New Regulatory Materials Clause Samples
The "New Regulatory Materials" clause defines how parties to an agreement will address the introduction of new laws, regulations, or official guidance that may affect their contractual obligations. Typically, this clause outlines procedures for notifying the other party when such regulatory changes occur and may require the parties to negotiate in good faith to amend the agreement to comply with the new requirements. Its core function is to provide a mechanism for adapting the contract to evolving legal or regulatory environments, thereby reducing the risk of non-compliance and ensuring the agreement remains enforceable.
New Regulatory Materials. All Regulatory Materials generated or arising from or in connection with activities under this Agreement after the Option Effective Date with respect to Licensed Products shall be owned by and held in the name of Gilead or its designee, and, except for Existing Regulatory Materials (which are addressed in Section 5.2.1), and any such Regulatory Materials issued in the name of Agenus, its Affiliates or contractors shall promptly following the Option Effective Date be assigned by Agenus to Gilead or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Gilead or its designee.
New Regulatory Materials. Without limiting Section 5.2.1 (Assignment of Regulatory Materials), all Regulatory Materials generated or arising from or in connection with activities under this Agreement with respect to Licensed Compounds or Licensed Products will be owned by and held in the name of Company or its designee, and any Regulatory Materials issued in the name of Maze or its Affiliates will promptly be assigned by Maze to Company or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Company or its designee.
New Regulatory Materials. All Regulatory Materials generated or arising from or in connection with activities under this Agreement with respect to Licensed Products after the Degrader License Effective Date for such Licensed Product will be owned by and held in the name of Seagen or its designee, and, except for Existing Regulatory Materials (which are addressed in Section 7.2.1 (Existing Regulatory Materials)), any such Regulatory Materials issued in the name of Nurix, its Affiliates or contractors will, promptly following the applicable Degrader License Effective Date, be assigned by Nurix to Seagen or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Seagen or its designee.
New Regulatory Materials. Except as set forth below, all Regulatory Materials for the Licensed Compound or the Licensed Product generated by Novartis under this Agreement in the Novartis Territory shall be owned by and held in the name of Novartis or its designee, and, except for the Existing Regulatory Materials (which are addressed in Section 4.2.1), any such Regulatory Materials issued in the name of BeiGene or its Affiliates shall promptly be assigned by BeiGene to Novartis or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Novartis or its designee. Notwithstanding the foregoing, all Regulatory Materials for any BeiGene Permitted Combination Products in Permitted Combinations in the Novartis Territory shall be owned by and held in the name of BeiGene or its designee.
New Regulatory Materials. All Regulatory Materials generated or arising from or in connection with activities under this Agreement with respect to Licensed Products in the Field in the Territory, including solely with respect to the Licensed Antibody portion of any Innovent Combination Product (the “New Regulatory Materials”) shall be owned by and held in the name of Coherus or its designee, provided, that in the event such ownership is not permitted under Applicable Law with respect to one or more of such New Regulatory Materials, Innovent shall hold such New Regulatory Materials in trust for, or for the sole benefit of, Coherus or its designee.
New Regulatory Materials. All Regulatory Materials generated or arising from or in connection with activities under this Agreement or any Ancillary Agreement with respect to Development Candidates, backups thereto or Licensed Products after the Effective Date for such Licensed Product will be owned by and held in the name of Sanofi or its designee, and, except for Existing Regulatory Materials (which are addressed in Section 5.2.1 (Existing Regulatory Materials)), any such Regulatory Materials issued in the name of Nurix, its Affiliates or contractors will, promptly be assigned by Nurix to Sanofi or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Sanofi or its designee.