Manufacturing Tech Transfer Plan definition

Manufacturing Tech Transfer Plan shall have the meaning as defined in Section 5.1.
Sample 1Sample 2
Manufacturing Tech Transfer Plan has the meaning set forth in Section 2.11(b).
Sample 1Sample 2
Manufacturing Tech Transfer Plan has the meaning set forth in Section 8.3 (ALJ Manufacturing Option; Technology Transfer).
Sample 1

Examples of Manufacturing Tech Transfer Plan in a sentence

  • After the successful completion of the Manufacturing Tech Transfer Plan and associated success criteria therein, Licensee shall itself, or through its Affiliates or Sublicensees, be responsible for all commercial supply of the Licensed Product in the Territory.

  • To facilitate the performance of activities under this Agreement, either Party may provide to the other Party certain biological materials or chemical compounds owned by or licensed to the supplying Party for use by the other Party (such materials or compounds and any progeny and derivatives thereof, collectively, “Materials”), including those materials to be provided by Sangamo to Pfizer as described in the Manufacturing Tech Transfer Plan.

  • NanoTx shall remain responsible for the drug master files until the completion of the Manufacturing Tech Transfer Plan.

  • In order to coordinate the detailed activities of Depomed and Collegium under the Transition Plan, including with regard to the Manufacturing Tech Transfer Plan, and to oversee, coordinate and manage the parties’ respective rights and obligations with regard to the Manufacture and supply of all Products, Line Extensions and Product Materials hereunder, Depomed and Collegium shall form a joint manufacturing committee (“JMC”) within thirty (30) days after the Closing Date.

  • At any time following approval of the Manufacturing Tech Plan, until Completion of the Manufacturing Tech Transfer, either Party shall have the right to propose an amendment to the Manufacturing Tech Transfer Plan to the JMC for review and discussion in accordance with this Section 7.3.1 (Manufacturing Tech Transfer Plan).

  • Notwithstanding anything to the contrary in Section 5.4 (Mersana Know-How Transfer), the JMC will manage and oversee the transfer of Know-How within the Mersana Technology as set forth in the Manufacturing Tech Transfer Plan.

  • Following approval by the JSC, such Manufacturing Tech Transfer Plan shall be included as part of the Joint Development Plan [**], in each case, subject to the applicable terms of this Agreement.

  • The Parties will complete the Manufacturing Tech Transfer Plan for each Product [***] as quickly as possible following mutual agreement thereof, but in any event within [***] prior to the anticipated Initiation of the applicable Phase II Clinical Trial.

  • Following the JSC’s approval of the Manufacturing Technology Transfer Plan pursuant to Section 7.3.1 (Manufacturing Tech Transfer Plan), the Parties will perform the Manufacturing Tech Transfer in accordance with the Manufacturing Tech Transfer Plan (including the applicable timelines set forth therein [**]).

  • Upon Pfizer’s reasonable request, Sangamo shall provide Pfizer (or at additional cost, its CMO, if not Sangamo’s CMO for SB-525) with reasonable technical assistance and information, which shall include the provision of technical assistance and information identified in Exhibit F (Manufacturing Tech Transfer Plan), to enable Pfizer (or its CMO) to understand and utilize such Licensed Know-How in the Manufacture of SB-525.

Related to Manufacturing Tech Transfer Plan

  • 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.

  • 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 Process means any process for—

  • Technology Transfer Plan will have the meaning set forth in Section 4.1.

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

  • 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.

  • Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).

  • 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.

  • 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.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • API means American Petroleum Institute.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • 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).

  • 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.

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

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Development Program means the implementation of the development plan.

  • 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.