Drug Substance Inventory Sample Clauses

Drug Substance Inventory. In relation to Drug Substance Inventory, Company may choose to (A) have all or a portion of the Drug Substance Inventory transferred to Company or any Third Party designated by Company (and not converted into drug product), or (B) request Licensor to convert all or a portion of the Drug Substance Inventory into drug product and transfer such drug product to Company or any Third Party designated by Company. In case of (A), the provisions set forth in sub-paragraph i. shall apply mutatis mutandis. In case of (B), the following shall apply: Licensor will manufacture and supply to Company up to [***] ([***]) batches of drug product with a batch size of [***] ([***]) liters for clinical use, to be delivered in bulk packaging, using and limited to the Drug Substance Inventory or portion thereof, and there shall be no additional cost to Company for such Drug Substance Inventory. Batch size shall be as requested by Company, whereby Company may choose between (aa) [***] ([***]) to (bb) [***] ([***]) liter batch. In addition, [***] ([***]) aseptic process simulation (“APS”) per calendar year and within the interval between biannual shutdowns shall be required to be performed prior to drug product manufacture. For clarity, an APS will need to be performed following each manufacturing suite shutdown, before the subsequent drug product batch manufacture. The Parties will work together in good faith to optimize drug product manufacture scheduling. Licensor will deliver the drug product batches according to the same attributes (including but not limited to strength, formulation, batch size and container closure system) as Licensor’s current process. The drug product will be released by Licensor for use in Phase I/II clinical trials, or for clinical trials for which additional Phase III release procedures are required following completion of additional Phase III release procedure studies subject to Section 3.1e)v. Delivery will be [***] Company’s manufacturing or storage site. Title to the Drug Product shall transfer to Company simultaneously with risk transfer according to the aforementioned Incoterms. Any change to the manufacturing process or outcome required by the Company will need to be agreed in advance and Company will bear the cost for its implementation. Within [***] ([***]) days of the Effective Date and every [***] ([***]) months thereafter, Company shall provide Licensor with an updated rolling forecast with the number of batches to be manufactured in the fol...
Sample 1
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Drug Substance Inventory. If and to the extent that CMIC requests that Drug Substance manufactured by Dyax for CMIC be held as Drug Substance Inventory, then Dyax shall be responsible for the handling and custody of such Drug Substance Inventory (including insurance to cover risk of loss of such Drug Substance Inventory); provided that all costs directly related to the handling, custody and insurance of the Drug Substance Inventory shall be reimbursed by CMIC.
Sample 1
Drug Substance Inventory. If and to the extent that Defiante requests that Drug Substance manufactured by Dyax for Defiante be held as Drug Substance Inventory, then Dyax shall be responsible for the handling and custody of such Drug Substance Inventory (including insurance to cover risk of loss of such Drug Substance Inventory); provided that all costs directly related to the handling, custody and insurance of the Drug Substance Inventory shall be reimbursed by Defiante.
Sample 1

Related to Drug Substance Inventory

  • Raw Materials Lonza shall procure all required Raw Materials as well as consumables other than those Raw Materials that are Customer Materials. Customer shall be responsible for payment for all consumables and Raw Materials ordered or irrevocably committed to be procured by Lonza hereunder. Upon cancellation of any Batch or termination of the Agreement, all unused Raw Materials shall be paid for by Customer within [***] days of invoice and at Customer’s option will either be (a) held by Lonza for future use for the production of Product, (b) delivered to Customer, or (c) disposed of by Lonza.

  • Inventory To the extent Inventory held for sale or lease has been produced by any Borrower, it has been and will be produced by such Borrower in accordance with the Federal Fair Labor Standards Act of 1938, as amended, and all rules, regulations and orders thereunder.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Inventories The Operator shall maintain detailed records of Controllable Material.

  • Product The term “

  • Remaining Inventories Xencor shall have the right to purchase from MorphoSys (or its Affiliate) all of the inventory of Licensed Products held by MorphoSys (or its Affiliate) as of the effective date of termination at a price equal to MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAP.

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

  • Physical Inventory Borrower shall conduct a physical count of the Inventory at such intervals as FINOVA requests and promptly supply FINOVA with a copy of such accounts accompanied by a report of the value (calculated at the lower of cost or market value on a first in, first out basis) of the Inventory and such additional information with respect to the Inventory as FINOVA may request from time to time.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.

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