Decision Making Regarding PoC Criteria and PoC Trial Design Sample Clauses

Decision Making Regarding PoC Criteria and PoC Trial Design. In the event that the JSC cannot resolve any dispute arising in the JPS with respect to the content of PoC Criteria, or with respect to the design or content of a PoC Trial, within [***] days after meeting and attempting to reach agreement on such dispute, such dispute shall be submitted promptly to the Executive Officers, who shall have a period of [***] days to resolve such dispute; provided, however, that, notwithstanding anything contained in this Agreement or any interpretation of this Agreement to the contrary, with respect to any such disputes involving the content of the PoC Criteria or the design or content of any PoC Trial, as to any given Development Candidate or Progressed Compound(s), GSK shall have final decision-making *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. authority regarding any such proposed PoC Criteria or PoC Trial design, provided that it asserts such final decision-making right in good faith, based upon credible scientific and medical evidence or upon some other rational basis in light of scientific, medical, safety and commercial considerations, and also takes into consideration the limitations thereon set forth in the definition of “PoC Trial”, as well as the Preliminary PoC Plan agreed upon by the Parties and ChemoCentryx’s reliance thereon on the conduct to date of the Early Development Program. In the event that GSK exercises such final decision-making authority, ChemoCentryx shall be obligated to conduct such PoC Trial at its sole cost and expense in accordance with the PoC Criteria and the PoC Trial design and content as finally determined by GSK, provided that in no event shall ChemoCentryx be obligated to expend in any such single PoC Trial expenditures in excess of [***] Dollars ($[***]); and provided further that in no event shall ChemoCentryx be obligated to conduct a single PoC Trial that has over [***] patients (inclusive of all active and placebo arms of such trial) even where to do so would cost less than [***] Dollars ($[***]), except as provided in the remainder of this paragraph. It is understood and agreed, however, that in the event that the total expenditures of any single PoC Trial would exceed [***] Dollars ($[***]) (as adjusted annually from the Effective Date by [***]% for inflation, “as adjusted”) ChemoCentryx may at its sole discretion, conduct, at its own expense, such Po...
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Related to Decision Making Regarding PoC Criteria and PoC Trial Design

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Plan As defined in Section 3.2(a).

  • Regulatory Compliance Program of the Sub-Adviser The Sub-Adviser hereby represents and warrants that:

  • Recognition of U.S. Special Resolution Regimes (i) In the event a Covered Party becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer of this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) from such Covered Party will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) were governed by the laws of the United States or a State of the United States.

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Updating List of Responsible Persons On or before the Closing Date, the Administrator will notify the Owner Trustee, the Indenture Trustee, the Servicer and the Depositor of each Person who is a Responsible Person for the Administrator. The Administrator may change such Persons by notifying the Owner Trustee, the Indenture Trustee, the Servicer and the Depositor.

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

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