Common use of Scope of Collaboration Clause in Contracts

Scope of Collaboration. This Agreement and the collaboration contemplated hereby shall relate to all of Aimmune’s Development Programs, including those existing as of the Original Effective Date and those undertaken from time-to-time during the Term, and commercialization plans for AR101; provided, however, that (i) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in all Major Territories, such Development Program shall automatically be excluded from the scope of this Agreement and the collaboration contemplated hereunder, (ii) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in one (1) or more, but not all, Major Territories, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude such Development Program solely in respect of such Major Territory(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product, and (iii) in the event Aimmune effects a Transfer in respect of the commercialization of AR101 in one (1) or more countries, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude the country(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product. Aimmune shall disclose to NHSc each new Development Program upon Aimmune’s decision to commence such Development Program and such new Development Program shall automatically be included within the scope of this Agreement and the collaboration contemplated hereby. All Development Programs or parts thereof, as well as commercialization plans for AR101 that are conducted during the Term, in each case that are within the scope of this Agreement at a particular time during the Term, in accordance with this Section 2.2, are referred to herein as the “In-Scope Programs”. For clarity, In-Scope Programs shall not include any products or programs of any counterparty in a Change of Control of Aimmune that were not Aimmune Products or Development Programs immediately preceding the closing of the relevant Change of Control.

Scope of Collaboration. This Agreement and the collaboration contemplated hereby shall relate to all of Aimmune’s Development Programs, including those existing as of the Original Effective Date and those undertaken from time-to-time during the Term, and commercialization plans for AR101; provided, however, that that, subject to Section 3.1, (i) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in all Major Territories, such Development Program shall automatically be excluded from the scope of this Agreement and the collaboration contemplated hereunder, hereunder and (ii) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in one (1) or more, but not all, Major Territories, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude such Development Program solely in respect of such Major Territory(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product, and (iii) in the event Aimmune effects a Transfer in respect of the commercialization of AR101 in one (1) or more countries, then the scope of this Agreement and the collaboration contemplated hereunder shall automatically be adjusted to exclude the country(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product. Aimmune shall disclose to NHSc each new Development Program upon Aimmune’s decision to commence such Development Program and such new Development Program shall automatically be included within the scope of this Agreement and the collaboration contemplated hereby. All Development Programs or parts thereof, as well as commercialization plans for AR101 that are conducted during the Term, in each case that are thereof within the scope of this Agreement at a particular time during the Term, in accordance with this Section 2.2, are referred to herein as the “In-Scope Programs”. For clarity, In-Scope Programs shall not include any products or programs of any counterparty in a Change of Control of Aimmune that were not Aimmune Products or Development Programs immediately preceding the closing of the relevant Change of Control.

Scope of Collaboration. This The Parties will work together to research, develop and commercialize Surgical Products pursuant to this Agreement in the Territory in accordance with their respective roles and responsibilities set forth below (the collaboration contemplated hereby “Roles and Responsibilities”). The Parties shall relate use commercially reasonable efforts in performing their obligations under this Agreement. Subject to all the previous sentence, the Parties’ respective primary responsibilities for these activities shall be as follows: (a) Responsibility of Aimmune’s Development Programs, including those existing as of the Original Effective Date and those undertaken from time-to-time during the Term, and commercialization plans for AR101; provided, however, that Xxxxxxx: (i) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in all Major Territories, such Development Program shall automatically be excluded from the scope of this Agreement Xxxxxxx will identify and the collaboration contemplated hereunder, specify Surgical Products for development and manufacture by PLC. (ii) in the event that Aimmune effects a Transfer in respect of an Aimmune Product under Development pursuant to a particular Development Program in one (1) or more, but not all, Major Territories, then the scope of this Agreement Xxxxxxx will distribute and the collaboration contemplated hereunder shall automatically be adjusted to exclude such Development Program solely in respect of such Major Territory(ies) in respect of which Aimmune has effected such Transfer in respect of such Aimmune Product, and market Surgical Products. (iii) Xxxxxxx will inform the SC of its sales and marketing plans and efforts, including customer requirements, market research results and competitor activities. (iv) All regulatory filings including, without limitation, those filings made in connection with an Applicable Regulatory Approval, with respect to the Surgical Products, in the event Aimmune effects a Transfer in respect Territory, excluding the United States and all countries of the commercialization European Union, shall be funded and undertaken by Xxxxxxx according to plans (“Xxxxxxx Regulatory Plans”) established by Xxxxxxx and reviewed by the SC. Xxxxxxx shall obtain and maintain all approvals and clearances with respect to the sale of AR101 Surgical Products in one (1) or more countries, then the scope Territory excluding the United States and all countries of this Agreement and the collaboration contemplated hereunder European Union. PLC shall automatically be adjusted to exclude provide Xxxxxxx with all necessary information for the country(ies) in respect of which Aimmune has effected such Transfer in respect preparation of such Aimmune Product. Aimmune regulatory filings and reasonable assistance necessary to support such filings. (v) Xxxxxxx shall disclose provide PLC with the necessary information on all applicable regulatory requirements including, without limitation, with respect to NHSc each new Development Program upon Aimmune’s decision the manufacture, promotion, marketing, sale or use of Surgical Products for any country where Xxxxxxx elects to commence such Development Program sell Surgical Products except the United States and such new Development Program shall automatically be included within countries of the scope of this Agreement and European Union. (vi) All Clinical Studies or Marketing Studies with respect to the collaboration contemplated hereby. All Development Programs or parts thereof, as well as commercialization plans for AR101 Surgical Products that are conducted during within the TermTerritory will be approved, funded and conducted by Xxxxxxx according to plans (“Marketing/Clinical Plans”) established by Xxxxxxx and reviewed by the SC. (vii) At no cost to Xxxxxxx, Xxxxxxx shall provide reasonable access to its principal clinical investigators in the Field of Use and to Xxxxxxx’ animal lab facilities for purposes of Pre-Clinical Studies (as defined in Section 4.1(b)(v) below), taking into account Xxxxxxx’ research priorities. (viii) Xxxxxxx shall reimburse PLC for [**] percent ([**]%) of the cost of work performed by [**] as described in that written quote, dated February 9, 2004 (the “Quote”), provided by [**] to Xxxxxxx, a copy of which is attached hereto as Schedule 4.1(a)(viii). (b) Responsibilities of PLC: (i) PLC will research, develop and manufacture Surgical Products. (ii) PLC will inform the SC with respect to research and development plans, manufacturing and design plans, and costs associated therewith. (iii) All regulatory filings including, without limitation, those filings made in connection with an Applicable Regulatory Approval, with respect to the Surgical Products, in each case that are within the scope United States and all countries of this Agreement at a particular time during the TermEuropean Union, shall be funded and undertaken by PLC according to plans (“PLC Regulatory Plans”) established by PLC and reviewed by the SC. PLC shall and PLC Parent shall cause PLC to obtain and maintain all approvals and clearances required with respect to the sale of the Surgical Products in the United States and the European Union, including, without limitation, approvals from the FDA and certifications from the Electrical Testing Laboratory (“ETL”) and/or Underwriter’s Laboratories (“UL”), as applicable. Xxxxxxx shall provide PLC with all necessary information for the preparation of such regulatory filings and reasonable assistance necessary to support such filings. (iv) Notwithstanding Sections 4.1(a)(iv) and 4.1(b)(iii), but subject to Section 4.1(b)(v) PLC shall be responsible for making Surgical Products in compliance with all regulatory requirements with respect to the Surgical Products in any country where Xxxxxxx elects to market and sell Surgical Products. (v) PLC shall be responsible for all costs and expenses associated with “Pre-Clinical Studies.” “Pre-Clinical Studies” shall mean animal studies, in accordance vitro studies, cadaver studies and other similar studies associated with this Section 2.2the research, are referred to herein as development and manufacture of Surgical Products. Notwithstanding the “In-Scope Programs”. For clarityforegoing, In-Scope Programs PLC shall not include any products or programs of any counterparty in a Change of Control of Aimmune that were not Aimmune Products or Development Programs immediately preceding the closing of the relevant Change of Controlbe responsible for human clinical studies.