Manufacturing Process Transfer definition

Manufacturing Process Transfer means the Commercially Reasonable Efforts of the parties undertaken pursuant to the Manufacturing Process Transfer Plan to transfer the Manufacturing Process (together with copies of relevant books and records) in SBL’s possession or under its control, to Client as set forth in greater detail in the Manufacturing Process Transfer Plan. SBL shall only be obligated to use its Commercially Reasonable Efforts in the implementation of the Manufacturing Transfer Plan, and in no case shall SBL personnel be required to visit the site of Client or any third party manufacturer. For the avoidance of doubt, the foregoing prohibition shall not be construed as a basis for SBL refusing to assist in the transfer of analytical methods to an independent laboratory, including a visit by SBL personnel to such site to assist in method transfer, if, and only as, reasonably necessary, and at Client’s cost and expense. For the avoidance of doubt, Manufacturing Process Transfer shall include, without limitation, the transfer of data, information, or samples of validated or SBL manufactured or partially manufactured Products or other indicia measured at various points during Manufacture, to the extent SBL possesses such data, information, or samples. SBL shall not be obligated to deliver the proprietary process information contained in any drug master file with respect to which SBL has granted Client a right of reference. SBL shall provide Manufacturing Process Transfer services with a capacity of one (1) full time employee equivalent (“FTE”) month for each of upstream, downstream and analytics, for a total maximum of three (3) FTE months. SBL will have no obligation to provide Manufacturing Process Transfer services more than twelve (12) months after termination of the MSA or applicable PSA. For clarity, SBL's assistance shall be time- based, and SBL shall in no way guarantee or ensure that after Manufacturing Process Transfer services is complete, Client or its third-party manufacturer will be able to manufacture the Product.
Sample 1Sample 2
Manufacturing Process Transfer has the meaning set forth in Section 4.7(b).
Sample 1Sample 2Sample 3
Manufacturing Process Transfer means the Commercially Reasonable Efforts of the parties undertaken pursuant to the Manufacturing Process Transfer Plan to transfer the Manufacturing Process (together with copies of relevant books and records) in *’s possession or under its control, to Client as set forth in greater detail in the Manufacturing Process Transfer Plan. * shall only be obligated to use its Commercially Reasonable Efforts in the implementation of the Manufacturing Transfer Plan, and in no case shall * personnel be required to visit the site of Client or any third party manufacturer. For the avoidance of doubt, the foregoing prohibition shall not be construed as a basis for * refusing to assist in the transfer of analytical methods to an independent laboratory, including a visit by * personnel to such site to assist in method transfer, if, and only as, reasonably necessary, and at Client’s cost and expense. For the avoidance of doubt, Manufacturing Process Transfer shall include, without limitation, the transfer of data, information, or samples of validated or * manufactured or partially manufactured Products or other indicia measured at various points during Manufacture, to the extent * possesses such data, information, or samples. * shall not be obligated to deliver the proprietary process information contained in any drug master file with respect to which * has granted Client a right of reference. * shall provide Manufacturing Process Transfer services with a capacity of one (1) full time employee equivalent (“FTE”) month for each of upstream, downstream and analytics, for a total maximum of three (3) FTE months. * will have no obligation to provide Manufacturing Process Transfer services more than twelve (12) months after termination of the MSA or applicable PSA. For clarity, *'s assistance shall be time- based, and * shall in no way guarantee or ensure that after Manufacturing Process Transfer services is complete, Client or its third-party manufacturer will be able to manufacture the Product. * Confidential material redacted and filed separately with the Commission.
Sample 1

Examples of Manufacturing Process Transfer in a sentence

  • For clarity, after completion of the applicable Manufacturing Process Transfer, Sections 7.1(a) and 7.1(b) shall govern ownership of Inventions that constitute a process, or an improvement, modification, or enhancement of a process, used in the manufacture of proteins following the primary recovery of such proteins.

  • In 2015, the Company signed a VCSEL Manufacturing Process Transfer agreement with Anadigics for early prototyping and initial development and a Manufacturing Services agreement with Wavetek for long term manufacturing.

  • After the completion of a Manufacturing Process Transfer for a HemOnc Product, Jazz shall be responsible, at its expense and through Jazz, its Affiliates or a designated Third Party manufacturer, for the manufacture and supply of all HemOnc Product required for use in the remaining clinical Development and the Commercialization of such HemOnc Product.

  • Cara shall cause its CMO to use diligent, good faith efforts to accept the technology transfer, and the Parties shall (and Cara shall cause its CMO to) work collaboratively and in good faith to conduct the full, accurate, and complete technology transfer under the Project Plan through the Completion of Analytical Procedures Transfer and Completion of Manufacturing Process Transfer.

  • In addition, Client shall be entitled to give notice to SBL of a Manufacturing Process Transfer and commence the preparation and effectuation of a Manufacturing Process Transfer Plan in the absence of a termination or expiration of a PSA in order to establish second source Manufacturing.

  • Notwithstanding the foregoing, Pfenex shall perform a Manufacturing Process Transfer for an applicable Product at Jazz’s request (A) not later than the applicable time set forth in the Development Plan and/or (B) if after good faith discussions with Pfenex with an opportunity for Pfenex to take corrective action, Jazz reasonably determines that Pfenex will be unable achieve the Manufacturing Process Transfer Criteria by the applicable time set forth in the Development Plan.

  • Upon any termination of a PSA or in connection with its expiration, Client shall be entitled to give notice to SBL of a Manufacturing Process Transfer, which shall commence the preparation and effectuation of a Manufacturing Process Transfer Plan for the Product identified therein.

  • Prior to Manufacturing Process Transfer under Section 4.7(b) (if applicable), Pfenex shall use reasonable efforts to manufacture and supply to Jazz all non-GMP HemOnc Products reasonably required for pre-clinical and process development studies in accordance with the specifications, quantities and timeline set forth in the applicable Development Plan.

  • Client shall pay SBL’s reasonable costs of assistance related to effectuation of the Manufacturing Process Transfer Plan.

  • On August 24, 2015, the Company announced a VCSEL Manufacturing Process Transfer Agreement with Anadigics, Inc.


More Definitions of Manufacturing Process Transfer

Manufacturing Process Transfer is defined in Section 5.2.
Sample 1

Related to Manufacturing Process Transfer

  • Manufacturing Process means any process for—

  • 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.

  • 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.

  • 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.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

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

  • 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.

  • 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;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

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

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.