Data Package definition

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

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Data Package means the documentation containing information regarding the Product and the processes, techniques, studies, and data in connection with the Product and documentation for the Product, as prepared for Quoin to obtain approval of the marketing authorization for the Product in the United States and Europe.

Data Package shall have the meaning set forth in Section 3.3.3.

Examples of Data Package in a sentence

• Notwithstanding the foregoing, if the Parties are unable to agree on an amendment to a Data Package (including whether or not such amendment is necessary or useful) despite their good faith efforts, [* * *] determination shall control.

• The Parties will discuss the Data Package at a JSC meeting to be organized no later than [***] from delivery of such Data Package to BMS and determine whether the proposed Licensed Compound Successfully Achieves [***], as applicable, and whether the applicable Data Package is complete.

• The Parties shall update the Research Plan and/or Research Budget as appropriate to account for the change in activities thereunder as a result of any amendment to the Data Package.

• Within [* * *] after Avidity delivers a complete Data Package (which the Parties agree is accurate and complete in all material respects) to the JRC, the JRC shall determine whether a Development Candidate should be further optimized by the Parties under and pursuant to the Research Plan.

• Upon receipt of such Data Package for a given Research Program, BMS shall review such Data Package, and BMS shall notify Avidity, no later than [***] after receiving such Data Package, of any reasonable requests for additional information and records related to such Research Program that is within Avidity’s (or its Affiliate’s) Control, and Avidity shall respond to such requests within [***] thereof.

More Definitions of Data Package

Data Package has the meaning set forth in Section 4.2.

Data Package means the Final [***] Data Package, Final Phase II Data Package or Final Phase III Data Package, as applicable.

Data Package means the data package containing such data and other contents as required in the applicable SOW.

Data Package means, with respect to a Termination Product, (a) all material Information in Roche’s Control that [*], (b) other Information related to the Termination Product that [*], and (c) all Regulatory Filings and Regulatory Approvals for the Termination Product.

Data Package has the meaning set out in Clause 6.2.

Data Package means a complete, detailed, data-cleaned, unbiased and unblended data package that contains the results of the first Proof of Concept Study in the following form: (i) a statistical analysis of results; (ii) analysis tables, data listings and illustrative figures; (iii) the table of adverse events; (iv) case report forms (CRFs) in hard copy or electronic form, or, alternatively, available for review by Biogen Idec employees during normal business hours at the principal office of AVEO in the United States, commencing upon delivery of the other parts of the Data Package; and (v) a narrative description of serious adverse events, in each case in the format compiled by AVEO, which shall be cGCP compliant and otherwise consistent with industry standards. The Data Package shall also contain (x) a copy (or rights of access for purposes of clause (iv) above) of the relevant IND and the information specified in clauses (i) – (v) for any Phase 1 Clinical Trial or any other Phase 2 Clinical Trial completed prior to completion of the first Proof of Concept Study, as well as all regulatory correspondence relating thereto, (y) copies of all AVEO In-Licenses entered into between the period commencing after the Effective Date through the date of delivery of the Data Package and (z) a copy of the initial Development Plan.

Data Package means: (a) with respect to the AR Mutant Program, an AR Mutant Data Package; and (b) with respect to the NIK Program, a NIK Data Package.