Common use of Key Assumptions Clause in Contracts

Key Assumptions. As of the Effective Date, the following items shall be deemed Key Assumptions which were used to prepare the initial Development Plan, the Regulatory Plan and the Commercialization Plan and associated Payment Schedule agreed upon by the Parties: • The budget and associated Payment Schedule are estimates based on activities that are currently planned in the long term for support clinical trials has been provided and are subject to change based on the assumptions listed below and may be modified in the future as the scope of the project becomes more fully defined. Abbott and Epizyme will agree upon modification of the scope and budget of long-term activities according to the terms of this agreement. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. [**]. EXHIBIT C REGULATORY PLAN Epizyme and Abbott will actively cooperate in the regulatory process for the development and global regulatory registration of the Diagnostic Test. The regulatory process includes the development of regulatory strategy, the sharing of regulatory information and data and the submission and liaison with global Regulatory Authorities. Abbott will serve as the formal sponsor of any submissions to global Regulatory Authorities that pertain to the Diagnostic Test, and therefore will be ultimately responsible for the submission of such required documentation per the jointly agreed timelines; provided, however, that the preparation, including strategy, for such submissions will be done in cooperation and consultation with Epizyme and Epizyme shall have the right to attend and participate in all meetings between Abbott and Regulatory Authorities relating to the co-development of the Diagnostic Test. Activities included in the regulatory process that are subject to this regulatory plan include the following: • Routine interactions of Abbott and Epizyme regulatory representatives to share regulatory information relevant to the agreed strategy for development and registration of the Diagnostic Test. • Abbott will inform Epizyme about any inspections from Regulatory Authorities related to the Diagnostic Test and will provide reports of any findings to Epizyme. • [**]. • [**]. • [**]. • Epizyme and Abbott will jointly develop a timeline and priority list for regulatory submissions. The timeline will include submission dates and anticipated approval dates for both the Diagnostic Test and the Epizyme Product. As a part of the regulatory plan regarding the timelines for regulatory submissions and target timelines for approval, [**]: Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**]. EXHIBIT D COMMERCIALIZATION PLAN Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of six pages were omitted. [**]. EXHIBIT E PAYMENT SCHEDULE Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**]. EXHIBIT F GOVERNANCE OF AGREEMENT EXHIBIT G GOVERNANCE ESCALATION PROCESS EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES CON’T EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES CON’T EXHIBIT I The parties recognize that a bona fide dispute as to certain matters may arise from time to time during the term of this Agreement which relates to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective representatives of the affected subsidiaries, divisions, or business units within [**] days after such notice is received (all references to “days” in this ADR provision are to calendar days). If the matter has not been resolved within [**] days of the notice of dispute, or if the parties fail to meet within such [**] days, either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

Appears in 1 contract

Sources: Development and Commercialization Agreement (Epizyme, Inc.)

Key Assumptions. As of the Effective Date, the following items shall be deemed Key Assumptions which were used to prepare the initial Development Plan, the Regulatory Plan and the Commercialization Plan and associated Payment Schedule agreed upon by the Parties: • The budget and associated Payment Schedule are estimates based on activities that are currently planned in the long term for support clinical trials has been provided and are subject to change based on the assumptions listed below and may be modified in the future as the scope of the project becomes more fully defined. Abbott and Epizyme will agree upon modification of the scope and budget of long-term activities according to the terms of this agreement. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. [**]. EXHIBIT C REGULATORY PLAN Epizyme and Abbott will actively cooperate in the regulatory process for the development and global regulatory registration of the Diagnostic Test. The regulatory process includes the development of regulatory strategy, the sharing of regulatory information and data and the submission and liaison with global Regulatory Authorities. Abbott will serve as the formal sponsor of any submissions to global Regulatory Authorities that pertain to the Diagnostic Test, and therefore will be ultimately responsible for the submission of such required documentation per the jointly agreed timelines; provided, however, that the preparation, including strategy, for such submissions will be done in cooperation and consultation with Epizyme and Epizyme shall have the right to attend and participate in all meetings between Abbott and Regulatory Authorities relating to the co-development of the Diagnostic Test. Activities included in the regulatory process that are subject to this regulatory plan include the following: • Routine interactions of Abbott and Epizyme regulatory representatives to share regulatory information relevant to the agreed strategy for development and registration of the Diagnostic Test. • Abbott will inform Epizyme about any inspections from Regulatory Authorities related to the Diagnostic Test and will provide reports of any findings to Epizyme. • [**]. • [**]. • [**]. • Epizyme and Abbott will jointly develop a timeline and priority list for regulatory submissions. The timeline will include submission dates and anticipated approval dates for both the Diagnostic Test and the Epizyme Product. As a part of the regulatory plan regarding the timelines for regulatory submissions and target timelines for approval, [**]: Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**]. EXHIBIT D COMMERCIALIZATION PLAN Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of six pages were omitted. [**]. EXHIBIT E PAYMENT SCHEDULE Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. License Fee Not Applicable Not Applicable Not Applicable $0.850M 1 [**]. ] [**] [**] [**] 2 [**] [**] [**] [**] 3 [**] [**] [**] [**] 4 [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] EXHIBIT F GOVERNANCE OF AGREEMENT EXHIBIT G GOVERNANCE ESCALATION PROCESS EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES CON’T EXHIBIT H GOVERNANCE ROLES AND RESPONSIBILITIES CON’T EXHIBIT I The parties recognize that a bona fide dispute as to certain matters may arise from time to time during the term of this Agreement which relates to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective representatives of the affected subsidiaries, divisions, or business units within [**] days after such notice is received (all references to “days” in this ADR provision are to calendar days). If the matter has not been resolved within [**] days of the notice of dispute, or if the parties fail to meet within such [**] days, either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

Appears in 1 contract

Sources: Development and Commercialization Agreement (Epizyme, Inc.)