Common use of Transfer of Acquired Regulatory Approvals Clause in Contracts

Transfer of Acquired Regulatory Approvals. Purchaser and Seller agree that the Regulatory Documentation in the possession or under the control of a Seller Group Member, whether in hard copy or electronic form, will be transferred at Closing. If, at any time after the Closing, any Regulatory Documentation that has not already been transferred to Purchaser comes into the possession or under the control of a Seller Group Member, then Seller shall promptly transfer or cause its Affiliates to transfer such Regulatory Documentation (including all adverse events and complaints) to Purchaser for no additional consideration. Purchaser and Seller further agree that, on the Closing Date, Seller shall submit the Withdrawal Notice to the FDA, ensuring that copies are provided to the appropriate FDA divisions. On the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from the Seller Group Members, an exclusive option to transfer ownership of the Acquired Regulatory Approvals for no additional consideration (“Option”), exercisable by Purchaser upon written notice to Seller during the Option Exercise Period. The “Option Exercise Period” shall be (a) if the Publication Date occurs on or prior to [***], the earlier of [***] following the Publication Date or [***]; and (b) if the Publication Date occurs after [***] following the Publication Date. The transfer of ownership of the Acquired Regulatory Approvals shall be effective on the date on which Purchaser provides notice of exercise of the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller shall provide an executed Seller FDA Letter to Purchaser, notifying the FDA that the Acquired Regulatory Approvals have been transferred to Purchaser as of the Option Closing Date. In addition, within [***] of the Option Closing Date, upon written request of Purchaser, Seller will transfer to Purchaser any “reserves” stored by Sharp Corporation pursuant to the Contract Packaging Quality Agreement, dated August 19, 2021, between Seller and Sharp Corporation, to the extent such material is available.

Transfer of Acquired Regulatory Approvals. Purchaser (a) Sellers and Seller agree that Purchasers shall establish a mutually acceptable and prompt communication and interaction process to ensure the Regulatory Documentation in the possession or under the control of a Seller Group Member, whether in hard copy or electronic form, will be transferred at Closing. If, at any time after the Closing, any Regulatory Documentation that has not already been transferred to Purchaser comes into the possession or under the control of a Seller Group Member, then Seller shall promptly orderly transfer or cause its Affiliates to transfer such Regulatory Documentation (including all adverse events and complaints) to Purchaser for no additional consideration. Purchaser and Seller further agree that, on the Closing Date, Seller shall submit the Withdrawal Notice to the FDA, ensuring that copies are provided to the appropriate FDA divisions. On the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from the Seller Group Members, an exclusive option to transfer ownership of the Acquired Regulatory Approvals for no additional consideration (“Option”)at the Closing. Prior to the Closing, exercisable by Purchaser the Parties shall reasonably agree upon written notice the form of the letters to Seller during the Option Exercise Periodapplicable regulatory authorities relating to the transfer of the Acquired Regulatory Approvals. The “Option Exercise Period” shall be (a) if Sellers and Purchasers hereby agree, from the Publication Date occurs on or prior to [***], Closing until the earlier of (i) [***] following the Publication Date or [***]; and (bii) if the Publication Date occurs after [***] months following the Publication Closing Date. The , to take all actions required by any Governmental Entity to effect the transfer of ownership of the Acquired Regulatory Approvals shall be effective on from a Seller or one of its Affiliates to a Purchaser or one of its Affiliates, and to cooperate with each other in order to effectuate the date on which Purchaser provides notice foregoing transfer of exercise of the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller shall provide an executed Seller FDA Letter to Purchaser, notifying the FDA that the Acquired Regulatory Approvals have been transferred Approvals; provided that neither Sellers nor any of their respective Affiliates shall be required to Purchaser as pay money to any Governmental Entity in connection with such actions, except for customary filing or application fees required to be paid by Seller or any of their respective Affiliates, all of which shall be reimbursed upon demand by Purchasers. (b) From the Option Closing Date. In addition, within until the earlier of (i) [***] of or (ii) [***] months from the Option Closing Date, upon written request a Seller or its applicable Affiliate shall hold and maintain each Acquired Regulatory Approval in its name for the account, risk and benefit of Purchasersuch Purchaser and its Affiliate, Seller will transfer to Purchaser any “reserves” stored by Sharp Corporation pursuant and Sellers and their applicable Affiliates shall serve as Purchasers’ and their applicable Affiliates’ agent for all required regulatory submissions relating to the Contract Packaging Quality Agreement, dated August 19, 2021, between Seller Product. (c) Sellers may retain an archival copy of any Acquired Regulatory Approval including supplements and Sharp Corporation, records that are required to the extent such material is availablebe kept under 21 C.F.R. §600.81.

Transfer of Acquired Regulatory Approvals. Purchaser (a) The Seller and Seller agree that the Regulatory Documentation in the possession or under the control of a Seller Group Member, whether in hard copy or electronic form, will be transferred at Closing. If, at any time after the Closing, any Regulatory Documentation that has not already been transferred to Purchaser comes into the possession or under the control of a Seller Group Member, then Seller shall promptly transfer or cause its Affiliates to transfer such Regulatory Documentation (including all adverse events and complaints) to Purchaser for no additional consideration. Purchaser and Seller further agree that, on the Closing Date, Seller shall submit the Withdrawal Notice to the FDA, ensuring that copies are provided to the appropriate FDA divisions. On the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals. The Seller Group Members, an exclusive option and the Purchaser shall use all commercially reasonable efforts to take any actions required by any Governmental Authority to effect the transfer ownership of the Acquired Regulatory Approvals for no additional consideration (“Option”)from the Seller to the Purchaser, exercisable by Purchaser upon written notice and shall cooperate with each other in order to Seller during effectuate the Option Exercise Period. The “Option Exercise Period” shall be (a) if the Publication Date occurs on or prior to [***], the earlier of [***] following the Publication Date or [***]; and (b) if the Publication Date occurs after [***] following the Publication Date. The foregoing transfer of ownership of the Acquired Regulatory Approvals. The Seller may retain an archival copy of any Acquired Regulatory Approvals shall including supplements and records that are required to be effective on kept under 21 C.F.R. §314.81. (b) Following the date on which Purchaser provides notice of exercise Closing, each of the Option Parties shall use its commercially reasonable efforts to take, or cause to be taken, all actions and is referred to herein as do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the “Option Closing Datetransactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required Consents of, Governmental Authorities and furnishing all information required by applicable Law or requested by such Governmental Authorities. Each Party shall cooperate fully with the other Party in promptly seeking to make such required registrations and filings and obtain all required Consents. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the making of such required registrations and filings or the receipt of any required Consents.” Within [***]of (c) The Seller will reasonably cooperate with the Option Closing DatePurchaser in disclosing any relevant records and reports which are required to be made, Seller shall provide an executed Seller FDA Letter maintained and reported pursuant to Purchaser, notifying applicable Law in the FDA that Territory with respect to the Acquired Regulatory Approvals have been transferred and coordinating with the Purchaser to Purchaser as make an orderly and prompt transition of the Option Closing Date. In addition, within [***] of Purchased Assets as soon as practicable after the Option Closing Date, upon written request of Purchaser, Seller will transfer to Purchaser any “reserves” stored by Sharp Corporation pursuant to the Contract Packaging Quality Agreement, dated August 19, 2021, between Seller and Sharp Corporation, to the extent such material is availableClosing.

Transfer of Acquired Regulatory Approvals. Purchaser Delivery of Acquired Assets and Seller agree that the Regulatory Documentation in the possession or under the control of a Seller Group Member, whether in hard copy or electronic form, will be transferred at Closing. If, at any time after Books and Records. (a) Promptly following the Closing, and in no event more than five (5) Business Days following the Closing, each of Seller Parent and Buyer shall submit all notices to each Regulatory Authority necessary to transfer each Regulatory Registration included in the Acquired Assets from Seller Parent to Buyer (and/or one or more of its designated Subsidiaries); provided, however, with respect to Cleviprex in such territories where providing notice within five (5) Business Days is not practicable, each of Seller Parent and Buyer shall use commercially reasonable efforts to submit all notices as promptly as practicable, and in no event more than forty-five (45) days, after the Closing Date. Seller Parent and Buyer shall use commercially reasonable efforts to complete the transfer of each Regulatory Registration included in the Acquired Assets as promptly as practicable after the Closing Date, and in no event more than applicable periods specified in the preceding sentence, for the benefit of Buyer (and/or one or more of its designated Subsidiaries), including a complete export of all electronic common technical document applications related to the Products. (b) Buyer shall use commercially reasonable efforts to assist Seller Parent in the transfer of the Regulatory Registrations included in the Acquired Assets, accept the transfer of such Regulatory Registrations and formalize with Seller Parent and any applicable Regulatory Authority, as promptly as practicable after the Closing Date, all necessary documents related thereto. Following the transfer of the Regulatory Registrations, Seller shall not retain any rights in any Regulatory Documentation that has not already been transferred Registration included in the Acquired Assets or (except as otherwise provided in this Agreement) Books and Records, including any rights to Purchaser comes into use or reference. (c) As soon as practical after the possession or under the control of a Seller Group Member, then Seller shall promptly transfer or cause its Affiliates to transfer such Regulatory Documentation Closing Date and in no event more than five (including all adverse events and complaints5) to Purchaser for no additional consideration. Purchaser and Seller further agree that, on Business Days following the Closing Date, Seller Parent shall, at its own cost and expense, deliver or cause to be delivered to Cardinal SPS (and/or any other third party logistics provider designated by Buyer), on behalf of Buyer (and/or one or more of its designated Subsidiaries), all Acquired Assets in physical possession of Integrated Commercialization Solutions, Inc. or any of Sellers’ other third party logistics providers, provided, however, that a four (4) weeks’ supply of Inventory shall submit be retained at Seller Parent’s third party logistics provider to support the Withdrawal Notice transition period pursuant to the FDATransition Services Agreement. Seller Parent shall, ensuring that copies are provided at Seller Parent’s cost and expense, continue to bear the risk of loss and maintain adequate insurance (or 56 self-insurance) against loss associated with the Acquired Assets until they have been delivered to Buyer’s designated shipper. From and after the time Buyer or Buyer’s designated shipper picks up the Acquired Assets from Seller Parent (or its agent), Buyer (and/or one or more of its designated Subsidiaries) shall bear all risk of loss for such items and shall be solely responsible for maintaining adequate insurance (or self-insurance) to protect the Acquired Assets against any such loss. However, for clarity, any Acquired Assets located at any of Seller Parent’s third party manufacturers pursuant to the appropriate FDA divisions. On terms of Business Contracts shall be deemed delivered “where is” effective as of the Closing Date and continue to be held by such third party manufacturers on Buyer’s (and/or one or more of its designated Subsidiaries’) behalf consistent with the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from the Seller Group Members, an exclusive option to transfer ownership of the Acquired Regulatory Approvals for governing Business Contract. (d) As soon as practical after the Closing Date and in no additional consideration event more than thirty (“Option”), exercisable by Purchaser upon written notice to Seller during the Option Exercise Period. The “Option Exercise Period” shall be (a30) if the Publication Date occurs on or prior to [***], the earlier of [***] days following the Publication Date or [***]; and (b) if the Publication Date occurs after [***] following the Publication Date. The transfer of ownership of the Acquired Regulatory Approvals shall be effective on the date on which Purchaser provides notice of exercise of the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller Parent shall provide an executed deliver to Buyer (or its designee) in physical and electronic form, the Books and Records. Promptly following the Closing, Seller FDA Letter Parent shall deliver to PurchaserBuyer a DVD, notifying CD, flash drive or similar electronic storage medium containing the FDA documents that Buyer has previously been granted access in the Acquired Regulatory Approvals have been transferred to Purchaser as “data room” maintained by Seller Parent in connection with Buyer’s review of the Option Business. (e) Seller Parent shall deliver, or instruct Seller Parent’s counsel to deliver, to Buyer (and/or one or more of its designated Subsidiaries) the original files of Seller Parent or Seller Parent’s counsel related to the Transferred Intellectual Property in the possession or control of Sellers promptly after the Closing Date (and in any case within thirty (30) days after the Closing Date). In additionSeller Parent shall also promptly forward, within [***] and/or instruct Seller Parent’s counsel to forward, to Buyer (and/or one or more of the Option Closing Date, upon written request of Purchaser, Seller will transfer to Purchaser its designated Subsidiaries) any “reserves” stored by Sharp Corporation pursuant correspondence or other communication related to the Contract Packaging Quality Agreement, dated August 19, 2021, between Transferred Intellectual Property that any Seller and Sharp Corporation, or any counsel to any Seller may receive from any intellectual property office in connection with the extent such material is availableTransferred Intellectual Property.

Transfer of Acquired Regulatory Approvals. Purchaser (a) The Seller and Seller agree that the Regulatory Documentation in the possession or under the control of a Seller Group Member, whether in hard copy or electronic form, will be transferred at Closing. If, at any time after the Closing, any Regulatory Documentation that has not already been transferred to Purchaser comes into the possession or under the control of a Seller Group Member, then Seller shall promptly transfer or cause its Affiliates to transfer such Regulatory Documentation (including all adverse events and complaints) to Purchaser for no additional consideration. Purchaser and Seller further agree that, on the Closing Date, Seller shall submit the Withdrawal Notice to the FDA, ensuring that copies are provided to the appropriate FDA divisions. On the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from establish a mutually acceptable and prompt communication and interaction process to ensure the Seller Group Members, an exclusive option to orderly transfer ownership of the Acquired Regulatory Approvals for no additional consideration (“Option”in accordance with Section 2.01(f) and Section 2.01(g), exercisable by Purchaser upon written notice to Seller during the Option Exercise Period. The “Option Exercise Period” Seller and the Purchaser shall be (a) if use all Commercially Reasonable Efforts to take any actions required by any Governmental Authority to effect the Publication Date occurs on or prior to [***], the earlier of [***] following the Publication Date or [***]; and (b) if the Publication Date occurs after [***] following the Publication Date. The transfer of ownership of the Acquired Regulatory Approvals shall be effective on from the date on which Purchaser provides notice of exercise of Seller to the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller shall provide an executed Seller FDA Letter to Purchaser, notifying and shall cooperate with each other in order to effectuate the FDA that foregoing transfer of the Acquired Regulatory Approvals. The Seller may retain an archival copy of any Acquired Regulatory Approvals have been transferred including supplements and records that are required to Purchaser as be kept under 21 C.F.R. §314.81. (b) Following the Closing, each of the Option Closing DateParties shall use its Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required Consents of, Governmental Authorities and furnishing all information required by applicable Law or requested by such Governmental Authorities. In additionEach Party shall cooperate fully with the other Party and its Affiliates in promptly seeking to make such required registrations and filings and obtain all required Consents. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the making of such required registrations and filings or the receipt of any required Consents. Each of the Parties shall each make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement promptly (and in any event, within [***] of after the Option Closing Date, upon written request of Purchaser, Seller will transfer Effective Date and shall supply as promptly as practicable to Purchaser the appropriate Governmental Authorities any “reserves” stored by Sharp Corporation additional information and documentary material that may be requested pursuant to the Contract Packaging Quality Agreement, dated August 19, 2021, between Seller and Sharp Corporation, HSR Act or other applicable antitrust laws. (c) Notwithstanding anything in this Agreement to the extent contrary, Purchaser shall take, or cause to be taken, all actions and shall do, or cause to be done, all things necessary, proper or advisable to eliminate each and every impediment under the HSR Act or any other antitrust law that is asserted by any Governmental Authority to permit the Closing to occur as promptly as reasonably practicable and in any event prior to the date that is [***] after the Effective Date or such material other date as mutually agreed to by the Parties in writing (such date, the “Outside Date”), including: (i) proposing, negotiating, committing to, effecting and agreeing to, by consent decree, hold separate order, or otherwise, the sale, divestiture, license, holding separate, and other disposition of or restrictions on the businesses, assets, properties, product lines, and equity or other business interests of, or changes to the conduct of business of the Purchaser (ii) creating, terminating, unwinding, divesting or assigning, subcontracting or otherwise securing substitute parties for relationships, ventures, and contractual or commercial rights or obligations of the Purchaser and (iii) otherwise taking or committing to take any action that would limit Purchaser’s freedom of action with respect to, or its ability to retain, hold or continue, directly or indirectly, any businesses, assets, properties, product lines, and equity or other business interests, relationships, ventures or contractual rights and obligations of the Purchaser. The Purchaser shall not be required to agree to take or enter into any such action described in clauses (i) through (iii) that is availablenot conditioned upon, or that becomes effective prior to, the Closing. (d) The Seller will reasonably cooperate with the Purchaser in disclosing any relevant records and reports which are required to be made, maintained and reported pursuant to applicable Law in the Territory with respect to the Acquired Regulatory Approvals and coordinating with the Purchaser to make an orderly and prompt transition of the Purchased Assets as soon as practicable after the Closing. (e) Following the Closing, upon request by Purchaser, the Seller will reasonably cooperate with the Purchaser and applicable Regulatory Authorities to enable the Purchaser to effectuate a conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA in order to effectuate First Commercial Sale by the Purchaser in the United States. All fees and expenses associated with the conversion of NDA number 212157 from “discontinued” status to active or “prescription” marketing status with the FDA, including all fees that were deferred during such discontinued status, shall be borne by the Purchaser.