Production of Product. (a) Heritage shall produce the products described on Schedule A attached hereto, as may be amended by the Parties hereafter from time to time (the “Products”), for Premier at [***] Heritage’s or Heritage’s wholly owned subsidiary, Jasper’s, [***] (the “Facilities”). [***] For the purposes of this paragraph, [***] facilities located at [***] are considered one Facility. Any facility that Heritage wishes to use, other than [***] to manufacture the Products must be approved by Premier in writing, in advance. For the avoidance of doubt, Heritage’s [***] facility must be approved by Premier before it may be used to manufacture the Products. Such facility approvals shall not be unreasonably withheld or delayed. Premier’s facility approval will be based, in part, on the successful completion of a trial production run that is sufficient in meeting finished product specifications, and an evaluation of the stability and specifications of trial production product within [***] of the trial production run.
Production of Product a. Section 2(a) of the Agreement is amended so that the first sentence that previously read: “Heritage shall produce the products described on Schedule A attached hereto, as may be amended by the Parties hereafter from time to time (the “Products”), for Premier at [***] Heritage’s or Heritage’s wholly owned subsidiary, Jasper’s facilities (the “Facilities”). [***]” now reads: “Heritage shall produce the products described on Schedule A and Schedule A-1 attached hereto, as may be amended by the Parties hereafter from time to time (the “Products,” each individual unit of Product “Unit”), for Premier at [***] Heritage’s or Heritage’s wholly owned subsidiary, Jasper’s facilities (the “Facilities”). [***], except that, notwithstanding anything herein to the contrary, [***].”
Production of Product. Except as provided in Sections 6, 7 and 8 of this Article V, GENENTECH, or Genentech Biopharmaceuticals Limited in the case of DNase as Vialed Product or Finished Product, or Genentech International Limited in the case of Genentech Products (except DNase) which are Vialed Product or Finished Product, shall be responsible for the manufacture of Clinical Requirements and Commercial Requirements of Bulk Product, Vialed Product or Finished Product, as the case may be, for which ROCHE has a license, for the Roche Territory.
Production of Product. Formosa shall manufacture and test NGX’s starting materials, intermediates and APIs in accordance with [***] SOPs, cGMPs, applicable laws and regulations, including all applicable FDA regulations, any applicable local laws and regulations in the place of manufacture, and any Investigational New Drug (IND), New Drug Application (NDA), Medicinal Application Authorization (MAA), and other regulatory filings or approvals for the Drug Product manufactured from the API (collectively, the “Regulatory Requirements”), and applicable contracts between Formosa and NGX. The manufactured material shall adhere to the specification supplied by NGX and be in compliance with all cGMPs and any other applicable Regulatory Requirements. Formosa will prepare for each batch of Product manufactured for NGX, the complete production record documentation (see Appendix 1, Batch Accompanying Documentation). The documentation will be readily accessible for review and inspection by NGX and regulatory authorities, and true and complete copies of these records will be sent to NGX by Formosa for each batch of Product produced (see Appendix I).
Production of Product. From the Product Price Commencement Date until the Expiry Date, ASM will use reasonable endeavours to produce Product each year in accordance with the Annual Programme (as described in Clause 9 (Programming of Deliveries) and as adjusted by the Quarterly Programme).
Production of Product. 14 4.4.1 Review for Factual Accuracy................................................ 14 4.4.2 Suppliers.................................................................. 14 4.5 Distribution Rights to the Members.................................................... 15 4.5.1 Distribution Rights Granted to Collxxx..................................... 15 4.5.2 Distribution Rights Granted to Sierra...................................... 15 4.5.3 Rights Reserved to the Company............................................. 15 4.5.4 Compensation to the Company................................................ 15 4.5.5 Third-Party Royalties...................................................... 16 4.5.6 Company Trademark License.................................................. 16 4.5.7 Company Infringement Indemnity............................................. 16 4.5.8 Cross-Marketing............................................................ 17 4.5.9 Customer Lists............................................................. 17 4.6 Development........................................................................... 17 4.6.1 Development Plan........................................................... 17 4.6.2 Enabling Technology........................................................ 17 4.6.3 Sierra's Development Responsibilities...................................... 18 4.6.4 Collxxx'x Xxxelopment Responsibilities..................................... 18 4.6.5 Cost of Services; Reimbursement............................................ 18 4.7 Customer Service, Licensing Fees...................................................... 18 4.7.1 Support.................................................................... 18 4.7.2 Platform License Fees...................................................... 19 4.8 OEM, On-Line Service and Similar Transactions......................................... 19 -------------------------------------------------------------------------------- -ii- 4
Production of Product a. Storage and Handling
Production of Product. (a) PCI shall conduct [ * ] Production in accordance with the Packaging Specifications and applicable federal, state and local laws and regulations including, without limitation, cGMP. PCI shall notify Aviron of any difficulty in meeting Packaging Specifications or any deviation therefrom immediately upon discovery of such difficulty. PCI shall not conduct [ * ] Production nor Store Stored Materials or Product at any other location other than the Aviron Facility without the prior written approval of Aviron, and shall keep all Product within the [ * ] Area. Before, during and after [ * ] Production of each batch of Product, PCI shall monitor the [ * ] Production and Storage environments (other than the freezers) and keep such records as all of the foregoing are required by the Packaging Specifications and cGMP. Each Party shall promptly notify the other of any new instructions or specifications required by the FDA or the United States Federal Food, Drug and Cosmetic Act, and of other applicable rules and regulations, and shall confer with each other with respect to the best means to comply with such requirements and shall [ * ] of implementing such changes on an [ * ].
Production of Product. (a) JASPER shall produce for BRAVO, at its facility in Joplin, Missouri (the "JASPER Facility"), the products described on Schedule A attached hereto, which may be amended by the parties hereafter from time to time (the "Products"). BRAVO shall provide JASPER with Purchase Orders that, at a minimum, will give the Products and quantities ordered, and delivery dates requested. Purchase Orders will be BRAVO's best estimate of its current requirements, but may be amended up or down to reflect changing demand for Products. JASPER shall notify BRAVO if requested delivery dates cannot be met, so the parties can discuss an acceptable production schedule.
Production of Product. 15 2. Supply of Clinical Requirements........................... 15 3.
