Drug Product. Except to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities and as set forth in section 6.2 hereof, Patheon shall not be liable nor have any responsibility for any deficiencies in, or other liabilities associated with, any Drug Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, “Drug Product Claims”). For greater certainty, Patheon shall have no obligation for any Drug Product Claims to the extent such Drug Product Claim (i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or marketability of the Drug Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable using the test methods set forth in the Specifications, (iii) results from a defect in the Active Compounds or Granulations (as the case may be) or Components supplied by the Client, (iv) is caused by actions of third parties occurring after such Drug Product is shipped by Patheon pursuant to Section 5.5, (v) is caused by actions or omissions of third party suppliers of Components in which deficiencies or defects were not detected or were not detectable by Patheon after conducting tests in accordance with the Specifications, (vi) is due to packaging or labelling defects or omissions for which Patheon has no responsibility, or (vii) is due to any other breach by the Client of its obligations under this Agreement.
Drug Product. At the request of Merck, and if agreed to by the Parties, such agreement not to be unreasonably withheld, conditioned or delayed, the Parties shall discuss and agree on the terms pursuant to which Moderna would Manufacture and supply of Drug Product to [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Drug Product. The term “
Drug Product. The Binding Forecast for any month (i) may not be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots respectively by Presentation for such month when it first appeared in the Semi- Binding Forecast and (ii) may not be changed from the quantities forecasted for such month in the first Binding Forecast to include such month, without the prior written consent of Biogen on a case-by-case basis.
Drug Product. The amounts forecasted by Bioverativ for each month within the Semi-Binding Forecast period may not be changed by Bioverativ to be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots by Presentation for such month when it first appeared in the Semi-Binding Forecast.
Drug Product. The dosage form in the final immediate packaging intended for human clinical or commercial use.
Drug Product. Company shall provide invoices to Client for Drug Product upon [*] (e.g. finished bulk, finished packaged, or finished packaged and labeled, including serialization).
Drug Product. The composition of the RPV LA is provided in Table 2. to those currently approved since the drug Table 2: Nominal composition of Rilpivirine 300-mg/mL prolonged release suspension for injection (G001) Components Quality Referencea Function Composition per Unit Dose (mg/vial) 2-mL dose 3-mL dose Rilpivirine (R278474) Active drug substance 600 900 Poloxamer 338 Glucose Monohydrate Sodium Dihydrogen Phosphate Monohydrate Citric Acid Monohydrate Sodium Hydroxide Water for Injection . ./ . ./ / . ./ . ./ . ./ 100 150 38.50 57.75 4 6 2 3 1.732 2.598 q.s. ad 2 mL q.s ad 3 mL a Where multiple compendia are listed, the compendium specific to the region of the submission is applied. The 300-mg/mL drug product is packaged in a 4-mL clear glass vial with rubber injection stopper and sealed with an aluminum cap, and stored at 5 °C. The drug product is supplied as a medicinal product kit which contains the drug product vial, a sterile-packed plastic syringe, a sterile-packed safety needle and a sterile-packed vial adapter. The drug product is aseptically manufactured by , , , and aseptically filling it into glass vials. Two different dosage units, 600-mg and 900-mg dose, are obtained by filling the vials to a fill volume allowing an extractable volume of 2.0 mL and 3.0 mL, respectively.
Drug Product. At any time during the Agreement Term and subject to this Section 6.2.2, Roche will have the right to transfer its obligations to supply Drug Product to Dermira under Section 6.1.4 after providing written notice to Dermira (the “Drug Product Transfer Notice”). Within [*****] ([*****]) days thereafter Roche will, (a) to the extent permitted under Third Party agreements, (i) provide to Dermira a copy of all Third Party agreements related solely to the supply of such Drug Product, and (ii) use [*****] efforts to assign to Dermira any such Third Party agreements described in (i) above which relate solely to such Drug Product and facilitate introductions to all Third Parties that are Manufacturing Drug Product on Roche’s behalf, and (b) to the extent Controlled by Roche and not previously provided to Dermira, provide Dermira with the Know-How necessary for the Manufacture of Drug Product, including applicable Drug Product release assays and protocols. Roche’s obligation to supply Drug Product (but not Drug Substance) under this Agreement shall expire [*****] ([*****]) [*****] after the completion of the activities described in the foregoing sentence. All internal costs and expenses incurred by Roche in performing the activities under this Section shall be borne by [*****], and [*****] will be solely responsible for any Third Party costs incurred by either Party. Notwithstanding the foregoing, for as long as Roche has available inventory of Drug Product, Dermira shall have the right to purchase its Drug Product requirements from such inventory.
Drug Product. [***] Time frame: [***] Cost per lot: [***] [***] Total cost [***]: [***] [***] Payment schedule: [***] [***] [***] [***] [***] [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
