Limits on JSC Decision Making Authority Sample Clauses

Limits on JSC Decision Making Authority. Notwithstanding anything to the contrary set forth in this Agreement, without C4’s prior written consent, no decision of the JSC or [***] (in the exercise of its final decision-making authority on any such matters as set forth in Section 4.2.4 (Decision Making Authority)), in each case, may (a) result in a material increase in the scope of activities required to be performed by C4 under this Agreement, including under any Candidate Development Plan or require C4 to dedicate FTEs in excess of the Sandbox Budget, (b) take or decline to take any action that would be reasonably likely to result in a violation of any Applicable Law, the requirements of any Regulatory Authority, or any agreement between C4 and any Third Party or that would be reasonably likely to result in the infringement, misappropriation, or other violation of any Intellectual Property of any Third Party, (c) impose any obligation on either Party that would be in violation of such Party’s written standard operating procedures, written business policies, or written compliance policies or procedures, or (d) conflict with this Agreement.
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Limits on JSC Decision Making Authority. Notwithstanding any provision to the contrary set forth in this Agreement, without each Party’s prior written consent, no decision of the JSC may (a) take or decline to take any action that would be reasonably likely to result in a violation of any Applicable Law, the requirements of any Governmental Authority, or any agreement between a Party and any Third Party or that would be reasonably likely to result in the infringement, misappropriation, or other violation of any Intellectual Property Rights of any Third Party; provided that such Party provides a copy of any such agreement to the other Party, (b) conflict with this Agreement, (c) excuse a Party from any obligation specifically enumerated under this Agreement, (d) negate any consent right or other right specifically allocated to a Party under this Agreement, (e) resolve any dispute involving the breach or alleged breach of this Agreement or amend or modify this Agreement or any of the Parties’ respective rights and obligations hereunder, (f) resolve a matter if the provisions of this Agreement specify that agreement of the Parties, including consent of each Party, is required for such matter, or (g) require a Party to perform any act that would cause such Party to breach any of its obligations hereunder.
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Limits on JSC Decision Making Authority. Except as provided under [***], neither Party shall have the authority to make any decision without the prior written consent of the other Party that would result in any revision or modification to any Discovery/Development Program (including any Discovery Plan or Development Plan thereunder) that (i) [***] or (ii) [***]. Further, except as expressly set forth herein, the JSC shall not have the power to amend the terms of, or waive compliance with, this Agreement.
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Limits on JSC Decision Making Authority. Notwithstanding anything to the contrary set forth in this Agreement, without Catalyst’s prior written consent, no decision of the JSC or Biogen (in the exercise of its final decision‑making authority on any such matters as set forth in Section 4.2.4 (Decision Making Authority)), in each case, may:
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Limits on JSC Decision Making Authority. Notwithstanding any provision to the contrary set forth in this Agreement, including Section 4.2.7(d) (Resolution of Disputes), in no event will any Party alone have the power or authority to: (a) modify or amend the terms and conditions of this Agreement (excluding the Research Plan); (b) impose any requirements on the other Party to undertake obligations beyond those for which it is responsible, or to forgo any of its rights, under this Agreement; (c) after the Initial Research Plan Amendment has been approved, make any material changes to the Research Plan, including any material reallocation of activities under the Research Plan or any material amendment to the Research Plan to add activities to the Research Plan, unless such changes [**]; (d) if the decision-making Party is CANbridge, allocate any activity to LogicBio under the Research Plan if the costs of such activity are not reasonably included in the Research Budget; (e) waive such Party’s compliance with the terms and conditions of this Agreement; (f) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; (g) impose any requirement on the other Party to perform any act that the other Party reasonably believes (i) to be inconsistent with Applicable Law, or (ii) would cause the other Party to infringe or misappropriate any Intellectual Property of any Third Party; (h) make any determination that such Party has fulfilled its obligations under this Agreement or that the other Party has breached this Agreement; or (i) make any decision that is expressly stated to require the mutual agreement of the Parties or approval of the other Party and to not be subject to the decision-making authority of the other Party under Section 4.2.7(d) (Resolution of Disputes).
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Limits on JSC Decision Making Authority. Neither Party shall have the authority to make any decision without the consent of the other Party that would result in a material increase in the other Party’s costs or expenses under this Agreement, the Target Validation Work Plan or any Research Work Plan or Development Plan. Notwithstanding the foregoing, the JSC shall have the right to, on a plan-by-plan basis, implement one or more Changes to any given Research Work Plan, Development Plan or Target Validation Work Plan; provided that [***]. Further, except as expressly set forth herein, the JSC shall not have the power to amend the terms of, or waive compliance with, this Agreement.
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Related to Limits on JSC Decision Making Authority

  • Decision-Making Authority BMS shall have the sole decision-making authority for the operations and Commercialization strategies and decisions, including funding and resourcing, related to the Commercialization of Products; provided that such decisions are not inconsistent with the express terms and conditions of this Agreement, including BMS’ diligence obligations set forth in Section 5.1.

  • Decision-Making The JDC shall make decisions unanimously, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.

  • Independent Due Diligence and Decision Making Each Consenting Stakeholder hereby confirms that its decision to execute this Agreement has been based upon its independent investigation of the operations, businesses, financial and other conditions, and prospects of the Company Parties.

  • Decision on Review A decision on review of a denied claim shall be made in the following manner:

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Authority of the Committee The Committee shall have full authority to interpret and construe the terms of the Plan and this Agreement. The determination of the Committee as to any such matter of interpretation or construction shall be final, binding and conclusive.

  • Selection and Payment of Appeal Panel In the event an Appellant delivers an Appeal Notice to the Appellee (together with proof of payment of the applicable bond) in compliance with the provisions of Paragraph 5.1 above, the Appeal will be heard by a three (3) person arbitration panel (the “Appeal Panel”).

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • Power; Authority It has all requisite power and authority to enter into this Agreement, to perform its obligations hereunder and to consummate the transactions contemplated hereby. The execution, delivery and performance of this Agreement, the purchase of the Transferred Assets and the consummation of the transactions provided for herein have been duly authorized by all necessary action on the part of the Buyer. This Agreement has been duly executed and delivered by the Buyer and constitutes the legal, valid and binding obligation of the Buyer enforceable against the Buyer in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or other laws affecting creditors’ rights and by general principles of equity (whether applied in a proceeding at law or in equity).

  • Audit Reports; Management Letters; Recommendations Promptly after any request by the Administrative Agent or any Lender, copies of any detailed audit reports, management letters or recommendations submitted to the board of directors (or the audit committee of the board of directors) of any Loan Party by independent accountants in connection with the accounts or books of any Loan Party or any of its Subsidiaries, or any audit of any of them.

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