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. Except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise of the Option to License with respect to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions shall be negotiated in good faith between the Parties within a period [***] upon exercise of each Option to License. The supply price of the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion wit...
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. 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. 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. 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. 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. 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.
Supply of Product. Pro-Fac Preferred Provider Status...................................3 4. Raw Product Plan.......................................................................4 5.
