Regulatory Contract Clauses (67)

Regulatory. 5.1.1 As between the Parties, Adaptimmune shall be responsible for holding and applying for any Regulatory Approvals or MAAs in relation to the Product and for sponsoring any Clinical Trials (including holding the IND). Adaptimmune shall have sole decision making authority in relation to any sponsorship of any Clinical Trials or progression of any Products through Clinical Trials and including the decision on whether to apply for any MAAs. 5.1.2 Adaptimmune shall be primarily responsible, and ac...t as the sole point of contact, for communications with Regulatory Authorities in connection with the development, commercialisation, and manufacturing of such Product. To the extent Noile-Immune is required to provide any information or response to a Regulatory Authority, such response will be discussed with Adaptimmune to the extent practicable and responding Party shall provide only such information as is necessary to comply with its legal obligations unless otherwise mutually agreed. Noile-Immune shall copy Adaptimmune on any material correspondence in relation to a Product (or anything which is likely to affect the safety or regulatory approval of any Product) received from a Regulatory Authority and where reasonably possible provide Adaptimmune an opportunity to comment on such correspondence. 5.1.3 Notwithstanding the foregoing, Noile-Immune shall provide such assistance as may reasonably be requested by Adaptimmune relating to regulatory matters (including preparation and filing for any INDs and MAAs and obtaining and maintaining Regulatory Approvals). Such assistance will include, without limitation, a right to reference the other Party's DMF(s), IND(s), and other regulatory filings, and to reference and utilize all toxicology/safety and other relevant scientific data developed by Noile-Immune solely in connection with a Product. Noile-Immune shall provide a letter of cross reference (or a letter of authorization) to Adaptimmune's regulatory filings upon request from Adaptimmune, to effectuate the provisions of this Clause 5.1.3 or alternatively (and including where no letter of cross reference is available) provide to Adaptimmune all relevant information in relation to the Noile-Immune Technology as may be reasonably required by Adaptimmune for Adaptimmune to prepare and file any documentation for any Regulatory Approval or to respond to any Regulatory Authority. 5.1.4 Nothing in this Clause 5.1 shall require any Party to breach its obligations to any Regulatory Authority under Applicable Law and/or its confidentiality obligations to any third party under non-disclosure agreement or other similar agreement. Page 15 6. COMMERCIALISATION 6.1 Commercialisation Generally. Adaptimmune shall use its Commercially Reasonable Efforts to commercialise and promote any Product following its decision to progress to filing an IND in relation to such Product. Adaptimmune shall be primarily responsible for and shall have sole decision making authority in relation to the commercialisation, manufacture and promotion of the Product following filing of IND; [***]. 6.2 Commercialisation Updates. Adaptimmune shall keep Noile-Immune informed of its commercialisation of any relevant Product and will provide [***] updates to Noile-Immune summarising progress in the development and commercialisation of any Products in relation to which any Research Plan has been completed. 6.3 Safety Event Reporting. Additionally, each Party shall provide to the other Party prompt written notice of any material safety events pertaining to any Product of which it becomes aware including any SUSARs, SAEs or other material events which might have general applicability to the development of any Product or the use of the Noile-Immune Technology in patients. The Parties will agree the terms of a pharmacovigilance agreement if reasonably required to facilitate such safety event reporting. View More

Regulatory. 6.1 Terns' Responsibilities. Terns will be responsible for all regulatory activities, at its cost, leading up to and including the obtaining of the Regulatory Approvals for the Covered Product from the Governmental Authority or Regulatory Authority on a country-by-country basis. Terns or its designee shall make, hold and own all Regulatory Filings and Regulatory Approvals. Terns shall only be required to apply for Regulatory Approval in those countries that in its sole discretion are commerciall...y viable. 6.2 Regulatory Obligations and Cost. Terns shall be responsible for the regulatory strategy, including strategy for filings and label content. Terns shall be solely responsible for all regulatory activities in connection with seeking Regulatory Approvals in the Territory, including communicating and preparing and filing all reports with the Regulatory Authorities. However, upon Terns reasonable request, Lilly agrees to reasonably cooperate with Terns, at [***] expense (which shall include [***]), if requested, in providing consultation with respect to the preparation and filing of all such reports, provided that under no circumstance shall Lilly's cooperation described above exceed [***]. All governmental fees associated with obtaining and maintaining any and all Regulatory Approvals shall be paid by Terns. View More

Regulatory. Lessee shall obtain and maintain in full force and effect any necessary certificates, licenses, permits and authorizations required for its use and operation of the Aircraft hereunder. Lessee agrees to conduct all operations contemplated by this Lease in compliance with all applicable provisions of the FARs, including, but not limited to, Part 91 thereof.