EX-10.12 12 filename12.htm [*] = 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 406 of the Securities Act of 1933, as...
Exhibit 10.12
[*] = 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 406 of the Securities Act of 1933, as amended.
EXECUTION VERSION
Clinical Collaboration Agreement
by and among
Portola Pharmaceuticals, Inc.,
Xxxxxxx-Xxxxx Squibb Company,
and
Pfizer Inc.
CLINICAL COLLABORATION AGREEMENT
This CLINICAL COLLABORATION AGREEMENT (the “Agreement”) is entered into and made effective as of October 16, 2012 (the “Effective Date”), by and among Portola Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having its principal place of business at 000 Xxxx Xxxxx Xxxxxx, Xxxxx 00, Xxxxx Xxx Xxxxxxxxx, XX 00000, XXX (“Portola”), Xxxxxxx-Xxxxx Squibb Company, a corporation organized and existing under the laws of Delaware, having its principal place of business at 000 Xxxx Xxxxxx, Xxx Xxxx, XX 00000 (“BMS”), and Pfizer Inc., a corporation organized and existing under the laws of Delaware, having its principal place of business at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, Xxx Xxxx 1017 (“Pfizer”). Each of Portola, BMS and Pfizer are referred to individually as a “Party” and collectively as the “Parties.”
ARTICLE 1
Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized, shall have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.
1.1 “Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” means, (a) direct or indirect, ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest, in the case of any other type of legal entity, (b) status as a general partner in any partnership, or (c) any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or
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[*] = 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 406 of the Securities Act of 1933, as amended.
other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.
1.2 “Apixaban” means the Factor Xa inhibitor being developed and commercialized by BMS and Pfizer, having the chemical structure set forth in Schedule 1.2.
1.3 “Applicable Laws” shall mean all applicable laws, rules and regulations (whether federal, state or local) which may be in effect from time to time and applicable to conduct under this Agreement, including current Good Manufacturing Practices (cGMP) and current Good Clinical Practices (cGCP).
1.4 “BMS/Pfizer Indemnitees” has the meaning set forth in Section 12.1.
1.5 “BMS/Pfizer Know-How” means any Know-How Controlled by BMS or Pfizer or any of their respective Affiliates as of the Effective Date or thereafter during the Term that is necessary or reasonably useful to conduct the Studies or to develop PRT064445 as an antidote for Apixaban.
1.6 “BMS/Pfizer Patents” means any Patent Rights Controlled by BMS or Pfizer or any of their respective Affiliates as of the Effective Date or thereafter during the Term that cover Apixaban and/or its use and that are necessary or reasonably useful to conduct the Studies or to develop PRT064445 as an antidote for Apixaban.
1.7 “BMS/Pfizer Technology” means BMS/Pfizer Know-How and BMS/Pfizer Patents.
1.8 “cGMPs” means all current Applicable Laws and regulations that apply to the manufacture of active ingredients and pharmaceutical products, including the United States regulations set forth under Title 21 of the United States Code of Federal Regulations parts 210, 211, as may be amended from time to time, as well as applicable guidance published by the FDA from time to time, and foreign equivalents.
1.9 “Claims” means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs and other reasonable expenses of any nature.
1.10 “Clinical Trial” means the “proof of concept” clinical study of PRT064445 as an antidote to Apixaban which is contemplated by the Parties, the outline of which as of the Effective Date is set forth in the initial Development Plan.
1.11 “Commercially Reasonable Efforts” means, with respect to carrying out a Party’s tasks and obligations under this Agreement, expending reasonable, diligent, good faith efforts and resources to accomplish such task or obligation as such Party would normally use to accomplish a similar task or obligation for a pharmaceutical product in a similar stage of development under similar circumstances. Commercially Reasonable Efforts requires that a Party, at a minimum, assign responsibility for such obligations to qualified employees, consultants or contractors, set goals and objectives for carrying out such obligations, and allocate resources designed to meet such goals and objectives.
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[*] = 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 406 of the Securities Act of 1933, as amended.
1.12 “Confidentiality Agreement” has the meaning set forth in Section 13.77.
1.13 “Control” or “Controlled” means, with respect to any Know-How, Patent Right, other intellectual property right, or any proprietary or trade secret information, that a Party or any of its Affiliates has the legal authority or right (whether by ownership, license or otherwise) to grant a license or a sublicense under such Know How, Patent Right, or intellectual property right to the other Party, or to otherwise disclose such proprietary or trade secret information to the other Party, all on the terms and conditions set forth in this Agreement and without breaching the terms of any then-existing agreement with any Third Party or misappropriating the proprietary or trade secret information of any Third Party.
1.14 “Development Plan” has the meaning set forth in Section 5.2.
1.15 “EMA” means the European Medicines Agency or any successor entity thereto.
1.16 “FDA” means the United States Food and Drug Administration or any successor entity thereto.
1.17 “Indemnified Party” has the meaning set forth in Section 12.4.
1.18 “Indemnifying Party” has the meaning set forth in Section 12.4.
1.19 “Invention” means any data, results, process, method, composition of matter, article of manufacture, discovery, finding or other Know-How that is developed, conceived, reduced to practice, authored or otherwise created by or on behalf of a Party as a result of carrying out its obligations under this Agreement, whether or not patentable.
1.20 “Joint Collaboration Committee” or “JCC” has the meaning set forth in Section 3.1.
1.21 “Joint Inventions” has the meaning set forth in Section 8.1(d).
1.22 “Joint Patents” has the meaning set forth in Section 8.2(b).
1.24 “Patent Rights” means all patents and patent applications (including certificates of invention and applications for certificates of invention), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, revalidations, extensions, registrations, pediatric exclusivity periods and supplemental protection certificates and the like of any such patents and patent applications, and any and all equivalents of the foregoing in any country or jurisdiction.
1.25 “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
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[*] = 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 406 of the Securities Act of 1933, as amended.
1.26 “Portola Indemnitees” has the meaning set forth in Section 12.2.
1.27 “Portola Know-How” means any Know-How Controlled by Portola or any of its Affiliates as of the Effective Date or thereafter during the Term that is necessary or reasonably useful to conduct the Studies or to develop Apixaban for use with PRT064445.
1.28 “Portola Patents” means any Patent Rights Controlled by Portola or any of its Affiliates as of the Effective Date or thereafter during the Term that cover PRT064445 and/or its use and are necessary or reasonably useful to conduct the Studies or to develop Apixaban for use with PRT064445.
1.29 “PRT064445” means the Factor Xa inhibitor antidote being developed by Portola, having the chemical structure set forth in Schedule 1.29.
1.30 “Regulatory Approval” means, with respect to a pharmaceutical product, all approvals, registrations, licenses or authorizations from the relevant Regulatory Authority in a country or jurisdiction that is specific to such product and necessary to develop, market and sell such product in such country or jurisdiction.
1.31 “Regulatory Authority” means any applicable government regulatory agency or authority responsible for granting Regulatory Approvals for pharmaceutical products, including the FDA, EMA and any corresponding national or regional regulatory authorities.
1.32 “Regulatory Filings” means, with respect to a pharmaceutical product, any submission to a Regulatory Authority of any appropriate regulatory application specific to such product, and shall include any submission to a regulatory advisory board and any supplement or amendment thereto with respect to such product.
1.33 “Studies” means the Clinical Trial as set forth in the Development Plan and any pre clinical safety and pharmacology studies required by the FDA or otherwise agreed upon by the parties (the “Preclinical Studies”) .
1.34 “Study Data” means all data generated by the Studies.
1.35 “Term” has the meaning set forth in Section 10.1.
1.36 “Third Party” means any Person other than a Party or an Affiliate of a Party.
1.37 “United States” or “US” means the United States of America, including its territories and possessions.
(a) “includes” and “including” shall mean respectively includes and including without limitation; “or” is used in the inclusive sense (i.e., “and/or”); “will” shall mean “shall”; references to “dollars” or “$”shall mean U.S. Dollars; “annual” refers to a calendar year; “quarterly” refers to a calendar quarter;
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[*] = 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 406 of the Securities Act of 1933, as amended.
(b) words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;
(c) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear;
(d) any reference to any laws or regulations refers to such laws or regulations as from time to time enacted, repealed or amended;
(e) the Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall include references to the Exhibits and attachments.
ARTICLE 2
(a) Subject to the terms and conditions of this Agreement, each of BMS and Pfizer hereby grants to Portola:
(i) a non-exclusive, fully paid, non-sublicenseable (but with the right to subcontract in accordance with Section 5.4) license under the BMS/Pfizer Technology to conduct the Studies pursuant to the Development Plan;
(ii) a non-exclusive, fully paid, non-sublicenseable (but with the right to subcontract in accordance with Section 5.4) license under the BMS/Pfizer Patents to develop (including seeking Regulatory Approval for) PRT064445 as an antidote for Apixaban;
(iii) a non-exclusive, fully paid, non-sublicenseable (but with the right to subcontract in accordance with Section 5.4) license under the BMS/Pfizer Know-How to develop (including seeking Regulatory Approval for) PRT064445 as an antidote for Factor Xa inhibitors; and
(iv) [*] license, [*] to [*] to [*], under [*], and [*] or [*] or [*], to [*] and [*].
(b) Subject to the terms and conditions of this Agreement, Portola hereby grants to each of BMS and Pfizer:
(i) a non-exclusive, fully paid, non-sublicenseable (but with the right to subcontract in accordance with Section 5.4) license under the Portola Know-How and the Portola Patents to conduct the Studies pursuant to the Development Plan; and
(ii) [*] license, [*] to [*] to [*], under [*], and [*] or [*] under [*], to [*], and [*].
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[*] = 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 406 of the Securities Act of 1933, as amended.
(c) The licenses set forth above are for the convenience of the Parties, and no inference shall be drawn as to whether such licenses would or would not have been necessary for the development and commercialization of PRT064445 as an antidote to Apixaban.
2.2 [*]. Each Party recognizes that it has [*] in [*] of the [*] which may be useful in [*]. If any Party desires [*] of [*], such Party shall bring it to the attention of the JCC for discussion. Except as expressly permitted by this Agreement, no Party shall [*] (including [*]) without the prior written consent of such other Party. In the event that a Party has granted its consent [*], such consent shall [*] (i.e., if [*] the consent [*] in [*] a [*], [*] in the [*] in any [*] consent).
ARTICLE 3
3.1 Joint Collaboration Committee
(a) The Parties will establish a joint steering committee (the “Joint Collaboration Committee” or “JCC”) to oversee the Parties’ activities under this Agreement. Within [*], Portola shall appoint two (2) representatives to the JCC, and each of BMS and Pfizer shall appoint one (1) representative to the JCC and notify the other Parties of the dates of availability for the first meeting of the JCC. The JCC may change its size from time to time by mutual consent of its members and each Party may replace its representatives at any time upon written notice to the other Parties. Each Party’s JCC representatives shall include an officer or employee of such Party with sufficient seniority to make decisions arising within the JCC’s responsibilities.
(b) The JCC will be responsible to: (i) discuss, coordinate and review the conduct of the Studies; (ii) discuss and approve any amendments to the Development Plan, including the protocols for the Studies and the statistical analysis plans; (iii) discuss and review the results of the Studies, including the data analysis; and (iv) perform other obligations specifically delegated to the JCC under the Agreement or otherwise agreed to by the Parties in writing.
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[*] = 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 406 of the Securities Act of 1933, as amended.
(c) The JCC shall not have the authority, and no Party may exercise its final decision-making authority under this Agreement, to: (i) modify or amend the terms and conditions of this Agreement; (ii) waive either Party’s compliance with the terms and conditions of this Agreement; (iii) determine any such issue in a manner that would conflict with the terms and conditions of this Agreement; (iv) increase either Party’s obligations with regard to the Development Plan without such Party’s consent; (v) unilaterally make a decision that is expressly stated to require the mutual agreement of the Parties or the consent of the other Party); or (v) render any interpretation of this Agreement that is binding upon the Parties.
3.2 Meetings of the Joint Collaboration Committee
(a) The JCC shall meet periodically, but at least once in every calendar quarter. The first meeting of the JCC shall be held as soon as reasonably practicable, but in no event later than [*]. Meetings shall be held at such dates and places as are mutually agreed or by teleconference or videoconference.
(b) Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend JCC meetings in a non-voting capacity, with the consent of the other such Party (which shall not be unreasonably withheld); provided, that if any such Party intends to have any Third Party (including any consultant) attend such a meeting, such Third Party will be subject to the prior approval of the other Parties and must be bound by confidentiality obligations consistent with the terms of this Agreement.
(c) Each of Portola, on the one hand, and BMS and Pfizer, on the other hand, shall appoint one (1) of its representatives on the JCC to act as co-chairpersons of the JCC. The chairpersons shall set agendas for JCC meetings, provided that the agendas will include any matter requested by any Party. The chairpersons shall be responsible for recording, preparing and, within a reasonable time, issuing minutes of each JCC meeting, which draft minutes shall be subject to review and approval by the JCC.
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[*] = 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 406 of the Securities Act of 1933, as amended.
(a) provide a single point of communication both internally within the Parties’ respective organizations and between the Parties regarding the Development Plan;
(b) plan and coordinate any cooperative efforts under this Agreement, if any, and any external communications; and
(c) take responsibility for ensuring that JCC activities, such as the conduct of required JCC meetings, occur as set forth in this Agreement and that relevant action items, if any, resulting from such meetings are appropriately carried out or otherwise addressed.
ARTICLE 4
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[*] = 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 406 of the Securities Act of 1933, as amended.
(a) Manufacture and Supply. BMS shall manufacture or have manufactured Apixaban [*] for the Studies. BMS shall supply [*] to Portola for use in the Studies as set forth in the Development Plan, with [*] by BMS. The cost of manufacture and supply (including the cost of shipping and importation) of Apixaban for the Studies shall be [*]. Apixaban shall be manufactured in accordance with Applicable Laws (including cGMP to the extent required by Applicable Laws) and shall be [*] Apixaban used by BMS for its own clinical trials of Apixaban.
ARTICLE 5
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[*] = 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 406 of the Securities Act of 1933, as amended.
(a) BMS and Pfizer Responsibilities. BMS and/or Pfizer shall be responsible for:
(i) manufacturing and supplying cGMP-grade Apixaban required for the Studies (with such manufacturing to be undertaken by BMS pursuant to Article 4);
(ii) providing Portola with the right of reference to regulatory materials of Apixaban that are reasonably necessary to conduct the Studies and to facilitate the Regulatory Approval for PRT064445 use as an antidote for Apixaban;
(iii) [*] the Preclinical Studies directed by Regulatory Authorities or otherwise agreed upon by the JCC;
(iv) [*] protocols and amendments relating to the use of Apixaban in the Clinical Trial;
(v) [*] the resulting Clinical Trial data relating to Apixaban;
(vi) providing [*] with respect to [*], which [*] may be provided by BMS or Pfizer [*];
(vii) [*] management of the Clinical Trial;
(viii) performing the regulatory activities as set forth in Section 6.1(c); and
(ix) performing such Preclinical Studies as the JCC (by mutual agreement) assigns to BMS or Pfizer and that BMS or Pfizer agrees to carry out (it being understood that the Clinical Study shall remain the responsibility of Portola).
(b) Portola Responsibilities. Portola shall be responsible for:
(i) manufacturing and supplying cGMP-grade PRT064445 required for the Studies;
(ii) providing BMS and Pfizer with the right of reference to regulatory materials of PRT064445 that are reasonably necessary to conduct the Studies and to facilitate the incorporation of PRT064445 into Apixaban labeling;
(iii) managing and conducting the Preclinical Studies in accordance with the Development Plan, or as otherwise directed by Regulatory Authorities (except to the extent the Parties mutually agree that certain Preclinical Studies will be conducted by BMS or Pfizer);
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[*] = 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 406 of the Securities Act of 1933, as amended.
(iv) managing and conducting the Clinical Trial in accordance with the Development Plan, or as otherwise directed by Regulatory Authorities, including entering into clinical trial agreements with clinical research organizations and other Third Parties contractors, such as academic recruitment sites, in connection with the Clinical Trial; [*] to the [*] that [*] of the [*] with respect to [*], and that [*] in the Clinical Trial [*] in the [*] (which shall include [*]);
(v) notifying BMS and Pfizer of any adverse events related to the Clinical Trial pursuant to the Pharmacovigilance Agreement provided for in Section 6.2;
(vi) providing the JCC with access to results and updates to Study Data and other documents, including: [*] and [*] related to [*] to [*]; and Study results, including [*] with respect to [*] and [*] and [*] for [*]. Notwithstanding the above, in the case of [*], or as [*] for [*], Portola shall [*] with [*] and [*] for [*] to [*] or [*].
(vii) considering, in good faith, any requests from BMS or Pfizer for additional data relating to development of PRT064445 with respect to Apixaban; and
(viii) performing the regulatory activities set forth in Section 6.1(d).
(a) Each Party shall use Commercially Reasonable Efforts to perform the activities allocated to it under the Development Plan in a timely and effective manner. Without limiting the foregoing, Portola will use Commercially Reasonable Efforts to [*] within [*] of [*].
(b) Each Party agrees that in performing its obligations under this Agreement: (i) it shall comply with all Applicable Laws, regulations and requirements, including generally accepted standards of good clinical practice; and (ii) it will not employ or engage any Person to perform such obligations who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.
(c) Each Party shall retain ownership of any materials that it provides to the other Parties under this Agreement, which shall be used by the other Parties solely for the purpose of carrying out its obligations under this Agreement. Upon expiration or termination of this Agreement, each Party shall promptly return or destroy, as the other Party shall instruct, any remaining materials provided to it by the other Party, except to the extent necessary to comply with its obligations under Applicable Laws.
(d) Each Party shall have the right to engage subcontractors for the performance of its obligations under the Development Plans, and shall cause the subcontractor(s) engaged by it to be bound by written obligations of confidentiality and invention assignment consistent with those contained herein, and such Party remains primarily responsible for the performance of such subcontractor(s).
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[*] = 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 406 of the Securities Act of 1933, as amended.
fully and properly reflect all work done and results achieved in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all Studies in formal written study reports according to Applicable Laws and national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. Each Party shall maintain such records in a professional manner in compliance with all Applicable Laws and regulations and no Party shall destroy any such records without the other Party’s consent. Each Party shall provide the JCC with regular reports detailing its activities under the Development Plan and the results of such activities at each regularly scheduled JCC meeting. The Parties shall discuss the status, progress and results of each Party’s activities under the Development Plan at such JCC meetings.
ARTICLE 6
6.1 Regulatory Responsibilities.
(a) The Development Plan shall set forth the regulatory strategy for the conduct of the Studies. Subject to Sections 6.1(b) and (c) below, Portola shall be responsible for preparing and filing of any and all Regulatory Filings necessary to conduct the Studies in
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[*] = 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 406 of the Securities Act of 1933, as amended.
accordance with the Development Plan. BMS and Pfizer shall assist and cooperate with Portola in connection with the preparation of such Regulatory Filings, as reasonably requested by Portola, including providing Portola with the right of reference to regulatory materials of Apixaban that are necessary to conduct the Studies. Portola shall keep BMS and Pfizer reasonably informed of regulatory developments relating to the Studies. Portola shall provide BMS and Pfizer for review and comment all draft Regulatory Filings related to the Studies (other than routine correspondence) at least [*] in advance of the intended date of submission, and shall consider in good faith BMS’ and Pfizer’s comments thereto. BMS and Pfizer shall have the right (in addition to Portola) to provide the timelines and protocols of the Studies, as they relate to Apixaban, to Regulatory Authorities.
(b) Each of BMS and Pfizer, on the one hand, and Portola, on the other hand, shall promptly notify the other Party of all meetings, conferences and discussions scheduled with any Regulatory Authority that pertains to Apixaban as it relates to PRT064445 (the “BMS/Pfizer Regulatory Authority Meeting”) or that pertains to PRT064445 as it relates to Apixaban (the “Portola Regulatory Authority Meeting”).
(c) For all BMS/Pfizer Regulatory Authority Meetings:
(i) BMS and Pfizer will prepare all strategy and correspondence for BMS/Pfizer Regulatory Authority Meetings, and will provide Portola with copies of any proposed strategy and correspondence pertaining to PRT064445 at least [*] prior to submission to a Regulatory Authority [*]. All strategy and correspondence related to the combination of Apixaban and PRT064445 shall be [*] prior to such meeting, provided that BMS and Pfizer shall [*] such Regulatory Filings and make other regulatory communications [*] or [*], or [*];
(ii) Upon BMS’ or Pfizer’s request, Portola shall provide BMS and Pfizer [*] regulatory materials of PRT064445 in a timely manner in order for BMS and Pfizer to prepare for the meeting;
(iii) BMS and Pfizer shall lead all BMS/Pfizer Regulatory Authority Meetings, [*], collectively, up to [*] Portola attendees may attend portions of any such meeting that pertains to PRT064445. In the event that BMS or Pfizer [*] at any such meeting, BMS or Pfizer [*] (without the [*], and without [*]).
(d) For all Portola Regulatory Authority Meetings:
(i) Portola will prepare all strategy and correspondence for Portola Regulatory Authority Meetings, and will provide BMS and Pfizer with copies of any proposed strategy and correspondence pertaining to Apixaban at least [*] prior to submission to a Regulatory Authority [*]. All strategy and correspondence related to the combination of Apixaban and PRT064445 shall be [*] prior to such meeting, provided that Portola shall [*] such Regulatory Filings and make other regulatory communications [*] or [*], or [*] (e.g., [*] with [*]) or [*];
(ii) Upon Portola’s request, BMS and Pfizer shall provide Portola [*] regulatory materials of Apixaban in a timely manner in order for Portola to prepare for the meeting;
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[*] = 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 406 of the Securities Act of 1933, as amended.
(iii) Portola shall lead all Portola Regulatory Authority Meetings. Up to [*] attendees from BMS and Pfizer, collectively, may attend portions of any such meeting that pertains to Apixaban. In the event that BMS or Pfizer would like additional attendees or if Portola has concerns regarding BMS’ or Pfizer’s attendance at any such meeting, the Parties may raise their concerns for discussion to the JCC (without the [*], and without [*]).
(e) Each Party may [*] in [*] and [*] for [*] without the consent of the other Party.
ARTICLE 7
(a) Within [*] subsequent to the Effective Date, BMS shall pay to Portola a one-time fee of [*], which amount shall be non-refundable.
(b) Within [*] subsequent to [*], BMS shall pay to Portola [*].
(c) The payments set forth in clauses (a) and (b) above shall be the full extent of any payments to be made by BMS or Pfizer in consideration of this Agreement, and any costs associated with any preclinical studies required by Regulatory Authorities that are not contemplated in the appended Development Plan shall be funded solely by Portola.
(d) Pfizer shall reimburse BMS for its portion of the fees described in clauses (a) and (b) above pursuant to the BMS/Pfizer Agreement, with the timing and manner of such reimbursement being determined by the JFC (as defined in the BMS/Pfizer Agreement).
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the JCC assigns to BMS or Pfizer responsibility for certain Studies, and BMS or Pfizer (as applicable) agrees to perform such Studies, such work shall be conducted by BMS or Pfizer at its own expense except that Portola shall provide BMS or Pfizer (as applicable), [*], with all the PRT064445 that is required to complete such Studies.
ARTICLE 8
8.1 Disclosure and Ownership of Inventions
(c) BMS Inventions. BMS shall solely own all Inventions that [*] (“BMS Inventions”). To the extent any BMS Invention is made by Portola, whether solely or jointly with BMS, Portola shall, and hereby does, transfer and assign to BMS, without additional consideration, all of Portola’s interest in such BMS Invention, which transfer and assignment BMS hereby accepts. Portola shall execute and deliver to BMS a deed(s) of such assignment, in a mutually agreeable form and will take whatever actions reasonably necessary, including the appointment of BMS as its attorney in fact solely to make such assignment, to effect such assignment.
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any jurisdiction throughout the world, without the duty of accounting or an obligation to seek consent from the other Party.
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Applicable Law (or any amendment or successor statute thereto) in any country or regulatory jurisdiction in the Territory, until no later than [*] prior to the expiration date for filing an Action in response to such certification, to elect to so enforce the Joint Patents or to pursue a settlement or otherwise secure the abatement of such infringement. If [*] elects not to commence an Action to enforce such Joint Patents (or claim within such Joint Patent that [*]) or to settle or otherwise secure the abatement of such infringement within such time period, or if [*] fails to commence an Action to enforce such Joint Patents or claim) or to settle or otherwise secure the abatement of such infringement within [*], then [*] shall have the right, but not the obligation, to commence an Action to enforce such Joint Patents (or claim) against such infringement. The enforcing Party of any Joint Patents (or claim) shall keep the other Party reasonably informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts. At the request of the enforcing Party, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own cost and expense, but shall at all times cooperate fully with the enforcing Party. In connection with any such proceeding, the enforcing Party shall not enter into any settlement admitting the invalidity of, or otherwise impairing the other Party’s rights in, the Joint Patents (or claim) without the prior written consent of the other Party. The enforcing Party shall be solely responsible for any expenses incurred by such Party as a result of such Action. If the enforcing Party recovers monetary damages in such Action, such recovery shall be allocated first to the reimbursement of the expenses incurred by the Parties in such Action, and any remaining amounts shall be shared between the Parties in proportion to its economic interests.
ARTICLE 9
(a) Except to the extent expressly authorized in this Article 9, or as otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of [*] thereafter, it shall (x) not use the disclosing Party’s Confidential Information for the [*] or [*]; or for any other purpose except as expressly provided for in this Agreement ; (y) treat the disclosing Party’s Confidential Information with the same degree of care the receiving Party uses to its own confidential information but in no event with less than a reasonable degree of care; and (z) reproduce the disclosing Party’s Confidential Information solely to the extent necessary to
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[*] = 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 406 of the Securities Act of 1933, as amended.
accomplish the receiving Party’s obligations under this Agreement, with all such reproductions being considered the disclosing Party’s Confidential Information.
(b) Notwithstanding anything to the contrary in this Section 9.1, the receiving Party may disclose the disclosing Party’s Confidential Information to its employees, consultants or agents on a need-to-know basis for the purpose of fulfilling the receiving Party’s obligations under this Agreement; provided, however, that (i) any such employees, consultants or agents are bound by written obligations of confidentiality at least as restrictive as those set forth in this Agreement, and (ii) the receiving Party remains liable for the compliance of such employees, consultants or agents with such obligations.
(c) Each receiving Party acknowledges that in connection with its and its representatives’ examination of the Confidential Information of the disclosing Party, the receiving Party and its representatives may have access to material, non-public information, and that the receiving Party is aware, and will advise its representatives who are informed as to the matters that are the subject of this Agreement, that state and federal laws impose restrictions on the dissemination of such information and trading in securities when in possession of such information. Each receiving Party agrees that it will not, and will advise its representatives who are informed as to the matters that are the subject of this Agreement to not, purchase or sell any security of the disclosing Party on the basis of the Confidential Information to the extent such Confidential Information constitutes material non-public information about the disclosing Party or such security.
(a) is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;
(b) is in the public domain or is publicly known by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain or becomes publicly known through no fault of the receiving Party;
(c) is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
(d) is developed by the receiving Party independently and without use of or reference to any Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.
18
[*] = 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 406 of the Securities Act of 1933, as amended.
(a) such disclosure: (i) is reasonably necessary for filing or prosecuting Patent Rights as contemplated by this Agreement; (ii) is reasonably necessary in connection with [*] or [*], or [*], is reasonably necessary for the [*]; (iii) is reasonably necessary for prosecuting or defending litigation as contemplated by this Agreement; or (iv) is made to any Third Party bound by written obligation of confidentiality and non-use similar to those set forth under this Article 9, to the extent otherwise necessary or appropriate in connection with the exercise of its rights or the performance of its obligations hereunder;
(b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants or financial advisors to provide advice to the receiving Party, provided that in each such case on the condition that such directors, attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations substantially consistent with those contained in this Agreement; provided, however, that the term of confidentiality for such directors, attorneys, independent accountants and financial advisors shall be no less than [*] from the date of disclosure; or (ii) to actual or potential investors, lenders, financing sources, investment bankers and/or acquirors solely for the purpose of evaluating an actual or potential investment, financing or acquisition; provided that in each such case on the condition that such actual or potential investors, lenders, financing sources, investment bankers and/or acquirers are bound by confidentiality and non-use obligations substantially consistent with those contained in the Agreement; provided, however, that the term of confidentiality for such investors, lenders, financing sources, investment bankers and/or acquirors shall be no less than [*] from the date of disclosure; or
(c) such disclosure is required by judicial or administrative process, provided that in such event, to the extent permitted, such Party shall promptly inform the other Party of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 8, and the Party disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order to ensure the continued confidential treatment of such Confidential Information.
19
[*] = 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 406 of the Securities Act of 1933, as amended.
publication. In addition, the Party seeking publication shall delay the submission for a period up to [*] in the event that the other Party determines that the proposed publication contains or may contain patentable subject matter, so that the other Party may draft and file patent applications directed to such subject matter. If the other Party fails to provide its comments to the Party seeking publication within such [*] period, such other Party shall be deemed to not have any comments, and the Party seeking publication shall be free to publish such proposed publication after the [*] period has elapsed. The Party seeking publication shall provide the other Party a copy of the publication at the time of the submission. Each Party agrees to acknowledge the contributions of the other Party and its employees in all publications as scientifically appropriate. If any Party engages any Third Party contractors or collaborators in the conduct of the Studies hereunder, such Party shall ensure that such Third Party contractors and collaborators (including academic collaborators) are bound by the procedure set forth in this Section 9.4 with respect to any publication relating to the Studies. Notwithstanding the foregoing, but subject to the review periods set forth above, (a) [*] shall [*] to [*] of the [*] of the [*] pursuant to the [*] set forth in the [*], (b) in the event that [*] any [*] set forth in [*] in the [*], such [*] shall [*] to [*] by such [*], and in each case of (a) and (b), [*] shall [*] to [*] or [*]. [*] shall [*] for the [*] (if such [*]) other than [*] specified on Schedule 9.4 without [*].
(a) A Party may disclose this Agreement and its terms in securities filings with the Securities Exchange Commission (“SEC”) (or equivalent foreign agency) to the extent required by Applicable Laws after complying with the procedure set forth in this Section 9.5. In such event, the Party seeking such disclosure will prepare a draft confidential treatment request and proposed redacted version of this Agreement to request confidential treatment for this Agreement, and the other Party agrees to promptly (and in any event, no less than [*] after receipt of such confidential treatment request and proposed redactions, or such shorter period of time to permit the Party seeking such disclosure to comply with Applicable Laws) give its input in a reasonable manner in order to allow the Party seeking disclosure to file its request within the time lines proscribed by Applicable Laws and regulations. The Party seeking such disclosure shall exercise reasonable efforts to obtain confidential treatment of the Agreement as represented by the redacted version reviewed by the other Party.
(b) Further, each Party acknowledges that the other Party may be legally required to make public disclosures (including in filings with the SEC or other agency) of certain material developments or material information generated under this Agreement and agrees that each Party may make such disclosures as required by Applicable Laws, provided that, to the extent permitted, the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure, and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with Applicable Laws or regulations) if the other Party demonstrates to the reasonable satisfaction of the Party seeking
20
[*] = 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 406 of the Securities Act of 1933, as amended.
disclosure, within [*] (or such shorter period of time to permit the Party seeking such disclosure to comply with Applicable Laws) of such Party’s providing the copy, that the public disclosure of previously undisclosed information will materially adversely affect the development and/or commercialization of PRT064445 or Apixaban, the Party seeking disclosure will remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed.
(c) If any Party desires to issue a press release or make a public announcement concerning the material terms of this Agreement or material developments or material information generated under this Agreement, including announcing the commencement of the Studies and the publication of data and results of the Studies in accordance with Section 9.5, such Party shall, no later than [*] prior to the anticipated date of any such announcement, provide the other Party with the proposed text of such announcement for prior review and approval by such other Party, such approval not to be unreasonably withheld or delayed. The Parties shall agree on language of a joint press release announcing the execution of this Agreement, which shall be issued by the Parties on a mutually agreed date not later than the first patient dosing in the Clinical Trial.
(d) The Parties agree that after a disclosure pursuant to subsection (b) or a press release pursuant to subsection (c) hereof has been reviewed and approved by the other Party, the disclosing Party may make subsequent public disclosures or issue a press release disclosing the same content without having to obtain the other Party’s prior consent and approval; provided such information remains accurate as of such time.
ARTICLE 10
(a) Termination by BMS or Pfizer.
(i) For Inability to Agree on [*] that is [*]. In the event that [*], which [*] is [*], and the Parties cannot reach agreement with respect to [*], this Agreement may
21
[*] = 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 406 of the Securities Act of 1933, as amended.
be terminated by BMS or Pfizer by providing written notice of termination to Portola (which termination will be effective immediately);
(ii) For Convenience [*]. This Agreement may be terminated by BMS or Pfizer [*] at its sole discretion and for any reason or no reason, by providing written notice of termination to Portola, which notice includes an effective date of termination at least [*] after the date of the notice; provided that in such event, no payment shall be due and payable to Portola pursuant to Section 7.1(b) if the [*] prior to Portola’s receipt of such written notice of termination or where such payment would otherwise accrue subsequent to the date of such notice (i.e. during the [*] subsequent to such notice but prior to the effective date of such termination);
(iv) For [*]. This Agreement may be terminated by [*] immediately, by providing written notice of termination to [*], upon a [*]. For the purpose of this Agreement, a “[*]” means (1) [*] that is [*], (b) [*] that is [*] or [*] or (c) [*] that is [*] or [*]; provided, however, that a [*] shall not include any [*], or [*], or [*]; provided, further, that a [*] shall not include any [*]r or [*].
(b) Termination by Either Party.
22
[*] = 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 406 of the Securities Act of 1933, as amended.
termination to the other Party, if there is a material safety issue identified with respect to PRT064445 or when used as an antidote to Apixaban.
ARTICLE 11
REPRESENTATIONS AND WARRANTIES AND COVENANTS
(a) it has the full right, power and authority and the legal right to enter into this Agreement, to perform its obligations hereunder;
(b) this Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms (subject to the general principles of equity and to bankruptcy, insolvency, moratorium and other similar Applicable Laws affecting the enforcement of creditors’ rights generally), and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; and
(c) it has communicated to the other Party any written notices from Third Parties to the effect that the use or sale of PRT064445 infringes the intellectual property rights of any Third Party.
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[*] = 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 406 of the Securities Act of 1933, as amended.
ARTICLE 12
(a) the negligence or willful misconduct of any of the Portola Indemnitees;
(b) any breach of this Agreement by Portola; or
(c) the development, distribution, transfer, handling, use, administration, manufacture, storage or other exploitation of PRT064445;
24
[*] = 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 406 of the Securities Act of 1933, as amended.
except in each case, to the extent such Claims result from the negligence or willful misconduct of any BMS/Pfizer Indemnitees or any breach of this Agreement by BMS or Pfizer.
(a) the negligence or willful misconduct of any of the BMS/Pfizer Indemnitees;
(b) the breach of this Agreement by BMS or Pfizer; or
(c) the development, distribution, transfer, handling, use, administration, manufacture, storage or other exploitation of Apixaban;
except in each case, to the extent such Claims result from the negligence or willful misconduct of any Portola Indemnitees or any breach of this Agreement by Portola.
25
[*] = 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 406 of the Securities Act of 1933, as amended.
ARTICLE 13
26
[*] = 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 406 of the Securities Act of 1933, as amended.
If to Portola:
Portola Pharmaceuticals, Inc.
000 Xxxx Xxxxx Xxxxxx, Xxxxx 00
Xxxxx Xxx Xxxxxxxxx, XX 00000
Attn: Chief Executive Officer
Fax: (000) 000-0000
with a copy to:
Xxxxxx LLP
0000 Xxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Esq.
Fax: (000) 000-0000
If to BMS:
Xxxxxxx-Xxxxx Squibb Company
Xxxxx 000 & Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx, XX 00000
Attn: Vice President, Business Development
Fax: 000-000-0000
with a copy to:
Xxxxxxx-Xxxxx Squibb Company
Xxxxx 000 & Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx, XX 00000
Attn: Vice President and Asst. General Counsel, Business Development
Fax: 000-000-0000
If to Pfizer:
Pfizer Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
Attention: Senior Vice President and Associate General Counsel,
Business Transactions
Fax: 0-000-000-0000
with a copy to:
Pfizer Inc.
000 Xxxx 00xx Xxxxxx
00
[*] = 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 406 of the Securities Act of 1933, as amended.
Xxx Xxxx, Xxx Xxxx 00000-0000
Attention: General Counsel
Fax: 0-000-000-0000
or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a business day (or if delivered or sent on a non-business day, then on the next business day); (b) on the business day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth (5th) business day following the date of mailing, if sent by mail.
13.5 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws.
(a) The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim arising from or related to this Agreement or the breach thereof, in accordance with this Agreement or otherwise in good faith. If the Parties do not so fully settle, and a Party wishes to pursue the matter, each such dispute, controversy or claim that is not promptly resolved that is not an Excluded Claim (defined in Section 13.6(f) below), such dispute, controversy or claim shall be finally resolved by binding arbitration administered by JAMS pursuant to JAMS’ Streamlined Arbitration Rules and Procedures then in effect (the “JAMS Rules”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof.
(b) The arbitration shall be conducted by a panel of three (3) persons experienced in the pharmaceutical business: within [*] after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within [*] of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by JAMS. The place of arbitration shall be [*], and all proceedings and communications shall be in English.
(c) Any Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Any Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages, except as provided in Section 13.6. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration.
(d) Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable New York statute of limitations.
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[*] = 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 406 of the Securities Act of 1933, as amended.
(e) The Parties agree that, in the event of a dispute over the nature or quality of performance under this Agreement, no Party may terminate this Agreement until final resolution of the dispute through arbitration or other judicial determination. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be refunded if an arbitrator or court determines that such payments are not due.
(f) As used in this Section, the term “Excluded Claim” means a dispute, controversy or claim that concerns (a) the scope, validity, enforceability, inventorship or infringement of a patent, patent application, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory. Excluded Claims shall be determined by a court of competent jurisdiction.
29
[*] = 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 406 of the Securities Act of 1933, as amended.
Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
13.13 Business Day Requirements. In the event that any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a business day then such notice or other action or omission shall be deemed to required to be taken on the next occurring business day. “[B][b]usiness [D][d]ay” means a day other than Saturday or Sunday on which the banks in San Francisco, California and New York City, New York are open for business.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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[*] = 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 406 of the Securities Act of 1933, as amended.
Xxxxxxx-Xxxxx Squibb Company | Portola Pharmaceuticals, Inc. | |||||||
By: | /s/ Xxxxxx X. Xxxxxxx | By: | /s/ Xxxxxxx Xxx | |||||
Name: | Xxxxxx X. Xxxxxxx | Name: | Xxxxxxx Xxx | |||||
Title: | Vice President | Title: | C.E.O. | |||||
Strategic Transaction Group | ||||||||
Pfizer Inc. | ||||||||
By: | /s/ Xxxxxx X. Xxxxxx, MD | |||||||
Name: | Xxxxxx X. Xxxxxx, MD | |||||||
Title: | SVP, Head Medicines Development Group Primary Care, Pfizer |
[SIGNATURE PAGE OF THE CLINICAL COLLABORATION AGREEMENT BY AND AMONG
PORTOLA PHARMACEUTICALS, INC., XXXXXXX-XXXXX SQUIBB COMPANY AND PFIZER, INC.]
[*] = 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 406 of the Securities Act of 1933, as amended.
List of Schedules and Exhibits
Schedule 1.2 | Chemical structure of Apixaban | |
Schedule 1.29 | Chemical structure of PRT064445 | |
Schedule 9.4 | [*] | |
Exhibit A | Initial Development Plan |
[*] = 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 406 of the Securities Act of 1933, as amended.
Schedule 1.2 | Chemical structure of Apixaban | |
[*] |
[*] = 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 406 of the Securities Act of 1933, as amended.
Schedule 1.29 | Chemical structure of PRT064445 | |
[*] |
[*] = 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 406 of the Securities Act of 1933, as amended.
Schedule 9.4
[*]
[*] = 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 406 of the Securities Act of 1933, as amended.
Exhibit A | Initial Development Plan | |
[*] |
[*] = 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 406 of the Securities Act of 1933, as amended.