Regulatory Transfer Sample Clauses

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready Licensed Product basis, promptly following the JSC’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3, Hookipa shall, and hereby does, assign and transfer to Gilead (or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate.

Regulatory Transfer. Seller agrees to make available to Buyer at Seller's offices all portions of the NDA 76-1021 file that Seller has not previously delivered to Buyer pursuant to Section 4.2(c) as soon as practicable but in no event later than 180 days after the Closing Date.

Regulatory Transfer. At Closing, Seller will provide to Buyer copies of all portions of NDA 76-1021 and the SNDAs necessary to allow Buyer to comply with its obligations as the application holder. Seller further agrees to notify the FDA of the transfer of NDA 76-1021 in accordance with Section 505(j) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.72. Buyer agrees to notify the FDA of the transfers of NDA 76-1021 and SNDAs effective immediately upon the Closing and to submit as the new owner an application Form FDA 356h.

Regulatory Transfer. If a Common Holder reasonably determines and delivers written notice to the Company that its holding of shares of Company Stock (x) has resulted in a violation of any law or governmental rule, regulation, order or decree to which such Common Holder is subject, or (y) has caused such Common Holder to become subject to and be required to comply with any law, regulation, order or decree to which it was not theretofore subject, the result of which violation or subjection and compliance, as the case may be, would be materially adverse to such Common Holder, the Company shall use its commercially reasonable efforts, after such Common Holder has complied with Section 1(b), to locate on behalf of the Common Holder a purchaser for all or part of the Company Stock held by such Common Holder.

Regulatory Transfer. 20 9.8 Post-Closing Delivery......................................... 20 9.9

Regulatory Transfer. ▇▇▇▇▇▇ hereby transfers to Cerus the regulatory rights and future responsibility for the Platelet System, the Plasma System and the RBC System in the respective Reverted Rights Regions applicable to each such System as of such date. ▇▇▇▇▇▇ will make a prompt subsequent orderly transfer of the related regulatory documents to Cerus.

Regulatory Transfer. (a) Relay shall (i) as promptly as possible and in any event in accordance with the timing set forth in the Technology Transfer Plan, provide all Regulatory Materials that relate to the Lead Candidate and Lead Product and (ii) promptly after the Effective Date use Commercially Reasonable Efforts to expeditiously transfer and assign to Licensee Relay’s entire right, title, and interest in and to the IND for the Lead Product in the Relay Phase Ia Trial (the “Relay IND” and such transfer, the “Relay IND Transfer”) ((i) and (ii) collectively, the “Regulatory Transfer”). The Regulatory Transfer will be conducted in accordance with the requirements of the Technology Transfer Plan, including the timing, method and format requirements set forth thereon. Relay will make available its personnel (and use Commercially Reasonable Efforts to cause its Third Party Subcontractors with relevant subject matter expertise to be available) on a reasonable basis to consult with Licensee with respect to the Regulatory Transfer. (b) As part of the Regulatory Transfer, Relay shall (i) duly execute and send to the FDA (with confirmed receipt) a letter transferring ownership of the Relay IND and designation as the sponsor for such Relay IND to Licensee, including an update to the Sponsor obligations as set forth in Schedule 3.2.3 attached hereto (the “Transfer of Sponsor Obligations”) executed by Relay, Licensee and the Relay Phase Ia Trial CRO, and deliver to Licensee copies thereof and (ii) execute or agree upon any necessary agreements (pursuant to Section 3.3.8 or 3.3.9) or amend any existing agreements (pursuant to Section 3.3.7), as necessary as part of such Relay IND Transfer. All such activities are a condition to completion of the Relay IND Transfer. (c) It is understood and agreed that there may be additional Regulatory Materials that are not identified at the time of the Regulatory Transfer but which are thereafter identified and are necessary or reasonably useful for the Regulatory Transfer. If, after the Regulatory Transfer, either Party identifies any additional Regulatory Materials with respect to the Lead Candidate or Lead Products in the Field in the Territory, such Party shall notify the other Party, and if such additional Regulatory Materials are in Relay’s Control and possession, then Relay shall transfer such additional Regulatory Materials to Licensee promptly after such identification and notification. (d) To the extent any additional Regulatory Materials are ...

Regulatory Transfer. In the event it becomes unlawful for a Preferred Member to continue to hold its Units, in whole or in part, or some or all of the Units held by a Preferred Member, or restrictions are imposed on a Preferred Member by any statute, regulation or governmental authority which, in the reasonable judgment of such Preferred Member, gives rise to a limitation under Applicable Law that will materially impair the ability of such Preferred Member or any of their respective Affiliates to conduct their respective businesses (a “Regulatory ​ ​ Requirement”), (a) such Preferred Member shall promptly inform the Company and of the occurrence of such Regulatory Requirement, to the extent permitted by Applicable Law, (b) Reorganized PublicCo and its controlled Affiliates, the Members and such Preferred Member shall cooperate in good faith to restructure the terms of such investment by such Preferred Member, including by amendment to this Agreement or any other agreement in a manner acceptable to the Company, such Preferred Member and the Members required to approve such amendment under the terms of this Agreement so as to remediate the circumstances giving rise to such Regulatory Requirement; provided, however, in no event shall the Company or any Member be required to agree to any amendment pursuant to this Section 13 if such amendment would adversely affect any material preference or right or increase or create any material obligation, in each case, of the Company or any Member set forth in this Agreement or any other agreement, without the consent of the Company and such Member, and (c) without limitation of the remedies available pursuant to the immediately preceding clause (b), such Preferred Member shall be permitted to sell or otherwise transfer its Units to any other Person, including any other Member, and Reorganized PublicCo and its controlled Affiliates shall, at such Preferred Member’s sole cost and expense, use commercially reasonable efforts to assist such Preferred Member in facilitating a sale or transfer by such Preferred Member of any or all of its Units of the Company as may be reasonably requested by such Preferred Member subject to Section 10.01(b) and Section 10.02. ​ ​ EXHIBIT A​ THIS JOINDER (this “Joinder”) to the Amended and Restated Limited Liability Company Agreement of Capstone Green Energy LLC, a Delaware limited liability company (the “Company”), dated as of December 7, 2023, as amended or restated from time to time, by and among the Company an...

Regulatory Transfer. BeiGene and its Affiliates hereby transfer and assign to BioAtla all rights, titles and interests in Regulatory Documentation in connection with the Collaboration Agreement, all BioAtla Know-How and any materials constituting BioAtla Know-How related to Candidates and the Products that BeiGene or its Affiliates received under the Collaboration Agreement, including without limitation any Regulatory Documentation and Regulatory Approvals as part of the Initial Technology Transfer and Technology Transfer pursuant to Amendment No. 2 thereto.