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.
(b) Heritage and Premier agree that all Products subject to this Agreement, and their current and subsequently modified respective formulas are confidential and proprietary, and the sole property of Premier unless otherwise agreed in writing by both Parties.
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, [***].”
b. Section 2(c) of the Agreement is amended so that the term “Units” as defined therein is now referred to as “Tetra Units”.
c. Section 2(d) of the Agreement is amended so that whereas it previously read: “During the Term, Premier shall have the right (but not the obligation) to order from Heritage quantities of Products in excess of [***] and provided Heritage has the capacity and the ability to produce such additional quantities of Products, Heritage agrees to produce such additional quantities per the pricing and terms on Schedule C.” it now reads: “During the Term, Premier shall have the right (but not the obligation) to order from Heritage quantities of Products in in excess of [***] and provided Heritage has the capacity and the ability to produce such additional quantities of Products, Heritage agrees to produce such additional quantities per the pricing and terms on Schedule C.”
d. Section 2(e) of the Agreement is amended so that whereas it previously read: [***] it now reads: [***]
e. Section 2(f) of the Agreement is amended so that whereas it previously read: [***] it now reads: [***]
f. Section 2(m) of the Agreement is amended so that the term “Units” appearing in the second complete sentence is replaced with the term “Tetra Units”.
g. Section 2(n) of the Agreement is amended so that the last sentence that previously read: “The final production quantity by Heritage and Jasper will count towards the MAOV requirements” now reads: “The final production quantity of Tetra Units by Heritage and Jasper will count toward the MAOV requirements for Tetra Units.”
h. Section 2(o)(i) of the Agreement is amended so that the first sentence that previously read: “All Products manufactured, packa...
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. 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. 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) Co-Packer shall produce the products described on Schedule A attached hereto, as may be amended by the Parties hereafter from time to time in [***] (the “Products”), for Buyer [***] (the “Heritage Facilities”) or the Jasper facility located at [***] (the “Jasper Facility”) (the Heritage Facilities and Jasper Facility are each individually a “Facility” and collectively are the “Facilities”). [***] For volumes produced at the Heritage Facilities, [***]. For volumes produced at the Jasper Facility, [***] Any facility that Co-Packer wishes to use, other than [***], to manufacture the Products must be approved by Buyer in writing, in advance. For the avoidance of doubt, any new Co-Packer facility must be approved by Buyer before it may be used to manufacture the Products. Such facility approvals shall not be unreasonably withheld or delayed. Buyer’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 30 days of the trial production run
(b) Co-Packer and Buyer agree that all Products subject to this Agreement, and their current and subsequently modified respective formulas are confidential and proprietary, and the sole property of Buyer unless otherwise agreed in writing by both Parties.
(c) Minimum Quarterly Order Volume. Buyer shall be required to order and accept for delivery from Co-Packer (in the aggregate from Heritage and Jasper) a Minimum Quarterly Order Volume of [***] individual units of the Products that meet the Specifications, and all other requirements under this Agreement (“Units”) during each three-month period of the Term commencing January 1, 2023 (“MQOV”). Acceptance of delivery means that Co-Packer has issued a Certificate of Analysis. The three-month periods are each a “Contract Period”. The Parties will meet in May of each year of the Term to discuss any changes to the MQOV for the subsequent year(s) of the Term. Any changes to the MQOV must be mutually agreed to by the Parties in writing. If any MQOV is changed by mutual written agreement, all calculations outlined in the Agreement will use the changed MQOV. For the avoidance of doubt, the MQOV shall never fall below [***] Units.
(d) During the Term, Buyer shall have the right (but not the obligation) to request production of Products in excess of [***]per month (the MQOV divided by 3). Co-Pa...
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.
(b) All Products manufactured, packaged and delivered by JASPER under the terms of this Agreement shall conform to the specifications supplied to JASPER by BRAVO as listed on Schedule A, which Schedule may from time to time be modified by BRAVO in writing. No change in Product specifications shall be binding on JASPER until BRAVO has provided written Product specifications for each SKU, and each specification is signed and dated by the parties. JASPER shall not unreasonably refuse or fail to sign off on Product Specifications submitted by BRAVO. Any additional net cost increases or decreases associated with any modifications to BRAVO's Product specifications shall be borne by or credited to BRAVO (the term "net costs" as used herein shall mean the net increase or decrease for the items referenced in Section 3 of this Agreement, as affected by changes in the Product specifications). JASPER also agrees to comply with all laws and regulations applicable to production of the Products, including laws and regulations of the United States Food and Drug Administration ("FDA"), United States Public Health Service ("PHS"), and any and all other applicable federal, state and local laws and regulations. JASPER warrants that the Products shall be released free from defects in workmanship and shall be manufactured in accordance with applicable good manufacturing practices ("GMP"), which shall comply with Food Manufacturing GMPs that may be adopted by the FDA and/or PHS as a minimum manufacturing standard. JASPER further warrants that the Products, when delivered to BRAVO in accordance with this Agreement, shall not be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act.
(c) Upon reasonable notice, and during normal operating hours, JASPER shall permit BRAVO representatives reasonable access to portions of ...
Production of Product. 15 2. Supply of Clinical Requirements........................... 15 3.
Production of Product a. Storage and Handling
3. Corden shall store and handle all Seattle Genetics Material and the Product in accordance with the Seattle Genetics Material and Product Specifications respectively, the Quality Agreement, Applicable Law, and under other appropriate conditions, including without limitation, appropriate temperature, humidity, light and cleanliness conditions in order to avoid any material adverse effect on the identity, strength, quality and/or purity of the Products. In addition to the foregoing, Corden shall store and handle all Seattle Genetics Material and the Product so as to prevent the commingling of same with Corden’s own inventories and supplies, or those held by Corden for Third Parties.
4. Corden, upon Seattle Genetics’ request shall store any goods which are addressed to Seattle Genetics, its Affiliates, or a designee, following receipt of instructions which are given by Seattle Genetics to Corden customer service, with the obligation to keep such goods in custody in accordance with Applicable Law and the Product Specifications and the storage specific conditions set forth in the Quality Agreement until further notice from Seattle Genetics.
5. Handling and storage of Seattle Genetics Material and Product are free of charge, in the case of Product, for [ * ] from the date the Product is cleared by Corden for delivery to Seattle Genetics or its designee in accordance with Section 3.3(b). In the event that storage in excess of [ * ] is required, the Parties will negotiate in good faith to find a good faith resolution. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
6. In case any Product is returned to Corden after having been shipped by Corden, due to any cause which is not connected to the actions undertaken by Corden, the reshipment costs along with any warehousing fees will be for the account of Seattle Genetics.
