Primary Manufacturing definition

Primary Manufacturing means the process used in the manufacture of an active drug substance (including, but not limited to the synthesis thereof), the result of which will be used in Secondary Manufacturing of a pharmaceutical product.

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Primary Manufacturing. A portion per unit of finished Product equivalent to PERMATEC's actual costs of synthesis of the Products (consisting of the reasonable overhead and out-of-pocket expenses attributable thereto), will be charged to BIOSANTE at PERMATEC's actual cost plus XXXXX%;

Examples of Primary Manufacturing in a sentence

• CAPTISOL shall be manufactured in Loures, Portugal (the “Primary Manufacturing Facility”) or Macau, People’s Republic of China (the “Backup Manufacturing Facility, together with the Primary Manufacturing Facility, the “Manufacturing Facilities”), both of which have been, or will have been, approved by the applicable governmental or regulatory authorities prior to the commencement of manufacturing of CAPTISOL at such facilities.

• At the request and expense of any Producer responsible for a Primary Manufacturing Stage for a KB Pipeline Product, KB shall use its best efforts to make reasonable adaptations to KB's Manufacturing Process for such Product as relates to the Manufacturing Stages for which such Producer is responsible to make such Manufacturing Process commercially suitable in such Producer's (or any of its Affiliates' or subcontractors' selected by such Producer) manufacturing facilities.

• KB also shall use its best efforts, upon reasonable notice from a Producer (if such Producer is responsible for a Primary Manufacturing Stage for a KB Pipeline Product), to obtain the right for such Producer's employees to make such visits to manufacturing facilities of KB's subcontractors as relates solely to those Primary Manufacturing Stages for which such Producer is responsible.

• If a Producer is responsible for a Primary Manufacturing Stage for a KB Pipeline Product, such Producer and KB shall each periodically provide the other with summaries of process performance gained from its (or any of its Affiliates' or subcontractors') experience in utilizing KB's Manufacturing Process for such Manufacturing Stage, and such Producer and KB shall each periodically provide the other with summaries of process performance gained from experience in Packaging KB Pipeline Products.