ACTIVE DRUG SUBSTANCE Sample Clauses

The 'Active Drug Substance' clause defines the specific chemical or biological component in a pharmaceutical product that is responsible for its therapeutic effect. This clause typically outlines the identity, purity, and quality standards that the active ingredient must meet, and may specify testing methods or regulatory requirements for its manufacture and supply. By clearly delineating what constitutes the active drug substance, the clause ensures both parties have a mutual understanding of the product's essential component, thereby reducing ambiguity and supporting compliance with regulatory standards.
ACTIVE DRUG SUBSTANCE. (a) POLYPEPTIDE will procure, test, and release the necessary raw material ingredients for the manufacturing of each batch/lot of bulk drug substance according to the Specification. (b) Certificates of Analysis, copies of Batch Records for manufacturing, and all Release Documents for items supplied to INTRABIOTICS must be submitted prior to the receipt of the materials at INTRABIOTICS or its designee, unless an alternative procedure has been agreed in writing between the parties.
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ACTIVE DRUG SUBSTANCE. CEPHALON will provide free of charge, and --------------------- deliver to CIRCA at its designated production facility not less than thirty (30) days in advance of the date of production of Product, appropriate quantities of Active Drug Substance which meets the specifications established in Schedule A. Following such delivery, CIRCA shall assume full responsibility for the safekeeping and safe handling, and shall bear all risk of loss, of all such Active Drug Substance that is in its possession. Legal title to all Active Drug Substance will remain with CEPHALON, provided however, that CIRCA shall reimburse CEPHALON for the replacement cost of any Active Drug Substance that is lost, contaminated, or destroyed while in the possession of CIRCA. CIRCA will use its best efforts to obtain maximum yield of Product from the Active Drug Substance provided by CEPHALON in connection with the formulation and packaging services provided hereunder. The parties anticipate that the combined yield loss suffered in the course of formulating and packaging the Product in any given lot shall not exceed five percent (5%). Notwithstanding the above, if the yield loss over any given twelve month period during the term hereof exceeds five percent (5%), then CIRCA will reimburse CEPHALON for its costs for that amount of Active Drug Substance lost that exceeds the aforementioned five percent (5%) maximum threshold. Notwithstanding the above, the parties agree to calculate the actual yield loss after production by CIRCA of the first ten (10) batches of Product, and to negotiate in good faith to adjust the aforementioned yield loss threshold if the actual yield loss proves to be substantially more than or less than five percent (5%).
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ACTIVE DRUG SUBSTANCE. Except for Asahi’s supply obligations pursuant to Section 7.2., CoTherix shall be responsible for manufacture of Active Drug Substance for Development and Commercialization at its or its Third Party Manufacturer’s manufacturing site. If CoTherix elects to employ a Third Party Manufacturer, all payment obligations to such Third Party Manufacturer shall be the sole responsibility of CoTherix. CoTherix shall also have sole responsibility for supervising any manufacturing activities conducted pursuant to such Third Party manufacturing contract.
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