Data Package definition

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

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

• Unless otherwise specified, all Products shall be packaged, marked, and otherwise prepared in accordance with the Procurement Specifications, Technical Data Package (TDP), applicable laws and regulations, and good commercial practices.

• The units of measurement within the AIE package submittal shall be consistent with the requirements of the Technical Data Package (TDP).

• All equipment (includes AAIE defined below), special and standard, including dimensional gages, measuring equipment, test fixtures, electronic and physical test equipment, and other test equipment used for examination and test of a product to determine conformance to the Technical Data Package (TDP) which may include drawings and specifications (e.g., Detail, Performance, Weapon specifications, and QAPs).

• Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package.

• However, please note that according to applicable law, there might be limitations on the use of a Data Package.

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 each Research Target, the complete results of the Development activities through the completion of IND Enabling Activities with respect to Research Products Directed to such Research Target, performed under the Research Plan for such Research Target (including, unless otherwise agreed by the Parties, at least one (1) Research Product that meets the Advancement Criteria and at least one (1) Backup Research Product), including all applicable CMC Data and such other information as AbbVie may reasonably request; it being understood and agreed that the Data Package with respect to a Research Target that is delivered [***] prior to the end of the Option Period pursuant to the parenthetical in Section 2.6.1 will, subject to Section 2.6, only contain information with respect to any applicable Research Product and Backup Research Product as in existence at the time of the requirement to deliver such Data Package under this Agreement, and (b) [***].