Common use of Interaction with Regulatory Authorities Clause in Contracts

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 comments with respect to any such submissions or communications made by Forest to Regulatory Authorities in the Territory.

Interaction with Regulatory Authorities. Forest After the Effective Date, each Party shall be responsible for[*] (subject provide to the oversight other Party a copy of any material correspondence or materials that it receives from or submits to a Regulatory Authority or any material decision made by a Regulatory Authority regarding, in each case, the Product, in respect of IMMEDICA, in the Territory and, in respect of LICENSOR, outside of the JDC [*])Territory. LICENSOR shall use reasonable efforts to cause that its licensees or assignees in relation to the Product outside the Territory to provide such information as is required by Section 5.2 above and this Section 5.3 to LICENSOR to enable LICENSOR to comply with its obligations. If such correspondence received by a Party is not in English, interactions then such copy will include a summary in English of all material matters addressed thereby. IMMEDICA shall provide reasonable advance written notice to LICENSOR of all material meetings, conferences, or calls with Regulatory Authorities in concerning the Territory Product (including the FDA) excluding meetings, conferences, or calls with respect Regulatory Authorities relating to the Development pricing and reimbursement of the Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field. Notwithstanding the foregoingProduct), [*], 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 LICENSOR shall be entitled permitted to have appropriate representatives of Adamas (or its Affiliates) with appropriate expertise [*] at attend all such meetings, conferences conferences, or discussions calls to the extent permitted by Applicable Law. IMMEDICA shall provide LICENSOR with the FDA copies of any materials relating to Memantine-Donepezil FDC Productsany material regulatory matter relating to the Product (excluding materials relating to pricing and reimbursement) and, which at a minimum when reasonably practicable, shall mean that Adamas provide copies of any documents to be presented to any Regulatory Authority in respect of such matters prior to their presentation thereto. In addition, during the term of the Agreement and its Affiliates with respect to all Product supplied and purchased under this Agreement, after the termination of this Agreement, each Party shall have the right to have promptly (and in any case within [*]. Forest shall provide Adamas with reasonable advance notice) notify the other Party of any information it receives regarding any threatened or pending action, as set forth above, of all such meeting, conferences inspection or discussions with communication by or from a concerned Regulatory Authority which may affect 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 safety or efficacy claims of the Securities Act Product or the continued marketing of 1933, as amendedthe Product. advance copies of all substantive submissions and written communications to the FDA in advance Upon receipt of such meetingsinformation, conferences or discussions, as well as any written correspondence received by Forest from the FDA Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. The materials to be provided under this Section 5.3 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 material interactions 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 Authority will be forwarded to the Development of Memantine-Donepezil FDC Products for Commercialization in the Territory in the Field [*] Adamas’ proposal or comments with respect to any such submissions or communications made by Forest to Regulatory Authorities in the Territoryother Party promptly after receipt.

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 comments with respect to any such submissions or communications made by Forest to Regulatory Authorities in the Territory.

Interaction with Regulatory Authorities. Forest Allergan shall be responsible for[*] (subject to the oversight of the JDC [*]), for all interactions with Regulatory Authorities relating to Development of the Co-Co Product. To the extent allowed by Applicable Law and as is reasonably practicable due to the nature and urgency of meetings with Regulatory Authorities, Allergan shall provide Editas reasonable advance notice of, and Editas shall have the right to attend, meetings with Regulatory Authorities (i) in the Co-Co Territory (including to the FDA) with respect extent such meetings are related to the Development of the MemantineCo-Donepezil FDC Products Co Products, [**]. If Editas does not attend any such meeting to which it has a right to attend pursuant to the foregoing, Allergan shall provide Editas with a written summary regarding such meeting. Each Party shall be solely responsible for Commercialization its costs and expenses related to such Party’s participation in any such meetings to the Territory in extent that such meeting occurs outside the FieldCo-Co Territory. Notwithstanding the foregoing, [*]until the IND Transfer, Forest Editas shall promptly lead interactions with Regulatory Authorities related to Development of the Initial Co-Co Product in the Co-Co Territory, provided that: (1) Editas shall update Allergan as to and provide Adamas Allergan with prior written or email copies of all communications and Regulatory Filings with such Regulatory Authorities; (2) Editas shall provide Allergan a meaningful opportunity to review and comment on, and Editas shall incorporate such comments into, any such communications and Regulatory Filings; and (3) to the extent allowed by Applicable Law and as is reasonably practicable due to the nature and urgency of meetings with Regulatory Authorities, Editas shall provide Allergan reasonable advance notice of all meetingsmeetings with such Regulatory Authorities, 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 Allergan shall have the right to have [*]. Forest shall provide Adamas participate in meetings with reasonable advance noticesuch Regulatory Authorities, as set forth above, of all and if Allergan does not attend any such meeting, conferences or discussions Editas shall provide Allergan 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 a written communications to the FDA in advance of summary regarding 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 comments with respect to any such submissions or communications made by Forest to Regulatory Authorities in the Territorymeeting.