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Collaboration And License Agreement

Collaboration Agreement

Collaboration And License Agreement | Document Parties: NEUROBIOLOGICAL TECHNOLOGIES INC /CA/ You are currently viewing:
This Collaboration Agreement involves

NEUROBIOLOGICAL TECHNOLOGIES INC /CA/

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Title: Collaboration And License Agreement
Date: 5/12/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

Collaboration And License Agreement, Parties: neurobiological technologies inc /ca/
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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.
 
     
* * *  
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).

 

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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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