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EX-10.30 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT

Collaboration Agreement

EX-10.30 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT | Document Parties: RIGEL PHARMACEUTICALS INC | PFIZER INC You are currently viewing:
This Collaboration Agreement involves

RIGEL PHARMACEUTICALS INC | PFIZER INC

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Title: EX-10.30 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
Governing Law: Delaware     Date: 5/6/2005
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward LLP    

EX-10.30 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT, Parties: rigel pharmaceuticals inc , pfizer inc
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EXHIBIT 10.30

 

COLLABORATIVE RESEARCH AND LICENSE AGREEMENT

 

THIS COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (the “Agreement”) is entered into as of January 18, 2005 by and between RIGEL PHARMACEUTICALS, INC. , a Delaware corporation with its offices at 1180 Veterans Boulevard, South San Francisco, California 94080 (“Rigel”), and PFIZER INC. , a Delaware corporation with its offices at 235 East 42 nd Street, New York, New York 10017 (“Pfizer”).  Rigel and Pfizer may be referred to herein individually as a “Party” or collectively, as the “Parties.”

 

RECITALS

 

WHEREAS, Pfizer is a pharmaceutical company engaged in the discovery, development, marketing, manufacture and distribution of pharmaceutical products;

 

WHEREAS, Rigel is a pharmaceutical company engaged in the discovery and development of novel pharmaceuticals including Syk tyrosine kinase inhibitors;

 

WHEREAS, Rigel and Pfizer desire to enter into a relationship to identify, develop and commercialize Syk tyrosine kinase inhibitors for use in the diagnosis, treatment or prevention of certain Allergy and Respiratory Conditions;

 

WHEREAS, Rigel is prepared to grant Pfizer a license to allow Pfizer to commercialize products arising from this relationship for such purposes; and

 

WHEREAS, Rigel is separately engaged in the development of products for allergic rhinitis, and the Parties have agreed to exclude that indication from the field of Allergy and Respiratory Conditions for purposes of this Agreement, subject to Section 5.5;

 

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Agreement, the Parties agree as follows:

 

1.                                       DEFINITIONS

 

1.1                                “Acquisition Proposal” shall mean any tender offer or exchange offer to the stockholders of Rigel, or an offer accepted by the Board of Directors of Rigel, with respect to a Business Combination or involving the purchase of [ * ] or more of the outstanding Voting Stock of Rigel, or newly issued securities, which after the issuance thereof, represent [ * ] or more of the Voting Stock of Rigel.

 

1.2                                “Advanced Preclinical Development” means any of the following activities: (i) the commencement of manufacturing process scale-up of a Compound, (ii) the selection of a solid dose formulation of a Compound, (iii) the initiation of preclinical toxicology studies of a Compound, or (iv) the synthesis by Pfizer or receipt by Pfizer of quantities of a Compound in excess of 200 grams as needed to commence toxicology studies.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.3                                “Affiliate” means a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with a Party.  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 entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

 

1.4                                “Allergy and Respiratory Conditions” means all human diseases and disorders resulting from an allergic reaction to an antigen, or primarily involving respiratory or pulmonary dysfunction, and shall include without limitation asthma and chronic obstructive pulmonary disease (“COPD”), but shall specifically exclude allergic rhinitis.  Allergy and Respiratory Conditions shall exclude autoimmune disorders, provided that asthma and COPD shall always be considered Allergy and Respiratory Conditions even if the underlying basis of asthma and COPD is an autoimmune disorder.

 

1.5                                “Business Combination” shall mean (a) merger, consolidation, reorganization, acquisition, liquidation, scheme or other analogous arrangement with a Third Party in which Rigel is a constituent corporation or party and pursuant to which Voting Stock of Rigel is or may be exchanged for cash, securities or other property, or (b) a sale of a material portion of the assets of Rigel representing not less than [ * ] of the fair market value of Rigel.

 

1.6                                “Business Day” means a day other than a Saturday, Sunday, bank or other public holiday in the state of New York.

 

1.7                                “Change of Control” means that any of the following has occurred:

 

(a)                                   any Person becomes the beneficial owner, directly or indirectly, of [ * ] or more of the Voting Stock of Rigel; or

 

(b)                                   Rigel enters into an agreement with any Person providing for the sale or other disposition of all or substantially all of the assets of Rigel; or

 

(c)                                   Rigel closes an agreement with any Person providing for a consolidation or merger of Rigel with another person or other entity (other than with any of Rigel’s subsidiaries) that results in the shareholders of Rigel immediately before the occurrence of the consolidation or merger receiving only cash for their Rigel shares or securities (whether or not in combination with cash) representing, in the aggregate, less than [ * ] of the Voting Stock of the surviving entity immediately after consolidation or merger; or

 

(d)                                   a change in Rigel’s Board of Directors occurs with the result that the members of the Board on the date of this Agreement (the “Incumbent Directors”) no longer constitute a majority of such Board of Directors, provided that any person becoming a director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest or the settlement thereof, including but not limited to a consent solicitation, relating to the election of directors of Rigel) whose election or nomination for election was supported by at least two-thirds (2/3) of the then Incumbent Directors shall be considered an Incumbent Director for purposes hereof; or

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(e)                                   Rigel enters into an agreement with any Person providing for the matters described in subsections (a) or (d) above.

 

1.8                                “Collaboration” means all activities performed by or on behalf of Rigel or Pfizer in the course of performing their obligations pursuant to the Research Program.

 

1.9                                “Combination Product” means a Product containing a Compound and one or more other pharmaceutically active agents.

 

1.10                         “Commence” or “Commencement” when used to describe a Phase I Trial, Phase II Trial, or Phase III Trial, means the first dosing of the first patient for such trial.

 

1.11                         “Commercialization” means all activities that are undertaken after Regulatory Approval of an NDA for a particular Product and that relate to the commercial marketing and sale of such Product including advertising, marketing, promotion, distribution, and Phase IV Trials.

 

1.12                         “Competing Product” means any Syk Inhibitor for Intrapulmonary Administration that has received Regulatory Approval for an indication in the Field, which Syk Inhibitor is not a Product.

 

1.13                         “Compound” means, initially, the compounds listed on Schedule 1.13 as of the Effective Date, and thereafter (i) shall exclude any of the compounds listed on Schedule 1.13 that are determined to fall within clause (a), (b) or (c) below, and (ii) shall be expanded to include all Compound Analogs and Derivatives, and all prodrugs, salts and polymorphs of each Compound, that are shown to inhibit SYK with an [ * ] and are not excluded from the definition of “Compound” pursuant to clauses (a), (b) or (c) below.  The following compounds shall be excluded from the definition of “Compound”:

 

(a)                                   any such compound that is shown to have an oral bioavailability in rats of greater than [ * ] ; and

 

(b)                                   any such compound that is eliminated from the definition of “Compound” pursuant to Section 3.3 or Section 3.4; and

 

(c)                                   any such compound that reverts to Rigel under Section 9.3.

 

Schedule 1.13 shall be updated from time to time, upon the request of either Party, to reflect additions or deletions that have occurred after the Effective Date.

 

1.14                         “Compound Analogs and Derivatives” shall mean (a) all compounds created through the addition or deletion of chemical moieties that are covalently bound to the [ * ] of the compounds listed on Schedule 1.13 (including compounds listed on such Schedule that are determined not to be Compounds), and (b) all stereoisomers of Compounds or of the compounds described in clause (a) of this Section 1.14, whether or not such stereoisomers are created through the addition or deletion of chemical moieties that are covalently bound to the [ * ] of such compounds.  For clarity, Compound Analogs and Derivatives shall exclude salts, polymorphs and physical forms of Compounds.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.15                         “Confidential Information” means all Information, and other information and materials, received by either Party from the other Party pursuant to this Agreement and that is designated as confidential at the time of disclosure or promptly thereafter.

 

1.16                         Control ” means, with respect to any intellectual property right, that a Party owns or has a license to such item or right, and has the ability to grant a license or sublicense in or to such right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.17                         “Develop” or “Development” means, with respect to the Product, the performance of all research, pre-clinical, clinical and regulatory activities required to obtain Regulatory Approval of a Product in the Territory; provided , however , that Develop or Development shall not include the performance by either Party of its obligations under the Research Program.

 

1.18                         “Development Plan” has the meaning set forth in Section 4.1.

 

1.19                         Diligent Efforts ” means the carrying out of obligations or tasks in a manner consistent with the efforts a Party devotes to research, development or marketing of a pharmaceutical product or products of similar market potential, profit potential or strategic value resulting from its own research efforts, taking into account technical and regulatory factors, target product profiles, product labeling, past performance, economic return, the regulatory environment and competitive market conditions in the therapeutic area, all based on conditions then prevailing.  Diligent Efforts requires that a Party, at a minimum, assign responsibility for such obligations to qualified employees, set annual goals and objectives for carrying out such obligations, and allocate resources designed to meet such goals and objectives.

 

1.20                         “Effective Date” means the date that the applicable waiting period under the HSR Act shall have expired or been terminated with respect to this Agreement.

 

1.21                         FDA ” means the United States Food and Drug Administration, or any successor federal agency thereto.

 

1.22                         Field ” means the prevention and treatment of Allergy and Respiratory Conditions in humans.

 

1.23                         “FTE” means the equivalent of one person working full time for one 12-month period in a research, development, commercialization, regulatory or other relevant capacity, approximating 1800 hours per year.  In the interests of clarity, though, a single individual who works more than 1800 hours in a single year shall be treated as one FTE regardless of the number of hours worked.

 

1.24                         “Generic Product” means any pharmaceutical product, other than a Product, that contains the same Compound as the relevant Product and can reasonably be or is reasonably used for the same indication or indications as such Product.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.25                         “Good Clinical Practices” or “GCP” means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.

 

1.26                         “Good Laboratory Practices” or “GLP” means current Good Laboratory Practices as specified in the United States Code of Federal Regulations at 21 CFR § 58 at the time of testing and all applicable ICH guidelines.

 

1.27                         “Good Manufacturing Practices” or “GMP” means current Good Manufacturing Practices and standards as provided for (and as amended from time to time) in European Community Directive 91/356/EEC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products) and in the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations Title 21 (21 CFR §§ 210-211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and subject to any arrangements, additions or clarifications agreed from time to time between the Parties.

 

1.28                         “Governmental Authority” means any court, agency, department or other instrumentality of any foreign, federal, state, county, city or other political subdivision.

 

1.29                         “HSR Act” means the United States Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

 

1.30                         “IND” means an Investigational New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to Commence human clinical trials in such jurisdiction, and including all regulations at 21 CFR § 312 et. seq. and equivalent foreign regulations.

 

1.31                         Information ” means information, results and data of any type whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.

 

1.32                         “Intrapulmonary Administration” means the delivery of a pharmaceutical product to the lung, and shall include without limitation dry powder formulations and aerosolized liquids or suspensions for delivery to the lung by means of the mouth, but shall exclude without limitation liquids or suspensions designed for intranasal administration.  Intrapulmonary Administration shall exclude the Oral Delivery and intravenous administration of drugs.

 

1.33                         “Know-How” means any non-public, proprietary Information and other data, instructions, processes, methods, formulae, materials, expert opinions and information, including without limitation, biological, chemical, pharmacological, toxicological, pharmaceutical,

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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physical and analytical, clinical, safety, manufacturing and quality control data and information.  Know-How does not include any rights under Patents.

 

1.34                         “Joint Research Committee” or “JRC” means the committee described in Section 2.1.

 

1.35                         “Launch” means the first shipment of a Product in commercial quantities for commercial sale by Pfizer, its Affiliates or its sublicensees to an unaffiliated Third Party in a country after receipt by Pfizer of the first Regulatory Approval for such Product in such country.

 

1.36                         “Major European Country” means the United Kingdom, Spain, France, Germany and Italy.

 

1.37                         “NDA” means a New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent Governmental Authority outside of the United States necessary for approval of a drug in such jurisdiction.

 

1.38                         “Net Sales” means

 

(a)                                   with respect to a Product (subject to subsections (b) and (c) below), the amount received by a Party or its Affiliate or a Third Party sublicensee for sales of such Product, to Third Parties, less (i) actual bad debts related to such Product and (ii) sales returns and allowances actually paid, granted or accrued, including, without limitation, trade, quantity and cash discounts and any other adjustments, including, but not limited to, those granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions, adjustments arising from consumer discount programs, including without limitation Pfizer Pfriends or similar programs, customs or excise duties, sales tax, consumption tax, value added tax, and other taxes (except income taxes) or duties relating to sales, and any payment in respect of sales to the United States government, any State government or any foreign government, or to any governmental or regulatory authority, or with respect to any government-subsidized program or managed care organization, and freight and insurance (to the extent that Pfizer bears the cost of freight and insurance for a Product); and

 

(b)                                   in the case of Combination Products,

 

(i)                                     if Pfizer and/or its Affiliates and/or any Third Party separately sells in such country during such year when it sells such Combination Product both (1) one or more Products as a single chemical entity and (2) other products containing active ingredient(s) as a single entity that are also contained in such Combination Product, the Net Sales attributable to such Combination Product during such year shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: A is Pfizer’s (or its Affiliates or Third Parties, as applicable) average Net Sales price per daily dose during such year for each Product in such Combination Product in such country and B is the sum of the average of Pfizer’s (or its Affiliates or Third Parties, as applicable) Net Sales price per daily dose during such year

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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in such country, for each product(s) containing, the active ingredient(s) in such Combination Product (other than the Product);

 

(ii)                                 if Pfizer and/or its Affiliates and/or any Third Party separately sells, in such country during such year when it sells such Combination Product, one or more Products as a single chemical entity but do not separately sell, in such country, other products containing active ingredient(s) that are also contained in such Combination Product, the Net Sales attributable to such Combination Product during such year shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: A is Pfizer’s (or its Affiliates or Third Parties, as applicable) average Net Sales price per daily dose during such year for each  Product in such Combination Product in such country, and C is Pfizer’s (or its Affiliates or Third Parties, as applicable) average Net Sales price per daily dose during such year for the Combination Product in such country;

 

(iii)                             if Pfizer and/or its Affiliates and/or Third Parties do not separately in such country during such year sell each Product contained in the Combination Product, then the Net Sales attributable to such Combination Product shall be D/(D+E) where D is the fair market value of the portion of the Combination Product that contains the Product and E is the fair market value of the portion of the Combination Product containing the other active ingredient(s) and the delivery device included in such Combination Product, as such fair market values are determined by mutual agreement of the Parties; and

 

(c)                                   if a Product is packaged with a delivery device or sold together with a delivery device for a single price, then the Net Sales for the purpose of determining the royalty due to the other Party pursuant to Section 6.3 shall include the sales price of both the Product and the delivery device.

 

1.39                         “Oral Delivery” means the administration of a human pharmaceutical product via the mouth in any form other than for the purpose of delivery of such product specifically to the lung.  Oral Delivery shall include without limitation the delivery of products in the form of a pill or a non-aerosolized liquid or suspension, or sublingually.

 

1.40                         “Other Topical Administration” means any topical administration of a human pharmaceutical product, including without limitation patches and ophthalmologic application, but excluding Intrapulmonary Administration and intranasal administration.

 

1.41                         “Patent” means: (a) an issued unexpired patent (including inventor’s certificate) that has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal or any like filing thereof; or (b) any pending patent application, including without limitation any continuation, division or continuation-in-part thereof and any provisional application.

 

1.42                         “Person” means an individual, corporation, partnership, company, joint venture, unincorporated organization, limited liability company or partnership, sole proprietorship,

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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association, bank, trust company or trust, whether or not legal entities, or any governmental entity or agency or political subdivision thereof.

 

1.43                         “Pfizer Know-How” means all Know-How Controlled by Pfizer or its Affiliates that is developed by or on behalf of Pfizer pursuant to the Collaboration and is necessary or useful for the research, development, manufacture, importation, use or sale of Compounds or Products, including without limitation Pfizer’s rights in any jointly-owned Know-How.

 

1.44                         “Pfizer Patents” means any Patents Controlled by Pfizer or its Affiliates that are based on inventions made by or on behalf of Pfizer pursuant to the Collaboration and are necessary or useful for the development, manufacture, importation, use or sale of Products, including without limitation Pfizer’s rights in any jointly-owned Patents.

 

1.45                         “Pfizer Quarter” means (i) in the United States, each of the four (4) thirteen (13) week periods as used by Pfizer in its audited financial reports, the first commencing on January 1 of any year, and (ii) in any country in the Territory other than the United States, each of the four (4) thirteen (13) week periods as used by Pfizer in its audited financial reports, the first commencing on December 1 of any year.

 

1.46                         “Pfizer Technology” means Pfizer Patents and Pfizer Know-How.

 

1.47                         “Phase I Trial” means a clinical trial that generally provides for the first introduction into humans of a Product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the Product, and generally consistent with 21 CFR § 312.21(a).

 

1.48                         “Phase II Trial” means a clinical trial of a Product on patients, including possibly pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such Product is safe for its intended use and to obtain sufficient information about such Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR § 312.21(b).  A Phase II Trial may be either a Phase II(a) Trial or a Phase II(b) Trial.

 

1.49                         “Phase II(a) Trial” means a Phase II Trial intended for dose exploration, dose response, duration of effect, kinetic/dynamic relationship and preliminary efficacy and safety study of a candidate drug in the target patient population.

 

1.50                         “Phase II(b) Trial” means a controlled dose ranging Phase II Trial to evaluate further the efficacy and safety of a candidate drug in the target patient population and to define the optimal dosing regimen.

 

1.51                         “Phase III Trial” means a clinical trial that provides for a pivotal human clinical trial of a Product, which trial is designed to: (a) establish that a Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed; (c) support Regulatory Approval of such Product; and (d) generally consistent with 21 CFR § 312.21(c).

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.52                         “Phase IV Trial” means clinical trial of a Product Commenced in a particular country after Regulatory Approval for such Product in such country in order to support commercialization of the Product.

 

1.53                         “Preclinical Development” means those Development activities performed prior to the filing of an IND.

 

1.54                         “Product” means any pharmaceutical product comprised of a Compound, alone or in combination with one or more therapeutically active ingredients, whether or not combined with an inhalation or similar device, the manufacture, use, sale, offer for sale or importation of which, in the absence of a license, would infringe any of the Rigel Patents including Patents jointly-owned by the Parties.

 

1.55                         “Proxy Solicitation” means any solicitation of proxies or stockholder consents (as such terms are defined under Regulation 14A and Regulation 14C of the Securities Exchange Act) to vote or seek to advise or influence in any manner whatsoever any Person with respect to the Voting Stock of Rigel.

 

1.56                         “R-112” means the Rigel Syk tyrosine kinase inhibitor that (a) is identified in IND No. 66,176 filed with the FDA for Rigel’s R-112 Nasal Spray; and (b) was the product candidate that entered into a Phase I Trial to treat allergic rhinitis in September 2002, and was the product candidate that entered into a Phase II Trial for allergic rhinitis in April 2004, sponsored by Rigel.

 

1.57                         “[ * ]” means the Syk tyrosine kinase inhibitor set forth in Schedule 1.57 .

 

1.58                         “Regulatory Approval” means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use or, in Pfizer’s reasonable judgment, widespread sale of a Product in a regulatory jurisdiction.

 

1.59                         “Regulatory Authority” means any Governmental Authority with responsibility for granting any licenses or approvals necessary for the marketing and sale of pharmaceutical products including, without limitation, the FDA and any drug regulatory authority of countries of the European Union, and Japan, and where applicable any ethics committee or any equivalent review board.

 

1.60                         “Regulatory Filing” means the NDA, biologic license application (“BLA”), IND, or any foreign counterparts thereof and any other filings required by regulatory authorities relating to the study, manufacture or commercialization of any Product.

 

1.61                         “Research Plan” has the meaning set forth in Section 3.1.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.62                         “Research Program” means the Research Program established by the Parties pursuant to this Agreement.

 

1.63                         “Research Term” means the period from the Effective Date to the later of (a) [ * ] thereafter, or (b) the completion by [ * ] on Exhibits A-1 and A-2 , subject to extension in the event the Parties commence de novo compound discovery under Section 3.10.

 

1.64                         “Rigel Know-How” means all Know-How Controlled by Rigel or its Affiliates that is necessary or useful for the research, development, manufacture, importation, use or sale of the Compounds or Products, including without limitation Rigel’s rights in any jointly-owned Know-How.

 

1.65                         “Rigel Patents” means any Patents Controlled by Rigel or its Affiliates that are necessary or useful for the research, development, manufacture, importation, use or sale of the Compounds or Products, including without limitation, the Patents listed on Schedule 1.65 , as well as Rigel’s rights in any jointly-owned Patents.  Patents owned jointly by the Parties shall be deemed Controlled by Rigel for purposes of this Section 1.65.

 

1.66                         “Rigel Technology” means Rigel Patents and Rigel Know-How.

 

1.67                         “Royalty Term” means on a country-by-country and Product-by-Product basis, the later of:  (A) the last to expire Valid Claim Controlled by Rigel covering a Product in such country, and (B) [ * ] years following the Launch of such Product in such country.

 

1.68                         “Standstill Period” shall mean the period commencing on the execution date of this Agreement and terminating [ * ] after such date.

 

1.69                         “SYK” shall mean an enzyme comprised of the amino acid sequence for spleen tyrosine kinase as identified on Schedule 1.69 , including all allelic variations or derivatives thereof, or homologues whose amino acid sequence has [ * ] or greater homology with such sequence.

 

1.70                         “Syk Inhibitor” means a compound whose primary known mechanism of action is the direct inhibition of SYK.

 

1.71                         “Term” has the meaning assigned to it in Section 9.1.

 

1.72                         “Territory” means worldwide.

 

1.73                         “Third Party” means a person or entity other than (a) Pfizer, (b) Rigel or (c) an Affiliate of either of them.

 

1.74                         “Valid Claim” means a claim of any issued, unexpired United States or granted foreign Rigel Patent (as Patent is defined in Section 1.41(a)) that has not been dedicated to the public, disclaimed, abandoned or held invalid or unenforceable by a court or other body of competent jurisdiction in an unappealed or unappealable decision, and that has not been explicitly disclaimed, or admitted by Rigel in writing to be invalid or unenforceable or of a scope not covering Products through reissue, disclaimer or otherwise.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.75                         “Voting Stock” means securities of any class or series of a corporation or association the holders of which are ordinarily, in the absence of contingencies, entitled to vote generally in matters put before the shareholders or members of such corporation or association.

 

2.                                       MANAGEMENT OF THE RESEARCH PROGRAM

 

2.1                                Joint Research Committee.

 

(a)                                   The Research Program established by this Agreement shall be overseen by a joint research committee composed of  four (4) representatives from each Party (the “Joint Research Committee” or “JRC”).  The Parties shall designate their JRC representatives within ten (10) days after the Effective Date.  An alternate member designated by a Party may serve temporarily in the absence of a permanent member of the JRC for such Party.  Each Party shall designate one of its representatives as a co-chair of the JRC.  The co-chairs of the JRC shall be jointly responsible for setting the agenda for each meeting, and each co-chair will be responsible for chairing alternating JRC meetings.  From time to time, the JRC may establish subcommittees or subordinate committees (that may or may not include members of the JRC itself) to oversee particular projects or activities, and such subcommittees or subordinate committees shall be constituted and shall operate as the JRC agrees.  The JRC shall disband automatically at the end of the Research Term, provided, however, that after termination of the Research Term, the JRC may continue to meet at its own discretion for purposes related to the Collaboration should the JRC unanimously decide that such continued meetings are in the best interest of the Collaboration.

 

(b)                                   All decisions of the JRC made pursuant to this Agreement shall be made by unanimous consent of its members.  If for any reason the JRC cannot reach unanimity within ten (10) Business Days of the JRC meeting at which such matter was first discussed, then, except as set forth in Section 2.1(c), the matter shall be referred to a vice president of Pfizer and a senior executive of Rigel for resolution.  Neither of such Pfizer vice president or Rigel senior executive shall at the time of determination be a member of the JRC or of any subcommittee of the JRC.  If such Pfizer vice president and Rigel senior executive cannot resolve the matter in good faith within ten (10) Business Days after attempting to find a mutually satisfactory resolution to the issue, then the matter shall be decided in good faith by such Pfizer vice president.

 

(c)                                   Any changes to the Research Plan expanding Rigel’s obligations or requiring Rigel to exert additional efforts shall require the unanimous consent of the JRC.  If the JRC fails to reach unanimous consent regarding any such change to the Research Plan, then the obligations of Rigel shall not be increased.

 

2.2                                Meetings.   The JRC shall hold meetings at such times and places as shall be determined by the JRC (it being expected that any in-person meetings will alternate between the offices of each Party), but in no event shall such meetings be held less frequently than once every three (3) months during the Research Term; and the JRC may:

 

(a)                                   conduct meetings in person, by videoconference or by telephone conference;

 


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(b)                                   invite other personnel of the Parties to attend meetings of the JRC as appropriate to the agenda for such meeting, after giving notice to the other Party;

 

(c)                                   act without a meeting if, prior to such action, a consent thereto is signed by the co-chairs of the JRC; and

 

(d)                                   by unanimous consent, amend or expand upon the foregoing procedures for its internal operation.

 

2.3                                Minutes.   At each meeting, the JRC shall elect a secretary who will prepare, within fifteen (15) Business Days after each meeting, minutes reporting in reasonable detail the actions taken by the JRC during such meeting, the status of the Research Program as described in the relevant JRC meeting, issues requiring resolution, and resolutions of previously reported issues.  Such minutes are to be reviewed and, if reasonably complete and accurate, signed by one JRC member from each Party.  The secretary shall revise such minutes as necessary to obtain such signatures.

 

2.4                                JRC Functions and Powers.   The research activities of the Parties under this Agreement shall be managed by the JRC only to the extent set forth herein (unless otherwise mutually agreed in writing by the Parties).  The JRC shall foster the collaborative relationship between the Parties in order to assist each Party in fulfilling its obligations under this Agreement, and shall in particular:

 

(a)                                   encourage and facilitate ongoing cooperation and information exchange between the Parties;

 

(b)                                   monitor the progress of the Research Program and the Parties’ diligence in carrying out their responsibilities thereunder;

 

(c)                                   prepare any amendments to the Research Plan, if the JRC should determine that any such amendments are necessary;

 

(d)                                   set priorities, allocate tasks and coordinate activities between the Parties, in each case as required to perform the Research Program;

 

(e)                                   perform such other functions as appropriate to further the purposes of this Agreement as mutually determined by the Parties.

 

The JRC shall have no power to amend this Agreement and shall have only such powers as are specifically delegated to it hereunder.

 

2.5                                Independence.   Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.  The relationship between Rigel and Pfizer is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner, other than as is expressly set forth in this Agreement.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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3.                                       CONDUCT OF THE RESEARCH PROGRAM AND SELECTION OF COMPOUNDS FOR PRECLINICAL DEVELOPMENT.

 

3.1                                Research Plan.   The Parties shall conduct the Research Program according to a research plan (the “Research Plan”).  The initial Research Plan has been approved by the Parties concurrent with the execution of this Agreement and is attached hereto as Exhibits A-1 and A-2 .  The Research Plan may be amended from time to time by the JRC during the Research Term, based upon the data obtained in the Research Program, provided such amendments do not violate or contradict any provision of this Agreement.  In the event of an inconsistency or disagreement between the Research Plan and this Agreement, the terms of this Agreement shall prevail.

 

3.2                                Conduct of Research.   The Parties shall use Diligent Efforts to conduct their respective tasks as assigned under the Research Plan throughout the Research Program.  In addition, the Parties shall conduct the Research Program in compliance in all material respects with the requirements of applicable laws, rules and regulations and all applicable GLP to attempt to achieve their objectives efficiently and expeditiously.

 

3.3                                Assessment of [ * ]. Rigel and Pfizer shall, [ * ] , use Diligent Efforts to carry out its obligations under the Research Plan as set forth in Exhibit A-1 with respect to the Compound designated as [ * ] .  With respect to such Compound, Pfizer shall have the option to retain the exclusive rights to [ * ] granted in Section 5.1 by paying to Rigel the amount set forth in Section 6.2(a)(i) no later than the earlier of (i) the date that is one hundred and eighty (180) days following Rigel’s completion of the tasks designated in Exhibit A-1 to be carried out by Rigel for [ * ] , and the delivery to Pfizer of the data resulting from such Rigel tasks; and (ii) Pfizer’s decision to commence Advanced Preclinical Development for [ * ] .  If Pfizer has not made the payment under Section 6.2(a)(i) within the time period set forth in this Section 3.3 (as such time period may be extended pursuant to Section 3.5), then [ * ] shall be deleted from the definition of “Compound” and Rigel may thereafter license, develop and commercialize such compound, subject to the restrictions set forth in Section 5.3.

 

3.4                                Assessment Of Other Compounds.

 

(a)                                   Rigel’s undertaking with respect to the Compounds under Sections 3.3 and 3.4 shall be to perform work directed towards the delivery to Pfizer of at least two (2) candidates for Advanced Preclinical Development within [ * ] from the Effective Date.  If Pfizer selects [ * ] for Advanced Preclinical Development under Section 3.3, then Rigel shall perform work directed towards the delivery to Pfizer of at least one (1) additional candidate for Advanced Preclinical Development under this Section 3.4.  If Pfizer does not select [ * ] for Advanced Preclinical Development under Section 3.3, then Rigel shall perform work directed towards the delivery to Pfizer of two (2) other candidates for Advanced Preclinical Development under this Section 3.4.  The Parties may also agree to extend the Research Term under Section 3.10 in pursuit of additional candidates for Advanced Preclinical Development.  Rigel and Pfizer shall, each at its own expense, use Diligent Efforts to carry out its obligations under the Research Plan as set forth in Exhibit A-2 , with respect to the Compounds other than [ * ] , but not to perform the tasks set forth on Exhibit A-2 with respect to various Compounds beyond the level reasonably necessary to deliver more than two (2) candidates for Advanced Preclinical Development.  With respect to Compound(s) other than [ * ] proposed by Rigel for Advanced Preclinical Development, Pfizer

 


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shall have the right to retain the exclusive license to such Compound(s) granted in Section 5.1 by paying to Rigel the amount set forth in Section 6.2(a)(i) or Section (a)(ii), as applicable, no later than the earlier of (i) the date that is one hundred and eighty (180) days following Rigel’s completion of the tasks designated in the Research Plan to be carried out by Rigel to enable Pfizer to consider a candidate for Advanced Preclinical Development, and the delivery to Pfizer of the data resulting from such Rigel tasks, provided , however , that such delivery takes place no sooner than twelve (12) months after the delivery of the data resulting from Rigel’s tasks for the first candidate, or such earlier time as the JRC might establish; and (ii) Pfizer’s decision to commence Advanced Preclinical Development for such Compound.  For avoidance of doubt, the payment by Pfizer of any Event Milestone Payment under Sections 6.2(a)(i) or 6.2(a)(ii) shall not relieve Rigel of its obligation to complete any remaining work under the Research Plan related to the delivery to Pfizer of two (2) candidates for Advanced Preclinical Development.

 

(b)                                   If Pfizer makes a payment under Section 6.2(a)(i) but does not make a payment under Section 6.2(a)(ii) within the time period specified in Section 3.4(a) (as such time period may be extended pursuant to Section 3.5), then, effective as of the date Pfizer is obligated to make its payment under Section 6.2(a)(ii), the definition of “Compound” shall thereafter be limited only to the Compound for which Pfizer has made its payment under Section 6.2(a)(i), and Rigel may thereafter license, develop and commercialize such compounds subject to the restrictions set forth in Section 5.3.

 

(c)                                   If Pfizer makes payments under both of Section 6.2(a)(i) and Section 6.2(a)(ii), then, subject to the other terms and conditions of this Agreement, all Compounds (i.e., after deletion of compounds by reason of Section 1.13(a), (b), (c) and (d)) shall remain available to Pfizer pursuant to the license set forth in Section 5.1, and Rigel shall remain subject to the restrictions set forth in Section 5.3.  If Pfizer should select additional Compounds for Advanced Preclinical Development other than the two (2) Compounds for which the Event Milestone Payments were made under Sections 6.2(a)(i) and 6.2(a)(ii), then Pfizer shall provide Rigel with written notice within thirty (30) days after any such Compound selection that does not trigger an Event Milestone Payment.

 

3.5                                Extension of Time Period.

 

(a)                                   Pfizer shall have the option (the “First Extension Option”) to extend the time period set forth in Section 3.3, with respect to [ * ] , by an additional one hundred and eighty (180) days if, in Pfizer’s good faith judgment, additional time is required for Pfizer to decide whether to commence Advanced Preclinical Development with respect to [ * ] .  Pfizer may exercise the First Extension Option by paying to Rigel fifty percent (50%) of the Event Milestone Payment due under Section 6.2(a)(i) prior to the date Pfizer’s option to retain exclusive rights to [ * ] expires under Section 3.3.  If Pfizer should exercise the First Extension Option, Pfizer shall have the right to retain the exclusive license to [ * ] granted in Section 5.1 by paying to Rigel the remaining fifty percent (50%) of the Event Milestone Payment due under Section 6.2(a)(i) within such one hundred and eighty (180) day extension period.  Each payment made to Rigel under this Section 3.5(a), if any, shall be fully-credited against the Event Milestone Payment due under Section 6.2(a)(i) should Pfizer make such Event Milestone Payment.  During the extension period set forth in this Section 3.5(a), Pfizer shall not commence

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Advanced Preclinical Development with respect to [ * ] until the Event Milestone Payment under Section 6.2(a)(i) has been paid in full.

 

(b)                                   Pfizer shall have the option (the “Second Extension Option”) to extend the time period set forth in Section 3.4(a), with respect to any Compound other than [ * ] , by an additional one hundred and eighty (180) days if, in Pfizer’s good faith judgment, additional time is required for Pfizer to decide whether to commence Advanced Preclinical Development with respect to such other Compound.  Pfizer may exercise the Second Extension Option by paying to Rigel fifty percent (50%) of the Event Milestone Payment due with respect to such Compound under Section 6.2(a)(i) or 6.2(a)(ii), as applicable, depending on whether Pfizer has previously made an Event Milestone Payment under Section 6.2(a)(i) prior to the date Pfizer’s option to retain exclusive rights to such Compound expires under Section 3.4.  If Pfizer should exercise the Second Extension Option, Pfizer shall have the right to retain the exclusive license to such Compound granted in Section 5.1 by paying to Rigel the remaining fifty percent (50%) of the Event Milestone Payment due with respect to such Compound under Section 6.2(a)(i) or 6.2(a)(ii), as applicable, within such one hundred and eighty (180) day extension period.  Each payment made to Rigel under this Section 3.5(b), if any, shall be fully-credited against the Event Milestone Payment due under Section 6.2(a)(i) or 6.2(a)(ii) should Pfizer make such Event Milestone Payment.  During the extension period set forth in this Section 3.5(b), Pfizer shall not commence Advanced Preclinical Development with respect to such other Compound until the Event Milestone Payment under Section 6.2(a)(i) or 6.2(a)(ii) for such Compound has been paid in full.

 

3.6                                Research Costs.   Except as provided in Section 3.10 and in this Section 3.6, [ * ] , and any external payments to Third Parties that [ * ] of the Research Program unless otherwise agreed upon by the JRC.  Regarding payments made in connection with the supply of clinical materials or the scale up of manufacturing processes for Compounds, (a) [ * ] , (b) [ * ] shall pay for the manufacture of the [ * ] , provided, however, that Pfizer has approved in advance the manufacture by Third Parties of such Compound and the selection of any such Third Party manufacturer.  In addition, Pfizer shall bear the costs of the services described in Schedule 3.6 .

 

3.7                                Records.   Each Party shall maintain complete and accurate records of all work conducted under the Research Program and all results, data and developments made pursuant to its efforts under the Research Program.  Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of the Research Program in sufficient detail and in a manner appropriate for patent and regulatory purposes.  Subject to bona fide confidentiality obligations to a Third Party, each Party shall have the right to request copies of such records of the other Party at reasonable times and upon reasonable notice to the extent necessary for such Party to conduct its research or perform its other obligations under this Agreement, or to secure or enforce Patents licensed under this Agreement.

 

3.8                                Reports.   During the Research Term, each Party shall report to the JRC no less than once per calendar quarter, which report shall include a written progress report summarizing the work performed under the Research Program, including analoging activities performed pursuant to Section 3.9.  The JRC shall define the format and the nature of the content of the quarterly report, which format and nature shall be adopted by both Parties.

 


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3.9                                Analogs.   Under the Research Plan, Pfizer shall have the right to design and synthesize salts, polymorphs and physical forms of Compounds as part of Pfizer’s activities under this Agreement.  Pfizer shall also have the right to make Compound Analogs and Derivatives as provided in this Section 3.9, and to request Rigel to commence de novo Compound discovery pursuant to Section 3.10.  De novo synthesis pursuant to Section 3.10 shall refer to the preparation of chemical compounds other than those containing the [ * ] of the compounds listed on Schedule 1.13 , that are designed to be Syk Inhibitors.

 

(a)                                   Pfizer’s chemistry efforts related to Compounds (other than the creation of salts, polymorphs and physical forms) shall be limited to the creation of Compound Analogs and Derivatives.  Pfizer shall inform the JRC of the nature of its chemistry efforts related to Compounds as part of its quarterly reports under Section 3.8, and such reports shall identify all Compound Analogs and Derivatives made or conceived by Pfizer during the period since its most recent report.  Ownership of any compounds conceived or created by Pfizer in the course of working with the Compounds shall be allocated as follows:

 

(i)                                     The JRC shall determine, as part of the Research Plan, the extent to which any particular Compound Analogs and Derivatives shall be tested to determine which of those compounds satisfy the definition of a Compound.  In the event that the JRC has determined that particular Compound Analogs and Derivatives satisfy the definition of a Compound, Pfizer shall have the right to file, prosecute and maintain patent applications covering such Compounds, which patent applications and patents issuing therefrom shall be Joint Patents, regardless of inventorship, and shall be prosecuted by Pfizer in compliance with Section 7.3(b).  Should Pfizer determine not to file, prosecute or maintain patent applications covering any Compounds created by Pfizer pursuant to this Section 3.9, Rigel shall then have the right to file, prosecute and maintain such patent applications, as Joint Patents, with Rigel playing the role assigned to Pfizer under Section 7.3(b).

 

(ii)                                 In the event that (A) the JRC determines that any of the particular Compound Analogs and Derivatives created under this Section 3.9 does not satisfy the definition of a Compound, or (B) the JRC has decided not to make further efforts to determine whether any of the particular Compound Analogs and Derivatives satisfies the definition of a Compound, then Pfizer shall assign to Rigel its entire right, title and interest in and to such compound and inventions and patent rights covering such compound, and Rigel shall have the sole right to file, prosecute and maintain patents covering such inventions as Rigel Patents, but without any duty to inform Pfizer as to its patenting activities.  If it is later determined that any compounds assigned to Rigel pursuant to this Section 3.9(a)(ii) satisfy the definition of a Compound, the rights to such Compounds shall be allocated in accordance with this Agreement (including without limitation the license and exclusivity provisions of Article 5 and the payment provisions of Article 6) and Rigel shall thereafter prosecute any Rigel Patents covering such Compounds in accordance with Article 7.  Pfizer agrees to execute any instruments of assignment reasonably necessary or useful to facilitate Rigel’s filing of patent applications related to such inventions under this Section 3.9(a)(ii).

 

(iii)                             In the event Pfizer’s activities in connection with making Compound Analogs and Derivatives pursuant to this Section 3.9 result in inventions that cover both Compounds and compounds that do not satisfy the definition of a Compound, the Parties

 


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shall use commercially reasonable efforts to prepare patent applications that cover, on the one hand, only Compounds, and on the other hand, only compounds other than Compounds.

 

(iv)                                Subject to the restrictions set forth in Section 5.3, Pfizer hereby grants Rigel an exclusive (even as to Pfizer), perpetual, royalty free, sublicensable license under Patents owned or Controlled by Pfizer that cover compositions of matter that (A) are conceived or created by Pfizer under this Section 3.9, and (B) do not satisfy the definition of a Compound, to make, have made, use, import, offer for sale and sell such compounds for all indications both within and outside the Field and in the Territory.

 

(b)                                   Pfizer may also request that Rigel commence a program to design or synthesize Compound Analogs and Derivatives as part of the Research Program, and Pfizer may request that the JRC amend the Research Plan to include such analog work.

 

(i)                                     If the JRC (with the consent of Rigel) should determine that such analog work is minor, then the JRC may amend the Research Plan accordingly to include Rigel’s performance of such analog work.  If the JRC should determine that such analog work is not minor, then Pfizer may request that Rigel commence an analog program pursuant to a new research plan that shall specify the nature and magnitude of the analog program and the budget for such program (it being understood that Rigel’s internal costs would be borne by Pfizer at an FTE rate of [ * ] ) but shall otherwise be subject to the terms and conditions of this Agreement except as the Parties may then agree.  Rigel shall not be obligated to conduct any analog work under this Section 3.9 without its consent.

 

(ii)                                 Rigel shall inform the JRC of the nature of its efforts related to the design and synthesis of Compound Analogs and Derivatives to the extent conducted by Rigel at the request of the JRC pursuant to this Section 3.9.  Such reporting shall occur as part of Rigel’s quarterly reports under Section 3.8, and such reports shall identify all Compound Analogs and Derivatives made or conceived by Rigel under this Section 3.9 during the period since its most recent report.  The JRC shall determine, as part of the amended Research Plan or new research plan, as appropriate, the extent to which any of such Compound Analogs and Derivatives shall be tested to determine which of those compounds satisfy the definition of a Compound.  In the event that the JRC determines that any particular Compound Analogs and Derivatives designed or synthesized by Rigel satisfy the definition of a Compound, then the rights to such Compound shall be allocated in accordance with this Agreement (including without limitation the license and exclusivity provisions of Article 5 and the payment provisions of Article 6).  Rigel shall own all compounds designed and synthesized by Rigel under this Section 3.9(b), and shall thereafter prosecute any patents covering Compounds as Rigel Patents in accordance with Article 7.  To the extent any patent applications cover compounds that are created by Rigel under this Section 3.9(b), none of which satisfy the definition of a Compound, Rigel shall have the sole right to file, prosecute and maintain patents covering such inventions without any duty to inform Pfizer as to its patenting activities.

 

3.10                         Pfizer Option To Request De Novo Compound Discovery.   As of the Effective Date, the Research Plan contemplates only the assessment of the existing Rigel library of compounds that have been demonstrated to be Syk tyrosine kinase inhibitors with a specified level of activity for potential Development and Commercialization by Pfizer, together with the

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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provisions of Section 3.9 regarding the creation of Compound Analogs and Derivatives.  However, Pfizer may request that Rigel commence a research program pursuant to a new research plan which plan will include, without limitation, de novo discovery of new Compounds, by providing notice to Rigel prior to the end of the Research Term.  If Pfizer provides such notice, then the Parties shall negotiate in good faith the terms and conditions of an amendment to this Agreement to provide for such a program.  Such amendment would need to specify, among other things, the nature and magnitude of the new discovery program, the allocation of costs (it being understood that Rigel’s internal costs would be borne by Pfizer at an FTE rate of [ * ] ), and the respective rights of the Parties regarding the ownership and licensing of any resulting compositions of matter.  If the Parties have not mutually agreed on an amendment of this Agreement within one hundred and eighty (180) days following the delivery of a notice by Pfizer pursuant to this Section 3.10, then Rigel shall have no obligation to conduct such a discovery program or to continue the negotiations with Pfizer.

 

4.                                       DEVELOPMENT AND COMMERCIALIZATION

 

4.1                                Development Plan.   The Development of each Product shall be governed by a development plan that describes the proposed overall program of Development (the “Development Plan”).  Pfizer shall have the sole right and responsibility for preparing the Development Plan for each Product. Pfizer shall provide annual written reports to Rigel regarding continuing Development activities and plans for the Products, and shall, upon Rigel’s request and no more than once per calendar year, meet with Rigel and discuss such Development activities and plans.  Pfizer shall conduct any Development of Products in compliance in all material aspects with the requirements under applicable laws, rules and regulations, including without limitation GLP, GCP and GMP, to attempt to achieve its objectives.

 

4.2                                Development Diligence.

 

(a)                                   Following its election to commence Advanced Preclinical Development of a Compound, Pfizer shall use Diligent Efforts to Develop or Commercialize, as applicable, at least one Compound at all times during the Term of this Agreement.

 

(b)                                   Pfizer shall inform Rigel within ten (10) Business Days following the occurrence of any event described under Schedule 8.5(b) .

 

4.3                                Regulatory Affairs.

 

(a)                                   Pfizer shall own and be responsible for preparing and submitting Regulatory Filings, seeking Regulatory Approvals, and maintaining Regulatory Approvals for Products, including preparing all reports necessary as part of an IND, NDA, DMF, BLA or other necessary filing required for Regulatory Approval.

 

(b)                                   With regard to sharing of Regulatory Filings, each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of its, its Affiliates’ and their respective suppliers’ Regulatory Filings, and Regulatory Approvals for Products.

 


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(c)                                   In conducting any Development activities hereunder, each Party shall: (a) ensure that its employees, agents, clinical institutions and clinical investigators comply with all FDA statutory and regulatory requirements with respect to Products, including but not limited to:  the Federal Food, Drug and Cosmetic Act, as amended (FFDCA), the Public Health Service Act (PHSA), regulatory provisions regarding protection of human subjects, financial disclosure by clinical investigators, Institutional Review Boards (IRB), GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or the FDA; and (b) not utilize, in conducting studies on Products any person or entities that at such time are debarred by FDA, or that, at such time, are under investigation by FDA for debarment action pursuant to the provisions of the Generic Drug Enforcement Act of 1992 (21 U.S.C. Section 335).

 

4.4                                Manufacture and Supply.  Except as otherwise specified in the Research Plan or in Section 3.6, Pfizer shall be responsible for the manufacture of preclinical and clinical materials for each Product, and for the commercial supply of each Product, and for all costs associated therewith.  Pfizer shall use Diligent Efforts to make necessary filings to obtain, or cause a Third Party manufacturer to obtain, Regulatory Approval for the manufacture of Products.

 

4.5                                Development Costs.   Pfizer shall be responsible for all costs associated with the Development and Commercialization of Products.  If Pfizer requests Rigel’s assistance with certain tasks related to the Development of Products, and Rigel agrees to assist, then Pfizer shall reimburse Rigel for any reasonable costs Rigel should incur associated with such tasks.  Within thirty (30) days after the end of each calendar quarter, Rigel shall submit to the Pfizer an accounting of all costs Rigel incurs under the Development Plan during that quarter, including reasonable detail demonstrating the specific basis for the costs and expenses included in the summary.  Such summary may include an allocation of time spent by Rigel personnel in conducting such Development activities, that shall be reimbursed at an FTE rate of [ * ] .  Pfizer shall on a quarterly basis, within forty five (45) days after the end of each Pfizer Quarter (provided that Rigel submitted its accounting report on time), prepare and submit to Rigel a reimbursement of the costs incurred by Rigel.

 

4.6                                Trademarks.  Pfizer shall select trademarks for the Product and shall own all such trademarks.

 

4.7                                Pricing.   Pfizer shall be solely responsible for the pricing and other terms of sale for Products.

 

5.                                       LICENSES AND RELATED RIGHTS

 

5.1                                License to Pfizer.   Subject to the terms of this Agreement, Rigel grants to Pfizer the following:

 

(a)                                   a worldwide, exclusive (even as to Rigel) license, with the right to sublicense, under the Rigel Technology, to make, have made, use, import, offer for sale and sell Compounds and Products for Intrapulmonary Administration in the Territory and in the Field; and

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(b)                                   solely with respect to those  Compounds for which Pfizer has Commenced human clinical trials of a Product for Intrapulmonary Administration, a worldwide, exclusive (even as to Rigel) license, with the right to sublicense, under the Rigel Technology, to make, have made, use, import, offer for sale and sell such Compounds and Products for Other Topical Administrations in the Territory.

 

For the avoidance of doubt, the licenses granted to Pfizer in this Section 5.1 convey no rights with respect to any Syk Inhibitor owned or Controlled by Rigel other than Compounds.

 

5.2                                Residual Know-How.   Except as provided in this Section 5.2, neither Party shall use Confidential Information of the other Party for any purpose outside the Collaboration.  In this regard, the Parties recognize that during the course of this Agreement, certain information in intangible form (excluding for this purpose, in electronic medium), may be retained by those employees or agents of a Party who have had access to the other Party’s Confidential Information (the “Residual Information”).  Each Party shall be free to use the Residual Information of the other Party for any purpose.  Notwithstanding the foregoing, compounds, materials, and written or tangible data (including data in electronic medium) of the other Party, to the extent not in the public domain, shall not be used for any purpose outside the Collaboration.

 

5.3                                Exclusivity.

 

(a)                                   During [ * ] :  Rigel and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, by itself or with any Third Party, Commercialize (i) any Syk Inhibitor in the Field, or (ii) any Compound for any purpose (unless the rights to such Compound have reverted to Rigel pursuant to Section 9.3), and Pfizer and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, by itself or with any Third Party, Commercialize (i) any Syk Inhibitor in the Field, or (ii) any Compound for any purpose.

 

(b)                                   During [ * ] :  Rigel and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, by itself or with any Third Party, conduct research on or Develop any Syk Inhibitor in the Field, and Pfizer and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, by itself or with any Third Party, conduct research on or Develop any Syk Inhibitor in the Field.

 

5.4                                Acquisition of Competing Product.   Notwithstanding the provisions of Section 5.3, which provisions shall not be deemed breached as a result of an acquisition or merger described in this Section 5.4, if Pfizer acquires a Competing Product through acquisition or merger with the whole or substantially the whole of the business or assets of another Person, Pfizer shall, within forty five (45) days from the date of Pfizer’s board approval of such acquisition or merger, notify Rigel of such merger or acquisition and as to whether Pfizer intends to divest its interest in such Competing Product.  If Pfizer elects to divest its interest in such Competing Product, Pfizer shall use reasonable efforts to identify a Third Party purchaser to whom Pfizer will divest its interest in such Competing Product and to enter into a definitive agreement with such Third Party for such divestiture as soon as reasonably practicable under the circumstances (which may be subject to the terms of a Hold Separate Transaction (as defined

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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below) as applicable).  If Pfizer elects not to divest its interest in such Competing Product or fails to enter into a definitive agreement with a Third Party to divest such Competing Product (other than as part of any Hold Separate Transaction) within [ * ] months after the closing of the acquisition or merger for which Pfizer has provided Rigel with notice, or if such divestiture is subject to the terms of a Hold Separate Transaction, within [ * ] months after the closing of the acquisition or merger for which Pfizer has provided Rigel with notice, then Rigel shall have the option, upon notice to Pfizer given no later than ninety (90) days after the earlier of: (i)  Pfizer’s election not to divest such Competing Product; and (ii) the end of either of such [ * ] month or [ * ] month period described above, as applicable, to terminate this Agreement, such termination to be effective upon the expiration of such ninety (90) day notice period unless waived by Rigel during such period.  As used herein, a “ Hold Separate Transaction ” shall mean any “hold separate” transaction (whether through the establishment of a trust or otherwise) involving the proposed sale of the applicable Competing Product pursuant to an agreement with any Governmental Authority responsible for antitrust laws.

 

5.5                                Pfizer’s Option to R-112 and Allergic Rhinitis.   In the event that Rigel either (a) terminates its active development of R-112 for allergic rhinitis, or (b) completes Phase II(b) Trials with respect to R-112; and Rigel has not licensed, assigned, or otherwise conveyed the right to develop and commercialize R-112 to a Third Party prior to the completion of such Phase II(b) Trials, then Rigel shall promptly provide Pfizer with notice of such occurrence together with all material information regarding the formulation, stability, safety and efficacy of R-112 and its backups; the status of discussions with FDA or any Governmental Authorities directly relating thereto; and relevant patent information (together, the “R-112 Notice”).  Upon Pfizer’s receipt of such notice and supporting information, Pfizer shall have [ * ] to provide Rigel with notice of Pfizer’s intent to negotiate an expansion of the Field to include allergic rhinitis, or an exclusive license to R 112 and its backups, or both.  If Pfizer elects to engage in such negotiations, then the Parties shall negotiate in good faith, for up to [ * ] following Pfizer’s receipt of the R-112 Notice (the “ [ * ] Day Period”), the terms and conditions of a license to expand Pfizer’s rights under this Agreement to include allergic rhinitis, R-112 and such additional Syk tyrosine kinase inhibitors as the Parties agree.  During the [ * ] Day Period, Rigel shall not negotiate with Third Parties with respect to such subject matter.  However, such negotiation shall be without obligation to actually enter into any agreement.  If Pfizer and Rigel do not agree on the terms and conditions of such a license within the [ * ] Day Period, then Rigel shall be free to grant such license(s) to any Third Party(ies) without further obligation to Pfizer.

 

5.6                                Bankruptcy.   All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the U.S. Bankruptcy Code.  The Parties shall retain and may fully exercise all of their respective rights and elections under the U.S. Bankruptcy Code.  The Parties agree that a Party that is a licensee of such rights under this Agreement shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, and that upon commencement of a bankruptcy proceeding by or against the licensing Party (such Party, the “Involved Party”) under the U.S. Bankruptcy Code, the other Party (such Party, the “Noninvolved Party”) shall be entitled to a complete duplicate of or complete access to (as such Noninvolved Party deems appropriate), any such intellectual property and all embodiments of such intellectual property,

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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provided the Noninvolved Party continues to fulfill its payment or royalty obligations as specified herein in full.  Such intellectual property and all embodiments thereof shall be promptly delivered to the Noninvolved Party (a) upon any such commencement of a bankruptcy proceeding upon written request therefore by the Noninvolved Party, unless the Involved Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the Involved Party upon written request therefor by the Noninvolved Party.  The foregoing is without prejudice to any rights the Noninvolved Party may have arising under the U.S. Bankruptcy Code or other applicable law.

 

5.7                                Negative Covenant.   Pfizer and its Affiliates shall not Develop or Commercialize Compounds or Products outside of the scope of the license granted to Pfizer under Section 5.1.

 

5.8                                HSR.   Promptly following signing of this Agreement, Pfizer and Rigel shall take (i) all actions necessary to make the filing required under the HSR Act, and (ii) reply at the earliest possible date with any requests for information received from the United States Federal Trade Commission (“ FTC ”) or Antitrust Division of the United States Department of Justice (“ DoJ ”) pursuant to the HSR Act.  The Parties shall, to the extent reasonably practicable, consult with one another prior to making any filings, responses to inquiries or other contacts with the FTC or DoJ concerning the transactions contemplated hereby and shall use commercially reasonable efforts to obtain any clearances related to this Agreement that are necessary under the HSR Act.  Each Party shall be responsible for its own costs in connection with such filing, except that Pfizer shall be solely responsible for the applicable filing fees.

 

5.9                                Access to Documents .  From and after the date of this Agreement and until the Effective Date, upon reasonable advance notice, each Party shall permit the other Party to have access, during normal business hours, to all Information concerning the Compounds as such Party from time to time may reasonably request.

 

6.                                       FINANCIAL TERMS

 

6.1                                Upfront Payment.   Pfizer shall pay to Rigel (a) an upfront payment of [ * ] payable within fifteen (15) days after the date of Pfizer’s receipt of an invoice from Rigel issued on or at any time after the Effective Date, and (b) on the date such [ * ] payment is made, five million dollars ($5,000,000), payable in exchange for 190,694 shares of Rigel common stock pursuant to the Common Stock Purchase Agreement attached hereto as Exhibit B .

 

6.2                                Milestone Payments.

 

(a)                                   Pfizer shall pay Rigel a milestone payment (each, an “ Event Milestone Payment ”) in respect of each of the following events (each, an “ Event Milestone ”) in the particular amounts specified below no later than ten (10) Business Days after the date of Pfizer’s receipt of an invoice from Rigel.  Pfizer will notify Rigel within ten (10) Business Days of the occurrence of each Event Milestone described in (iii) to (xii) below that entitles Rigel to issue the invoice concerned.

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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For Compounds

 

Event Milestone

(i)

 

[ * ]

 

Earlier of Pfizer’s determination to commence Advanced Preclinical Development of the first Compound, or 180 days (as this may be extended pursuant to Section 3.5) from delivery to Pfizer by Rigel of the data resulting from the completion by Rigel of its tasks under the Research Plan for such Compound.

 

 

 

 

 

(ii)

 

[ * ]

 

Earlier of Pfizer’s determination to commence Advanced Preclinical Development of a second Compound, or 180 days (as this may be extended pursuant to Section 3.5) from delivery to Pfizer by Rigel of the data resulting from the completion by Rigel of its tasks under the Research Plan for such Compound.

 

 

 

 

 

(iii)

 

[ * ]

 

Commencement of Phase I Trial for the first Compound

 

 

 

 

 

(iv)

 

[ * ]

 

Commencement of Phase II(a) Trial for the first Compound

 

 

 

 

 

(v)

 

[ * ]

 

Commencement of Phase II(b) Trial for the first Compound

 

 

 

 

 

(vi)

 

[ * ]

 

Commencement of Phase III Trials for the first Compound

 

 

 

For Products
(other than
Combination Products)

 

For Combination
Products

 

Event Milestone

(vii)

 

[ * ]

 

[ * ]

 

Acceptance of an NDA for the first Product or Combination Product, as applicable, in the United States

 

 

 

 

 

 

 

(viii)

 

[ * ]

 

[ * ]

 

Acceptance of filings for Regulatory Approval for the first Product or Combination Product, as applicable, in three of the five Major European Countries

 

 

 

 

 

 

 

(ix)

 

[ * ]

 

[ * ]

 

Acceptance of filing for Regulatory Approval for the first Product or Combination Product, as applicable, in Japan

 

 

 

 

 

 

 

(x)

 

[ * ]

 

[ * ]

 

Launch of the first Product or Combination Product, as applicable, in the United States

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(xi)

 

[ * ]

 

[ * ]

 

Launch of the first Product or Combination Product, as applicable, in three of the five Major European Countries

 

 

 

 

 

 

 

(xii)

 

[ * ]

 

[ * ]

 

Launch of the first Product or Combination Product, as applicable, in Japan

 

(b)                                   [ * ] of the Event Milestone Payments in subsections (vii) through (xii) above, shall be credited against the royalty payments set forth in Section 6.3, provided , however , no royalty payment shall be reduced by more than [ * ] by any such credit.

 

(c)                                   All Event Milestone Payments set forth in this Section 6.2 shall be paid to Rigel only once regardless of the number of Compounds or Products developed under the Collaboration.  Event Milestone Payments owed to Rigel under this Section 6.2 which refer to the “first Compound” or “first Product” shall be paid to Rigel for the first Compound or first Product to achieve such Event Milestone, regardless of whether such Compound or Product comprises the first Compound selected by Pfizer pursuant to Section 3.3 or 3.4(a).  Royalty payments set forth in Section 6.3 shall be paid to Rigel for each Product sold.

 

(d)                                   If a Phase II(b) Trial or Phase III Trial of a Product Commences, or a Product is the subject of an NDA, such Product shall be deemed to have achieved the Event Milestones prior to that stage of Development, and if a related Event Milestone Payment for such earlier stage of clinical trial has not been previously paid, it shall then be paid.

 

(e)                                   In the event that a Party has given the other Party any notice of termination of this Agreement under Section 9, no further Event Milestone Payments shall become due during such notice period.

 

6.3                                Royalty Payments.   Pfizer shall pay Rigel the following royalty payments based on Net Sales of each Product in the Territory:

 

(a)                                   [ * ] for Net Sales in a calendar year up to [ * ] ;

 

(b)                                   [ * ] for Net Sales in a calendar year over [ * ] and up to [ * ] ;

 

(c)                                   [ * ] for Net Sales in a calendar year over [ * ] and up to [ * ] ; and

 

(d)                                   [ * ] for Net Sales in a calendar year over [ * ] .

 

Notwithstanding the foregoing, (i) for Net Sales based on sales of a Product in the United States, any payments owed with respect to such Product pursuant to this Section 6.3 shall be reduced (x) by [ * ] for any period of time during the Royalty Term during which no Patent under the Rigel Patents with a Valid Claim covering such Product are in effect in the United States, subject to Section 6.4, and (y) by [ * ] if during the relevant Pfizer Quarter there is Generic Competition

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

24



 

in the United States; provided that in no event shall such payments be reduced by more than [ * ] as a result of the events described in clauses (x) and (y)  above occurring; and (ii) for Net Sales based on sales of a Product in a country in the Territory, other than the United States, any payments owed with respect to such Product pursuant to this Section 6.3 shall be reduced by [ * ] in the country concerned if during the relevant Pfizer Quarter there is Generic Competition in such country.

 

6.4                                Pending Patent Applications.   If a pending patent application that is included within the Rigel Patents issues in a country after the Royalty Term has already expired in such country, and such issued Patent contains a Valid Claim, then Pfizer shall, (a) within sixty (60) days after receipt from Rigel of evidence of such issuance from the relevant Governmental Authority, pay to Rigel royalties based on Net Sales in such country from the date of the expiration of the Royalty Term in such country up to and including the date of issuance of such Patent and (b) continue to make Royalty Payments in such country so long as there is a Valid Claim Controlled by Rigel covering a Product in such country.  This Section 6.4 shall also apply if there has been a reduction in the royalty payments paid to Rigel pursuant to Section 6.3 and a Rigel Patent with a Valid Claim later issues (in which case the amount of any related royalty reduction effected pursuant to Section 6.3 shall then be paid to Rigel).

 

6.5                                Payments and Payment Reports.   All royalties due under Section 6.3 shall be paid within sixty (60) days of the end of the relevant Pfizer Quarter for which such royalties are due.  Each royalty payment shall be accompanied by a statement stating the number, description, and aggregate Net Sales, by country, of each Product sold during the relevant Pfizer Quarter.

 

6.6                                Payment Method.   All payments due under this Agreement to Rigel shall be made by bank wire transfer in immediately available funds to an account designated by Rigel.  All payments hereunder shall be made in the legal currency of the United States of America.

 

6.7                                No Credits or Refunds.   Other than as set forth under Sections 3.5, 6.2(b) and 6.12, all payments to Rigel hereunder shall be noncreditable and nonrefundable.

 

6.8                                Taxes. It is understood and agreed between the Parties that any payments made under Section 6.1 or 6.2 of this Agreement are inclusive of any value added or similar tax imposed upon such payments.  In addition, in the event any of the payments made by Pfizer pursuant to Section 6 become subject to withholding taxes under the laws of any jurisdiction, Pfizer shall deduct and withhold the amount of such taxes for the account of Rigel to the extent required by law, such amounts payable to Rigel shall be reduced by the amount of taxes deducted and withheld, and Pfizer shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Rigel an official tax certificate or other evidence of such tax obligations together with proof of payment from the relevant Governmental Authority of all amounts deducted and withheld sufficient to enable Rigel to claim such payment of taxes. Any such withholding taxes required under applicable law to be paid or withheld shall be an expense of, and borne solely by, Rigel.  Pfizer will provide Rigel with reasonable assistance to enable Rigel to recover such taxes as permitted by law.

 

6.9                                Blocked Currency.   In each country where the local currency is blocked and cannot be removed from the country, royalties accrued in that country shall be paid to Rigel in

 


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

25



 

the country in local currency by deposit in a local bank designated by Rigel, unless the Parties otherwise ag


 
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