Manufacturing Transition Date definition

Manufacturing Transition Date means January 1, 2012, unless another date is agreed to between the Parties for GSK to begin Manufacturing itself in accordance with Section 2.5 and 3.2 (the “Manufacturing Transition Date”).
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Manufacturing Transition Date has the meaning set forth in Section 7.3.3 (Completion of Manufacturing Tech Transfer).
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Manufacturing Transition Date means [**]. 1.163 “Materials” means any tangible compositions of matter, articles of manufacture, assays, chemical, biological or physical materials, and other similar materials. 1.164 “Material Regulatory Event” means a material regulatory issue relating to a Licensed Product in which a Regulatory Authority will not initiate review or refuses to accept filing of an NDA, MAA or other similar marketing application with respect to such Licensed Product on the basis of submission of a completed development program as agreed by the JSC, or if an accelerated or conditional approval with respect to such Licensed Product is ultimately unable to be converted to full approval. 1.165 “Material Safety Event” means a material safety event (whether as to the type of event or magnitude or severity of the safety issue) that arises prior to Completion of the Arvinas Clinical Trials Transfer and is reasonably likely to cause the continuation of the Arvinas Clinical Trial Activities to impose an unacceptable risk for patient safety.
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Examples of Manufacturing Transition Date in a sentence

  • Unless otherwise agreed by the Parties in writing, the Clinical Supply Agreement and Commercial Supply Agreement shall expire upon Zymeworks’ fulfillment of all orders placed by Jazz in accordance with the terms of the Clinical Supply Agreement and the Commercial Supply Agreement on or before the Manufacturing Transition Date, provided that Zymeworks’ obligations with respect to Licensed Antibodies and Licensed Products supplied to Jazz prior to such expiration shall survive expiration.

  • Jazz shall have the right to enter into an agreement directly with any of Zymeworks’ CMOs prior to the Manufacturing Transition Date to obtain supply of Licensed Antibodies and Licensed Products[***].

  • Following a Manufacturing Technology Transfer under Section 7.2 and receipt of approval from applicable Regulatory Authorities for Jazz or Jazz’s CMO to manufacture Licensed Antibody and Licensed Product, as applicable, Zymeworks shall continue to supply Jazz with, and Jazz shall continue to purchase from Zymeworks, Licensed Antibodies and Licensed Products as requested by Jazz in accordance with the Commercial Supply Agreement until the Manufacturing Transition Date.

  • Notwithstanding anything to the contrary in this Agreement or in the Original Manufacturing Agreement or MSA (as applicable), on and after the Manufacturing Transition Date, Partner shall be required to use no less than the same level of diligence efforts in conducting the Manufacture and supply of the Product as required of Atara prior to the Manufacturing Transition Date under the Original Manufacturing and Supply Agreement and the Original Commercialization Agreement.

  • Prior to the Manufacturing Transition Date, Atara shall perform and carry out its Manufacturing responsibilities set forth in this Agreement and the Original Manufacturing and Supply Agreement or MSA, as applicable.

  • Prior to the Manufacturing Transition Date, Partner shall purchase from Atara or its Affiliates all of Partner’s, and its Affiliates’ and Approved Sublicensees’ requirements of Product in the Field in the Territory pursuant to the terms and conditions of the MSA, provided that until such time as the Parties have executed the MSA, Partner shall purchase from Atara or its Affiliates all of Partner’s, and its Affiliates’ and Approved Sublicensees’ requirements of Product in the Field in the Territory [***].

  • Jazz shall have the right to enter into an agreement directly with any of Zymeworks’ CMOs prior to the Manufacturing Transition Date to obtain supply of Licensed Antibodies and Licensed Products [***].

  • Without prejudice to the generality of the foregoing, Seller shall indemnify Buyer against Employment Costs and Employment Liabilities arising from Seller’s acts or omissions or vicarious liabilities and the acts or omissions or vicarious liabilities of any Seller’s Affiliate in respect of any such employees or their Employee Representatives which occurred at any time prior to the EAME Manufacturing Transition Date or such other date of transfer.

  • Partner shall be permitted to terminate this Agreement (i) in its entirety, (ii) on a Region-by-Region basis, and (iii) elsewhere in the Territory on a country by country basis, at will, (a) prior to the Manufacturing Transition Date, with [***] prior written notice to Atara, and (b) on or after the Manufacturing Transition Date, with [***] prior written notice to Atara.

  • Such a system is used in lieu of a separate solar PV system where components of the system are designed and attached to a building independent of building architecture.


More Definitions of Manufacturing Transition Date

Manufacturing Transition Date has the meaning given in Section 8.5(a) hereto.
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Manufacturing Transition Date means [***].
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Manufacturing Transition Date means the earlier of (i) the date on which Buyer accepts the last shipment of SNF Units manufactured by NMT and shipped to Buyer pursuant to Buyer's final Purchase Order submitted to NMT under the Transitional Manufacturing Agreement and (ii) December 31, 2002.
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Related to Manufacturing Transition Date

  • Transition Date means the date on which this contract comes into effect for all purposes.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Contract Transition Period means the 90 day transition as defined in Section F of this Contract.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • 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.

  • Transition Period means the period beginning with the Registration Date and ending as of the earlier of: (i) the date of the first annual meeting of stockholders of the Company at which directors are to be elected that occurs after the close of the third calendar year following the calendar year in which the Registration Date occurs; and (ii) the expiration of the “reliance period” under Treasury Regulation Section 1.162-27(f)(2).

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Manufacturing Process means any process for—

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Benchmark Transition Start Date means, in the case of a Benchmark Transition Event, the earlier of (a) the applicable Benchmark Replacement Date and (b) if such Benchmark Transition Event is a public statement or publication of information of a prospective event, the 90th day prior to the expected date of such event as of such public statement or publication of information (or if the expected date of such prospective event is fewer than 90 days after such statement or publication, the date of such statement or publication).

  • Term SOFR Transition Event means the determination by the Administrative Agent that (a) Term SOFR has been recommended for use by the Relevant Governmental Body, (b) the administration of Term SOFR is administratively feasible for the Administrative Agent and (c) a Benchmark Transition Event or an Early Opt-in Election, as applicable, has previously occurred resulting in a Benchmark Replacement in accordance with Section 2.14 that is not Term SOFR.

  • transitional period means the period starting on the commencement date and ending three months after that date.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Implementation Period means the period from the date of signing of the Agreement and up to the issuance of Final Acceptance Certificate for the project.

  • Supply Start Date means the date(s) specified in clause 2.8;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Implementation Date means the date, occurring after the Approval Date, on which the Merger is implemented by the Merging Parties;

  • Transition Plan means a transition plan, acceptable to the LHIN that indicates how the needs of the HSP’s clients will be met following the termination of this Agreement and how the transition of the clients to new service providers will be effected in a timely manner; and

  • License Period means the period beginning from the Commencement Date and ending on the Termination Date.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.