SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 9, 2016
Microlin Bio, Inc.
(Exact name of registrant as specified in its charter)
| Delaware |
000-55425 |
45-4507811 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
135 East 57th Street, 24th Floor
New York, NY |
10022 |
| (Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (646)
406-6243
|
___________________________________________________
(Former name or former address, if changed since
last report) |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] |
Written communications pursuant to Rule 425 under the Securities Act (17CFR 230.425) |
|
|
| [ ] |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
| [ ] |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
| [ ] |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
SECTION 1 – REGISTRANT’S
BUSINESS AND OPERATIONS
Item 1.01 Entry Into a Material Definitive
Agreement
On February 9, 2016 we entered into a License
Agreement (the “Agreement”) with Université Laval, a Canadian university, under which we have agreed to jointly
develop microRNA-based treatments for Alzheimer’s Diseases (AD). Under the Agreement, we have been granted the exclusive
worldwide license for the development and the commercialization of novel molecules and methods against certain microRNAs found
to play a role in AD. The Agreement requires us to undertake commercially reasonable efforts to commercialize or otherwise develop
the licensed technology. The agreement sets forth certain performance milestones which we are required to meet, including:
- Commencing a phase I clinical trial with respect to a product within two (2) years;
- Commencing a phase II clinical trial with respect to a product within five (5) years;
and
- Commencing a clinical phase III trial with respect to a product within seven (7) years.
We may satisfy these obligations through our
own efforts or through the efforts of one or more sub-licensees. If, despite using commercially reasonable efforts to do so, and
taking into account delays which are due to factors (including technical or regulatory issues) which are out of our reasonable
control or not reasonably foreseeable, the foregoing time frames will be extended in good faith. We are required to submit reports
to Université Laval regarding our development activities on a bi-annual basis.
In consideration for the license granted under
the Agreement, we have agreed to pay upfront royalties, annual royalties, and certain milestone payments tied to the start of clinical
trial phases and, eventually commercial product sales.
Within 30 days of the Agreement, we shall enter
into a sponsored research agreement with Université Laval for research to be performed at the university for a period of
two years. In the event of a breach by either party, the Agreement may be cancelled upon 90 days written notice. We may terminate
the Agreement, in whole or with respect to a particular patent or patent application, upon 60 days’ notice.
The foregoing is a summary of the material
terms of the Agreement, which contains additional terms and covenants and should be reviewed in its entirety for additional information.
The Agreement is filed herewith as Exhibit 10.1.
SECTION 9 – Financial
Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
*** The copy of the Agreement filed herewith has been redacted
to remove certain confidential information. We intend to file a confidential treatment request with the Commission regarding this
information.
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 hereunto duly authorized.
Microlin Bio, Inc.
/s/ Joseph Hernandez
Joseph Hernandez
Executive Chairman
Date: February 10, 2016
LICENSE
AGREEMENT
between
Microlin
Bio, Inc.
and
UNIVERSITÉ
LAVAL
| Article 1 –
DEFINITIONS |
1 |
| Article 2 –
GRANT |
4 |
| Article 3 –
EFFECTIVE DATE AND EXPIRY |
4 |
| Article 4 –
ABSENCE OF GUARANTEE |
5 |
| Article 5 –
IMPROVEMENTS |
5 |
| Article 6 –
OWNERSHIP |
6 |
| Article 7 –
OBLIGATIONS AND COMMITMENTS OF THE LICENSEE |
6 |
| Article 8 –
OBLIGATIONS OF THE UNIVERSITY |
7 |
| Article 9 –
CLAIM OR LEGAL ACTION FILED BY THIRD PARTY |
8 |
| Article 10 –
CLAIM OR ACTION FILED AGAINST A THIRD PARTY |
8 |
| Article 11 –
FINANCIAL CONSIDERATIONS |
9 |
| Article 12 –
ACCOUNTING JOURNALS, REGISTERS AND REPORTS |
13 |
| Article 13 –
USE FOR EDUCATION, RESEARCH AND PUBLICATION |
14 |
| Article 14 –
PUBLICITY |
15 |
| Article 15 –
TERMINATION |
15 |
| Article 16 –
NOTIFICATION |
16 |
| Article 17 –
CONFIDENTIALITY |
16 |
| Article 18 –
CLAIMS, RESPONSIBILITY AND INDEMNIFICATION |
17 |
| Article 19 –
ASSIGNMENT |
17 |
| Article 20 –
INDEPENDENCE |
18 |
| Article 21 –
PARTIAL INVALIDITY |
18 |
| Article 22 –
APPLICABLE LAWS |
18 |
| Article 23 –
VENUE |
18 |
| Article 24 –
INTEGRALITY AND MODIFICATIONS |
18 |
| Article 25 –
RENUNCIATION |
18 |
| Article 26 –
FORCE MAJEURE |
18 |
| Article 27 –
SUCCESSORS AND LEGAL REPRESENTATIVES |
19 |
| Article 28 –
LANGUAGE |
19 |
| Article 29 –
INTERVENTION |
19 |
LICENSE
AGREEMENT
| BETWEEN: | Université
Laval, a private corporation duly incorporated under the provisions of an act of
the National Assembly, sanctioned on December 8, 1970 (S.Q. 1970, c. 78), having its
head office in Québec, Province of Québec, herein represented by Edwin
Bourget who is the Vice-President for Research and Innovation, and who declares that
he is duly authorized to act as representative of the University;
(Hereafter designated as the “University”); |
| AND: | Microlin
Bio, Inc., a public corporation, having its head office at 135 E. 57th Street 24th
Floor, New York, NY, 10022 , herein represented by M Joseph Hernandez, who declares that
he is duly authorized to act as representative for the purpose;
(Hereafter designated as the “Licensee”);
(Hereafter designated individually the “Party” or collectively as the “Parties”). |
WHEREAS the University is the owner of all rights,
titles, and interests in the technology described within this Agreement;
WHEREAS
the Licensee wishes to obtain a license from the University, who accepts, to commercially exploit the aforesaid technology
on a exclusive basis;
THEREFORE,
in light of the conditions, commitments and agreements set forth herein, including the preamble, which is an integral part thereof,
the Parties agree to the following:
Article 1 – DEFINITIONS
In
this Agreement and its appendix, unless the context of a specific article indicates otherwise, the terms listed below shall be
defined as indicated hereafter. The singular shall include the plural; the masculine shall include the feminine, and vice versa:
| 1.1 | “Affiliate”
shall mean, with respect to a Party, any corporation, firm, partnership or other entity
which, at the time in question, directly or indirectly controls, is controlled by or
is under common control with such Party. For the purposes of this definition “control”
shall mean (i) owns, directly or indirectly, more than fifty percent (50%) (or such lesser
percentage that is the maximum allowed to be owned by a foreign entity in a particular
jurisdiction) of the voting stock or shares of such corporation, firm, partnership or
other entity, or (ii) has the power to direct, directly or indirectly, or cause
the directions of, the management or policies of such corporation, firm, partnership
or other entity, whether through the ownership of voting securities, by contract or in
any other manner; |
| 1.2 | Commercialization”
or “Commercialize” shall mean any activities directed to producing,
manufacturing, marketing, promoting, pricing/reimbursement, distributing, importing or
selling a Product; |
| 1.3 | “Commercially
Reasonable Efforts” shall mean the commitment of resources and efforts in accordance
with reasonable business, legal, medical, and scientific judgment that are consistent
with the efforts, resources and judgment that a public company of similar size and position
of Licensee in the marketplace would use in Developing and Commercializing its other
pharmaceutical products and compounds which are of similar market potential and at a
similar stage in their life cycle, taking into account market exclusivity, safety, efficacy,
product labeling or anticipated labeling, market potential, past performance (if any),
economic return potential (including pricing and reimbursement status achieved), medical
and clinical considerations, the regulatory environment, and competitive market conditions
in the therapeutic area, including the global impact of regional marketing, launch and
pricing decisions, all as measured by the facts and circumstances at the time such efforts
are due; |
| 1.4 | “Develop”
or “Development” shall mean any activities directed to research, discovery
and preclinical and clinical drug development of a Product, including without limitation
test method development and stability testing, toxicology, formulation, manufacturing
process or method, quality assurance/quality control development, statistical analysis,
clinical studies (including such studies conducted after marketing authorization of a
Product has been obtained or for additional indications or label expansion for which
marketing authorization has been obtained) , regulatory affairs, product approval and
registration or any other activity that may be required by a regulatory authority for
the obtaining, maintaining or expansion of the marketing authorization of a Product; |
| 1.5 | “Improvements”
shall mean all Patent Rights that claim any changes, modifications, perfection, additions,
updates and upgrades applied to the Technology by the Licensee and/or its sublicensees
after
the
Effective
Date
and
that
are
dominated
by the
Technology; |
| 1.6 | “Intellectual
Property Rights” shall mean all registered and/or unregistered intellectual
property rights including all rights relating to patents, copyrights, industrial designs,
integrated circuits, new plant varieties, inventions (whether or not they may be patentable),
discoveries, commercial secrets, know-how, domain names, trademarks, brand names and
all other rights recognized under statutory law or common law as applied above, including
all requests for protection; |
| 1.7 | “Confidential
Information” shall mean all information disclosed by one Party to the other
Party hereunder in any verbal, written, or electronic form, particularly information
concerning customers and suppliers, details of agreements, conventions, commitments,
offers, options, proposed contracts and contracts, banking data, financial data, sales
data, relations with existing and future customers, sales operations, services, marketing
data, plans, research results, production formulae and methods, technologies, inventions,
improvements and perfection, and intellectual properties and the Parties agree that this
list is neither exhaustive nor limitative; |
| 1.8 | “Invention”
shall mean the invention described in the patent application entitled “microRNA-132/212
for the treatment of neurodegenerative disorders ” and listed in Appendix I; |
| 1.1 | “Net
Sales Price” shall mean the price billed for the commercially sold Products
by the Licensee or one of its Sublicensees to independent customers, less the costs of
transportation, customs, volume discounts, wholesale discounts, guarantees, cash discounts
and relative taxes. In the case of a transfer or sale of Products at a price below market
value to a person or corporation having a non arm's-length relationship with the Licensee
or its Sublicensee, the Net Sales Price shall be deemed to correspond to the price billed
for similar products sold, within the same time frame, to independent customers. The
same disposition shall be applied for Products transferred at no cost for promotion purposes
by the Licensee or its Sublicensee; |
| 1.9 | “Patent
Rights” shall mean all worldwide patents and patent applications within the
Technology, together with all registrations, reissues, reexaminations or extensions of
any kind with respect to any of such patents and any continuation, divisional, continuation-in-part,
substitute or provisional application thereof; |
| 1.2 | “Products”
shall mean the product or products produced from or the service or services derived from
the Technology; |
| 1.10 | “Royalties”
means any income derived from a licence or a sub-licence, especially including any lump-sum
or any percentage applicable to the Net Sales Price of Products produced from or the
service or services derived from the Technology held by the University, together with
any Improvements thereof as well as any other income from the licence or sub-licence.
The Term Royalties excludes the amounts received by the Licensee for research work undertaken
on behalf of third parties;; |
| 1.3 | “Interest
Rate” shall mean a rate of one and one-half per cent (1.5%) per month, composed
monthly, i.e. the equivalent of nineteen point fifty-six per cent (19.56%) per year; |
| 1.11 | “Technology
– Technologies” shall mean, as of the Effective Date, the Intellectual
Property Rights, patent applications, documents, models, patterns, technical information,
specifications and prototypes, that are not in the public domain, pertaining to the Invention; |
| 1.12 | “Third
Party” shall mean any entity other than a Party; |
| 1.13 | “Territory”
“Territory” shall mean the world. It is agreed that the University
may from time to time reduce the extent of this territory if it becomes obvious to the
University that the Licensee cannot satisfy the performance conditions established for
the Products as specified in Article 7.2. In this event, and whenever Articles 9 and/or
10 of the present Agreement are invoked, the term “Territory” shall
mean the world, leaving aside each of the geographic regions stipulated by the deduction
or reduction. |
Article 2 – GRANT
Subject
to the terms and conditions of the present Agreement, the University hereby grants an exclusive license under the Technology to
the Licensee, who accepts it, conferring thereby the exclusive right, authorization, and privilege to manufacture, sell, have
made, offer for sale, import, Develop and Commercialize and otherwise commercially exploit the Products and to use and commercially
exploit the Technology in the Territory in accordance with the terms and conditions of the present Agreement.
The
Licensee shall enjoy the right to grant sublicenses to third parties, subject to the prior written consent of the University.
This consent, however, will not be withheld without reason. The University shall benefit from a delay of fifteen (15) working
days from the date of receipt of the Licensee's written notice to accept or reject the application for a sublicense. Upon expiry
of that period, the University shall be deemed to have accepted the sublicense application. The written notice of application
for a sublicense shall contain sufficient details concerning the prospective sublicensee, including specifically all corporate
and financial information and the identity of the shareholders, to enable the University to make a decision.
Licensee
shall provide the University with a copy of the sublicense agreement signed by the the Licensee and sublicensee within thirty
(30) days of entering into such sublicense.
Without
limiting the scope of the above, the Licensee shall not permit a third party to use or commercially exploit the Technology or
to manufacture, sell or commercially exploit the Products, either directly or indirectly, without having first granted a sublicense,
which must comply with the provisions of the present Agreement. All sublicense agreements shall incorporate the licensing terms
and conditions stipulated herein and a copy of the agreement shall be transmitted to the University as soon as it is signed by
the Licensee and the Sublicensee.
| 2.3 | Technology
Transfer
Without
limiting any other provision of this Agreement beginning promptly after the Effective
Date and from time to time thereafter upon the reasonable request of Licensee, University
shall transfer to the Licensee, at it cost and expenses, all tangible items within the
Technology, to the extent not previously transferred to the Licensee hereunder and as
reasonably necessary for the Licensee to exercise the rights and licenses granted by
the University to the Licensee hereunder. Without limiting the foregoing and in connection
with such transfer of such Technology, the University shall make reasonable efforts,
at the request and expense (including significant labour costs and expenses) of the Licensee,
to make available such personnel reasonably familiar with the transferred Technology
to consult with and assist the Licensee in implementing such Technology. |
Article 3 – EFFECTIVE
DATE AND EXPIRY
This
Agreement shall become effective when fully executed by the Parties (“Effective Date”) and continue in full
force and effect until expiration, revocation or invalidation of the last patent or the abandonment of the last patent application
within the Patent Rights, whichever is later, unless it is terminated earlier pursuant to Article 15 of this Agreement.
Article 4 – ABSENCE
OF GUARANTEE
| 4.1 | The
Licensee recognizes that the rights that it has received under the terms of the present
Agreement convey no legal, conventional, or other guarantee from the University. |
| 4.2 | Without
limiting the scope of the preceding, except as provided expressly herein, the Licensee
agrees that the University has made no express or implied guarantee, declaration or condition,
including implicit guarantees concerning the marketable quality, market value, or possibilities
of adapting the Technology or Products to a particular use or of selling Products after
the use of the Technology by the Licensee or its sublicensees. |
| 4.3 | The
Licensee agrees that the University has made no express or implied guarantee, declaration
or condition concerning the patentability of the Technology, the validity of the patent(s),
the extent of claims, or the fact that the commercial exploitation of these patents does
not violate any other patent. |
Article 5 – IMPROVEMENTS
| 5.1 | As
between the Parties, the Licensee shall be the sole owner of all rights, titles and interests
of all Improvements. It is agreed, however, that the Licensee shall automatically grant
to the University an irrevocable, royalty free, non-exclusive
license to use any Improvements without fees in connection
with
the
use
of the
Technology
for
its own
internal
teaching
and research and training purposes pursuant
to Article
13. |
| 5.2 | As
between the Parties, the University shall be the sole owner of all rights, titles and
interests of all improvements made solely by the University to the Products and the Technology
pursuant to its rights to use the Technology for its own internal teaching and research
purposes under Article 13. University hereby grants to Licensee an exclusive option to
an exclusive license for a period of 5 years after the Effective date under all rights
and titles in any such improvements to the Technology as developed in Dr Sebastien Hébert’s
lab by Dr. Hébert and/or his research team ( including all related intellectual
property rights, information, know-how, materials or other subject matter reasonably
necessary for the practice of such improvements) (“University improvements”)
to research, develop, manufacture and commercialize and exploit such University improvements.
As such in the event that University receives a written declaration of any University
improvements, it shall first offer any such rights to Licensee with sixty (60) days prior
written notice. Such notice shall contain a description of such University improvements
to be licensed and any other relevant information to entitle Licensee to make an informed
decision. Licensee shall than inform University by written notice, within such sixty
(60) days period (the “Option Period”), whether or not it accepts to obtain
a license under such University improvements. If Licensee does not reply within the Option
Period, it shall be presumed to have refused to exercise its option pursuant to this
Section 5.2 with respect to the University improvements referred to the notice. If the
Licensee does reply within the Option Period in exercise of its option pursuant to this
Section 5.2, Licensee and the University shall enter into exclusive negotiations and
shall use good faith efforts to execute a license agreement with respect to such University
improvements in accordance with this Section 5.2. Terms and conditions of any such license
agreement to be |
entered
into are to be negotiated in good faith and agreed upon between Licensee and University, according to commercially reasonable
terms and conditions in accordance with industry norms for similar intellectual property rights at the time the Parties negotiate
any such license agreement, within a period of sixty (60) days following the end of the Option Period (the Negotiation Period),
which may be extended , if necessary, upon mutual agreement of both parties to complete such license agreement. If an agreement
is not reached by the end of such additional period, Licensee right of the first refusal to these University improvements will
expire. Both Licensee and University shall inform the other Party in writing and without delay, of all Improvements and University
improvements applied by it to the Technology respectively.
Except
as expressly provided otherwise under this Agreement, until the end of the Option Period and Negotiation Period (and any extension
thereof), the University shall not offer any rights in any University improvements to any Third Party and shall not discuss with
or provide any information to any Third Party regarding any University improvements or terms under which such University improvements
would be licensed.
Article 6 – OWNERSHIP
The
Licensee hereby acknowledges that the University is the sole owner of any and all Intellectual Property Rights attached to the
Technology and University improvements. The Licensee shall not contest its validity, directly or indirectly, or register for its
own benefit any Intellectual Property Right concerning the Technology, Products, or University improvements. Moreover, the Licensee
shall ensure that these same provisions apply to each of its sublicensees.
Article 7 – OBLIGATIONS
AND COMMITMENTS OF THE LICENSEE
The
Licensee shall take Commercially Reasonable Efforts to commercialize or otherwise exploit the Technology, including incorporating
its use in the manufacturing and sale of the Products. Licensee shall be deemed to have satisfied its diligence obligations under
this Section with respect to the Technology or a Product so long as Licensee met the milestones for Development of a Product as
set forth in Section 7.2 (“Diligence Milestones”) on or before the date set forth therein, as may be extended pursuant
to Sections 7.2.4 and 7.2.5. Licensee shall be deemed to have failed its diligence obligations under this Section should Licensee
fail to meet any Diligence Milestone on or before the date specified in Section 7.2, as may be extended pursuant to Sections 7.2.4
and 7.2.5, except to the extent such failure is caused by demonstrated toxicity or drug safety issues determined in accordance
with industry standards or inadequate efficacy demonstrated by the Technology and/or Products.
| 7.2 | Performance
Conditions |
The
Licensee shall respect the following performance conditions:
| 7.2.1 | The
Licensee will commence a phase I clinical trial with respect to a Product within two
(2) years from the Effective Date. |
| 7.2.2 | The
Licensee will commence a phase II clinical trial with respect to a Product within five
(5) years from the Effective Date. |
| 7.2.3 | The
Licensee will commence a clinical phase III trial with respect to a Product within seven
(7) years from the Effective Date. |
| 7.2.4 | As
used throughout this Agreement, the “commencement” or “start”
of a clinical trial for a Product shall mean the first dosing of a patient in such clinical
trial. |
| 7.2.5 | Notwithstanding
the foregoing, Licensee may satisfy its obligations under this Article 7 through itself
and/or its sublicensees, as applicable. In the event that Licensee is unable to meet
such time frame or date under its obligations under this Article 7 despite using Commercially
Reasonable Efforts to do so, taking into account delays which are due to factors (including
technical or regulatory issues) which are out of the reasonable control of or not reasonably
foreseeable by Licensee, University and Licensee agree to extend the foregoing time frames
and dates in good faith. |
Within
ninety (90) days after June 30 and December 31 of each calendar year ending prior to the First Commercial Sale of a Product by
Licensee, a Licensee Affiliate or a Licensee sublicensee, Licensee shall provide to University a written report in substantially
the form set forth in Appendix II, which summarizes the activities undertaken by Licensee, its Affiliates and sublicensees during
the immediately preceding calendar year in connection with the Development of the Products, including progress toward the development
activities outlined in Section 7.2.
| 7.4 | Marking
Products and promotional material |
In
an attempt to discourage patent infringements, the Licensee shall ensure that the numbers of registered patents and patents
pending within the Technology appear on the applicable Product covered by such patents as required in accordance with the applicable
patent statutes or regulations in the country or countries of sale thereof.
Article 8 – OBLIGATIONS
OF THE UNIVERSITY
The
University declares that, to the best of its knowledge, it is the owner of all of the Technology pertaining to the Invention.
The
University declares that, as of the date of signature of this Agreement, it has received no claim or contestation, real or presumed,
concerning the Technology.
Article 9 – CLAIM
OR LEGAL ACTION FILED BY THIRD PARTY
| 9.1 | The
Licensee and the University shall, as soon as they obtain knowledge thereof, disclose
to the other Party any claim, legal action, or any other action concerning the infringement
of a patent or Intellectual Property Right owned by a third party in conjunction with
the exercise of any of the rights granted under the present Agreement to that party or
to any of the sublicensees on the Territory. The Parties shall collaborate to prepare
a suitable course of action to respond to the claim or defend the action.. |
| 9.2 | The
Licensee shall assume all costs related to these procedures, including all fees and disbursements
of legal counsel and expert witnesses retained for the purpose. In the event that the
action is allowed or if a settlement is reached that limits the full and complete enjoyment
of the rights set forth herein, that portion of the Territory applicable to the claim
or action shall automatically be excluded from the present Agreement. |
Article 10 – CLAIM
OR ACTION FILED AGAINST A THIRD PARTY
| 10.1 | The
Licensee and the University shall, as soon as they obtain knowledge thereof, disclose
to the other Party any infringement to the Technology and any violation of any related
right. The Parties shall collaborate to prepare a suitable course of action to undertake
in the Territory as a result of the aforementioned infringement or violation. |
| 10.2 | Notwithstanding
the foregoing, Licensee shall have the first right, but not the obligation, to institute
procedures for infringement of the Technology or violation of any related right. |
| 10.3 | If
the Licensee decides not to institute procedures for infringement of the Technology that
would
be consistent
with
Commercially
Reasonable
Efforts
within ninety (90) days following the receipt of a notice from the University specifying
that the Technology has been infringed or that one of the rights granted hereunder has
been infringed as well, the University may institute such procedures alone in its own
name at its own expense. In any case, including in whichthe Parties cannot agree on the
procedures to be instituted, each Party shall supply assistance, documents, witnesses
and reasonable information which the enforcing Party may require to institute procedures
for infringement of the Technology pursuant to this Article 10, including joining any
action as a party-plaintiff as may be required under applicable laws, and the enforcing
Party shall keep the other Party regularly informed of the status and progress of such
enforcement efforts, and shall reasonably consider the other Party’s comments on
such efforts. |
| 10.4 | Unless
otherwise agreed on before legal proceedings are undertaken, all damages, interest or
other settlements resulting from legal proceedings undertaken pursuant to this article
will beshared between the University and the Licensee as follows below once the expenses,
including legal fees, are paid, considering the participation of each one of the parties
to the proceedings and the damages each one of them will have sustained: enforcing Party
shall retain the remainder, less the amount of any Royalties that would have been due
to the University on sales
of Products lost by Licensee as a result of the infringement had Licensee’s sublicensee(s) made such sales. |
| 10.5 | If
Licensee
decides
not
to institute
procedures
for
infringement
of the
Technology
that
would
be consistent
with
Commercially
Reasonable
Efforts
within
ninety
(90)
days
following
the
receipt
of a
notice
from
the University
specifying
that
the Technology
has been
infringed,
and University
elects
to institute
such procedures
alone
in its own
name
at its own
expense
pursuant
to Section
10.3,
then University
shall
not
settle or
otherwise
compromise
any such
proceeding
in any
manner
that
would
adversely
affect the
Technology
or Licensee’s
rights
and licenses
hereunder;
provided
that
University
may grant
a non-exclusive,
non-sublicenseable,
and non-transferable
license
under
the applicable
Patent
Rights
with
respect
to
that
part
of the
Territory
in which
such proceeding
has
been initiated
to such third
party
in connection
with any
settlement
thereof. |
Article 11 – FINANCIAL
CONSIDERATIONS
In
consideration for the license granted to the Licensee under the terms and conditions of the present Agreement, the Licensee agrees
to pay the amounts to the University as established and calculated hereafter:
| 11.1.1 | The
Licensee shall pay a lump-sum amount *** upon the Effective Date; |
| 11.1.2 | The
Licensee shall pay a calendar quarterly payment to the University, for the duration of
the Agreement, equal to ***. |
| 11.1.3 | The
Licensee shall pay to the University a percentage *** Sublicensing Income for sublicenses
granted by the Licensee after the Effective Date. “Sublicensing Income” shall
mean, cash or stock option or participation in a company or Person received by Licensee
in consideration of a grant to any Third Party or Third Parties of a sublicense under
the Patent Rights, to make, have made, use, market, sell, distribute and import the Products,
including but not limited to upfront fees, milestone payments, or license maintenance
fees. |
| 11.1.4 | Notwithstanding
the above, the Licensee shall pay to the University, each year, starting on the second
anniversary of the Effective Date, an annual maintenance fee of *** payable within thirty
(30) days after receipt of the invoice, until such time that Licensee is commercially
selling Products and paying earned Royalties or minimum annual royalties thereon to University
(“Annual Maintenance Fee”). |
| 11.1.5 | The
Licensee shall pay the following miles stones payment: |
| - | ***
at the start of the first phase I clinical trial for a Product by the Licensee or its
Sublicensees. This payment should be made within sixty (60) days from the start of such
phase I clinical trial. |
| - | ***
at the start of the phase II clinical trial for a Product by the Licensee or its Sublicensees.
This payment should be made within sixty (60) days from the start of the phase II clinical
trial. |
| - | ***
at the start of the phase III clinical trial for a Product by the Licensee or its Sublicensees.
This payment should be made within sixty (60) days from the start of the phase III clinical
trial. |
| - | ***
at the submission of an application for marketing approval of a Product to the applicable
regulatory agency by the Licensee or its Sublicensees. This payment should be made within
sixty (60) days from such submission. |
| - | ***
upon the first commercial sale of a Product by the Licensee or its Sublicensees in the
first Key Market (“First Commercial Sale”). This payment should be made within
sixty (60) days from such first sale. For purposes of this Section, “Key Market”
shall mean the United States, Canada, France, Germany, Italy, Spain, the United Kingdom,
and Japan. |
| - | The
Licensee shall pay to the University, at the end of each calendar year, starting after
the first anniversary of the First Commercial Sale, minimum royalties of *** (“Annual
Minimum Royalty”) payable within thirty (30) days after receipt of the invoice;
provided that any earned Royalties due on the Products sold by Licensee and its sublicensees
during such calendar year pursuant to Section 11.1.2 . The Annual Minimum Royalty will
be readjusted at *** starting at the end of the second calendar year after the First
Commercial Sale; |
| 11.1.6 | Within
thirty days (30) of the Effective Date the Licensee and University will enter into a
Sponsored Research Agreement under which Licensee will sponsor research to be performed
in the laboratory of Sébastien Hébert (“Principal Investigator”)
at CHU de Québec Université Laval on reasonable and customary terms for
a period of two (2) years (“Research Program”). The research will
be conducted in accordance with a plan and budget mutually agreed upon between University,
the Principal Investigator and Licensee. Except as the Parties may otherwise agree, the
amount of the research funding for costs and expenses, excluding overhead, will not exceed
*** each year of the Research Program and the amount of overhead will not exceed ***
of such costs and expenses each year of the Research Program. An initial plan and budget
of the Research Program is attached as Appendix III. |
For
clarity, University will retain ownership of all inventions and other intellectual property that are conceived or first reduced
to practice by the Principal Investigator, or by other faculty, staff or personnel associated with University in the course of
performing the Research Program. University hereby grants to Licensee an exclusive option to an exclusive license to and under
all rights and titles in any such inventions and other intellectual property ( including all related intellectual property
rights,
information, know-how, materials or other subject matter reasonably necessary for the practice of such inventions) (“Research
Program Inventions”) to research, develop, manufacture and commercialize and exploit such Research Program Inventions in
accordance with the terms and conditions of Sections 5.2 and 5.3 above as applied to such Research Program Inventions, mutatis
mutandis, so that each reference to “University improvements” shall be deemed a reference to such Research Program
Inventions.
| 11.1.7 | The
Royalties payable by the Licensee pursuant to Section 11.1.2 and Section 11.1.3 will
be determined quarterly on the thirtieth (30th) day of the months of March, June, September
and December of each year as of and throughout the duration of this Agreement. The Licensee
must pay such Royalties within thirty (30) days following the end of each quarter in
which they were received by the Licensee during the quarter in question. |
| 11.1.8 | All
Royalties must be paid in compliance with the conditions stipulated in Article 11.4 (payment).
Except as otherwise provided herein, no deduction, cross claim or set off will be made,
except in connection with the deductions specified under any applicable legislation,
especially income tax deductions for non-residents which may be required from the University
by a government organization having jurisdiction. |
For
greater clarity, Licensee agrees to require its sublicensees to comply with the provisions of this Agreement as such provisions
are applicable to the exercise by sublicensees of rights licensed to Licensee hereunder. Licensee hereby guarantees, and shall
remain responsible for, the performance of its permitted sublicensees under this Agreement. Any such sublicenses by Licensee shall
include an obligation for the sublicensee to account for and report its Net Sales, and Licensee shall pay to University (or arrange
for the sublicensee to pay to University, with Licensee remaining responsible for any failure of the sublicensee to pay amounts
when due under this Agreement) any amounts set forth in this Section 11 as if such amount were due by Licensee.
It
is agreed that the Royalties shall not be subject to either the Goods and services tax (GST), the Québec sales tax (QST),
or any other similar tax. However, in the event that applicable tax laws are modified and/or reinterpreted, taxes will be payable
to the University in addition to the Royalties paid by the Licensee and sub-licensees.
| 11.2 | Costs
relating to Patents |
| 11.2.1 | In
addition to the amounts specified in Article 11.1, the Licensee shall reimburse University
for all reasonable out-of-pocket costs incurred by the University for the filing for,
prosecution and maintenance of the Patent Rights before the coming into force of this
Agreement within thirty (30) days of the receipt of an invoice by the Licensee for such
expenses. |
| 11.2.2 | The
University shall be responsible for making decisions and giving instructions concerning
the filing for, prosecution and maintenance of the Patent Rights; provided that University
shall first consult with Licensee as to the filing, prosecution and maintenance of such
patents and patent applications and shall furnish to Licensee copies of documents relevant
to any such filing, prosecution and maintenance. For purposes of this Article 11.2, “prosecution
and maintenance” of patents and patent applications shall be deemed to include,
requests for re-examinations, reissues or extensions of patent terms. |
| 11.2.3 | The
Licensee shall reimburse University for all reasonable out-of-pocket costs incurred by
the University after the Effective Date for the filing for, prosecution and maintenance
of the Patent Rights. Such payments shall be due thirty (30) days following receipt of
invoice by Licensee for such expenses. If Licensee elects to no longer pay the expenses
of a patent or patent application within the Patent Rights in any country, Licensee shall
notify University not less than thirty (30) days prior to such action and the license
granted to Licensee hereunder with respect to such patent or patent application shall
become nonexclusive. |
| 11.2.4 | If
Licensee elects not to file, prosecute or maintain a Patent Right
in a
country
pursuant
to its
right
under
Section
11.2.2,
then in such event, such Patent Right shall
no longer
be included
within
the Patent
Rights
licensed
hereunder. |
| 11.2.5 | Small
Entity Status – The University and the Licensee declare that, as of the Effective
Date, they both qualify for Small Entity Status for payment of patent maintenance fees
for the Territory. The Licensee acknowledges that the University has informed it that
in the event of any change that might cause the Licensee to lose its status as a small
entity, or of the signature of a sublicense contract with a sublicensee that is not a
small entity or who loses its small entity status, the patents may be invalidated in
that part of the Territory affected by the change. Consequently, the Licensee shall inform
the University without delay of any change in the status of the Licensee and/or its sublicenses. |
Any
late payment of Royalties or of any other financial consideration shall bear interest at the established Interest Rate or the
maximum rate permitted by law, computed from the payment due date to the date of receipt of payment in full.
All
payments made in accordance with the terms and conditions of the present Agreement shall be presented in the form of a cheque,
in US currency, payable to the order of Université Laval, and addressed to the attention of the Vice Rector for Research
and Innovation, one signatory of the present Agreement, at the address stipulated in Article 16.
Article 12 – ACCOUNTING
JOURNALS, REGISTERS AND REPORTS
| 12.1 | The
Licensee and each of its sublicensees shall keep and maintain proper accounting journals
and complete and exact registers concerning the license granted under the present Agreement,
indicating the number, Net Sales Price and date of sale or other similar information
concerning any other form of transfer of the Products. |
| 12.2 | The
Licensee shall present to the University, within thirty (30) days from the end of each
quarter, as stipulated in Article 11.1.2 (Quarterly payment), a report indicating the
number and Net Sales Price of all Products sold during the reporting period by the Licensee
and each of its sublicensees, together with any other information that the University
may reasonably request. The Licensee shall also present to the University, within ninety
(90) days from the end of the fiscal year, a report signed by an executive officer of
the Company, containing the number and Net Sales Price of Products sold during the reported
financial year by the Licensee and each of its sublicensees. |
| 12.3 | The
Licensee shall ensure that all journals and registers mentioned in the present Agreement
are maintained for at least five (5) years following the end of the calendar quarter
to which they pertain and available for inspection, no more than one per calendar year,
on their premises during normal working hours, upon reasonable written notice but no
earlier than 5 business days after the receipt of such written notice. The inspection
shall be conducted by an independent firm of chartered accountants, appointed by the
University and reasonable acceptable to Licensee, and shall be conducted in accordance
with the accounting procedures generally used by the Licensee as consistently applied
to all products of Licensee which procedures shall never be less stringent then those
of the International Financial Reporting Standards (IFRS) adopted by the International
Accounting Standards Board subject to such charter accountants executing a reasonable
confidentiality agreement prior to commencing any inspection. Except as otherwise expressly
provided herein, these accounting procedures must comply with generally accepted accounting
procedures. University shall bear the cost of the inspection, except that Licensee will
bear the cost of the inspection if a variation or error producing an underpayment in
Royalties or other amounts payable exceeding the greater of five percent (5%) of the
amount paid for the period covered by the inspection is established in the course of
such inspection. The chartered accountants shall limit their opinion to the University
concerning any variation or error producing an underpayment to the amounts of Royalties
or other amounts payable for the period under review. The conclusions and opinion of
these chartered accountants shall definitively bind the Licensee and the University.
Any additional payment to be made to the University or any reimbursement to be made to
the Licensee as a result of the audit, shall be payable immediately, together with interest
accrued since the initial due date at the established Interest Rate. |
Article 13 – USE
FOR EDUCATION, RESEARCH AND PUBLICATION
The
Licensee acknowledges and accepts that the University has a role of education, training and research. In respect thereof, and
insofar as adequate measures have been established to protect Intellectual Property Rights, the University is authorized to use
the Technology for its own internal teaching and research purposes, and to publish them in the normal course of the dissemination
of knowledge, including the publication of essays, master'’s theses and doctoral dissertations, provided
that University agrees to submit to Licensee for its review a copy of any proposed publication or
disclosure
of information relating to the Technology or University improvements at least thirty (30) days prior to the proposed date of submission
for publication, and agree to consider in good faith all comments received during that time. If Licensee determines that the proposed
publication or disclosure contains patentable subject matter requiring protection, in order to protect the potential patentability
of such subject matter, Licensee may require the delay of the publication for a period of time not to exceed an additional sixty
(60) days for the purpose of allowing the pursuit of such protection in accordance with the terms and conditions of Section 11.2.2
as applied to such patentable subject matter, mutatis mutandis, so that each reference to Patent Right shall be deemed a reference
to such patentable subject matter and the exercise of the option to license such patentable subject matter in accordance with
the terms and conditions of Sections 5.2 and 5.3 as applied to such patentable subject matter, mutatis mutandis, so that each
reference to University improvements shall be deemed a reference to such patentable subject matter. Further, if Licensee believes
that any such material submitted for review contains Confidential Information (as defined in Section 1.3) of Licensee, University
agrees to remove such Confidential Information from the proposed publication or disclosure.
Article 14 – PUBLICITY
The
Licensee shall not make note of the participation of the University or of University personnel in any public announcement, publicity,
or information document to be made public unless the University has signified its prior authorization, in writing, not to be unreasonably
withheld. The same shall apply in relation to any other announcement related to this license. The Licensee and the University
shall ensure that any such publicity does not convey any understanding that the University supports any product, procedure or
practice of any kind whatsoever. Notwithstanding the foregoing, the Parties shall agree upon a mutual press release to announce
the execution of this Agreement; thereafter, each Party may each disclose to any Third Party the information contained in such
press release without the need for further approval by the other Party.
Article 15 – TERMINATION
| 15.1 | Termination
without notice |
The
Agreement shall be cancelled, in accordance with the law, without notice or notification in the event of the following:
| 15.1.1 | If
the Licensee files for protection under the U.S. Bankruptcy Act or any such act concerning
insolvency and/or bankruptcy, or if any legal action pertaining to any such act, or any
other act, is filed against the Licensee; provided that if any such legal action is filed
against Licensee, this Agreement will be reinstated (wherein the effective date of reinstatement
shall be the date of automatic cancellation) under this Section 15.1 if such case is
withdrawn or dismissed within ninety (90) days of such filing. Further: (a) during such
ninety (90)-day period, University will not grant a license to any Third Party that could
preclude full reinstatement of Licensee’s rights and licenses hereunder, and (b)
University will not assert the Patent Rights against |
Licensee
resulting from Licensee’s use or sale of the Products during such ninety (90) day period, except, in the event of reinstatement,
University may pursue a claim for earned Royalties or other payments that would have otherwise been due during such ninety (90)-day
period.
| 15.2 | Termination
with notice |
Either
Party may, upon ninety (90) days following a written notice to the effect, terminate this Agreement, without prejudice to its
rights and recourses, if the other Party is in material breach of one or more of the terms and conditions of this Agreement, and
if such material breach is not corrected within ninety (90) days following written notification containing a description thereof;
Licensee may terminate this Agreement, in its entirety or as to any particular patent or patent application within the Patent
Rights, or as to any particular Product, at any time by giving University at least sixty (60) days prior written notice. From
and after the effective date of such termination under this Section 15.2 with respect to a particular patent or patent application,
such patent(s) and application(s) in the particular country shall cease to be within the Patent Rights for all purposes of this
Agreement, and all rights and obligations of Licensee with respect to such patent(s) and patent application(s) shall terminate;
from and after the effective date of a termination under this Section 15.2 with respect to particular Product, the license granted
to Licensee under Section 2.1 shall terminate with respect to such Product. For greater certainty, the parties agree that in the
event of any such termination, any payment due to University at the time of such termination shall remain to be payable to
University.
| 15.3 | Results
of Termination or Expiration |
| 15.3.1. | Notwithstanding
the termination or expiration of this Agreement in its entirety, all parties shall continue
to be bound by the applicable provisions of Article 4 – (Absence of Guarantee),
Article 6 – (Ownership), Article 10 – (Claim or Action Filed
against a third party), 11.3 (Late Payment), Article 14 – (Publicity), Article
17 – (Confidentiality) (for the period specified therein) and Article 18 –
(Claims, Responsibility and Indemnification) of the Agreement. Except as otherwise provided
in this Article 15, all rights and obligations of the parties under this Agreement shall
terminate upon the termination or expiration of this Agreement in its entirety. |
| 15.3.2. | After
the termination or expiration of this Agreement, all unpaid royalties or other financial
considerations, which at the time of such termination or expiration has already accrued,
shall be paid within thirty (30) days following the aforementioned termination or expiration,
pursuant to Article 11.1 of the Agreement. Upon expiration (but not an earlier termination)
of this Agreement, the licenses granted to Licensee under Article 2 shall become fully
paid-up royalty-free and irrevocable. |
| 15.3.3. | Upon
termination of the present Agreement in its entirety, all rights held by the Licensee
by virtue thereof, including, but not limited to the right to manufacture, sell, |
and
commercially exploit the Products in the Territory shall cease immediately, subject to the specifically authorized privilege granted
to the Licensee to sell on a non-exclusive basis its inventory of Products and to terminate the manufacturing of any products
then being manufactured. This privilege is granted for a limited period that shall terminate within six (6) months following the
termination date. Upon termination of this Agreement by University for any reason, any sublicense granted by Licensee hereunder
shall survive, provided that any such sublicensee is not in breach of its sublicense and provided further that the sublicensee
promptly, and no later than 10 business days following such termination of this Agreement, agrees in writing to be bound
by the applicable terms of this Agreement.
Article 16 – NOTIFICATION
| 16.1 | All
notices, payments, or other communications required to be made or given pursuant to the
terms of this Agreement shall be delivered to the parties by messenger or registered
mail at the addresses set forth below: |
| FOR THE UNIVERSITY: | | Thierry
Bourgeois Assistant
to the Vice President, Research and Innovation
Pavillon
des sciences de l’éducation
Université
Laval
2320,
rue des Bibliothèques, room 1482
Québec
(Québec) G1V 0A6
E-mail :
biper@vrr.ulaval.ca
Telephone :
(418) 656-2131, ext. 13506
|
| | | |
| FOR THE LICENSEE: | | Joseph Hernandez, CEO and Executive Chairman
Microlin
Bio, Inc.
135
East 57th Street 24th Floor
New
York, NY, 10022
e-mail:
jhernandez@microlinbio.com
Telephone:
646 612 4000
|
| 16.2 | Unless
otherwise stipulated within this Agreement, a notice to be delivered in accordance with
the provisions of this Agreement shall be deemed to have been received by the addressee
on the actual day of delivery, if delivered by messenger, or on the third (3rd) day following
the date of mailing, if it is delivered by registered mail. |
Article 17 – CONFIDENTIALITY
| 17.1 | Within the
limits of the present Agreement, it is agreed that the Parties may be called upon to
exchange Confidential Information. Considering the nature of this Confidential Information,
and their respective interests, the Parties agree to take all reasonable measures required
to ensure the confidential nature thereof, to prevent any inopportune disclosure thereof. |
| 17.2 | Each
Party shall use its best efforts to prevent the unauthorized disclosure, publication
or dissemination of the Confidential Information and, in any case, the effort deployed
shall not be less than the effort utilized to protect its own confidential information;
except that: (i) each Party may disclose Confidential Information of the other Party
to: (A) its employees, consultants and other persons on a need-to-know basis in accordance
with the receiving Party’s exercise of its rights or performance of its obligations
under this Agreement; provided that such persons are bound by obligations of confidentiality
and non-disclosure with respect to such Confidential Information which are substantially
similar in scope and duration as those set forth in this Article 17; and (B) its existing
and potential investors, collaborators and advisers (including financial, accounting
and legal advisers) with a need to know, under appropriate confidentiality terms; and
(ii) each party may disclose Confidential Information of the other Party to government
or regulatory authorities to the extent that such disclosure is required by applicable
law, regulation, agency or court order or is reasonably necessary in connection with
the prosecution of any patent or patent application. This Article 17 shall remain in
effect during the term of this Agreement and for five (5) years thereafter. |
| 17.3 | Neither
Party shall have any obligation for confidentiality concerning information that: |
| a) | was
already lawfully in its possession without obligations of confidentiality before it was
received from the other Party; |
| b) | is
or becomes public knowledge through no fault or action of the Party; |
| c) | is
legally received by the Party from a Third Party who has no obligation of confidentiality
with respect thereto; |
| d) | is
independently developed by the Party without using the Confidential Information delivered
under the terms and conditions of this Agreement. |
Article 18 – CLAIMS,
RESPONSIBILITY AND INDEMNIFICATION
| 18.1 | It
is specifically agreed that the University shall have no responsibility for loss incurred
by any person resulting
from
the
subsequent
use by
Licensee
or
its
sublicensees
of
the Technology licensed to the Licensee under the terms of this License Agreement, or
to any subsequent sublicensee by the Licensee. |
| 18.2 | The
Licensee shall indemnify the University and hold it harmless against any claim filed
against the University relating to the use of the Technology licensed to the Licensee,
and any subsequent sublicensee, and to any Product manufactured or sold by the Licensee
and any subsequent sublicensee by virtue of the applicable license or sublicense. |
Article 19 – ASSIGNMENT
Neither
Party shall, in any way whatsoever, assign, transfer, or dispose of its rights or obligations under this agreement without the
prior written consent of the other Party, except that Licensee may assign, transfer or dispose of its rights or obligations under
this Agreement without the prior written consent of University to a party that succeeds to all or substantially all of Licensee’s
business or
assets
relating to this Agreement whether by sale, merger, operation of law or otherwise; provided that such assignee or transferee agrees
in writing to be bound by the terms and conditions of this Agreement.
Article 20 – INDEPENDENCE
The
present Agreement shall not constitute an agency, partnership, joint venture, or temporary association between the Parties.
Article 21 – PARTIAL
INVALIDITY
If
a competent tribunal finds that one or more of the provisions of the present Agreement is invalid or unenforceable, only that
portion of the Agreement declared invalid or unenforceable shall be invalidated, and the remaining provisions and the remainder
of the present Agreement shall be integrally applied.
Article 22 – APPLICABLE
LAWS
The
Parties agree that the present Agreement shall be governed and interpreted in accordance with the laws in force in the Province
of Québec, Canada.
Article 23 – VENUE
The
Courts of the city of Québec, province of Québec, Canada, shall have jurisdiction, to the exclusion of the Courts
of any other State, in respect of any dispute, controversy or claim arising out of or in connection with this Agreement.
Article 24 – INTEGRALITY
AND MODIFICATIONS
The
present Agreement and its Appendices shall constitute the entire Agreement binding the Parties and replacing all previous oral
and written communications, representations and agreements. Moreover, any addition or modification to this present Agreement shall
be made in writing, and shall be signed by both Parties.
Article 25 – RENUNCIATION
The
failure of either of the Parties to exercise one or more of its rights on any particular occasion, as set forth in the Agreement,
shall not be interpreted as a waiver of its rights and recourses, and shall not affect either the Agreement, in any manner, or
any right set forth therein.
Article 26 – FORCE
MAJEURE
The
Parties agree that neither Party shall be held responsible for any default or delay caused by force majeure, which is defined
as an outside, unforeseeable, irresistible event. Examples of force majeure include, but are not limited to natural disasters,
fires, labour unrest, and the imposition of regulations or ordinances by government authorities.
Article 27 – SUCCESSORS
AND LEGAL REPRESENTATIVES
The
present Agreement is of benefit to both Parties and binds their respective successors, assignees, heirs and legal representatives.
Article 28 – LANGUAGE
The
Parties have expressly agreed that this Agreement be drawn up in English only. Les Parties aux présentes ont expressément
requis que la présente entente soit rédigée en anglais seulement.
Article 29 – INTERVENTION
The
following researcher Sébastien Hébert, having read the present Agreement and having accepted its terms and conditions,
insofar as they are applicable to him, hereby intervene in the present Agreement. The researcher acknowledge that he is bound
thereby and, if applicable, that he shall take whatever steps are required to ensure that all members of his team at the University
are informed of their obligations under the terms and conditions of the present Agreement.
Mrs.
Gertrude Bourdon, general director of the CHU de Québec-Université Laval, having read the present Agreement and
having accepted its terms and conditions, insofar as they are applicable to the CHU de Québec-Université Laval,
hereby agrees to the terms and conditions in the present Agreement.
IN
WITNESS WHEREOF, the Parties have signed this Agreement in Québec, in two (2) copies.
The
University:
UNIVERSITÉ
LAVAL
By:
/s/ Edwin Bourget |
|
The
Licensee:
MICROLINBIO
INC.
By:
/s/ Joseph Hernandez |
| |
| |
Edwin
Bourget
Vice-President
for Research and Innovation |
|
Joseph
Hernandez
President
and CEO |
| Date: |
|
Date: |
|
| |
|
Sébastien
Hébert
Date : |
|
| CHU
de Québec-Université Laval |
| By :
/s/ Gertrude Bourdon |
|
Gertrude
Bourdon
General
Director
Date
: |
|
APPENDIX
I
As
of the date of the signature of the present Agreement, the invention « microRNA-132/212 for the treatment of neurodegenerative
disorders » mentioned therein is more fully described by the applications for the following patents:
DESCRIPTION
OF THE INVENTION
PATENT
No. /
APPLICATION
No. |
COUNTRY |
FILING
DATE
/
DELIVERY
DATE |
COMMENT |
| 62/053308 |
United
States |
September,
22 2014 |
|
| PCT/CA2015/050931 |
PCT |
September,
22 2015 |
|
Appendix
II
Progress
report for Microlinbio
CASE
NO. [________]
Six
months ended [________]
Product:
[Description
of Product]
Product
development:
[Summary
of activities to support regulatory approval by month, year]
Preclinical
development:
[Summary
of progress of preclinical by month, year]
Clinical
development:
[Summary
of progress of clinical trials by month, year]
Regulatory
development:
[Summary
of progress of regulatory approval by month, year]
APPENDIX
III
Research
Program
Microlin Bio Inc.
Université Laval
Press release
For immediate release
Microlin Bio Signs Exclusive
License and Research Agreement with Université Laval to Develop microRNA-Based Treatments for Alzheimer’s Disease
New York, NY and Québec,
QC, February 8th, 2016 /GLOBE NEWSWIRE/ -- Microlin Bio, Inc. (Microlin) and Université Laval, today announced that
they have entered into an exclusive license and research agreement through which, Microlin and Université Laval will jointly
develop microRNA-based treatments for Alzheimer’s Diseases (AD). The program will be led by Université Laval Professor
of Neuroscience Sébastien Hébert, a renowned expert in the use of microRNA to treat AD. Microlin will hold the exclusive
worldwide license for the development and the commercialization of novel molecules and methods against certain microRNAs found
to play a role in AD.
Dr. Hébert, professor at
Université Laval’s Faculty of Medicine and researcher at the CHU de Québec Research Centre (chercheur au Centre
de recherché du CHU de Québec-Université Laval) has demonstrated that specific microRNAs can restore AD-like
pathologies and memory impairments in mice.
Microlin's CEO and Chairman, Joseph
Hernandez, said, "This agreement represents a significant milestone for the Company and greatly enhances our pipeline. The
technology we are licensing has the potential to lead to a novel AD treatment and bring relief to the millions of patients suffering
from this debilitating disease. The collaboration is in line with our strategy to in-license and develop highly promising microRNA-based
technologies with the potential to change the paradigm of medicine. Moreover, it leverages our deep microRNA expertise and expands
our current efforts, including those in oncology. We believe that this pioneering science is synergistic with our current portfolio
and compatible with Microlin's product development capabilities."
Edwin Bourget, Université
Laval’s Vice-President for research and Innovation, said, "We are pleased to be collaborating with Microlin and believe
that it is the right partner to further develop this novel therapeutic approach into a clinical application for AD patients. In
his pioneering research, Dr. Hébert has exhibited improvement in memory in AD models using microRNA-targeted therapies.
We are certain that Microlin will contribute significantly to the development of this technology and advance its clinical application.”
About Alzheimer’s Disease (AD)
AD is a type of dementia that causes problems
with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere
with daily tasks. AD is by far the most common cause of dementia in the United States and in most countries in the world. In most
people with Alzheimer’s, symptoms first appear in their mid-60s. Experts suggest that more than 5 million Americans have
AD. Unless the disease can be effectively treated or prevented, the number of people with AD will increase significantly as the
U.S. population ages.
About microRNA
MicroRNAs are recently discovered naturally
occurring RNA molecules (composed of 19 to 25 nucleotides) that do not encode proteins but instead regulate gene expression and
various biological pathways. The improper balance of microRNAs is linked to many human disorders, including cancer and neurodegenerative
diseases. As such, replacement or inhibition of deregulated microRNAs may act as a potent means to treat cancers and neurodegenerative
disease, including AD.
About Université Laval
Université Laval, located in the
world heritage city of Québec, is the first French-language university in North America. One of Canada’s top research
universities, it is ranked 6th among the country’s institutions of higher learning, with a research budget of over $325 million
last year. Université Laval boasts over 3,200 professors, lecturers, and teaching staff who share their knowledge with some
48,000 students, including 25% at the graduate level. In 2014, it was ranked first in Canada and ninth in the world for sustainable
development out of 300 STARS-accredited institutions.
About CHU de Québec-Université
Laval
CHU de Québec- Université
Laval is the most important academic health care institution in the province of Québec and one of the biggest in Canada.
The CHU de Québec-Université Laval offers general and specialized care, but mostly ultra-specialized care throughout
Eastern Quebec, which represents nearly two million persons. In partnership with Université Laval and focused on the future,
the CHU de Québec-Université Laval also has core missions in teaching, in research in many fields of excellence and
in the evaluation of health technologies and professional practices. In order to accomplish those missions, CHU de Québec
counts 13,000 employees, 1,500 doctors, dentists and pharmacists, 317 chercheurs réguliers et associés, 192 chercheurs
affiliées et 680 bénévolesesearchers. For more information, visit www2.chudequebec.ca.
About Microlin Bio, Inc. (Microlin)
Microlin Bio, Inc. is a development stage
biotechnology company focused on the development of microRNA-based therapeutics in cancer and neurodegenerative disease, including
AD. For more information, please visit www.microlinbio.com
Microlin Bio Forward-Looking Statements
This press release contains “forward-looking
statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development
and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve
inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes
and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements
in the press release should be evaluated together with the many uncertainties that affect Microlin Bio’s business and Microlin
Bio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events,
or otherwise.
Sources:
The Ruth Group
Lee Roth (investors)
646 536-7012
lroth@theruthgroup.com
Andrée-Anne Stewart
Relations médias
Direction des communications
Université Laval
418 656-3952
Andree-anne.stewart@dc.ulaval.ca
Pascale St-Pierre
Relations médias
Direction des communications
CHU de Québec-Université Laval
418 525-4387
Pascale.st-pierre@chuq.qc.ca