Information Sharing; Decision Making Sample Clauses

Information Sharing; Decision Making. Until completion of the Relay IND Transfer Date, Relay will provide updates regarding its Development activities with respect to the Relay Phase Ia Trial and comply with Section 3.9.1, and will provide such other information with respect to the Relay Phase Ia Trial as is reasonably requested by Licensee and is in Relay’s Control. Relay will also provide notice to Licensee and the opportunity to review and approve any decision for which Licensee has final decision making rights with respect to the Relay Phase Ia Trial under Section 10.7.3(b).
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Information Sharing; Decision Making. After the Relay IND Transfer Date, Relay will provide updates regarding its Development activities with respect to the Relay Phase Ia Trial and comply with Section 3.9.1, and will provide such other information with respect to the Relay Phase Ia Trial as is reasonably requested by Licensee and is in Relay’s Control. If Licensee is conducting Clinical Trials of the Lead Product during the time period that Relay is conducting the Relay Phase Ia Trial, Licensee will provide material updates to Relay regarding Licensee’s Development activities, and will provide such other material information as is reasonably requested by Relay, and notice of DLT and SAEs, as provided in Section 3.9.1, mutatis mutandis. Relay will also provide notice to Licensee and the opportunity to review and approve any decision for which Licensee has final decision making rights with respect to the Relay Phase Ia Trial under Section 10.7.3(b).

Related to Information Sharing; Decision Making

  • Decision Making The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows: (a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing: (i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *]; (ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and (b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.

  • Initial Decision Maker The Architect will serve as the Initial Decision Maker pursuant to Article 15 of AIA Document A201–2017, unless the parties appoint below another individual, not a party to this Agreement, to serve as the Initial Decision Maker.

  • Post-Closing Access to Information For a period of seven (7) years from the Closing Date, except as prohibited by applicable Law, Seller and Buyer shall, subject to compliance by the other with the provisions of Section 5.12 and the Transition Services Agreement, afford to each other and to each other’s Representatives reasonable access and duplicating rights (with copying costs to be borne by the requesting party) during normal business hours to all books and records, documents and other information (collectively, “Information”) within the knowledge, possession or control of the other party or its Affiliates solely to the extent relating to (a) in the case of requests by Buyer, the FH Business, Transferred FH Companies (and their Closing Subsidiaries), FH Assets, the Acquired FH Assets, Assumed Liabilities or Transferred Employees and (b) in the case of requests by Seller, the Excluded Businesses, the Excluded Assets or the Retained Liabilities, insofar in each case as such access is reasonably required by Seller or Buyer or any of their Subsidiaries or Affiliates for legitimate business reasons and does not violate any applicable Law or any confidentiality obligations applicable to Seller or Buyer or any of their Subsidiaries or Affiliates, as the case may be (and shall use reasonable efforts to cause persons or firms possessing relevant Information to give similar access) and, to the extent practicable, such Information is identified by the requesting party with reasonable specificity; provided, however, that no party shall be required to disclose any Information if (i) it believes in good faith that doing so presents a significant risk, based on advice of counsel (which can be inside counsel) of resulting in a loss of the ability to successfully assert a claim of Privilege or (ii) Seller or any of its Subsidiaries, on the one hand, and Buyer or any of its Subsidiaries, on the other hand, are adverse parties in a litigation (other than a litigation with respect to a claim for indemnification under this Agreement) and such information is reasonably pertinent thereto; provided, further, that, in the case of clause (i) above, the parties hereto shall reasonably cooperate in seeking to find a way to allow disclosure of such information without resulting in a loss of the ability to successfully assert a claim of Privilege; provided, further, that Seller and its Affiliates shall not be required to provide Buyer or its Representatives with any information related to the Sale Process or Seller’s or its Representatives’ evaluation thereof, including projections, financial or other information related thereto other than projections, financial or other information prepared in the ordinary course of the FH Business without being primarily prepared for the Sale Process. Without limiting the generality of the foregoing, Information may be requested under this Section 5.9 for audit and accounting purposes and in connection with Actions, as well as for purposes of fulfilling disclosure and reporting obligations.

  • Additional Submissions – Information Access The claimant shall then have the opportunity to submit written comments, documents, records and other information relating to the claim. The Plan Administrator shall also provide the claimant, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the claimant’s claim for benefits.

  • Class, Collective and Representative Action Waiver THE PARTIES AGREE THAT COVERED CLAIMS WILL, AT EITHER PARTY’S ELECTION, ONLY BE ARBITRATED ON AN INDIVIDUAL BASIS AND THAT EACH WAIVES THE RIGHT TO PARTICIPATE IN OR RECEIVE COMPENSATION FROM ANY CLASS, COLLECTIVE OR REPRESENTATIVE PROCEEDING. NO PARTY MAY BRING A CLAIM ON BEHALF OF OTHER INDIVIDUALS; ANY ARBITRATOR HEARING A COVERED CLAIM MAY NOT COMBINE MORE THAN ONE INDIVIDUAL’S CLAIM OR CLAIMS INTO A SINGLE CASE OR TO ARBITRATE ANY FORM OF A CLASS, COLLECTIVE OR REPRESENTATIVE PROCEEDING. SHOULD ANY PORTION OF THE FOREGOING WAIVER BE FOUND INVALID, THE REMAINING PORTION THAT IS VALID WILL BE ENFORCED TO THE FULLEST EXTENT ALLOWED BY APPLICABLE LAW.

  • Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).

  • SITE-BASED DECISION MAKING A. The District shall provide the training and staff development to support accountability/site- based decision-making activities. Teachers shall be given release time to attend these programs. B. Participation on the SAC shall not serve as a basis for the evaluation of any teacher. C. A minimum of three (3) to a maximum of five (5) teachers from each school shall serve on their school’s budget advisory committee formed for the purpose of making recommendations on the school’s general fund budget. Teacher members shall be elected by the faculty. Minutes from such meetings may be requested by the faculty and may be posted on the CTA bulletin board at the school by the Association Representative.

  • Claim Decision Upon receipt of such claim, the Plan Administrator shall respond to such claimant within ninety (90) days after receiving the claim. If the Plan Administrator determines that special circumstances require additional time for processing the claim, the Plan Administrator can extend the response period by an additional ninety (90) days for reasonable cause by notifying the claimant in writing, prior to the end of the initial ninety (90) day period, that an additional period is required. The notice of extension must set forth the special circumstances and the date by which the Plan Administrator expects to render its decision. If the claim is denied in whole or in part, the Plan Administrator shall notify the claimant in writing of such denial. The Plan Administrator shall write the notification in a manner calculated to be understood by the claimant. The notification shall set forth: (i) The specific reasons for the denial; (ii) The specific reference to pertinent provisions of the Agreement on which the denial is based; (iii) A description of any additional information or material necessary for the claimant to perfect the claim and an explanation of why such material or information is necessary; (iv) Appropriate information as to the steps to be taken if the claimant wishes to submit the claim for review and the time limits applicable to such procedures; and (v) A statement of the claimant’s right to bring a civil action under ERISA Section 502(a) following an adverse benefit determination on review.

  • HHS Single Audit Unit will notify Grantee to complete the Single Audit Determination Form If Grantee fails to complete the form within thirty (30) calendar days after receipt of notice, Grantee maybe subject to sanctions and remedies for non-compliance.

  • Accounting Decisions All decisions as to accounting principles, except as specifically provided to the contrary herein, shall be made by the General Partner.

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