Interaction with Regulatory Authorities. Notwithstanding anything in this Section 4 or otherwise, the Manager shall not act for or on behalf of the Company in its relationships with regulatory authorities except to the extent specifically authorized by the Company from time to time.
Interaction with Regulatory Authorities. Each Party shall be responsible for the scheduling, conduct and preparation of materials for meetings, interactions or communications with Regulatory Authorities in its territory, subject to Section 5.1(b)(i). Each Party shall [***] notify the other Party of any meeting (whether in person or by conference call) requested or scheduled with, and shall promptly provide to the other any communications sent to or from, the FDA, EMEA, Health Canada or such other Regulatory Authorities reasonably requested by a Party. The other Party may, on reasonable prior notice to the first Party, have no more than [***] representatives participate in any such meeting. In addition, the other Party shall send relevant subject matter experts to any such meeting if requested by the first Party. In addition, each Party shall assist such other Party in answering any questions or issues from, and shall provide any data requested by or required for Regulatory Materials to be prepared and submitted by such other Party with Regulatory Authorities or other Governmental Authorities in such other Party’s territory, including, as applicable, such questions or issues regarding Manufacturing.
Interaction with Regulatory Authorities. Forest shall be responsible for[*] (subject to the oversight of the JDC [*]), interactions with Regulatory Authorities in the Territory (including the FDA) with respect to the Development of the Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field. Notwithstanding the foregoing, [*], Forest shall promptly provide Adamas with prior written or email notice of all meetings, conferences and discussions scheduled with the FDA concerning all Memantine-Donepezil FDC Products (including advisory committee meetings and any other meeting of experts convened with the FDA concerning the Memantine-Donepezil FDC Products) within [*] after Forest or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give Adamas a reasonable opportunity to attend such meetings, conferences and discussions). Adamas shall be entitled to have representatives of Adamas (or its Affiliates) with appropriate expertise [*] at all such meetings, conferences or discussions with the FDA relating to Memantine-Donepezil FDC Products, which at a minimum shall mean that Adamas and its Affiliates shall have the right to have [*]. Forest shall provide Adamas with reasonable advance notice, as set forth above, of all such meeting, conferences or discussions with the FDA and [*] = 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. advance copies of all substantive submissions and written communications to the FDA in advance of such meetings, conferences or discussions, as well as any written correspondence received by Forest from the FDA with respect to such meetings, conferences or discussions. Forest shall promptly forward to Adamas copies of all minutes thereof and summaries of all such meetings, conferences and discussions with the FDA, including copies of all contact reports produced by or on behalf of Forest or its Affiliates. Forest shall consider in good faith Adamas’ reasonable proposals or comments to any substantive submissions or communications made by Forest to Regulatory Authorities in the Territory (including the FDA) with respect to the Development of Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field [*] Adamas’ proposal or comment...
Interaction with Regulatory Authorities. PFIZER shall direct any interactions relating to the Compound between XXXXX and any Regulatory Authority that occur after the Effective Date.
Interaction with Regulatory Authorities. Subject to Section 6.1(a), Roche shall be responsible for all interactions with Regulatory Authorities relating to Development in the Territory. Roche shall update Prothena as to all material communications with Regulatory Authorities on matters related to the Licensed Products. Roche will provide to Prothena any copies of material written communications [*]. To the extent allowed by Applicable Law and as [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. is reasonably practicable due to the nature and urgency of meetings with Regulatory Authorities, Prothena shall have the right to participate in meetings with Regulatory Authorities throughout the Territory [*]. Upon request by Roche, Prothena shall provide reasonable support for Roche’s meetings with Regulatory Authorities in the Royalty Territory relating to the Licensed Products.
Interaction with Regulatory Authorities. All interaction with Regulatory Authorities (both written and oral) that directly affects the Product or Production shall be conducted in accordance with the provisions of this Section 6. At RevitaLid’s request, Nephron will authorize Regulatory Authorities to review on RevitaLid’s behalf applications related to the Production.
Interaction with Regulatory Authorities. After the Effective Date, [ * ]
Interaction with Regulatory Authorities. For the period beginning on the Effective Date and ending on the effective date of the transfer of the applicable Regulatory Filing, LICENSEE shall lead1 all interactions with any Regulatory Authority relating to the Compound. Notwithstanding the foregoing, for the period beginning after the Effective Date and ending on the effective date of the transfer of the applicable Regulatory Filing in such country, if LICENSEE so reasonably requests, PFIZER will participate, by telephone, in certain interactions with Regulatory Authorities relating to the Compound, at LICENSEE’s direction and expense, provided that LICENSEE shall provide PFIZER written notice at least ten (10) Business Days prior to any such meetings.
Interaction with Regulatory Authorities. For the period beginning on the Effective Date and ending on the effective date of the transfer of the applicable Regulatory Filing, LICENSEE shall lead all interactions with any Regulatory Authority relating to the Compound (as between PFIZER and LICENSEE). Notwithstanding the foregoing, for the period beginning after the Effective Date and ending on the effective date of the transfer of the applicable Regulatory Filing in such country, if LICENSEE so reasonably requests, PFIZER will participate, by telephone, in interactions with Regulatory Authorities relating to any Compound, at LICENSEE’s direction and expense; provided that LICENSEE shall provide PFIZER written notice at least ***** prior to any such meetings.
Interaction with Regulatory Authorities. All interaction with Regulatory Authorities (both written and oral) that directly affects Product or the Production of Product shall be conducted in accordance with the provisions of this Article 10. At CLIENT's request, XXXXXX will authorize Regulatory Authorities to review on CLIENT's behalf applications related to the Production of Products. 10.2.2
