Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the U.S. Development of the Product for the Initial Indications and for any Joint Additional Indication in the U.S. consistent with the then-current U.S. Development Plan and in accordance with this Agreement. (b) Takeda shall devote Diligent Efforts to the ROW Development of the Product for the Initial Indications and for any Joint Additional Indications for all the Level 1 Markets, and such other countries of the Royalty Territory wherein Takeda at its discretion elects to Develop the Product (as described in further detail in this Section 3.5 below), in accordance with its plan of ROW Development, the overall plan and updates of which shall be submitted to the JSC for such countries pursuant to Section 3.2. (c) Without limiting the generality of Section 3.5(b), Takeda shall (i) devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in the Level 1 Markets, and (ii) file for Regulatory Approval of the Product with the EMEA promptly after, but in no event more than nine (9) months after, the submission for Regulatory Approval of the Product for such indication in the U.S., unless Takeda is required to conduct any additional Development activities to comply with the EMEA's requirements. Any failure by Takeda to comply with the terms of this Section 3.5(c) shall be deemed a material breach of this Agreement by Takeda in any applicable country or countries of the Level 1 Markets, and Affymax shall have the right to terminate this Agreement with respect to the applicable country(ies) of the Level 1 Markets pursuant to the terms of Section 13.2(b)(i). (d) Without limiting the generality of Section 3.5(b), at any time after the date of the first approval of NDA for the Product in the U.S. (for [*]) of the Level 2 Markets) or the date of the first Regulatory Approval from the EMEA (for the other countries of the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇), ▇▇▇▇▇▇▇ may request Takeda, with regard to one or more countries of the Level 2 Markets where Takeda has not yet determined or initiated efforts to Develop and Commercialize the Product, to inform Affymax of its decision on whether or not it shall devote the Diligent Efforts to Develop and Commercialize the Product for the Initial Indication and the Joint Additional Indication, if any, in such country(ies). (i) If Takeda informs Affymax of its decision to devote the Diligent Efforts in such country(ies), then: (1) Takeda shall thereafter be obligated to devote Diligent Efforts in such country(ies); (2) Takeda shall develop a plan setting forth, for such country(ies) of the Level 2 Markets, a schedule of activities to be performed by Takeda for the filing of Regulatory Approval for the Product in each such country within one hundred and twenty (120) days after such Affymax's request which period of response may be extended by Affymax's consent; (3) Affymax shall have a right to review and comment on the plan provided by Takeda and Takeda shall consider in good faith any reasonable comments from Affymax; and (4) in the case of failure by Takeda to comply with such Diligent Effort obligation with respect to such country(ies), Affymax shall have the right to terminate this Agreement with respect to such country(ies) pursuant to the terms of Section 13.2(b)(i). (ii) If Takeda informs Affymax of its decision not to use such Diligent Efforts in such country(ies) or fails to provide Affymax with such a plan with respect to such country(ies) of the Level 2 Markets within the above-mentioned one hundred and twenty (120) day period, or any extension thereof as agreed jointly by the Parties, then (1) Affymax may prepare a plan it believes is commercially reasonable for both Parties to pursue for the Development and Commercialization of the Product in such country(ies) and provide it to Takeda within a reasonable time; (2) if the Parties agree on a plan with respect to such country(ies) of the Level 2 Markets, then Takeda shall devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in each such country(ies) under this Agreement; and (3) if Affymax informs Takeda of its intention not to provide such plan as mentioned in Section 3.5(d)(ii)(1), or, both Parties cannot agree on such plan within ninety (90) days after Takeda's receipt of such plan, then such country(ies) shall thereafter be excluded from the Licensed Territory and Affymax shall thereafter have a right, with a right to sublicense to Third Parties, to Develop and Commercialize the Product for the applicable Initial Indications or Joint Additional Indications, if any, in such country(ies) by using the Takeda Technology and the Regulatory Materials without any consideration to Takeda. (e) With respect to any country in the Royalty Territory other than the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ shall have the discretion to decide whether and to what extent to Develop, seek Regulatory Approval for, and Commercialize the Product. (f) Each Party shall conduct its Development activities under this Agreement in good scientific manner and in compliance in all material respects with all applicable Laws, including without limitation applicable GCP, GLP, and GMP.
Appears in 1 contract
Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the U.S. Development of the Product for the Initial Indications and for any Joint Additional Indication in the U.S. consistent with the then-current U.S. Development Plan and in accordance with this Agreement.
(b) Takeda shall devote Diligent Efforts to the ROW Development of the Product for the Initial Indications and for any Joint Additional Indications for all the Level 1 Markets, and such other countries of the Royalty Territory wherein Takeda at its discretion elects to Develop the Product (as described in further detail in this Section 3.5 below), in accordance with its plan of ROW Development, the overall plan and updates of which shall be submitted to the JSC for such countries pursuant to Section 3.2.
(c) Without limiting the generality of Section 3.5(b), Takeda shall (i) devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in the Level 1 Markets, and (ii) file for Regulatory Approval of the Product with the EMEA promptly after, but in no event more than nine (9) months after, the submission for Regulatory Approval of the Product for such indication in the U.S., unless Takeda is required to conduct any additional Development activities to comply with the EMEA's requirements. Any failure by Takeda to comply with the terms of this Section 3.5(c) shall be deemed a material breach of this Agreement by Takeda in any applicable country or countries of the Level 1 Markets, and Affymax shall have the right to terminate this Agreement with respect to the applicable country(ies) of the Level 1 Markets pursuant to the terms of Section 13.2(b)(i).
(d) Without limiting the generality of Section 3.5(b), at any time after the date of the first approval of NDA for the Product in the U.S. (for [*]) of the Level 2 Markets) or the date of the first Regulatory Approval from the EMEA (for the other countries of the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇), ▇▇▇▇▇▇▇ may request Takeda, with regard to one or more countries of the Level 2 Markets where Takeda has not yet determined or initiated efforts to Develop and Commercialize the Product, to inform Affymax of its decision on whether or not it shall devote the Diligent Efforts to Develop and Commercialize the Product for the Initial Indication and the Joint Additional Indication, if any, in such country(ies).
(i) If Takeda informs Affymax of its decision to devote the Diligent Efforts in such country(ies), then:
(1) Takeda shall thereafter be obligated to devote Diligent Efforts in such country(ies);
(2) Takeda shall develop a plan setting forth, for such country(ies) of the Level 2 Markets, a schedule of activities to be performed by Takeda for the filing of Regulatory Approval for the Product in each such country within one hundred and twenty (120) [*] days after such Affymax's request which period of response may be extended by Affymax's consent;
(3) Affymax shall have a right to review and comment on the plan provided by Takeda and Takeda shall consider in good faith any reasonable comments from Affymax; and
(4) in the case of failure by Takeda to comply with such Diligent Effort obligation with respect to such country(ies), Affymax shall have the right to terminate this Agreement with respect to such country(ies) pursuant to the terms of Section 13.2(b)(i).
(ii) If Takeda informs Affymax of its decision not to use such Diligent Efforts in such country(ies) or fails to provide Affymax with such a plan with respect to such country(ies) of the Level 2 Markets within the above-mentioned one hundred and twenty (120) [*] day period, or any extension thereof as agreed jointly by the Parties, then
(1) Affymax may prepare a plan it believes is commercially reasonable for both Parties to pursue for the Development and Commercialization of the Product in such country(ies) and provide it to Takeda within a reasonable time;
(2) if the Parties agree on a plan with respect to such country(ies) of the Level 2 Markets, then Takeda shall devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in each such country(ies) under this Agreement; and
(3) if Affymax informs Takeda of its intention not to provide such plan as mentioned in Section 3.5(d)(ii)(1), or, both Parties cannot agree on such plan within ninety (90) [*] days after Takeda's receipt of such plan, then such country(ies) shall thereafter be excluded from the Licensed Territory and Affymax shall thereafter have a right, with a right to sublicense to Third Parties, to Develop and Commercialize the Product for the applicable Initial Indications or Joint Additional Indications, if any, in such country(ies) by using the Takeda Technology and the Regulatory Materials without any consideration to Takeda.
(e) With respect to any country in the Royalty Territory other than the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ shall have the discretion to decide whether and to what extent to Develop, seek Regulatory Approval for, and Commercialize the Product.
(f) Each Party shall conduct its Development activities under this Agreement in good scientific manner and in compliance in all material respects with all applicable Laws, including without limitation applicable GCP, GLP, and GMP.
Appears in 1 contract
Performance; Diligence. (a) Each Party shall devote Diligent Efforts to the U.S. Development of the Product for the Initial Indications and for any Joint Additional Indication in the U.S. consistent with the then-current U.S. Development Plan and in accordance with this Agreement.
(b) Takeda shall devote Diligent Efforts to the ROW Development of the Product for the Initial Indications and for any Joint Additional Indications for all the Level 1 Markets, and such other countries of the Royalty Territory wherein Takeda at its discretion elects to Develop the Product (as described in further detail in this Section 3.5 below), in accordance with its plan of ROW Development, the overall plan and updates of which shall be submitted to the JSC for such countries pursuant to Section 3.2.
(c) Without limiting the generality of Section 3.5(b), Takeda shall (i) devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in the Level 1 Markets, and (ii) file for Regulatory Approval of the Product with the EMEA promptly after, but in no event more than nine (9) months after, the submission for Regulatory Approval of the Product for such indication in the U.S., unless Takeda is required to conduct any additional Development activities to comply with the EMEA's ’s requirements. Any failure by Takeda to comply with the terms of this Section 3.5(c) shall be deemed a material breach of this Agreement by Takeda in any applicable country or countries of the Level 1 Markets, and Affymax shall have the right to terminate this Agreement with respect to the applicable country(ies) of the Level 1 Markets pursuant to the terms of Section 13.2(b)(i).
(d) Without limiting the generality of Section 3.5(b), at any time after the date of the first approval of NDA for the Product in the U.S. (for [*[ * ]) of the Level 2 Markets) or the date of the first Regulatory Approval from the EMEA (for the other countries of the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇), ▇▇▇▇▇▇▇ may request Takeda, with regard to one or more countries of the Level 2 Markets where Takeda has not yet determined or initiated efforts to Develop and Commercialize the Product, to inform Affymax of its decision on whether or not it shall devote the Diligent Efforts to Develop and Commercialize the Product for the Initial Indication and the Joint Additional Indication, if any, in such country(ies).
(i) If Takeda informs Affymax of its decision to devote the Diligent Efforts in such country(ies), then:: [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(1) Takeda shall thereafter be obligated to devote Diligent Efforts in such country(ies);
(2) Takeda shall develop a plan setting forth, for such country(ies) of the Level 2 Markets, a schedule of activities to be performed by Takeda for the filing of Regulatory Approval for the Product in each such country within one hundred and twenty (120) days after such Affymax's ’s request which period of response may be extended by Affymax's ’s consent;
(3) Affymax shall have a right to review and comment on the plan provided by Takeda and Takeda shall consider in good faith any reasonable comments from Affymax; and
(4) in the case of failure by Takeda to comply with such Diligent Effort obligation with respect to such country(ies), Affymax shall have the right to terminate this Agreement with respect to such country(ies) pursuant to the terms of Section 13.2(b)(i).
(ii) If Takeda informs Affymax of its decision not to use such Diligent Efforts in such country(ies) or fails to provide Affymax with such a plan with respect to such country(ies) of the Level 2 Markets within the above-mentioned one hundred and twenty (120) day period, or any extension thereof as agreed jointly by the Parties, then
(1) Affymax may prepare a plan it believes is commercially reasonable for both Parties to pursue for the Development and Commercialization of the Product in such country(ies) and provide it to Takeda within a reasonable time;
(2) if the Parties agree on a plan with respect to such country(ies) of the Level 2 Markets, then Takeda shall devote Diligent Efforts to obtaining Regulatory Approval of the Product for the Initial Indication and for any Joint Additional Indication in each such country(ies) under this Agreement; and
(3) if Affymax informs Takeda of its intention not to provide such plan as mentioned in Section 3.5(d)(ii)(1), or, both Parties cannot agree on such plan within ninety (90) days after Takeda's ’s receipt of such plan, then such country(ies) shall thereafter be excluded from the Licensed Territory and Affymax shall thereafter have a right, with a right to sublicense to Third Parties, to Develop and Commercialize the Product for the applicable Initial Indications or Joint Additional Indications, if any, in such country(ies) by using the Takeda Technology and the Regulatory Materials without any consideration to Takeda.
(e) With respect to any country in the Royalty Territory other than the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ shall have the discretion to decide whether and to what extent to Develop, seek Regulatory Approval for, and Commercialize the Product.
(f) Each Party shall conduct its Development activities under this Agreement in good scientific manner and in compliance in all material respects with all applicable Laws, including without limitation applicable GCP, GLP, and GMP. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 1 contract