6.3	Licensor Support in Regulatory Matters	22
6.4	Recalls	22
6.5	Pharmacovigilance Agreement	22
ARTICLE 7	MANUFACTURING	23
7.1	Supply Agreement	23
7.2	Merck Manufacturing	23
7.3	Manufacturing Technology Transfer	23
ARTICLE 8	FINANCIAL PROVISIONS	24
8.1	Initial Fee	24
8.2	Option Exercise Fee	24
8.3	Milestone Payments	25
8.4	Commercial Event Payments	26
8.5	Royalty Payments for Product	27
8.6	Compulsory License	28
8.7	Reductions, Deductions and Reimbursements	28
8.8	Timing of Payment	29
8.9	Mode of Payment and Currency; Invoices	29
8.10	Royalty Reports and Records Retention	30
8.11	Legal Restrictions	30
8.12	Late Payments	30
8.13	Audits	31
8.14	Taxes	31
ARTICLE 9	INVENTIONS AND PATENTS	32
9.1	Patent Listing under Public Health Services Act	32
9.2	Further Assurances	32
9.3	Ownership of Inventions	32
9.4	Patent Prosecution and Maintenance	32
9.5	Enforcement of Patents and Know-How	35
9.6	Third Party Actions Claiming Infringement	36

ARTICLE 10	CONFIDENTIALITY	38
10.1	Confidentiality Obligations	38
10.2	Use	38
10.3	Required Disclosure	39
10.4	Publications	39
10.5	Press Releases and Disclosure	39
10.6	Agreement Filing	40
ARTICLE 11	REPRESENTATIONS, WARRANTIES AND COVENANTS	41
11.1	Representations and Warranties	41
11.2	Additional Representations and Warranties of Licensor	41
11.3	Licensor Covenants	45
ARTICLE 12	INDEMNIFICATION AND INSURANCE	45
12.1	Indemnification by Merck	45
12.2	Indemnification by Licensor	45
12.3	No Consequential Damages	45
12.4	Notification of Claims; Conditions to Indemnification Obligations	46
12.5	Insurance	46
ARTICLE 13	TERM AND TERMINATION	46
13.1	Term and Expiration	46
13.2	Termination of the Agreement for Convenience	47
13.3	Termination upon Material Breach	47
13.4	Effects of Expiration or Termination	47
13.5	Termination on Bankruptcy or Insolvency; Right of First Negotiation	50
13.6	Other Remedies	51
ARTICLE 14	DISPUTE RESOLUTION	51
14.1	Disputes	51
14.2	JSC Discussion Disputes	51
14.3	Injunctive Relief	51
ARTICLE 15	MISCELLANEOUS PROVISIONS	51
15.1	Relationship of the Parties	51

15.2	Assignment	51
15.3	Performance and Exercise by Affiliates	53
15.4	Change of Control	53
15.5	Further Actions	54
15.6	Accounting Procedures	54
15.7	Force Majeure	54
15.8	No Trademark Rights	54
15.9	Entire Agreement of the Parties; Amendments	54
15.10	Captions	54
15.11	Governing Law	55
15.12	Non-Solicitation of Employees	55
15.13	Notices and Deliveries	55
15.14	Waiver	56
15.15	Severability	56
15.16	No Implied License	56
15.17	Interpretation	56
15.18	Counterparts	56

 

 

 

 

 

 

 

 

 

 

 

1.1	“Abili-T Trial” means that certain Phase IIb clinical study of Product being conducted by Licensor as of the Effective Date for treatment of SPMS that has the ClinicalTrials.gov Identifier NCT01684761.

 

 

 

 

1.2	“Adverse Event” means any serious untoward medical occurrence in a patient or subject who is administered Product, but only if and to the extent that such serious untoward medical occurrence is required under Laws to be reported to applicable Regulatory Authorities.

 

1.3

“Affiliate” means a Person that controls, is controlled by or is under common control with a Party, but only for so long as such control exists.  For the purposes of this Section 1.3, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person or entity, whether by the ownership of more than fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

 

1.4

“Calendar Quarter” means each three (3) month period commencing January 1, April 1, July 1 or October 1 of any year; provided, however, that: (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first full Calendar Quarter thereafter; and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement.

 

1.5

“Calendar Year” means the period beginning on the 1st of January and ending on the 31st of December of the same year; provided, however, that (a) the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the same year, and (b) the last Calendar Year of the Term shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of termination or expiration of this Agreement.

 

1.6	“CDA” means that certain non-disclosure agreement by and between Licensor and Merck Serono S.A. dated February 15, 2011.

 

1.7

“cGCP” means the current standards, practices and procedures set forth in the International Conference on Harmonization (ICH) guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance” including related requirements imposed by the FDA, and equivalent non-US regulations or standards, as applicable, as such standards, practices, procedures, requirements and regulations may be amended from time to time.

 

1.8

“cGLP” means the current good laboratory practice regulations promulgated by the FDA, published at 21 US C.F.R. § 58, and equivalent non-US regulations or standards, as applicable, as such current laboratory practices, regulations and equivalent non-US regulations or standards may be amended from time to time.

 

1.9

“cGMP” means those current practices, as amended from time to time, related to the manufacture of pharmaceutical products and any precursors thereto promulgated in guidelines and regulations of standard compilations including the GMP Rules of the World Health Organization, the US Code of Federal Regulations, the Guide to Inspection of Bulk Pharmaceutical Chemicals (established by the US Department of Health and Human Services), the Pharmaceutical Inspection Convention, and the European Community Guide to Good Manufacturing Practice in the production of pharmaceutical products.

 

 

 

 

1.10

“Change of Control” means, with respect to a Person: (a) a transaction or series of related transactions that results in the sale or other disposition of all or substantially all of such Person’s assets; or (b) a merger or consolidation in which such Person is not the surviving corporation or in which, if such Person is the surviving corporation, the shareholders of such Person immediately prior to the consummation of such merger or consolidation do not, immediately after consummation of such merger or consolidation, possess, directly or indirectly through one or more intermediaries, a majority of the voting power of all of the surviving entity’s outstanding stock and other securities and the power to elect a majority of the members of such Person’s board of directors; or (c) a transaction or series of related transactions (which may include a tender offer for such Person’s stock or the issuance, sale or exchange of stock of such Person) if the shareholders of such Person immediately prior to the initial such transaction do not, immediately after consummation of such transaction or any of such related transactions, own, directly or indirectly through one or more intermediaries, stock or other securities of the entity that possess a majority of the voting power of all of such Person’s outstanding stock and other securities and the power to elect a majority of the members of such Person’s board of directors.

 

1.11	“Clinical Trial” means a clinical trial in human subjects that has been approved by a Regulatory Authority and Institutional Review Board or Ethics Committee, and is designed to measure the safety and/or efficacy of Product.  Clinical Trials shall include Phase II Trials and Phase III Trials.

 

1.12

“Combination Product” means Product that: (a) includes one or more distinct pharmaceutically active ingredients that is/are the subject of its/their own separate MAAs (in addition to the MAA associated with Product); or (b) is combined with one or more products, devices, pieces of equipment or components that are proprietary (i.e., not “off-the-shelf”) and provide more than de minimis value to such Combination Product.

 

1.13

“Commercialization” or “Commercialize” means any and all activities undertaken before and after Regulatory Approval of a MAA for Product and that relate to the marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of Product, and interacting with Regulatory Authorities regarding the foregoing.

 

1.14

“Commercially Reasonable Efforts” means: (a) with respect to the efforts to be expended by a Party with respect to any objective, such reasonable, diligent, and good faith efforts as such Party would normally use to accomplish a similar objective under similar circumstances; and (b) with respect to any objective relating to Development or Commercialization of Product by a Party, the application by such Party, consistent with the exercise of its prudent scientific and business judgment, of diligent efforts and resources to fulfill the obligation in issue, consistent with the level of efforts such Party would devote to a product at a similar stage in its product life as Product and having profit potential and strategic value comparable to that of Product, taking into account, without limitation, commercial, legal and regulatory factors, target product profiles, product labeling, past performance, the regulatory environment and competitive market conditions in the therapeutic area, safety and efficacy of Product, the strength of its proprietary position and such other factors as such Party may reasonably consider, all based on conditions then prevailing.  For clarity, Commercially Reasonable Efforts, (i) with respect to a given task or objective, will not mean that a Party guarantees that it will actually accomplish such task or objective or (ii) prior to receipt of Regulatory Approval, with respect to Development of Product in the Field in the Territory generally, will not mean that a Party is permitted to permanently stop all attempts to Develop Product for purposes of obtaining Regulatory Approval.

 

 

1.15	“Competing Product” means any ***, *** product in any dosage form, formulation, presentation or package configuration which exhibits activity *** by means of ***.

 

1.16

“Compulsory License” means a compulsory license under Licensor Technology obtained by a Third Party through the order, decree, or grant of a competent Governmental Body or court, authorizing such Third Party to develop, make, have made, use, sell, offer to sell or import a Competing Product or Product in the Field in any country in the Territory.

 

1.17

“Confidential Information” of a Party, means information relating to the business, operations or products of a Party or any of its Affiliates, including any Know-How, not known or generally available to the public, that such Party previously disclosed to the other Party under the CDA, discloses to the other Party under this Agreement, or otherwise becomes known to the other Party by virtue of this Agreement or the CDA.

 

1.18

“Controlled” means, with respect to (a) Patent Rights, (b) Know-How or (c) biological, chemical or physical material, that a Person or one of its Affiliates owns or has a license or sublicense to such Patent Rights, Know-How or material (or in the case of material, has the right to physical possession of such material) and has the ability to grant a license or sublicense to, or assign its right, title and interest in and to, such Patent Rights, Know-How or material as provided for in this Agreement, or as is otherwise applicable, without violating the terms of any agreement or other arrangement with any Third Party.

 

1.19

“Cover”, “Covering” or “Covered” means, with respect to Product, that the making, using, selling, or offering for sale of Product would, but for a license granted in this Agreement under the Licensor Patent Rights, infringe a Valid Claim of the Licensor Patent Rights in the country in which the activity occurs.

 

1.20

“Development” or “Develop” means, with respect to Product, the performance of all pre-clinical and clinical development (including toxicology, pharmacology, test method development and stability testing, process development, formulation development, quality control development, statistical analysis), Clinical Trials, and regulatory activities that are required to obtain Regulatory Approval of Product.

 

1.21	“EMA” means the European Medicines Agency or a successor agency thereto.

 

 

1.22	“European Commission” means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.

 

1.23	“European Union” or “EU” means the European Union, as may be redefined from time to time.

 

1.24	“Executive Officers” means, together, a member of the senior management of the pharmaceutical division of Merck and the Chief Executive Officer of Licensor.

 

1.25	“Existing Third Party Agreement(s)” means the agreement(s) set forth on Schedule 1.25.

 

1.26	“FDA” means the United States Food and Drug Administration or a successor federal agency thereto.

 

1.27	“Field” means any prophylactic, palliative or therapeutic treatment, or diagnosis, of Multiple Sclerosis (“MS”), including Primary Progressive Multiple Sclerosis (otherwise known as PPMS), Secondary Progressive Multiple Sclerosis (“SPMS”) and Relapsing Remitting Multiple Sclerosis (“RRMS”).

 

1.28

“First Commercial Sale” means, on a country-by-country basis, the first commercial transfer or disposition for value of Product in the Field in such country to a Third Party by Merck, or any of its Affiliates or Sublicensees, in each case, after all Regulatory Approvals necessary for such sale or disposition  have been obtained in such country.

 

1.29	“FTE” means a full time equivalent person year, comprising *** hours per year, of scientific or technical work spent on, or directly related to, Development Support, Regulatory Support or Manufacturing Support, as applicable.

 

1.30	“FTE Rate” means the annual rate of $*** USD per FTE.

 

1.31

“Governmental Body” means any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal); (d) multi-national or supranational organization or body; or (e) individual, entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.

 

1.32

“IFRS” means the International Financial Reporting Standards, the set of accounting standards and interpretations and the framework in force on the Effective Date and adopted by the European Union as issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRIC), as such accounting standards may be amended from time to time.

 

 

 

1.33	“Indication” means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition for which a MAA may be obtained.

 

1.34	“IND” means an investigational new drug application submitted to applicable Regulatory Authorities for approval to commence Clinical Trials in a given jurisdiction.

 

1.35

“Know-How” means any: (a) scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain or otherwise publicly known, including discoveries, inventions, trade secrets, devices, databases, practices, protocols, regulatory filings, methods, processes (including manufacturing processes, specifications and techniques), techniques, concepts, ideas, specifications, formulations, formulae, data (including pharmacological, biological, chemical, toxicological, clinical and analytical information, quality control, trial and stability data), case reports forms, medical records, data analyses, reports, studies and procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), summaries and information contained in submissions to and information from ethical committees, or Regulatory Authorities, and manufacturing process and development information, results and data, whether or not patentable, all to the extent not claimed or disclosed in a patent or patent application; and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material, including drug substance samples, intermediates of drug substance samples, drug product samples and intermediates of drug product samples, and proprietary equipment, procedures or methodologies relating to the manufacturing of Product. The fact that an item is known to the public shall not be taken to exclude the possibility that a compilation including the item, and/or a development relating to the item, is (and remains) not known to the public.  “Know-How” includes any rights, including copyright, database or design rights, protecting such Know-How.  “Know-How” excludes Patent Rights.

 

1.36

“Knowledge” means, with respect to a matter that is the subject of a given representation, or warranty of Licensor, the knowledge of any officer or director of Licensor, or such other employee of Licensor who would reasonably be expected to have knowledge of the matter in question, has, or should reasonably be expected to have, after making reasonable inquiry into the relevant subject matter; provided, however, that any officer, director or employee of Licensor shall be deemed to have knowledge of a Third Party’s Patent Right only if such officer, director or employee has actual knowledge of such Third Party’s Patent Right or would be found to be on notice of such Third Party’s Patent Right as determined by reference to United States patent laws.  “Knowingly” means with Knowledge.

 

1.37	“Law” or “Laws” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any Governmental Body.

 

 

*** Confidential material redacted and filed separately with the Commission.

 

 

1.38

“Licensor Bankruptcy Event” means: (a) voluntary or involuntary proceedings by or against Licensor are instituted in bankruptcy under any insolvency Law, which proceedings, if involuntary, shall not have been dismissed within ninety (90) days (or sixty (60) days if during the Option Period) after the date of filing; (b) a receiver or custodian is appointed for Licensor; (c) proceedings are instituted by or against Licensor for corporate reorganization, dissolution, liquidation or winding-up of Licensor, which proceedings, if involuntary, shall not have been dismissed within ninety (90) days (or sixty (60) days if during the Option Period) after the date of filing; (d) substantially all of the assets of Licensor are seized or attached and not released within sixty (60) days thereafter; or (e) the deterioration of Licensor’s financial position during the Term such that Merck’s rights under this Agreement are reasonably likely to be adversely affected (as such deterioration is determined in Merck’s good faith discretion, following prior notice to Licensor and an opportunity of five (5) days for Licensor to provide a written objection to such determination setting forth in reasonable detail Licensor’s good faith basis for such objection).

1.39

“Licensor Know-How” means all Know-How that is Controlled by Licensor or, subject to Section 15.2(f), any of its Affiliates, as of the Effective Date or at any time thereafter during the Term, and that is: (a) *** for the Development, manufacture or Commercialization of Product; or (b) *** in the Development, manufacture or Commercialization of Product; or (c) for Know-How Controlled by Licensor or its Affiliates as of ***, *** for the (1) Development or manufacture of Product anywhere in the world for purposes of Commercializing Product in the Territory in the Field or (2) Commercialization of Product in the Territory; or (d) for Know-How *** Controlled by Licensor or its Affiliates after ***, *** for the (1) Development or manufacture of Product anywhere in the world for purposes of Commercializing Product in the Territory in the Field or (2) Commercialization of Product in the Territory.

 

1.40

“Licensor Patents” means all Patent Rights that are Controlled by Licensor or, subject to Section 15.2(f), any of its Affiliates, as of the Effective Date or at any time thereafter during the Term, and that are: (a) *** for the Development, manufacture or Commercialization of Product; or (b) *** in the Development, manufacture or Commercialization of Product; or (c) for Patent Rights Controlled by Licensor or its Affiliates as of ***, *** for the (1) Development or manufacture of Product anywhere in the world for purposes of Commercializing Product in the Territory in the Field or (2) Commercialization of Product in the Territory; or (d) for Patent Rights *** Controlled by Licensor or its Affiliates after ***, *** for the (1) Development or manufacture of Product anywhere in the world for purposes of Commercializing Product in the Territory in the Field or (2) Commercialization of Product in the Territory.  Listed on Schedule 1.40 are all Licensor Patents existing as of the Effective Date; provided, that Licensor shall update Schedule 1.40 from time-to-time to include any new Licensor Patents.

 

1.41

“Licensor Technology” means the Licensor Patents and Licensor Know-How.  For the avoidance of doubt, the Licensor Technology includes any Licensor Patents and/or Licensor Know-How Controlled by Licensor pursuant to any Existing Third Party Agreement or any Third Party License Agreement.  For clarity, “Licensor Technology” includes:  (a) the *** by *** are *** and *** in order to *** ***, which *** is *** to by ***, as of the Effective Date, as ***; and (b) any improvements to Product that Licensor may make on or following the Effective Date, including improvements to the *** by *** are ***, *** and *** or by *** are *** ***.

 

 

 

 

1.42	“Licensor Trademarks” means those trademarks set forth on Schedule 1.42 and any other trademarks that Licensor may have registered, or uses, in connection with (x) the Licensor Technology in the Field in the Territory, or (y) the Product in the Territory.

 

1.43

“MAA” means: (a) a Marketing Authorization Application, or a New Drug Application (NDA), submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. C.F.R.§ 314.3 et seq; (b) a Biologics License Application submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. C.F.R. § 601; and (c) any equivalent application submitted in any country in the Territory, including a European Marketing Authorization Application, together, in each case, with all additions, deletions or supplements thereto, and as any and all such requirements may be amended, or supplanted, at any time.

 

1.44	“Major EU Market” means any of Germany, the United Kingdom, France, Spain or Italy.

 

1.45	“Merck Competitor” means any company that (itself or through an Affiliate) is developing or commercializing a product in the Field.

 

1.46

“Net Sales” means the gross amounts invoiced by Merck or any of its Affiliates or Sublicensees for sales of Product to independent or unaffiliated Third Party purchasers of such Product, less the following deductions to the extent allocable thereto:  (a) ***or *** or ***; (b) *** or *** or ***, ***, regardless of ***; (c) *** or ***; (d) *** in the *** for *** and any other ***relating to *** or *** of Product; (e) *** and *** and *** *** in connection with *** or *** of Product ***; (f) *** and *** or *** made to *** or ***, or any Third *** or ***; and (g) *** related to *** of Product paid to Third Parties (specifically excluding any commissions paid to sales personnel, sales representatives and sales agents who are employees or consultants of (or members of a contract sales force engaged by or on behalf of) Merck or its Affiliates or any Sublicensees).  For clarity, sale of Product by Merck or any of its Affiliates or Sublicensees to another of these entities for resale by such entity to a Third Party shall not be deemed a sale for purposes of this definition of “Net Sales”.

 

 

 

 

 

1.47

“Out-of-Pocket Expenses” means expenses actually paid by a Party or its Affiliate to any Third Party; provided, that “Out-of-Pocket Expenses” shall not include expenses paid to any consultants (or service providers of like kind), except for travel expenses associated with a consultant (or service provider of like kind).

 

1.48

“Patent Rights” means: (a) an issued or granted patent, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination or renewal thereof; (b) a pending patent application, including any continuation, divisional, continuation-in-part, substitute or provisional application thereof; and (c) all counterparts or foreign equivalents of any of the foregoing issued by or filed in any country or other jurisdiction.

 

1.49	“Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government or agency or political subdivision thereof.

 

1.50

“Phase II Trial” means a clinical trial of Product in human patients, the principal purposes of which are to make a preliminary determination that Product is safe for its intended use, to determine its optimal dose, and to obtain sufficient information about Product’s efficacy to permit the design of Phase III Trials, and which is consistent with 21 US CFR § 312.21(b).

 

1.51

“Phase III Trial” means a clinical trial of Product in human patients, which trial is  designed to (a) establish that Product is safe and efficacious for its intended use and (b) (i) define warnings, precautions and adverse reactions that are associated with Product in the dosage range to be prescribed; (ii) be conducted as a pivotal trial for purposes of filing a MAA for Product; (iii) be either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Regulatory Approval of a MAA of Product; and (iv) be consistent with 21 US CFR § 312.21(c).

 

1.52	“Price Approvals” means, in those countries in the Territory where Regulatory Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such pricing and/or pricing reimbursement approval or determination.

 

1.53	“Product” means a preparation of autologous myelin-reactive T-cells manufactured using (i) Licensor Technology or (ii) a derivative of Licensor Technology).  As of the Effective Date, Product is referred to by Licensor as “Tcelna”.

 

 

 

 

1.54	“Regulatory Authority” means: (a) in the US, the FDA; (b) in the EU, the EMA or the European Commission; or (c) in any other jurisdiction anywhere in the world, any regulatory body with similar regulatory authority over pharmaceutical or biotechnology products.

 

1.55

“Regulatory Approval” means any and all approvals, licenses, registrations, or authorizations of the relevant Regulatory Authority, including Price Approvals, necessary for the Development, manufacture, use, storage, import, transport or Commercialization of Product in a particular country or jurisdiction. For the avoidance of doubt, Regulatory Approval to Commercialize Product shall include Price Approval.

 

1.56	“Representatives” means employees, consultants, contractors, advisors and agents of a Party.

 

1.57	“Royalty Term” means, on a country-by-country basis, the period from the First Commercial Sale of Product in such country until the later of: (a) ***; or (b) *** years after such First Commercial Sale of Product in such country.

 

1.58	“Sublicensee” means a Person other than an Affiliate of Merck to which Merck (or its Affiliate) has, pursuant to Section 4.2, granted sublicense rights under any of the license rights granted under Section 4.1; provided, that “Sublicensee” shall exclude distributors.

 

1.59

“Tax” or “Taxes” means any federal, state, local or foreign income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not.

 

1.60	“Territory” means all the countries of the world except Japan.

 

1.61	“Third Party” means any Person other than Licensor, Merck or any of their respective Affiliates.

 

1.62	“Third Party Action” means any Action made by a Third Party against either Party that claims that Product, or Product’s use, Development, manufacture or sale in the Territory infringes or misappropriates such Third Party’s intellectual property rights.

 

1.63

“Third Party License Agreement” means any agreement entered into by a Party or its Affiliate with a Third Party, or any amendment or supplement thereto, in each case following the Effective Date, whereby royalties, fees or other payments are to be made by a Party or its Affiliate to such Third Party in connection with the grant of rights under intellectual property rights Controlled by such Third Party, which rights are *** to research, Develop, manufacture, have made, import, export, use or Commercialize Product in the Field in the Territory.  Notwithstanding the foregoing, an agreement entered into by Merck or its Affiliate with a Third Party, or any amendment or supplement thereto, in each case following the Effective Date, whereby royalties, fees or other payments are to be made by Merck or its Affiliate to such Third Party in connection with the grant of rights under intellectual property rights Controlled by such Third Party, which rights have the *** effect of ***, will not be considered a Third Party License Agreement hereunder.

 

 

 

1.64	“United States” or “US” means the United States of America, its territories and possessions.

 

1.65	“USD” or “$” means the lawful currency of the United States.

 

1.66

“Valid Claim” means a claim of any issued Patent Right which has not expired, lapsed or been revoked, abandoned or held unenforceable or invalid by a final decision of a court or governmental or supra-governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, reexamination or disclaimer or otherwise.

 

1.67	Other Terms.  The definition of each of the following terms is set forth in the section of the Agreement indicated below: