Regulatory Transfer. The Investor represents that, to its knowledge as of the date the Investor executes this Agreement, the Investor is not aware of any laws, regulations or similar considerations that would prohibit its participation in this Agreement or the applicable Note. Notwithstanding anything to the contrary in this Agreement, to the extent that any laws, regulations or similar considerations applicable to the Investor do not permit the Investor to continue to hold interests in this Agreement or the applicable Note, the Investor understands and agrees that the Issuer may, with prior consent and cooperation of NextSeed, require the Investor to Transfer its interests under this Agreement and the applicable Note to the Issuer (such Transfer, a “Regulatory Transfer”), in an amount equal to the unpaid balance of the Principal or an amount otherwise required by the applicable law, regulation or similar consideration requiring such Regulatory Transfer. Each Investor agrees and consents that the Issuer may take any actions that may be necessary or advisable to effectuate the intent of this Section 9(g).
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. 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. 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. 20 9.8 Post-Closing Delivery......................................... 20 9.9
Regulatory Transfer. Xxxxxx 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. Xxxxxx will make a prompt subsequent orderly transfer of the related regulatory documents to Cerus.
Regulatory Transfer. No later than [*] following the database lock for clinical data under the Current Phase III Protocol uniQure will, or will cause its designee to, transfer and assign to Partner all rights, title, and interests in and to all Regulatory Approvals, Reimbursement Approvals, and all other Regulatory Submissions required under Applicable Law in the Territory to be held by Partner related to Commercialization or Development of the Licensed Product in the Field in the Territory in the possession and Control of uniQure, its Affiliates, or designees (the “Assigned Regulatory Materials”), including copies of all such Assigned Regulatory Materials in electronic format, or such other format maintained by uniQure or its designee or otherwise agreed by the Parties. uniQure shall promptly, but no later than [*] after the Effective Date, provide Complete Regulatory Files for all interactions with any Regulatory Authorities or Governmental Authorities in the Territory, and a catalogue of the Complete Regulatory Files, in a format that is suitable for Partner’s electronic storage system. “Complete Regulatory Files” means (a) each individual sequence submitted in its entirety, unaltered from the original submission, including: (i) full folder structure of each individual sequence, (ii) portable document format (“PDF”) all documents submitted within that sequence, and (iii) all extensible markup language (“XML”) documents submitted in that sequence; (b) documentation submitted to or received from, and oral or written correspondence with, any Regulatory Authorities or Governmental Authorities related to the Licensed Products and any companion diagnostic, including meeting minutes, notes pertaining to formal or informal discussions, electronic mail correspondence, telephone conversation records, Regulatory Submissions, and communications related to Clinical Trials, Development, and Manufacturing, and (c) all technical information relating to the Licensed Products that uniQure has in its possession and that is required to be submitted to a Regulatory Authority for the purpose of obtaining any Regulatory Approval of the Licensed Products. The Parties will review and discuss the detailed timeline and each Party’s roles and responsibilities through the JSC and will consult with applicable Regulatory Authorities regarding such assignment and transfer sufficiently in advance thereof.
Regulatory Transfer. Promptly after the CD123 Option Effective Date, MacroGenics will, or will cause its designee to, transfer and assign (and hereby does assign and transfer) to Gilead all rights, title and interests in and to all INDs and all other Regulatory Submissions that solely relate to MGD024 and the MGD024 Product (the “Assigned Regulatory Materials”), including copies of 48 all such Assigned Regulatory Materials in electronic format, to the extent the same have not been previously made available to Gilead, which transfer will [***] the CD123 Option Effective Date.
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.
