Qualifying Data Package definition

Qualifying Data Package means, with respect to each Galapagos Program, a downloadable copy of each item set forth on Schedule I, delivered via a Data Room.
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Qualifying Data Package means, with respect to an Arcus Program (whether such Arcus Program is a New Target Program or not) for a New Target or Replaced Target in the Inflammation Therapeutic Area or with respect to an Optioned GLP Initial New Target Program, a downloadable copy of each item set forth on Exhibit C to this Amendment No. 2, delivered via a Data Room.”
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Qualifying Data Package means, with respect to each Assembly Program, a downloadable copy of each item set forth on Schedule
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Examples of Qualifying Data Package in a sentence

  • For each Galapagos Program, if the JSC cannot reach consensus on a matter within its jurisdiction (including any matter referred to it by any other Committee) within […***…] Business Days (or […***…] Business Days for Qualifying Data Package disputes) after a Party affirmatively states in writing that a decision must be made, then such dispute shall be decided in accordance with Section 1.5(b)(i)(B), 1.5(b)(i)(C) or Section 1.5(b)(i)(D), as applicable.

  • If such dispute is regarding whether a Clinical Trial constitutes a Triggering Clinical Trial or whether or when a Qualifying Data Package has been delivered, in each case, for any Galapagos Program, then either Party may refer such dispute to the Parties’ Subject Matter Experts for Development after the […***…] Business Day after a Party requests a meeting of the JSC to make such a determination.

  • Without limitation to the foregoing, with respect to each Galapagos Program, the JSC shall determine whether a Clinical Trial constitutes a Triggering Clinical Trial and whether and when a Qualifying Data Package has been delivered, in each case, for such Galapagos Program as further described in Sections 2.3(c) and 2.3(d).

  • The JSC shall promptly (and in no case later than […***…] Business Days after such notice from Galapagos) make a good faith determination of whether the information in the Data Room constitutes a complete Qualifying Data Package with respect to such Clinical Trial and Galapagos Program, and the provisions of Section 8.2(b) shall apply.

  • With respect to each Arcus Molecule, if Arcus has not delivered a Qualifying Data Package to Gilead pursuant to Section 14.3(b)(iii)(A) or Section 14.3(b)(iii)(B) as of [***] months after expiration or termination of the Collaboration Term, Arcus shall deliver to Gilead via the applicable Data Room all data and information with respect to such Arcus Molecule in the possession or Control of Arcus at such time.

  • In addition, Arcus shall upload to such Data Room concurrently with such Qualifying Data Package (A) any Arcus Third Party Agreements applicable to such Arcus Program (from which Arcus may redact [***]), and (B) an Arcus Third Party Obligations Schedule and Arcus Flow-Down Provisions Schedule for such Arcus Program.

  • In the event of New Target Option Extension with respect to a New Target Program for an Initial New Target, Arcus shall deliver the Qualifying Data Package with respect to such New Target Program in accordance with Section 3.3(d) or 8.3(b)(vi).

  • The JSC shall promptly (and in no case later than [***] Business Days after such notice from Arcus) make a good faith determination of whether the information in the Data Room constitutes a complete Qualifying Data Package with respect to such Clinical Trial and Arcus Program, and the provisions of Section 8.3(b) shall apply.

  • Notwithstanding [***] exercise of final decision-making authority under Section 2.4(b)(vi), the Development Plan for the [***] will include Development activities (x) necessary to complete a [***] Clinical Trial for a Gilead Product in such Assembly Program, and (y) sufficient to generate a Qualifying Data Package for such Assembly Program on the occurrence of the Completion Date for [***] Clinical Trial.

  • Within [***] days after such written notice from Gilead, Assembly shall deliver to Gilead, with respect to such Assembly Program, a written notice including instructions and credentials with which Gilead may access a Data Room containing the data and information (existing and available as of the date of Assembly’s notice) with respect to such Assembly Program that would be required to be included in a Qualifying Data Package.


More Definitions of Qualifying Data Package

Qualifying Data Package means, with respect to each Arcus Program, a downloadable copy of each item set forth on Schedule E, delivered via a Data Room.
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Qualifying Data Package means, with respect to each Assembly Program, a downloadable copy of each item set forth on Schedule 1.183 (as may be amended by agreement of the Parties), delivered via a Data Room.
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Related to Qualifying Data Package

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

  • 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.

  • Qualifying patient means a person who:

  • Qualifying week means the 15th week before the expected week of childbirth.

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