Manufacture of Products. (a) In accordance with the terms of this Agreement, BIRI shall perform the MANUFACTURING SERVICES with respect to each PRODUCT, XANODYNE shall order and purchase each of the PRODUCTS in finished dosage form from BIRI, and BIRI shall sell and deliver such purchased PRODUCTS to XANODYNE. Subject to the terms and conditions contained herein, BIRI shall perform the MANUFACTURING SERVICES in accordance with: (i) the SPECIFICATIONS for each of the PRODUCTS; (ii) all regulations now in place or hereafter established by the FDA (including, but not limited to, GOOD MANUFACTURING PRACTICES, and 21 C.F.R. Part 11), DEA or any other GOVERNMENTAL AGENCY that are applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT; and (iii) all material requirements of other federal, state or local laws and regulations applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT. (b) BIRI shall be responsible for (i) obtaining all materials, ingredients and components required to manufacture each of the PRODUCTS in accordance with the SPECIFICATIONS; and (ii) supplying all other equipment, materials and personnel necessary for the performance of the MANUFACTURING SERVICES and delivery of the PRODUCTS in finished package form to XANODYNE. BIRI shall maintain in its inventory such quantity of materials, ingredients and components necessary for BIRI to perform its obligations hereunder in reliance on Xanodyne's most recently submitted forecast pursuant to Section 5.5. (c) BIRI shall perform the MANUFACTURING SERVICES at its PLANT in Columbus, Ohio. (d) BIRI shall ensure that, at the time of delivery of the PRODUCTS to a common carrier for shipment to XANODYNE: (a) the PRODUCTS shall conform to the SPECIFICATIONS; (b) the PRODUCTS shall, subject to XANODYNE's timely provision of compliant and accurate LABELING and artwork, not be adulterated or misbranded under applicable laws; and (c) the PRODUCTS shall have a remaining shelf life of not less than [**] months on products with a [**] month expiry and [**] months on products with a [**] month expiry unless mutually agreed upon by both parties in advance of shipment.
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Samples: Manufacturing Agreement (Xanodyne Pharmaceuticals Inc), Manufacturing Agreement (Xanodyne Pharmaceuticals Inc)
Manufacture of Products. (a) In accordance with the terms of this Agreement, BIRI shall perform the MANUFACTURING SERVICES with respect to each PRODUCT, XANODYNE shall order and purchase each of the PRODUCTS in finished dosage form from BIRI, and BIRI shall sell and deliver such purchased PRODUCTS to XANODYNE. Subject to the terms and conditions contained hereinin this Agreement, BIRI Company will utilize Manufacturer as its exclusive manufacturer for the lines of products (the "Products"), the brands, of which are attached hereto as SCHEDULE 1A. and the formulae and specifications to be provided in Product Purchase Orders (as hereinafter defined) to be submitted by Company (the "Specifications").
(b) Manufacturer shall perform provide the MANUFACTURING SERVICES manufacturing and filling services set forth in accordance with: SCHEDULE 1B (i) collectively the SPECIFICATIONS for each of the PRODUCTS; (ii) all regulations now in place or hereafter established by the FDA (including"Filling Services"), including but not limited to, GOOD MANUFACTURING PRACTICESlabor, chemicals (excluding fragrance oil), compounding, filling and packaging, and 21 C.F.R. Part 11)shall deliver the Products to Company on a turn-key basis in finished, DEA or any other GOVERNMENTAL AGENCY that are applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT; packaged and (iii) all material requirements of other federalsalable form. In addition, state or local laws Manufacturer shall provide, and regulations applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT.Company shall purchase from Manufacturer, as ordered by Company
(b) BIRI shall be responsible for (i) obtaining caps and collars as a manufactured component, i.e., cost of all materialscomponents of caps and collars, ingredients including but not limited to, resin, as well as labor and components required to manufacture each all other costs in connection with delivery of the PRODUCTS in accordance with the SPECIFICATIONS; and such manufactured component shall be borne by Manufacturer,
(ii) supplying Apple Pencils as a on a turn-key basis in finished, packaged and salable form, with cost of all components as well as labor and all other equipment, materials and personnel necessary for the performance of the MANUFACTURING SERVICES and costs in connection with delivery of the PRODUCTS in finished package form to XANODYNE. BIRI Apple Pencils shall maintain in its inventory such quantity of materials, ingredients and components necessary for BIRI to perform its obligations hereunder in reliance on Xanodyne's most recently submitted forecast pursuant to Section 5.5be borne by Manufacturer.
(c) BIRI Manufacturer agrees to supply 100% of the total requirements of Company in connection with the Filling Services for Products. In the event Manufacturer cannot supply 100% of the total requirements of Company, then in such event, Company shall perform have the MANUFACTURING SERVICES at its PLANT in Columbusright to procure Filling Services for Products from a third party, Ohioand the quantities so procured shall be credited against the minimum purchase quantities has hereinafter set forth.
(d) BIRI Company will supply Manufacture with all components for the Products at its expense, including fragrance oil, but excluding butane, alcohol, colorant, resin and pencil components which shall ensure that, at be supplied by Manufacturer in sufficient quantities to meet the time requirements of delivery Company.
(e) All Products will be stored in the Manufacture's warehouse as set forth in PARAGRAPH 12 hereof. During the first year of the PRODUCTS to a common carrier for shipment to XANODYNE: (a) the PRODUCTS shall conform to the SPECIFICATIONS; (b) the PRODUCTS shallTerm, subject to XANODYNE's timely provision of compliant and accurate LABELING and artwork, not be adulterated or misbranded under applicable laws; and (c) the PRODUCTS Company shall have a remaining shelf life the right to terminate Distribution Services upon three (3) months notice to Manufacturer. After the first year of not less than [**] the Term Company shall have the right to terminate Distribution Services upon six (6) months on products with a [**] month expiry and [**] months on products with a [**] month expiry unless mutually agreed upon notice to Manufacturer. If Distribution Services are terminated, then all merchandise produced by both parties in advance of shipmentManufacturer will be shipped Freight Collect, F.O.B. destinations selected by Company.
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Manufacture of Products. (a) In accordance with the terms of a. JI shall use its commercially reasonable efforts to conduct such preparations, validations, testing and analyses, as shall enable it to manufacture Products pursuant to this Agreement, BIRI shall perform the MANUFACTURING SERVICES with respect to each PRODUCT, XANODYNE shall order and purchase each of the PRODUCTS in finished dosage form from BIRI, and BIRI shall sell and deliver such purchased PRODUCTS to XANODYNE. Subject Agreement according to the terms and conditions contained herein, BIRI shall perform the MANUFACTURING SERVICES Specifications agreed to in accordance with: (i) the SPECIFICATIONS for each of the PRODUCTS; (ii) all regulations now in place or hereafter established writing by the FDA (including, but not limited to, GOOD MANUFACTURING PRACTICES, and 21 C.F.R. Part 11), DEA or any other GOVERNMENTAL AGENCY that are applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT; and (iii) all material requirements of other federal, state or local laws and regulations applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCTParties.
(b) BIRI b. JAKKS and the Toymax Companies shall be responsible for (i) obtaining all materials, ingredients and components required continue to use JI to manufacture each of the PRODUCTS Existing Toymax Products in accordance with the SPECIFICATIONS; Specifications in effect for the Existing Toymax Products and the prices identified in the Product and Price List, subject to the provisions of Section 4. The quantity of Existing Toymax Products ordered by the Toymax Companies or JAKKS shall be determined by JAKKS in its discretion, provided, however, that JAKKS agrees that JI shall have the exclusive right to manufacture all Products in the Current Toymax Product Line provided that JI meets JAKKS delivery requirements (and JI agrees to use reasonable commercial efforts to comply with JAKKS' delivery requirements, provided that JI shall not be required to agree to deliver Products in less than 28 days, and (i) for Products incorporating computer chips or Integrated circuits, such longer period as is reasonably required to obtain such chips or integrated circuits, but no longer than prevailing industry availability for such component, and (ii) supplying all for Products incorporating other equipmentcomponents from dedicated third party suppliers, materials such longer lead time as reasonably required to obtain such components, but no longer than prevailing industry availability for such component), and personnel necessary that JI is otherwise in accordance with the provisions of this Agreement. In the event that JAKKS or the Product Vendee desires to manufacture a Modified Toymax Product, then such commitment is subject to agreement between JI and JAKKS or the Product Vendee, as the case may be, upon the price, Specifications, quantities and delivery dates for such Modified Toymax Product.
c. After the date hereof, JAKKS agrees to use commercially reasonable efforts to order from JI or arrange for the performance Toymax Companies or other of JAKKS' Affiliates to order from JI a Significant Amount of New Products, provided that (i) agreement can be reached with JI on the MANUFACTURING SERVICES prices, Specifications, quantities, and delivery dates (collectively referred to as the "New Product Manufacturing Terms") for such New Products, and (ii) that the quality of Products delivered by JI after the PRODUCTS in finished package form to XANODYNE. BIRI shall maintain in its inventory such quantity of materials, ingredients and components necessary for BIRI to perform its obligations hereunder in reliance on Xanodyne's most recently submitted forecast pursuant to Section 5.5.
(c) BIRI shall perform the MANUFACTURING SERVICES date hereof is at its PLANT in Columbus, Ohio.
(d) BIRI shall ensure that, at the time of delivery of the PRODUCTS to a common carrier for shipment to XANODYNE: (a) the PRODUCTS shall conform least equal to the SPECIFICATIONSquality of Existing Toymax Products manufactured by JI under the Existing Manufacturing Agreement prior to the date hereof. If JI and JAKKS or its Affiliate do not reach agreement on the price for such New Product, and JAKKS or one of its Affiliates obtains a more favorable price for such New Product from another third party manufacturer, then, provided that JI has previously manufactured that generic type of product for JAKKS or its Affiliates (including the Toymax Companies), then JAKKS or an Affiliate shall give notice to JI of such competitive price and the other New Product Manufacturing Terms on which such third party manufacturer was willing to manufacture the New Product, and if JI advises JAKKS or its Affiliate within one (1) business day that JI agrees to manufacture such New Product on such New Product Manufacturing Terms, then JAKKS will place such order for such New Product with JI (and the amount so ordered shall be included in the calculation of Significant Amount); (b) the PRODUCTS shallrights conferred upon JI in this sentence shall not in any way be deemed to expand, subject to XANODYNE's timely provision modify, or otherwise affect the obligations of compliant and accurate LABELING and artwork, not be adulterated or misbranded under applicable laws; and (c) JAKKS undertaken in the PRODUCTS shall have a remaining shelf life first sentence of not less than [**] months on products with a [**] month expiry and [**] months on products with a [**] month expiry unless mutually agreed upon by both parties in advance of shipmentthis paragraph.
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