Interaction with Competent Authorities Clause Samples

Interaction with Competent Authorities. After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from Competent Authorities and/or the FDA, within ten (10) days of submission or receipt, as the case may be.

Interaction with Competent Authorities. After the Effective Date, each Party shall provide to the other Party a copy in English of any material correspondence that it submits to or receives from a Competent Authority regarding the Fentanyl Product in the Territory. Such correspondence shall be provided within *** of submission or receipt, as the case may be.

Interaction with Competent Authorities. After the HSR Date, each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority regarding any Licensed Product. If such correspondence is not received in English, a summary in English of all material matters addressed thereby will be provided. Such correspondence or summary shall be provided within *** business days of receipt thereof by the relevant Party. Following Governmental Approval, BDSI shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product, and BDSI shall be permitted to have one representative attend all such meetings, conferences, or calls. With respect to any Licensed Product following Governmental Approval thereof, Meda shall provide BDSI with copies of any materials relating to any material regulatory matter and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, and, in either case, if such primary materials are not in English, a summary in English of all material matters addressed thereby, so that the Development Committee, if practicable, shall have an opportunity to review and approve thereof in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be forwarded to BDSI within ***. Further, Meda agrees to take such reasonable actions, provide such documentation, and allow such access as necessary to enable BDSI to comply with Section 3.2 and Sections 4.1.1, 4.2, 4.3, 4.4, 4.5.2 and 4.6 of the CDC Agreement and Arius to comply with Article VI of the Arius Two Agreement.

Interaction with Competent Authorities. After the Effective Date, each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority regarding any Licensed Product. Such correspondence or summary shall be provided within *** of receipt thereof by the relevant Party. BDSI shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product and BDSI shall be permitted to have one regulatory representative attend all such meetings, conferences, or calls that could reasonably be anticipated to materially concern issues that are related or relevant to BEMA generally or any BEMA-based Products other than Licensed Products. With respect to any Licensed Product, Collegium shall provide BDSI with copies of any materials relating to any material regulatory matter in the Territory and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, so that BDSI, if practicable, shall have an opportunity to review in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be considered Collegium’s Confidential Information.

Interaction with Competent Authorities. (a) After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from Competent Authorities, within ten (10) days of submission or receipt, as the case may be. Within five (5) days after receipt of an Approval Letter for the Product in the Territory, Atrix will notify the appropriate Competent Authorities in ---------- ** Confidential Treatment Requested. writing that Sanofi-Synthelabo will be the contact for all communications with the Competent Authorities concerning the Product in the Territory, except for those issues relating to CMC. (b) Within five (5) days after Atrix notifies Sanofi-Synthelabo of receipt by Atrix of an Approval Letter for the Product in the Territory, Sanofi-Synthelabo will notify the appropriate Competent Authorities in writing that Sanofi-Synthelabo is accepting the transfer from Atrix described in Section 10.03(a), and assuming responsibility for all communications with the Competent Authorities concerning the Product in the Territory, except for those issues relating to CMC. Sanofi-Synthelabo shall provide Atrix with a copy of any significant correspondence regarding the Product that it submits to or receives from the Competent Authorities, within ten (10) days prior to the date of submission or within ten (10) days from receipt, as the case may be.

Interaction with Competent Authorities. (a) After execution of this Agreement, each Party shall provide to the other Party a copy of any significant correspondence regarding the Product in the Territory that it submits to or receives from Competent Authorities, within ten (10) days of submission or receipt, as the case may be. Within five (5) days after receipt of an Approval Letter for the Product in the Territory, Atrix will notify the appropriate Competent Authorities in ---------- ** Confidential Treatment Requested.