EX-10.28 LICENSE AND COLLABORATION AGREEMENT

 

1.3          “Affiliate” shall mean (i) any corporation or business entity of which more than fifty percent (50%) (or if the jurisdiction where such entity is domiciled prohibits foreign ownership of such entity, the maximum foreign ownership interest permitted under such laws, provided that Merck or Metabasis actually controls such entity) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by Merck or Metabasis; or (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds more than fifty percent (50%) (or if the jurisdiction where such entity is domiciled prohibits foreign ownership of such entity, the maximum foreign ownership interest permitted under such laws, provided that such entity actually controls Merck or Metabasis) of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of Merck or Metabasis; or (iii) any corporation or business entity of which more than fifty percent (50%) (or if the jurisdiction where such entity is domiciled prohibits foreign ownership of such entity, the maximum foreign ownership interest permitted under such laws, provided that the owning entity actually controls the owned entity) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a corporation or business entity described in (i) or (ii).

 

1.4          “Alliance Manager” shall have the meaning set forth in Section 2.9.

 

1.5          “Biological Target” shall mean AMP-activated protein kinase.

 

1.6          “Calendar Quarter” shall mean each respective period of three (3) consecutive months ending on March 31, June 30, September 30 and December 31.

 

1.7          “Calendar Year” shall mean each respective period of twelve (12) months commencing on January 1 and ending on December 31.

 

1.8          “[***] Technology” shall mean (a) any and all [***] of a [***]; and/or (b) any method of making or using any of the foregoing.

 

1.9          “Change of Control” shall mean with respect to a party:  (a) a sale of all or substantially all of such party’s assets or business relating to this Agreement; (b) a merger, reorganization or consolidation involving a party in which the stockholders of such party immediately prior to such transaction cease to own collectively a majority of the voting equity securities of a successor entity; or (c) a person or entity, or group of persons or entities, acting in concert acquire 50% or more of the voting equity securities or management control of such party, except for a bona fide equity financing with arm’s-length financial investors.

 

1.10        “Clinical Trial” shall mean a Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial, or any studies conducted following Marketing Authorization that include the administration of Product to humans.

 

1.11        “Collaboration” shall have the meaning provided in Section 2.1.

 

1.12        “Collaboration Compound” shall mean any compound [***], the primary mechanism of action of which is [***], and that is in the Control of [***] during the [***] (in

 

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each case, whether or not identified or synthesized [***] and/or whether or not identified or synthesized [***]).

 

1.13        “Combination Product” shall mean a Product which includes one or more pharmaceutically active ingredients other than Collaboration Compound(s) in addition to Collaboration Compound(s).  All references to Product in this Agreement shall be deemed to include Combination Product.

 

1.14        “Competitive Product” shall mean, with respect to a Product being commercialized by or on behalf of a Related Party in a particular country, any preparation in final form being commercialized by a non Related Party in such country [***], delivered by the same route of administration as such Product, whether for sale by prescription, over-the-counter or any other method.

 

1.15        “Compulsory License” shall mean, in the case of a Product, a compulsory license obtained by a Third Party through the order, decree or grant of a Regulatory Authority, authorizing such Third Party to manufacture, use, sell, offer for sale or import such Product in a particular country.

 

1.16        “Confidential Information” shall have the meaning provided in Section 9.1.

 

1.17        “Control” shall mean, with respect to any Know-How, Information, Patent or other intellectual property right, possession by a party of the ability (whether by ownership, license or otherwise) to grant access, a license or a sublicense to such Know-How, Information or intellectual property right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.18        “Co-Promotion Option” shall have the meaning provided in Section 3.6.

 

1.19        “Co-Promotion Territory” shall mean the USA.

 

1.20        “[***]” shall have the meaning provided in Exhibit A hereto.

 

1.21        “Estimated Product Launch Date” shall have the meaning provided in Section 3.6.

 

1.22        “European Market” shall mean: (a) any one of the following countries: the United Kingdom, France, Germany, Italy or Spain; or (b) the European Union as a whole.

 

1.23        “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the USA.

 

1.24        “Field” shall mean the use of Collaboration Compounds for all human and animal uses.

 

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1.25        “First Commercial Sale” shall mean, with respect to any Product, the first sale for end use or consumption of such Product in a country, excluding, however, any sale or other distribution for use in a Clinical Trial.

 

1.26        “Full Time Equivalent” or “FTE” shall mean the equivalent of a full-time scientist’s work time over a twelve-month period (including normal vacations, sick days and holidays).  The portion of an FTE year devoted by a scientist to the Collaboration shall be determined by dividing the number of full days during the applicable twelve-month period devoted by such employee to the Collaboration by the total number of working days during such twelve-month period.

 

1.27        “FTE Rate” shall mean the amount Merck will pay Metabasis during the Research Term to support one (1) Metabasis FTE dedicated to the Collaboration.  The FTE Rate will be [***] per FTE.  The FTE Rate shall include all personnel, equipment, reagents and all other expenses including support staff and overhead for or associated with an FTE; provided, however, that payment by Merck of the FTE Rate shall not be deemed to give Merck any ownership interest in any equipment, reagents or other property purchased by Metabasis using such funding.

 

1.28        “Good Laboratory Practices” or “GLP” shall mean current Good Laboratory Practices regulations as promulgated by the FDA.

 

1.29        “HepDirect Technology” shall mean (a) any and all [***] that are activated by any [***] and/or (b) any method of making or using any of the foregoing.

 

1.30        “HepDirect[ *** ] Patents” shall mean Metabasis Patents claiming any Invention directed to HepDirect Technology or [***] Technology either (a) having an effective priority date for such Invention that is before the Effective Date; or (b) having an effective priority date for such Invention that is after the Effective Date but that (i) do not claim the composition of matter of or a method of use for a Preclinical Candidate, or (ii) do not specifically claim a method of manufacture of a Preclinical Candidate.

 

1.31        “IND” shall mean an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

 

1.32        “IND-Enabling GLP Toxicology Studies” shall mean genotoxicity, acute toxicology, safety pharmacology, and sub-chronic toxicology studies, in species that satisfy applicable regulatory requirements, using applicable GLPs, that meet the standard necessary for submission as part of an IND filing with a Regulatory Authority.

 

1.33        “Indication” means a separate and distinct disease or medical condition in humans for which a Product has received Marketing Authorization, meaning that such Indication is contained in the Product’s labeling approved by a Regulatory Authority as part of the Marketing Authorization for such Product.  The parties agree that: (i) [***]; (ii) the [*** ]( e.g. , [***]); and (iii) the [***] ( e.g. , [***]).

 

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1.34        “Information” shall mean any and all information and data, including without limitation Merck Know-How, Metabasis Know-How, and all other scientific, preclinical, clinical, regulatory, manufacturing, marketing, financial, legal, and commercial information and data, whether communicated in writing or orally or by any other method, which is provided by one party to the other party in connection with this Agreement.

 

1.35        “Initiates” shall mean, with respect to a Clinical Trial, the administration of the first dose to the first human in such Clinical Trial.

 

1.36        “Invention” shall mean any process, method, composition of matter, article of manufacture, discovery or finding, whether or not patentable.

 

1.37        “Joint Development Committee” and “JDC” shall have the meaning provided in section 3.2.

 

1.38        “Joint Research Committee” and “JRC” shall have the meaning provided in Section 2.2.

 

1.39        “Joint Information and Inventions” shall mean all protocols, formulas, data, Inventions, Know-How, and trade secrets, patentable or otherwise, resulting from the Collaboration developed or invented jointly by at least one employee of Merck or others acting on behalf of Merck and at least one employee of Metabasis or others acting on behalf of Metabasis, during the Research Term [***], where inventorship of an Invention, whether patentable or not, is to be determined in accordance with the patent laws of the USA.

 

1.40        “Jointly-Owned Off-Target Compound” shall mean any compound within the Joint Information and Inventions the primary mechanism of action of which is [***].

 

1.41        “Joint Patents” shall mean all Patents that claim Joint Information and Inventions.

 

1.42        “Joint Technology” shall mean Joint Information and Inventions and Joint Patents.

 

1.43        “Know-How” shall mean all tangible and intangible (a) techniques, technology, practices, trade secrets, Inventions, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results and descriptions, software and algorithms and (b) compounds, compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical materials.

 

1.44        “Major Market” shall mean the USA, the European Union or Japan.

 

1.45        [ ***]

 

1.46        [ ***]

 

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1.47        “Marketing Authorization” shall mean all approvals from the relevant Regulatory Authority in a country or other regulatory jurisdiction (including without limitation all applicable pricing and governmental reimbursement approvals) that are necessary to market and sell a Product for human use in such country or regulatory jurisdiction.

 

1.48        “Materials” shall have the meaning provided in Section 2.8.

 

1.49        “Merck Information and Inventions” shall mean all protocols, formulas, data, Inventions, Know-How, and trade secrets, patentable or otherwise, resulting from the Collaboration that are [***] for the research, development, manufacture, marketing, use or sale of any Collaboration Compound or Product in the Field and are developed solely by employees of Merck or others acting on behalf of Merck during the Research Term [***].

 

1.50        “Merck Know-How” shall mean all Know-How that during the Term (i) is in Merck’s Control, (ii) is not generally known and (iii) is [***] for the conduct of the Collaboration and/or the research, development, manufacture, marketing, use or sale of any Collaboration Compound or Product in the Field.

 

1.51        “Merck Patents” shall mean, to the extent Controlled by Merck as of the Effective Date or during the Term, all Patents that are [***] for the development, manufacture, use or sale of any Collaboration Compound or Product in the Field, but excluding the Joint Patents.

 

1.52        “Merck Technology” shall mean the Merck Patents and Merck Know-How.

 

1.53        “Metabasis Information and Inventions” shall mean all protocols, formulas, data, Inventions, Know-How, and trade secrets, patentable or otherwise, resulting from the Collaboration that are necessary or useful for the research, development, manufacture, marketing, use or sale of any Collaboration Compound or Product in the Field and are developed solely by employees of Metabasis or others acting on behalf of Metabasis during the Research Term [***].

 

1.54        “Metabasis Know-How” shall mean all Know-How that during the Term (i) is in Metabasis’ Control, (ii) is not generally known and (iii) is necessary or useful for the conduct of the Collaboration and/or the research, development, manufacture, marketing, use or sale of any Collaboration Compound or Product in the Field.

 

1.55        “Metabasis Marks” shall have the meaning provided in Exhibit A hereto.

 

1.56        “Metabasis Patents” shall mean, to the extent Controlled by Metabasis as of the Effective Date or during the Term, all Patents that are necessary or useful for the development, manufacture, use or sale of any Collaboration Compound or Product in the Field, but excluding the Joint Patents.

 

1.57        “Metabasis Sales Force” shall have the meaning provided in Exhibit A hereto.

 

1.58        “Metabasis Technology” shall mean the Metabasis Patents and Metabasis Know-How.

 

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1.59        “Metabolic Disease Indication” shall mean any of the following Indications:  diabetes, dyslipidemia and obesity.

 

1.60        “NDA” shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the US Food, Drug and Cosmetics Act, or similar application or submission for Marketing Authorization of a Product filed with a Regulatory Authority in a country or other regulatory jurisdiction to obtain marketing approval for a biological, pharmaceutical or diagnostic product for human use in that country or regulatory jurisdiction.

 

1.61        “Net Sales” shall mean the gross invoice price of Product sold by Merck or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:

 

(a)           trade and quantity discounts other than early payment cash discounts;

 

(b)           returns, rebates, chargebacks and other allowances;

 

(c)           retroactive price reductions that are actually allowed or granted; and

 

(d)           a fixed amount equal to [***] of the amount invoiced to cover bad debt, sales or excise taxes, early payment cash discounts, transportation and insurance, custom duties, and other governmental charges.

 

With respect to sales of a particular Combination Product, and on a country-by-country basis, the “Net Sales” for royalty purposes hereunder shall be calculated by multiplying the actual Net Sales (calculated in the manner described above) of such Combination Product by the fraction [***], in which A is [***], and B is [***].  All [***] shall be calculated as the [***] during the applicable accounting period for which the Net Sales are being calculated.  If, on a country-by-country basis, no [***], is made in such country during the applicable accounting period, or if the [***] cannot be determined for an accounting period, then the “Net Sales” for royalty purposes hereunder for sales of such Combination Product in each such country shall be determined by multiplying the Net Sales (calculated in the manner described above) of such Combination Product in such country by a fraction, determined by mutual agreement of the parties, that reflects the [***] to the end user in such country; provided that in no event will the [***] be less than [***] for purposes of this paragraph.

 

1.62        “Non-Merck Product” shall have the meaning provided in Exhibit A hereto.

 

1.63        “Patents” shall mean (a) all patents, certificates of invention, applications for certificates of invention, and patent applications, including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention, together with (b) any renewal, division, continuation (in whole or in part), or continued prosecution applications of any of such patents, certificates of invention and patent applications, and any and all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any foreign counterparts of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.

 

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1.64        “PCC Criteria” shall mean the criteria that a particular Collaboration Compound must satisfy prior to nomination for assessment and review by Merck’s Preclinical Development Review Committee (or its successor committee) for entry into IND-Enabling GLP Toxicology Studies, as set forth in an exhibit to the Research Plan (as such exhibit may be modified by the JRC or JDC from time to time).

 

1.65        “Phase 1 Clinical Trial” shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

 

1.66        “Phase 2 Clinical Trial” shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b).

 

1.67        “Phase 3 Clinical Trial” shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).

 

1.68        “Preclinical Candidate” shall mean a Collaboration Compound that Merck’s Preclinical Development Review Committee (or its successor committee) approves for entry into IND-Enabling GLP Toxicology Studies or that is actually entered into IND-Enabling GLP Toxicology Studies by Merck or a Related Party.

 

1.69        “Product” shall mean any pharmaceutical or biological preparation in final form containing a Preclinical Candidate (i) for sale by prescription, over-the-counter or any other method or (ii) for administration to human patients in a Clinical Trial, for any and all uses in the Field.

 

1.70        “Product Patents” shall mean any Metabasis Patents that claim the composition of matter of a Preclinical Candidate or Product under development or commercialization by or on behalf of Merck, or any method of use or manufacture thereof, but excluding, in any event, any and all HepDirect[***] Patents.

 

1.71        “Project Leader” shall have the meaning provided in Section 2.2(d).

 

1.72        “Regulatory Authority” shall mean any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Product in the any country in the world, including, in the USA, the FDA.

 

1.73        “Related Party” shall mean Merck, its Affiliates and sublicensees (which term does not include distributors) permitted under this Agreement.  Notwithstanding the foregoing, in no event shall Metabasis be considered a Related Party.

 

1.74        “Research Plan” shall mean the plan that sets out the research work to be performed by Metabasis and Merck in conducting the Collaboration, as such plan may be developed, amended or modified by the JRC or the parties as contemplated under this Agreement.

 

1.75        “Research Term” shall mean the three-year period commencing on the Effective Date, subject to extension for one additional year by mutual written agreement of the parties [***].

 

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1.76        “Royalty Term” shall mean, in the case of any Product, in any country, the period of time commencing on the First Commercial Sale of such Product in such country and ending upon the [***] of (a) [***] after the date of First Commercial Sale of such Product in such country, and (b) the expiration of the last to expire of the Metabasis Patents, Merck Patents or Joint Patents containing a Valid Patent Claim relating to such Product in such country.

 

1.77        “Tail Period” shall mean, if this Agreement is terminated prior to the [***] of the Effective Date, the period beginning on the date of such termination and ending on the [***] of the Effective Date; provided, however, that if the Research Term is extended beyond the [***] of the Effective Date, such period shall continue until the date that is [***] after the expiration or termination of such extended Research Term.

 

1.78        “Term” shall have the meaning provided in Section 10.1.

 

1.79        “Third Party” shall mean an entity other than Merck and its Related Parties, and Metabasis and its Affiliates.

 

1.80        “USA” shall mean the United States of America, its territories and possessions.

 

1.81        “Valid Patent Claim” shall mean a claim of an issued and unexpired patent included within the Metabasis Patents, Merck Patents or Joint Patents that either (i) claims Collaboration Compound or Product as a composition-of-matter or (ii) claims a method of use for, or method of manufacture of, Collaboration Compound or Product, which claim has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or has not been appealed within the time allowed for appeal, and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

 

2.                                       COLLABORATION

 

2.1          Collaboration.   Subject to the terms and conditions of this Agreement, Metabasis and Merck shall conduct a discovery collaboration during the Research Term to identify or synthesize Collaboration Compounds satisfying the PCC Criteria for potential development by Merck in the Field (collectively, the “Collaboration” ), with an initial focus on the treatment of diseases and disorders associated with the metabolic syndrome.  The activities to be undertaken in the course of the Collaboration shall be set forth in the initial Research Plan, which shall be developed, and may be amended from time to time, by the JRC in accordance with this Article 2.

 

2.2          Joint Research Committee.   No later than ten (10) days following the Effective Date, the parties shall establish a committee to facilitate the Collaboration as follows:

 

(a)           Composition of the Joint Research Committee.   The Collaboration shall be conducted under the direction of a joint research committee (the “Joint Research Committee” or “JRC” ) composed of three (3) named representatives of Merck and three (3) named representatives of Metabasis.  Each party may change its representatives to the JRC from time to time in its sole discretion, effective upon notice to the other party of such change.  These representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Collaboration.  Additional representatives or consultants may from

 

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time to time, by mutual consent of the parties, be invited to attend JRC meetings, subject to such representative’s or consultant’s written agreement to comply with confidentiality and non use obligations equivalent to those set forth in Article 9 hereof.  Each party shall bear its own expenses related to the attendance of such meetings by its representatives.  The JRC shall be chaired by a representative of Merck.  Except as expressly provided in this Section 2.2, the JRC’s decision-making authority shall be limited to scientific and technical matters related to the conduct of the Collaboration.  The JRC shall have the authority to develop and agree upon the initial Research Plan, as described below, and thereafter to modify the Research Plan, including, without limitation, the allocation by scientific discipline of the FTEs at Metabasis funded by Merck in accordance with Section 2.4, subject to the limitations set forth below in this Section 2.2.  Decisions of the JRC shall be made by unanimous vote, with each party’s representatives on the JRC collectively having one (1) vote.  In the event that the JRC cannot or does not, after good faith efforts, reach agreement on an issue, such issue shall be referred to the Alliance Managers, who shall meet promptly thereafter and shall negotiate in good faith to resolve such issue.  If they cannot resolve such issue within ten (10) business days of commencing such negotiations, then such issue shall be referred to the Executive Vice President, Worldwide Basic Research for Merck and the Executive Vice President of Research and Development for Metabasis.  Such officers of the parties shall meet promptly thereafter and shall negotiate in good faith to resolve such issue.  If they cannot resolve such issue within thirty (30) days of commencing such negotiations, then the resolution and/or course of conduct shall be determined by the [***], but [***] will provide [***] with respect to matters for which [***] and will give good faith consideration to [***] and make reasonable efforts to take [***].  Notwithstanding the foregoing, in no event shall the JRC [***] have the right:

 

(i)            to modify or amend the terms and conditions of this Agreement other than the Research Plan;

 

(ii)           to determine which [***] personnel perform Collaboration activities or act as [***] representatives on the JRC;

 

(iii)         to determine the specific means by which [***] executes the activities for which it is responsible under the Research Plan;

 

(iv)          to require [***] to perform tasks inconsistent with the approved Research Plan;

 

(v)            to approve an initial Research Plan that would require, or to modify or amend the Research Plan in any manner that would require, [***] beyond that specified in, or agreed upon in accordance with, Section [***] or to incur expenses not contemplated by this Agreement; or

 

(vi)          to determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement.

 

No later than thirty (30) days following the Effective Date, the parties shall convene the inaugural JRC meeting (the “Inaugural Meeting” ).  The principal focus of the Inaugural Meeting shall be discussion of, and agreement upon, the initial Research Plan, including the

 

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allocation by scientific discipline of the Initial Metabasis FTEs provided for in Section 2.4.  If the JRC is unable to agree unanimously upon the initial Research Plan within thirty (30) days after the Effective Date, the issue shall be resolved as described in the first paragraph of this Section 2.2(a) .  The preliminary allocation of the Initial Metabasis FTEs is agreed by the parties to be [***] FTEs and [***] FTEs.  Any modification of the allocation by scientific discipline of the Initial Metabasis FTEs shall require the unanimous approval of all JRC members [***].

 

(b)           Meetings.   The JRC shall meet in accordance with a schedule established by mutual agreement of the parties, but no less frequently than once per Calendar Quarter, with the location for such meetings alternating between Metabasis and Merck facilities (or such other locations as is mutually agreed by the parties).  Alternatively, the JRC may meet by means of teleconference, videoconference or other similar communications equipment.  The JRC shall confer solely regarding the status of the Collaboration, review relevant data, consider and advise on any technical issues that arise, consider issues of priority, and review and advise on any budgetary and FTE-allocation matters relating to the Collaboration which are referred to the JRC.  No JRC meeting may be conducted unless at least two (2) representatives of each party are participating.

 

(c)           Minutes.   The hosting party shall have responsibility for preparing definitive minutes of such JRC meeting, a draft of which shall be circulated for comment to all members of the JRC within fifteen (15) days after the relevant meeting.  Such minutes shall provide a description, in reasonable detail, of the Collaboration progress during the period since the most recent JRC meeting and of the discussions at the meeting, a list of any actions or determinations approved by the JRC at such meeting, and the identification of any issues that were not resolved by the JRC at such meeting.  The Project Leaders for the parties shall discuss any comments on such minutes and finalize the minutes by no later than thirty (30) days after such meeting.  Any disagreement on the minutes shall be resolved in accordance with Section 2.2(a).

 

(d)           Project Leaders.   Merck and Metabasis each shall appoint a person (a “Project Leader” ) from the JRC to coordinate its part of the Collaboration.  The Project Leaders shall be the primary contact between the parties with respect to the Collaboration.  Each party shall notify the other party as soon as practicable upon changing this appointment; provided, however, that each party’s Project Leader shall at all times be a representative on the JRC.

 

2.3          Conduct of the Collaboration.   Subject to the terms and conditions of this Agreement, each party shall be responsible for managing and controlling its respective research obligations under the Research Plan.  Each party shall proceed diligently and in a timely manner with the work set out in the Research Plan by using their respective good faith efforts to allocate sufficient time, effort, equipment and facilities to the Collaboration and to use personnel with sufficient skills and experience as are required to accomplish the Collaboration in accordance with the terms of this Agreement and Research Plan.  In no event shall Metabasis be obligated to devote to the Collaboration more than the number of FTEs being funded by Merck under this Agreement.  Each party shall be entitled to utilize the services of Affiliates to perform its Collaboration responsibilities.  Each party shall be entitled to utilize the services of Third Parties to perform its Collaboration responsibilities only upon the prior written consent of the JRC (not to be unreasonably withheld).  Notwithstanding any such use of Affiliates or Third Parties, each

 

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party shall remain at all times responsible for the performance of its respective responsibilities under the Collaboration and shall obtain the written agreement of each such Third Party, prior to the time such Third Party initiates work, to comply with confidentiality and non use obligations equivalent to those set forth in Article 9 and to assign ownership of Inventions made in the course of Collaboration activities to such party.

 

2.4          Use of Merck Research Funding and Metabasis FTE Commitments.  Metabasis shall apply the research funding it receives from Merck under this Agreement to carry out its Collaboration activities in accordance with the Research Plan and the terms and conditions of this Agreement.  During the Research Term, Metabasis shall dedicate [***] FTEs to the Collaboration to work directly on the Collaboration (the “Initial Metabasis FTEs” ), all of which shall be funded by Merck in accordance with Section 5.2.  In the event that the JRC modifies the Research Plan such that the total number of FTEs dedicated to the Collaboration by both parties in the aggregate ( “Aggregate FTEs” ) will exceed [***], then [***] of the total number of Aggregate FTEs in excess of the most recently agreed number of Aggregate FTEs shall be Metabasis FTEs (the “Additional Metabasis FTEs” ); provided, however, that [***]; and provided, further, that [***].  After the initial designation by [***], [***] shall not have the right [***] to modify such allocation without the prior written consent of [***].  All of the Additional Metabasis FTEs provided by Metabasis shall be funded by Merck in accordance with Section 5.2.

 

2.5          Exchange of Compounds and Information.   Promptly following the Effective Date, Metabasis shall disclose to Merck all Collaboration Compounds known to Metabasis as of the Effective Date and, subject to availability, shall provide samples of such Collaboration Compounds to Merck.  During the Research Term, each party shall promptly disclose to the other party any and all Collaboration Compound(s) identified by such party in the course of the Collaboration as a result of screening compound libraries Controlled by such party.  In addition, during the Research Term, each party shall promptly disclose to the other party any and all compounds synthesized by such party in the course of performing Collaboration activities (regardless of whether such compounds constitute Collaboration Compounds).  At a party’s request, and subject to availability, the other party shall provide to such party samples of any such compound(s) for use by such party in accordance with this Agreement.  Nothing herein shall require either party to disclose information received from a Third Party that remains subject to bona fide confidentiality obligations to such Third Party.

 

2.6          Records and Reports.

 

(a)           Records.   Metabasis and Merck shall each maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of the Collaboration by such party.

 

(b)           Quarterly Reports.   Within thirty (30) days following the end of each Calendar Quarter during the Research Term, each party shall provide to the other party a written progress report in English which shall describe the work performed by such party to date on the Collaboration and the allocation by scientific discipline of such party’s FTEs to Collaboration activities, evaluate the work performed in relation to the goals of the Collaboration and provide

 

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such other information required by the Collaboration or reasonably requested by the other party relating to the progress of the goals or performance of the Collaboration.  Without limiting the generality of the foregoing, each such progress report will disclose any Collaboration Compounds identified or synthesized by such party during such Calendar Quarter.

 

2.7          Compliance.   Each party shall conduct the Collaboration in accordance with all applicable laws, rules and regulations, including, without limitation, GLPs, if applicable.  In addition, if animals are used in research hereunder, each party will comply with the Animal Welfare Act or any other applicable local, state, national and international laws or regulations relating to the care and use of laboratory animals.  The parties are encouraged to use the highest standards, such as those set forth in the Guide for the Care and Use of Laboratory Animals (NRC, 1996), for the humane handling, care and treatment of such research animals.  Any animals which are used in the course of the Collaboration, or products derived from those animals, such as eggs or milk, will not be used for food purposes, nor will these animals be used for commercial breeding purposes.  Metabasis shall notify Merck in writing of any deviations from applicable regulatory or legal requirements that relate to or may impact the Collaboration.  Merck shall notify Metabasis in writing of any deviations from applicable regulatory or legal requirements to the extent such deviation(s) could reasonably be expected to have a material adverse effect on the Collaboration.  Each party hereby certifies that it will not and has not employed or otherwise used in any capacity the services of any person debarred under Section 21 USC 335a in performing any services hereunder.

 

2.8          Materials.   During the Research Term, each party may provide the other party with chemical or biological materials, including without limitation Collaboration Compound(s), for the purpose of conducting the Collaboration (collectively, the “Materials” ).  Each party shall use the Materials supplied by the other party solely for the purposes of carrying out its respective activities under the Collaboration in accordance with the terms of this Agreement and, in the case of Merck, of developing, manufacturing and/or commercializing Collaboration Compound(s) and/or Product(s) in accordance with this Agreement.  Neither party shall transfer, deliver or disclose any such Materials of the other party, or any derivatives, analogs, modifications or components thereof, to any Third Party without the prior written approval of the providing party, except that: (a) Metabasis may transfer Materials provided by Merck to Metabasis’ permitted subcontractors under Section 2.3 of its Collaboration activities for the sole purpose of performing such Collaboration activities; and (b) Merck may transfer Materials provided by Metabasis (i) to Merck’s permitted subcontractors under Section 2.3 of its Collaboration activities for the sole purpose of performing such Collaboration activities or (ii) to Merck’s Related Parties and their agents for the sole purpose of developing, manufacturing and/or commercializing Collaboration Compound(s) and/or Product(s); subject in each case to the terms and conditions of this Agreement.  The Materials are not to be used in humans, except as contemplated by this Agreement and permitted by applicable law.  Upon expiration or termination of the Collaboration, (x) Metabasis shall, at Merck’s option, deliver to Merck or destroy (in accordance with instructions from Merck) any unused Materials supplied by Merck, and any derivatives, analogs, modifications or components thereof, and (y) Merck shall deliver to Metabasis or destroy (in accordance with instructions from Metabasis) any unused Materials supplied by Metabasis, and any derivatives, analogs, modifications or components thereof; provided that for so long as the license set forth in Section 4.1(a)(ii) remains in effect and Merck is conducting development and/or commercialization activities on at least one Collaboration Compound and/or

 

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Product hereunder, Merck may retain any quantities supplied by Metabasis of Preclinical Candidates and Products.

 

2.9          Alliance Managers.   Each of the parties shall appoint one senior representative to act as its Alliance Manager.  The role of the Alliance Manager is to act as a single point of contact between the parties to ensure a successful collaboration.  The Alliance Managers shall attend all JRC and JDC meetings as non-voting participants, unless they are also appointed members of such committee pursuant to Section 2.2 or Section 3.2, as applicable; provided, however, that an Alliance Manager may bring any matter to the attention of any committee if such Alliance Manager reasonably believes that such matter warrants such attention.

 

Each party may change its designated Alliance Manager from time to time upon written notice to the other party.  Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager.  Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment within the JRC and the JDC.  Each Alliance Manager also shall:

 

(i)            identify and bring disputes to the attention of the JRC or JDC, as applicable, in a timely manner and be the point of first referral in all matters of conflict resolution;

 

(ii)           provide a single point of communication for seeking consensus both internally within the parties’ respective organizations and between the parties;

 

(iii)         plan and coordinate cooperative efforts and internal and external communications; and

 

(iv)          take responsibility for ensuring that JRC and JDC meetings and the production of meeting minutes occur as set forth in this Agreement and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed.

 

3.                                       DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS

 

3.1          Clinical Development and Registration.   Subject to the terms and conditions of this Agreement, Merck shall control, and be solely responsible for the costs associated with, the worldwide preclinical and clinical development and registration of Products by or on behalf of either party, including without limitation any and all studies that include the administration of Collaboration Compound or Product to humans.

 

3.2          Joint Development Committee: Composition, Meetings and Cost.   Promptly (but no later than thirty (30) days) following approval of the first Preclinical Candidate, Merck and Metabasis shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC” ) with an equal number of (not to exceed four (4)) representatives of each party.  Merck’s representatives on the JDC shall disclose to Metabasis’ representatives on the JDC, within a reasonable period of time, all information and documentation in Merck’s Control relating to the development of Products that is reasonably necessary, in Merck’s opinion, for Metabasis’ representatives to participate in the proceedings of the JDC, potentially including non-clinical and Clinical Trial results, final protocols, draft and final study reports, original and

 

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revised development plans for Product and regulatory submissions and correspondence with regard to Product.  The Joint Development Committee shall meet in accordance with a schedule established by mutual agreement of the parties, but no less frequently than once per Calendar Quarter, with the location for such meetings alternating between Metabasis and Merck facilities (or such other locations as may be determined by the JDC).  Alternatively, the JDC may meet by means of teleconference, videoconference or other similar communications equipment.  Each party shall bear its own expenses related to the attendance of such meetings by its representatives.  The JDC shall be chaired by a representative of Merck.  [***] shall provide [***] with [***] within [***] of [***].  [***] shall be the holder of all NDAs for Products throughout the world.

 

3.3          Decision-Making.   [***] shall have final decision-making authority on the Joint Development Committee and in general regarding development and regulatory work and issues relating to Products worldwide.  However, [***] representatives on the JDC will provide [***] representatives on the JDC with an opportunity to present [***] with respect to [***] and will give good faith consideration thereto.  [***] representatives on the JDC will make reasonable efforts to take [***] into account when developing recommendations to [***].

 

3.4          Commercialization of Products.   Subject to the terms and conditions of this Agreement (including, without limitation, Articles 5 and 6), and subject to Metabasis’ Co-Promotion Option set forth in Section 3.6, Merck shall control, and be solely responsible for the costs associated with, the worldwide commercialization of Products.  Merck shall have final decision-making authority for all issues relating to commercialization of Products, including, but not limited to, all reimbursement and pricing matters.  The appropriate Merck marketing representatives shall meet with the appropriate Metabasis representatives once during each Calendar Year to review the worldwide commercialization of Products, for information purposes only.  Furthermore, in the event that Metabasis and Merck enter into a co-promotion agreement with respect to a Product, Metabasis shall be kept informed regarding the commercialization of such Product in the USA through a joint commercialization committee to be established by the parties pursuant to Exhibit A .

 

3.5          Manufacturing.   Merck shall be responsible for the worldwide supply of all Collaboration Compounds and Products developed and/or commercialized hereunder.

 

3.6          Co-Promotion Option.   Subject to the terms and conditions of this Agreement, Merck hereby grants to Metabasis the option to co-promote Products in the Co-Promotion Territory (the “Co-Promotion Option” ).  Metabasis may exercise the Co-Promotion Option, at its sole discretion, by written notice to Merck, given no later than [***] in advance of Merck’s good faith estimated launch date of the first Product in the Co-Promotion Territory (the “Estimated Product Launch Date” ), of which Estimated Product Launch Date Merck shall keep Metabasis regularly and fully informed.  If Metabasis exercises its Co-Promotion Option, the parties shall negotiate in good faith and enter into a co-promotion agreement governing such co-promotion activities no later than [***] prior to the Estimated Launch Date.  Such co-promotion agreement shall include, without limitation, the terms set forth in Exhibit A hereto.  Metabasis shall not have the right to assign, sublicense, delegate or otherwise transfer its Co-Promotion Option or any of its rights or obligations under the co-promotion agreement entered into pursuant

 

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to this Section 3.6 to any Third Party or in connection with a Change of Control of Metabasis, except with the prior written consent of Merck.

 

3.7          Disclosure Regarding Additional Compounds and Preclinical Candidates.   During the Term, Merck shall keep Metabasis regularly and fully informed as described in this Section 3.7 regarding the worldwide development and commercialization of Products by Merck or its Related Parties.  Such information shall be communicated to Metabasis through the Joint Development Committee.  In addition, to the extent not previously disclosed to the other party in writing pursuant to Section 2.5, and no less frequently than quarterly, each party shall provide the other party with a written report disclosing the initial generation or acquisition of any Collaboration Compound by or on behalf of such party or any of its Affiliates/Related Parties.  In addition, each such report by Merck shall include the approval or designation of any Preclinical Candidate during such period.  The provisions of this Section 3.7 shall survive expiration or termination of the Research Term for so long as Merck has a license under Section 4.1(a)(ii).

 

3.8          Adverse Experience Reporting.   Subject to Article 9 hereof, each party agrees throughout the Term to notify the other party within two (2) working days, in English, of any information of which such party becomes aware concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof (hereinafter “Adverse Experience” ), where such Adverse Experience is Serious and associated with the clinical uses, studies, investigations, tests and commercialization of Product, whether or not determined to be attributable to Product.  Each party shall furnish the other party with copies of all other Adverse Experiences reported to such party in connection with the  commercialization of Product, in English, within ten (10) working days after receipt.  “Serious” as used in this Section refers to an experience which results in death, is immediately life threatening, results in persistent and significant disability/incapacity or requires in-patient hospitalization, or prolongation of existing hospitalization, or is a congenital anomaly, cancer or an overdose.  Other important medical events that may jeopardize the patient or may require intervention to prevent one of the outcomes previously listed should also be considered Serious.

 

It is understood and agreed that these Adverse Experience reporting requirement provisions are based on the policies and procedures of Merck and regulatory reporting requirements.  Accordingly, in the event of changes to regulatory requirements for Adverse Experience reporting, Metabasis agrees to comply with such revised notification requirements.

 

4.                                       LICENSES

 

4.1          License Grants.

 

(a)           By Metabasis.

 

(i)            Collaboration License.   Subject to the terms and conditions of this Agreement, Metabasis hereby grants to Merck, during the Research Term, an exclusive (even as to Metabasis, except as set forth below in this Section 4.1(a)(i)), worldwide, royalty free license, without the right to sublicense except as permitted under Section 2.3, under the Metabasis Technology and Metabasis’ interest in the Joint Technology solely to perform Merck’s obligations under the Research Plan as expressly authorized by this Agreement.  The

 

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exclusivity of the foregoing license shall be subject to Metabasis’ retained right to practice under the Metabasis Technology and the Joint Technology solely to perform Metabasis’ obligations under the Research Plan as expressly authorized by this Agreement and to practice under the Metabasis Technology and the Joint Technology for purposes other than research, development and commercialization of Collaboration Compounds and Products.

 

(ii)           Development and Commercialization Licenses relating to Collaboration Compounds.   Subject to the terms and conditions of this Agreement, Metabasis hereby grants to Merck, during the Term, an exclusive (even as to Metabasis, except as set forth below in this Section 4.1(a)(ii)), worldwide, royalty bearing license, with the right to sublicense, under the Metabasis Technology and Metabasis’ interest in the Joint Technology, to research, develop, make, have made and use Collaboration Compounds for the sole purpose of identifying and developing Preclinical Candidates and Products in the Field and to develop, make, have made, use, sell, offer for sale, have sold and import Preclinical Candidates and Products in the Field; provided, however, that Merck and its Related Parties shall not initiate or conduct, or have conducted, IND-Enabling GLP Toxicology Studies or any Clinical Trial of, or sell, offer for sale or have sold, any Collaboration Compound or any Product, unless and until Merck has approved or designated such Collaboration Compound as a Preclinical Candidate. If Metabasis exercises the Co-Promotion Option, the exclusivity of the foregoing license shall be subject to Metabasis’ retained right to practice under the Metabasis Technology and the Joint Technology solely to co-promote Products in the Co-Promotion Territory in accordance with Section 3.6, Exhibit A hereto and any co-promotion agreement entered into by the parties in connection therewith.  The exclusivity of the foregoing license shall also be subject to Metabasis’ retained right to practice under the Metabasis Technology and the Joint Technology for purposes other than research, development and commercialization of Collaboration Compounds and Products.

 

(b)           By Merck.

 

(i)            Collaboration License.   Subject to the terms and conditions of this Agreement, Merck hereby grants to Metabasis, during the Research Term, a non exclusive, worldwide, royalty free license, without the right to sublicense, under the Merck Technology and Merck’s interest in the Joint Technology solely to perform Metabasis’ obligations under the Research Plan.

 

4.2          Exclusivity.   [***], each party agrees that it shall not, directly or indirectly, [***], except pursuant to, and subject to the terms and conditions of, this Agreement, including, without limitation, Article 10 hereof.  Without limiting the generality of the foregoing, during the Term, Merck and its Related Parties shall not initiate or conduct, or have conducted, IND-Enabling GLP Toxicology Studies or any Clinical Trial of, or sell, offer for sale or have sold any Collaboration Compound or any Product, unless Merck has approved such Collaboration Compound as a Preclinical Candidate.

 

4.3          Diligence Obligations.   Merck shall use reasonable efforts, consistent with the usual practice followed by Merck in pursuing the development, commercialization and marketing of its other pharmaceutical products for the treatment of diabetes (and no less than the efforts used by Merck with respect to its other pharmaceutical products of similar commercial potential), at its own expense, to develop and commercialize, itself or through Related Parties, as

 

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promptly as reasonably practicable, [***] on a commercially reasonable basis in the Major Markets and in such other countries throughout the world where in Merck’s reasonable opinion it is commercially viable to do so.  In the event that (a) Merck’s development and commercialization efforts with respect to Preclinical Candidates and Products substantially cease for a period of [***] or more, or (b) Merck makes a determination to discontinue its development and commercialization efforts with respect to Preclinical Candidates and Products, then Merck shall provide Metabasis with prompt written notice thereof.  In addition, if Metabasis in good faith believes that Merck’s good faith development and commercialization efforts with respect to Preclinical Candidates and Products have substantially ceased for a period of [***] or more, then Metabasis may provide Merck with written notice thereof, in which event Merck shall have sixty (60) days from the date of such notice in which to provide Metabasis with a written description of its then-current efforts with respect to Preclinical Candidates and Compounds and its rationale for concluding that such efforts are reasonable.

 

4.4          Retained Rights; No Implied Licenses.   Subject to Sections 4.2 and 7.1(b), Metabasis hereby expressly reserves the right to practice, and to grant licenses under, the Metabasis Technology and the Joint Patents for any and all purposes other than the specific purposes for which Merck has been granted an exclusive license under Section 4.1(a).  Subject to Sections 4.2 and 7.1(b), Merck hereby expressly reserves the right to practice, and to grant licenses under, the Merck Technology and the Joint Patents for any and all purposes.  No right or license under any Patents or Information is granted or shall be granted by implication.  All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement.

 

5.                                       FEES AND PAYMENTS

 

5.1          Upfront Fee.  Merck shall make a one-time, non refundable, non creditable payment to Metabasis equal to US$5,000,000 within thirty (30) days of the Effective Date.

 

5.2          Research Funding.   During the Research Term, Merck shall make research funding payments to Metabasis for the applicable number of FTEs per year determined in accordance with Section 2.4, quarterly in advance, at the FTE Rate; provided, however, that the payments for the first Calendar Quarter and the last Calendar Quarter of the Research Term shall be made on a pro rata basis and payment for the first Calendar Quarter shall be made within ten (10) days after the first day of the Research Term.  All other FTE payments shall be made on the first business day of each Calendar Quarter during the Research Term.  Within thirty (30) days following the end of each Calendar Quarter, Metabasis shall provide Merck with a list of names of people providing FTEs to the Collaboration and the percentage of their time worked on the Collaboration on a monthly basis.  If Metabasis fails, in any Calendar Year, to provide the specified aggregate number of FTEs, then, in addition to any other rights that Merck has under this Agreement, Merck shall be entitled to [***]; provided, however, that if the amount of any such [***] exceeds the amount of Merck’s remaining research funding obligations under this Section 5.2, then Merck shall be entitled to [***] to Metabasis under this Article 5; and provided, further, that, notwithstanding the provisions of Section 5.3(c), in the event that Merck’s other payment obligations to Metabasis under this Article 5 during the Calendar Year immediately following the Calendar Year in which the [***] occurred (the “Following Calendar Year”) are lower in amount than the amount of such [***], all of such [***] to such other payment

 

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obligations shall be [***] Merck by Metabasis within thirty (30) days following the end of the Following Calendar Year.

 

5.3          Milestone Payments.

 

(a)           Preclinical Milestone.   Within thirty (30) days following initiation of [***] with respect to a Collaboration Compound, Merck shall pay to Metabasis a preclinical milestone payment of [***].  The foregoing preclinical milestone payment shall be payable on a Collaboration Compound-by-Collaboration Compound basis; provided, however, that this milestone payment shall only be payable with respect to the first [***] to achieve such milestone.

 

(b)           Development Milestones.   Within thirty (30) days following the first occurrence of each of the events set forth below with respect to any Collaboration Compound or a Product containing such Collaboration Compound, Merck shall pay to Metabasis the milestone payment set forth below (whether such milestone is achieved by Merck or a Related Party):

 

 

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Milestone payments [***] set forth in this Section 5.3(b) shall be payable [***].  Milestone payments [***] set forth in this Section 5.3(b) shall be payable on a Collaboration Compound-by-Collaboration Compound basis, but each of such payments shall be payable [***]; provided, however, that if (A) [***] and (B) [***], then Merck shall be entitled to [***].

 

(c)           Milestones Non-Refundable and Non-Creditable.   All payments made to Metabasis pursuant to this Section 5.3 are non-refundable and, except as expressly set forth in Section 5.3(b), may not be credited against any other payments payable by Merck to Metabasis under this Agreement.

 

5.4          Royalties.   Merck shall pay to Metabasis royalties on Net Sales of each Product by Merck and its Related Parties, on a Product-by-Product and country-by-country basis, until the expiration of the Royalty Term with respect to such Product, at the applicable rates set forth below:

 

(a)           [***] of that portion of total annual Net Sales of such Product [***];

 

(b)           [***] of that portion of total annual Net Sales of such Product [***]; and

 

(c)           [***] of that portion of total annual Net Sales of such Product [***];

 

provided, however, that if (1) a particular Product is labeled for human use and (A) there is no Valid Patent Claim covering such Product in the country of sale, or (B) gross sales of Competitive Products of such Product in such country by any non Related Party attain, on a Calendar Year basis, [***] or more in such country of sale as measured by [***] OR (2) the

 

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Product is labeled for animal use and there is a Valid Patent Claim in the country of sale, then the royalty rates applicable to Net Sales of such Product in such country thereafter for the remainder of the Royalty Term for such Product in such country shall be [***] of the amounts set forth in (a) through (c) above; and provided further that if a particular Product is labeled for animal use and (A) there is no Valid Patent Claim covering such Product in the country of sale, or (B) gross sales of Competitive Products of such Product in such country by any non-Related Party attain, on a Calendar Year basis, [***] or more in such country of sale as measured by [***], then the royalty rates applicable to Net Sales of such Product in such country thereafter for the remainder of the Royalty Term for such Product in such country shall be [***] of the amounts set forth in (a) through (c) above.

 

5.5          Change in Sales Practices.   The parties acknowledge that during the Term, Merck’s sales practices for the marketing and distribution of Product may change to the extent to which the calculation of the payment for royalties on Net Sales may become impractical or even impossible.  In such event the parties agree to meet and discuss in good faith new ways of compensating Metabasis to the extent currently contemplated under Section 5.4, subject to the mutual written agreement of the parties.

 

5.6          Royalties for [ *** ].   In those cases where Merck or its Affiliates sell [***] to an independent Third Party and do not receive any consideration from such independent Third Party with respect to sales of [***], the royalty obligations under Section 5.4 shall be applicable to the sale price of the [***]; provided that (a) such sale of [***] is in the best interest of maximizing the commercial value of such [***] and (b) each other product that is sold by Merck or its Affiliate to such independent Third Party is also sold without Merck or its Affiliate receiving any consideration from such independent Third Party with respect to sales of such product other than the reasonable arm’s-length price of such product, it being the parties’ intent that Merck may not utilize the [***] to such Third Party to obtain a [***] for other products sold by Merck to such Third Party.

 

5.7          Compulsory Licenses.   If a Compulsory License is granted to a Third Party with respect to Product in any country with a royalty rate lower than the royalty rate provided by Section 5.4, then the royalty rate to be paid by Merck on Net Sales in that country under Section 5.4 shall be [***] for the period during which such Compulsory License is in effect.  Merck shall use commercially reasonable efforts to oppose the granting of any such Compulsory License, and if any such Compulsory License is granted, to eliminate or limit such Compulsory License to the extent possible.

 

5.8          Third Party Licenses.   In the event that Merck or its Related Parties are required to obtain one or more licenses under Patents o