Exclusive Right to Commercialize Products. During the Business Planning Period, FMI will continue to be responsible for and will book all sales of Products in the Territory. After the Business Planning Period, Roche and its Sublicensees shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory, subject to activities designated for FMI to conduct under a Tactical Plan approved by the JOC. To the extent applicable, the foregoing right shall be subject to the rights granted under the Existing Third Party Rights. If FMI receives any order from a prospective purchaser located in a country in the Territory, FMI shall promptly refer that order to Roche, and Roche shall process such order for such purchaser in the Territory in accordance with the terms of this Agreement. If Roche receives any order from a prospective purchaser located in the FMI Territory, then Roche shall promptly refer that order to FMI. The Parties will discuss an appropriate transition plan for the Existing Third Party Rights. However, after the Business Planning Period, at Roche’s request, and to the extent possible under the Existing Third Party Rights without incurring any termination fee, penalty or similar fee, FMI will terminate any or all of the Existing Third Party Rights. Notwithstanding the above, if there is any termination fee, penalty or similar fee, Roche shall have the right to pay such termination fee, penalty or similar fee to terminate any or all of the Existing Third Party Rights. Moreover, Roche shall have the right, in coordination with FMI, to engage in negotiations with the Third Parties to which the Existing Third Party Rights pertain, with the intent of allowing Roche to intervene to terminate such Existing Third Party Rights. Unless otherwise agreed expressly by the Parties, for any companion diagnostic assay Product that is also for use in indicating a therapeutic or referencing a clinical trial of a Third Party (“Universal CDx Product”), such Third Party shall have the right to recommend use of such Universal CDx Product in the Territory to the extent allowable under Applicable Law, including using or referencing such Universal CDx Product name, logo and trade dress in such Third Party therapeutics label, package insert, or in its promotional and regulatory materials.
Appears in 2 contracts
Samples: Ex Us Commercialization Agreement (Foundation Medicine, Inc.), Ex Us Commercialization Agreement (Foundation Medicine, Inc.)
Exclusive Right to Commercialize Products. During Subject to the Business Planning Period, FMI will continue to be responsible for and will book all sales terms of Products in the Territory. After the Business Planning Periodthis Agreement, Roche and its Sublicensees shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory, subject to activities designated for FMI to conduct under a Tactical Plan approved by the JOC. To the extent applicable, the foregoing right shall be subject to the rights granted under the Existing Third Party Rights. If FMI receives any order from a prospective purchaser located in a country in the Territory, FMI shall promptly refer that order to Roche, and Roche shall process such order for such purchaser in the Territory in accordance with the terms of this Agreement. If Roche receives any order from a prospective purchaser located in the FMI Territory, then Roche shall promptly refer that order to FMI. The Parties will discuss an appropriate transition plan for the Existing Third Party Rights. However, after the Business Planning Period, at At Roche’s request, and to the extent possible under the Existing Third Party Rights without incurring any termination fee, penalty or similar fee, FMI will terminate any or all of the Existing Third Party Rights. Notwithstanding the above, if there is any termination fee, penalty or similar fee, Roche shall have the right to pay such termination fee, penalty or similar fee to terminate any or all of the Existing Third Party Rights. Moreover, Roche shall have the right, in coordination with FMI, to engage in negotiations with the Third Parties to which the Existing Third Party Rights pertain, with the intent of allowing Roche to intervene to terminate such Existing Third Party Rights. Unless otherwise agreed expressly by the Parties, for any companion diagnostic assay Product Product, that is also for use in indicating a therapeutic or referencing a clinical trial of a Third Party (“Universal CDx Product”), such Third Party shall have the right to recommend use of such Universal CDx Product in the Territory to the extent allowable under Applicable Law, including using or referencing such Universal CDx Product name, logo and trade dress in such Third Party therapeutics label, package insert, or in its promotional and regulatory materials. Without limiting the foregoing, Third Parties with Regulated Claims on a Universal CDx Product, including F1CDx, in any country shall be permitted, to the extent permitted by Applicable Law, to recommend the use of and promote a Universal CDx Product, including F1CDx, to their customers, including as a companion diagnostic for such Third Party’s therapeutics. To the extent that FMI enters into any in vitro diagnostic development agreement with any Third Party that contemplates a Regulated - 13 - ***Confidential Treatment Requested*** Claim on F1CDx in the Territory, and to the extent such Third Party desires to promote F1CDx in the Territory, FMI will include in its in vitro diagnostic development agreement with such Third Party an obligation that any promotion of F1CDx by such Third Party will comply with Applicable Laws and be consistent with the F1CDx brand and product messaging guidelines provided by FMI and the terms and conditions set forth in this Agreement.
Appears in 2 contracts
Samples: Ex Us Commercialization Agreement (Foundation Medicine, Inc.), Ex Us Commercialization Agreement
Exclusive Right to Commercialize Products. During Subject to the Business Planning Period, FMI will continue to be responsible for and will book all sales terms of Products in the Territory. After the Business Planning Periodthis Agreement, Roche and its Sublicensees shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory, subject to activities designated for FMI to conduct under a Tactical Plan approved by the JOC. To the extent applicable, the foregoing right shall be subject to the rights granted under the Existing Third Party Rights. If FMI receives any order from a prospective purchaser located in a country in the Territory, FMI shall promptly refer that order to Roche, and Roche shall process such order for such purchaser in the Territory in accordance with the terms of this Agreement. If Roche receives any order from a prospective purchaser located in the FMI Territory, then Roche shall promptly refer that order to FMI. The Parties will discuss an appropriate transition plan for the Existing Third Party Rights. However, after the Business Planning Period, at At Roche’s request, and to the extent possible under the Existing Third Party Rights without incurring any termination fee, penalty or similar fee, FMI will terminate any or all of the - 13 - ***Confidential Treatment Requested*** Existing Third Party Rights. Notwithstanding the above, if there is any termination fee, penalty or similar fee, Roche shall have the right to pay such termination fee, penalty or similar fee to terminate any or all of the Existing Third Party Rights. Moreover, Roche shall have the right, in coordination with FMI, to engage in negotiations with the Third Parties to which the Existing Third Party Rights pertain, with the intent of allowing Roche to intervene to terminate such Existing Third Party Rights. Unless otherwise agreed expressly by the Parties, for any companion diagnostic assay Product Product, that is also for use in indicating a therapeutic or referencing a clinical trial of a Third Party (“Universal CDx Product”), such Third Party shall have the right to recommend use of such Universal CDx Product in the Territory to the extent allowable under Applicable Law, including using or referencing such Universal CDx Product name, logo and trade dress in such Third Party therapeutics label, package insert, or in its promotional and regulatory materials. Without limiting the foregoing, Third Parties with Regulated Claims on a Universal CDx Product, including F1CDx, in any country shall be permitted, to the extent permitted by Applicable Law, to recommend the use of and promote a Universal CDx Product, including F1CDx, to their customers, including as a companion diagnostic for such Third Party’s therapeutics. To the extent that FMI enters into any in vitro diagnostic development agreement with any Third Party that contemplates a Regulated Claim on F1CDx in the Territory, and to the extent such Third Party desires to promote F1CDx in the Territory, FMI will include in its in vitro diagnostic development agreement with such Third Party an obligation that any promotion of F1CDx by such Third Party will comply with Applicable Laws and be consistent with the F1CDx brand and product messaging guidelines provided by FMI and the terms and conditions set forth in this Agreement.
Appears in 1 contract
Samples: Ex Us Commercialization Agreement (Foundation Medicine, Inc.)