Manufacturing Transfer Plan definition

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

  • 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.

  • 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.

  • 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.

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

  • The decisions referred to in the fourth and fifth paragraphs of this Article are not subject to appeal or recourse before the Constitutional Court.

  • 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.

  • Promptly upon AnaptysBio’s written notice therefor (“Manufacturing Transfer Date”), the Parties shall develop a plan for transitioning the Manufacturing of Compounds and Products to AnaptysBio or its designee (which designee may be an Affiliate, Sublicensee or a Third Party manufacturer) (the “Manufacturing Transfer Plan”), which Manufacturing Transfer Plan shall leverage Centessa’s existing Third Party manufacturers and internal subject matter experts (“Manufacturing Technology Transfer”).

  • Promptly after the Effective Date, the Parties shall develop a plan for transitioning the Manufacturing of Compounds and Licensed Products to Biodexa or its designee (which designee may be an Affiliate, Sublicensee or a Third Party manufacturer) (the “Manufacturing Transfer Plan”), which Manufacturing Transfer Plan shall leverage Melior’s existing Third Party manufacturers and its licensee, Bukwang.

  • To set in place mechanisms for monitoring and review of the implementation of the child protection standards GOVERNING PRINCIPLESThe Child Protection Policy is guided by the fundamental principles laid down under United Nations Convention on the Rights of the Child as well as under the Juvenile Justice (Care & Protection of Children) Act 2015 for realisation of the rights of all children and includes in particular -1.


More Definitions of Manufacturing Transfer Plan

Manufacturing Transfer Plan has the meaning set forth in Section 5.7.
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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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Related to Manufacturing Transfer Plan

  • Manufacturing Process means any process for—

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • 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.

  • 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.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, 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.

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

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • 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, 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.

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

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

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

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

  • 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.