Proof of Mechanism definition

Proof of Mechanism means the demonstration of biologically significant effect of a Cue Biologic [***], as determined by the Joint Steering Committee pursuant to Section 2.2.2.
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Proof of Mechanism means, with respect to the FA Program and each Discovery Program, achievement of the milestones or metrics determined by the JSC and identified as such in the applicable Development Plan.
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Proof of Mechanism means, with respect to the FA Program and each Discovery Program, achievement of the milestones or metrics determined by the JSC and identified as such in the applicable Development Plan. 1.88 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent Right, the preparation, filing, prosecution and maintenance of such Patent Right, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent Right. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any enforcement actions taken with respect to a Patent Right. 1.89 “Public Official or Entity” means (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality or subdivision of any government, military or international governmental organization, including any ministry or department of health or any state-owned or affiliated company or hospital, or (b) any candidate for political office, any political party or any official of a political party. 1.90 “Regulatory Approval” means all approvals of the applicable Regulatory Authority necessary for the commercial marketing and sale of a product in a country(ies), excluding any pricing and reimbursement approvals that may be required. 1.91 “Regulatory Approval Application” means (a) a BLA, or (b) any other application to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction. 1.92 “Regulatory Authority” means the FDA in the United States or any Governmental Authority in another country or regulatory jurisdiction in the Territory that is a counterpart to the FDA and holds responsibility for granting Regulatory Approval for a product in such country or regulatory jurisdiction, including the EMA and PMDA, and any successor(s) thereto. 1.93 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to any Collaboration Product, excluding Patent Rights, that precludes the use of any clinical data collected and filed for such Collaboration Product for the benefit of any Regulatory Approval for a generic or biosimilar product (for any use), inc...
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Examples of Proof of Mechanism in a sentence

  • Following a determination by the Joint Steering Committee that such Cue Biologic has achieved Proof of Mechanism as reflected in the meeting minutes of the Joint Steering Committee, such Cue Biologic shall constitute a Proposed Product Candidate.

  • The Research Program is directed to: (i) the Research by Company of Cue Biologics up to Proof of Mechanism for each of the Initial Indications; and, subject to Section 2.2.2; (ii) the further Research and/or Development by Merck of Proposed Product Candidates.

  • If the JSC cannot agree on the Proof of Mechanism Endpoints, the matter shall be escalated to *** and ***, or their respective designees with the power and authority to resolve such matter.

  • FivePrime shall propose the Proof of Mechanism Endpoints in the draft FivePrime Early Development Plan and the JSC shall approve or modify, subject to ***, such Proof of Mechanism Endpoints.

  • Such Proof of Mechanism Endpoints may consist of a determination of pharmacodynamic effect, a biomarker measurement, or a functional effect, or any combination of such metrics or other metrics.

  • If the Parties still cannot agree on a matter after such escalation, then ***, provided that any such Proof of Mechanism Endpoint selected by *** shall be an endpoint that has proven to be measurable and is relevant to the indication of interest, unless both Parties agree otherwise.

  • If FivePrime elects to pursue Track 2 Development with respect to such Committed Lead Target, then FivePrime shall use its Commercially Reasonable Efforts, consistent with the terms of this Agreement, to develop such Committed Lead Target through to achievement of the Proof of Mechanism Endpoints as mutually agreed by the Parties in advance.

  • Ono (directly or through its Affiliates or Third Party subcontractors) shall be solely responsible for conducting all its activities contemplated by the Research Plan to be performed for Successful Biclonics, including Preclinical Proof of Mechanism Product.

  • During the Evaluation Period, Company shall promptly provide Merck with any additional information relating to the Company Candidate in Company’s possession that is requested by Merck, and the Parties shall extend the Evaluation Period as reasonably necessary in order to: (i) perform any additional testing required to establish Proof of Mechanism as set forth in this Agreement; and (ii) provide Merck with a reasonable period of time to consider such additional testing.

  • The “Co-Co Trigger Date” shall mean (a) with respect to the AADC Program, Voyager’s receipt of topline data with respect to the Existing Pivotal Trial, which data Voyager shall submit to Neurocrine promptly after availability thereof and (b) with respect to the FA Program, the date upon which the JSC determines that Proof of Mechanism has been achieved.

Related to Proof of Mechanism

  • Proof of age means a valid driver license or other government- issued identification card that contains a photograph of the person and confirms the person's age as twenty-one (21) years of age or older;

  • Proof of Concept has the meaning set forth in Section 2.3.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Proof of Claim means a proof of Claim Filed against any of the Debtors in the Chapter 11 Cases.

  • Proof of Loss means the Insured's executed notice of Claim and proof of Loss, substantially in the Form of Exhibit C.