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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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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Mitazalimab is also supported by new posi- tive biomarker data, Proof of Mechanism, from the clinical Phase I study and strong preclinical data.

Related to Proof of Mechanism

  • Proof of age The Company may require evidence of Age of any Annuitant or Owner.

  • 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 satisfactory written proof that a loss occurred for which the Group Policy provides benefits, which is not subject to any exclusion, and which meets all other conditions for benefits. Proof of Loss includes any other information We may reasonably require in support of a claim for benefits under the Group Policy.

  • Proof of payment means, as applicable, a copy of the check, confirmation of credit card or debit card payment, or confirmation of wire or automated clearinghouse transfer, and any other information required to demonstrate that payment has been made according to the EPA requirements, in the amount due, and identified with the appropriate docket number and Respondent’s name.

  • Proof of vaccination means documentation provided by a tribal, federal, state or local government, or a health care provider, that includes an individual’s name, date of birth, type of COVID-19 vaccination given, date or dates given, depending on whether it is a one-dose or two-dose vaccine, and the name/location of the health care provider or site where the vaccine was administered. Documentation may include but is not limited to a COVID-19 vaccination record card or a copy or digital picture of the vaccination record card, or a print-out from the Oregon Health Authority’s immunization registry.

  • Selection Criteria means and includes all of the requirements, considerations,

  • Random selection process means a process by which currently income-eligible households are selected for placement in affordable housing units such that no preference is given to one applicant over another except for purposes of matching household income and size with an appropriately priced and sized affordable unit (e.g., by lottery).

  • proof of B-BBEE status level of contributor means:B-BBEE Status level certificate issued by an authorized body or person;A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice;Any other requirement prescribed in terms of the B-BBEE Act;

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Proof of Interest means a proof of Interest filed in any of the Debtors in the Chapter 11 Cases.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • muscular dystrophy means a group of hereditary genetic muscle disease that weakens the muscles that move the human body and persons with multiple dystrophy have incorrect and missing information in their genes, which prevents them from making the proteins they need for healthy muscles. It is characterised by progressive skeletal muscle weakness, defects in muscle proteins, and the death of muscle cells and tissue;

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • Proof of Disability means documented clinical findings that prove that You are Disabled.

  • Proof of Purchase means an original tax invoice clearly confirming a Purchase. The Proof of Purchase must clearly specify:

  • Dose profile means the dose as a function of position along a line.

  • Fitch Criteria means the Collateral Amount shall equal the sum of (i) the product of A multiplied by the mark-to-market value of the outstanding Transactions dxxxxmined by Party A in good faith from time to time, and (ii) the product of B multiplied by the current aggregate notional amount of the outstanding Transactions, where:

  • Instantaneous flow measurement means the flow measured during the minimum time required for the flow-measuring device or method to produce a result in that instance. To the extent practical, instantaneous flow measurements coincide with the collection of any grab samples required for the same sampling period so that together the samples and flow are representative of the discharge during that sampling period.

  • Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Administrative merits determination means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

  • Fixing Sponsor means the Fixing Sponsor as specified in § 1 of the Product and Underlying Data.

  • ASAM criteria means admission, continued service, transfer, and discharge criteria for the treatment of substance use disorders as published by the American Society of Addiction Medicine (ASAM).

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.