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AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT

Collaboration Agreement

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT | Document Parties: Cytokinetics, Inc | Glaxo Group Limited You are currently viewing:
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Cytokinetics, Inc | Glaxo Group Limited

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Title: AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
Date: 11/27/2006

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT, Parties: cytokinetics  inc , glaxo group limited
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Exhibit 10.67

Execution Version
Confidential

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT

     This Amendment to Collaboration and License Agreement (the " Amendment "), effective as of November 27, 2006, 5 p.m. Eastern Standard Time (the " Amendment Effective Date "), is made by and between Cytokinetics, Inc., a Delaware corporation (" CK ") and Glaxo Group Limited, a United Kingdom corporation (" GSK ") (each a " Party ;" together the " Parties ").

BACKGROUND

     A. CK and GSK have entered into that certain Collaboration and License Agreement by and between the Parties dated June 20, 2001, as amended (the " Agreement "); and

     B. The Parties wish to further amend the Agreement in order to modify the rights and obligations of the Parties under the Agreement, all on the terms and conditions set forth below.

     NOW, THEREFORE, for and in consideration of the covenants, conditions and undertakings hereinafter set forth, the Parties agree to amend the Agreement as follows:

     1.  Definitions . As used in this Amendment, the following terms shall have the indicated meanings:

          (a) Terms from the Agreement . All capitalized terms not defined herein shall have the meaning ascribed to them in the Agreement, except to the extent otherwise expressly set forth in this Amendment.

          (b) " Additional Indication " shall mean any indication, dosing schedule or combination regimen for a KSP Product that is determined from or evaluated in connection with the conduct of the CK Clinical Studies, other than an Enhanced Indication.

          (c) " Assigned Patents " shall mean all Patents (including GSK and its Affiliates’ interest in jointly owned Patents) that claim any CK Target, CK Compound and/or CK Product (including any target, compound and/or product that was a Collaboration Target, Development Compound or Licensed Product prior to the Amendment Effective Date) or that claim the development, composition, making, use or any portion thereof, in each case to the extent that the claimed subject matter of which was conceived or created by or under authority of GSK or any of its Affiliates; and all related documentation. Without limiting the foregoing, the Assigned Patents include, to the extent claiming the subject matter described in the previous sentence: (i) all Patents related to KSP, any Compound inhibiting KSP, or any KSP Product (including SB-992 or SB-921), and (ii) all Patents which claim subject matter that is or was (A) identified as reasonably necessary for the discovery, development, manufacture, use or sale of any CK Compound, CK Target or CK Product (including any compound, target or product that was a Compound, Development Compound, Collaboration Target, or Licensed Product prior to the Amendment Effective Date), (B) used or applied by or under authority of GSK or its Affiliate at least in part to any CK Compound, CK Product or CK Target, each as contemplated in Section 1.32 of the Agreement, or (iii) within the scope of Section 1.13 or 1.53 of the Agreement. The

 

 

 

Assigned Patents existing as of the Amendment Effective Date include those Patents set forth in Appendix IV attached hereto and incorporated herein. Notwithstanding the foregoing, Assigned Patents shall not include any Patents that claim CENP-E or any Compound, Development Compound or Licensed Product being developed by GSK that inhibits CENP-E, including, without limitation, GSK’s Development Compound, GSK-923295.

          (d) " CK Clinical Studies " shall mean clinical studies for a KSP Product conducted by or on behalf of CK, including such non-clinical studies as CK determines are [***] to support such clinical studies.

          (e) " Enhanced Indication " shall mean any indication, dosing schedule or combination regimen for a KSP Product that (i) was evaluated in a Phase [***] trial conducted by or on behalf of GSK prior to the Amendment Effective Date and (ii) is further evaluated in connection with the conduct of the CK Clinical Studies.

          (f) " Final Study Report " shall have the meaning ascribed in Appendix I hereto.

          (g) " GSK Option " shall have the meaning set forth in Section 18 of this Amendment.

          (h) " GSK-Ongoing Study " shall have the meaning set forth in Section 8(a) of this Amendment.

          (i) " GSK-Sponsored Studies " shall mean all clinical studies that have been sponsored by GSK or any of its Affiliates in connection with the Agreement, or otherwise in respect to SB-921 and/or SB-992, that were initiated by or under authority of GSK or its Affiliates prior to the Amendment Effective Date.

          (j) " June 2006 Amendment " shall mean the letter amendment to the Agreement, dated June 16, 2006, that was entered into by and between CK and GSK.

          (k) " KSP Product " shall mean any CK Product that includes a CK Compound that meets the Compound Criteria for KSP (including any CK Product that includes SB-921 or SB-992).

          (l) " [***] " shall mean any [***] that uses an inhibitor of a CK Target for [***] applications, including [***].

          (m) " Optioned Product(s) " shall have the meaning set forth in Section 18(c) of this Amendment.

          (n) " September 2005 Amendment " shall mean that certain Amendment to Collaboration and License Agreement, dated September 21, 2005 that was entered into by and between CK and GSK.

          (o) " SB-921 " shall mean the Development Compound designated by GSK as SB-743921.

 

     

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          (p) " SB-921 Product " means a KSP Product incorporating SB-921.

          (q) " SB-992 " shall mean the Development Compound designated by GSK SB-715992 and also known as ispinesib .

          (r) " SB-992 Product " means a KSP Product incorporating SB-992.

          (s) " SB-992 [***] " shall have the meaning set forth in Section 11 of this Amendment.

          (t) " Third Party-Sponsored Study(ies) " shall have the meaning set forth in Section 8(e) of this Amendment.

     2.  Designation of Mitotic Kinesin Targets as CK Targets . Notwithstanding anything to the contrary in the Agreement, all Mitotic Kinesin Targets (including all Mitotic Kinesin Targets previously designated as Collaboration Targets, i.e., KSP, [***] and [***]) are hereby deemed, and shall be deemed, to be CK Targets under the Agreement, with the sole exception of CENP-E. The Mitotic Kinesin Targets (including previous Collaboration Targets) designated as CK Targets as of the Amendment Effective Date are set forth in Appendix V of this Amendment, attached hereto and incorporated herein. Except as expressly provided to the contrary in this Amendment, the terms and conditions of the Agreement shall apply to all CK Targets designated as such under this Section 2 in the same manner as if the Mitotic Kinesin Targets each became a CK Target under Section 2.7 of the Agreement.

     3.  Designation of CK Compounds . The Parties hereby designate, and CK shall hereafter designate, all Compounds that meet the Compound Criteria with respect to any CK Target as CK Compounds, including all such Compounds previously designated as Development Compounds against such CK Targets (i.e., SB-921 and SB-992) and including all Compounds that meet the requirements of Section 1.5(a) of the Agreement.

     4.  Collaboration Targets; CENP-E; Unselected Targets . The Mitotic Kinesin Target CENP-E remains a Collaboration Target and a Lead Target under the Agreement as of the Amendment Effective Date and shall be subject to all of the terms and conditions of the Agreement and this Amendment, including those that may cause CENP-E to become a CK Target. No Mitotic Kinesin Target shall at any time be considered a Collaboration Target or Lead Target, except for CENP-E and, if GSK exercises the GSK Option in accordance with this Amendment, KSP. No target shall be considered an Unselected Target at any time.

5. Research Program.

          (a) Research Term . The terms of the June 2006 Amendment which provide that the Research Term is extended only with regard to CENP-E shall be interpreted to mean that the Research Term shall be extended until June 19, 2007 for all purposes under the Agreement, except that the scope of the ongoing Research Program is and shall be restricted only to the Collaboration Target, CENP-E, as more particularly set forth in this Amendment. The Research Term for CENP-E shall be considered for all purposes under the Agreement to end on June 19, 2007, unless further extended under Section 2.8 of the Agreement, but in all cases subject to the terms and conditions of the Agreement and this Amendment. Notwithstanding the foregoing, (i)

 

     

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the Exclusivity Period under Section 4.1.1 for Compounds, Development Compounds and Licensed Products directed to CK Targets other than CENP-E shall end on [***], subject to Section 24 below with regard to KSP and SB-992 and SB-921; and (ii) the Exclusivity Period under Section 4.1.2 with respect to all Mitotic Kinesin Targets other than KSP and CENP-E shall end on [***], subject to Section 24 below.

          (b) Limited Scope . Notwithstanding the extension of the Research Term for CENP-E as described in Section 5(a) of this Amendment, the Research Program ended as of June 19, 2006 with respect to, and shall exclude, all Mitotic Kinesin Targets, other than CENP-E. Notwithstanding anything to the contrary, there shall be no extensions of the Research Program under the terms of the Agreement, as amended by this Amendment, other than for CENP-E.

     6.  Independent Development by CK . Notwithstanding anything else to the contrary in the Agreement, CK shall have the exclusive right to control, at its sole discretion and expense, all further research, development, manufacturing, and commercialization of the CK Targets, CK Compounds and CK Products (including KSP Products) (itself and through Third Parties) without further obligation to GSK, except subject to (i) the GSK Option set forth in this Amendment and (ii) the obligation to pay royalties to GSK pursuant to Section 4.7 of the Agreement on CK Products, including KSP Products. Accordingly, all references in the September 2005 Amendment to the CK Subfield, and any other limitations in the Agreement on research, development, manufacture or commercialization by CK (itself or through Third Parties) of CK Targets, CK Compounds and CK Products are hereby terminated and deleted. Such research, development, manufacture and commercialization by and under authority of CK shall not be considered part of, and shall not be subject to the terms and conditions applicable to, the collaboration under the Agreement, except pursuant to the GSK Option. For purposes of this Section 6 and the other terms of the Agreement, the term "CK Product" shall be deemed to include [***] that include a CK Compound.

     7.  Joint Development Committee .

          (a) The JDC established pursuant to Section 2.1.1 of the September 2005 Amendment is hereby dissolved. Sections 2.1.1 and 2.1.2 of the September 2005 Amendment are hereby deleted from the Agreement, and shall have no further force or effect, provided that CK shall provide quarterly updates relating to SB-921 Products and SB-992 Products through the Project Team for GSK-923295, or to another team of individuals designated by GSK with similar functional responsibilities, unless and until the GSK Option expires.

          (b) If GSK exercises the GSK Option: (i) unless the JDC has previously been established for CENP-E in accordance with the terms of Section 3.5 of the Agreement, the Parties shall establish the JDC for the Optioned Products, (ii) with respect to Optioned Products, the JDC shall have the rights, responsibilities and obligations as set forth in Section 2.1.1 of the September 2005 Amendment; (iii) [***] shall have the right to [***] on all matters relating to any [***] for an Optioned Product or otherwise relating to the [***] or [***] of any Optioned Product for any [***]; (iii) [***] shall have the right to [***] on matters relating to the [***] or [***] of Optioned Products for any [***]; and (iv) [***] shall have the right to [***] on matters relating to the [***] or [***]of Optioned Products for any [***] other than [***] or [***]. This

 

     

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Section 7(b) shall not modify the operation of Section 3.5 of the Agreement with regard to CENP-E.

     8.  GSK-Sponsored Studies; Third Party-Sponsored Studies .

          (a) GSK shall not [***], and represents and warrants that it has not [***], any [***] in any study for SB-992 or SB-921 [***], including those studies for SB-992 and SB-921 that were ongoing as of [***] (each, a " GSK-Ongoing Study "). After the Amendment Effective Date, GSK shall keep CK fully and promptly informed regarding the progress and results of the GSK-Ongoing Studies. After the Amendment Effective Date, GSK shall provide CK with copies of any [***] from [***] regarding any GSK-Ongoing Study promptly upon receipt. GSK shall use [***] efforts to complete the GSK-Ongoing Studies and the collection of data and Final Study Report for each such GSK-Ongoing Study.

          (b) GSK shall continue to maintain the IND for SB-992 and SB-921 (i.e., IND [***] with an initial filing date of [***] for SB-992 and IND [***] with an initial filing date of [***] for SB-921) until each such IND is transferred to CK as set forth herein. GSK shall use [***] efforts to complete and file the Annual Report for IND [***] in accordance with the timings as required by law for filing of such Annual Report. After GSK files the Annual Report for IND [***] due following the Amendment Effective Date, GSK shall transfer IND [***] and IND [***] to CK. Prior to transfer of each IND, GSK shall allow, and hereby authorizes, CK to cross reference such IND. Concurrent with its [***] for IND [***] to [***], GSK shall provide [***] thereof to CK.

          (c) After the Amendment Effective Date, GSK agrees to complete the Final Study Reports for the GSK-Ongoing Studies for SB-992 and SB-921 within [***] ([***]) [***] following [***] for the relevant GSK-Ongoing Study. If all data from the GSK-Ongoing Study for SB-921 has been collected by GSK and the Final Study Report for such study completed prior to the date that GSK transfers IND [***] to CK, GSK shall file the Final Study Report for such study with the FDA. If such Final Study Report is not completed before the transfer of IND [***], GSK shall complete the Final Study Report and submit it to CK for filing with the FDA. GSK shall complete the Final Study Reports for the GSK-Ongoing Studies for SB-992 and submit it to CK for filing with the FDA. Prior to finalization of each Final Study Report for the GSK-Ongoing Studies, GSK shall provide CK with [***] and provide CK [***] thereon; provided, however, that GSK shall have [***] in finalizing any Final Study Report. After transfer of the INDs for SB-992 and SB-921 to CK, CK shall have responsibility for such INDs, shall file the Annual Report for IND [***] with the FDA and shall undertake and fulfill all obligations imposed on holders of INDs under law with respect to IND [***] and IND [***], including filing all reports that may be due in connection with such INDs, other than as set forth above.

          (d) After the Amendment Effective Date, GSK shall complete and publish manuscripts for GSK-Sponsored Studies, [***], [***] after the Amendment Effective Date; provided, however, that GSK shall not publish any manuscript until after CK has had [***] to review and comment on the manuscript. GSK shall [***] CK’s [***] with respect thereto, consistent with prior practice between GSK and CK regarding publication of manuscripts for SB-992 and SB-921.

 

     

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          (e) After the Amendment Effective Date, GSK and its Affiliates shall not conduct or have conducted under their respective authority any clinical activities with regard to SB-992 or SB-921, other than GSK’s activities in accordance with the foregoing for SB-992 and SB-921 under the GSK-Ongoing Studies.

           (f) After the Amendment Effective Date, CK shall be responsible, at its expense, for providing any materials or services (e.g., [***], [***], [***], [***] or [***], etc.) to Third Parties to the extent required by the terms of any Third Party Agreements that GSK assigns to CK pursuant to this Amendment, in each case to the extent necessary to enable such Third Parties to complete their studies with respect to SB-992 or SB-921, as applicable (the " Third Party-Sponsored Studies "). For clarity, CK does not assume any responsibility, liability, or other Losses arising out of any activities or obligations in connection with such Third Party-Sponsored Studies or Third Party Agreements to the extent that the activities occurred, or if the obligation matured, prior to the time at which the particular agreement is assigned to CK, including Losses arising out of any failure to comply with any Third Party Agreements that occurred prior to the date of assignment of the particular Third Party Agreement to CK, except to the extent CK would have had responsibility therefor prior to such assignment. All such Losses shall be within the scope of GSK’s obligation to indemnify, defend and hold harmless under Section 10.2.1 of the Agreement. Similarly, to the extent of CK’s obligation to indemnify under Section 10.2.2 of the Agreement, CK shall remain obligated to indemnify GSK with respect to activities under the Third Party Agreements that occur after the Third Party Agreement has been assigned to CK after the Amendment Effective Date. CK shall have no responsibility for any materials or services which GSK was required, but failed, to provide prior to the Amendment Effective Date under such Third Party Agreements. GSK shall retain responsibility for providing such materials and services.

     9.  Transition and Information Exchange .

          (a) Section 4.4.2 of the Agreement shall continue to apply with respect to all CK Targets, CK Compounds and CK Products, including the KSP Products. Without limiting the foregoing, as set forth in Section 4.4.2 of the Agreement, commencing upon the Amendment Effective Date with respect to all CK Targets, CK Compounds and CK Products designated as such under this Amendment, GSK shall cooperate fully with CK to provide CK with all Licensed Technology and Information to which CK has a right or license under the Agreement and which is necessary or useful for CK to further research, develop, produce or otherwise exploit any such CK Target, CK Compound, or CK Product. Such cooperation shall include (i) the reasonable disclosure of all such Information, to the extent such Information is not within the possession or control of CK (including, without limitation, [***] (including with respect to the [***])); (ii) transfer of [***] and [***] of [***] and [***] (to the extent such [***] were [***], or [***], by GSK with respect to the CK Compound or CK Product and excluding the GSK [***] and [***] with other products); (iii) [***] (including transfer of the [***] for the [***] in accordance with Section [***] of this Amendment); (iv) transfer of [***], and [***] such materials were [***] by GSK with respect to CK Compounds, CK Products or CK Targets; and (v) to the extent reasonably transferable and specifically developed or used in connection with any CK Product, CK Compound or CK Target, transfer of [***], all to the extent that such material is not in the possession of CK, and such other disclosures and transfers as are reasonably necessary or useful

 

     

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for CK to exercise its full rights with respect to such CK Product, CK Target or CK Compound granted to CK under the Agreement. In particular and without limiting the foregoing, GSK shall provide to CK the Information, materials and assistance described on Appendix I , attached hereto and incorporated herein, with respect to SB-992 and SB-921, to the extent such Information and materials (i) were not previously supplied to CK for SB-921 under the September 2005 Amendment, (ii) are not otherwise in the current possession of CK, and (iii) other than the Final Study Reports for the GSK-Ongoing Studies for SB-992 and SB-921, exist at the time of the Amendment Effective Date and are in GSK’s possession or control. All Information described in this Section 9(a) shall be delivered to CK after the Amendment Effective Date within [***] ([***]) [***] after CK’s written request, except to the extent that GSK has obtained CK’s written agreement to a longer period of time when delivery is not possible within such [***] ([***]) [***] period, such agreement not to be unreasonably withheld. Except as set forth in Section 8 of this Amendment, nothing in this Section or this Amendment shall obligate GSK to update or complete materials provided to CK under this Amendment.

          (b) Without limiting the foregoing, GSK shall also provide CK with such assistance as CK reasonably requests from time to time to assist CK in [***] and [***] the Information and materials provided by GSK.

          (c) In accordance with Section 4.4.2 of the Agreement, CK shall [***] GSK’s [***] with respect to all activities, materials and assistance provided by GSK to CK under Section 4.4.2 of the Agreement and this Section 9. GSK shall provide [***] to CK of such [***] after they are [***], which CK shall [***] within [***] of receipt of such [***] from GSK.

     10.  Generic and Brand Names . GSK shall transfer sponsorship and ownership to CK of all of GSK’s generic names and brand names for SB-992 and SB-921, including all goodwill associated therewith, promptly after the Amendment Effective Date, excluding GSK’s general corporate trade marks, trade dress and logo used for its products generally. CK shall have the right to use the numerical compound identifier originally designated by GSK for SB-992 and SB-921, that is, SB-715992 and SB-743921, for any CK Product.

 

     

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     11.  [***] of SB-992 .

          (a) GSK shall provide to CK, at GSK’s expense, the [***] of SB-992 [***] and [***] in GSK’s [***], including [***], as of the [***], excluding any [***] of SB-992 [***] by GSK for any [***] for SB-992 (the " SB-992 [***] "). GSK represents and warrants that, to its knowledge, the SB-992 [***] of [***] is [***], the SB-992 [***] of [***] is [***] in [***], and the SB-992 [***] of [***] is [***]. GSK represents and warrants, to its knowledge, that the SB-992 [***] also includes [***] of [***] which shall be [***] by GSK promptly following the Amendment Effective Date. GSK shall [***] the SB-992 [***] to CK’s [***] as soon as practicable following the Amendment Effective Date, but in no event later than [***] ([***]) [***] after the Amendment Effective Date.

          (b) CK shall be responsible, at its cost, for [***] and [***] (itself or through [***]) CK’s requirements for SB-992 [***] and [***] in [***] of the SB-992 [***] provided by GSK. GSK shall provide CK with such assistance, documentation, and Information as is reasonably requested by CK in connection with [***] the SB-992 [***] to CK and CK or [***] of SB-992 [***] and [***], including documentation, such as, but not limited to, [***]. CK shall be responsible, at its expense: (i) for any [***] of SB-992 [***] that [***], including [***] to GSK for [***] with respect to [***] under Section [***] of this Amendment to the extent set forth in Section 4.4.2 of the Agreement; and (ii) for [***] and [***] of [***] SB-992 [***] that have been [***] to CK under this Section 11.

          (c) To the extent Losses arise out of any [***] of the SB-992 [***] to [***] with [***], other [***] or [***], any [***], or other [***] to the [***], or [***] of the SB-992 [***] for [***] in [***] shall be deemed to be within the scope of GSK’s obligation to indemnify CK under Section 10.2.1 of the Agreement. CK shall be responsible for any Losses arising out of the [***] by CK or [***] of any SB-992 [***] and [***] in [***] of the SB-992 [***] and shall have no right to indemnity from GSK for such Losses under Section 10.2.1 of the Agreement.

     12.  [***] Studies . Subject to [***] by CK in accordance with Section 4.4.2 of the Agreement, GSK shall [***] studies for [***] of [***] and [***] of SB-921 and SB-992 and shall [***] to CK all [***] and [***] from time to time as such [***] become available and as CK otherwise requests.

 

     

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     13.  Third Party Agreements .

          (a) GSK represents and warrants to CK, as of the Amendment Effective Date and to its knowledge, that it has granted no right or license or interest to any Third Party under the Assigned Patents or other intellectual property rights of GSK prior to the Amendment Effective Date that would conflict or interfere with CK’s ability to develop and commercialize SB-992 or SB-921 after the Amendment Effective Date.

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