Manufacturing Transfer definition

Manufacturing Transfer has the meaning set forth in Section 6.4 (Manufacturing Transfer).
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Manufacturing Transfer is defined in Section 6.1 hereof.
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Manufacturing Transfer has the meaning set forth in Section 3.2.2.
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Examples of Manufacturing Transfer in a sentence

  • The Clinical Supply Agreements will provide for the terms and conditions of the transfer of Xxxxx’x manufacturing technology at the end of [ ]*, provided, however, that the Parties agree that such transfer will be made at Licensee’s cost and expense, less an amount equal to the Xxxxx Manufacturing Transfer Cost, to be estimated and agreed by the parties in good faith.

  • With respect to sales of 500mg Product made in the Territory prior to the Manufacture Transfer Date for the 500mg Product, the royalty payable by Depomed to BLS pursuant to Section 4.6 of the BLS Manufacturing Transfer Agreement shall be allocated between the parties according to the royalty percentage set forth in Section 8.1(a).

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

  • With respect to sales of 500mg Product made in the Territory on or after the Manufacture Transfer Date for the 500mg Product, the royalty payable by Depomed to BLS pursuant to Section 4.6 of the BLS Manufacturing Transfer Agreement shall be the sole responsibility of Depomed.

  • Biogen Idec shall be solely responsible for the Manufacture of Collaboration Compounds and Products for commercial supply, subject to Section 6.4. After the Manufacturing Transfer Period, Biogen Idec shall apply Commercially [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

  • Effective as of the First Sales Booking Date and thereafter until such time (if ever) as the BLS Supply Agreement is assigned to Santarus, Santarus will be designated as Depomed’s “Distributor” (as defined in the BLS Supply Agreement) under the BLS Supply Agreement to perform Depomed’s distribution and “Marketing” (as defined in the BLS Manufacturing Transfer Agreement) activities with respect to the 1000mg Product.

  • Selecta shall retain the responsibility to Manufacture preclinical, clinical and commercial supplies of the Licensed Particles to be included in Licensed Products, subject to Section 5.3 (Manufacturing Transfer), and shall supply Spark’s preclinical, clinical and commercial requirements of the Licensed Particles.

  • For the avoidance of doubt, nothing in this Section 5.7 shall give rise to the Technology Transfer Option under Section 5.4 (Manufacturing Transfer).

  • Without jeopardizing the approval of the MAA in the name of Gemphire, Beijing SL shall, as soon as possible after the Manufacturing Transfer, submit an MAA in its own name to the NMPA to market the Licensed Products as locally manufactured products in mainland China.

  • Following the Manufacturing Transfer Date and except as set forth in the Research Plan or any Additional Research Plan, Vertex will have sole and exclusive control over all matters related to the Manufacture and supply of Licensed Agents and Products for Exploitation in the Field in the Territory.


More Definitions of Manufacturing Transfer

Manufacturing Transfer means the transfer of production of the Business from Seller to Buyer, within 4 months of the Initial Closing Date, as measured by Buyer’s ability to produce at least 20 boxes of product of the Business at Buyer’s facility. Seller and Buyer have agreed on the plan and timeline related to the Manufacturing Transfer attached hereto as Schedule 2.02(h).
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Related to Manufacturing Transfer

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

  • 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 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.

  • 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 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.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

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

  • 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 Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • 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;

  • 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.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Technology Transfer Agreement has the meaning given in Section 2.2(a).

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

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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.

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.