Responsibility For Regulatory Interactions. Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all costs incurred in connection with the provision, review (and translation, if applicable) of such Regulatory Submissions pursuant to the foregoing. Ironwood will make available to Astellas with respect to the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Products in the Territory.
Appears in 1 contract
Responsibility For Regulatory Interactions. Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all costs incurred in connection with the provision, review (and translation, if applicable) of such Regulatory Submissions pursuant to the foregoing. Ironwood will make available to Astellas with respect to the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Products in the Territory.
Appears in 1 contract
Responsibility For Regulatory Interactions. Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] Ajinomoto shall be responsible for any translations all regulatory matters relating to Products in the Field in the Territory, including payment of Regulatory Submissions provided by Astellas and shall bear all costs incurred in connection associated with the provision, review (and translation, if applicable) of such Regulatory Submissions pursuant to the foregoing. Ironwood will make available to Astellas with respect to the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and obtaining Regulatory Approvals for Products in the Field in the Territory. Ajinomoto shall have sole authority in the Territory with respect to (i) obtaining Regulatory Approvals for Products in the Field and subsequently maintaining such Regulatory Approvals; (ii) communicating with Regulatory Authorities about Products in the Field; and (iii) preparing and submitting supplements, communications, annual reports, adverse event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions. Ajinomoto shall keep Albireo reasonably (but at least on a [***] basis) informed regarding the status and progress of such activity, including, Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. without limitation, providing Albireo with as much advance notice as possible of all meetings scheduled with a Regulatory Authority involved in such Regulatory Submission, providing Albireo with a copy, and English abstract of, all written correspondence from a Regulatory Authority involved in such Regulatory Submission, and providing Albireo with an abstract of oral correspondence from a Regulatory Authority involved in such Regulatory Submission. Ajinomoto shall provide Albireo with any data Controlled by Ajinomoto necessary to comply with requirements from Regulatory Authorities outside the Territory, with respect to the Product in the Field, and if reasonably requested by Albireo, English translations of all pre-clinical and clinical study reports related to such data.
Appears in 1 contract
Responsibility For Regulatory Interactions. Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all costs incurred in connection with the provision, review (and translation, if applicable) of such Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Submissions pursuant to the foregoing. Ironwood will make available to Astellas with respect to the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Products in the Territory.
Appears in 1 contract
