EXHIBIT 10.2
CERTAIN CONFIDENTIAL
PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“***”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT OF
1934.
Collaboration And License
Agreement
This Collaboration and License
Agreement (this “Agreement” ) is made
and entered into as of November 29, 2007 (the
“Effective Date” ) by and between Buck Institute for Age
Research , a California non-profit public benefit
corporation having a principal place of business at 8001 Redwood
Boulevard, Novato, CA 94945 (“ Institute ”), and
Neurobiological
Technologies, Inc. , a Delaware corporation having a
principal place of business at 2000 Powell Street, Suite 800,
Emeryville, California 94608 ( “NTI” ).
Institute and NTI are sometimes referred to herein individually as
a “Party” and collectively as the
“Parties.”
Recitals
Whereas , NTI is a
biotechnology company engaged in the business of in-licensing and
developing central nervous system-related drug candidates;
Whereas , Institute is a
non-profit research institute focused on aging and age-related
disease;
Whereas , Institute
possesses certain patent rights related to fibroblast growth
factor-2 ( “FGF” ) and the potential use of FGF
to treat certain human diseases;
Whereas , NTI desires to
fund, and Institute agrees to collaborate with NTI to perform,
research related to FGF in order to discover and develop
pharmaceutical products that incorporate or are based on FGF to
treat certain diseases in humans; and
Whereas , NTI desires to
obtain, and Institute is willing to grant to NTI, an exclusive,
worldwide license under Institute’s FGF patent rights and
technology resulting from the performance of the research funded by
NTI hereunder to develop and commercialize pharmaceutical products
that incorporate or are based on FGF on the terms and conditions
provided in this Agreement.
Now, Therefore , in
consideration of the foregoing and the covenants and promises
contained in this Agreement, the Parties hereby agree as
follows:
Agreement
1. Definitions.
As
used herein, the following terms shall have the following
meanings:
1.1
“Affiliate” means any entity that, directly or
indirectly, through one or more intermediates, is controlled by,
controls, or is under common control with NTI or Institute, as the
case may be, as of or after the Effective Date. For purposes of
this definition only, the term “control” means the
possession of the power to direct or cause the direction of the
management and policies of an entity, whether by ownership of
voting stock or partnership interest, by contract or otherwise,
including direct or indirect ownership of more than fifty percent
(50%) of the voting interest in the entity in question; provided,
however, that if local law requires a minimum percentage of local
ownership, control will be established by direct or indirect
beneficial ownership of one hundred percent (100%) of the maximum
ownership percentage that may, under such local law, be owned by
foreign interests.
1.2
“Claims” has the meaning set forth in
Section 9.1.
1.3
“Clinical Candidate” shall mean a Product candidate
for which NTI has initiated the preparation of an IND.
1.4
“Commercially Reasonable Efforts” means, as applied
to a Party, those efforts and diligence (including with respect to
the allocation of resources and personnel) consistent with the
reasonable efforts and diligence that would be typically exerted by
a biotechnology or pharmaceutical company in a similar circumstance
in pursuing the research, development, and commercialization of
products of similar nature and comparable market potential. With
respect to NTI, NTI shall be deemed to be using Commercially
Reasonable Efforts as long as it is expending not less than $
* * *
per year on Product development during the period from the end of
the Research Program Term until the initiation of the first Phase
II Clinical Trial of a Product and thereafter not less than $* * *
per year on Product development until the completion of the first
Phase III Clinical Trial of a Product.
1.5
“Control” or “Controlled” means
the ability and the right of a Party to grant a license or
sublicense as provided for herein to the other Party without either
(a) creating an obligation of such Party to make any payments
to any Third Party in consideration therefor, or (b) violating
the terms of any agreement or other arrangement with any Third
Party.
1.6
“Damages” means any and all costs, losses, claims,
liabilities, fines, penalties, damages and expenses, court costs,
and reasonable fees and disbursements of counsel, consultants, and
expert witnesses incurred by a Party hereto (including any interest
payments which may be imposed in connection therewith).
1.7
“FDA” means the United States Food and Drug
Administration or any successor thereto having the administrative
authority to regulate the investigation, development, and marketing
of human pharmaceutical products in the United States.
1.8
“First Commercial Sale” means, with respect to a
Product, the first sale of such Product by NTI or its Sublicensees
to a Third Party following receipt of Marketing Authorization in
the country or territory of sale; provided, however, that Product
shipped by NTI or its Sublicensees to a Third Party prior to
receipt of Marketing Authorization therefor in a particular country
or territory where such Product is intended for sale shall be
deemed for the purposes hereof a First Commercial Sale to the
extent such Product is sold to a Third Party for sale in that
country or territory after such Marketing Authorization is
obtained.
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Confidential Information,
indicated by [***], has been omitted from this filing and filed
separately with the Securities and Exchange Commission.
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1.9
“FTE” means the full-time equivalent effort, based
on an employee working one thousand eight hundred eighty (1,880)
hours per year, of one employee who participates directly in the
research and development activities contemplated under this
Agreement and who has appropriate scientific or technical expertise
given his/her responsibilities under the Research Plan.
1.10
“Good Laboratory Practices” or
“GLP” means the regulations set forth in 21
C.F.R. Part 58 and the requirements thereunder imposed by the
FDA, and the equivalent thereof in jurisdictions outside the United
States.
1.11
“IND” means an investigational new drug application
and associated documents required to be filed with the FDA or a
comparable government agency outside of the United States to obtain
approval to commence human clinical trials of a Product.
1.12
“Information” means any data, results, and
information of any type whatsoever, in any tangible or intangible
form, including, without limitation, know-how, trade secrets,
practices, techniques, methods, processes, inventions (patentable
or otherwise), developments, specifications, formulations,
formulae, materials or compositions of matter of any type or kind,
technology, test data including pharmacological, biological,
chemical, biochemical, toxicological, preclinical and clinical test
data, analytical and quality control data, stability data, studies,
and procedures.
1.13
“Institute’s Patent Rights” means the
Institute’s Ellerby Patent Rights and the Institute’s
Greenberg Patent Rights.
1.14
“Institute’s Ellerby Patent Rights” means
(a) U.S. provisional patent application serial number
60/701,752, and any U.S. non-provisional patent application
claiming the benefit of or priority to U.S. provisional patent
application serial number 60/701,752, including all continuations
and divisions thereof; (b) International patent application
serial number PCT/US2006/028680 and any U.S. non-provisional patent
application claiming the benefit of or priority to
PCT/US2006/028680 including any continuations and divisionals
thereof, (c) continuations-in-part applications filed at any time
during the term of the Agreement, to the extent they claim subject
matter specifically described in the patent applications in
(a) and (b); (d) U.S. patents issuing from any of the
patent applications set forth in (a), (b) and (c), including,
without limitation, all extensions, registrations, confirmations,
reissues, substitutions, revalidations, reexaminations, renewals,
or any like filings thereof; and (e) all counterparts to any
of the foregoing patents and patent applications set forth in (a),
(b), (c) and (d) filed in or issued by any country or
jurisdiction other than the United States.
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1.15
“Institute’s Greenberg Patent Rights” means
(a) U.S. provisional patent application serial number
60/357,310, and any U.S. non-provisional patent application
claiming the benefit of or priority to U.S. provisional patent
application serial number 60/357,310 (including U.S. patent
application serial number 10/503,786), including all continuations
and divisions thereof; (b) International patent application
serial number PCT/US2003/004575 and any U.S. non-provisional patent
application claiming the benefit of or priority to
PCT/US2003/004575 (including U.S. patent application serial number
10/503,786), and including any continuations and divisionals
thereof, (c) continuations-in-part applications filed at any
time during the term of the Agreement, to the extent they claim
subject matter specifically described in the patent applications in
(a) and (b); (d) U.S. patents issuing from any of the
patent applications set forth in (a), (b) and (c), including,
without limitation, all extensions, registrations, confirmations,
reissues, substitutions, revalidations, reexaminations, renewals,
or any like filings thereof; and (e) all counterparts to any
of the foregoing patents and patent applications set forth in (a),
(b), (c) and (d) filed in or issued by any country or
jurisdiction other than the United States
1.16
“Joint Program Inventions” has the meaning set
forth in Section 6.1.
1.17
“Joint Research Committee” or
“JRC” has the meaning set forth in
Section 2.1(a).
1.18
“Marketing Authorization” means the requisite
governmental approval for the marketing and sale of a Product in a
given country or territory.
1.19
“NDA” means a New Drug Application filed with the
FDA or any equivalent filed with the regulatory authorities in any
country or territory other than the United States to obtain
approval for the marketing and sale of a Product in such country or
territory, but excluding any pricing or reimbursement
approvals.
1.20
“Net Sales” means the amount received by NTI or
Sublicensees for the sale of Products, less the following:
(a) customary trade and quantity discounts actually allowed
and taken; (b) allowances actually given for returned Product;
(c) freight and insurance, if separately identified on the
invoice; and (e) value added tax, sales, use, or turnover
taxes, excise taxes, and customs duties included in the invoiced
price. In addition, Net Sales by NTI or Sublicensees hereunder are
subject to the following:
(a) In the case of pharmacy incentive programs,
hospital performance incentive program charge backs, disease
management programs, similar programs, or discounts on
“bundles” of products, all discounts and the like shall
be allocated among products on the basis on which such discounts
and the like were accrued, or if such basis cannot be determined,
proportionately to the list prices of such products;
(b) In the case of any sale or other disposal of
Product by NTI or Sublicensees to an affiliated party for resale,
the Net Sales shall be calculated as above on the value charged or
invoiced on the first arm’s length sale to a Third Party;
and
(c) If NTI or Sublicensees make a sale or other
disposal of Product to a customer in a particular country other
than on normal commercial terms or as part of a package of products
and services, the Net Sales of that Product shall be deemed to be
“the fair market value” of such Product (i.e., the
value that would have been derived had said Product been sold as a
separate product to a similar customer in the country concerned on
normal commercial terms).
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1.21
“Patent” means (a) issued and unexpired U.S.
patents including, without limitation, any extension, registration,
confirmation, reissue, substitution, revalidation, reexamination,
renewal, or any like filing thereof, (b) pending patent
applications, including without limitation any provisional,
continuation, division, or continuation-in-part thereof, and
(c) all counterparts to any of the foregoing issued by or
filed in any country or jurisdiction other than the United
States.
1.22
“Phase II Clinical Trial” means a human clinical
trial conducted in any country that is intended to initially
evaluate the effectiveness of a pharmaceutical product for a
particular indication or indications in patients with the disease
or indication under study, or that otherwise satisfies the
requirements of 21 CFR 312.21(b) or its foreign equivalent.
1.23
“Phase III Clinical Trial” means a pivotal human
clinical trial conducted in any country that satisfies the
requirements of 21 CFR 312.21(c) or its foreign equivalent, which
trial is designed to (a) establish that a pharmaceutical
product is safe and efficacious for its intended use,
(b) define warnings, precautions, and adverse reactions that
are associated with the product in the dosage range to be
prescribed; and (c) support Marketing Authorization of such
product.
1.24
“Principal Investigator” has the meaning set forth
in Section 2.3.
1.25
“Product” means any product (including, without
limitation, (i) a member of the FGF family (for example,
FGF-2, FGF-4, etc.) or a fragment or derivative thereof, or
(ii) a functional mimetic of a member of the FGF family), the
manufacture, use, importation, offer for sale, or sale of which
would constitute a misappropriation and/or infringement of Program
Technology or Institute’s Ellerby Patent Rights but for a
license thereunder.
1.26
“Program Inventions” means Joint Program Inventions
and Sole Program Inventions.
1.27
“Program Know-How” means Information, whether or
not patentable, that is conceived, generated, discovered, or
created by one or both Parties or their Affiliates, or by any Third
Party working on behalf of one or both Parties or their Affiliates,
at any time during the Research Program Term as a direct result of
the performance of the activities under the Research Program.
Program Know-How shall include Results and Program Inventions and
shall exclude Program Patents.
1.28
“Program Patents” means all Patents owned or
Controlled by either Party or both Parties that are directed to,
and claim an invention that is, Program Know-How. For clarity,
Program Patents only includes Patents owned or Controlled by either
Party or both Parties after the Effective Date, and does not
include Patents owned or Controlled by a Party as of the Effective
Date.
1.29
“Program Technology” means the Program Know-How and
Program Patents.
1.30
“Research Program” means the research and
development program to be conducted by the Parties in accordance
with the Research Plan under this Agreement to discover, research
and/or develop Products for the prevention or treatment of disease
in humans.
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1.31
“Research Program Term” has the meaning set forth
in Section 2.6.
1.32
“Research Plan” means the plan for conducting the
Research Program attached hereto as Exhibit B , as it
may be amended or updated from time to time in accordance with
Section 2.5.
1.33
“Results” means any research, preclinical,
clinical, development, or testing results, data, and related
Information generated, developed, created, or originated by or for
Institute or NTI in connection with the Research Plan or Research
Program.
1.34
“Sole Program Inventions” has the meaning set forth
in Section 6.1.
1.35
“Sublicensee” means any person or entity, including
Affiliates, to which a Party or such Party’s sublicensee
grants a sublicense under the intellectual property rights licensed
to such Party under this Agreement (a) to perform any portion
of such Party’s activities under the Research Program in
accordance with Section 2.11, (b) to research and/or
develop a Product, or (c) to make, have made, use, sell, offer
for sale and/or import a Product (which, for the purposes hereof,
will include the right to distribute, market, or promote a
Product).
1.36
“Third Party” means any person or entity other than
NTI, Institute, or an Affiliate or Sublicensee of either of
them.
1.37
“Valid Claim” means either: (a) a claim of an
issued and unexpired patent that has not been (i) canceled
with prejudice, (ii) been declared invalid by an irreversible
and unappealable decision of a court or other appropriate body of
competent jurisdiction, (iii) admitted to be invalid or
unenforceable through disclaimer or otherwise, or
(iv) abandoned; or (b) a claim of a pending patent
application filed and kept pending in good faith and that has not
been (i) canceled with prejudice, (ii) withdrawn from
consideration without the ability to resubmit or refile, (iii)
finally determined to be unallowable by the applicable governmental
authority (and from which no appeal is or can be taken), or
(iv) abandoned.
2. Research
Program.
2.1 Joint
Research Committee.
(a) Membership. Within ten (10) days after the
Effective Date, the Parties shall form a joint committee (the
“Joint Research Committee” or
“JRC” ) that shall oversee and direct the
collaborative research activities being conducted by the Parties
under the Research Program. Each Party shall appoint three
(3) representatives to be such Party’s members of the
JRC. Each Party shall select a co-chairperson of the JRC. A Party
may change any of its appointments to the JRC at any time upon
giving written notice to the other Party.
(b) Responsibilities. The JRC shall be responsible for
the day-to-day management of the Research Program. The JRC has the
following duties: (1) preparing updates, amendments, and
revisions to the Research Plan; (2) overseeing and directing
the conduct of the work under the Research Plan;
(3) prioritizing activities under the Research Program;
(4) reviewing the budget contained in the Research Plan,
proposed expenditures, and actual expenditures in connection with
the Research Program; and (5) reviewing results from
activities conducted under the Research Program.
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The
Parties may also mutually agree in writing that the JRC shall have
additional specified responsibilities. All decisions of the JRC
shall be by unanimous consent of its members. In the event that the
JRC cannot reach a unanimous decision with respect to a particular
matter, such matter shall be referred to a senior executive of each
Party who shall promptly meet and endeavor to reach mutually
acceptable resolution in a timely manner. In the event that such
persons cannot resolve the issue, NTI shall have the right to
resolve the issue in its reasonable discretion, except that such
resolution shall not place any additional obligations on Institute.
For the avoidance of doubt, the JRC shall not have the authority to
amend or modify any term or condition of this Agreement or make any
determinations regarding whether a Party has breached this
Agreement. For the avoidance of doubt, once NTI has selected a
Clinical Candidate, NTI shall be solely responsible for directing
and overseeing further development.
2.2 JRC
Meetings. The JRC shall meet, either in person or by
videoconference, at least once per calendar quarter during the
Research Program Term, and shall have its final meeting three (3)
months after the expiration of the Research Program Term. At least
every six (6) months, the agenda of the JRC meeting shall
include the review of any inventions arising from the
Parties’ conduct of the Research Program. The Parties also
may conduct informal exchange of information as needed by
electronic mail or videoconference to communicate regarding the
Research Program. Attendance and participation in JRC meetings
shall be at the respective expense of the participating Parties.
The co-chairpersons of the JRC shall work together cooperatively to
assure that an agenda is prepared and circulated to the JRC members
at least ten (10) days before each JRC meeting, and shall
assure that minutes are prepared for each JRC meeting and
circulated to each Party. The Parties will alternate responsibility
for the preparation of minutes of each committee meeting. The
co-chairpersons will review and approve JRC minutes before they
become effective. The first meeting of the JRC shall occur not
later than thirty (30) days after the Effective Date. Each
Party will use diligent efforts to cause all of its JRC
representatives to attend all JRC meetings. Each Party also may
allow a reasonable number of its other employees to attend specific
JRC meetings as non-voting participants, if reasonably useful to
the functioning of the JRC and the Research Program.
2.3
Principal Investigators. Each Party shall appoint a principal
investigator reasonably acceptable to the other Party (each, a
“Principal Investigator” ) who shall serve as
the primary point of communication and coordination between the
Parties with respect to the Research Program and shall be
responsible for such Party’s internal day-to-day activities
under the Research Program. Subject to the foregoing, each Party
shall have the right to replace its Principal Investigator from
time to time with another individual reasonably acceptable to the
other Party by providing prior written notice to the other Party.
The initial Principal Investigators are listed on
Exhibit A . During the Research Program Term, the
Principal Investigators shall meet to discuss the progress of the
respective activities of each Party under the Research Program at
least monthly in person, by phone, or by video conference. Each
meeting of the JRC shall be considered a meeting of the Principal
Investigators for purposes of the foregoing. Each Principal
Investigator shall be responsible for: (a) monitoring progress
against the Research Plan; (b) receiving and submitting
requests for information, materials, and/or assistance between the
Parties; (c) coordinating the preparation of, and providing,
all proposed updates or amendments to the Research Plan to the JRC;
and (d) performing such other activities as requested by the
JRC.
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2.4
Undertaking and Scope of Research Program. Subject to the terms
and conditions set forth herein, the Parties agree to conduct the
Research Program concerning the discovery, research, and
pre-clinical development of Products on a collaborative basis
during the Research Program Term. Each Party shall use diligent
efforts to perform its responsibilities set forth in the Research
Plan, including by using diligent efforts to meet the schedule and
budget set forth therein. Each Party shall conduct all of its
activities under the Research Plan in a good, scientific manner,
and in compliance in all material respects with the requirements of
applicable laws, rules, and regulations, including, where
applicable, GLP, to attempt to achieve the objectives under the
Research Plan efficiently and expeditiously. Each Party shall
ensure that all individuals performing work by or on behalf of such
Party shall be reasonably qualified.
2.5
Research Plan. The specific research and development activities
to be performed by each Party in connection with the Research
Program, and the applicable timelines and budget (with respect to
Institute) for such activities, shall be defined in a detailed
Research Plan. Each Party agrees to conduct its activities under
the Research Program in accordance with the Research Plan, as such
plan may be modified or updated by the JRC. The initial Research
Plan for the first year of the Research Program Term is attached
hereto as Exhibit B . The JRC will review the Research
Plan for each year on at least a semiannual basis during the course
of the year to determine if any changes are necessary given the
progress and results of the Research Program as of such date. The
JRC shall be responsible for reviewing and approving changes to the
Research Plan. If the Parties agree to extend the Research Program
Term as contemplated in Section 2.6, the Parties shall work
collaboratively in an effort to propose to the JRC, no later than
ninety (90) days prior to the beginning of the extended Research
Program Term, an updated Research Plan, including an updated
budget, covering the additional year of the Research Program Term.
Additionally, subject to the minimum funding requirements set forth
in Section 5.1, each Party shall have the right to request
changes to the Research Plan at any time. In the event that a Party
desires a change to the Research Plan, it shall submit to the JRC a
proposed Research Plan for approval. The JRC shall promptly review
each such proposal and approve it, reject it, and/or propose
modifications thereto. All updated and modified Research Plans
shall become effective only to the extent approved in writing by
the JRC. If any change or update is not approved, then the
pre-existing Research Plan shall remain in effect. Notwithstanding
the foregoing, any extension of the Research Program Term in
accordance with Section 2.6 shall remain contingent upon the
approval in writing by the JRC of an updated Research Plan and
budget covering the additional one (1) year extension period
prior to the expiration of the then-current Research Program
Term.
2.6
Research Program Term. The Research Program shall, unless
earlier terminated as provided in this Section 2.6, be
conducted for an initial period of one (1) year commencing on
the Effective Date (such period, the “Research Program
Term” ). The Research Program Term may be extended twice,
each for an additional one (1) year period, only upon a
written extension signed by authorized representatives of each
Party within at least one hundred twenty (120) days prior to
the expiration of the then-current Research Program Term; provided,
however, that any such extension shall be contingent upon the
approval in writing by the JRC in accordance with Section 2.5
of an updated Research Plan covering the additional one
(1) year period prior to the expiration of the then-current
Research Program Term.
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NTI
may terminate the Research Program upon sixty (60) days’
written notice at any time during the Research Program Term if
either (a) NTI has selected a Clinical Candidate and has
generated substantially all of the data necessary to support the
filing of an IND for such Clinical Candidate or (b) it
reasonably determines that substantially all of the key objectives
for the Research Program as set forth in the Research Plan cannot
be substantially met. In addition, the JRC may terminate the
Research Program at any time during the Research Program Term if it
unanimously determines the Research Program is no longer
scientifically useful or that all potential Products would not be
commercially viable. In the event that either the Research Program
Term is terminated as permitted herein or the Research Program
Term, as it may be extended, expires prior to the three
(3) year anniversary of the Effective Date and, in each case,
a Clinical Candidate does not exist at the time of such termination
or expiration, this Agreement shall automatically terminate.
2.7
Personnel. The scientific priorities and direction for the
Research Program will be determined by the JRC. Unless otherwise
agreed in writing by the Parties, Institute shall dedicate two
(2) FTEs to performing Institute’s responsibilities
under the Research Plan during the Research Program Term. NTI shall
provide sufficient FTEs to conduct its obligations and activities
under the Research Program.
2.8
Research Materials. Except pursuant to the licenses expressly
granted to a Party pursuant to this Agreement, each Party shall use
all materials and other Information provided by or on behalf of the
other Party solely as necessary to perform its responsibilities
under the Research Program. Without limiting the foregoing, each
Party shall use all biological materials in a safe manner and in
compliance with applicable federal, state, and local laws and
regulations, including National Institutes of Health guidelines.
Each Party acknowledges that the other Party cannot and does not
guarantee the safety, non-toxicity, fitness, or efficacy of any
biological materials provided by the other Party, and each Party
accepts any and all risk resulting from its use of biological
materials provided to it by the other Party. All quantities of
biological materials including, without limitation, all Products
provided by a Party to the other are experimental in nature, are
not for use in humans, AND ARE PROVIDED “AS IS” AND
WITHOUT ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED.
2.9
Records. Each Party shall maintain complete and accurate
records (including those records required by law or regulation) of
all work conducted by or on behalf of such Party under the Research
Program and all Information generated by or on behalf of such Party
under the Research Program. Such records shall be complete and
accurate, and shall fully and properly reflect all work done and
results achieved in the performance of the Research Program in
sufficient detail and in good scientific manner appropriate for
patent and regulatory purposes.
2.10
Reports. During the conduct of the Research Program, each Party
shall report to the JRC at each JRC meeting the results of its work
under the Research Program. Each Party also will prepare and submit
to the other Party and the JRC an annual written progress report
summarizing the work performed by such Party under the Research
Plan and the results thereof.
2.11 Use of
Third Party Contractors. Each Party may contract its activities
under the Research Program to consultants and contractors, but only
if and to the extent approved by the JRC in writing. Each Party
shall manage and coordinate the services of its approved
consultants and contractors and shall bear full responsibility for
the performance or non-performance of any duties delegated thereto,
including without limitation compliance with the confidentiality
provisions of this Agreement.
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2.12
Disclaimer of Warranty. NEITHER PARTY PROVIDES ANY WARRANTY,
EITHER EXPRESS OR IMPLIED, REGARDING THE RESEARCH PLAN, THE PROGRAM
TECHNOLOGY, OR ANY PRODUCT OR DELIVERABLE PROVIDED PURSUANT TO THE
RESEARCH PLAN, AND EACH PARTY HEREBY DISCLAIMS ALL EXPRESS AND
IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION THE IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
AND NON-INFRINGEMENT.
3. License
Grants.
3.1
Research License. Each Party hereby grants to the other Party a
non-exclusive license to practice the Patents and Information
Controlled by such Party solely as necessary for such other Party
to perform its responsibilities under the Research Program in
accordance with the Research Plan during the Research Program Term.
Without limiting any rights and licenses granted in any other
portion of this Agreement, it is understood and agreed that this
Section 3.1 does not grant to a Party any right or license
under the other Party’s Patents and Information to: (a)
manufacture, distribute, sell, or otherwise provide any commercial
products or services using or based upon any such Patents or
Information; or (b) perform any activities outside the
Research Plan or after the termination or expiration of the
Research Program Term. Neither Party may grant sublicenses under
the foregoing research licenses without the prior written consent
of the other Party, which consent shall not be unreasonably
withheld or delayed.
3.2 License
to NTI. Subject to the terms and conditions of this Agreement
and the retained rights specified in Section 3.3 below,
Institute hereby grants to NTI an exclusive, worldwide,
royalty-bearing license under all of Institute’s right,
title, and interest in, to, and under the Institute’s Patent
Rights and the Program Technology to make, have made, use, import,
offer for sale, and sell Products. NTI shall have the right to
grant sublicenses under the foregoing licenses subject to the
provisions of this Section 3.2. If NTI grants any such
sublicense, NTI shall promptly disclose to Institute the identity
of the Sublicensee. NTI shall ensure that all sublicenses granted
by NTI hereunder are consistent with the terms and conditions of
this Agreement. NTI may grant sublicenses through multiple tiers of
Sublicensees consistent with this Agreement to its Affiliates and
to Third Parties if NTI is responsible for the activities of such
Sublicensees with respect to the Institute Patent Rights, Program
Technology, and Products as if the activities were carried out by
NTI, including the payment of royalties due to Institute hereunder,
whether or not such amounts are paid to NTI by a Sublicensee. NTI
must deliver to Institute a true and correct copy of each
sublicense granted by NTI as permitted herein, and any modification
or termination thereof, within thirty (30) days after
execution, modification, or termination (which copy may only be
redacted to delete information not relevant to determining whether
such sublicense is consistent with the provisions of this
Agreement).
10
3.3
Retained Rights. For clarity, the license rights granted to NTI
in Section 3.2 shall be subject to the retained rights of the
Institute to: (a) perform the Research Program in accordance
with the Research Plan during the Research Program Term;
(b) use and practice the Institute’s Patent Rights and
Program Technology solely for educational and non-commercial
research purposes; (c) exploit any rights under the
Institute’s Greenberg Patent Rights except for the rights
granted to NTI hereunder related to Products; and (d) publish
the general scientific findings from research related to the
Institute Patent Rights and Program Technology, subject to the
provisions of Sections 10 and 11.3. In addition, because the
Institute Patent Rights have been developed, at least in part, with
funding from the United States Government, the licenses granted to
NTI under this Agreement are subject to the United States
Government’s rights under the Bayh-Dole Act, as codified at
35 U.S.C. §§ 200-212 (the “Act” ) and
all regulations implementing the Act. Each Party retains
exclusively all its rights in all its Patents, Information and
other intellectual property rights, and grants the other Party no
rights therein (implied or otherwise), other than the license
rights expressly granted in this Agreement.
3.4 Mutual
Covenant. Each Party covenants that it will not use or practice
any of the other Party’s intellectual property rights
licensed under this Section 3 except for the purposes
expressly permitted in the applicable license grant.
4. Diligence.
4.1 General
Diligence Requirements. NTI covenants to Institute that it,
either on its own or through its Affiliates or Sublicensees, shall,
at its own expense, use Commercially Reasonable Efforts to develop,
seek Marketing Authorization for, and commercialize at least one
Product worldwide. As between the Parties, NTI shall be
responsible, at its expense, for all development and manufacturing
activities, for the preparation, filing, and maintenance of NDAs
for Products in each country worldwide, and commercializing
Products. By January 31 of each calendar year for the term of
this Agreement, NTI shall provide Institute a written report of its
activities in this regard during the preceding calendar year, and a
summary of any such activities for the upcoming year.
4.2
Specific Diligence Requirements. NTI shall, either on its own
or through its Affiliates or Sublicensees, (a) * * * within * * *
after the termination or expiration of the Research Program Term,
(b) * * * within * * * after the termination or expiration of the
Research Program Term, (c) * * * within * * * after the termination
or expiration of the Research Program Term, and (d) * * * within *
* * after the termi
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