Regulatory Transfers. 11.5.1. No later than thirty (30) days prior to the anticipated date of Regulatory Approval for the XLRS Product in the United States, the Parties shall finalize a mutually agreed regulatory transfer plan for the XLRS Product, which shall include a timeline for execution of such transfer. Thereafter, AGTC shall, at AGTC’s expense, commence transfer to Biogen of ownership of the INDs and Orphan Drug Designations and related filings and documentation for the XLRS Product submitted to any Regulatory Authority in the Territory, and the Marketing Application and related filings and documentation for the XLRS Product submitted to the FDA and the initial Regulatory Approval for the XLRS Product in the United States in accordance with such regulatory transfer plan, and shall complete such transfer within ninety (90) days after the date of Regulatory Approval for the XLRS Product in the United States, which time period may be extended due to a delay caused by a Regulatory Authority; provided, however, that with respect to any Orphan Drug Designations for the XLRS Product in the ROW Territory, AGTC shall transfer such Orphan Drug Designations to Biogen no later than sixty (60) days after the dosing of the first subject in the Pivotal Trial for the XLRS Product, which time period may be extended due to a delay caused by a Regulatory Authority. Thereafter, Biogen will be the sole owner of all INDs, Orphan Drug Designations, Marketing Applications, Regulatory Approvals and related filings and documentation submitted to any Regulatory Authority before, on or after the date of such transfer with respect to the XLRS Product in all countries in the Territory, to the extent that Biogen was not already the owner of any such INDs, Orphan Drug Designations, Marketing Applications, Regulatory Approvals or related filings and documentation in any country in the Territory. Notwithstanding the foregoing, Biogen may request that AGTC continue any ongoing Clinical Trials and, with respect to any associated regulatory filings or CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. TRIPLE ASTERISKS [***] DENOTE OMISSIONS. 53 documentation submitted to any Regulatory Authority with respect to any ongoing Clinical Trial that AGTC is continuing at Biogen’s request at the time of such transfer, AGTC shall not be obligated to transfer ownership of such regulatory filings or documentation to Biogen until the completion of such Clinical Trial.
Regulatory Transfers. 2.5.1 As soon as reasonably practicable following the Effective Date and following the instructions of Orchard, UCLB shall use all reasonable endeavours to (i) procure that UCL and the UCL Principal Researchers shall transfer to Orchard and do all things necessary to transfer to Orchard all Regulatory Submissions and Regulatory Incentives filed by, or in the name or under the control of, any of them (alone or in connection with others) in respect of each of the Projects, and (ii) transfer to Orchard all Materials under their control relating to the foregoing Regulatory Submissions and Regulatory Incentives.
Regulatory Transfers. (a) Notwithstanding anything to the contrary in this Agreement, upon delivery to the General Partner of a reasonably acceptable legal opinion that one or more members of the Class A Group’s continued ownership of Class A Preferred Units, directly or indirectly, would result in a violation of applicable Law, such members of the Class A Group (collectively, the “Regulatory Transferors”) will be entitled to Transfer all, but not less than all, of their Class A Preferred Units (collectively, the “Regulatory Units”) to one or more Third Parties that are not Competitors without consent from any other Person; provided that such Regulatory Transferors must first comply with the provisions of Section 6.8(b) (such Transfer, a “Regulatory Transfer”).
Regulatory Transfers. Except to the extent provided otherwise in the Transition Services Agreement, Buyer and Seller shall (a) cooperate with one another and use their respective reasonable best efforts to complete, execute and file with the applicable Governmental Authorities all documentation required to effect the transfer of the Purchased Regulatory Approvals as soon as reasonably practicable following the Closing; (b) without limiting the foregoing, file the Buyer FDA Transfer Letter and the Seller FDA Transfer Letter, respectively, with FDA promptly, but in any event within five Business Days, after the Closing Date; and (c) without limiting the foregoing, file the Buyer Health Canada Transfer Letter and the Seller Health Canada Transfer Letter, respectively with Health Canada promptly, but in any event within five Business Days, after the Closing Date. Except to the extent provided otherwise in the Transition Services Agreement, transfer of title to the Purchased Regulatory Approvals shall be effective as of the Closing. For clarity, Buyer shall be responsible for all out-of-pocket costs incurred in connection with any regulatory transfers contemplated in this Section 4.5 and in Section 4.6, including without limitation, costs arising from procurement of certain ancillary documents, registration file transfer, document transfer, archive copying and document legalization.
Regulatory Transfers. Except to the extent provided otherwise in the Transitional Services Agreement, Buyer and Seller shall (a) cooperate with one another and use their respective reasonable best efforts to complete, execute and file with the applicable Governmental Authorities all documentation required to effect the transfer of the Purchased Regulatory Approvals as soon as reasonably practicable following the Closing; and (b) without limiting the foregoing, file the Buyer FDA Transfer Letter and the Seller FDA Transfer Letter, respectively, with FDA promptly, but in any event within five Business Days, after Seller’s receipt of written notice from FDA acknowledging the filing of the DMF. Except to the extent provided otherwise in the Transitional Services Agreement, transfer of title to the Purchased Regulatory Approvals shall be effective as of the Closing.
Regulatory Transfers. (a) The Buyer shall file, at its own expense, as soon as possible after the Closing, requests for the re-issuance or transfer of the Transferred Product Registrations to show the Buyer or its Affiliates as the holder of the Transferred Product Registrations. The Buyer shall be solely responsible for the prosecution of such filings and for securing any such further approvals from any relevant Governmental Authority as may be required for the transactions contemplated by this Agreement or the operation of the Business following the Closing. The Buyer shall take all necessary steps to obtain the re-issuance or transfer of the Transferred Product Registrations described in this Section 5.12 as promptly and diligently as possible. The Buyer shall notify the Seller of the decision of any relevant Governmental Authority with respect to such re-issuance or transfer within three Business Days after such decision. The Seller shall provide all reasonable assistance with the re-issuance or transfer of the Transferred Product Registrations as may be necessary or appropriate for the Buyer to effect such re-issuance or transfer in accordance with this Section 5.12.
Regulatory Transfers. Buyer and Sellers shall file the Buyer FDA Transfer Letters and the Sellers FDA Transfer Letters, respectively, with FDA on the date reasonably determined by Sellers that is no later than January 30, 2018. Except to the extent provided otherwise in the Transitional Services Agreement, transfer of title to the Purchased Regulatory Approvals shall be effective as of the Closing. Except to the extent provided otherwise in the Transitional Services Agreement, promptly after the Closing and in any event within 120 calendar days after the Closing, provided that Buyer transfers the relevant delegation of authority to Sellers prior to such time, Sellers and Buyer shall make all appropriate filings and submissions with Governmental Authorities, including the Centers for Medicare & Medicaid Services, the Veteran’s Administration and the FDA to transfer all regulatory responsibilities in respect of the Products, if any (excluding all retained Liabilities and except as contemplated by Section 4.6 and the Transitional Services Agreement). Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential Portions are marked: [***]
Regulatory Transfers. Seller and Buyer shall reasonably cooperate with each other to file (a) no later than five Business Days after the Closing Date, all appropriate and necessary transfer documentation with respect to the Purchased Regulatory Approvals, and (b) as soon as practicable following the Closing Date, all appropriate and necessary documentation with respect to obtaining FDA approval of the removal of the Seller Marks from the REMS supporting documentation and the inclusion of Buyer’s biologics license number, name, corporate logo and NDC on Product labeling.
Regulatory Transfers. 5.5.1 As soon as practicable after the Execution Date and in any event within 30 days prior to the Closing Date, Buyer and Seller shall agree on a timetable and plan for the Transfer of the Purchased Product Registrations to Buyer and its Affiliates (the “Transfer Plan”), taking into account regulatory procedures relating to the Transfer of the Purchased Product Registrations. Buyer and Seller shall (and shall cause their respective Affiliates to) use their respective commercially reasonable efforts, in accordance with the Transfer Plan, to (a) cooperate with one another and (b) complete and execute all documentation required, in each case, to effect the Transfer of the Purchased Product Registration at Closing or as soon as reasonably practicable following the Closing. Buyer and Seller shall prepare and file all documents necessary to Transfer the Purchased Product Registrations as promptly and as diligently as possible in accordance with the Transfer Plan. In each case, the filing Party shall use commercially reasonable efforts to provide the non-filing Party with advanced drafts of any documents to be filed with a Governmental Authority pursuant to this Section 5.5.1 and give the non-filing Party the right and a reasonable amount of time to review and comment on the same prior to filing. The filing Party shall consider in good faith any reasonable comments timely provided by the non-filing Party.
Regulatory Transfers. The Seller agrees to, and to cause its Affiliates and other business associates to, cooperate with the Purchaser (subject to Purchaser reimbursing Seller for any costs or other expenses incurred by Seller or its Affiliates related to regulatory transfers) following the Closing Date to transfer all regulatory approvals and product registrations of the Seller to the Purchaser or its designee. In connection therewith, the Seller shall execute and deliver to the Purchaser a regulatory letter in the form of Exhibit F to this Agreement at Closing. The Seller grants to the Purchaser the right to refer to the Seller’s regulatory filings related to the manufacture, marketing, sale and distribution of each of the Products. Upon request from the Purchaser, the Seller will supply the Purchaser with copies of such filings.
