Manufacturing Responsibilities definition

Manufacturing Responsibilities means all the manufacturing, production, quality control, quality assurance, stability testing, packaging, storage, GMP Facility design, construction and validation and related steps, processes, or actions required for
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Manufacturing Responsibilities means all the manufacturing, production, quality control, quality assurance, stability testing, packaging, storage, GMP Facility design, construction and validation and related steps, processes, or actions required for Revance to produce Product, in conformance with the Specifications and Regulatory Standards, as contemplated by this Agreement.
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Manufacturing Responsibilities has the meaning specified in Section 2.2;
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Examples of Manufacturing Responsibilities in a sentence

  • In the event the Client rejects Drug Product in accordance with this Section 6.1 and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon will credit the Client’s account for Patheon’s invoice price to the Client for such defective Drug Product.

  • Unless it is determined that the cause of any customer complaint resulted from a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, all costs incurred in respect of this Section 6.4 shall be borne by the Client.

  • Except for the Client’s right to terminate this Agreement in accordance with the applicable provisions of Section 8 hereof and the indemnity provided in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 shall be the Client’s sole remedy for any failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities.

  • The expenses of such testing shall be borne by Patheon if the non-conformity with the Patheon Manufacturing Responsibilities is confirmed, and otherwise by Santarus.

  • Except to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities and as set forth in section 6.2 hereof, Patheon shall not be liable nor have any responsibility for any deficiencies in, or other liabilities associated with, any Drug Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, “Drug Product Claims”).

  • Agios retains the right to determine whether a Third Party or Celgene shall conduct the applicable Agios Commercial-Scale Manufacturing Responsibilities, and the terms thereof, provided that such manufacturing still conforms to the requirements of Section 4.1(a).

  • Each of the following terms is defined in the Section set forth opposite such term: Term Section Agreement Recitals Amended and Restated License Agreement Recitals Aradigm Recitals Confidential Information 7.1 (d) Damages 8.1 DEA 2.4 Dedicated Equipment 2.9 Deficiency Notice 5.4 Development and License Agreement Recitals DMF 6.3 Firm Order 3.3 Forecast 3.2 GLP 6.4 Indemnified Party 8.3 Indemnifying Party 8.3 Manufacturing Responsibilities 2.2 Novo Nordisk Delivery Technologies, Inc.

  • Patheon shall provide the Client with reasonable access at mutually agreeable times to any of its facilities in which the Products are manufactured, stored, handled or shipped in order to permit the Client's verification of Patheon's compliance with the Patheon Manufacturing Responsibilities and with all applicable laws and regulations.

  • In the event Santarus rejects Finished Products in accordance with this Section 3.5 and the rejected Finished Product is determined not to conform to the Patheon Manufacturing Responsibilities, Patheon will credit Santarus' account for Patheon's invoice price to Santarus for such non-conforming Finished Products.

  • Notwithstanding anything to the contrary, such obligation of indemnity will not apply to the extent that such Damages are proximately caused by: (1) Novo Nordisk Delivery Technologies, Inc.’s material default or breach of this Agreement, including any failure to meet applicable Manufacturing Responsibilities or any defect or latent defect in a Packaged Device and/or Packaged Dosage Form as delivered by Novo Nordisk Delivery Technologies, Inc.


More Definitions of Manufacturing Responsibilities

Manufacturing Responsibilities means all the manufacturing, production, quality control, quality assurance, stability testing, packaging, storage, GMP Facility design, construction and validation and related steps, processes, or actions required for CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE REVANCE THERAPEUTICS, INC., HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT REVANCE THERAPEUTICS, INC. TREATS AS PRIVATE AND CONFIDENTIAL. Revance to produce Product, in conformance with the Specifications and Regulatory Standards, as contemplated by this Agreement.
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Related to Manufacturing Responsibilities

  • extended producer responsibility ’ (EPR) means responsibility of any producer of packaging products such as plastic, tin, glass, wrappers and corrugated boxes, etc., for environmentally sound management, till end-of-life of the packaging products ;

  • Responsibilities means the responsibilities delegated to BNY under the Rule as a Foreign Custody Manager with respect to each Specified Country and each Eligible Foreign Custodian selected by BNY, as such responsibilities are more fully described in Article III of this Agreement.

  • 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.

  • Area of responsibility means the geographical area, as

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

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • Statement of Work means the description of activities performed in completing the Project, as specified in the Contract and as may be amended.

  • 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.

  • Service Specifications means the following documents, as applicable to the Services under Your order:

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

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • 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.