Supply of Product. 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals.
4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.”
4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port.
4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable.
4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval.
4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date.
4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory.
4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will di...
Supply of Product. Salix shall use reasonable efforts to supply the Product during the Co-Promotion Period in sufficient quantities to satisfy the levels of Product sales forecasted in the then current Marketing Plan. Salix shall maintain reasonable inventory levels of the Product in order to ensure their ability to fulfill this obligation. Salix shall have the sole responsibility and right to fill orders with respect to the Product. Altana shall not solicit orders for the Product but, if for any reason, Altana shall receive an order for the Product, Altana shall promptly forward to Salix any such orders. All orders for Product shall be subject to acceptance by Salix, in its sole discretion, which acceptance shall not be unreasonably withheld. Salix may cancel any order for Product at any time after acceptance without incurring any liability to Altana. Salix shall be solely responsible for responding to requests from Target Physicians for individual patients who need the Product but are unable to afford it. Any such request shall be forwarded by Altana to Salix for processing. Salix shall have the sole right and responsibility for establishing and modifying the terms and conditions of the sale of the Product, including (a) the price at which the Product will be sold, (b) whether the Product will be subject to trade or quantity discounts, (c) whether any discount will be provided for payments on accounts receivable, (d) whether the Product will be subject to rebates, returns and allowances or retroactive price reductions, (e) the channels of distribution of the Product, and (f) whether credit [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. is to be granted or refused in connection with any sale of Product. In the event that Salix fails to supply the Product as required pursuant to this Agreement for any reason other than a Force Majeure, which such failure results in lost sales for Altana, the Parties shall meet and attempt to negotiate a mutually agreeable and commercially reasonable solution. If the Parties cannot reach such an agreement within a reasonable period of time, the issue will be dealt with as contemplated under Section 4.4 of this Agreement.
Supply of Product. 5.01. Until the earlier of (i) December 31, 2000 or (ii) earlier termination of this Agreement, SBCL shall supply EXIGENT with clinical samples to be reasonably agreed to by the parties to enable EXIGENT to validate tests for its POCT research and development of PRODUCT. SBCL shall supply such samples to EXIGENT and EXIGENT shall reimburse SBCL for SBCL's internal costs, if any, for retrieving such samples. EXIGENT shall bear all costs of transporting such samples from SBCL's facilities to EXIGENT's facilities and all associated liabilities for transport of such samples. EXIGENT also shall bear all cost and liability associated with such validation studies. (EXIGENT does not hereby assume liability properly assessed against any third party.)
5.02. Within 90 days after FDA APPROVAL, or when otherwise agreed upon by the parties, SBCL and EXIGENT shall agree upon terms (including price per each unit of PRODUCT) for supply of PRODUCTS by EXIGENT to SBCL. EXIGENT shall supply SBCL with all of its requirements of PRODUCT as reasonably requested by SBCL and shall ship such PRODUCTS from EXIGENT's facility to the facility specified by SBCL. EXIGENT shall have the fight and obligation to supply SBCL with all of SBCL's requirements for PRODUCT (including packaging). SBCL shall pay EXIGENT an amount equal to EXIGENT's production costs plus XXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] for the instruments and the,, cartridges and reagents comprising the PRODUCTS. For purposes of this Section 5.02, EXIGENT's production costs will be all direct and indirect manufacturing costs, overheads, packaging and labeling related to the manufacture of POCT PRODUCTS. Costs not related to the manufacture of POCT PRODUCTS, including without limitation research and development, administration, sales and marketing, distribution and other miscellaneous non-manufacturing costs, shall not be included in production costs. Warranty costs shall be included in production costs but shall not be subject to the XXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] markup. Upon FDA APPROVAL, SBCL shall purchase a minimum of XXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] instruments during the first t...
Supply of Product. The JDC shall be responsible for determining the sources of, and arrangements for, the manufacture and supply of Products that the JDC believes will result in long-term profit maximization for such Products. The JDC shall endeavor to [ * ].
Supply of Product. (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase [******] Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and (ii) for each year thereafter during the term of this Agreement, the twelve (12) month period beginning on July 1 and ending on June 30. All Product supplied hereunder shall be manufactured by Mallinckrodt strictly in accordance with the Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B.
(b) The specifications for Product (including, without limitation, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications").
(c) Notwithstanding anything to the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt [******] hereunder, [******] thereafter, shall be [******] sold by Mallinckrodt to all unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the [******] business units in such immediately previous Contract Year.
Supply of Product. Supplier will sell Products to Purchaser under the terms of this Agreement. Unless stated otherwise in a Sub-Agreement, this Agreement is not a requirements contract, outputs contract, or an exclusive dealing contract. Supplier will manufacture and supply Product to Purchaser, in compliance with this Agreement, upon acceptance of an Order. If Supplier anticipates any difficulty in supplying Product, Supplier will notify Purchaser promptly and initiate discussions on how to resolve the issue. Supplier will maintain and implement disaster recovery plan adequate to minimize any business disruptions. Purchaser may review Supplier’s disaster recovery plan upon request.
Supply of Product. 9 5.2 Identification................................................................................10 5.3 Trade, Sample and Placebo Product Price.......................................................11 5.4 Forecasts, Delivery and Quality...............................................................11 5.5 Rejection and Replacement.....................................................................11
Supply of Product. For any purchase order for Products Recipient submits in accordance with this Agreement, Supplier shall, or shall cause its relevant Affiliates to, supply the requested Product and quantities, and shall use commercially reasonable efforts to deliver the Products specified in such order within Supplier’s lead time for such Products as specified in Appendix A. Delivery will be FCA port of export, Incoterms® 2020 rules. If Supplier or its relevant Affiliate will not be able to deliver ordered Product within such period, Supplier shall notify Recipient and provide Recipient with an estimate of the Delivery time of such Product.
Supply of Product. If NVS is Manufacturing such Terminated Products on the effective date of termination, at HMI’s written request, which shall be exercised no later than [***] after the effective date of termination, the Parties will negotiate in good faith a supply agreement under which NVS will supply to HMI such quantities of Terminated Candidates and Terminated Products until the earlier of (a) such time as HMI has established an alternate, validated source of supply for such Terminated Candidates and Terminated Products, and (b) [***] from the anniversary of the effective date of termination of this Agreement. In addition, upon any such termination, any Development Supply Agreements or Commercial Supply Agreements for such Terminated Candidate or Terminated Product shall terminate.
Supply of Product. Supplier agrees to supply Products pursuant to the terms and conditions of this Agreement. Supplier shall sell Product to Cisco or its Authorized Purchasers solely for purposes of allowing Cisco or its Authorized Purchasers to incorporate such Product into (or bundle such Product with) Cisco’s products. Supplier shall manage all aspects of delivery and fulfillment of Products to Authorized Purchasers and/or to a Hub. Notwithstanding anything to the contrary in this Agreement, an Authorized Purchaser may not purchase Product from Supplier under this Agreement for any other customer of such Authorized Purchaser or for any other purpose.
