Complete Data Package definition

Complete Data Package has the meaning set forth in Section 3.3.1(i).
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Complete Data Package has the meaning set forth in Section. 1.39 “[…***…] Development Plan” has the meaning set forth in Section. 1.40 “[…***…] Payment” has the meaning set forth in Section 6.2.2.
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Complete Data Package means (a) all Regulatory Materials and other information and documentation regarding the conduct and results of each of the Development activities relating to the Products, (b) all data, results, reports and any other information relating to, or generated from Development activities or research relating to the Products, regardless of the form in which they are created or presented, and (c) all other material data in the Selling Parties’ control generated by the Development, Manufacturing and Commercialization activities with respect to the Products, in each case, as presented in a form and substance reasonably satisfactory to Purchaser. “Confidential Information” shall mean all information of a confidential or proprietary nature (whether or not specifically labeled or identified as “confidential”), in any form or medium, whether in writing, orally, electronically or otherwise, including, but not limited to, the following: (a) internal business information (including historical and projected financial information and budgets and information relating to strategic and staffing plans and practices, business, training, marketing, promotional and sales plans and practices, cost, rate, and pricing structures, and accounting and business methods); (b) trade secrets, know-how, compilations of data and analyses, techniques, systems, formulae, recipes, research, records, reports, manuals, documentation, models, data, and data bases relating thereto; (c) inventions, innovations, improvements, developments, methods, designs, analyses, drawings, reports, and all similar or related information (whether or not patentable); and (d)
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Examples of Complete Data Package in a sentence

  • Following delivery of the Complete Data Package to AbbVie as contemplated by Section 3.3.1(i), Receptos shall exercise Commercially Reasonable Efforts to meet with the FDA regarding the status of Development for ABT-308 in the Lead Indication with a goal of assessing whether such Development may proceed directly to the initiation of a Phase 3 without another Phase 2 (the “FDA Post-Study Meeting”).

  • Ablynx acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means the delivery by Ablynx to AbbVie of the (i) RA Complete Data Package by the date set forth in the Initial Development Plan and Budget, and (ii) SLE Complete Data Package by the date set forth in the Initial Development Plan and Budget, in each case, unless otherwise mutually agreed to by the Parties.

  • Receptos shall use Commercially Reasonable Efforts to complete the Development Plan Study and deliver the Complete Data Package to AbbVie pursuant to the timeline outlined in the Development Plan and Budget.

  • Without limiting the foregoing requirement for Receptos to utilize Commercially Reasonable Efforts throughout the term of the Development Plan Study, the Parties hereby agree that the burden of proving that Receptos has used such Commercially Reasonable Efforts shall be solely an obligation of Receptos in the event that the Complete Data Package is not delivered to AbbVie prior to December 31, 2016 ***.

  • If Galapagos does not provide the Crohn’s Disease Complete Data Package by […***…], upon Galapagos’ showing that such delay is due to causes relating to Development or regulatory issues, AbbVie hereby agrees to extend such delayed date until such Development or regulatory issues are fully resolved in a reasonable period of time.

  • Galapagos acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3A means that the provision by Galapagos to AbbVie of the Crohn’s Disease Complete Data Package is expected by […***…].

  • If Galapagos does not provide the Complete Data Package by […***…], upon Galapagos’ showing that such delay is due to causes relating to Development or regulatory issues, ▇▇▇▇▇▇ hereby agrees to extend such delayed date until such Development or regulatory issues are fully resolved in a reasonable period of time.

  • Disease Complete Data Package and to make a good faith determination of whether all Phase 2B Crohn’s Disease Success Criteria have been met, and, no later than at the end of the Crohn’s Disease Review Period, AbbVie shall notify Galapagos of such determination by providing written notice to Galapagos (the “Crohn’s Disease Review Notice”).

  • Galapagos acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means that the provision by Galapagos to ▇▇▇▇▇▇ of the Complete Data Package is expected by […***…].


More Definitions of Complete Data Package

Complete Data Package has the meaning set forth in Section 4.1.
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Complete Data Package means (a) all Regulatory Materials and other information and documentation regarding the conduct and results of each of the Development activities relating to the Products, (b) all data, results, reports and any other information relating to, or generated from Development activities or research relating to the Products, regardless of the form in which they are created or presented, and (c) all other material data in the Selling Parties’ control generated by the Development, Manufacturing and Commercialization activities with respect to the Products, in each case, as presented in a form and substance reasonably satisfactory to Purchaser.
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Related to Complete Data Package

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

  • Work package means a major sub-division of the proposed project.

  • Project Completion Schedule means the progressive Project Milestones set forth in Schedule-J for completion of the Project Highway on or before the Scheduled Completion Date;

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

  • Deliverables means the goods, services, and work product, including all reports and project documentation, required to be provided by Grantee to the System Agency.