Common use of Technology Transfer; Assistance with Buyer Regulatory Filings Clause in Contracts

Technology Transfer; Assistance with Buyer Regulatory Filings. (a) Seller and Buyer will use commercially reasonable efforts to effect an orderly transfer of the Product Technology from Seller to Buyer pursuant to the terms of this Agreement as soon as practicable following the Closing Date. Seller will provide reasonable cooperation and assistance to Buyer, including, to the extent reasonably requested by Buyer, making available certain Seller personnel within relevant and appropriate functions and positions during normal business hours as reasonably requested by Buyer, in connection with such transfer of the Product Technology and Buyer’s preparation of all filings required to be filed with the FDA in order to obtain the necessary approvals for the manufacture and sale of on-market Products by Buyer in or for the Territory. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken under this Section 7.3(a). (b) Except with respect to Seller’s assistance in connection with the transfer of the Product Technology as set forth above in Section 7.3(a), Buyer shall have sole responsibility for obtaining, and shall use commercially reasonable efforts to obtain, all regulatory approvals necessary for the offer, sale, importation, manufacture, distribution, marketing, promotion, import, export, pricing and reimbursement of the Products, including, without limitation, supplementing the Product ANDA to include facilities designated by Buyer and to delete Seller’s facilities, and assuming all responsibility for maintenance of the Product ANDAs. All decisions regarding the validation of Products and the conduct of regulatory activities with respect to the Products after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities shall be at its sole cost. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.

Technology Transfer; Assistance with Buyer Regulatory Filings. (a) Seller Sellers and Buyer will use commercially reasonable efforts to effect an orderly transfer of the Product Technology from Seller Sellers to Buyer pursuant to the terms of this Agreement as soon as practicable following the Closing Date. Seller Sellers will provide reasonable cooperation and assistance to Buyer, including, to the extent reasonably requested by Buyer, making available certain Seller Sellers’ personnel within relevant and appropriate functions and positions during normal business hours as reasonably requested by Buyer, in connection with such transfer of the Product Technology and Buyer’s preparation of all filings required to be filed with the FDA in order to obtain the necessary approvals for the manufacture and sale of on-market Products by Buyer in or for the Territory. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken under this Section 7.3(a). (b) Except with respect to Seller’s Sellers’ assistance in connection with the transfer of the Product Technology as set forth above in Section 7.3(a), Buyer shall have sole responsibility for obtaining, and shall use commercially reasonable efforts to obtain, all regulatory approvals necessary for the offer, sale, importation, manufacture, distribution, marketing, promotion, import, export, pricing and reimbursement of the Products, including, without limitation, supplementing the Product ANDA to include facilities designated by Buyer and to delete Seller’s Sellers’ facilities, and assuming all responsibility for maintenance of the Product ANDAs. All decisions regarding the validation of Products and the conduct of regulatory activities with respect to the Products after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities shall be at its sole cost. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. discretion, and all such regulatory activities shall be at its sole cost. Sellers shall use commercially reasonable efforts in providing reasonable cooperation and pre-launch regulatory assistance to Buyer for unlaunched Products, including making available Sellers’ personnel. In addition, solely with respect to the Supply Pipeline Products, Sellers shall use commercially reasonable efforts to provide validation support services for Supply Pipeline Products from Sellers’ facilities as may be reasonably requested by Buyer. For the avoidance of doubt, Buyer shall bear the reasonable costs (including Direct Costs) incurred by Sellers in connection with any such pre-launch regulatory assistance and validation support services provided pursuant to this Section 7.3(b). (c) With respect to [****], from and after the Closing Date until the earlier of (i) the receipt of final Product Approval or (ii) [****] following the Closing Date, such Seller agrees to use commercially reasonable efforts to make available to Buyer, upon Buyer’s reasonable request, personnel knowledgeable to answer questions regarding the pre-Closing development of [****] either by teleconference or videoconference; provided that, for the avoidance of doubt, such Seller will not perform technical work in connection with the foregoing assistance. Notwithstanding any term or provision of this Section 7.3 to the contrary, Section 7.3(a) and Section 7.3(b) shall not apply with respect to [****].

Technology Transfer; Assistance with Buyer Regulatory Filings. (a) Seller Sellers and Buyer will use commercially reasonable efforts to effect an orderly transfer of the Product Technology from Seller Sellers to Buyer pursuant to the terms of this Agreement as soon as practicable following the Closing Date. Seller Sellers will provide reasonable cooperation and assistance to Buyer, including, to the extent reasonably requested by Buyer, including making available certain Seller personnel within relevant and appropriate functions and positions during normal business hours as reasonably requested by BuyerSellers’ personnel, in connection with such transfer of the Product Technology and Buyer’s preparation of all filings required to be filed with the FDA in order to obtain the necessary approvals for the manufacture and sale of on-market Products by Buyer in or for with respect to such transfer of the TerritoryProduct Technology. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken under this Section 7.3(a). (b) Except with respect to Seller’s Sellers’ assistance in connection with the transfer of the Product Technology as set forth above in Section 7.3(a), Buyer shall have sole responsibility for obtaining, and shall use commercially reasonable efforts to obtain, all regulatory approvals necessary for the offer, sale, importation, manufacture, distribution, marketing, promotion, import, export, pricing and reimbursement of the Products, including, without limitation, supplementing the Product ANDA to include facilities designated by Buyer and to delete Seller’s Sellers’ facilities, and assuming all responsibility for maintenance of the Product ANDAs. All decisions regarding the validation of Products and the conduct of regulatory activities with respect to the Products after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities shall be at its sole cost. [****] = Certain confidential information contained Sellers shall use commercially reasonable efforts in this documentproviding reasonable cooperation and pre-launch regulatory assistance to Buyer for unlaunched Products, marked by bracketsincluding making available Seller personnel. In addition, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested solely with respect to the omitted portionsSupply Products, Seller shall use commercially reasonable efforts to provide validation support services for Supply Products from Sellers’ facilities as may be reasonably requested by Buyer. For the avoidance of doubt, Buyer shall bear the reasonable costs (including Direct Costs) incurred by Sellers in connection with any such pre-launch regulatory assistance and validation support services provided pursuant to this Section 7.3(b).

Technology Transfer; Assistance with Buyer Regulatory Filings. (a) Seller and Buyer will use commercially reasonable efforts to effect an orderly transfer of the Product Technology from Seller to Buyer pursuant to the terms of this Agreement as soon as practicable following the Closing Date. Seller will provide reasonable cooperation and assistance to Buyer, including, to the extent reasonably requested by Buyer, including making available certain Seller personnel within relevant and appropriate functions and positions during normal business hours as reasonably requested by Buyerpersonnel, in connection with such transfer of the Product Technology and Buyer’s preparation of all filings required to be filed with the FDA in order to obtain the necessary approvals for the manufacture and sale of on-market Products by Buyer in or for with respect to such transfer of the TerritoryProduct Technology. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken under this Section 7.3(a). (b) Except with respect to Seller’s assistance in connection with . Following completion of the transfer of the Product Technology as set forth above in contemplated by this Section 7.3(a) with respect to Product ANDA for [***], at Buyer’s option upon written notice to Seller, Seller shall deliver to Buyer such portion of the supply of [***] (if any) of Seller and its Affiliates as of the time of completion of such transfer as Buyer may elect in such written notice; provided that Buyer shall pay the then-current allocable cost per unit except to the extent already paid for by Buyer (or by the Manufacturer and reimbursed Buyer), . (b) Buyer shall have sole responsibility for obtaining, and shall use commercially reasonable efforts to obtain, all regulatory approvals necessary for the offer, sale, importation, manufacture, distribution, marketing, promotion, import, export, pricing and reimbursement of the Products, including, without limitation, supplementing the Product ANDA to include facilities designated by Buyer and to delete Seller’s facilities, and assuming all responsibility for maintenance of the Product ANDAs. All decisions regarding the validation of Products and the conduct of regulatory activities any and all actions reasonably necessary or required to obtain and maintain the Regulatory Approvals required for Product ANDA (“Regulatory Activities”) with respect to the Products after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities shall be at its sole cost. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.the

Technology Transfer; Assistance with Buyer Regulatory Filings. (a) Seller and Buyer will use commercially reasonable efforts to effect an orderly transfer of the Product Technology from Seller to Buyer pursuant to the terms of this Agreement as soon as practicable following the Closing Date. Seller will provide reasonable cooperation and assistance to Buyer, including, to the extent reasonably requested by Buyer, including making available certain Seller personnel within relevant and appropriate functions and positions during normal business hours as reasonably requested by Buyerpersonnel, in connection with such transfer of the Product Technology and Buyer’s preparation of all filings required to be filed with the FDA in order to obtain the necessary approvals for the manufacture and sale of on-market Products by Buyer in or for with respect to such transfer of the TerritoryProduct Technology. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken under this Section 7.3(a). (b) Except with respect to Seller’s assistance in connection with the transfer of the Product Technology as set forth above in Section 7.3(a), Buyer shall have sole responsibility for obtaining, and shall use commercially reasonable efforts to obtain, all regulatory approvals necessary for the offer, sale, importation, manufacture, distribution, marketing, promotion, import, export, pricing and reimbursement of the Products, including, without limitation, supplementing the Product ANDA to include facilities designated by Buyer and to delete Seller’s facilities, and assuming all responsibility for maintenance of the Product ANDAs. All decisions regarding the validation of Products and the conduct of regulatory activities any and all actions reasonably necessary or required to obtain and maintain the Regulatory Approvals required for Product ANDA (“Regulatory Activities”) with respect to the Products after the Closing Date shall be made by Buyer in its sole and absolute discretion, and all such regulatory activities Regulatory Activities shall be at its sole cost. [****] = Certain confidential information contained Seller shall use commercially reasonable efforts in this documentproviding reasonable cooperation and pre-launch assistance to Buyer for unlaunched Products, marked by brackets, has including (i) making available personnel of Seller and its Affiliates who have been omitted directly involved in development and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 filing of the Securities Exchange Act of 1934Product ANDA, (ii) any cooperation and assistance as amended. Confidential treatment has been requested may be mutually agreed, (iii) with respect to the omitted portions.Regulatory Activity, and (iv) any