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 Month of July 2015
001-13248
(Commission File Number)
SCIVAC
THERAPEUTICS INC.
(Exact
name of Registrant as specified in its charter)
Gad
Feinstein Rd.
POB
580
Rehovot,
Israel 7610303
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover
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): ____
As
previously reported, on July 9, 2015, SciVac Therapeutics Inc., formerly Levon Resources Ltd. (the “Company”),
announced the completion of its reverse takeover transaction (the “Transaction”), pursuant to which the Company
acquired all of the issued and outstanding securities of SciVac Ltd., an Israeli corporation (“SciVac”), in
exchange for 517,514,016 common shares of the Company (the “Common Shares”), resulting in the former SciVac
securityholders holding 68.4% of the issued and outstanding Common Shares and the Company’s shareholders immediately prior
to consummation of the Transaction controlling the remaining 31.6%. The Company’s shareholders immediately prior to the
effective time of the Transaction received, in exchange for each common share of the Company then held, one Common Share, and
0.5 of a common share of Levon Resources Ltd., formerly 1027949 B.C. Ltd. The Company filed a Material Change Report (the “MCR”)
on SEDAR in Canada, containing additional details of the Transaction. The MCR is furnished as Exhibit 99.1 to this Report on Form
6-K and is incorporated herein by reference.
Additionally,
the Company filed on SEDAR in Canada that certain License Agreement, dated June 2004, by and between Savient Pharmaceuticals,
Inc. and SciGen, Ltd., together with the several amendments thereto (as amended, the “License”), relating to
the intellectual property underlying Sci-B-Vac, the Company’s third generation hepatitis B vaccine. Pursuant to a series
of assignments, the License is now between SciVac, as licensee, and Ferring International Center S.A., as licensor. A copy of
the License, together with the amendments thereto, is furnished as Exhibit 99.2 to this Report on Form 6-K and is incorporated
herein by reference.
Exhibit
Index
| Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Material
Change Report |
| |
|
|
| 99.2 |
|
Ferring
License Agreement |
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.
| |
SciVac
Therapeutics Inc. |
| |
|
| Date:
July 20, 2015 |
By: |
/s/
Dr. Curtis Lockshin |
| |
|
Dr. Curtis Lockshin |
| |
|
Chief Executive
Officer |
Exhibit 99.1
FORM
51-102F3
MATERIAL
CHANGE REPORT
| Item
1: |
Name
and Address of Company |
| |
|
| |
SciVac
Therapeutics Inc. (formerly Levon Resources Ltd.) |
| |
13
Gad Feinstein Rd. |
| |
Rehovot,
76100 |
| |
Israel |
| |
|
| Item
2: |
Date
of Material Change |
| |
|
| |
July
9, 2015 and July 13, 2015 |
| |
|
| Item
3: |
News
Release |
| |
|
| |
The
news releases announcing the material changes were issued on July 9, 2015 and July 13, 2015 through the facilities of Marketwired
via Canadian Disclosure and copies were filed on SEDAR. |
| |
|
| Item
4: |
Summary
of Material Change |
Completion
of Reverse Takeover Transaction
SciVac
Therapeutics Inc. (the “Company”, formerly Levon Resources Ltd.) (“Levon”) announced the
completion of the previously announced plan of arrangement (the “Transaction”) pursuant to which SciVac Ltd.
(“SciVac”) completed a reverse takeover of Levon. In connection with the Transaction, the Company acquired
100% of the issued and outstanding securities of SciVac in exchange for 517,514,016 common shares of the Company (the “Common
Shares”), resulting in the former SciVac securityholders holding 68.4% of the issued and outstanding Common Shares and
the Levon shareholders immediately prior to the effective time of the Transaction controlling the remaining 31.6%. On completion
of the Transaction, the Company changed its name from Levon Resources Ltd. to SciVac Therapeutics Inc.
Listing
on the Toronto Stock Exchange
The
Company also announced that the Toronto Stock Exchange (the “TSX”) issued a bulletin confirming the listing
of the Common Shares on the TSX under the symbol “VAC”, commencing at the opening of the TSX on July 14, 2015. Also
commencing at the opening of markets on July 14, 2015, the Common Shares became quoted on the OTCQX under the symbol “SVACF”.
| Item
5: |
Full
Description of Material Change |
| |
|
| 5.1
|
Full
Description of Material Change |
Completion
of Reverse Takeover Transaction
The
Company announced the completion of the Transaction pursuant to which SciVac completed a reverse takeover of Levon. In connection
with the Transaction, the Company acquired 100% of the issued and outstanding securities of SciVac in exchange for 517,514,016
Common Shares, resulting in the former SciVac securityholders holding 68.4% of the issued and outstanding Common Shares and the
Levon shareholders immediately prior to the effective time of the Transaction controlling the remaining 31.6%. On completion of
the Transaction, the Company changed its name from Levon Resources Ltd. to SciVac Therapeutics Inc.
At
the closing of the Transaction, all holders of common shares of Levon immediately prior to the effective time of the Transaction
received, in addition to one Common Share, 0.5 of a common share of 1027949 BC Ltd. (“Spinco”) in exchange
for each common share of Levon held by them. Other than CAD$27 million in cash retained by the Company, all other assets and liabilities
of Levon were transferred or assumed by Spinco. As a result of the Transaction, the Company will operate the business of SciVac.
At
the closing of the Transaction, the Transaction had been granted conditional approval by the TSX.
The
Supreme Court of British Columbia issued a final order approving the Transaction on June 4, 2015 and the Transaction became effective
at 12:01 a.m. on July 9, 2015 (the “Effective Time”).
The
Company’s previous management team resigned at or about the Effective Time, and the following persons assumed the following
offices: Curtis A. Lockshin – Chief Executive Officer; James J. Martin – Chief Financial Officer; Steven D. Rubin
– Chairman; and Shayla Forster – Corporate Secretary.
The
previous members of the board of directors of the Company resigned at or about the Effective Time and were replaced by the following
individuals: Steven D. Rubin (Chairman); Curtis A. Lockshin; Dmitry Genkin; Kate Inman; Adam Logal; and David Rector. In accordance
with the conditional approval of the TSX, the Company will appoint an additional independent director within 90 days following
the listing of the Common Shares on the TSX.
Listing
on the Toronto Stock Exchange
The
Company also announced that the TSX issued a bulletin confirming the listing of the Company’s Common Shares on the TSX under
the symbol “VAC”, commencing at the opening of the TSX on July 14, 2015. Also commencing at the opening of markets
on July 14, 2015, the Common Shares became quoted on the OTCQX under the symbol “SVACF”.
| 5.2
|
Disclosure
for Restructuring Transactions |
Not
applicable.
| Item
6: |
Reliance
on subsection 7.1(2) of National Instrument 51-102 |
Not
applicable.
| Item
7: |
Omitted
Information |
Not
applicable.
| Item
8: |
Executive
Officer |
For further
information, please contact Jim Martin, Chief Financial Officer at +972-8-948-0625 or jmartin@scivactherapeutics.com
July 20, 2015.
Exhibit
99.2
LICENSE
AGREEMENT
This
License Agreement is made and signed in June of 2004, by and between SAVIENT PHARMACEUTICALS, INC. (formerly known as Bio-Technology
(General) Corp), a Delaware corporation having its place of business at 14th Floor, One Tower Center, East Brunswick,
New Jersey, United States of America, facsimile number +1 732 418 9011 (“Savient”), and SCIGEN LTD., a public
company incorporated under the laws of Singapore, having a place of business at 152 Beach Road, Suite 2607/08, Gateway East, Singapore
189721, facsimile number +65 6779 3784 (“Scigen”).
PREMISES
| 1st. |
Savient
and Scigen are parties to the Scigen-Distribution Agreement, whereby Scigen has an exclusive marketing and distribution license
for the Vaccine in the Territory, which Scigen-Distribution Agreement is revoked herein; |
| |
|
| 2nd. |
In
December 1997, Bio-Technology General (Israel) Limited obtained OCS approval in principle to the erection of a manufacturing
facility in Asia and is obligated to submit any definitive technology transfer agreement to the OCS to complete the approval
process; |
| |
|
| 3rd. |
Savient
and Scigen are parties to the Production Rights Agreement under which Scigen was granted specified rights and licenses, subject
to certain pre-conditions that were not fulfilled, which Production Rights Agreement is revoked herein; and |
| |
|
| 4th. |
The
Parties wish to replace the Prior Agreements and the terms and conditions thereunder with the terms and conditions of this
Agreement. |
IN
CONSIDERATION of the mutual undertakings and covenants set forth herein, the sufficiency of which is hereby acknowledged, the
Parties hereby agree as follows:
1.
Definitions For the purposes of this Agreement, the following terms shall
have the meaning set forth below:
| |
1.1. |
“Affiliate”
of either one of the Parties hereto shall mean any individual sole proprietorship, firm, partnership, corporation, trust,
joint venture or other entity, whether de jure or de facto, which, directly or indirectly, controls, is controlled
by or is under common control with such person or entity. As used in this definition, “control” means the possession,
directly or indirectly, of the power to direct or cause the direction of the policies and management of a person or entity,
whether by the ownership of stock, by contract or otherwise. |
| |
|
|
| |
1.2. |
“Agreement”
means this License Agreement. |
| |
1.3. |
“Batch”
means a production run of HBsAg using approximately six hundred (600) liters of medium at a rate of approximately twenty (20)
liters per day. |
| |
|
|
| |
1.4. |
“Be’er
Tuvia Facility” means BTGIL’s new facility in Be’er Tuvia, Israel, to which the Process and the Technology
have not been successfully transferred. |
| |
|
|
| |
1.5. |
“BERNA”
means BERNA Biotech Limited, of Rehhagstrasse 79, 3018 Bern, Switzerland, and its successors and assigns. |
| |
|
|
| |
1.6. |
“BTGIL”
means Bio-Technology General (Israel) Ltd., a wholly owned subsidiary of Savient, existing under the laws of Israel and having
a place of business in Rehovot, Israel. |
| |
|
|
| |
1.7. |
“CHO”
means Chinese Hamster Ovary. |
| |
|
|
| |
1.8. |
“Clone”
means genetically engineered CHO cells encoding the Hepatitis B Antigen. |
| |
|
|
| |
1.9. |
“CMC”
means a third party contract manufacturer in India or the PRC selected by Scigen for the manufacture of Product, which can
include a joint venture entity involving Scigen. |
| |
|
|
| |
1.10. |
“Combination
Vaccine” means a vaccine containing portions of two or more separate vaccines, in all cases including the Product. |
| |
|
|
| |
1.11. |
“Confidential
Information” means the Technology, the Process, and all information and data of any kind, which by its nature is
confidential or proprietary, whether such information is disclosed orally, by observation during visits to or inspections
of the disclosing Party’s facilities, or in writing or in any other form. For the avoidance of doubt, Confidential Information
shall be deemed to include information and data exchanged between the Parties prior to the Signature Date, under any of the
Prior Agreements and information received by Scigen and/or the CMO or transmitted between them. |
| |
|
|
| |
1.12. |
“Distributor”
means a third party to which Scigen may grant the right to Market Product in any country or countries in the Territory, pursuant
to Section 7 below. |
| |
|
|
| |
1.13. |
“Effective
Date” shall have the meaning ascribed to such term in Section 2.1 below. |
| |
|
|
| |
1.14. |
“Facility”
means a production facility selected by Scigen to be constructed in India and a production facility selected by Scigen to
be constructed in the PRC, both for the production of Product exclusively for Scigen. For the avoidance of doubt, there may
only be one production facility in operation in each said country at any given time. |
| |
1.15. |
“Formulated”
means sterilized bulk Product with added buffer followed by adsorption onto alhydrogel. |
| |
|
|
| |
1.16. |
“HBsAg”
means CHO-derived Hepatitis B Antigen. |
| |
|
|
| |
1.17. |
“Hepatitis
B Antigen” means S, Pre-S1 and Pre-S2 epitopes of the hepatitis B virus. |
| |
|
|
| |
1.18. |
“Hepatitis
B Competitor” means [redacted]. |
| |
|
|
| |
1.19. |
“License
Period” shall have the meaning ascribed to it in Section 16.1. |
| |
|
|
| |
1.20. |
“Marketing
Plan” means Scigen’s non-binding five (5) year plan for the marketing of the Product in the Territory, which
is attached hereto as Exhibit A, and made a part hereof. |
| |
|
|
| |
1.21. |
“Licensed
Indications” means all pharmaceutical uses for which Regulatory Approval is obtained for the Product. |
| |
|
|
| |
1.22. |
“Market”
or “Marketing” means use and/or dealing in and/or testing and/or promotion and/or marketing and/or distribution
and/or sale of the Product. |
| |
|
|
| |
1.23. |
“Minimum
Quantity” means [redacted]. |
| |
|
|
| |
1.24. |
“Net
Sales” means the ex-works selling price for Product (in bulk or in its final presentation) invoiced and collected
by Scigen, or an Affiliate or designee of Scigen, from a Distributor, as established in a bona fide arms’ length transaction
between Scigen or an Affiliate or designee of Scigen and such Distributor. Net Sales shall also include the fair market value
of Product transferred to related parties or on consignment. Net Sales shall specifically exclude the fair market value of
amounts of Product actually used by Scigen for testing which is specifically required by a regulatory authority in the Territory
and/or used by Scigen as product samples, provided the quantity of Product actually utilized for purposes of such testing
and/or product samples shall not exceed ten percent (10%) of annual Product sales during any given Royalty Year during this
Agreement. With respect to Marketing of Combination Vaccine, Net Sales shall be equal to a percentage of the total sales price
for the Combination Vaccine calculated by multiplying such total sales price by the ratio that the retail price of Product
contained in the Combination Vaccine bears to the total retail price of the components in the Combination Vaccine. To the
extent that this formula is inapplicable at any particular time, the Parties shall discuss and agree in good faith upon an
alternative mechanism to govern the Royalty base for Combination Vaccines. |
| |
1.25. |
“OCS”
means the Office of the Chief Scientist of the Ministry of Trade, Industry and Labor of Israel. |
| |
|
|
| |
1.26. |
“OCS
Approval” means the OCS’s written approval of the conveyance of production rights to Scigen in India and in
the PRC pursuant to this Agreement as well as approval of the transfer of Technology under the Three-Way Agreement (if required). |
| |
|
|
| |
1.27. |
“Party”
or “Parties” means Savient or Scigen or both of them, depending on the context. |
| |
|
|
| |
1.28. |
“Patent
Rights” means Savient’s patent rights in patents directed to the manufacture of HBsAg, as listed in Exhibit
B which is attached hereto and made a part hereof, as well as any reissues, supplementary protection certificates
and extensions of such patents. |
| |
|
|
| |
1.29. |
“PRC”
means the People’s Republic of China. |
| |
|
|
| |
1.30. |
“Prior
Agreements” means the Scigen-Distribution Agreement and the Production Rights Agreement. |
| |
|
|
| |
1.31. |
“Process
Design Package” means the documentation listed in Exhibit C which is attached hereto and made a part
hereof. |
| |
|
|
| |
1.32. |
“Process”
means Savient’s proprietary process for the production of the Product, as was used at the Rehovot Facility for the production
of the Vaccine. |
| |
|
|
| |
1.33. |
“Product”
means HBsAg, either in bulk or Formulated, meeting the Specifications, to be manufactured by Scigen or CMO and for sale by
Scigen as Hepatitis B virus vaccine, but is not the Vaccine. “Product” shall include HBsAg for sale as a Therapeutic
or as part of a Combination Vaccine. |
| |
|
|
| |
1.34. |
“Production
Rights Agreement” means the License Agreement entered into as of December 23, 1997 by and between Savient and Scitech
Genetics Pte. Ltd, a predecessor in interest to Scigen, as amended by Amendment No. 1 of January 18, 1998, an additional amendment
effective June 1, 1999 and Amendment No. 3 effective February 1, 2001. |
| |
|
|
| |
1.35. |
“Rehovot
Facility” means BTGIL’s facility in Rehovot, Israel, at which the Process and the Technology were previously
used for the manufacture of the Vaccine for Savient. |
| |
|
|
| |
1.36. |
“Regulatory
Approval” means all governmental approvals required for the commercial production of the Product in any country
in the Territory, or required to Market Product for Licensed Indications in any country of the Territory. |
| |
1.37. |
“Royalty”
shall have the meaning ascribed to such term in Section 10.1 below. |
| |
|
|
| |
1.38. |
“Royalty
Year” means, as to each individual country in the Territory, consecutive twelve (12) month periods commencing upon
the date of Regulatory Approval being obtained therein. |
| |
|
|
| |
1.39. |
“Scigen-Distribution
Agreement” means the License Agreement entered into as of November 22, 1988 by and between Savient and Scitech Medical
Products Pte. Ltd, a predecessor in interest to Scigen, with respect to the marketing and distribution of the Product, as
amended by Amendment No. 1 of October 1, 1995, Amendment No. 2 of December 22, 1996 and Amendment No. 3 effective December
1997, |
| |
|
|
| |
1.40. |
“Signature
Date” means the first date upon which the signatures of both Parties shall have been affixed to this Agreement. |
| |
|
|
| |
1.41. |
“Specifications”
means characteristics which, subject to the relevant Regulatory Approvals, are the same or may be substantially similar to
those set forth in Exhibit D which is attached hereto and made a part hereof, or such other mutually agreed
upon specifications. |
| |
|
|
| |
1.42. |
“Technology”
means the Clone and information which relates to the manufacture of Vaccine, which shall include all trade secrets generally
disclosed in the Process Design Package, including, without limitation, manufacturing procedures, the Specifications, standard
operating procedures or protocols for the Process and the analytical tests and quality control and testing procedures and
validation protocols and expertise applied to the manufacture of the Vaccine, and information and data relating to the attempt
to transfer the Process to the Be’er Tuvia Facility; provided, however that it shall not include (i) detailed
design, engineering services, construction or adaptation of the Facility; (ii) supervision of any of the aforementioned activities;
(iii) procurement or compliance with local standards and requirements; (iv) programs for the running-in and operation of the
Facility; (v) validation and related standard operating procedures for the Facility; (vi) any scale changes at the Facility
or work flowing from such changes; (vii) the transfer of the Product into any receptacle other than bottles and into vials
from bottles. |
| |
|
|
| |
1.43. |
“Term”
shall have the meaning ascribed to it in Section 16.1. |
| |
1.44. |
“Territory”
means those countries listed in Exhibit E, which is attached hereto and made a part hereof, and as may be modified
in accordance with this Agreement. |
| |
|
|
| |
1.45. |
“Therapeutic”
means Product for use against infections caused by the Hepatitis B virus. |
| |
|
|
| |
1.46. |
“Three-Way
Agreement” means an agreement, to be reached between Savient, Scigen and the CMO, pursuant to which the Technology
will be transferred to the CMO, for the sole purpose of manufacturing the Product at the Facility. |
| |
|
|
| |
1.47. |
“Timetable”
means the agreed timetable for the transfer of the Technology as recorded as part of Exhibit F, which is attached
hereto and made a part hereof. |
| |
|
|
| |
1.48. |
“Triggering
Date” means the first day of the first calendar quarter that commences after the Facility first starts producing
Product. |
| |
|
|
| |
1.49. |
“Vaccine”
means Hepatitis B virus vaccine containing HBsAg that was manufactured for Savient at the Rehovot Facility, but (for the avoidance
of doubt) is not the Product. |
| |
|
|
| |
1.50. |
“Validation
of the Process” means production of HBsAg meeting the Specifications at the Facility in three (3) consecutive Batches,
through use of the Process, using at least one (1) seven and a half (7.5) liter bioreactor (Celligen Plus) with a working
volume of four and two tenths (4.2) liters. |
2.
Precondition to this Agreement Becoming Effective
| |
2.1. |
Save
for the provisions of Sections 4.4, 4.5 and 18 below, which shall be binding upon the Parties as of the Signature Date, this
Agreement shall go into force and effect upon receipt of OCS Approval (the “Effective Date”). |
| |
|
|
| |
2.2. |
The
Prior Agreements are hereby terminated as of the Effective Date by mutual agreement of the Parties and neither Party shall
have any obligation, liability or claim to or against the other Party in respect thereto. |
| |
|
|
| |
2.3. |
Without
derogating from the generality of the foregoing, the Parties hereby release and discharge each other and their respective
Affiliates, successors and assigns from any claims, demands, and rights of action arising out of and/or based upon any act
or omission committed by either of them or an Affiliate under the Prior Agreements, prior to the Effective Date, including,
without limitation, any demand for payment or reimbursement of any payment. Nothing in Section 2.2 or this Section 2.3 shall,
however, preclude Scigen from selling any remaining inventory of Vaccine in countries in the Territory in which Scigen has
obtained Regulatory Approval. |
3.
License Grant
| |
3.1. |
Savient
hereby grants to Scigen the following rights, and only for the Licensed Indications: |
| |
|
3.1.1. |
the
exclusive right and license to Market Product in the Territory; |
| |
|
|
|
| |
|
3.1.2. |
the
right to sublicense, subject to the conditions set forth in Section 7, one or more Distributors (including Affiliates of Scigen)
to Market Product in the Territory under the exclusive license granted pursuant to the preceding Section 3.1.1; |
| |
|
|
|
| |
|
3.1.3. |
the
exclusive right and license to utilize the Technology and other Confidential Information disclosed by Savient and/or BTGIL
hereunder, solely for the purpose of manufacturing, or having manufactured, Product as provided by Section 3.2 below, at one
Facility in India and at one Facility in the PRC (subject to the conditions set forth in Sections 3.3 and 6 below); and |
| |
|
|
|
| |
|
3.1.4. |
the
non-exclusive right and license to sell Product to BERNA or other licensees, if any, if they are authorized in writing by
Savient to receive Product, should BERNA or any such other licensee so request and agree. |
| |
3.2. |
Notwithstanding
the provisions of Section 3.1.3 above, Savient shall transfer the Technology once and only once during the Term to Scigen
or the CMO in India on behalf of Scigen, as provided in this Agreement, for utilization solely at the Facility, but not for
the production of any product other than the Product. However, Clones may be replaced in accordance with the provisions of
Exhibit F. |
| |
|
|
| |
3.3. |
Should
Scigen or any CMO (“Current CMO”) suspend the Technology transfer, refuse to accept the Technology transfer,
fail to complete construction or Validation of the Process or cease for any reason, during the Term, to manufacture Product
(collectively, “Production Cessation”), then following notice to Savient in writing, as provided below,
Scigen may transfer the Process and the Technology to another CMO (“New CMO”) as provided in this Agreement
or elect to manufacture Product itself at its own wholly owned facility and at its own responsibility and expense. In such
event: |
| |
|
3.3.1. |
Scigen
shall notify Savient promptly in writing of any Production Cessation or anticipated Production Cessation and of its intention
to replace the Current CMO; |
| |
|
|
|
| |
|
3.3.2. |
Any
transfer of Technology to a New CMO shall be carried out by Scigen: (a) with no responsibility or expense to Savient; and
(b) shall be subject to Savient, Scigen and such New CMO negotiating and having entered into a Three-Way Agreement on terms
and conditions to be agreed upon between the three parties, based on the initial Three-Way Agreement with the first CMO; |
| |
|
|
|
| |
|
3.3.3. |
The
Current CMO (or Scigen, if Scigen incurs the Production Cessation) shall transfer the Process, the Technology, the Clone and
any clone derived therefrom to the New CMO (or Scigen, if Scigen is to manufacture Product). The Current CMO (or Scigen, as
the case may be) will or may continue to manufacture Product for Scigen in accordance with this Agreement whilst the Technology
is being transferred to the New CMO (or Scigen, as the case may be) and the New CMO or Scigen is preparing to manufacture
the Product. Subject to Section 3.3.4, at no time will more than one (1) CMO at one (1) Facility be manufacturing Product
in India pursuant to this Agreement. Likewise, subject to Section 3.3.4, at no time will more than one (1) CMO at one (1)
Facility be manufacturing Product in the PRC pursuant to this Agreement; and |
| |
|
|
|
| |
|
3.3.4. |
During
the transition period before the New CMO replaces the Current CMO, the New CMO may manufacture Product as is necessary to
obtain Regulatory Approval. |
| |
3.4. |
For
the avoidance of doubt, and without derogating from the provisions of any Three-Way Agreement between Savient, Scigen and
a CMO, Scigen will be fully responsible to ensure that a Current CMO ceases the manufacture of the Product and use of the
Process, maintains and transfers the Clone and any clone derived therefrom under the correct storage conditions to Scigen
or the New CMO along with the Technology pursuant to the preceding Section 3.3 of this Agreement, immediately upon the termination
of any Three-Way Agreement, under the correct conditions. |
4. Regulatory
Approvals
| |
4.1. |
Scigen
shall be fully responsible for promptly preparing, duly filing and actively prosecuting applications for Regulatory Approval
of the Product in each country in the Territory, in its own name, or only if it is not possible to file for Regulatory Approval
of the Product except in the name of a Distributor, then in the name of the Distributor. Scigen agrees to submit, within two
(2) years from the Effective Date, a clinical plan in relation to the Therapeutic vaccine and undertakes to commence clinical
trials in relation thereto within three (3) years from the Effective Date. Scigen shall keep Savient currently informed about
the progress made towards obtaining Regulatory Approval of the Product in each country in the Territory and shall provide
Savient with written reports in reasonable detail on a quarterly basis. Scigen shall also promptly notify Savient, in writing,
of the receipt of Regulatory Approval of the Product in each country in the Territory, as soon as such Regulatory Approval
is obtained. |
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4.2. |
Savient
shall use reasonable efforts to accommodate Scigen’s reasonable requests for assistance in its efforts to prepare applications
for Regulatory Approvals of the Product. Scigen shall reimburse Savient for its expenses and pay Savient for man-days that
Savient may devote towards rendering such assistance, at the rates set forth in Section 8.5 below. Scigen acknowledges and
agrees, that following the expiry of six (6) months from the Effective Date, neither Savient nor BTGIL shall have any further
obligation under this Section 4.2. |
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4.3. |
Scigen
shall diligently initiate the process of obtaining Regulatory Approval of the Product in countries within the Territory as
both a vaccine and as a Therapeutic, as soon as possible and, in any event, within six (6) months of the Triggering Date for
the vaccine and within two (2) years of the Triggering Date for the Therapeutics. In the event that Scigen has not diligently
initiated any steps to commence the process of obtaining Regulatory Approval of the Product in any particular country in the
Territory within the relevant time period or does initiate but fails to obtain Regulatory Approval of the Product as a vaccine
in any country within two (2) years of the Triggering Date and within four (4) years of the Triggering Date with respect to
Therapeutics, Savient shall have the right, at its full discretion, to convert the right and license granted to Scigen in
respect of the Product under Sections 3.1.1 and 3.1.2 above from exclusive to non-exclusive with respect to such country as
to a vaccine and/or a Therapeutic (to the extent that Regulatory Approval has not been obtained) or if neither is attained,
to remove such country from the scope of the Territory, by written notice to Scigen. Notwithstanding the foregoing, should
Scigen be making demonstrable, good faith, best efforts to obtain such Regulatory Approval, Savient shall refrain from taking
any action pursuant to this Section 4.3, for as long as Scigen continues diligently to successfully prosecute such Regulatory
Approval. |
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4.4. |
Savient
shall operate in good faith and utilize its best efforts to undertake such actions and execute, process and deliver any and
all such documents, certificates and instruments as may be necessary or appropriate to obtain OCS approval promptly of this
Agreement and its implementation, and, if required by the OCS, the Three-Way Agreement. Provided that Savient has made such
good faith efforts, failure to obtain OCS approval shall not be deemed as a breach of this Agreement. |
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4.5. |
Scigen
hereby acknowledges that the execution by Scigen and/or the CMO of a direct undertaking vis-a-vis the OCS to comply with the
requirements of applicable law, may be a condition precedent to OCS approval of this Agreement, the Three-Way Agreement and
their implementation. Scigen undertakes to execute, process and deliver, and to cause the CMO to execute, process and deliver,
such undertakings and instruments as may be necessary or appropriate to obtain OCS approval promptly. |
5. Marketing
| |
5.1. |
Scigen
undertakes to replace the Marketing Plan with an updated version to include Therapeutics and Combination Vaccines covering
the five (5) years as from the date of Validation of the Process, immediately upon Validation of the Process. |
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5.2. |
Following
receipt of Regulatory Approval of the Product in each country in the Territory, Scigen will commence commercialization thereof
promptly by diligently taking all steps reasonably required to Market Product in such country. If Scigen’s sales of
Product, in any particular country in the Territory do not reach the Minimum Quantity during any [redacted] period following
receipt of Regulatory Approval for the Product therein, the right and license granted to Scigen under Sections 3.1.1 and 3.1.2
above shall [redacted]. Should Scigen’s sales of Product in such country fail to reach the Minimum Quantity during any
[redacted] period following such conversion, Savient shall [redacted]. |
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5.3. |
Scigen
will not, directly or indirectly, Market Product outside the Territory or sell or otherwise transfer Product to any person
or entity within the Territory that it has reason to believe will export Product from the Territory or Market Product outside
the Territory or set up a base to do so. |
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5.4. |
Scigen
is willing to supply BTGIL with Product for Marketing in Israel, if Savient or BTGIL so requests, on terms and conditions
to be mutually agreed upon. |
6. Manufacture
of Product
| |
6.1. |
Manufacture
of the Product by Scigen or the CMO at the Facility shall be subject to this Agreement and a Three-Way Agreement to be entered
into among Savient, Scigen and the CMO. |
| |
6.2. |
Scigen
shall be responsible to Savient, jointly and severally with the CMO, for the Facility and those matters set forth in Exhibit
G which is attached hereto and made a part hereof, including, without limitation, the selection, design, engineering,
construction, testing, running-in, validation, operation and maintenance of the Facility so that the Facility is running with
a target capability of producing [redacted] of [redacted] micrograms or [redacted] micrograms, or a combination thereof, per
annum, by the target date of [redacted], unless the Technology is transferred to a second CMO in accordance with Section 3.3,
in which case, the target date shall be extended to [redacted]. The Parties acknowledge that the failure to meet the target
capability or date set forth above shall not constitute a material breach of this Agreement. |
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6.3. |
Upon
reasonable written notice to Scigen, representatives of Savient shall be permitted at all reasonable times during business
hours to inspect the Facility. |
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6.4. |
Savient
shall be entitled to receive and to test samples of the Product in order to confirm that applicable quality standards are
being maintained at the Facility. |
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6.5. |
Scigen
shall comply with all regulatory requirements and ensure that the Product will consistently meet the Specifications and that
applicable quality standards can be maintained. |
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|
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6.6. |
[redacted]. |
7. Distributors
| |
7.1. |
Scigen
shall be entitled, in its sole discretion and at its sole responsibility, to Market Product through Distributors pursuant
to arrangements with such Distributors consistent and complying with the following: |
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7.1.1. |
Distributor
shall keep confidential, shall not disclose Confidential Information disclosed to it by Scigen or the CMO and shall return
to Scigen or to the CMO all documents containing such Confidential Information promptly, upon the termination of the distributorship;
and |
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7.1.2. |
Distributor
will not, directly or indirectly. Market Product outside the Territory or sell or otherwise transfer Product to any person
or entity within the Territory that it has reason to believe will export Product from the Territory or Market Product outside
the Territory or set up a base to do so; and |
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|
7.1.3. |
that
if it is not possible to file for Regulatory Approval of the Product except in the name of the Distributor, then upon termination
of the Distributorship, Distributor shall, at Scigen’s request, and without cost, promptly assign to Scigen or Scigen’s
nominee, any application for Regulatory Approval of the Product theretofore made in the Territory, or any such Regulatory
Approval. If any such application cannot be so transferred or assigned, Distributor, shall, at Scigen’s request and
responsibility, actively continue to process such application and shall assign such Regulatory Approval of the Product to
Scigen when received. Once received, Distributor will not retain any residual rights to any such application or Regulatory
Approval; and |
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7.1.4. |
that
the Distributor shall report promptly to Scigen, and Scigen shall in turn promptly report to Savient, on all adverse effects
and to BTGIL on all adverse effects. |
| |
7.2. |
For
the avoidance of doubt, Scigen shall refrain from disclosing any Confidential Information that constitutes any aspect of the
Technology to any Distributor. |
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7.3. |
Scigen
shall promptly notify Savient, in writing, of the appointment of each Distributor and its name and address. |
8. Technology
Transfer
| |
8.1. |
Transfer
of the Technology pursuant to Section 3.2, shall be carried out in accordance with the procedures set out in Exhibit
F, which may be adjusted by mutual agreement of the Parties in writing, it being understood and agreed that the Process
will be transferred at the scale which it was used by BTGIL at the Rehovot Facility, namely; [redacted]. |
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8.2. |
To
assist in the transfer of the Technology, Savient shall provide to Scigen or the CMO on behalf of and with Scigen, the Process
Design Package which includes, inter alia, standard operating procedures and assays for analytical testing of the Product.
Savient shall also provide training for Scigen’s or the CMO’s scientific and technical teams, initially in Israel
and subsequently as is necessary at the Facility, and shall assist Scigen and/or the CMO on behalf of and with Scigen in the
use of the Process and the Technology at the Facility, all in accordance with said Exhibit F. |
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8.3. |
The
Parties hereby agree that the Technology shall be transferred by Savient and/or BTGIL to Scigen or the CMO on behalf of Scigen,
in accordance with the Timetable, it being understood and agreed that Savient’s ability to perform its obligations in
a timely manner is expressly contingent on the timely performance by Scigen or the CMO of all tasks that Scigen is responsible
to carry out, pursuant to this Agreement. In order to facilitate the coordination between the Parties, Scigen shall provide
Savient, within ten (10) days of the Effective Date, with a GANTT chart showing its timetable for the design, engineering,
construction, running-in, testing and Validation of the Process, to be updated on a quarterly basis until Validation of the
Process. |
| |
8.4. |
Save
as provided under Section 8.5, each Party shall be responsible for the travel and living expenses of its own personnel and
Savient shall not be responsible for the travel and living expenses of personnel of the CMO. |
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| |
8.5. |
Savient
shall devote up to [redacted] to rendering of technical assistance, training and guidance to, Scigen or the Indian CMO at
one or more of the Be’er Tuvia Facility, the Rehovot Facility and the Facility in India at Scigen’s direction.
Such technical assistance, training and guidance shall be rendered at such times as may be reasonably requested from time
to time by Scigen and mutually agreed by the Parties, provided, however, that the same shall be limited to [redacted] of Savient
and/or BTGIL personnel to the Facility. To the extent Savient and/or BTGIL personnel are requested to devote more than such
number of man-days at any location and to take additional trips, Savient shall use its best efforts to accommodate Scigen’s
request. Scigen shall, within thirty (30) days of Savient’s invoice therefor, compensate [redacted]. For purposes hereof,
“man-days” shall include travel time to and from locations in the Territory. Payments shall be made by wire transfer
and in U.S. Dollars to such bank account as Savient may designate from time to time during the Term. Scigen acknowledges and
agrees, that following the expiry of [redacted] from the Effective Date, neither Savient nor BTGIL shall have any further
obligation under this Section 8.5. |
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8.6. |
Without
derogating from the provisions of Section 6.2 above, Scigen and the CMO shall be responsible, inter alia, for those
matters relating to the Facility which are set forth in said Exhibit G. For the avoidance of doubt, nothing
in Exhibit G shall be construed as diminishing from any of Scigen’s obligations pursuant to this Agreement. |
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8.7. |
Scigen
shall keep Savient and cause the CMO to keep Savient currently informed about the Facility and its progress, including, without
limitation, the design, engineering construction, running-in, testing, validation and operation thereof and shall provide
Savient with written reports in reasonable detail and on a quarterly basis, including a GANTT chart reflecting the timetable
for the above. |
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| |
8.8. |
Scigen
undertakes to complete the Validation of the Process within [redacted] of receipt of the Process Design Package. |
9. Milestone
Payments; Consideration For Rights and Licenses
| |
9.1. |
The
following non-refundable, milestone payments are due to Savient as full and complete consideration for the rights and licenses
granted hereby, which rights and licenses are intended to replace and supersede the rights granted under the Prior Agreements: |
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|
9.1.1. |
[redacted],
receipt of which Savient hereby acknowledges; and |
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9.1.2. |
[redacted]
which shall be due and payable within seven (7) days of the Effective Date, unless the Effective Date is before November 24,
2004, in which case this sum shall be payable only on December 1, 2004. |
10. Royalties and Reporting
| |
10.1. |
Scigen
shall pay or cause to be paid to Savient during the Term a royalty at a fixed rate of [redacted] of Net Sales of Therapeutics
and [redacted] of Net Sales of other Products in the Territory (the “Royalties”). |
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10.2. |
Scigen
shall report to Savient in writing, within thirty (30) days of the end of each calendar quarter. Net Sales during such quarter
along with a calculation of the Royalties owed to Savient, broken down by types of Product (vaccines, Combination Vaccines
and Therapeutics) and country. Each such report shall be signed by Scigen’s Chief Financial Officer and accompanied
by payment of the amount due. |
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10.3. |
By
January 31st of each year during the Term, Scigen shall furnish Savient with a written statement certified by Scigen’s
Chief Financial Officer, containing Net Sales during the just ended calendar year. Savient shall have the right to request
certification of such statement, by an independent auditor. Savient shall be solely responsible for the cost of such auditor,
unless such auditor finds any material inaccuracy in the statement, in which case Scigen shall forthwith pay to Savient the
full cost of the independent auditor and any additional payment due under such auditor’s certification. |
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10.4. |
All
payments to be made to Savient pursuant to this Agreement shall be made in United States Dollars to such bank account as Savient
may direct from time to time during the Term. |
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| |
10.5. |
Scigen
shall keep and shall cause its Affiliates to keep true and complete records in accordance with generally accepted accounting
principles on Net Sales in relation to the Product. Such records shall contain sufficient detail to enable the determination
of any Royalty or other payment due to Savient hereunder. |
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10.6. |
Upon
reasonable written notice to Scigen, Savient, through its designated CPA, shall have access during normal business hours and
at Savient’s expense to all such records of Scigen and its Affiliates at the end of every calendar year and within the
period of three (3) years thereafter. |
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10.7. |
Savient’s
CPA shall report to Savient on such records only to the extent reasonably necessary to enable Savient to assess whether the
obligation of Scigen with respect to the maintenance of such records has been fulfilled and/or to determine the amount of
any Royalty or other payment due to Savient hereunder. The CPA shall be obligated to maintain the confidentiality of such
records. |
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10.8. |
Scigen
shall withhold and pay to the appropriate authorities in respect of any amount due to Savient as Royalties, any and all withholding
taxes imposed by any taxing authority. In such event, Scigen shall provide Savient with evidence of such withholding and payment.
All payments due herein shall otherwise be made without any set-offs or deductions of any nature. |
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10.9. |
Foreign
currency shall be converted into United States Dollars using an exchange rate equal to the exchange rate for the purchase
of United States Dollars, as reported by The Wall Street Journal, on the last day of the calendar quarter for which
the payment is due. |
11.
Representations and Warranties by Savient
| |
11.1. |
Scigen
acknowledges that it has been advised by Savient that [redacted]. |
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11.2. |
Savient
represents and warrants to Scigen as follows: |
| |
|
11.2.1. |
Savient
has all right, title and interest in and to the Vaccine, the Patent Rights, the Process and the Technology, which are free
and clear of any liens, charges, encumbrances or other security interests in the Territory; |
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11.2.2. |
[redacted];
and |
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11.2.3. |
The
Clone, shall be provided to Scigen in viable condition and shall be unchanged from that used in the Rehovot Facility. |
| |
11.3. |
EXCEPT
AS SPECIFICALLY SET FORTH IN SECTION 11.2, SAVIENT DISCLAIMS ALL OTHER EXPRESS AND IMPLIED WARRANTIES ON THE PRODUCT, PROCESS
AND THE TECHNOLOGY (AS SUCH TERMS ARE DEFINED IN SECTION 1 ABOVE). For the avoidance of doubt, Savient does not warrant that
the Process and the Technology shall enable Scigen to produce HBsAG meeting the Specifications, at the Facility. |
12. Representations.
Warranties and General Undertakings by Scigen
| |
12.1. |
Scigen
represents, warrants, guarantees and undertakes to Savient that: |
| |
|
12.1.1. |
Subject
to Section 11.2, Scigen is accepting the Process and the Technology “as is”; |
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|
12.1.2. |
Scigen
is responsible for the selection of the Facility and has or shall carefully examine Scigen’s and the CMO’s plans
for the Facility; |
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|
12.1.3. |
Scigen
is and shall be fully responsible for the adequacy of the Facility and shall ensure that the Facility shall be completely
appropriate for the purposes of this Agreement; and |
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|
12.1.4. |
Scigen
has, and any CMO shall have, the financial and technical resources in order to select, design, engineer, construct, validate,
test, run-in, operate and maintain the Facility, within the time frame indicated in Section 6.2 above, at its own expense,
and to carry out, inter alia, the responsibilities listed in Exhibit G. |
| |
12.2. |
Scigen
undertakes and guarantees to Savient as follows: |
| |
|
12.2.1. |
Scigen
shall comply, and shall ensure that the CMO complies, with the relevant terms of this Agreement; and |
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|
12.2.2. |
In
carrying out Scigen’s undertakings and responsibilities pursuant to this Agreement, Scigen shall comply, and shall ensure
that the CMO and/or Distributors comply, in all material respects, with all laws and regulations, licenses, permits, approvals
and procedures applicable in the Territory. |
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12.3. |
Scigen,
at its own expense, shall be responsible for obtaining and causing to remain in effect such licenses, permits, approvals,
and consents as may be required for its performance and responsibilities under this Agreement, and also those of any Distributor
and the Facility. Such licenses, permits, approvals and consents shall, wherever possible, be in Scigen’s own name. |
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12.4. |
Scigen
shall be responsible for the design, engineering, construction, validation, testing, running-in, operation and maintenance
of the Facility as illustrated in Exhibit G attached hereto and the CMO’s performance and responsibilities
in relation thereto. |
| |
12.5. |
Scigen
shall immediately report to Savient on: |
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|
12.5.1. |
any
material development coming to its attention which may, in any way, materially and adversely affect its performance under
this Agreement or the performance of the CMO under this Agreement or the Three-Way Agreement; and |
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|
12.5.2. |
any
breach by the CMO of the terms and conditions of this Agreement or any of its undertakings under the Three-Way Agreement;
and |
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12.5.3. |
any
adverse event alleged or known to be a result of the use of Product. |
13. Indemnification
| |
13.1. |
Scigen
shall assume responsibility for, and shall defend, indemnify and hold Savient, BTGIL and their Affiliates harmless against
and from any and all losses, claims, suits, proceedings, expenses (including reasonable attorneys’ fees and expenses
at trial and appellate levels), recoveries and damages, including costs and expenses of a total or partial Product recall
arising out of, based on or caused by, any claim of a third party relating to or resulting from any breach by Scigen (or any
employee, agent, contractor or Affiliate of one or more of Scigen or the CMO or a Distributor) of any of its obligations hereunder
including the representations, warranties, undertakings and guarantees of Section 12, or from the manufacture and/or supply
of Product by the CMO for Scigen, or from the supply of Product by Scigen to BERNA or to any other authorized licensee of
Savient who purchases Product from Scigen, or from the negligence or other wrongdoing of Scigen or any of the above, provided
that Scigen shall incur no obligation to defend, indemnify or hold Savient, BTGIL and their Affiliates harmless against and
from any liabilities resulting from a breach by Savient or BTGIL (or any employee, agent or contractor of Savient, or BTGIL
or their Affiliates) of any of their obligations hereunder or from Savient’s or BTGIL’s gross negligence or other
wrongdoing of Savient or BTGIL or their Affiliates (or any employee, agent or contractor thereof). |
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| |
13.2. |
In
no event shall Savient (or BTGIL or their Affiliates) be liable for any representation or warranty, express or implied, with
respect to the Product or the Technology which may have been made or given by Scigen or the CMO; or any Distributor; or any
employee, agent, or contractor of Scigen or of the CMO or of any Distributor, and which representation or warranty was not
specifically authorized by Savient in writing, and Scigen shall indemnify Savient and hold it harmless against and from any
liability, loss or expense resulting from any such representation or warranty. |
| |
13.3. |
Savient
shall promptly notify Scigen in writing of its receipt of notice of any claim or any actual or threatened legal action initiated
against Savient as to which this Section 13 applies. Savient shall cooperate with Scigen in the defense of the claim or action
and Scigen shall keep Savient informed of developments in such action. |
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13.4. |
In
the case of an action against Savient, BTGIL or their Affiliates to which this Section 13 applies, Scigen shall consult Savient
with respect to the choice of attorneys for the defense of the action, and furthermore, in addition to the attorneys selected
by Scigen to defend the action, Savient shall also be entitled to engage at its own expense its own attorneys to assist in
such defense. |
14. Prosecution
and Maintenance of Patent Rights; Infringement
| |
14.1. |
All
Patent Rights and Technology which are now or hereafter owned or licensed by Savient shall continue to be owned by Savient, |
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14.2. |
Savient
and only Savient, shall have the right, but not the obligation, to apply for additional patent(s) in respect of the Technology
and/or the Product, and any and all such patents as may be issued shall be the property solely of Savient. |
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| |
14.3. |
Savient
shall be solely responsible for and shall have the right, in Savient’s sole discretion, to prepare, file, prosecute,
maintain or to abandon any patent or patent application. |
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| |
14.4. |
Scigen
shall be responsible for ensuring that it is free to operate in the Territory and Scigen shall refrain from committing any
act, and shall ensure that the CMO does not commit any act, which Scigen has reason to believe, infringes upon an issued patent
in the Territory. It is understood and agreed that Savient does not hereby and will not warrant to Scigen or the CMO that
the Technology, the Process, the Product or, without limitation, manufacture, use or Marketing of the Product does not and
will not infringe any patent owned by a third party, and Savient shall have no responsibility whatsoever to defend against
any claim, suit and/or proceeding asserted or filed against Savient and/or Scigen and/or the CMO, a Distributor or their Affiliates
(or any employee, agent or contractor thereof). Scigen shall assume full responsibility for, and shall defend, indemnify and
hold Savient harmless against and from any and all such patent infringement suits filed by a third party directly or indirectly
in relation to the Product, the Process, the Technology or the Facility. |
15. Relationship of Parties
| |
15.1. |
Scigen
acknowledges that Savient has no obligation to supply Vaccine to Scigen. |
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| |
15.2. |
The
relationship between Scigen and Savient under this Agreement is that of licensor and licensee, and nothing contained in this
Agreement shall constitute either Party as the agent or representative of the other Party for any purpose whatsoever. |
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| |
15.3. |
In
particular, but without derogating from the generality of the foregoing, neither Party shall have any right to assume or create
any obligation, contract or commitment, expressed or implied, or make any representation, on behalf, or in the name, of the
other Party, and each Party shall indemnify and hold harmless the other Party against and from any liability arising from
any such act by such Party. |
16. Term and Termination
| |
16.1. |
Unless
earlier terminated pursuant to any provision of this Agreement, this Agreement shall remain in force on a country-by-country
basis in the Territory (the “Term”) until the date which is [redacted] after the date of commencement of
the first Royalty Year in respect of such country (each, a “License Period”). Upon expiry of the full term
of the first License Period having commenced, Scigen shall have the option, exercisable not less than thirty (30) days before
such date of expiry, to extend this Agreement in respect of all the countries not previously removed from the scope of the
Territory (each as from the respective date of expiry) for an [redacted] by payment to Savient of a one-time lump sum payment
of [redacted]. Royalties will continue to be payable for the duration of the extended License Periods. |
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| |
16.2. |
Provided
that the license has been in effect for, and elapsed after, a [redacted] License Period with respect to a country in the Territory,
Scigen shall thereafter have a royalty-free license to Market in such country and when all the License Periods have expired
in each country in the Territory, a royalty-free license to manufacture the Product in India and the PRC. |
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| |
16.3. |
Except
as provided in Section 16.2, upon expiration or termination of this Agreement, Scigen and the CMO shall immediately cease
the manufacture, marketing, sale and distribution of Vaccine and/or Product (as the case may be) and shall return to Savient
all Technology and other Confidential Information in their possession, including the Clone and all clones derived therefrom.
Upon the expiration or termination of this Agreement, Scigen shall, at Savient’s request, promptly assign to Savient
or Savient’s nominee, any application for Regulatory Approval theretofore made in the Territory, or any Regulatory Approval.
If any application cannot be so transferred or assigned, Scigen shall, at Savient’s request, actively continue to process
such application and shall assign such Regulatory Approval when received, and Savient shall reimburse Scigen for its reasonable
out-of-pocket expenses. Once transferred, Scigen will not retain any residual rights to any such application or Regulatory
Approval. |
| |
16.4. |
Savient
shall have the right to terminate this Agreement by written notice to Scigen if Scigen should: |
| |
|
16.4.1. |
be
declared bankrupt or insolvent, or request or suffer the appointment of a receiver for its assets, or make a composition with
its creditors or take or suffer any similar action in consequence of debt; |
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|
|
|
| |
|
16.4.2. |
fail
to make any payment due Savient under this Agreement for a period of forty-five (45) days following notice from Savient that
such payment is due; |
| |
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| |
|
16.4.3. |
fail
to prevent the Technology from being transferred without Savient’s and the OCS’ prior written consent; |
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| |
|
16.4.4. |
fail
to prevent the manufacture and Marketing of the Product outside the Territory in contravention of any provision hereof; |
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|
| |
|
16.4.5. |
fail
to prevent the continued production of Product that is not in accordance with the Specifications; or |
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|
|
|
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|
16.4.6. |
otherwise
breach any material provision of this Agreement and fail to cure such breach within sixty (60) days after Savient gives notice
of such breach to Scigen. |
| |
16.5. |
Scigen
shall have the right to terminate this Agreement by written notice to Savient if Savient should: |
| |
|
16.5.1. |
be
declared bankrupt or insolvent, or request or suffer the appointment of a receiver for its assets, or make a composition with
its creditors or take or suffer any similar action in consequence of debt; or |
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|
|
|
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|
16.5.2. |
breach
any material provision of this Agreement and fail to cure such breach within sixty (60) days after Scigen gives notice of
such breach to Savient. |
| |
16.6. |
No
Party shall be entitled to any compensation upon, or by reason of, the expiration or termination of this Agreement for any
reason, other than for the material breach of this Agreement by the other Party, except that each Party shall be entitled
to collect any debt then owed to it by the other Party or the CMO, or an Affiliate or a Distributor and shall have any rights
that this Agreement provides upon termination. |
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|
|
| |
16.7. |
Scigen
shall have the right to terminate this Agreement if OCS Approval has not been attained within a reasonable period of time.
Scigen shall render written notice that it wishes to terminate. The Parties shall meet within thirty (30) days of such notice,
and discuss how to expedite OCS Approval. If the Parties do not reach agreement, then Scigen may exercise such right by giving
ninety (90) days written notice, at any time following the meeting, upon the expiration of which this Agreement shall terminate.
If OCS Approval is attained by or before the expiry of said ninety (90) day notice period, then this Agreement shall not be
terminated, Section 2.1 will apply and this Agreement shall go into force and effect. |
17. Force
Majeure
| |
17.1. |
Each
Party shall be relieved of its obligations under this Agreement to the extent that fulfillment of such obligations shall be
prevented by strikes, embargoes, riots, fires, floods, war, hurricanes, windstorms, acts or defaults of common carriers, governmental
laws, acts or regulations, contamination, shortages of materials or any other occurrence, whether or not similar to the foregoing,
beyond the reasonable control of the Party whose performance is affected thereby. |
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|
|
| |
17.2. |
If
any Party is prevented from fulfilling its obligations under this Agreement by reason of a circumstance covered by this Section
17, the Party unable to fulfill its obligations shall, upon the occurrence of any such circumstance, promptly notify the other
Parties of such circumstance and of the likely duration thereof, use its reasonable commercial efforts to alleviate each circumstance
and promptly continue performance hereunder upon the cessation of such circumstance. |
18. Confidentiality
| |
18.1. |
Commencing
on the Signature Date, during the Term and at all times thereafter, each of Savient and Scigen shall retain in strict confidence
all Confidential Information obtained from the other pursuant to, or in connection with, this Agreement. Neither Party shall
disclose any Confidential Information of the other to any person, firm or corporation, including Affiliates or any other third
party. Neither Party shall use any such Confidential Information for any purpose not contemplated by this Agreement. |
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|
|
| |
18.2. |
Notwithstanding
the foregoing, each of the Parties may disclose Confidential Information of the other: |
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|
18.2.1. |
to
its, or its Affiliates, directors, officers, employees and consultants, to the extent, if any, required for the performance
of their duties in connection with this Agreement, provided each such person is individually and personally obligated in writing
to comply with confidentiality undertakings no less stringent than the provisions of this Section 18; |
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|
|
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|
18.2.2. |
to
the extent necessary to obtain Regulatory Approvals; |
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|
|
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|
18.2.3. |
to
the extent reasonably required to obtain or defend Patent Rights in the Territory; or |
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|
|
|
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|
18.2.4. |
to
the extent required by law, regulation or judicial order, provided that prior to disclosure pursuant to this clause the disclosing
Party gives to the other Party prompt notice of such required disclosure and fully cooperates with such Party’s efforts
to obtain a protective order or other appropriate remedy; and provided further that any such disclosure shall be in writing,
shall, to the extent possible, be designated confidential at the time of disclosure, and shall be held by the recipient in
accordance with the provisions of this Section 18. |
| |
18.3. |
The
obligations of nondisclosure and nonuse pursuant to this Section 18 shall not apply to any Party with respect to any Confidential
Information of the other Party that such Party can establish by written record: |
| |
|
18.3.1. |
was
known to such Party prior to the disclosure thereof by the other Party; or |
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|
|
|
| |
|
18.3.2. |
was
in the public domain prior to the disclosure thereof to such Party or subsequently entered the public domain by some means
other than as a result of a breach of this Agreement by such Party; or |
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|
|
|
| |
|
18.3.3. |
was
subsequently disclosed to such Party by a third party having a lawful right to make the disclosure. |
19. Limitation on Remedies
Except
as specifically set forth herein, no Party shall be liable to the other Party under any circumstances for any special, indirect,
incidental or consequential damages, lost profits, business interruption losses, or loss of business relationships.
20. Governing
Law; Litigation
| |
20.1. |
This
Agreement shall be governed by, and construed in accordance with, the laws of the State of New Jersey, United States of America,
without regard to the conflicts of laws provisions therein. |
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|
|
| |
20.2. |
Scigen
hereby irrevocably submits to the jurisdiction of the federal courts and the state courts of the State of New Jersey with
respect to any legal proceedings in connection with this Agreement, confirms that the service of process out of such courts
and delivered by certified mail or courier, fees prepaid, shall be deemed to be service upon Scigen for purposes of such legal
proceedings; waives any objection it may have that such legal proceedings have been brought in an inconvenient forum; and
agrees to produce witnesses, in New Jersey which are reasonably identified by Savient for depositions or as witnesses at trial.
All such proceedings shall be conducted in the English language. |
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|
|
| |
20.3. |
Nothing
contained herein shall bar Savient from applying to any court for injunctive relief to prevent the breach or threatened breach
of the provisions hereof. Without derogating from the generality of the foregoing, Scigen hereby consents to the jurisdiction
of such country or countries in which Scigen elects to bring suit and to the entry of an injunction in favor of Savient preventing
the manufacture, Marketing of Product and the use of the Technology, including the Clone, and all clones derived therefrom,
the Process and other Confidential Information. |
21. Insurance
| |
21.1. |
Scigen
shall maintain and keep in force for the Term of this Agreement comprehensive “all risks” general liability insurance,
covering third party liability, employers’ liability (and extending to “all risks” construction operations)
and completed operations, contractual and broad form property damage and bodily injury and Scigen’s indemnification
obligations hereunder. Such insurance shall have a limit which is the lower of [redacted] United States Dollars [redacted]
per annum combined single limit for property damage and bodily injury or the maximum amount of insurance cover that Scigen
can get using its best efforts. Such insurance shall be placed with a first class insurance carrier with at least a BBB rating
by Standard & Poors. Such policies shall include: (i) Savient, BTGIL and Affiliates as co-insured; (ii) a “Cross
Liability” clause; (iii) waiver by the insurer, of any right of subrogation against any of the named insured including
any of their employees and/or anyone acting on their behalf; (iv) cover the liability of any individual employed by or acting
on behalf of the insured; and (v) an express condition pursuant whereto such insurance shall not expire or be cancelled or
modified without at least thirty (30) days prior written notice to Savient. Promptly after execution and delivery of this
Agreement, Scigen shall furnish a certificate of insurance evidencing the foregoing coverage and limit. |
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21.2. |
Employers’
liability insurance shall cover any employee of any kind. |
22. Notices
| |
22.1. |
All
notices and other communications required or desired to be given or sent by one Party to the other Party shall be in writing
and shall be deemed to have been given: (a) on the date of delivery, if delivered to the persons identified below, (b) five
(5) business days after mailing if mailed, with proper postage, by certified or registered mail, postage prepaid, return receipt
requested, addressed as set forth below, (c) on the date of receipt if sent by telecopy, and confirmed in writing in the manner
set forth in (b) on or before the next day after the sending of the telecopy, or (d) three (3) business days after delivery
to a nationally recognized overnight courier service marked for overnight delivery, as follows: |
If
to Scigen:
Scigen
Ltd.
152
Beach Road
Suite
2607/08
Singapore
189721
Attn:
Executive Vice Chairman
Telecopier:
+ 65 6779 3784
Telephone:
+ 65 6779 6638
With
a copy (that will not constitute notice) to:
Larkin
Hoffman Daly & Lindgren Ltd.
1500
Wells Fargo Plaza
7900
Xerxes Avenue South
Minneapolis,
Minnesota 55431-1194
USA
Attn:
Todd I. Freeman
Telecopier:
+ 1 952-842-1713
if
to Savient:
Savient
Pharmaceuticals Inc.
146
Floor
One
Tower Center
East
Brunswick, NJ 08816
Attn:
CEO
Telecopier:
+ 732-418-9011
Telephone:
+ 732-565-4705
With
a copy (that will not constitute notice) to:
Bio-Technology
General (Israel) Ltd.
Kiryat
Weizmann
Building
17
Rehovot
76326, Israel
Attn:
General Manager
Telecopier:
+ 972 8 9409041
and
Baratz,
Bar-Nathan, Horn & Co.
1
Azrieli Center
Round
Tower, 18th floor
Tel-Aviv
67021
Israel
Attn:
Yael Baratz
Telecopier:
+ 972 3 6960986
or
to such other address as may be designated by notice; provided that any notice of change of address shall be effective only upon
receipt.
23. Miscellaneous
| |
23.1. |
Any
payment not received when due shall bear interest from the due date at the rate of [redacted] per month (or such other percentage,
if lower, as shall not exceed the maximum rate permitted by law). |
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|
|
| |
23.2. |
This
Agreement, together with the exhibits attached hereto, constitutes the entire agreement between the Parties with respect to
Savient and BTGIL’s HBsAg-based technology, know-how and products in any form, and supersedes all prior understandings,
agreements and discussions between them and/or their Affiliates, oral or written, with respect to such subject matter. |
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|
| |
23.3. |
This
Agreement shall not be modified or amended except by a written instrument referencing this Agreement signed by the Parties
hereto. |
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|
|
| |
23.4. |
No
Party shall assign its rights or obligations under this Agreement, either in whole or in part, without the prior written consent
of the other Party except to a party acquiring all of the assigning Party’s business to which this Agreement relates.
Notwithstanding the foregoing, Savient may assign any of its rights and obligations to BTGIL, provided that Savient remains
responsible for the performance of any such obligations. |
| |
|
|
| |
23.5. |
This
Agreement has been prepared jointly and shall not be strictly construed against either Party. |
| |
23.6. |
No
waiver or failure to act, with respect to any breach or default under this Agreement, whether or not the other Party has notice
thereof, shall be deemed to be a waiver with respect to any subsequent breach or default, whether of a similar or different
nature. |
| |
|
|
| |
23.7. |
Those
provisions of this Agreement which are intended to survive the termination, expiration or nullification of this Agreement,
including, without limitation, the provisions of Sections 2, 3.4, 6.3, 10.5, 10.6, 13, 14.4, 15, 16.2, 16.3, 16.6, 18, 19,
20, 22, 23.1, 23.4, 23.6, 23.7, 23.8, 23.11 and 23.12 shall so survive and shall be enforceable according to the terms set
forth herein. |
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|
|
| |
23.8. |
The
provisions of this Agreement are severable. The invalidity, in whole or in part, of any provision of this Agreement shall
not affect the validity or enforceability of any other of its provisions. If one or more provisions hereof shall be declared
invalid or unenforceable, the remaining provisions shall remain in full force and effect and shall be construed in the broadest
possible manner to give effect to the purposes hereof. The Parties further agree to replace such void or unenforceable provisions
of this Agreement with valid and enforceable provisions which will achieve, to the extent possible, the economic, business
and other purposes of the void or unenforceable provisions. |
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23.9. |
The
Parties will execute and deliver such other instruments and take such other steps as may be necessary to fully effect this
Agreement. |
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|
|
| |
23.10. |
The
Parties agree that press releases and other public communications of any sort relating to this Agreement or the matters contemplated
hereby are subject to the approval of both Parties hereto, such approval not to be unreasonably withheld; provided, however,
that Savient and Scigen may make such public communications as may be required of them as a publicly traded corporation in
the United States of America in the case of Savient and Australia in the case of Scigen, and/or any other country in which
either of the Parties is listed as a publicly-traded company on a recognized stock exchange. |
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|
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23.11. |
Nothing
in this Agreement, express or implied, is intended to confer on any person other than the Parties hereto, or their respective
permitted successors and assigns, any benefits, rights or remedies. All titles and article headings contained in this Agreement
are inserted only as a matter of convenience and reference. They do not define, limit, extend or describe the scope of this
Agreement or the intent of any of its provisions. |
[INTENTIONALLY
LEFT BLANK]
| |
23.12. |
Neither
Scigen nor Savient shall settle or compromise any claim or action in a manner that imposes any material restrictions or obligations
on the other Party without such other Party’s prior written consent, which consent shall not be unreasonably withheld. |
IN
WITNESS WHEREOF, Savient and Scigen are duly authorized for themselves and their Affiliates and have caused this Agreement
to be executed by their duly authorized representatives as of the dates written below.
SCIGEN
LTD.
| By:
|
Signed
“Saul Mashaal” |
|
| |
Saul
Mashaal |
|
| Title:
|
Executive
Vice Chairman |
|
| Date: June 2nd, 2004 |
|
SAVIENT
PHARMACEUTICALS INC.
| By:
|
Signed
“Sim Faas” |
|
| |
Sim
Fass |
|
| Title:
|
Chairman
& CEO |
|
| Date: June 3, 2004 |
|
List
of Exhibits
| A |
Marketing
Plan |
| B |
Patents |
| C |
Process
Design Package |
| D |
Specifications |
| E |
Territory |
| F |
Procedure
and Timetable for Transfer of Technology |
| G |
Responsibilities
with respect to the Facility |
EXHIBIT
A
[Redacted]
EXHIBIT
B
[Redacted]
EXHIBIT
C
[Redacted]
EXHIBIT
D
[Redacted]
EXHIBIT
E
[Redacted]
EXHIBIT
F
[Redacted]
EXHIBIT
G
[Redacted]
AMENDMENT
TO LICENSE AGREEMENT
This
amendment (the “Amendment”) to that certain License Agreement of June 2004 (the “Agreement”) by and between
SAVIENT PHARMACEUTICALS, INC. (f/k/a BIO¬TECHNOLOGY (GENERAL) CORP.), a Delaware corporation, having a place of business at
14th Floor, One Tower Center, East Brunswick, New Jersey 08816, USA (“Savient”) and SCIGEN LTD., a public company
incorporated under the laws of Singapore, having a place of business at 152 Beach Road, Suite 26-07/08, Gateway East, Singapore
189721 (“Scigen”) is effective the 24th day of January, 2005.
PREMISES
WHEREAS,
Savient and Scigen entered into the Agreement, a copy of which is attached hereto as Exhibit A, wherein Savient granted Scigen
certain rights and licenses with regard to the manufacture, marketing, sale and distribution of “Product,” as defined
in said Agreement;
WHEREAS,
Savient is a party to a Technology Transfer Agreement dated March 14, 2002 as amended on October 31, 2003 (the “Technology
Transfer Agreement”) with Berna Biotech Ltd., a corporation organized under the laws of Switzerland, having a place of business
at Reahag Strasse 79, 3018, Bern, Switzerland (“Berna”) whereby Savient agreed to supply Berna with certain specified
amounts of Vaccine (as defined in the Technology Transfer Agreement) and the exclusive right and license to promote, market, sell
and distribute the vaccine in countries specified in the Technology Transfer Agreement;
WHEREAS,
neither Savient nor any of its facilities are currently manufacturing the Vaccine, nor does Savient anticipate that it will be
able to supply Vaccine to Berna in the foreseeable future;
WHEREAS,
Savient and Berna have agreed to terminate the Technology Transfer Agreement at the same time as this Amendment;
WHEREAS,
Savient and Scigen wish to amend the Agreement to grant Scigen the exclusive right to supply Product to Berna for the promotion,
marketing, sale and distribution in such countries of the Territory as determined by Scigen in its sole discretion and expand
the Territory as currently set forth on Exhibit E to the Agreement in which Scigen may appoint distributors for the Product;
WHEREAS,
Savient and Scigen wish to amend the Agreement to grant Scigen the exclusive right to supply Product to Berna and expand the Territory
as currently set forth on Exhibit E to the Agreement in which Scigen may appoint distributors for the Product;
WHEREAS,
Scigen and Intercell AG, a corporation organized under the laws of Austria, having a place of business at Campus Vienna Biocenter
6, A-1030, Vienna, Austria (“Intercell”) intend to engage in collaborative research, development, manufacturing and
commercialization activities with respect to a new vaccine product (a “Collaboration Vaccine Product”, as more fully
defined in this Amendment);
WHEREAS,
in order to enable Intercell and Scigen to pursue the collaboration as required to develop a Collaborative Vaccine Product, it
will be necessary to make amendments to the Agreement, as more fully set forth in this Amendment, to allow such development pursuant
the related Intercell and Scigen agreement (the “Collaborative Agreement); and
WHEREAS,
Scigen has requested and Savient has agreed to amend the Agreement in connection with other matters as more fully set forth below;
NOW,
THEREFORE, in consideration of the mutual promises and covenants contained herein, the Parties hereby agree as follows:
1.) Amendment
of Section 1 - Definitions.
| |
(a) |
Section
1.10 is hereby deleted and replaced with the following: |
| |
|
|
| |
|
“1.10
“Combination Vaccine” means (i) a vaccine containing portions of two or more separate vaccines, in all
cases including the Product; or (ii) any product containing both (x) the Product and (y) one or more other active agents,
toxins, radioisotopes or other active ingredients, which for the purposes of this Agreement, shall include only Intercell’s
IC31 adjuvant and not any other adjuvant, which do not by themselves constitute Products, and which are components of the
Combination Vaccine whether packaged separately but sold together or packaged and sold together. For the avoidance of doubt,
(A) the term “Combination Vaccine” includes the Collaboration Vaccine Product,” and (B) while a “Combination
Vaccine” (including the Collaboration Vaccine Product) contains the Product, a “Combination Vaccine” (including
the Collaboration Vaccine Product) shall not itself be deemed a “Product” for purposes of this Agreement. |
| |
|
|
| |
(b) |
Section
1.18 is hereby amended by adding the words “and a Combination Vaccine” at the end of such Section. |
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|
|
| |
(c) |
Section
1.24 is hereby deleted and replaced with the following: |
| |
|
|
| |
|
“1.24
“Net Sales” means the ex-works selling price for Product (in bulk or in its final presentation) or Combination
Vaccine (calculated as set forth below) invoiced and collected by Scigen, or an Affiliate or designee of Scigen or a Sub-Licensee,
for the first sale of such Product or Combination Vaccine to a third party, as established in a bona fide arms’ length
transaction between Scigen or an Affiliate or designee of Scigen or Sub-Licensee and such third party. Net Sales shall also
include the fair market value of Product transferred by Scigen to related parties for onward sale or use or on consignment.
Net Sales shall specifically exclude: (i) the fair market value of amounts of Product actually used in clinical trials to
develop and obtain regulatory approval for Collaboration Vaccine Product; and (ii) the fair market value of amounts of Product
actually used by Scigen or its contractors for product testing which is specifically required by a regulatory authority in
the Territory and/or used by Scigen as product samples for which no consideration is paid, provided the quantity of Product
actually utilized for purposes of such clinical trials and product testing and/or product samples shall not exceed in the
aggregate for all of these purposes ten percent (10%) of annual Product sales during any given Royalty Year during this Agreement.
With respect to Net Sales of Combination Vaccine, for which no royalty has previously been paid to Savient on Product used
in the manufacture of such Combination Vaccine, and for which the Product and each of the other active agents or active ingredients
not constituting Products have established market prices when sold separately (market prices as to Product being defined as
the ex works price charged by Scigen, its Affiliates or Sub-Licensees as manufacturers, or in the case of other active agents
or active ingredients being defined as the ex works price charged by the manufacturer, in a direct arms length sale to a third
party), Net Sales shall be determined by multiplying the sales price for each Combination Vaccine by a fraction, the numerator
of which shall be the established market price for the Product contained in the Combination Vaccine and the denominator of
which shall be the sum of the established market prices for the Product plus the other active agents or active ingredients
contained in the Combination Vaccine. To the extent that this formula is inapplicable at any particular time, the Parties
shall discuss and agree in good faith upon a fair and equitable method of calculating Net Sales for the Combination Vaccine
in question.” |
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(d) |
Section
1.28 is hereby deleted and replaced with the following: |
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|
|
| |
|
“1.28
“Patent Rights” means Savient’s patent rights in patents directed to the manufacture of HBsAg, as
listed in Exhibit B which is attached hereto and made a part hereof and any other patents and patent rights
of Savient that would, but for the license granted herein, be infringed by the manufacturer, use, sale, offer for sale or
import of Product or Combination Vaccine, as well as any reissues, supplementary protection certificates and extensions of
such patents.” |
| |
|
|
| |
(e) |
Section
1.33 is hereby deleted and replaced with the following: |
| |
|
|
| |
|
“1.33
“Product” means HBsAg, either in bulk or Formulated, meeting the Specifications, to be manufactured by
Scigen or CMC or a Sub-licensee and for sale by Scigen or Sublicensee as Hepatitis B virus vaccine, but is not the Vaccine.
“Product” shall include, but not be limited to, HBsAg for sale as a Therapeutic or as part of a Combination Vaccine. |
|
|
|
| |
(f) |
Section
1.42 is hereby deleted and replaced with the following: |
| |
|
|
| |
|
“1.42
“Technology” means the Clone, know-how, and information which relates to the manufacture of Vaccine, which
shall include all trade secrets generally disclosed in the Process Design Package, including, without limitation, manufacturing
procedures, the Specifications, standard operating procedures or protocols for the Process and the analytical tests and quality
control and testing procedures and validation protocols and expertise applied to the manufacture of the Vaccine, and information
and data relating to the attempt to transfer the Process to the Be’er Tuvia Facility; provided, however that it shall
not include (i) detailed design, engineering services, construction or adaptation of the Facility; (ii) supervision
of any of the aforementioned activities; (iii) procurement or compliance with local standards and requirements; (iv) programs
for the running-in and operation of the Facility; (v) validation and related standard operating procedures for the Facility;
(vi) any scale changes at the Facility or work flowing from such changes; or (vii) the transfer of the Product into any receptacle
other than bottles and into vials from bottles.” |
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|
|
| |
(g) |
Section
1.45 is hereby deleted and replaced with the following: |
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|
|
| |
|
“1.45
“Therapeutic” means Product or Combination Vaccine for use against infections caused by the Hepatitis B
virus.” |
| |
(h) |
Section
1.51 is hereby added to read as follows: |
| |
|
|
| |
|
“1.51
“Collaborative Agreement” means the agreement entered into between Scigen and Intercell for the development
of a Collaborative Vaccine Product.” |
| |
|
|
| |
(i) |
Section
1.52 is hereby added to read as follows: |
| |
|
|
| |
|
“1.52
“Collaboration Vaccine Product” means a Therapeutic vaccine based on HBsAg and one or more other components
such as Intercell’s IC31adjuvant, which vaccine is developed by Intercell and Scigen in the course of their collaboration.” |
| |
|
|
| |
(j) |
Section
1.53 is hereby added to read as follows: |
| |
|
|
| |
|
“1.53
“Intercell” means Intercell AG, a corporation organized under the laws of Austria having a place of business
at Campus Vienna Biocenter 6, A-1030, Vienna, Austria.” |
| |
|
|
| |
(k) |
Section
1.54 is hereby added to read as follows: |
| |
|
|
| |
|
“1.54
“Sub-Licensee” means any party, other than an Affiliate, including, without limitation, collaborators,
development or commercialization partners, a Distributor, sales and marketing or other form of agent, assignee or similar
party to whom Scigen has sublicensed any of its rights hereunder to manufacture, import, export, distribute, market or sell
Product.” |
2.) Amendment
of Section 3 - License Grant.
| |
(a) |
The
entirety of Section 3.1 (including all subsections) is hereby deleted and replaced with the following: |
“3.1
Savient hereby grants to Scigen the following rights, and only for the Licensed Indications:
3.1.1
the exclusive right and license to Market Product in the Territory;
3.1.2
the right to sublicense, subject to the conditions set forth in Section 7, one or more Distributors (including Affiliates of Scigen)
or other Sub-Licensees to Market Product in the Territory under the exclusive license granted pursuant to the preceding Section
3.1.1;
3.1.3
the exclusive right and license (a) to utilize the Technology and other Confidential Information disclosed by Savient and/or BTGIL
hereunder, and (b) under the Patent Rights, for the purpose of manufacturing, or having manufactured. Product as provided by Section
3.2 below, at one Facility in India and at one Facility in the PRC (subject to the conditions set forth in Sections 3.3 and 6
below); (ii) the exclusive right and license (x) to utilize the Technology and other Confidential Information so disclosed by
Savient and/or BTGIL hereunder, and (y) under the Patent Rights, for the purpose of manufacturing, or having manufactured. Product
in other facilities and countries throughout the Territory, subject to the provisions of Section 23.13 below, (iii) to use, sell,
offer to sell and import Product manufactured by Scigen in accordance with this Agreement, in the Territory, for use in Combination
Vaccines; and (iv) to sublicense any of the rights granted to Scigen hereunder to Sub-Licensees, subject to the applicable terms
and conditions of this Agreement; and
3.1.4
the exclusive right and license to sell Product to BERNA for resale in the territory awarded by Scigen to BERNA in an agreement
between such parties (“Berna Territory”) and to appoint BERNA as a Distributor of Product in the Berna Territory.”
| |
(b) |
Sections
3.5, 3.6 and 3.7 are hereby added to read as follows: |
“3.5
Notwithstanding anything to the contrary in this Agreement, including, without limitation, anything else wherein this Section
3 and only to the extent necessary to manufacture and commercialize the Collaboration Vaccine Product and Therapeutic, in the
event, during the term of the Collaborative Agreement, of (i) any termination or failure to extend this Agreement, or (ii) an
uncured breach by Scigen, not accompanied by a breach by Intercell, of its obligations under the Collaborative Agreement or such
other agreement between Scigen and Intercell to supply Product for use in connection with the Collaboration Vaccine Product that
remains uncured for the period granted under such agreements for cure, the breach and cure of which was not rightfully contested
in writing by Scigen, then Intercell shall have the right, to be exercised by written notice to be provided to Savient and Scigen
within sixty (60) days of such event, to assume Scigen’s rights and obligations on a co-exclusive basis with Scigen under
this Agreement. In the event Intercell exercises such right, (a) Intercell shall be deemed a party to this Agreement in addition
to Scigen and Intercell and Savient shall, as soon as practicable, enter into a confirmatory separate agreement containing the
same terms and conditions of this Agreement that are relevant to the relationship contemplated herein; (b) Intercell shall be
entitled to all the rights and benefits (and subject to all the obligations) of Scigen under this Agreement only to the extent
necessary to manufacture and commercialize the Collaboration Vaccine Product and Therapeutic; and (c) any termination of this
Agreement shall be deemed effective only as against Scigen and this Agreement shall be effective, and shall be deemed to have
remained effective without interruption, as to Intercell. In such event, Savient specifically consents to any such assignment
and assumption of Scigen’s rights and obligations under this Agreement by Intercell, without the requirement of a novation,
and Savient hereby grants to Scigen all rights required to (x) enable Scigen transfer to Intercell the Process, the Clone (and
any derivatives) and any other Technology, and any and all related Confidential Information, and other relevant information, data
and materials, subject to Section 23.13 below; (y) enable Scigen to provide to Intercell such consulting services, in each case
as reasonably required by Intercell to exercise all of its rights under this Agreement.
3.6
Nothing contained in this Agreement, or in the definition of the terms “manufacture,” “produce or production”
as used in this Agreement, shall be deemed to in any way restrict Scigen or a third party, subject to Section 23.13 below, engaged
by Scigen on Scigen’s behalf from formulating Formulated Product and filling and packaging commercial containers for Product
from bulk Product, or using Product in the manufacture of Combination Vaccine, anywhere in the world, without restriction.
3.7
The Parties agree and acknowledge that the Process and any Technology, Confidential Information and related information, data
and materials provided to Scigen under this Agreement are specific to the Product and its manufacture, marketing, sale and distribution
and do not relate to, and consequently no restrictions, subject to Section 23.13 below, shall apply hereunder with respect to
other products (including products using the Product, such as Combination Vaccine) and the manufacture thereof.”
3.) Amendment
of Section 4 - Regulatory Approvals.
| |
(a) |
Section
4.3 is hereby deleted and replaced with the following: |
“4.3
Scigen shall diligently initiate the process of obtaining Regulatory Approval of the Product in countries within the Territory
as both a vaccine and a Therapeutic, as soon as possible and, in any event, within [redacted] of the Triggering Date for the vaccine
and within [redacted] of the Triggering Date for the Therapeutics. In the event that Scigen has not diligently initiated any steps
to commence the process of obtaining Regulatory Approval of the Product in any particular country in the Territory within the
relevant time period or does initiate but fails to obtain Regulatory Approval of the Product as a vaccine in any country within
[redacted] of the Triggering Date and within [redacted] of the Triggering Date with respect to Therapeutics, Savient shall have
the right, at its full discretion, to convert the right and license granted to Scigen in respect of the Product under Sections
3.1.1. and 3.1.2. above from exclusive to non-exclusive with respect to such country as to a vaccine and/or a Therapeutic (to
the extent that Regulatory Approval has not been obtained) by written notice to Scigen. Notwithstanding the foregoing, should
Scigen be making demonstrable, good faith, best efforts to obtain such Regulatory Approval, Savient shall refrain from taking
any action pursuant to this Section 4.3, for as long as Scigen continues diligently to prosecute such Regulatory Approval.”
| |
(b) |
Section
4.6 is hereby added to read as follows: |
“4.6
For the avoidance of doubt, Sections 4.1 through 4.5 and Section 16.3 do not apply to, and nothing in this Agreement shall create
any rights or obligations with respect to, regulatory approvals (and any related information, data or materials) relating to Collaboration
Vaccine Product. Notwithstanding the foregoing, in lieu of the diligence and other obligations required under this Section 4,
Intercell and Scigen will exercise commercially reasonable efforts to develop and commercialize Collaboration Vaccine Product.
All diligence obligations under this Section 4 shall be deemed satisfied as a result of the foregoing.”
4.) Amendment
of Section 5 - Marketing.
| |
(a) |
Section
5.2 is hereby deleted in its entirety and replaced by the following: |
“5.2
Following receipt of Regulatory Approval of the Product in each country in the Territory, Scigen will commence commercialization
thereof promptly by diligently taking all steps reasonably required to Market Product in such country. If Scigen’s sales
of Product, in any particular country in the Territory do not reach the Minimum Quantity during any [redacted] period following
receipt of Regulatory Approval for the Product therein, the right and license granted to Scigen under Sections 3.1.1 and 3.1.2
above shall [redacted]. Should Scigen’s sales of Product in such country fail to reach the Minimum Quantity during any [redacted]
period following such conversion, Savient shall have the right to remove such country from the scope of the Territory, by written
notice to Scigen. In such event Intercell shall have the right to assume Scigen’s rights and obligations hereunder in respect
of such country to the extent necessary to manufacture and commercialize the Collaboration Vaccine Product and Therapeutic therein,
and the provisions of Section 3.5 shall apply, mutatis mutandis.
| |
(b) |
Section
5.3 is hereby deleted in its entirety. |
5.) Amendment
of Section 7 - Distributors. Section 7.1.2 is hereby deleted in its entirety.
6.) Amendment
of Section 8 - Technology Transfer.
| |
(a) |
Section
8.2 is hereby deleted in its entirety and replaced by the following; |
“8.2
If in the course of the implementation of Exhibit F (the “Work Plan”), Scigen’s representative(s) direct a change
in the work, Savient shall have no responsibility for the resulting impact of such changes, notwithstanding any other provision
of this Agreement.”
| |
(b) |
Section
8.3 is hereby deleted in its entirety. |
| |
(c) |
Section
8.5 is hereby deleted and replaced with the following: |
“8.5
Savient shall devote up to [redacted] man-days in rendering technical assistance to Scigen as provided in the Work Plan attached
hereto as Exhibit F. Notwithstanding anything to the contrary that may be inferred from any provision of the Agreement, Savient
shall not be liable to render any technical services to Savient or the CMO or any Sub-Licensee at any time other than as provided
under said Exhibit F. To the extent Savient and/or BTGIL personnel do devote more than the number of man days or trips set out
in Exhibit F to rendering technical services to Scigen, Scigen shall, within thirty (30) days of Savient’s invoice therefor,
compensate Savient and/or BTGIL for excess man-days and trips, at the rate of US Dollars [redacted] per day, per person and reimburse
Savient and/or BTGIL’s personnel’s direct travel, lodging and other travel related expenses for such excess days and/or
trips. For purposes hereof, “man days” shall include travel time to and from locations in the Territory. Payments
shall be made by wire transfer and in U.S. Dollars to such bank account as Savient may designate from time to time. Nothing in
the Work Plan or in any additional technical assistance that may be rendered by Savient or BTGIL pursuant to the Agreement shall
be construed as changing the scope of Savient’s representations and warranties, pursuant to Section 11, in any manner.
7.) Amendment
of Section 10 - Royalties and Reporting. Section 10.1 is hereby deleted and replaced with the following:
“10.1
Scigen shall pay or cause to be paid to Savient during the Term a royalty at a fixed rate of [redacted] percent [redacted] of
Net Sales (the “Royalties”).”
8.) Amendment
of Section 12.2.2 (Representations, Warranties and General Undertakings by Scigen) and Section 13.1 and 13.2
(Indemnification) - All references to a “Distributor” in these provisions are hereby changed to
“Sub-Licensee”.
9.) Amendment
of Section 14 - Prosecution and Maintenance of Patent Rights; Infringement.
| |
(a) |
Section
14.4 is hereby deleted and replaced with the following: |
“14.4
Scigen shall be responsible for ensuring that it is free to operate in the Territory and Scigen shall refrain from committing
any act, and shall ensure that the CMO and any Sub-Licensee do not commit any act, which Scigen has reason to believe, infringes
upon an issued patent in the Territory. It is understood and agreed that Savient does not hereby and will not warrant to Scigen
or the CMO or any Sub-Licensee that the Technology, the Process, the Product or, without limitation, manufacture, use or Marketing
of the Product does not and will not infringe any patent owned by a third party, and Savient shall have no responsibility whatsoever
to defend against any claim, suit and/or proceeding asserted or filed against Savient and/or Scigen and/or the CMO and/or a Sub-Licensee
or their Affiliates (or any employee, agent or contractor thereof). Scigen shall assume full responsibility for, and shall defend,
indemnify and hold Savient harmless against and from any and all such patent infringement suits filed by a third party directly
or indirectly in relation to the Product, the Process, the Technology or the Facility.”
| |
(b) |
Section
14.5 is hereby added to read as follows: |
“14.5
For the avoidance of doubt, nothing in this Agreement shall create in Savient any rights or obligation with respect to or otherwise
affect any patents or other intellectual or industrial property right relating to Collaboration Vaccine Product.”
10.) Amendment
of Section 16 (Term and Termination). Section 16.3 is hereby deleted and replaced with the following:
| |
(a) |
“16.3
Except as provided in Sections 3.5 and 16.2, upon expiration or termination of this Agreement, Scigen and the CMO and any
manufacturing Sub-Licensee shall immediately cease the manufacture, marketing, sale and distribution of Product and shall
return to Savient all Technology and other Confidential Information in their possession, including the Clone and all clones
derived therefrom. Upon the expiration or termination of this Agreement, Scigen shall, at Savient’s request, promptly
assign to Savient or Savient’s nominee, any application for Regulatory Approval theretofore made in the Territory, or
any Regulatory Approval. If any application cannot be so transferred or assigned, Scigen shall, at Savient’s request,
actively continue to process such application and shall assign such Regulatory Approval when received, and Savient shall reimburse
Scigen for its reasonable out-of- pocket expenses. Once transferred, Scigen will not retain any residual rights to any such
application or Regulatory Approval. |
11.) Amendment of Section 18 - Confidentiality. Section 18.2.1 is hereby deleted and replaced with the following:
“18.2.1
to its (or its Affiliates) directors, officers, employees, Sub-Licensees, commercial and research and development collaborators,
and consultants, to the extent, if any, required for the performance of their duties in connection with this Agreement, provided
each such person is individually and personally obligated in writing to comply with confidentiality undertakings no less stringent
than the provisions of this Section 18;”
12.) Amendment
of Section 23 - Miscellaneous.
| |
(a) |
Section
23.4 is hereby deleted and replaced with the following: |
“23.4
Subject to the specific rights that may be granted to Intercell under Section 3.5 above, no Party shall assign its rights or obligations
under this Agreement, or any intellectual property rights or Technology licensed under this Agreement, either in whole or in part,
without the prior written consent of the other Party except to a party acquiring all of the assigning party’s business to
which this Agreement relates. Notwithstanding the foregoing, Savient may assign any of its rights and obligations to BTGIL, provided
that BTGIL agrees to be bound by and assumes this Agreement and all of Savient’s obligations hereunder. Any assignment in
violation of this Section 23.4 shall be null and void. Subject to the foregoing, this Agreement shall be binding upon and inure
to the benefit of the Parties and their respective successors and permitted assigns.”
| |
(b) |
Sections
23.13 and 23.14 are hereby added to read as follows: |
“23.13
Notwithstanding anything hereinabove to the contrary, where approval is required by OCS in order to engage in any act contemplated
under this Agreement, such approval shall be deemed a condition precedent for such act.
23.14
Scigen will pay, within five (5) business days of its receipt, to Savient [redacted] percent [redacted] of [redacted] Scigen received
for a sublicense or other grant of rights to any Sub-Licensee, (a “Sub-License Agreement”). Scigen shall supply to
Savient a complete unredacted copy of each such Sub-License Agreement, together with such payment, provided that Savient shall
not disclose such Sub-License Agreement in whole or in part to any third party. “Consideration” shall mean any and
all non-royalty consideration, in any form, received by Licensee from such Sub-Licensee (other than consideration based on Net
Sales for which a royalty is due under this Agreement). Scigen covenants and agrees that it will not intentionally structure the
financial terms of such Sub-License Agreements in a manner intended to avoid, reduce or diminish the amount of Consideration that
would otherwise be subject to the terms of this Section 23.14 or its obligations to pay the specified portion thereof to Savient.
This Section 23.14 shall not apply to a grant of rights in or relating to; (i) the Territory as such term was defined prior to
this Amendment; or (ii) the Berna Territory. The provisions of Sections 10 shall apply, mutatis mutandis, to payments and
reports that shall be due to Savient in respect of any Consideration, and all references to Affiliates thereunder shall be construed
as including Sub-Licensees. For the avoidance of doubt, Scigen does not guarantee the compliance by any Sub-Licensee with any
undertaking to acquire a minimum quantity of Product or to otherwise comply with any commercial provision of a Sub-License Agreement.”
13.) Amendment
of Exhibit E – Territory. Exhibit E is hereby deleted and replaced with the revised Exhibit E attached to
this Amendment and made a part hereof.
14.) Amendment
of Exhibit F - Procedure and Timetable for the Transfer of Technology. Exhibit F is hereby deleted and replaced
with the revised Exhibit F (captioned Work Plan) attached to this Amendment and made a part hereof.
15.) General. Except
as expressly modified by this Amendment, all terms, conditions and provisions of the Agreement shall continue in full force
and effect as set forth in the Agreement. In the event of a conflict between the terms and conditions of the Agreement
and the terms and conditions of this Amendment, the terms and conditions of this Amendment shall prevail. Each Party
represents and warrants to the other Party that this Amendment has been duly authorized, executed and delivered by it and
constitutes a valid and legally binding agreement with respect to the subject matter contained herein. This Amendment shall
not be modified or rescinded except in a writing signed by the Parties.
IN
WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives.
| |
SAVIENT PHARMACEUTICALS, INC. |
| |
|
| |
By:
|
Signed “Philip K. Yachmetz” |
| |
Its: |
|
| |
|
|
| |
SCIGEN LTD. |
| |
|
| |
By:
|
Signed
“Saul Mashaal” |
| |
Its: |
|
EXHIBIT
E
[Redacted]
EXHIBIT
F
[Redacted]
SECOND
AMENDMENT TO LICENSE AGREEMENT
THIS
SECOND AMENDMENT (this “Amendment”) to that certain License Agreement of June 2004 and as amended on January
24, 2005 (the “Agreement”) by and between SAVIENT PHARMACEUTICALS, INC. (f/k/a BIO-TECHNOLOGY (GENERAL) CORP.), a
Delaware corporation, having a place of business at 14th Floor, One Tower Center, East Brunswick, New Jersey 08816, USA (“Savient”)
and SCIGEN LTD., a public company incorporated under the laws of Singapore, having a place of business at 152 Beach Road, Suite
26-07/08, Gateway East, Singapore 189721 (“Scigen”) is effective the 15th day of March, 2005.
PREMISES
WHEREAS,
Savient has requested and Scigen has agreed to amend the Agreement as fully set forth below;
WHERAS,
This Amendment replaces in its entirety the previously executed Second Amendment to License Agreement, which previously executed
amendment was executed in error. Each of the parties agree that the previously executed Second Amendment to License Agreement
is ineffective.
NOW,
THEREFORE, in consideration of the mutual promises and covenants contained herein, the Parties hereby agree as follows:
16.) Amendment
of Section 10.2 - Royalties and Reporting
| |
(a) |
Section
10.2 is hereby deleted and replaced with the following: |
“10.2
Scigen shall report to Savient in writing, within thirty (30) days of the end of each calendar quarter, Net Sales during such
quarter along with a calculation of the Royalties owed to Savient, broken down by types of Product (vaccines, Combination Vaccines
and Therapeutics), the country of manufacture and the country of sale. Each such report shall be signed by Scigen’s Chief
Financial Officer and accompanied by payment of the amount due.”
IN
WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives.
| |
SAVIENT PHARMACEUTICALS, INC. |
| |
|
|
| |
By:
|
Signed
“Philip K. Yachmetz” |
| |
Name: |
Philip
K. Yachmetz |
| |
Title: |
Snr.
Vice President – Business Development, General Counsel & Secretary |
| |
|
|
| |
SCIGEN LTD. |
| |
|
| |
By:
|
Signed
“Saul Mashaal” |
| |
Name: |
|
| |
Title: |
|
THIRD
AMENDMENT TO LICENSE AGREEMENT
THIS
THIRD AMENDMENT (this “Amendment”) to that certain License Agreement of June 2004 (the “Agreement”) by
and between SAVIENT PHARMACEUTICALS, INC. (f/k/a BIO-TECHNOLOGY (GENERAL) CORP.), a Delaware corporation, having a place of business
at 14lh Floor, One Tower Center, East Brunswick, New Jersey 08816, USA (“Savient”) and SCIGEN LTD., a public company
incorporated under the laws of Singapore, having a place of business at 152 Beach Road, Suite 26-07/08, Gateway East, Singapore
189721 (“Scigen”) is effective the 15th day of June, 2005 (the “Effective Date”).
PREMISES
WHEREAS,
Savient and Scigen entered into the Agreement, as amended by that certain Amendment to License Agreement effective January 24,2005
and that certain Second Amendment to License Agreement effective March 15, 2005, wherein Savient granted Scigen certain rights
and licenses with regard to the manufacture, marketing, sale and distribution of “Product,” as defined in said Agreement;
WHEREAS,
Savient and Scigen wish to amend the Agreement to grant Scigen the right to manufacture or have manufactured the Product in Israel;
WHEREAS,
Scigen has requested and Savient has agreed to amend the Agreement in connection with other matters as more fully set forth below;
NOW,
THEREFORE, in consideration of the mutual promises and covenants contained herein, the Parties hereby agree as follows:
17.) Amendment
of Section I - Definitions.
| |
(a) |
Section
1.9 is hereby deleted and replaced with the following: |
“1.9
“CMO” means a third party contract manufacturer in Israel, India or the PRC selected by Scigen for the manufacture
of Product, which can include a joint venture entity involving Scigen.”
| |
(b) |
Section
1.14 is hereby deleted and replaced with the following: |
“1.14
“Facility” means a production facility selected by Scigen to be constructed in Israel, a production facility
selected by Scigen to be constructed in India, and a production facility selected by Scigen to be constructed in the PRC, all
for the production of Product exclusively for Scigen. For the avoidance of doubt, there may only be one production facility in
operation in each said country at any given time.
18.) Amendment
of Section 3 - License Grant.
| |
(a) |
The
entirety of Section 3.1 (including all subsections) is hereby deleted and replaced with the following: |
“3.1
Savient hereby grants to Scigen the following rights, and only for the Licensed Indications:
3.1.1 the
exclusive right and license to Market Product in the Territory;
3.1.2 the
right to sublicense, subject to the conditions set forth in Section 7, one or more Distributors (including Affiliates of Scigen)
or other Sub-Licensees to Market Product in the Territory under the exclusive license granted pursuant to the preceding Section
3.1.1;
3.1.3 the
exclusive right and license (a) to utilize the Technology and other Confidential Information disclosed by Savient and/or BTGIL
hereunder, and (b) under the Patent Rights, for the purpose of manufacturing, or having manufactured, Product as provided by Section
3.2 below, at one Facility in Israel, at one Facility in India, and at one Facility in the PRC (subject to the conditions set
forth in Sections 3.3 and 6 below); (ii) the exclusive right and license (x) to utilize the Technology and other Confidential
Information so disclosed by Savient and/or BTGIL hereunder, and (y) under the Patent Rights, for the purpose of manufacturing,
or having manufactured, Product in other facilities and countries throughout the Territory, subject to the provisions of Section
23.13 below, (iii) to use, sell, offer to sell and import Product manufactured by Scigen in accordance with this Agreement, in
the Territory, for use in Combination Vaccines; and (iv) to sublicense any of the rights granted to Scigen hereunder to Sub-Licensees,
subject to the applicable terms and conditions of this Agreement; and
3.1.4 the
exclusive right and license to sell Product to BERNA for resale in the territory awarded by Scigen to BERNA in an agreement between
such parties (“Berna Territory”) and to appoint BERNA as a Distributor of Product in the Berna Territory.”
| |
(b) |
Section
3.2 is hereby deleted and replaced with the following: |
“3.2
Notwithstanding the provisions of Section 3.1.3 above, Savient shall transfer the Technology once and only once during the Term
to Scigen or the CMO in Israel or India on behalf of Scigen, as provided in this Agreement, for utilization solely at the Facility,
but not for the production of any product other than the Product. However, Clones may be replaced in accordance with the provisions
of Exhibit F.”
19.) Amendments
of Section 8 - Technology Transfer.
| |
(a) |
Section 8.2 is hereby deleted and replaced with the following: |
“8.2
If in the course of the implementation of Exhibit F (the “Work Plan”) Scigen’s representative(s) direct a change
in the work or request BTGIL to transfer the Technology, in whole or in part, to the representatives of the CMO in Israel in place
of the representatives of the CMO in India, Savient shall have no responsibility for the resulting impact of such changes, notwithstanding
any other provision of this Agreement. Scigen shall defend, indemnify and hold Savient harmless against and from any and all losses,
claims, suits, proceedings, expenses (including reasonable attorneys’ fees and expenses at trial and appellate levels),
recoveries and damages based on or caused by any claim of Shreya Bio-Tech Private, in respect of its being substituted by the
CMO in Israel at any stage of the Work Plan.”
| |
(b) |
A
new Section 8.3 is hereby added to read as follows: |
“8.3
For the sake of good order Scigen hereby confirms that nothing in the inclusion of the representatives of the CMO in Israel in
the implementation of the Work Plan shall be deemed or construed as requiring Savient to repeat any part of the Work Plan that
has already been carried out prior to the execution of the Third Amendment to this Agreement, or that Savient has agreed to any
extension or deviation whatsoever from such Work Plan and the timetable set out therein.”
20.) General.
Except as expressly modified by this Amendment, all terms, conditions and provisions of the Agreement shall continue in full
force and effect as set forth in the Agreement. In the event of a conflict between the terms and conditions of the Agreement and
the terms and conditions of this Amendment, the terms and conditions of this Amendment shall prevail. Each Party represents and
warrants to the other Party that this Amendment has been duly authorized, executed and delivered by it and constitutes a valid
and legally binding agreement with respect to the subject matter contained herein. This Amendment shall not be modified or rescinded
except in a writing signed by the Parties.
IN
WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives.
| |
SAVIENT
PHARMACEUTICALS, INC. |
| |
|
|
| |
By:
|
Signed
“Philip K. Yachmetz” |
| |
Name: |
Philip
K. Yachmetz |
| |
Title: |
Snr.
Vice President – Corporate |
| |
|
Strategy,
General Counsel & Secretary |
| |
|
|
| |
SCIGEN
LTD. |
| |
|
|
| |
By:
|
Signed
“Saul Mashaal” |
| |
Its: |
Executive
Vice-Chairman |
AMENDMENT
AND WAIVER TO LICENSE AGREEMENT
THIS
AMENDMENT AND WAIVER TO LICENSE AGREEMENT (this “Amendment”) is dated as of 14 February, 2012 and is entered
into by and among Ferring International Center S.A , a corporation duly incorporated under the laws of Switzerland, having its
principal place of business at Ch. De la Vergognausaz 50, 1162 Saint-Prex, Switzerland (“Ferring”) and SCIGEN
LTD., a public company incorporated under the laws of Singapore with its registered address at 152 Beach Road, Suite 26-07/08,
Gateway East, Singapore 189721 (“Scigen”), and is made with reference to that certain License Agreement dated
as of June 2004, as amended and revised from time to time (the “Agreement”), by and among Savient Pharmaceuticals,
Inc. (“Savient”) and Scigen, and subsequently assigned by Savient to Ferring.
Capitalized
terms used herein without definition shall have the same meanings herein as set forth in the Agreement after giving effect to
this Amendment.
RECITALS
WHEREAS,
Savient and Scigen entered into the Agreement in June 2004, as amended by that certain Amendment to License Agreement effective
January 24, 2005, that certain Second Amendment to License Agreement effective March 15, 2005 and that certain Third Amendment
Agreement effective June 15, 2005, wherein Savient granted Scigen certain rights and licenses with regard to the manufacture,
marketing, sale and distribution of the Product. On 18 July 2005 as a result of the transaction the Agreement was assigned by
Savient to Ferring.
WHEREAS,
Scigen has failed to comply with certain of its obligations in the Agreement in relation to Regulatory Approval (Section 4 of
the Agreement) and Marketing (Section 5 of the Agreement) and subject to the conditions provided for herein, Ferring is willing
to agree to such amendments and limited waiver.
NOW
THEREFORE, in consideration of the mutual promises and covenants contained herein, the Parties hereby agree as follows:
1.
Waivers
| 1.1 |
[redacted],
Ferring does hereby irrevocably fully and finally waive, release and forever discharge Scigen (and its affiliated and subsidiary
entities and its members, shareholders, officers, directors, employees, representatives, agents, attorneys, successors, and
assigns, partners, estates, heirs, personal representatives, executors and administrators, as applicable) from any and all
rights, actions, claims, debts, demands, costs, contracts, liabilities, obligations, damages and causes of action whether
known, suspected or unknown, whether in law or in equity, which Ferring had or now has or may claim to have. |
| |
|
| 1.2 |
[redacted],
Ferring hereby irrevocably fully and finally waives its right to exercise the right to convert the Product license from an
exclusive to a non-exclusive license, or its right to remove a country from the scope of the Territory, as provided for in
Section 4.3 and 5.2 of the Agreement (as the Sections read prior to the amendments to be made to those Sections in accordance
with this Amendment). |
2.
Amendments
| 2.1 |
Section
4.1 of the Agreement is amended by deleting the word “promptly” from the first line of the Section. |
| |
|
| 2.2 |
Section
4.3 of the Agreement is hereby amended by deleting it in its entirety and replacing it with the following: |
| |
|
| |
“4.3
Scigen shall initiate the process of obtaining Regulatory Approval of the Product in the countries within the Territory as
both a vaccine and as a Therapeutic. The obligations in this Section 4.3 are not time specific and Scigen shall have complete
discretion as to the timeframe for the initiation process of obtaining Regulatory Approval of the Product in the countries
within the Territory.” |
| |
|
| 2.3 |
Section
5.2 of the Agreement is hereby amended by adding at the end thereof the following new sentence: |
| |
|
| |
“The
Provisions of this Section 5.2 shall not apply to any country of the Territory where Regulatory Approval of the Product has
been received prior to the date of 6 February 2012.” |
3.
General
| 3.1 |
Except
as expressly modified by this Amendment, all terms, conditions and provisions of the Agreement shall continue in full force
and effect as set forth in the Agreement. |
| |
|
| 3.2 |
In
the event of a conflict between the terms and conditions of the Agreement and the terms and conditions of this Amendment,
the terms and conditions of this Amendment shall prevail. |
| |
|
| 3.3 |
Each
party represents and warrants to the other Party that this Amendment has been duly authorized, executed and delivered by it
and constitutes a valid and legally binding agreement with respect to the subject matter contained herein. |
| |
|
| 3.4 |
This
Amendment shall not be modified or rescinded except in writing signed by both Parties. |
| |
|
| 3.5 |
This
Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument. Signature pages to this Amendment may be delivered by the parties to each other
by facsimile transmission or email in a pdf format. |
| |
|
| 3.6 |
Headings
in this Amendment are included herein for convenience of reference only and shall not constitute a part of this Amendment
for any other purpose or be given any substantive effect. |
| |
|
| 3.7 |
The
provisions relating to Governing Law and litigation set out in Section 20 of the Agreement shall apply to this Amendment. |
[remainder
of page left blank intentionally]
[Signature
Page of Amendment and Waiver to License Agreement]
IN
WITNESS WHEREOF, the Parties have caused this Amendment and Waiver to License Agreement to be executed by their duly authorized
representatives.
| Ferring
International Center S.A. |
|
| |
|
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| Signed
“Michel Pettigrew” |
|
| Signature |
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| |
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| By: |
Michel
Pettigrew |
|
| Title: |
President
of the Executive Board and COO |
|
| |
|
|
| Signed
“Peter Wilden” |
|
| Signature |
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| |
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| By: |
Peter
Wilden |
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| Title: |
CFO |
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| |
|
|
| SCIGEN
LTD. |
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| |
|
|
| Signed
“Slawomir Ziegert” |
|
| Signature |
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| |
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| By: |
Slawomir
Ziegert |
|
| Title: |
CEO |
|