Regulatory Technology Transfer Clause Samples

Regulatory Technology Transfer. Upon Company’s written request, Licensor shall (to the extent allowed or consented to by Law), at Licensor’s cost and expense, assign to Company all applications and filings made by or on behalf of Licensor with any Regulatory Authority with respect to any Products, including any IND, MAA or orphan drug designations or any other application for regulatory consultations or consideration, including sponsorship thereof (the “Regulatory Documents”). To the extent any of the Regulatory Documents cannot be assigned to Company, Licensor hereby grants to Company and its Affiliates an exclusive (even as to Licensor), worldwide, license and right of reference under the Regulatory Documentation (with the right to sublicense and grant further rights of reference) under the Regulatory Documents as necessary to research, Develop, manufacture, have manufactured, use, Commercialize and otherwise exploit the Compounds and Products.

Regulatory Technology Transfer. Effective after the Continuation Date, upon Company’s written request, Licensor shall (to the extent permitted by Law or otherwise), at Licensor’s cost and expense, assign to Company all applications and filings made by or on behalf of Licensor with any Regulatory Authority in the Company Territory with respect to the Collaboration Compound or Product, including any IND, MAA or orphan drug designations or any other application for regulatory consultations or consideration, including sponsorship thereof in the Company Territory. *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities Exchange Commission.

Regulatory Technology Transfer. Upon Company’s written request, Licensor shall (to the extent allowed or consented to by Law), at Licensor’s cost and expense, assign to Company (a) all applications and filings made by or on behalf of Licensor with any Regulatory Authority with respect to any Products, including any IND, MAA or orphan drug designations or any other application for regulatory consultations or consideration, including sponsorship thereof (the “Regulatory Documents”), and (b) those agreements related to the conduct of Clinical Trials with respect to the Compound or Product, if any, set forth on Schedule 2.4. To the extent any of the Regulatory Documents cannot be assigned to Company, Licensor hereby grants to Company and its Affiliates an exclusive (even as to Licensor), worldwide, license and right of reference under the Regulatory Documentation (with the right to sublicense and grant further rights of reference) under the Regulatory Documents as necessary to research, Develop, manufacture, have manufactured, use, Commercialize and otherwise exploit the Compounds and Products.

Regulatory Technology Transfer. Upon Company’s written request, Licensor shall, at Licensor’s cost and expense, assign to Company all applications and filings made by or on behalf of Licensor with any Regulatory Authority with respect to Licensed Product, including any IND (including the IND existing as of the Effective Date (the “Existing IND”)), BLA or orphan drug designations or any other application for regulatory consultations or consideration, including sponsorship thereof, as more fully detailed in Schedule 2.5. Notwithstanding the foregoing, the Parties acknowledge the assignment and transfer of all regulatory materials pursuant to this Section 2.5 is subject to the acceptance of the applicable Regulatory Authority. Accordingly, until such acceptance by each applicable Regulatory Authority, Licensor shall remain responsible for performing any tasks required by a Regulatory Authority, including, but not limited to, responding to any requests or communications with a Regulatory Authority; provided, however, that Licensor shall consult with Company regarding such obligations prior to taking any actions and Company shall have the final decision-making authority with respect to any such actions to be taken by Licensor.