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 has the meaning set forth in Section 4.1.
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Examples of Complete Data Package in a sentence

  • 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.

  • 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.

  • 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”).

  • 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 ***.

  • 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 Xxxxxx of the 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, Xxxxxx 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 3.1.3A 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 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.


More Definitions of Complete Data Package

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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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;

  • Deliverables means the work product and other output of the Services required to be delivered by Contractor as part of the Services, as specified in the relevant section of the Contract.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Tax Package has the meaning assigned in Section 6.01(b);

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Test Complete has the meaning stated in Section 3.4(c).

  • Review Package A package of documents consisting of a memorandum outlining the analysis and recommendation (in accordance with the Servicing Standard) of the Master Servicer or the Special Servicer, as the case may be, with respect to the matters that are the subject thereof, and copies of all relevant documentation.

  • Phase 3 Study means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety in order to obtain Regulatory Approval in any country, as further described in 21 C.F.R. 312.21(c) with respect to the United States, or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Project Plans mean the plans for the Project that are attached to this Agreement as Exhibit “B.”

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Project Deliverables means the Project deliverables set out in Schedule 2. Project Material means all the material including but not limited to documents, computer software, and data stored by any means which is created by the Fellow in the course of undertaking the Project.

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Completion Schedule means the fulfilment of the Related Services by the Supplier in accordance with the terms and conditions set forth in the Contract;