Examples of Qualifying Data Package in a sentence
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.
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.
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.
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 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.
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.
For purposes of Section 8.3(c) of the Agreement, the Parties agree that [***], shall be deemed the date that the JSC determined that the data package delivered for each 2021 Optioned Program constituted a Qualifying Data Package.
In addition, Assembly shall upload to such Data Room concurrently with such Qualifying Data Package (A) any Assembly Third Party Agreements applicable to such Assembly Program (from which Assembly may redact [***]), and (B) an Assembly Third Party Obligations Schedule for such Assembly 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).