Manufacturing Phase definition

Manufacturing Phase means: the period during which the Manufacturing Activities to be provided by SYNCO in accordance with this Agreement will be carried out and which period commences on the date that SYNCO starts with the production of the Engineering Batch, if any, and ends upon completion of the manufacturing and SYNCO release of the GMP Batch as specified in the applicable Service Specific Addendum.

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Manufacturing Phase means that portion of the term of this Agreement following the Distribution Phase during which LINVATEC manufactures Product and controls all regulatory issues related to Product.

Manufacturing Phase shall have the meaning given such term in Section 2.2.

Examples of Manufacturing Phase in a sentence

Therefore, during the Distribution Phase REGEN shall maintain the Design File and during the Manufacturing Phase LINVATEC shall maintain the Design File.
During the Transitional Phase, if any, and Initial Manufacturing Phase (but only if at such time the Exclusive License remains exclusive), E-C will provide up to 4000 man-hours of engineering support services in scope mutually agreed by the Parties (“Engineering Support Services”), of which a minimum of 2000 man-hours will be applied to an IMP project.
REGEN hereby transfers to LINVATEC the responsibility to maintain the Design File during the Manufacturing Phase.
After the conclusion of the Initial Manufacturing Phase, E-C will, for so long as the Exclusive License remains exclusive, continue providing up to five hundred (500 man-hours of Engineering Support Services in scope mutually agreed by the Parties on an annual basis at no additional cost to D-R, with such obligations pro-rated in the event that the Exclusive License becomes non-exclusive mid-year.
This Distribution Phase will end at the start of the Manufacturing Phase.
The terms and conditions set forth in this Section A, Manufacturing Phase, Section B, Medical Device Provisions, as well as the terms and conditions set forth in Section C, Standard Terms and Conditions, shall be applicable to this portion of the Agreement.
During the Manufacturing Phase LINVATEC shall inform REGEN, in writing, of any significant Product design changes, including supporting documentation describing the changes and obtain REGEN’s approval prior to implementation.
XOMA will purchase for its own account and for delivery to the Facility any such additional dedicated equipment for the Project during the Manufacturing Phase, as either set forth in the Work Plan or as approved in advance in writing by Onyx, which approval shall not be unreasonably withheld.
During the Manufacturing Phase, either party shall have the right to terminate any or all activities under this agreement for any reason and at any time upon six (6) months prior written notice to the other party.
Subsequently, during the Manufacturing Phase, LINVATEC will assume control of the Design File and the manufacture of Product, either by itself or through third party suppliers, which may or may not be the same as REGEN’s suppliers.

More Definitions of Manufacturing Phase

Manufacturing Phase means: the period during which the Manufacturing Activities, if any, will be carried out, and which period commences on the date that FCDI begins production of the first GMP Batch and ends upon completion of the Manufacturing Activities whereby the last GMP Batch is to be manufactured and released, as described in the applicable Work Order.

Manufacturing Phase has the meaning in Clause 1.6.

Manufacturing Phase means the period of time immediately following the Process Implementation Phase, during which GSK shall manufacture and supply to DENDREON mutually agreed upon quantities of Product for human clinical trial and commercial use. For the avoidance of doubt, the Manufacturing Phase shall be deemed to have commenced upon the successful completion of the three (3) Conformance Batches.