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 has the meaning set forth in Section 4.2.

Examples of Data Package in a sentence

• Galapagos will have (***) days after the date Adaptimmune provides the Collaboration Trial Data Package in which to review such Collaboration Trial Data Package.

• The JSC and JPT will not have the power to (a) amend, waive, or modify any term of this Agreement, (b) give any consents or notifications required to be given by or to either Party under the Agreement, or (c) enter into or give any legal commitments on behalf of either Party, including in relation to amendments to the Collaboration Trial Data Package and agreement to the initial Technology Transfer Plan.

• If Galapagos does submit any such request during the (***)-day period, then the Collaboration Trial Data Package will not be considered final and complete until the information requested by Galapagos pursuant to this Section 2.6.2(b) (Collaboration Trial Data Package) is provided.

• Within [***] days after Data Lock for the PRX019 Phase 1 Clinical Trial (or such earlier time as reasonably requested by Celgene in writing), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package.

• Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] days after receiving such Phase 1 Data Package, notify Prothena of any reasonable requests for additional then-existing information and records related thereto that is within Prothena’s (or its Affiliates’) possession or Control, and Prothena shall respond to such requests within [***] Business Days thereof.

More Definitions of Data Package

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

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

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.

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) [***].

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