has the meaning given to this term in clause 4.1.2(b) of this IP Agreement;
“New
IPR” means all Intellectual Property Rights, Derived Data, Improvements, discoveries and inventions, patentable or otherwise,
that are first invented, conceived, developed, generated, or made by or on behalf of either Party, their employees and contractors in
the course of activities conducted pursuant to any of the Project Documents;
“New
NV IPR” has the meaning given to this term in clause 4.1.2(a) of this IP Agreement;
“NV”
has the meaning given to this term in the preamble of this IP Agreement;
“NV
Background IPR” means any and all Intellectual Property Rights, Technology and data owned or Controlled by NV or any of its
Affiliates:
| (a) | in
existence as of immediately prior to the Effective Date; or |
| (b) | arising
during the Term but independently from this IP Agreement and the other Project Documents; |
“NV
Data” means:
| (a) | anonymized
data owned or Controlled by NV as of the Effective Date relating to KSA individuals who have
signed applicable consents allowing such data to be shared with Company (“NV KSA
Data”); and |
| (b) | at
any given time during the Term, the curated classified variant list Controlled by NV and
used by NV for diagnostics at such time (the “NV Variant List”); |
“NV
Derived Data” means Derived Data that is Manipulated by NV or its Affiliates;
“NV
Facility” has the meaning given to this term in the recitals of this IP Agreement;
“NV
Indemnitee” has the meaning given to this term in clause 8.3.2 of this IP Agreement;
“NV
IPR” means all the NV Technology, NV Patents, NV Know-How, NV Data, New NV IPR and NV Trademarks;
“NV
Know-How” means any Know-How owned or Controlled by NV as of the Effective Date that is necessary for Company to operate the
KSA Facility or receive the benefit of the Project Documents or is otherwise provided to Company by NV pursuant to any of the Project
Documents;
“NV
Patents” means any Patents owned or Controlled by NV as of the Effective Date that is necessary for Company to operate the
KSA Facility or receive the benefit of the Project Documents;
“NV
Secondees” has the meaning given to this term in clause 4.1.2(b) of this IP Agreement;
“NV
Technology” means any Technology owned or Controlled by NV as of the Effective Date that is necessary for Company to operate
the KSA Facility or receive the benefit of the Project Documents;
“NV
Trademarks” means the Trademarks listed in Schedule 2 (NV Trademarks) and, subject to clause 2.7 of Schedule 2 (NV
Trademarks), any and all Composite Marks;
“Other
GCC Member State” means each member state of the GCC, excluding KSA;
“Party”
or “Parties” has the meaning given to it in the preamble of this IP Agreement;
“Patents”
means patents (including utility, utility model, plant and design patents, and certificates of invention), patent applications (including
additions, provisional, national, regional, and international applications, as well as original, continuation, continuation-in-part,
divisionals, continued prosecution applications, reissues, and re-examination applications), patent or invention disclosures, registrations,
applications for registrations, and any term extension or other governmental action which provides rights beyond the original expiration
date of any of the foregoing;
“Person”
means any individual, corporation, sole proprietorship, limited liability company, partnership, joint venture, association, joint stock
company, fund, trust, unincorporated organization or Governmental Authority;
“Personal
Data” has the meaning given to it in Applicable Data Protection Laws;
“Project
Documents” means, collectively, this IP Agreement, the Joint Venture Agreement, the Laboratory Services Agreement and the Consultancy
Agreement;
“Promotional
Material” means any and all material used in the promotion of, or otherwise in connection with the Purpose (whether written
or recorded in any medium) as permitted in this IP Agreement, and includes artwork, advertising materials (irrespective of the medium
in which they are recorded), display materials, brochures, videos, broadcasts, and posters (including any internet or web-based materials);
“Provider”
has the meaning given to this term in clause 7.1 of this IP Agreement;
“Purpose”
has the meaning in clause 2.1.1(a) of this IP Agreement;
“Recipient”
has the meaning given to this term in clause 7.1 of this IP Agreement;
“Regulator”
or “Regulatory Authority” means any national, regional, state or local regulatory agency, department, bureau, commission,
council or other Governmental Authority whose review and/or approval is necessary for performing clinical and/or laboratory services
in the applicable regulatory jurisdiction and granting regulatory approvals or having regulatory or supervisory authority over a Party
or a Party’s assets, resources or business;
“Renewal
Term” has the meaning given to this term in clause 9.1 of this IP Agreement;
“Royalty
Fee” has the meaning given to this term in clause 5.2 of this IP Agreement;
“Royalty
Term” has the meaning given to this term in clause 5.3 of this IP Agreement;
“SCCA”
has the meaning given to this term in clause 22.2.2 of this IP Agreement;
“Tax”
means all forms of taxation and statutory, governmental, state, federal, provincial, local, government or municipal charges, duties,
imposts, contributions, levies, withholdings or other liabilities in the nature of taxation wherever chargeable and whether of KSA or
any other jurisdiction (including, for the avoidance of doubt, social security contributions in KSA and Germany and corresponding obligations
elsewhere) and any penalty, fine, surcharge, interest, charges or costs relating to it or them;
“Tax
Credit” means a credit against, relief or remission for, or repayment of, any Tax;
“Tax
Deduction” means any amount which Company is required by Applicable Law to deduct or withhold on account of Tax from any payment
by Company to NV (or a relevant Affiliate) in respect of any payments made under this IP Agreement;
“Technology”
means all proprietary information, both business and technical, tangible and intangible, including inventions and discoveries (whether
patented, patentable or not), algorithms, business rules, routines, processes, devices, prototypes, schematics, test methodologies, software,
systems, original works of authorship, documents, data and Know-How;
“Term”
has the meaning given to this term in clause 9.1 of this IP Agreement;
“Third
Party” means any individual, partnership, joint venture, corporation or other legal entity that is not a Party or an Affiliate;
“Third
Party IPR” has the meaning given to this term in clause 2.4 of this IP Agreement;
“Trademark”
means any and all trademarks, service marks, trade names, service names, brand names, trade dress, logos, certifications, accounts, corporate
names and any and all other indications of origin (whether or not registered), including any and all goodwill associated therewith, and
any and all applications, registrations and renewals in connection therewith;
“Transition
Period” has the meaning given to this term in clause 9.3.6 of this IP Agreement;
“VAT”
means:
| (a) | any
Tax imposed in relation to the Unified Agreement for Value Added Tax for the GCC; |
| (b) | any
other Tax of a similar nature, imposed in a member state of the GCC; or |
| (c) | any
other similar Taxes imposed anywhere in the world; and |
“Willful
Misconduct” means conduct that is unreasonable, deliberate and carried out by a Party in the knowledge that it will result
in significant injury or damage to the other Party.
PART
2 - INTERPRETATION
In
this IP Agreement:
| (a) | any
reference to “Schedule” or “Annex”, unless the context otherwise
requires, is a reference to the relevant schedule or annex of and to this IP Agreement, and
any reference to a “clause”, “section” or “paragraph”,
unless the context otherwise requires, is a reference to a clause in this IP Agreement, a
section or paragraph in the relevant Schedule and a paragraph in the relevant Annex, respectively; |
| (b) | The
clause, section and paragraph headings and the contents page in this IP Agreement are included
for convenience purposes only and shall not affect the interpretation of this IP Agreement. |
| (c) | Unless
the context otherwise requires, the words “this IP Agreement,” “hereof,”
“hereunder,” “herein,” “hereby,” or words of similar
import shall refer to this IP Agreement as a whole and not to a particular clause or other
subdivision hereof. |
| (d) | Whenever
the context requires, the words used herein shall include the masculine, feminine, and neuter
gender, and the singular and the plural. |
| (e) | Any
reference to a Party or the Parties means a party or the parties to this IP Agreement, including
their successors in interest and permitted assigns. |
| (f) | Any
reference to “persons” includes natural persons, companies, corporations, partnerships,
limited liability companies, firms, associations, organizations, Governmental Authorities,
foundations and trusts (in each case, whether or not having separate legal personality). |
| (g) | Any
reference to a date refers to the Gregorian calendar. |
| (h) | Any
reference to a statute, statutory provision or subordinate legislation shall, except where
the context otherwise requires, be construed as referring to such legislation as amended
and in force from time to time and to any legislation which re-enacts or consolidates (with
or without modification) any such legislation. |
| (i) | Unless
otherwise defined, terms used in the healthcare industry or other relevant business context
shall be interpreted in accordance with their generally understood meaning in that industry
or business context. |
| (j) | Any
phrase introduced by the terms “including”, “include”, “in
particular” or any similar expression shall be construed as illustrative and shall
not limit the sense of the words preceding those terms. |
| (k) | Any
reference to “writing” or “written” includes email (but not faxes),
save with respect to Formal Notices, where service in accordance with clause 11 is required. |
| (l) | Any
reference to any agreement or other instrument shall, except where expressly provided to
the contrary, include any amendment, restatement, amendment and restatement, modification,
variation or novation (in whole, or in part) to such agreement or other instrument. |
SCHEDULE
2 NV Trademarks
[***]
SCHEDULE
3 Permitted Encumbrances
[***]
SCHEDULE
4 NV IPR Claims
[***]
Schedule
5 Acknowledgement and Undertaking
[***]
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