Option Trigger Data Package definition

Option Trigger Data Package means a written report (including an electronic report) containing specified information and data for the indicated Research Program as follows, such list may be modified by the Parties subject to the Parties mutual written agreement: (a) with respect to the CD123 Program: each of the following ***; and (b) with respect to each of the A33 Program ***.
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Option Trigger Data Package means the written report containing specified information and data on the results of the Initial Phase 1 Clinical Trial. The Option Trigger Data Package shall include ***.
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Examples of Option Trigger Data Package in a sentence

  • Servier may exercise each such Option by providing MacroGenics written notice within *** after the receipt of the Option Trigger Data Package for the corresponding Program (each an “Option Period”).

  • For clarification purposes MacroGenics shall not have the ability to alter the the specified information and data required for the Option Trigger Data Package set forth in Section 1.63.

  • The primary objective of each Research Program is to generate, create and/or obtain the data and documentation necessary to complete the Option Trigger Data Package for such Program.

  • Neither the availability and finalization of such Supplemental Data nor any modification to the Initial Phase 1 Clinical Trial that the Parties may agree upon shall in any way delay the timing of the delivery of the Option Trigger Data Package to Servier in accordance with Section 3.3.2. To the extent that any provision of a Research Plan conflicts or is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall control.

  • The availability and finalization of such Supplemental Data and/or any modification to the Initial Phase 1 Clinical Trial that the Parties may agree upon shall not in any way delay the timing of the delivery of the Option Trigger Data Package to Servier in accordance with Section 3.3.2. To the extent that any provision of the Research Plan conflicts or is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall control.

  • In consideration for the Option as granted by MacroGenics to Servier hereunder and to review the Option Trigger Data Package, Servier shall pay MacroGenics a non-refundable, non-creditable payment of Twenty Million Dollars ($20,000,000) (the “Option Grant Fee”) within *** after the Effective Date and the date of receipt of the corresponding invoice.

  • MacroGenics shall provide Servier with each Option Trigger Data Package ***.

  • MacroGenics shall provide Servier with the Option Trigger Data Package ***.

  • MacroGenics hereby grants Servier an exclusive, royalty and other fee-free license, with the right to sublicense only to Servier’s Affiliates, under MacroGenics IP, to (a) conduct the activities, if any, allocated to Servier under each Research Plan and (b) use the Option Trigger Data Package for each Research Program solely for purposes of evaluating Program DARTs to determine whether to exercise its Option for the Program that is subject to such Option.

  • MacroGenics hereby grants Servier an exclusive, royalty and other fee-free license, with the right to sublicense only to Servier’s Affiliates, under MacroGenics IP, to (a) conduct the activities, if any, allocated to Servier under the Research Plan and (b) use the Option Trigger Data Package solely for purposes of evaluating Program Antibodies to determine whether to exercise its Option.

Related to Option Trigger Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Notice-triggering PI means the PI identified in CCC § 1798.29(e) whose 25 unauthorized access may trigger notification requirements under CCC § 1709.29. For purposes of this 26 provision, identity shall include, but not be limited to, name, identifying number, symbol, or other 27 identifying particular assigned to the individual, such as a finger or voice print, a photograph or a 28 biometric identifier. Notice-triggering PI includes PI in electronic, paper or any other medium.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Milestone is defined in Section 5.3.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Flip-In Trigger Date shall have the meaning set forth in Section 11(a)(iii) hereof.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Initial Triggering Event means any of the following events or transactions occurring after the date hereof:

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Milestone Event has the meaning set forth in Section 8.2.1.