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.
2.5.2 Until such time as all the Regulatory Submissions and Regulatory Incentives referred to or subject to the provisions of Clause 2.5.1 are transferred into the name or control of Orchard, UCLB shall procure that UCL and the UCL Principal Researchers shall:
(a) hold the same on trust and on behalf of Orchard and shall not dispose of, allow to lapse, transfer or license to another (other than Orchard or its designee) or otherwise deal in, amend or vary any of the Regulatory Submissions and Regulatory Incentives without the prior written consent of Orchard, not to be unreasonably withheld or delayed;
(b) promptly and within [***] of receipt, forward to Orchard any and all communications received with respect to any of the Regulatory Submissions and Regulatory Incentives; and,
(c) do all things and all acts as may reasonably be requested by Orchard in connection with the Regulatory Submissions and Regulatory Incentives including writing to Regulatory Authorities with respect to the same.
2.5.3 UCLB shall not, and shall procure that UCL and the UCL Principal Researchers shall not, other than at Orchard’s request or in order to comply with this Agreement, file any Regulatory Submission or seek or obtain any Regulatory Incentives with respect to any Gene Therapy Product which is being developed as of the Effective Date without Orchard’s prior written consent, not to be unreasonably withheld or delayed.
2.5.4 If during the period of [***] from the Effective Date, any member of the Xxxxxx Research Group and/or Xxxxxxxx Research Group (operating under the direction or supervision of either of the UCL Principal Researchers, including the UCL Principal Researchers themselves) intends to file any Regulatory Submission or seek or obtain any Regulatory Incentives with respect to any gene therapy product or therapy directed to any of the Indications, then the follo...
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 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.
11.5.2. No later than thirty (30) days prior to the anticipated date of completion of the Clinical Study Report for such FIH Trial, which Clinica...
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.
(b) The Buyer is hereby granted permission to conduct the Business for its own account during the period from the Closing Date until the date on which all Transferred Product Registrations have been transferred to or obtained by the Buyer or its Affiliates under the Transferred Product Registrations held by the Seller or its Affiliates as of the Closing Date.
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. 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. 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. 5.8.1 Schedule 5.8.1 sets forth a timetable and plan for the Transfer of each Purchased Marketing Authorization to Buyer or its applicable designee pursuant to this Section 5.8 (such schedule, the “Marketing Authorizations Transfer Plan”). Buyer shall provide Seller with details of the identity of each Person to whom Xxxxx proposes to Transfer a Purchased Marketing Authorization pursuant to this Section 5.8.1 pursuant to and in accordance with the Marketing Authorizations Transfer Plan and shall ensure that all proposed transferees of Purchased Marketing Authorizations are legally authorized to hold the Purchased Marketing Authorizations to be Transferred to them and Exploit the Products in the jurisdictions covered by such Purchased Marketing Authorizations. Seller shall promptly notify Buyer if Seller reasonably believes that any proposed transferee does not meet the criteria in the immediately preceding sentence or Seller has experienced significant product quality or legal or regulatory compliance issues with such proposed transferee. The Parties may, in accordance with the Marketing Authorizations Transfer Plan, discuss Seller’s reasons for such belief and whether any Purchased Marketing Authorizations should be transferred to such proposed transferee, and Buyer shall consider Seller’s reasonable comments in good faith; provided that, unless Seller reasonably believes that it cannot lawfully effect such Transfer to such proposed transferee (in which case Buyer shall identify another proposed transferee to accept such Purchased Marketing Authorization), Buyer shall have sole discretion as to the identity of the proposed transferee. Unless otherwise agreed in writing by Xxxxxx, Buyer shall not permit any proposed transferee to which Xxxxxx has objected under this Section 5.8
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. Subject to applicable law and in compliance with the terms of this Agreement (other than Section 3.4(a), Section 3.7, Section 3.8 and Section 3.10), and subject to the terms of this Section 3.4(e), to the extent an Investor (or its Permitted Transferees) has a Regulatory Issue such Limited Partner shall be permitted to Transfer the Units of such Limited Partner to any Person (an “Unaffiliated Transferee”) if (i) the General Partner approves the Unaffiliated Transferee (such approval not to be unreasonably withheld, but it being understood that, among other reasons, it is reasonable for the General Partner to withhold its approval of any Unaffiliated Transferee if (x) a Transfer of Units to such Unaffiliated Transferee would mandate any filings or disclosure obligations pursuant to any laws or regulations (other than customary Securities and Exchange Commission filings regarding ownership), (y) such Unaffiliated Transferee is a competitor of the Partnership, SXE or any of their respective Subsidiaries or (z) granting such Unaffiliated Transferee the rights under this Agreement would breach any contractual obligation of the Partnership or its Subsidiaries), (ii) such Unaffiliated Transferee signs a joinder to this Agreement as a Limited Partner and such other documentation reasonably acceptable to the General Partner and (iii) if requested by the General Partner, prior to effecting the Transfer to the Unaffiliated Transferee, such Limited Partner makes all additional Capital Contributions contemplated by Exhibit A to be made by such Limited Partner and receives Class B Units in respect thereof in amount equal to the quotient obtained by dividing the amount of such additional Capital Contributions by the Class B Issue Price.
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).
