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COLLABORATIVE RESEARCH & LICENSE AGREEMENT

Content License Agreement

COLLABORATIVE RESEARCH & LICENSE AGREEMENT | Document Parties: ICAGEN, INC | PFIZER INC You are currently viewing:
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Title: COLLABORATIVE RESEARCH & LICENSE AGREEMENT
Governing Law: New York     Date: 11/5/2007
Industry: Biotechnology and Drugs     Law Firm: Wilmer Cutler     Sector: Healthcare

COLLABORATIVE RESEARCH & LICENSE AGREEMENT, Parties: icagen  inc , pfizer inc
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Exhibit 10.1

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

COLLABORATIVE RESEARCH & LICENSE AGREEMENT

Dated August 13, 2007

Between

ICAGEN, INC.

and

PFIZER INC

 


TABLE OF CONTENTS

 

Section 1

   Definitions    1

Section 2

   Collaborative Research Program    8

Section 3

   Licenses    14

Section 4

   Funding    16

Section 5

   Stock Purchase    22

Section 6

   Treatment of Confidential Information    22

Section 7

   Intellectual Property Rights    25

Section 8

   Acquisition of Rights from Third Parties    27

Section 9

   Legal Action    27

Section 10

   Term, Termination & Disengagement    28

Section 11

   Representations & Warranties    32

Section 12

   Indemnification    34

Section 13

   Notices    35

Section 14

   Miscellaneous    36

Exhibit A

   Permitted Disclosures   

Exhibit B

   Stock Purchase Agreement   

 


C OLLABORATIVE R ESEARCH AND L ICENSE A GREEMENT

This COLLABORATIVE RESEARCH & LICENSE AGREEMENT is entered into as of August 13, 2007 (the “Effective Date”) by and between PFIZER INC , a Delaware corporation, having an office at 235 East 42 nd Street, New York, New York 10017 (“Pfizer”), and ICAGEN, INC. (“Icagen”), a Delaware corporation, having an office at 4222 Emperor Boulevard, Suite 350, Durham, North Carolina 27703.

WHEREAS , Icagen has expertise in the discovery, research, and development of ion channels and ion channel modulators that may be useful as therapeutics; and

WHEREAS , Icagen is a biotechnology company that has research programs directed to the identification of modulators of the Research Targets (as defined below); and

WHEREAS , Pfizer is a major pharmaceutical company that has the capability to undertake research for the discovery and evaluation of agents for treatment of disease and also the capability for clinical analysis, manufacturing and marketing of such agents; and

WHEREAS , the parties plan to collaborate to identify one or more drug candidates suitable for development and commercialization as pharmaceutical products; and

WHEREAS , Pfizer desires to obtain and Icagen is willing to grant an exclusive license under Icagen's right, title and interest in the Patent Rights and Technology so that Pfizer can manufacture, use, sell, offer for sale and import the Products.

NOW, THEREFORE , the parties agree as follows:

1. D EFINITIONS .

Wherever used in this Agreement, the terms defined in this Section 1 shall have the following specified meanings:

1.1 “[**] Royalty-Bearing Product” means any Compound or Product that is not developed for a Research Target Indication and contains (a) a Pfizer Compound Developed In The Research Program or (b) a Joint Compound.

1.2 “Affiliate” means, with respect to Pfizer or Icagen (as applicable), any corporation or other legal entity owning, directly or indirectly, [**] percent ([**]%) or more of the voting

 


capital shares or similar voting securities of Pfizer or Icagen; or any corporation or other legal entity [**] percent ([**]%) or more of the voting capital shares or similar voting rights of which is owned, directly or indirectly, by Pfizer or Icagen; or any corporation or other legal entity [**] percent ([**]%) or more of the voting capital shares or similar voting rights of which is owned, directly or indirectly, by a corporation or other legal entity which owns, directly or indirectly, [**] percent ([**]%) or more of the voting capital shares or similar voting securities of Pfizer or Icagen; or any corporation or other legal entity the board of which is controlled by Pfizer or Icagen.

1.3 “Area” means research, development or commercialization with respect to modulators of the Research Targets.

1.4 “Candidate Compound” or “CAN” means a Compound that is formally endorsed by the appropriate Pfizer governance body as having met the requirements for advancement into clinical development and designated as a Candidate Compound in accordance with Section 2.8.

1.5 “Combination Product” means any human pharmaceutical product in which one or more active pharmaceutical ingredients that are not Compounds are either (i) physically, chemically or otherwise combined or mixed with the Compound to produce a single entity for commercial distribution or (ii) packaged together with the Compound in a single package or unit for commercial distribution.

1.6 “Commercially Reasonable Efforts” means, with respect to a Research Program obligation, Compound or Product, those efforts and resources that the party required to make such efforts generally uses (as applicable in the context used in this Agreement) in researching, developing, seeking regulatory approvals, manufacturing, promoting, detailing and marketing its other pharmaceutical products that are comparable to the applicable Compound(s) or Product(s), or in carrying out its other research programs relating to such comparable products, taking into account product labeling or anticipated labeling, market potential, past performance (if any), economic return potential, medical and clinical considerations, the present and future regulatory environment, and competitive market conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due, but without taking into account any payment obligations to the other party under this Agreement and, with respect to Pfizer’s efforts and resources, without taking into account considerations relating to Excluded Pfizer Compounds.

1.7 “Commitment Year” means a twelve-month period commencing on the Effective Date or any anniversary of the Effective Date during the Research Term.

1.8 “Compound” means a Pfizer Compound, Icagen Compound or Joint Compound.

1.9 “Controlled” means the legal authority or right of a party hereto, whether direct or through Affiliates controlled by such party, to grant a license or sublicense of intellectual property rights to the other party hereto, or to provide compounds or biological material to or otherwise disclose proprietary or trade secret information to such other party, without breaching the terms of any agreement with a third party, infringing the intellectual property rights of a third party, or misappropriating the proprietary or trade secret information of a third party.

 

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1.10 “Cover” , “Covering” or “Covered” means, with respect to a Compound, a Product or Technology, that, in the absence of a license granted under a Valid Claim, the making, use, offering for sale, sale, or importation of the Compound or Product or the practice of the Technology would infringe such Valid Claim or, in the case of Valid Claims that have not yet issued, would infringe such Valid Claim after issuance.

1.11 “Developed In The Research Program” means generated, identified or created in the Research Program. With respect to Research Compounds, any Compound designated as such during the [**] months following the Research Term shall be considered to have been Developed In The Research Program. For clarity, Patent Rights and Technology will not be deemed to have been Developed In The Research Program to the extent that such Patent Rights and Technology are claimed or disclosed in the patents, patent applications, patent disclosures or notebooks of the relevant party as of the Effective Date.

1.12 “Excluded Pfizer Compounds” means compounds excluded pursuant to Sections 2.3(b)(ii), 2.3(b)(iii), 2.3(b)(iv), 2.3(b)(v), or 2.3(b)(vi).

1.13 “Excluded Research Target 3 Compounds” means the compounds Controlled by Pfizer that are within the existing Pfizer Research Target 3 research program and identified in the Research Plan as Excluded Research Target 3 Compounds.

1.14 “FTE” means the time and work output equal to one full time employee who is proficient in the performance of the duties assigned to such employee pursuant to the Research Plan.

1.15 “Full Royalty-Bearing Product” means any Compound or Product that contains (a) a Candidate Compound that is developed for a Research Target Indication or a non-Research Target Indication, or (b) a Pfizer Compound Developed in the Research Program that is developed for a Research Target Indication, or (c) a Joint Compound that is developed for a Research Target Indication.

1.16 “Generic Product” means, with respect to a Product in any country, a product that is a “pharmaceutical equivalent” (as that term is used in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDA Center for Drug Evaluation and Research or any successor publication). Notwithstanding the foregoing, Generic Products shall not include products that Pfizer or any of Pfizer’s Affiliates or sublicensees have authorized or otherwise permitted to become available.

1.17 “Icagen Compound” means any synthetic or natural chemical compound or biological material that is introduced into the Research Program and is:

 

  (a) Covered by Icagen Patent Rights or otherwise Controlled by Icagen; or

 

  (b) any salt, ester, amide, complex, chelate, hydrate, stereoisomer, crystalline or amorphous form, prodrug, metabolite or metabolic precursor of any of the compounds or materials described in the preamble above.

For the avoidance of doubt, virtual screening of Icagen’s compound file does not constitute the introduction of such compounds into the Research Program and the results of such screening and associated intellectual property shall belong to Icagen regardless of whether the

 

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algorithm used to screen the Icagen compound file is provided by Icagen or Pfizer; provided that , if the compounds identified in the virtual screen are screened in an assay in the Research Program such compounds shall be considered Icagen Compounds introduced into the Research Program.

1.18 “Icagen Confidential Information” means all information Controlled by Icagen and regarding Icagen’s technology, products, business or objectives or regarding the Compounds or Products that is disclosed by Icagen to Pfizer pursuant to this Agreement to the extent that such information is not (i) as of the date of disclosure to Pfizer, known to Pfizer other than by virtue of a prior confidential disclosure to Pfizer by Icagen; or (ii) disclosed in published literature, or otherwise generally known to the public through no fault or omission of Pfizer; or (iii) obtained from a third party free from any obligation of confidentiality to Icagen; or (iv) independently developed by Pfizer without using Icagen Confidential Information.

1.19 “Icagen Patent Rights” means all Patent Rights, other than Joint Patent Rights, Controlled by Icagen and Covering Icagen Technology including Icagen Compounds and, without limitation, the Patent Rights listed in the Research Plan.

1.20 “Icagen Technology” means Technology Controlled by Icagen that:

 

  (a) was developed by employees of or consultants to Icagen alone in the course of the Research Program, or

 

  (b) (x) in the case of Compounds, is introduced into the Research Program and (y) in the case of Technology other than Compounds, relates to a Research Compound, Candidate Compound or Product, and, in either case, is or was:

 

  (i) developed by employees of or consultants to Icagen alone or jointly with third parties, either prior to the Effective Date, at any time during the Research Term; or

 

  (ii) acquired by purchase, license, assignment or other means from third parties by Icagen, either prior to the Effective Date, at any time during the Research Term.

1.21 “Joint Compound” means any (a) synthetic or natural chemical compound or biological material other than an Icagen Compound or a Pfizer Compound that is Covered by Joint Patent Rights or (b) salt, ester, amide, complex, chelate, hydrate, stereoisomer, crystalline or amorphous form, prodrug, metabolite or metabolic precursor of any compound or material described in the foregoing clause (a).

1.22 “Joint Patent Rights” means all Patent Rights jointly Controlled by the parties and Covering Joint Technology including Joint Compounds.

1.23 “Joint Technology” means Technology other than Icagen Technology or Pfizer Technology that is:

 

  (a) developed by employees of or consultants to Pfizer and Icagen jointly with each other in the performance of the Research Program; or

 

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  (b) acquired by purchase, license, assignment or other means from third parties by Icagen and Pfizer jointly with each other as part of the conduct of the Research Program.

1.24 “NDA” means a New Drug Application or other application for authority to market a Product filed with the U.S. FDA.

1.25 “Net Sales” means:

 

  (a) with respect to a Product that is not a Combination Product, the gross amount invoiced by Pfizer, its Affiliates and its sublicensees on sales of such Product to third parties, less (i) bad debts related to such Product and (ii) sales returns and allowances actually paid, granted or accrued with respect to invoiced amounts, including trade, quantity and cash discounts and any other adjustments, including, 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 or other 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 including allowances, discounts, adjustments, rebates, reimbursements and similar payments in respect of sales to the United States government, any state government or any foreign government, or to any other governmental authority, or with respect to any government-subsidized program or managed care organization, and (iii) freight and shipping insurance (to the extent that Pfizer bears the cost of freight and shipping insurance for a Product); and

 

  (b)

with respect to a Combination Product, (x) 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) the Product(s) contained in such Combination Product as single chemical entity(-ies), and (2) the other products contained in such Combination Product containing active ingredient(s) as single entity(-ies), 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 the Product(s) 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 in such country, for the other product(s) containing active ingredient(s) in such Combination Product; (y) 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, the Product(s) contained in such Combination Product as single chemical entity(-ies) but do not separately sell, in such country, other product(s) 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

 

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Affiliates’ or third parties’, as applicable) average Net Sales price per daily dose during such year for the Product(s) 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; and (z) if Pfizer and/or its Affiliates and/or third parties does not separately sell, in such country during such year when it sells such Combination Product, the Product(s) contained in such Combination Product as single chemical entity(-ies), 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(s) and E is the fair market value of the portion of the Combination Product that contains the other active ingredient(s) included in such Combination Product, as such fair market values are determined by mutual agreement of the parties. If the parties are unable to agree upon such fair market values, the parties shall jointly appoint a third party expert to determine such matter or, in the absence of agreement regarding the appointment of a third party expert, submit such matter to binding arbitration for resolution by a single arbitrator pursuant to the commercial arbitration rules of the American Arbitration Association.

Net Sales shall be determined from books and records maintained in accordance with generally accepted accounting principles in the United States (“US GAAP” ), as consistently applied by Pfizer with respect to sales of all its pharmaceutical products.

1.26 “[**]” means [**].

1.27 “Patent Rights” means patents, and patent applications that have been pending less than [**] years, whether domestic or foreign, including all continuations, continuations-in-part, divisionals, and renewals, and letters of patent granted thereon, and all reissues, re-examination and extensions thereof.

1.28 “Pfizer Compound” means any synthetic or natural chemical compound or biological material that is introduced into the Research Program and is:

 

  (a) Covered by Pfizer Patent Rights or otherwise Controlled by Pfizer; or

 

  (b) any salt, ester, amide, complex, chelate, hydrate, stereoisomer, crystalline or amorphous form, prodrug, metabolite or metabolic precursor of any of the compounds or materials described in the preamble above.

For the avoidance of doubt, virtual screening of Pfizer’s compound file does not constitute the introduction of such compounds into the Research Program and the results of such screening and associated intellectual property shall belong to Pfizer regardless of whether the algorithm used to screen the Pfizer compound file is provided by Pfizer or Icagen; provided that , if the compounds identified in the virtual screen are screened in an assay in the Research Program such compounds shall be considered Pfizer Compounds introduced into the Research Program.

1.29 “Pfizer Confidential Information” means all information Controlled by Pfizer and regarding Pfizer’s technology, products, business or objectives or regarding the Compounds

 

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or Products that is disclosed by Pfizer to Icagen pursuant to this Agreement to the extent that such information is not (i) known, as of the date of disclosure to Icagen, to Icagen other than by virtue of a prior confidential disclosure to Icagen by Pfizer; or (ii) disclosed in published literature, or otherwise generally known to the public through no fault or omission of Icagen; or (iii) obtained from a third party free from any obligation of confidentiality to Pfizer; or (iv) independently developed by Icagen without using Pfizer Confidential Information.

1.30 “Pfizer Patent Rights” means all Patent Rights, other than Joint Patent Rights, Controlled by Pfizer and Covering Pfizer Technology including Pfizer Compounds.

1.31 “Pfizer Technology” means Technology Controlled by Pfizer that:

 

  (a) was developed by employees of or consultants to Pfizer alone in the course of the Research Program, or

 

  (b) (x) in the case of Compounds, is introduced into the Research Program and (y) in the case of Technology other than Compounds, relates to a Research Compound, Candidate Compound or Product, and, in either case, is or was:

 

  (i) developed by employees of or consultants to Pfizer alone or jointly with third parties, either prior to the Effective Date, at any time during the Research Term; or

 

  (ii) acquired by purchase, license, assignment or other means from third parties by Pfizer, either prior to the Effective Date, at any time during the Research Term.

1.32 “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 is generally consistent with U.S. 21 C.F.R. §312.21(a) or any foreign counterpart thereof.

1.33 “Phase II Trial” means a clinical trial generally consistent with U.S. 21 C.F.R. §312.21(b) or any foreign counterpart thereof.

1.34 “Phase III Trial” means a clinical trial generally consistent with U.S. 21 C.F.R. §312.21(c) or any foreign counterpart thereof.

1.35 “Product” means any pharmaceutical product (including a Combination Product), in all dosage forms and formulations, that contains a Compound, and is Covered by a Valid Claim.

1.36 “Research Compound” means a Compound that has been selected by the Joint Research Committee as evidenced by meeting minutes, based on having met the criteria therefor set forth in the Research Plan, for further investigation.

1.37 “Research Plan” means the written plan describing the research in the Area to be carried out during each Commitment Year by Pfizer and Icagen pursuant to this Agreement.

 

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1.38 “Research Program” means the collaborative research program in the Area to be conducted by Pfizer and Icagen during the Research Term pursuant to the Research Plan and this Agreement.

1.39 “Research Target(s)” means any (or all) as the context requires of the ion channel targets identified in the Research Plan as “Research Target 1”, “Research Target 2” and “Research Target 3”.

1.40 “Research Target Indication(s)” means an indication for which the modulation of a Research Target by the relevant Compound is or would reasonably be expected to be material to the expected therapeutic effect of such Compound.

1.41 “Research Term” means the period beginning on the Effective Date and ending on the date on which the Research Program terminates, including any extensions thereto that are mutually agreed by the parties pursuant to Section 2.1.

1.42 “Technology” means and includes all materials, compounds, technology, technical information, intellectual property, know-how, expertise and trade secrets.

1.43 “Term” means the period commencing on the Effective Date and ending as set forth in Section 10.1.

1.44 “Valid Claim” means a claim within Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights so long as such claim shall not have been (a) abandoned by either Pfizer (in the case of Pfizer Patent Rights) or Icagen (in the case of Icagen Patent Rights) or both (in the case of Joint Patent Rights) or (b) held invalid in a final decision rendered by a tribunal of competent jurisdiction from which no appeal has been or can be taken.

2. C OLLABORATIVE R ESEARCH P ROGRAM .

2.1 Purpose. Throughout the Research Term, Icagen and Pfizer shall conduct the Research Program to discover and develop Products. The Research Term shall begin on the Effective Date and, unless terminated earlier in accordance with Section 10.3, continue for two years. The Research Term may be extended upon mutual agreement of the parties. Pfizer shall notify Icagen at least [**] days prior to the end of the then-current Research Term whether Pfizer desires to extend the Research Term and, if Pfizer so notifies Icagen that Pfizer does desire to extend the Research Term, the parties shall discuss whether and on what terms they would be willing to agree to such extension, including without limitation the Research Targets with respect to which the parties will continue to conduct research during such extension.

2.2 Research Plan . The Research Plan for the first Commitment Year has been approved by Pfizer and Icagen as of the date of this Agreement. For each Commitment Year after the first year, the Research Plan shall be prepared by the Joint Research Committee for submission to and approval by Pfizer and Icagen no later than sixty (60) days before the end of the prior Commitment Year.

2.3 Exclusivity .

 

  (a)

Icagen Exclusivity . During the Research Term and for six (6) months thereafter, Icagen agrees that neither it nor any of its Affiliates that it controls shall conduct

 

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research itself or sponsor any other research, or engage in any research sponsored by any third party, in the Area, without Pfizer’s consent; provided that , if at any time during the Research Term or during the six (6) months immediately following the Research Term Pfizer ceases to conduct research and development on Compounds that modulate any Research Target, Pfizer shall notify Icagen of such cessation and thereafter the foregoing prohibition shall not apply to such Research Target.

 

  (b) Pfizer Exclusivity . During the Research Term and for six (6) months thereafter, Pfizer agrees that neither it nor any of its Affiliates shall conduct research itself or sponsor any other research, or engage in any research sponsored by any third party, in the Area, without Icagen’s consent; provided that , subject to Section 3.3, the exclusivity provisions herein shall not apply to:

 

  (i) research activities of Pfizer or any of its Affiliates (including sponsored research) in the event that an Affiliate of Icagen, that is not controlled by Icagen, conducts research itself or sponsors any other research, or engages in any research sponsored by any third party, in the Area; or

 

  (ii) the Excluded Research Target 3 Compounds and the research activities of Pfizer or any of its Affiliates (including sponsored research) with respect thereto; or

 

  (iii) compounds that Pfizer or any of its Affiliates licenses or acquires from a third party that are in a Phase II Trial or further advanced in development; or

 

  (iv) compounds acquired by Pfizer or any of its Affiliates from a third party through an acquisition by Pfizer or any of its Affiliates of all or substantially all of the assets of such third party, an acquisition of more than fifty percent (50%) of the shares or other equity interests of such third party or a merger or consolidation of such third party or an affiliate of such third party with or into Pfizer or any of its Affiliates; or

 

  (v) compounds licensed or acquired by Pfizer or any of its Affiliates, that at the time of license or acquisition (x) are not yet in a Phase II Trial or later development but (y) are at least one stage of development more advanced than any Compound or Product under this Agreement and have reached a stage of development equivalent to Candidate Compound status or later (e.g., if the most-advanced Compound under this Agreement is a Candidate Compound, then the in-licensed compound must be at least at the Phase I Trial stage); or

 

  (vi) non-small molecule compounds.

Each of the foregoing exclusions may be claimed jointly or independently.

 

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  (c) Consequences of Breach . If Pfizer or any of its Affiliates conducts, sponsors or engages in any research in breach of the exclusivity obligations set forth in Section 2.3(b) above, then Pfizer’s sole and exclusive liability and Icagen’s sole and exclusive remedy for such breach shall be that (i) any compounds and products arising from such research shall be deemed to be Compounds and Products for all purposes under this Agreement with prospective effect from the date of such breach, including without limitation for purposes of Pfizer’s milestone and royalty payment obligations hereunder and (ii) from and after such breach, Icagen shall have no further obligation under Section 2.3(a) above. For the avoidance of doubt, a breach by Pfizer or any of its Affiliates of the exclusivity obligations set forth in Section 2.3(b) above shall not constitute an Event of Termination.

2.4 Joint Research Committee .

 

  (a) Purpose . Pfizer and Icagen shall establish a joint research committee (the “ Joint Research Committee ”):

 

  (i) to review and evaluate progress under the Research Plan;

 

  (ii) to prepare the Research Plan for each Commitment Year;

 

  (iii) to approve any budgets or resource allocation;

 

  (iv) to approve and reject Research Compounds for or from the Research Program;

 

  (v) to identify and recommend CANs for acceptance by Pfizer; and

 

  (vi) to coordinate and monitor publication of research results obtained and the exchange of information and materials that relate to the Research Program.

 

  (b) Membership . Pfizer and Icagen each shall appoint, in its sole discretion, three members to the Joint Research Committee. Substitutes may be appointed at any time. The members initially shall be:

 

  (i) Pfizer Appointees: [**]

 

  (ii) Icagen Appointees: [**]

 

  (c) Chair . The Joint Research Committee shall be chaired by two co-chairpersons, one appointed by Pfizer and the other appointed by Icagen.

 

  (d) Meetings . The Joint Research Committee shall meet at least quarterly during the Research Term and thereafter as needed for the purpose described in Section 2.8(b), at places and on dates selected by each party in turn. Representatives of Pfizer or Icagen or both, in addition to members of the Joint Research Committee, may attend such meetings at the invitation of either party.

 

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  (e) Minutes . The Joint Research Committee shall keep accurate minutes of its deliberations which record all proposed decisions and all actions recommended or taken. Drafts of the minutes shall be delivered to all Joint Research Committee members within ten (10) business days after each meeting. The party hosting the meeting shall be responsible for the preparation and circulation of the draft minutes. Draft minutes shall be edited by the co-chairpersons and shall be issued in final form only with their approval and agreement.

 

  (f) Decisions . All decisions of the Joint Research Committee shall be made by consensus; provided that the Joint Research Committee may not amend this Agreement or increase Pfizer’s or Icagen’s obligations hereunder without the consent of Pfizer or Icagen (as applicable). If the Joint Research Committee is unable to reach any decision by consensus, either party may, by notice to the other party, escalate the matter to the President of Icagen and the Global Head of Research of Pfizer for resolution, and in the event of any such escalation, such escalation officers shall promptly meet and discuss the matter in an effort to reach a mutually agreeable resolution.

 

  (g) Expenses . Pfizer and Icagen shall each bear all expenses of their respective members related to their participation on the Joint Research Committee.

 

  (h) Dissolution . Unless otherwise agreed by the parties, the Joint Research Committee shall dissolve upon the completion of its responsibilities pursuant to Section 2.8(b).

2.5 Reports and Materials .

 

  (a) Reports . During the Research Term, Pfizer and Icagen each shall furnish to the Joint Research Committee:

 

  (i) summary written reports within thirty (30) days after the end of each three-month period commencing on the Effective Date, describing its progress under the Research Plan; and

 

  (ii) comprehensive written reports within thirty (30) days after the end of each Commitment Year, describing in detail the work accomplished by it under the Research Plan during the Commitment Year and discussing and evaluating the results of such work.

 

  (b) Materials . Icagen and Pfizer shall, during the Research Term, as a matter of course as described in the Research Plan, or upon each other’s written or oral request, furnish to the other samples of biochemical, biological or synthetic chemical materials that are part of Pfizer Technology, Icagen Technology or Joint Technology and that (i) are necessary or useful for the other party to carry out its responsibilities under the Research Plan or (ii) are generated in the Research Program. To the extent that the quantities of materials requested by either party exceed the quantities set forth in the Research Plan, the requesting party shall reimburse the other party for the reasonable costs of such materials if they are furnished.

 

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  (c) Post-Research Term Reports. After the Research Term, Pfizer shall furnish to Icagen semi-annual written reports summarizing in reasonable detail Pfizer’s development and commercialization activities with respect to Compounds and Products and material developments with respect thereto, which reports shall, without limiting the foregoing, include: progress on research and development, status and results of clinical trials, status of applications for regulatory approvals, a summary of manufacturing, marketing and sales activities for the prior six-month period, as well as plans therefor for the subsequent twelve-month period. The post-Research Term reports delivered by Pfizer to Icagen hereunder will be considered Pfizer Confidential Information.

2.6 Laboratory Facility and Personnel . Icagen shall provide suitable laboratory facilities, equipment and personnel for the work to be done by Icagen in carrying out the Research Program.

2.7 Commercially Reasonable Efforts . Pfizer and Icagen each shall use Commercially Reasonable Efforts to achieve the objectives of the Research Program and Research Plan, including without limitation by using Commercially Reasonable Efforts to provide for screening in the Research Program all small molecule compounds Controlled by such party (other than, in the case of Pfizer, the Excluded Pfizer Compounds) that such party believes have potential to modulate a Research Target and by using Commercially Reasonable Efforts to identify Research Compounds and Candidate Compounds. In addition:

 

  (a) Pfizer shall use Commercially Reasonable Efforts to develop and commercialize Candidate Compounds and Products containing Candidate Compounds throughout the Term; and

 

  (b) Pfizer’s license rights pursuant to Section 3.4 shall terminate with respect to any Candidate Compound with respect to which Pfizer ceases to exercise such Commercially Reasonable Efforts and the consequences set forth in Section 10.4(c) shall apply to such Candidate Compound unless (i) Pfizer is using Commercially Reasonable Efforts to develop a Compound that is more advanced than such Candidate Compound or that is a back-up for such Candidate Compound and (ii) upon such cessation, Pfizer notifies Icagen in writing of such back-up or more advanced Compounds, provided that such back-up or more advanced Compounds shall be subject to the milestone payment and royalty provisions of this Agreement as if the Compounds were Research Compounds, Candidate Compounds or Products; and

 

  (c) after the Research Term, Icagen shall use Commercially Reasonable Efforts, as reasonably requested by Pfizer and at Pfizer’s expense, to provide to Pfizer or any Affiliate or sublicensee of Pfizer any agreed technical assistance reasonably necessary to enable Pfizer or such Affiliate or sublicensee to manufacture, use, sell, offer for sale or import any Product for which Pfizer retains its license rights under Section 3.4.

2.8 Identification of Research Compounds and Candidate Compounds .

 

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  (a) Within [**] days after the results of the initial screening of a Compound are presented to the Joint Research Committee, the Joint Research Committee shall determine whether such Compound meets the criteria for further study set forth in the Research Plan and either designate such Compound as a Research Compound or a Compound that is henceforth eliminated from the Research Program. In any event, any Compound that is not so designated as a Research Compound during the Research Term and for [**] months thereafter shall thereupon cease to be subject to the Research Program, provided that any Compound designated as a Research Compound during the [**] month period following the Research Term shall, for all purposes under this Agreement, be deemed to be a Compound designated as a Research Compound in the Research Program. With respect to any such Compound that ceases to be subject to the Research Program (i) that is a Pfizer Compound, Icagen shall have no rights therein pursuant to this Agreement except as otherwise set forth in Sections 2.8(c), 3.2 and 4, (ii) that is an Icagen Compound, Pfizer shall have no rights therein pursuant to this Agreement except as otherwise set forth in Section 3.2 and (iii) that is a Joint Compound, the parties shall have the rights therein set forth in Section 3.2, provided that Pfizer shall have the right to pursue development of such Joint Compound in accordance with Section 2.8(c) (in which case all of the provisions of this Agreement shall apply to such Joint Compound as if such Joint Compound had never been eliminated from the Research Program) or to license the rights to such Joint Compound in accordance with Section 3.5.

 

  (b) On at least a [**] basis during the Research Term and on an as needed basis during the [**] years immediately following the Research Term, the Joint Research Committee shall review the development status of each Research Compound and shall eliminate from the Research Program any Research Compound that the Joint Research Committee determines does not demonstrate potential to become a Candidate Compound or otherwise is inappropriate to continue to develop. In making any such determination and in designating Candidate Compounds, the parties and the Joint Research Committee shall be guided by the [**] set forth in the Research Plan. All eliminated Research Compounds shall cease to be subject to the Research Program. With respect to any such Research Compound that ceases to be subject to the Research Program (i) that is a Pfizer Compound, Icagen shall have no rights therein pursuant to this Agreement except as otherwise set forth in Sections 2.8(c), 3.2 and 4, (ii) that is an Icagen Compound, Pfizer shall have no rights therein pursuant to this Agreement except as otherwise set forth in Section 3.2 and (iii) that is a Joint Compound, the parties shall have the rights therein set forth in Section 3.2, provided that Pfizer shall have the right to pursue development of such Joint Compound in accordance with Section 2.8(c) (in which case all of the provisions of this Agreement shall apply to such Joint Compound as if such Joint Compound had never been eliminated from the Research Program) or to license the rights to such Joint Compound in accordance with Section 3.5.

 

  (c)

Pfizer shall determine whether to prepare a [**] attached to the Research Plan) as to any Research Compound, and the appropriate governance body within Pfizer

 

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shall determine whether any Research Compound that is the subject of such a Notice shall be designated a Candidate Compound. Subject to the expiration of Pfizer’s right to designate Icagen Compounds as Candidate Compounds as set forth in Section 2.8(d), any Compound, other than an Icagen Compound or a Pfizer Compound introduced into the Research Program and subsequently eliminated from the Research Program in accordance with Section 2.8(a) or 2.8(b) above, that is clinically developed by Pfizer or any of its Affiliates or sublicensees for a Research Target Indication at any time after the Effective Date and as to which, at the time of commencement of the first Phase I Trial of such Compound, the modulation of a Research Target by such Compound is or would reasonably be expected to be material to its therapeutic effect, shall be deemed to be a Candidate Compound. Pfizer shall notify Icagen of any such designation (or initiation of clinical trials) within [**] days of the date that such event occurs.

 

  (d) Notwithstanding anything in this Agreement to the contrary, Pfizer shall have no rights pursuant to this Agreement to any Icagen Compound that is eliminated from the Research Program pursuant to Section 2.8(a) or 2.8(b) or is not designated by Pfizer as a Candidate Compound within [**] years after the end of the Research Program, except as provided in Section 3.2. Nothing in this Section 2.8 shall be construed as limiting in any way the other terms of this Agreement, including but not limited to, the provisions of Section 2.3 and Section 7.1.

3. L ICENSES ; C OMPOUND O WNERSHIP AND R IGHTS .

3.1 Ownership . All Icagen Confidential Information, Icagen Technology and Icagen Patent Rights shall be owned by Icagen. All Pfizer Confidential Information, Pfizer Technology and Pfizer Patent Rights shall be owned by Pfizer. All Joint Technology and Joint Patent Rights shall be owned jointly by Icagen and Pfizer. Subject to Sections 2.7(b) and 3.5 and without limiting the rights provided to Pfizer under clause (i) of Section 3.4(a), in any country in which the use of Joint Patent Rights requires the consent of all owners, each of Icagen and Pfizer will grant such consent upon written request of the other.

3.2 Grants of Research Licenses . Icagen and Pfizer each grants to the other a nonexclusive, irrevocable, worldwide, royalty-free, perpetual license, including the right to grant sublicenses to Affiliates, (a) under Patent Rights and Technology Controlled by such party to make and use Compounds developed in or introduced into the Research Program solely for research purposes, and (b) under Patent Rights and Technology Controlled by such party and Developed In The Research Program solely for research purposes. For clarity, this Section 3.2 does not grant either party any right or license under or with respect to Patent Rights or Technology Controlled by the other party to develop, sell or manufacture for sale any Compound or Technology.

3.3 Excluded Pfizer Compounds . Icagen acknowledges that the Excluded Pfizer Compounds are excluded in their entirety from this Agreement and shall not be deemed Compounds, Research Compounds, Candidate Compounds or Products subject to the terms of this Agreement. Except for limited testing of Excluded Research Target 3 Compounds approved by the Joint Research Committee, with Icagen’s express consent, Pfizer shall not introduce any

 

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of the Excluded Pfizer Compounds into the Research Program. In the event that Pfizer introduces Excluded Research Target 3 Compounds into the Research Program in accordance with the immediately preceding sentence, Pfizer shall not disclose to Icagen the compound structures of such Excluded Research Target 3 Compounds without Icagen’s prior written consent.

3.4 Grant of Commercial License .

 

  (a) License Grant . Subject to the terms and conditions of this Agreement, Icagen hereby grants to Pfizer as of the Effective Date (i) an exclusive (even as to Icagen), worldwide license, including the right to grant sublicenses in accordance with Section 3.4(f), to manufacture, use, sell, offer for sale and import Products under all of Icagen's right, title and interest in the Icagen Patent Rights, Joint Patent Rights, Joint Technology and Icagen Technology, and (ii) a non-exclusive, worldwide license, including the right to grant sublicenses in accordance with Section 3.4(f), to manufacture, use, sell, offer for sale and import pharmaceutical products (other than Products) under all Icagen Patent Rights and Icagen Technology Developed In The Research Program, provided that any such pharmaceutical product manufactured, used, sold, offered for sale or imported pursuant to this clause (ii) shall require payment by Pfizer to Icagen of [**] percent ([**]%) of the milestone and royalty payments specified in Section 4 of this Agreement payable with respect to Candidate Compounds and Full Royalty-Bearing Products but will not otherwise be subject to the provisions of this Agreement applicable to Candidate Compounds and Products. Notwithstanding the foregoing, Pfizer shall not have any license pursuant to this Section 3.4(a) with respect to Products containing Compounds as to which Pfizer’s rights have lapsed pursuant to Section 2.8.

 

  (b) Term of License . The term of the grant set forth in Section 3.4(a) shall commence on the Effective Date and shall terminate on the date of the last to expire of the licensed Patent Rights.

 

  (c) Paid-Up License . With respect to each Product, Pfizer shall have a fully paid-up perpetual, royalty-free license under the Icagen Technology and the Joint Technology to manufacture, use, sell, offer for sale and import of such Product, on a country-by-country basis, after the expiration (but not the early termination pursuant to Section 10.3) of the Term applicable to such Product in such country.

 

  (d) Retained Rights . The license granted by Icagen in Section 3.4(a) is subject to a retained right of Icagen to perform Icagen’s obligations and exercise Icagen’s rights under this Agreement.

 

  (e) [**] .

 

  (f)

Sublicensing . Any sublicense granted by Pfizer must be granted pursuant to a written agreement that subjects the sublicensee to all relevant restrictions, limitations and obligations in this Agreement. Pfizer shall be responsible for failure by its sublicensees to comply, and Pfizer guarantees to Icagen the compliance by each of its sublicensees, with all relevant restrictions, limitations

 

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and obligations in this Agreement. In the event of a material default by any sublicensee that is not an Affiliate of Pfizer under a sublicense agreement, Pfizer will inform Icagen and take such action, after consultation with Icagen, that in Pfizer’s reasonable business judgment is required to address such default. Pfizer shall provide Icagen with a copy of each sublicense agreement, in final executed form, that Pfizer enters into in accordance with this Section 3.4(f) with sublicensees that are not Affiliates of Pfizer not later than thirty (30) days after the execution of such sublicense agreement; provided that , subject to the applicable requirements of the [**] licensor of copies of sublicense agreements, Pfizer may redact the financial terms from such copies.

3.5 Rights to Joint Compounds . After the expiration of the Research Term and [**] months thereafter, Icagen may request that Pfizer grant Icagen a license to develop and commercialize specified Joint Compounds. The granting of any license to Icagen under this Section 3.5 shall be in Pfizer’s sole discretion and on terms and conditions to be negotiated in good faith. Notwithstanding anything to the contrary in this Agreement, and for the avoidance of doubt notwithstanding anything to the contrary in Section 3.1 or Section 6.1(a),Pfizer’s development and commercialization of any Joint Compound shall require payment by Pfizer to Icagen of royalties and milestones pursuant to Section 4.

4. F UNDING .

4.1 Technology Access and License Fee . In consideration of the licenses granted in Sections 3.2 and 3.4, the exclusivity granted by Icagen in Section 2.3 and Icagen’s related technical knowledge and expertise, Pfizer shall pay to Icagen the following one-time technology access and license fees upon execution of this Agreement:

 

a. Technology Access and License Fee with respect to Research Target 1:

   $ [ **]

b. Technology Access and License Fee with respect to Research Target 2:

   $ [ **]

c. Technology Access and License Fee with respect to Research Target 3:

   $ [ **]

Total:

   $ 12,000,000  

4.2 Research Funding . The annual research funding for each year of the Research Term shall be $5,500,000 (five million five hundred thousand US Dollars), which shall be payable by Pfizer to Icagen in equal quarterly installments in advance for research and development activities scheduled to be performed by [**] FTEs at Icagen during each three (3) month quarterly period.

4.3 Additional Research Funding . Pfizer shall provide up to a further $[**]US Dollars) per annum to fund additional FTEs at Icagen or elsewhere (for example, a contract research

 

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organization) if required by the Research Plan and agreed by the Joint Research Committee. Payments will be made in advance in equal quarterly installments.

4.4 Development Milestone Payments . Pfizer shall pay Icagen, on the completion of each development event set forth below by Pfizer or any of its Affiliates or sublicensees ( “Development Event” ), (i) the payment listed opposite such Development Event with respect to Full Royalty-Bearing Products, or (ii) [**] percent ([**]%) of the payment listed opposite such Development Event with respect to [**] Royalty-Bearing Products. For the sake of clarity, should both clause (i) and clause (ii) above be applicable to a Compound or Product, Icagen shall be entitled to receive the greater of the applicable payments, but in no circumstances shall Icagen receive payment under both clauses (i) and (ii) in respect of the same Compound or Product. Except as otherwise set forth below for Development Events (a), (b), (c), (d), (e), (f) and (g), Pfizer shall be obligated to make a payment with respect to each Compound or Product that is the subject of the Development Event:

 

Development Event

   Amount

a. Designation* of a CAN by Pfizer for each of the first three Candidate Compounds

   $ [**]

b. Commencement (dosing of first subject) of a Phase I Trial in any country for the first Candidate Compound targeting Research Target 1

   $ [**]

c. Commencement (dosing of first subject) of a Phase I Trial in any country for the first Candidate Compound targeting Research Target 2

   $ [**]

d. Commencement (dosing of first subject) of a Phase I Trial in any country for the first Candidate Compound targeting Research Target 3

   $ [**]

e. Commencement (dosing of first patient) of a Phase II Trial in any country for the first Candidate Compound targeting Research Target 1

   $ [**]

f. Commencement (dosing of first patient) of a Phase II Trial in any country for the first Candidate Compound targeting Research Target 2

   $ [**]

g. Commencement (dosing of first patient) of a Phase II Trial in any country for the first Candidate Compound targeting Research Target 3

   $ [**]

h. Commencement (dosing of first patient) of the first Phase III Trial for each Candidate Compound

   $ [**]

i. NDA filing in USA for each Product

   $ [**]

j. NDA approval in USA for each Product

   $ [**]

 

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k. Approval of an application for marketing authorization by EMEA (or by the applicable regulatory authority in the first of the United Kingdom, France, Spain, Italy or Germany if EMEA approval is not sought) for each Product

   $ [**]

l. Approval of an application for marketing authorization by the applicable regulatory authority in Japan for each Product

   $ [**]

* Includes a deemed designation as set forth in Section 2.8(c).

  

Pfizer shall promptly notify Icagen of each achievement of a Development Event and, within thirty (30) days after each such achievement, pay to Icagen the corresponding milestone payment amount.

4.5 Sales Milestones . Pfizer shall pay Icagen, on achievement of each commercialization event set forth below (“ Commercialization Event ”), the payment listed opposite such Commercialization Event with respect to each Product. Pfizer shall be obligated to make each such payment only once with respect to each Product that is the subject of the Commercialization Event. All payments made by Pfizer pursuant to this Section 4.5 with respect to a Product shall be credited fully against future sums due to Icagen pursuant to Section 4.6 of this Agreement with respect to Net Sales of such Product; provided that such crediting does not reduce any particular future payment pursuant to Section 4.6 by more than [**]% of the amount otherwise due:

 

Commercialization Event

   Amount

a. First twelve-calendar-month period in which aggregate annual sales of such Product exceed $[**]

   $ [**]

b. First twelve-calendar-month period in which aggregate annual sales of such Product exceed $[**]

   $ [**]

c. First twelve-calendar-month period in which aggregate annual sales of such Product exceed $[**]

   $ [**]

Pfizer shall promptly notify Icagen of each achievement of a Commercialization Event and, within sixty (60) days after each such achievement, pay to Icagen the corresponding milestone payment amount.

4.6 Royalty.

 

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  (a) Pfizer shall pay Icagen a royalty based on the Net Sales of each Full Royalty-Bearing Product and each [**] Royalty-Bearing Product. Except as otherwise set forth in Sections 4.6(b) and 4.6(c), such royalty shall be paid on a country-by-country basis from the date of the first commercial sale (the date of the invoice of Pfizer or any Affiliate or sublicensee of Pfizer with respect to such sale) of such Product in each such country until the expiration of the last Valid Claim within the Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights to expire with respect to such Product in such country.

 

  (b) If the manufacture and sale of a Product takes place in countries where there are no Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights Covering such Product but Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights Covering the Product exist in the U.S., Pfizer will pay to Icagen a royalty on the Net Sales of such Product in each such country for the period from the first commercial sale of such Product in such country until the earlier of (i) ten (10) years after the first commercial sale of such Product in such country or (ii) the expiration of the last to expire Valid Claim within the Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights Covering the Product in the U.S.

 

  (c) Notwithstanding Sections 4.6(a) and 4.6(b) above, Pfizer will pay no royalty on Net Sales of any Product in any country during any calendar quarter in which a Generic Product (with respect to such Product) launched by a third party accounts for more than [**] percent ([**]%) of the combined unit sales of the Product and such Generic Product in such country in such calendar quarter.

4.7 Royalty Rates . The royalty payable (or to be paid) on each Full Royalty-Bearing Product each calendar year shall be based on increments of worldwide Net Sales with respect to such Full Royalty-Bearing Product according to the following schedule. The corresponding royalty payable (or to be paid) on each [**] Royalty-Bearing Product, will be [**] percent ([**]%) of that specified in the following schedule:

 

Annual Net Sales

   Royalty
Rate
(%)
 

Less than $[**]

   [**] %

[**]

  

Greater than $[**]

   [**] %

By way of example only, if the Net Sales of a Full Royalty-Bearing Product were $[**], subject to any adjustments permitted under this Agreement, a royalty of [**]% would be due in respect of the first $[**] of Net Sales, with the remaining $[**] of Net Sales being subject to a royalty of [**]%. By way of further example only, if the Net Sales of a [**] Royalty-Bearing Product were $[**], subject to any adjustments permitted under this Agreement, a royalty of [**]% would be due in respect of the first $[**] of Net Sales, with the remaining $[**] of Net Sales being subject to a royalty of [**]%.

4.8 Royalty Reduction . If Pfizer's manufacture, use or sale of a Product (excluding any portion of a Combination Product comprising active ingredient(s) other than Compounds) in any country would, in the reasonable opinion of Pfizer, infringe a claim in an issued, unexpired

 

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patent or in a published patent application owned by a third party, Pfizer may deduct [**] percent ([**]%) of any royalty payment that Pfizer is required to pay to such third party from the royalty that would otherwise be payable to Icagen with respect to such Product in such country, provided that the total royalty amount payable to Icagen with respect to such Product in such country for any calendar quarter is never reduced by more than [**]% in this manner. Notwithstanding the foregoing provisions of this Section 4.8, [**].

4.9 [**] Payments . If [**] is required to make license royalty or milestone payments pursuant to the [**] as a consequence of [**] will reimburse [**] for such payments, in the case of royalty payments, up to a maximum of [**] percent ([**]%) of Net Sales and, in the case of milestone payments, only payments made by [**] pursuant to [**] as a result of [**] receipt of milestone payments under Sections 4.4 and 4.5 hereof resulting from [**], of each Development Event or Commercialization Event, up to a maximum of [**] percent ([**]%) of each such [**] milestone payment.

4.10 Animal Health Products. The parties acknowledge that the royalty rates set forth in Section 4.7 and the milestone payments set forth in Sections 4.4 and 4.5 are based on the expectation that Products will be administered to human patients. If Pfizer identifies or develops a Product which represents a commercial opportunity in the area of animal health, the parties will negotiate, as mutually agreed, a new royalty rate and milestone schedule for such Product applicable to the animal field to account for development costs and changes in the cost of goods, selling price and projected annual Net Sales. It is understood, however, that the royalty rate specified in Section 4.7 and the milestones set forth in Sections 4.4 and 4.5 shall be modified only as Pfizer and Icagen agree.

4.11 Royalty Payment Dates . Royalties shall be paid by Pfizer on Net Sales within sixty (60) days after the end of each calendar quarter in which such Net Sales are made. Such payments shall be accompanied by a statement showing the Net Sales of each Product by Pfizer or any Affiliate or sublicensee of Pfizer in each country, the applicable royalty rate for such Product, and a calculation of the amount of royalty due, including any offsets.

4.12 Royalty Accounting. The Net Sales used for computing the royalties payable to Icagen by Pfizer shall be computed and paid in US dollars by wire transfer in immediately available funds to a U.S. account designated by Icagen, or by other mutually acceptable means. For purposes of determining the amount of royalties due, the amount of Net Sales in any foreign currency shall be computed by (a) converting such amount into U.S. dollars at the prevailing commercial rate of exchange for purchasing dollars with such foreign currency as published in The Wall Street Journal for the close of the last business day of the calendar quarter for which the relevant royalty payment is to be made by Pfizer and (b) deducting the amount of any governmental tax, duty, charge, or other fee actually paid in respect of such conversion into, and remittance of U.S. dollars.

4.13 Other Payments . Unless otherwise specified in this Agreement, payments pursuant to this Agreement other than royalty payments shall be paid by Pfizer in U.S. currency by wire transfer in immediately available funds to an account designated by Icagen, or by other mutually acceptable means within sixty (60) days of Pfizer’s receipt of an invoice from Icagen.

4.14 Taxes. It is understood and agreed between the parties that any payments made under this Agreement are inclusive of any value added or similar tax imposed upon such

 

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payments. In addition, in the event any such payments made by either party to the other party become subject to withholding taxes under the laws or regulations of any jurisdiction (including any applicable international tax conventions), the paying party shall deduct and withhold the amount of such taxes for the account of the other party to the extent required by applicable laws or regulations, such amounts payable to such other party shall be reduced by the amount of taxes deducted and withheld, and the paying party shall pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to such other party 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 such other party to claim such payment of taxes. Any such withholding taxes required under applicable laws or regulations to be paid or withheld shall be an expense of, and borne solely by, such other party. The paying party will provide the other party with reasonable assistance to enable such other party to reduce the amount of such taxes or recover such taxes as permitted by applicable laws or regulations. Notwithstanding the foregoing, if any payments made by a party to the other party under this Agreement become subject to withholding taxes as a consequence of this Agreement having been assigned to such paying party (e.g., if the paying party is the assignee of an original party to this Agreement and payments made by companies in such paying party’s jurisdiction do not enjoy the benefits of tax treaty(-ies) that are applicable to payments made by companies in the jurisdiction of such paying party’s assignor), then the paying party shall pay to the other party such additional amounts as are necessary so that such other party receives the amounts that such other party would have received if such payments were not subject to such withholding taxes.

4.15 Record-keeping by Icagen. Icagen shall keep (a) for [**] years from the conclusion of each calendar year during the Research Term complete and accurate records of its efforts under the Research Program and its provision of FTEs required pursuant to the Research Plan and (b) for [**] years from the date of each payment of any royalties pursuant to Section 4.9 complete and accurate records of such payments. The records shall conform to good accounting principles as applied to a similar company similarly situated. Pfizer shall have the right at its own expense during the relevant [**] year period to appoint an independent certified public accountant reasonably acceptable to Icagen to inspect said records to verify such provision of FTEs pursuant to the Research Plan and such royalty payments pursuant to Section 4.9. Upon reasonable notice by Pfizer, Icagen shall make its records available for inspection by the independent certified public accountant during regular business hours at the place or places where such records are customarily kept, to verify the accuracy of the expenditures of efforts. This right of inspection shall not be exercised [**] in any calendar year and not [**] with respect to records covering any specific period of time. All information concerning such expenditures of efforts and royalty payments, and all information learned in the course of any audit or inspection, shall be deemed to be Icagen Confidential Information, except to the extent that it is necessary for Pfizer to reveal the information in order to enforce any rights it may have pursuant to this Agreement or if disclosure is required by law. The failure of Pfizer to request verification of any expenditures of efforts prior to the end of the relevant [**] year period shall be considered acceptance by Pfizer of the accuracy of such expenditures of efforts, and Icagen shall have no obligation to maintain any records pertaining to such expenditures of efforts beyond such [**] year period. If Icagen’s provision of FTEs over any calendar year was less, on average over the course of the calendar year, than [**] percent ([**]%) of the FTEs funded by Pfizer pursuant to

 

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Sections 4.2 and 4.3, Icagen shall reimburse Pfizer for any overpayment of FTE funding and for the cost of such audit.

4.16 Record-keeping by Pfizer. Pfizer shall, and shall require its Affiliates and sublicensees to, keep for [**] years from the date of each payment of royalties under this Agreement complete and accurate records, on a country-by-country basis, of gross sales by Pfizer, its Affiliates and sublicensees, and deductions from gross sales taken in determining Net Sales, of each Product in such country in sufficient detail to allow the accruing royalties to be determined accurately. Icagen shall have the right for a period of [**] years after the end of the calendar year for which any royalty report or statement is received with respect to royalties due and payable to appoint at its expense an independent certified public accountant reasonably acceptable to Pfizer to inspect the relevant records of Pfizer to verify such report or statement. Pfizer shall make its records available for inspection by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Icagen, to verify the accuracy of the reports and payments. Such inspection right shall not be exercised [**] in any calendar year nor [**] with respect to sales in any given period. All information learned in the course of any audit or inspection shall be deemed to be Pfizer Confidential Information, except to the extent that it is necessary for Icagen to reveal the information in order to enforce any rights it may have pursuant to this Agreement or if disclosure is required by law or regulation or the rules of any stock exchange. The failure of Icagen to request verification of any report or statement during said [**] year period shall be considered acceptance of the accuracy of such report, and Pfizer shall have no obligation to maintain records pertaining to such report or statement beyond said [**] year period. Any underpayment determined by such audit or inspection shall promptly be paid by Pfizer, plus interest at the interest rate set forth in Section 4.17, from the date of any such underpayment. If Pfizer has underpaid amounts due under this Agreement by more than [**] percent ([**]%) over any reporting period, Pfizer shall also reimburse Icagen for the cost of such audit.

4.17 Late Payments . All payments under this Agreement shall bear interest from the date due until paid at a rate equal to the prime rate of Citibank, NA as announced on the date such payment was due plus [**] percent ([**]%), compounded on a calendar quarterly basis. In addition, Pfizer shall reimburse Icagen for all reasonable costs and expenses, including without limitation reasonable attorneys’ fees and legal expenses, incurred in the collection of late payments.

5. S TOCK P URCHASE . On the date hereof, Pfizer and Icagen are entering into a Stock Purchase Agreement substantially in the form attached hereto as Exhibit B .

6. T REATMENT OF C ONFIDENTIAL I NFORMATION .

6.1 Confidentiality .

 

  (a)

Except as otherwise provided herein, Pfizer and Icagen will, during the term of this Agreement and for [**] years thereafter, keep confidential and not use for any purpose other than the research, development, manufacture and commercialization of Compounds and Products and the seeking of patent protection and regulatory approvals for Compounds and Products in accordance with this Agreement, and will cause its Affiliates to keep confidential and not use

 

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for any purpose other than the research, development, manufacture and commercialization of Compounds and Products and the seeking of patent protection and regulatory approvals for Compounds and Products in accordance with this Agreement, any Icagen Confidential Information (in the case of Pfizer and its Affiliates) or Pfizer Confidential Information (in the case of Icagen and its Affiliates), as the case may be. For the purposes of this Section 6 it is understood that Joint Technology shall be deemed Confidential Information of both parties such that neither party may use or disclose such Confidential Information except to the extent provided herein with respect to the licenses granted each party with respect to Joint Technology; provided that each party shall have the right, subject to such party’s obligations under Section 2.3 and Section 4, to use, disclose and otherwise exploit, either alone or with third parties, Joint Technology (other than Joint Compounds), including such Joint Technology that is Covered by Joint Patent Rights, for research, development and commercialization activities outside the Research Program without any duty to account to the other party.

 

  (b) Pfizer and Icagen each agree that any disclosure of the other’s Confidential Information to any officer, employee or agent of (including without limitation any contract research organization employed by) such receiving party or of any of its Affiliates shall be made only if and to the extent necessary to carry out its responsibilities under this Agreement and shall be limited to the maximum extent possible consistent with such responsibilities (i.e., shall only be disclosed to those officers, employees and agents who have a need to know the Confidential Information in furtherance of the purposes of this Agreement). Each party shall take such action, and shall cause its Affiliates to take such action, to preserve the confidentiality of the other party’s Confidential Information as required under Section 6.1(a) as it would customarily take to preserve the confidentiality of its own Confidential Information. Each party, upon the other’s request, will return all the Confidential Information, including all remaining biological, synthetic chemical and biochemical materials, disclosed or transferred to such party by such other party pursuant to this Agreement, including all copies and extracts of documents, within sixty (60) days of such request after expiration or termination of this Agreement, except for (i) one (1) copy of any such copies and extracts of documents, which may be kept solely for the purpose of monitoring such party’s compliance with and complying with continuing obligations under this Agreement and (ii) any copies or materials necessary for such party to exercise its rights with respect to Compounds and Products, including without limitation those set forth in Section 3.2, that survive expiration or termination of this Agreement.

 

  (c) Icagen and Pfizer each represent to the other that all of its employees, and any consultants to such party, participating in the Research Program who shall have access to Pfizer Technology, Icagen Technology, Joint Technology, Pfizer Confidential Information or Icagen Confidential Information are bound by agreement or other legal obligation to maintain such information in confidence.

 

  (d)

Neither Icagen nor Pfizer shall disclose or transfer any information or material to the other party hereunder if such disclosure or transfer would violate any duty or

 

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obligation to any third party, including any duty of confidentiality to any third party.

6.2 Publication . Notwithstanding any matter set forth in this Agreement to the contrary, results obtained in the course of the Research Program may only be submitted for publication following scientific review by the Joint Research Committee and subsequent written approval by both Icagen and Pfizer. Written approval or disapproval of the proposed publication shall be provided by both Pfizer and Icagen within thirty (30) days for a manuscript, within fourteen (14) days for an abstract for presentation at, or inclusion in the proceedings of, a scientific meeting, and within fourteen (14) days for a transcript of an oral presentation to be given at a scientific meeting.

6.3 Publicity . The parties recognize that each party may from time to time desire to issue press releases and make other public statements or disclosures regarding the subject matter of this Agreement. In such event, the party desiring to issue a press release or make a public statement or disclosure shall provide the other party with a copy of the proposed press release, statement or disclosure for review and approval in advance, which advance approval shall not be unreasonably withheld, conditioned or delayed. No other public statement or disclosure concerning the existence or terms of this Agreement shall be made, either directly or indirectly, by either party hereto, without first obtaining the written approval of the other party. Once any public statement or disclosure has been approved in accordance with this Section 6.3, then either party may appropriately communicate information contained in such permitted statement or disclosure. Notwithstanding the foregoing provisions of this Section 6.3, a party may (a) disclose the existence, terms and subject matter of this Agreement where required, as reasonably determined by the disclosing party, by applicable law or regulation, by applicable stock exchange rule or by order of a court or other legal process, (b) disclose the existence and terms of this Agreement under obligations of confidentiality to agents, advisors, contractors, investors, acquirors and sublicensees, and to potential agents, advisors, contractors, investors, acquirors and sublicensees, in connection with such party’s activities hereunder and in connection with such party’s financing or strategic activities and (c) publicly announce any of the matters set forth in Exhibit A , provided that such announcements do not entail disclosure of non-public technical or scientific information (which, for clarity, excludes clinical trial results) and the announcing party provides the other party with a copy of the proposed text of such announcement sufficiently in advance of the scheduled release or publication thereof to afford such other party a reasonable opportunity to review and comment upon the proposed text, and provided further that, subject to the announcing party’s obligations to comply with requirements imposed by applicable law or regulation, by applicable stock exchange rule or by order of a court or other legal process, the announcing party shall use reasonable efforts to provide the other party with an advance draft of any such public announcement in order to provide such other party with an opportunity to review such draft and provide comments thereon to the announcing party prior to such public announcement.

6.4 Disclosure of Inventions . Each party shall promptly inform the other about all inventions that are conceived, made or developed in the course of carrying out the Research Program by employees of, or consultants to, either of them solely, or jointly with employees of, or consultants to the other.

 

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6.5 Disclosure Required by Law. If either party is requested to disclose the other's Confidential Information in connection with a legal or administrative proceeding or is otherwise required by law, regulation or legal process to disclose the other's Confidential Information, such party will if practicable give the other party prompt notice of such request. The party whose Confidential Information is subject to such request or requirement may seek, at its expense, an appropriate protective order or other remedy or waive compliance with the provisions of this Agreement. If such party seeks a protective order or other remedy, the other party will cooperate as reasonably requested by the party seeking such order or other remedy. If the party seeking such order or other remedy fails to obtain a protective order or waive compliance with the relevant provisions of this Agreement, the other party will disclose only that portion of Confidential information that its legal counsel reasonably determines such party is required to disclose.

6.6 Clinical Trial Register. Each party acknowledges and agrees that the other party may publish the protocols and results of clinical studies conducted by such other party with Compounds on its clinical trial register or a government sponsored clearinghouse such as www.clinicaltrials.gov or other publicly available websites such as www.clinicalstudyresults.org and that such publication will not be a breach of the confidentiality and publications obligations provided in this Section 6. The foregoing does not give a party the right to make such disclosures in respect of clinical trials sponsored by the other party.

6.7 Use of Materials . Pfizer and Icagen recognize that the biological, synthetic chemical and biochemical materials that are part of Pfizer Technology, Icagen Technology or Joint Technology, represent commercial assets. The use by a party of such materials Controlled by the other party is limited to activities to be performed under this Agreement or otherwise permitted under Section 3.2. Both parties acknowledge that such materials are for laboratory use only and are not for consumption by, or treatment of, humans or non-laboratory animals. Both parties will use these materials in compliance with all applicable federal, state and local laws, regulations and ordinances.

7. I NTELLECTUAL P ROPERTY R IGHTS . The following provisions relate to the filing, prosecution and maintenance of Icagen and Joint Patent Rights during the term of this Agreement:

7.1 Filing, Prosecution and Maintenance by Icagen . With respect to Icagen Patent Rights, as between Icagen and Pfizer, Icagen shall have the exclusive right:

 

  (a) to file applications for letters patent on any invention included in such Patent Rights; provided, however, that Icagen shall consult with Pfizer regarding countries in which such patent applications should be filed and shall file patent applications in those countries where Pfizer requests that Icagen file such applications; and, further provided, that Icagen, at its option, may file in countries where Pfizer does not request that Icagen file such applications;

 

  (b) to take all reasonable steps to prosecute all pending and new patent applications included within such Patent Rights with counsel selected by Icagen in its sole discretion, but after considering in good faith Pfizer’s views with respect to such counsel;

 

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  (c) to respond to oppositions, interferences, nullity actions, re-examinations, revocation actions and similar proceedings filed by third parties against the grant of letters patent for such applications;

 

  (d) to maintain in force any letters patent included in such Patent Rights by duly filing all necessary papers and paying any fees required by the patent laws of the particular country in which such letters patent were granted; and

 

  (e) and obligation to notify Pfizer in a timely manner of any decision not to file an application or to abandon a pending application or an issued patent included in such Patent Rights. Thereafter, subject to any limitations imposed on Icagen by any third party agreement, Pfizer shall have the option, at its expense, of filing and/or continuing to prosecute any such patent application or of keeping the issued patent in force.

Pfizer shall have the right to file, on behalf of and as an agent for Icagen, all applications and take all actions necessary to obtain patent extensions pursuant to 35 U.S.C. Section 156 and foreign counterparts for Patent Rights described in this Section 7.1 licensed to Pfizer that are available based on regulatory approvals of Products for which Pfizer retains its license rights under Section 3.4; provided that , with respect to all patent extensions for such Products, Pfizer shall consult with Icagen and its counsel as to the patent to be chosen for extension and Pfizer shall base its selection of the patent for extension solely on the best commercial interest of the Product. Icagen will execute such further documents and take such further actions as may be requested by Pfizer in this regard at Pfizer’s expense.

7.2 Copies of Documents . Each party shall provide or cause to be provided to the other party (or the other party’s designee), prior to filing, copies of all patent applications and substantive correspondence with patent offices that such party has prepared for filing pursuant to Section 7.1 or 7.4, for the purpose of obtaining substantive comment of the other party’s patent counsel. Each party shall also provide to the other party copies of all documents relating to prosecution of all such patent applications in a timely manner.

7.3 Reimbursement of Costs for Filing, Prosecuting and Maintaining Patent Rights . Within [**] days of receipt of invoices from Icagen, Pfizer shall reimburse Icagen for all the costs of Icagen’s performance of the duties set forth in Section 7.1 with respect to patent applications and patents in countries where Pfizer requests that patent applications and patents be filed, prosecuted and maintained except that in the event Pfizer objects to Icagen’s choice of patent counsel in Section 7.1(b) in good faith, including provision of legal services at reasonable fees consistent with Pfizer practice, and after considering Pfizer’s views Icagen selects such patent counsel, Pfizer shall only be obliged to reimburse [**] percent ([**]%) of the costs incurred by Icagen in using such patent counsel. Such reimbursement shall be in addition to payments under Section 4. However, Pfizer may, upon [**] days notice, request that Icagen discontinue the performance of duties set forth in Section 7.1 with respect to given patent applications and patents in any country. Icagen shall pay the costs of Icagen’s performance of the duties set forth in Section 7.1 in those countries in which Pfizer does not request that Icagen perform such duties, but in which Icagen, at its option, elects to do so; provided that if Pfizer elects not to pay for Icagen’s performance of the duties set forth in Section 7.1, with respect to patent applications and patents in any country, such patent applications and patents shall be

 

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solely owned by Icagen and shall be excluded from the Icagen Patent Rights and Pfizer’s licenses thereunder.

7.4 Filing, Prosecution and Maintenance by Pfizer . With respect to Joint Patent Rights, Pfizer shall have those rights and duties ascribed to Icagen and Icagen shall have those rights and duties ascribed to Pfizer in Section 7.1 (but not the duties ascribed to Pfizer in Section 7.3), and Pfizer shall conduct such duties with in-house counsel of Pfizer or with counsel selected by Pfizer in its sole discretion, but after considering in good faith Icagen’s views with respect to such counsel.

8. A CQUISITION OF R IGHTS FROM T HIRD P ARTIES . During the Research Term, Icagen and Pfizer shall each promptly notify each other of all material opportunities to acquire in any manner from third parties, technology or patents or information which may be useful in or may relate to the Research Program that come to the attention of such party; provided that Pfizer shall not be obligated to notify Icagen of any third party technology that relates to the Excluded Pfizer Compounds. Icagen and Pfizer shall decide if such rights should be acquired in connection with the Research Program and, if so, whether by Icagen, Pfizer or both. If acquired, such rights shall become part of the Confidential Information, Technology or Patent Rights, whichever is appropriate, of the acquiring party or parties.

9. L EGAL A CTION .

9.1 Actual or Threatened Infringement. When information comes to the attention of Pfizer to the effect that any Icagen Patent Rights, Pfizer Patent Rights or Joint Patent Rights relating to a Candidate Compound or Product has been or is threatened to be unlawfully infringed, Pfizer shall have the first right at its expense to take such action as it may deem necessary to prosecute or prevent such unlawful infringement, including the right to bring or defend any suit, action or proceeding involving any such infringement. Pfizer shall notify Icagen promptly of the receipt of any such information and of the commencement of any such suit, action or proceeding. If Pfizer determines that it is necessary or desirable for Icagen to join any such suit, action or proceeding, Icagen shall, at Pfizer's expense, execute all papers and perform such other acts as may be reasonably required to permit Pfizer to commence such action, suit or proceeding in which case Pfizer shall indemnify and hold Icagen free, clear and harmless from any and all damages and costs and expenses of litigation, including attorneys fees. If Pfizer brings a suit, it shall have the right first to reimburse itself out of any sums recovered in such suit or in its settlement for all costs and expenses, including attorney's fees, related to such suit or settlement, and any remainder shall be paid [**] percent ([**]%) to Icagen and [**] percent ([**]%) to Pfizer. If Pfizer does not, within [**] days after giving notice to Icagen of the above-described information (or within [**] days after any paragraph IV certification under 21 C.F.R. Part 314 by a third party to the effect that any Icagen Patent Right, Pfizer Patent Right or Joint Patent Right is invalid, unenforceable or otherwise not infringed by a generic version of a Product), notify Icagen of Pfizer's intent to bring suit against any infringer, Icagen shall have the right to bring suit for such alleged infringement, but it shall not be obligated to do so. If Icagen determines that it is necessary or desirable for Pfizer to join any such suit, action or proceeding, Pfizer shall, at Icagen's expense, execute all papers and perform such other acts as may be reasonably required to permit Icagen to commence such action, suit or proceeding in which case Icagen shall indemnify and hold Pfizer free, clear and harmless from any and all damages and costs and expenses of litigation, including attorneys fees. If Icagen brings a suit, it shall have the

 

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