Geron Decision Package Sample Clauses

Geron Decision Package. In the event Xxxxxxx provides a Continuation Notification under Section 2.1.8 above, then within [*] ([*]) days thereafter Xxxxxxx shall provide to Geron the following, to the extent such items are in the possession of Xxxxxxx and its Affiliates by the date of delivery of any Continuation Notification and have not yet been provided to Geron, directly or through the JSC: (i) preliminary and/or interim (as the case may be under the applicable trial protocol) de-identified data, results and analysis from the Lead Phase 2 Low Risk MDS Study; (ii) a proposed Work Plan setting forth the design and synopsis (and associated Development Budget) for those Additional Studies which are US Studies and that would be included, pursuant to Section 4.8.1, under the CDP if Geron were to exercise its US Opt-In Rights, whether or not such Additional Studies have been initiated by Xxxxxxx as of such time; (iii) the then-projected date of First Commercial Sale in the U.S. of the Licensed Product being developed under the CDP along with a preliminary estimate of the average annual Promoting Costs in the U.S. for the Licensed Product; and (iv) the following Development Cost information associated with any Development activities under the Global Development Plan (only to the extent that such activities have been initiated by Xxxxxxx as of such time) for any Additional Studies that are US Studies that, pursuant to Section 4.13.1(b), would become incorporated into the CDP upon Geron’s exercise of its US Opt-In Rights: (x) the total Development Costs, if any, incurred through the end of the last full Xxxxxxx Calendar Quarter immediately preceding the date of the Geron Decision Package; (y) a good faith estimate of the Development Costs incurred since the last day of the last full Xxxxxxx Calendar Quarter immediately preceding the date of the Geron Decision Package; and (z) a good faith projection of the Development Costs anticipated to be incurred during the period between the date of the Geron Decision Package and the end of the Geron Election Period, in each case under the Development Budget associated with such Additional Studies (collectively, the “Geron Decision Package”). For the avoidance of doubt, the Initial Development Budget for any such Additional Studies that are US Studies referenced in clause (ii) above shall not become subject to the annual Budget Variance Limit, and Geron shall owe to Xxxxxxx no part of the Development Costs incurred thereunder, or any part of the De...
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Related to Geron Decision Package

  • 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.

  • 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.

  • Review of Decision Within sixty (60) days after the Secretary’s receipt of a request for review, he or she will review the Company’s determination. After considering all materials presented by the Claimant, the Secretary will render a written opinion, written in a manner calculated to be understood by the Claimant, setting forth the specific reasons for the decision and containing specific references to the pertinent provisions of this Agreement on which the decision is based. If special circumstances require that the sixty (60) day time period be extended, the Secretary will so notify the Claimant and will render the decision as soon as possible, but no later than one hundred twenty (120) days after receipt of the request for review.

  • Final Decision Concessionaire covenants that the decision of the Commissioner of Department, relative to the performance of the terms and conditions of this Agreement, shall be final and conclusive.

  • 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.

  • Arbitration Decision The arbitrator’s decision will be final and binding. The arbitrator shall issue a written arbitration decision revealing the essential findings and conclusions upon which the decision and/or award is based. A party’s right to appeal the decision is limited to grounds provided under applicable federal or state law.

  • Notice of Decision If the Plan Administrator denies part or all of the claim, 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: (a) The specific reasons for the denial; (b) A reference to the specific provisions of the Agreement on which the denial is based; (c) A description of any additional information or material necessary for the claimant to perfect the claim and an explanation of why it is needed; (d) An explanation of the Agreement’s review procedures and the time limits applicable to such procedures; and (e) A statement of the claimant’s right to bring a civil action under ERISA Section 502(a) following an adverse benefit determination on review.

  • 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.

  • Arbitration Decisions Unless otherwise agreed by the Parties, the arbitrator(s) shall render a decision within ninety (90) Calendar Days of appointment and shall notify the Parties in writing of such decision and the reasons therefor. The arbitrator(s) shall be authorized only to interpret and apply the provisions of this LGIA and shall have no power to modify or change any provision of this Agreement in any manner. The decision of the arbitrator(s) shall be final and binding upon the Parties, and judgment on the award may be entered in any court having jurisdiction. The decision of the arbitrator(s) may be appealed solely on the grounds that the conduct of the arbitrator(s), or the decision itself, violated the standards set forth in the Federal Arbitration Act or the Administrative Dispute Resolution Act. The final decision of the arbitrator(s) must also be filed with FERC if it affects jurisdictional rates, terms and conditions of service, Interconnection Facilities, or Network Upgrades.

  • Arbitrator’s Decision Within thirty (30) days after the appointment of the third arbitrator, the three (3) arbitrators shall decide whether the parties will use Landlord’s or Tenant’s submitted Fair Market Rental Value and shall notify Landlord and Tenant of their decision. The decision of the majority the three (3) arbitrators shall be binding on Landlord and Tenant.

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