Manufacturing Transfer Plan definition

Manufacturing Transfer Plan has the meaning set forth in Section 5.7.
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Manufacturing Transfer Plan means a written detailed plan for the transfer of each of the manufacturing steps included in the Product Manufacturing in the Territory, as such plan may be amended or updated from time to time;
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Manufacturing Transfer Plan means the plan covering the Manufacturing Technology Transfer to Organon which the Parties shall agree upon as promptly as practicable after the Effective Date, but in no event longer than [*] days after the Effective Date.
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Examples of Manufacturing Transfer Plan in a sentence

  • Once agreed, the Manufacturing Transfer Plan shall be incorporated herein by reference, and the Parties will execute on the Manufacturing Transfer Plan.

  • Without limiting the foregoing, after completion of the Manufacturing Transfer Plan, Denali shall, and shall use Commercially Reasonable Efforts to [***], provided that Denali shall use Commercially Reasonable Efforts to Confidential 52 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission.

  • Without limiting the foregoing, Takeda shall not become the Manufacturing Lead with respect to any Collaboration Program until the completion of the applicable Manufacturing Transfer Plan.

  • Notwithstanding anything to the contrary in this Agreement, each Manufacturing Transfer Plan and any Manufacturing Technology Transfer shall be subject to the terms and conditions of the agreements between the Manufacturing Lead and its applicable Third Party Providers of manufacturing services and technology (each agreement, a “CMO Supply Agreement”).

  • No Manufacturing Transfer Plan shall require Takeda to assume any CMO Supply Agreements between Denali and its Third Party Provider for Manufacturing activities for the relevant Collaboration Program unless Takeda consents to do so.

  • In such instance, Denali shall, in accordance with the applicable Manufacturing Transfer Plan, [***].

  • The Manufacturing Transfer Plan shall include [***]the following terms: (i[***] before Manufacturing of the Product for the Licensed Territory is fully transitioned from EyePoint to Alimera, and agreement by the Parties on updated forecasts and other terms under this Agreement to enable such transition; (ii) agreement on [***] terms to wind down and terminate this Agreement, including [***]; and (iii) a technology transfer plan[***].

  • Following the transfer contemplated by the Manufacturing Transfer Plan, Licensee shall ensure that the supply of the Product Manufactured by or on behalf of Licensee and its Affiliates that is introduced into the market for sale in the Field in the Territory meets all quality standards required by Applicable Law, including cGMP.

  • In the event the assignment of any such CMO Supply Agreement is conditioned (other than for notice), the Parties shall discuss such conditions in good faith and, if the Parties, mutually agree to satisfy such conditions for the assignment of the applicable CMO Supply Agreement, the Manufacturing Transfer Plan shall address such matter.

  • Following agreement on such Manufacturing Transfer Plan, the Parties shall each use *** to carry out their respective obligations thereunder in a timely fashion; provided, however, the Supply Chain Transfer or initiation of Independent Manufacturing shall only occur if and when Menarini makes the applicable election pursuant to Section 6.2(a).


More Definitions of Manufacturing Transfer Plan

Manufacturing Transfer Plan shall have the meaning set forth in Section 3.6.
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Manufacturing Transfer Plan is defined in Section 4.2(a) (Manufacturing Transfer Plans).
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Related to Manufacturing Transfer Plan

  • Manufacturing Process means any process for—

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

  • 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 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.

  • 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.

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

  • Development Plan has the meaning set forth in Section 3.2.

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • 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).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • 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.

  • 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;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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).

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Designated Products means products provided by Motorola to Licensee with which or for which the Software and Documentation is licensed for use.

  • Project Specific IPRs means: (a) IPRs in the Services provided by the Supplier (or by a third party on behalf of the Supplier) specifically for the purposes of the Contract and all updates and amendments of these items created during the Contract Period; and/or (b) IPRs arising as a result of the provision of the Services by the Supplier (or by a third party on behalf of the Supplier) under the Contract, [including the rights in or to any database developed and supplied by the Supplier to the Customer in accordance with the terms of this Contract;