Transition; Manufacturing; Inventory. Xxxxxxx agrees, and agrees on behalf of its Affiliates, to reasonably cooperate with Legend and its designee(s) to facilitate a smooth, orderly and prompt transition of the program and activities with respect to Reverted Products, including any ongoing Development, CMC Development, Manufacturing and Commercialization of Reverted Products to Legend or its designee(s), during the Agreement Wind-Down Period, in accordance with this Section 12.4.3 and the applicable provisions of ARTICLE VI; provided, however that Xxxxxxx and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue promotion of any Products after the effective date of termination. If Xxxxxxx or its Affiliate Manufactured any Product, or component thereof or other material used for the Manufacture of Product, at the time of termination, then Xxxxxxx (or its Affiliate) shall continue to provide for manufacturing of such Product, component or other material, for Legend, at the Supply Costs therefor, from the date of notice of such termination until such time as Legend is able, using Diligent Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Product, component or other material, may be procured and legally sold throughout the United States, Greater China and Xxxxxxx Territory, but in any event no longer than [***] after the effective date of termination. If a Manufacturing Subcontractor Manufactures a Product, or component thereof or other material used for the Manufacture of Product, on Xxxxxxx’x or its Affiliate’s behalf at the time of termination, upon request of Legend, Xxxxxxx shall use Diligent Efforts to transfer the applicable Manufacturing Subcontract to Legend on or promptly after the effective date of termination. Prior to expiration of the Agreement Wind-Down Period, (i) Legend shall have the right to purchase from Xxxxxxx, and Xxxxxxx shall sell to Legend if requested by Legend, all of Xxxxxxx’x and its Affiliate’s existing inventory of Reverted Products, or components thereof or other material used for the Manufacture of Reverted Products, at Xxxxxxx’x Supply Cost for such Products, components or other materials (taking into account the portion, if any, of such Supply Costs for such inventory previously shared by Legend under this Agreement) and (ii) Xxxxxxx shall transfer to Legend, or its designee, all applicable cell banks used for the Manufacture of Reverted Products.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Legend Biotech Corp), Collaboration and License Agreement (Legend Biotech Corp)
Transition; Manufacturing; Inventory. Xxxxxxx agrees, and agrees on behalf of its Affiliates, to reasonably cooperate with Legend and its designee(s) to facilitate a smooth, orderly and prompt transition of the program and activities with respect to Reverted Products, including any ongoing Development, CMC Development, Manufacturing and Commercialization of Reverted Products to Legend or its designee(s), during the Agreement Wind-Down Period, in accordance with this Section 12.4.3 12.4.2 and the applicable provisions of ARTICLE VI; provided, however that Xxxxxxx and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue promotion of any Products after the effective date of termination. If Xxxxxxx or its Affiliate Manufactured any Product, or component thereof or other material used for the Manufacture of Product, at the time of termination, then Xxxxxxx (or its Affiliate) shall continue to provide for manufacturing of such Product, component or other material, for Legend, at the Supply Costs therefor, from the date of notice of such termination until such time as Legend is able, using Diligent Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Product, component or other material, may be procured and legally sold throughout the United States, Greater China and Xxxxxxx Territory, but in any event no longer than [***] after the effective date of termination. If a Manufacturing Subcontractor Manufactures a Product, or component thereof or other material used for the Manufacture of Product, on Xxxxxxx’x or its Affiliate’s behalf at the time of termination, upon request of Legend, Xxxxxxx shall use Diligent Efforts to transfer the applicable Manufacturing Subcontract to Legend on or promptly after the effective date of termination. Prior to expiration of the Agreement Wind-Down Period, (i) Legend shall have the right to purchase from Xxxxxxx, and Xxxxxxx shall sell to Legend if requested by Legend, all of Xxxxxxx’x and its Affiliate’s existing inventory of Reverted Products, or components thereof or other material used for the Manufacture of Reverted Products, at Xxxxxxx’x Supply Cost for such Products, components or other materials (taking into account the portion, if any, of such Supply Costs for such inventory previously shared by Legend under this Agreement) and (ii) Xxxxxxx shall transfer to Legend, or its designee, all applicable cell banks used for the Manufacture of Reverted Products.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Legend Biotech Corp), Collaboration and License Agreement (Legend Biotech Corp)
Transition; Manufacturing; Inventory. Xxxxxxx GSK agrees, and agrees on behalf of its Affiliates, to reasonably cooperate with Legend Alector and its designee(s) to facilitate a smooth, orderly and prompt transition of the program and activities with respect to Reverted Licensed Antibodies and Licensed Products, including any ongoing Development, CMC Development, Manufacturing and Commercialization of Reverted Licensed Antibodies or Licensed Products to Legend Alector or its designee(s), during the Agreement Wind-Down Period, in accordance with this Section 12.4.3 and the applicable provisions of ARTICLE VI; provided, however that Xxxxxxx and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue promotion of any Products after the effective date of termination. If Xxxxxxx GSK or its Affiliate Manufactured any Licensed Antibody or Licensed Product, or component thereof of either of the foregoing or other material used for the Manufacture of Licensed Antibody or Licensed Product, at the time of termination, then Xxxxxxx GSK (or its Affiliate) shall continue to provide for manufacturing of such Licensed Antibody, Licensed Product, component or other materialand material for Alector, for Legend, at the Supply Costs therefor, [***] from the date of notice of such termination until such time as Legend Alector is able, using Diligent Commercially Reasonable Efforts to do so, to secure an acceptable alternative commercial *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. manufacturing source from which sufficient quantities of such Licensed Antibody, Licensed Product, component or other material, and material may be procured and legally sold throughout the United States, Greater China States and Xxxxxxx OUS Territory, but in any event no longer than [***] [***] (or in the case of termination by GSK under Section 12.2 above for Alector’s breach, [***] [***]) after the effective date of termination. If a Manufacturing Subcontractor Manufactures a Licensed Antibody or Licensed Product, or component thereof of either of the foregoing or other material used for the Manufacture of Licensed Antibody or Licensed Product, on Xxxxxxx’x GSK’s or its Affiliate’s behalf at the time of termination, upon request of Legend, Xxxxxxx Alector GSK shall use Diligent Commercially Reasonable Efforts to transfer the applicable Manufacturing Subcontract to Legend Alector on or promptly after the effective date of termination. Prior to expiration of the Agreement termination or Wind-Down Period, (i) Legend shall have the right to purchase from Xxxxxxxas applicable, and Xxxxxxx until such transfer shall sell cooperate fully to Legend if requested by Legend, all of Xxxxxxx’x and its Affiliate’s existing inventory of Reverted Products, or components thereof or other material used for make the Manufacture of Reverted Products, at Xxxxxxx’x Supply Cost for such Products, components or other materials (taking into account the portion, if any, benefits of such Supply Costs for such inventory previously shared by Legend under this Agreement) and (ii) Xxxxxxx Manufacturing Subcontract available to Alector or its designee(s). GSK shall as soon as reasonably practicable after the effective date of termination or Wind-Down Period, as applicable, transfer to LegendAlector, or its designee, all applicable cell banks used for the Manufacture of Reverted Products (subject to any Third Party agreements and Alector’s payments there under for any transfer or use of such cell banks), Licensed Antibodies and Licensed Products, or component of either of the foregoing and other material (including reference standards) used for the Manufacture of Licensed Antibody or Licensed Product. To the extent the Manufacture of Licensed Antibody or Licensed Product requires the use of GSK Manufacturing Know-How, Alector shall not transfer such GSK Manufacturing Know-How to a CMO (other than an Approved CMO) without the prior written approval of GSK, such approval not to be unreasonably withheld, delayed or conditioned.
Appears in 1 contract
Samples: Collaboration and License Agreement (Alector, Inc.)
Transition; Manufacturing; Inventory. Xxxxxxx agrees, AbbVie and agrees on behalf of its Affiliates, to Affiliates shall reasonably cooperate with Legend Infinity and its designee(s) designees to facilitate a smooth, orderly and prompt transition to Infinity or its designees of the program and activities with respect to Reverted Licensed Compounds and Products, including any ongoing Development, CMC Development, Manufacturing and Commercialization of Reverted Products Licensed Compounds and Products, for a period requested by Infinity (not to Legend or its designee(s), during the Agreement Wind-Down Period, in accordance with this Section 12.4.3 and the applicable provisions of ARTICLE VI; provided, however that Xxxxxxx and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue promotion of any Products exceed [**] after the effective date of terminationTerm). Except as expressly stated in this ARTICLE 12, all out-of-pocket costs incurred by the Parties in connection with transition activities conducted under this ARTICLE 12 shall be borne by the AbbVie. If Xxxxxxx AbbVie or its Affiliate Manufactured or had Manufactured any Product, Licensed Compound or component thereof or other material used for the Manufacture of Product, Product at the time of termination, then Xxxxxxx AbbVie (or its Affiliate) shall continue to provide for manufacturing Manufacturing of such Product, component Licensed Compound or other material, Product for LegendInfinity, at the Supply Costs [**] therefor, from the effective date of notice of such termination until such time as Legend Infinity is able, using Diligent Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Product, component Licensed Compound or other material, Product may be procured and legally sold throughout the United States, Greater China and Xxxxxxx Territory, but in any event no longer than [***] months after the effective date of termination. If a Manufacturing Subcontractor Sublicensee Manufactures a Product, Licensed Compound or component thereof or other material used for the Manufacture of Product, Product on Xxxxxxx’x AbbVie’s or its Affiliate’s behalf at the time of termination, upon request of LegendInfinity, Xxxxxxx AbbVie shall use Diligent Efforts to transfer the applicable Manufacturing Subcontract Sublicense to Legend Infinity on or promptly after the effective date of termination. Prior to Upon the expiration of such period or the Agreement Wind-Down Periodexpiration or termination of this Agreement, (i) Legend Infinity shall have the right to purchase from XxxxxxxAbbVie, and Xxxxxxx AbbVie shall sell to Legend Infinity if requested by LegendInfinity, all of Xxxxxxx’x AbbVie’s and its Affiliate’s existing inventory of Reverted Products, or components thereof or other material used for the Manufacture of Reverted Products, Licensed Compounds and Products at Xxxxxxx’x Supply Cost a price equal to [**] for such Products, components or other materials Licensed Compounds and Products (taking into account the portion, if any, Supply Price for any portion of such Supply Costs for such inventory previously shared by Legend AbbVie under this Agreement) and (ii) Xxxxxxx shall transfer to Legend, or its designee, all applicable cell banks used for the Manufacture of Reverted Products).
Appears in 1 contract
Samples: Collaboration and License Agreement (Infinity Pharmaceuticals, Inc.)