Limitations on Decision-Making. (a) Notwithstanding anything in Section 3.11 (Final Decision-Making Authority) or elsewhere in this Agreement, neither Party shall have the deciding vote on, and no Committee shall have decision-making authority regarding, any of the following matters: (i) creation of and amendments to the Global Brand Strategy and Global Medical Affairs Strategy for Licensed Products; (ii) creation of and amendments to the Development Plans (subject to Astellas’ final decision making authority with respect to [***] therefor pursuant to Section 3.11(b)(iii) (Final Decision-Making Authority)); (iii) the imposition of any requirement on the other Party to undertake obligations beyond those for which it is responsible under this Agreement, or to forgo any of its rights under this Agreement, including, without limitation, the imposition on the other Party of an obligation to engage in, pay for, or otherwise be financially responsible for, any obligations or activities that represent a material increase to those obligations and activities mutually agreed upon in the Clinical Development Plan and associated agreed-upon budget; (iv) the imposition of any requirements that the other Party takes or declines to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of any Third Party; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. (v) the resolution of any dispute involving the breach or alleged breach of this Agreement; (vi) the determination of whether the Parties will conduct any Joint Studies (other than those set forth in the Clinical Development Plan); (vii) the determination of whether a Party exerts Commercially Reasonable Efforts under this Agreement; (viii) any decision that is expressly stated to require the mutual agreement (or similar language) of a Committee or the Parties or the approval of the other Party (but not “approval” of a Committee); (ix) any matters that would excuse such Party from any of its obligations under this Agreement; or (x) modifying the terms of this Agreement or taking any action to expand or narrow the responsibilities of any Committee. (b) The decision-making Party shall make its decision in good faith, subject to the terms and conditions of this Agreement. (c) For clarity, approval by a Committee shall not be understood to mean approval by a Party.
Appears in 1 contract
Sources: License and Collaboration Agreement (Frequency Therapeutics, Inc.)
Limitations on Decision-Making. (a) Notwithstanding anything in Section 3.11 (Final Decision-Making Authority) or elsewhere in this Agreement, neither Neither Party shall have the deciding vote on, and no Committee shall have decision-making authority regarding, any of the following matters:
: (i) creation of and amendments to the Global Brand Strategy and Global Medical Affairs Strategy for Licensed Products;
(ii) creation of and amendments to the Development Plans (subject to Astellas’ final decision making authority with respect to [***] therefor pursuant to Section 3.11(b)(iii) (Final Decision-Making Authority));
(iii) the imposition of any requirement requirements on the other Party to undertake obligations beyond those for which it is responsible under this Agreementincreased costs or obligations, or to forgo any of its rights rights, under this Agreement, including, without limitation, the imposition on the other Party of an obligation to engage in, pay for, or otherwise be financially responsible for, any obligations or activities that represent a material increase to those obligations and activities mutually agreed upon in the Clinical Development Plan and associated agreed-upon budget;
; (ivii) the imposition of any requirements that the other Party takes or declines to take any action that would result in a violation of any Applicable Law or any agreement with any Third Party or the infringement of intellectual property rights of any Third Party; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(viii) the resolution of any a dispute involving the breach or alleged breach of this Agreement;
; (vi) the determination of whether the Parties will conduct any Joint Studies (other than those set forth in the Clinical Development Plan);
(viiiv) the determination of whether a Party Hutchmed Entity exerts Commercially Reasonable Efforts under this Agreement;
; (viiiv) any decision that is expressly stated to require the mutual agreement (or similar language) of a Committee or the Parties or the approval of the other Party (but not “approval” of a Committee);
; (ixvi) any matters that would excuse such Party from any of its obligations under under, or waive any term of, this Agreement; or
or (xvii) modifying the terms of this Agreement or taking any action to expand or narrow the responsibilities of any Committee. In no event may the decision-making Party unilaterally determine that it has fulfilled any obligations hereunder or that the non-deciding Party has breached any obligations hereunder. In no event may Hutchmed unilaterally determine that any events required for the payment of milestone payments have not occurred and in no event may Epizyme unilaterally determine that the events required for the payment of milestone payments have occurred.
(b) The In no event shall Hutchmed exercise its final decision-making Party shall make its decision in good faith, subject authority with respect to the terms and conditions Licensed Products in the Territory in a manner that Epizyme has notified Hutchmed (including through the applicable Committee or Subcommittee) is reasonably expected to have a material adverse effect on the Manufacturing, Development or Commercialization for any Licensed Product outside the Territory, or scope, validity or enforceability of this Agreement.
any Licensed IP. In no event shall Epizyme exercise its final decision-making authority with respect to the Licensed Products outside the Territory in a manner that Hutchmed has notified Epizyme (cincluding through the applicable Committee or Subcommittee) is reasonably expected to have a material adverse effect on the Development or Commercialization of any Licensed Product in the Territory. For clarity, approval by a Committee shall not be understood to mean approval by a Party.
Appears in 1 contract
Sources: License Agreement (Epizyme, Inc.)
Limitations on Decision-Making. (a) Notwithstanding anything in Section 3.11 (Final Decision-Making Authority) or elsewhere to the contrary set forth in this Agreement, neither Party shall have without the deciding vote onother Party’s prior written consent, and no Committee shall have decision-making authority regarding, any decision of the following JSC or a Party’s Executive Officer (in the exercise of a Party’s final decision‑making authority on any such matters:
), in each case, may (ia) creation of and amendments to the Global Brand Strategy and Global Medical Affairs Strategy for Licensed Products;
(ii) creation of and amendments to the Development Plans (subject to Astellas’ final decision making authority with respect to result in a [***] therefor pursuant to Section 3.11(b)(iii) (Final Decision-Making Authority));
(iii) the imposition of any requirement on in the other Party to undertake obligations beyond those for which it is responsible Party’s obligations, costs, or expenses under this Agreement, or any Global Development Plan or Territory-Specific Development Plan (including any budget set forth in a Global Development Plan or a Territory-Specific Development Plan), unless, in each case, such actions are necessary for Blueprint to forgo comply with Applicable Law as the Territory Sponsor or as the owner and holder of any of its rights under this AgreementRegulatory Submission, including, without limitation, the imposition on the other Party of an obligation to engage in, pay forRegulatory Approval, or otherwise be financially responsible forReimbursement Approval, any obligations or activities that represent as applicable, for a material increase to those obligations and activities mutually agreed upon Collaboration Product in the Clinical Development Plan and associated agreed-upon budget;
Territory, (ivb) the imposition of any requirements that the other Party takes take or declines decline to take any action that would [***] result in a violation of any Law Applicable Law, the requirements of any Regulatory Authority, or any agreement with any Third Party (including any agreement pursuant to which Blueprint Controls any Blueprint Technology or CStone Controls any CStone Product Technology or CStone General Collaboration Technology) or would [***] result in the infringement or misappropriation of intellectual property rights of any Third Party; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(v) the resolution of any dispute involving the breach or alleged breach of this Agreement;
(vi) the determination of whether the Parties will conduct any Joint Studies (other than those set forth in the Clinical Development Plan);
(vii) the determination of whether a Party exerts Commercially Reasonable Efforts under this Agreement;
(viii) any decision that is expressly stated to require the mutual agreement (or similar language) of a Committee or the Parties or the approval of the other Party (but not “approval” of a Committee);
(ix) any matters that would excuse such Party from any of its obligations under this Agreement; or
(x) modifying the terms of this Agreement or taking any action to expand or narrow the responsibilities of any Committee.
(b) The decision-making Party shall make its decision in good faith, subject to the terms and conditions of this Agreement.
(c) For clarityimpose any obligation on either Party that would be in violation of such Party’s written standard operating procedures, approval by a Committee shall not be understood written business policies, or written compliance policies or procedures, or (d) conflict with this Agreement, any Clinical Supply Agreement, any Commercial Supply Agreement, any Safety Agreement, or any other agreement between the Parties related to mean approval by a Partythe subject matter set forth herein.
Appears in 1 contract
Sources: License and Collaboration Agreement (Blueprint Medicines Corp)
Limitations on Decision-Making. (a) Notwithstanding anything in Section 3.11 (Final Decision-Making Authority) or elsewhere in this Agreement, neither Neither Party shall have the deciding vote on, and no Committee shall have decision-making authority regarding, any of the following matters:
: (i) creation of and amendments to the Global Brand Strategy and Global Medical Affairs Strategy for Licensed Products;
(ii) creation of and amendments to the Development Plans (subject to Astellas’ final decision making authority with respect to [***] therefor pursuant to Section 3.11(b)(iii) (Final Decision-Making Authority));
(iii) the imposition of any requirement requirements on the other Party to undertake obligations beyond those for which it is responsible under this Agreementincreased costs or obligations, or to forgo any of its rights rights, under this Agreement, including, without limitation, the imposition on the other Party of an obligation to engage in, pay for, or otherwise be financially responsible for, any obligations or activities that represent a material increase to those obligations and activities mutually agreed upon in the Clinical Development Plan and associated agreed-upon budget;
; (ivii) the imposition of any requirements that the other Party takes or declines to take any action that would result in a violation of any Applicable Law or any agreement with any Third Party or the infringement of intellectual property rights of any Third Party; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(viii) the resolution of any a dispute involving the breach or alleged breach of this Agreement;
; (vi) the determination of whether the Parties will conduct any Joint Studies (other than those set forth in the Clinical Development Plan);
(viiiv) the determination of whether a Party Hutchmed Entity exerts Commercially Reasonable Efforts under this Agreement;
; (viiiv) any decision that is expressly stated to require the mutual agreement (or similar language) of a Committee or the Parties or the approval of the other Party (but not “approval” of a Committee);
; (ixvi) any matters that would excuse such Party from any of its obligations under under, or waive any term of, this Agreement; or
or (xvii) modifying the terms of this Agreement or taking any action to expand or narrow the responsibilities of any Committee. In no event may the decision-making Party unilaterally determine that it has fulfilled any obligations hereunder or that the non-deciding Party has breached any obligations hereunder. In no event may Hutchmed unilaterally determine that any events required for the payment of milestone payments have not occurred and in no event may Epizyme unilaterally determine that the events required for the payment of milestone payments have occurred.
(b) The In no event shall Hutchmed exercise its final decision-making Party shall make its decision in good faith, subject authority with respect to the terms and conditions Licensed Products in the Territory in a manner that Epizyme has notified Hutchmed (including through the applicable Committee or Subcommittee) is reasonably expected to have a material adverse effect on the Manufacturing, Development or Commercialization for any Licensed Product outside the Territory, or scope, validity or enforceability of this Agreement.
any Licensed IP. In no event shall Epizyme exercise its final decision-making authority with respect to the Licensed Products outside the Territory in a manner that Hutchmed has notified Epizyme (cincluding through the applicable Committee or Subcommittee) is reasonably expected to have a material adverse effect on the Development or Commercialization of any Licensed Product in the Territory. For clarity, approval by a Committee shall not be understood to mean approval by a Party.
Appears in 1 contract