Combination Therapies Clause Samples
The Combination Therapies clause defines how products or treatments that involve the use of multiple therapeutic agents, including the licensed product and one or more additional components, are addressed within the agreement. It typically outlines how rights, obligations, and financial terms such as royalties or revenue sharing apply when the licensed product is sold or used as part of a combination with other drugs, devices, or therapies. This clause ensures that both parties understand how to handle the complexities of combination products, preventing disputes over revenue allocation and clarifying each party’s entitlements in such scenarios.
Combination Therapies. (a) The JRDC shall discuss whether to include in the Development Plan for a Product the Development of such Product for use with other products to the extent not already provided for in the Development Plan (each, a “Combination Therapy”), including products developed or sold by a Third Party or that are in the public domain. Subject to this Section 5.3, each Party shall have the right to propose to the JRDC studies for co-development of Products with other products under the applicable Development Plan.
(b) The Development Plan shall address the conduct of any Clinical Trial for a Combination Therapy and shall (i) specify which Party will be responsible for each activity for the Development of such Combination Therapy and (ii) specify which Party will be responsible for obtaining supplies of the Product or other product in such Combination Therapy as necessary. The JRDC shall review and approve the terms of any agreement with a Third Party in connection with any supply or other aspect of Development of such Combination Therapy.
Combination Therapies. (a) Notwithstanding anything to the contrary herein, the development of any Antibody that is the subject of development under the Discovery Program (and that is not an IO Antibody or a Multi-Indication Antibody or a Refused Candidate) for use in combination with (i) any IO Discovery Program Antibody shall be permitted under this Agreement and governed by Section 2.10(b)(ii) of the IO Discovery Agreement, and (ii) any IO Licensed Product shall be permitted under this Agreement and governed by Section 5.6(d)(i) of the IO License and Collaboration Agreement.
(b) If the Parties do not agree to the development of any Antibody that is the subject of development under the Discovery Program (and that is not an IO Antibody or a Multi-Indication Antibody or a Refused Candidate) for use with an IO Discovery Program Antibody that is proposed by [***], then, notwithstanding anything to the contrary herein, [***] may [***].”
Combination Therapies. (a) The development of any Licensed Product for use with an “IO Discovery Program Antibody” (as defined in the IO Discovery Agreement) shall be permitted under this Agreement and governed by the terms of Section 2.10(b)(ii) of the IO Discovery Agreement. The development of any Licensed Product for use with an IO Licensed Product shall be permitted under this Agreement and governed by the terms of Section 5.6(d)(i) of the IO License and Collaboration Agreement. Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets and three asterisks [***], have been separately filed with the Commission.
(b) If the Parties do not agree to the development of any Licensed Product for use with an IO Licensed Product that is proposed by [***], then, notwithstanding anything to the contrary herein, [***] may [***].
(c) If the Parties do not agree to the development of any Licensed Product for use with an IO Discovery Program Antibody that is proposed by [***], then, notwithstanding anything to the contrary herein, [***] may [***].”
Combination Therapies. (a) The development of any Licensed Product for use with an "IO Discovery Program Antibody" (as defined in the IO Discovery Agreement) shall be permitted under this Agreement and governed by the terms of Section 2.10(b)(ii) of the IO Discovery Agreement. The development of any Licensed Product for use with an IO Licensed Product shall be permitted under this Agreement and governed by the terms of Section 5.6(d)(i) of the IO License and Collaboration Agreement.
(b) If the Parties do not agree to the development of any Licensed Product for use with an IO Licensed Product that is proposed by [***], then, notwithstanding anything to the contrary herein, [***] may [***].
(c) If the Parties do not agree to the development of any Licensed Product for use with an IO Discovery Program Antibody that is proposed by [***], then, notwithstanding anything to the contrary herein, [***] may [***]."
Combination Therapies. (a) [ * ]. For clarity, during the Term, [ * ] shall be [ * ] (b) [ * ]. Notwithstanding anything to the contrary (including Section 5.2.4(b)) hereunder, but subject to Section 3.2.4(b)(vi), after the [ * ] anniversary of the Effective Date, if SeaGen proposes a Clinical Trial for use of the Licensed Product in combination (including concomitant or sequential therapy) with a [ * ] (alone or in further combination with one or more other products approved for the applicable tumor type) for consideration by the JSC under Section 5.2.4(b), and such Clinical Trial for such combination is not approved to be included in the Development Plan by Merck through the JSC within [ * ] days following SeaGen’s request, then SeaGen (or its Affiliates) may carry out such Clinical Trial (alone or with any Third Party) for the Licensed Product for use in combination (including concomitant or sequential therapy) with such [ * ] (such Clinical Trial, a [ * ] and such combination therapy, a [ * ]), provided that (i) SeaGen (and its Affiliates), as applicable, [ * ] and (ii) SeaGen (and its Affiliates) [ * ]. Notwithstanding anything to the contrary hereunder, Section [ * ] shall apply[ * ]. For purposes of [ * ].