Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. (i) The .1-DC will have the responsibility for the overall coordination and oversight of the Development of the Products in the Field in the Licensed Territory in accordance with the applicable Development Plan and oversight of the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each of the Development Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, and any Collaboration Budget pursuant to 5.2, 5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating the Development of the Products in the Field in Licensed Territory; (C) overseeing, reviewing and coordinating Medical Affairs Activities with respect to each Product in the Field in the Licensed Territory; (D) reviewing and approving the Development Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget and all amendments thereto; (E) reviewing and approving each Collaboration Proposal; (F) developing, reviewing, and approving each Collaboration Plan and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development activities and Medical Affairs Activities being conducted by the Parties.

Appears in 1 contract

Sources: License Agreement (Melinta Therapeutics, Inc. /New/)

Joint Development Committee. The Parties hereby establish a joint development committee (i) The .1-DC will the “Joint Development Committee” or the “JDC”), composed of [*] of each Party that have [*] in the responsibility for the overall coordination development of products similar to Tirasemtiv and oversight of Product, to monitor and coordinate the Development of Tirasemtiv and Product under the Products in Collaboration. All JDC representatives shall have sufficient authority within the Field in the Licensed Territory in accordance applicable Party to make decisions [*] arising with the applicable scope of the JDC’s responsibilities. The JDC shall in particular: (a) coordinate the activities of the Parties under the Development Plan and oversight of oversee the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each implementation of the Development Plan; [*] = Certain confidential information contained in this document, Development Plan Budgetmarked by brackets, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, has been omitted and any Collaboration Budget filed separately with the Securities and Exchange Commission pursuant to 5.2Rule 24b-2 of the Securities Exchange Act of 1934, 5.3 as amended. (b) establish the protocol and 5.5, respectively; (B) overseeing, reviewing and coordinating statistical analysis plan for each human clinical trial conducted under the Development of the Products in the Field in Licensed Territory; Plan; (Cc) overseeing, reviewing prepare and coordinating Medical Affairs Activities with respect approve annual or interim amendments to each Product in the Field in the Licensed Territory; (D) reviewing and approving the Development Plan, including the Development Plan Budget; (d) provide a forum for and facilitate communications between the Parties with respect to the Development of Tirasemtiv and Product; (e) monitor and coordinate all regulatory actions, Medical Affairs communications and submissions for Tirasemtiv and Product under the Development Plan, Medical Affairs Plan Budget and all amendments thereto; including allocating related medical affairs responsibilities between the Parties; (Ef) reviewing and approving each Collaboration Proposal; (F) developinguntil formation of the JMAC, reviewing, and approving each Collaboration Plan and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development oversee medical education activities and Medical Affairs Activities being conducted by establish a joint review process for medical affairs materials, including disease state awareness, medical education and other non-promotional materials; (g) establish joint subcommittees, as appropriate, to carry out its functions; and (h) perform such other functions as may be appropriate to further the Partiespurposes of this Agreement with respect to the Development of Tirasemtiv and Product.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Joint Development Committee. The Parties shall establish a joint development committee (i) The .1-DC will the “Joint Development Committee” or the “JDC”), composed of [*] of each Party that have [*] in the responsibility for development of products similar to the overall coordination Compounds and oversight of Collaboration Products, to monitor and coordinate the Development of the Compounds and Collaboration Products in under the Field in Collaboration. All JDC representatives will have sufficient authority within the Licensed Territory in accordance applicable Party to make decisions [*] [*] arising with the applicable scope of the JDC’s responsibilities. The JDC shall in particular: (a) coordinate the activities of the Parties under the Development Plan and oversight of oversee the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each implementation of the Development Plan, ; (b) establish the protocol and statistical analysis plan for each human clinical trial conducted under the Development Plan; (c) prepare and approve annual or interim amendments to the Development Plan (including the Cytokinetics Development Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, ); (d) provide a forum for and any Collaboration Budget pursuant facilitate communications between the Parties with respect to 5.2, 5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating the Development of the Compounds and Collaboration Products; (e) review the data and results of [*] a Collaboration Product [*] such Collaboration Product [*] in which case [*]; (f) monitor and coordinate all regulatory actions, communications and submissions for the Compounds and Collaboration Products in the Field in Licensed Territory; (C) overseeing, reviewing and coordinating Medical Affairs Activities with respect to each Product in the Field in the Licensed Territory; (D) reviewing and approving under the Development Plan, including allocating related medical affairs responsibilities between the Parties; (g) until formation of the JMAC, oversee medical education activities and establish a joint review process for medical affairs materials, including disease state awareness, medical education and other non-promotional materials; (h) establish joint subcommittees, as appropriate, to carry out its functions; and (i) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget and all amendments thereto; (E) reviewing and approving each Collaboration Proposal; (F) developing, reviewing, and approving each Collaboration Plan of the Compounds and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development activities and Medical Affairs Activities being conducted by the PartiesProducts.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Joint Development Committee. The Parties shall establish a joint development committee (i) The .1-DC will the “Joint Development Committee” or the “JDC”), composed of up to [ * ] of each Party that have [ * ] in the responsibility for development of products similar to the overall coordination Compounds and oversight of Collaboration Products, to monitor and coordinate the Development of the Compounds and Collaboration Products in under the Field in Collaboration. All JDC representatives will have sufficient authority within the Licensed Territory in accordance applicable Party to make decisions [ * ] arising with the applicable scope of the JDC’s responsibilities. The JDC shall in particular: (a) coordinate the activities of the Parties under the Development Plan and oversight of oversee the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each implementation of the Development Plan, ; (b) establish the protocol and statistical analysis plan for each human clinical trial conducted under the Development Plan; (c) prepare and approve annual or interim amendments to the Development Plan (including the Cytokinetics Development Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, ); (d) provide a forum for and any Collaboration Budget pursuant facilitate communications between the Parties with respect to 5.2, 5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating the Development of the Compounds and Collaboration Products; (e) review the data and results of [ * ] a Collaboration Product [ * ] such Collaboration Product [ * ] in which case [ * ]; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (f) monitor and coordinate all regulatory actions, communications and submissions for the Compounds and Collaboration Products in the Field in Licensed Territory; (C) overseeing, reviewing and coordinating Medical Affairs Activities with respect to each Product in the Field in the Licensed Territory; (D) reviewing and approving under the Development Plan, including allocating related medical affairs responsibilities between the Parties; (g) until formation of the JMAC, oversee medical education activities and establish a joint review process for medical affairs materials, including disease state awareness, medical education and other non-promotional materials; (h) establish joint subcommittees, as appropriate, to carry out its functions; and (i) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget and all amendments thereto; (E) reviewing and approving each Collaboration Proposal; (F) developing, reviewing, and approving each Collaboration Plan of the Compounds and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development activities and Medical Affairs Activities being conducted by the PartiesProducts.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Joint Development Committee. The Parties shall establish a joint development committee (i) The .1-DC will the “Joint Development Committee” or the “JDC”), composed of [*] of each Party that have [*] in the responsibility for development of products similar to the overall coordination Compounds and oversight of Collaboration Products, to monitor and coordinate the Development of the Compounds and Collaboration Products in under the Field in Collaboration. All JDC representatives will have sufficient authority within the Licensed Territory in accordance applicable Party to make decisions [*] arising with the applicable scope of the JDC’s responsibilities. The JDC shall in particular: (a) coordinate the activities of the Parties under the Development Plan and oversight of oversee the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each implementation of the Development Plan, ; (b) establish the protocol and statistic analysis plan for each human clinical trial conducted under the Development Plan; (c) prepare and approve annual or interim amendments to the Development Plan (including the Cytokinetics Development Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, ); (d) provide a forum for and any Collaboration Budget pursuant facilitate communications between the Parties with respect to 5.2, 5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating the Development of the Compounds and Collaboration Products; (e) review the data and results of [*] therefor; (f) monitor and coordinate all regulatory actions, communications and submissions for the Compounds and Collaboration Products in the Field in Licensed Territory; (C) overseeing, reviewing and coordinating Medical Affairs Activities with respect to each Product in the Field in the Licensed Territory; (D) reviewing and approving under the Development Plan, including allocating related medical affairs responsibilities between the Parties; [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. (g) until formation of the JMAC, oversee medical education activities and establish a joint review process for medical affairs materials, including disease state awareness, medical education and other non-promotional materials; (h) establish joint subcommittees, as appropriate, to carry out its functions; and (i) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget and all amendments thereto; (E) reviewing and approving each Collaboration Proposal; (F) developing, reviewing, and approving each Collaboration Plan of the Compounds and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development activities and Medical Affairs Activities being conducted by the PartiesProducts.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Joint Development Committee. The Parties hereby establish a joint development committee (i) The .1-DC will the “Joint Development Committee” or the “JDC”), composed of [*] of each Party that have [*] in the responsibility for the overall coordination development of products similar to Tirasemtiv and oversight of Product, to monitor and coordinate the Development of Tirasemtiv and Product under the Products in Collaboration. All JDC representatives shall have sufficient authority within the Field in the Licensed Territory in accordance applicable Party to make decisions [*] arising with the applicable scope of the JDC’s responsibilities. The JDC shall in particular: (a) coordinate the activities of the Parties under the Development Plan and oversight of oversee the Development of any Product under a Collaboration Plan. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial two (2) representatives on the JDC. Company shall appoint a person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall include any agenda items proposed by Licensee. (ii) The JDC shall have responsibility for: (A) overseeing the flow and transfer of information between the Parties related to each implementation of the Development Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, ; (b) establish the protocol and any Collaboration Budget pursuant to 5.2, 5.3 and 5.5, respectively; (B) overseeing, reviewing and coordinating statistical analysis plan for each human clinical trial conducted under the Development of the Products in the Field in Licensed Territory; Plan; (Cc) overseeing, reviewing prepare and coordinating Medical Affairs Activities with respect approve annual or interim amendments to each Product in the Field in the Licensed Territory; (D) reviewing and approving the Development Plan, including the Development Plan Budget; [*] = Certain confidential information contained in this document, Medical Affairs marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) provide a forum for and facilitate communications between the Parties with respect to the Development of Tirasemtiv and Product; (e) monitor and coordinate all regulatory actions, communications and submissions for Tirasemtiv and Product under the Development Plan, Medical Affairs Plan Budget and all amendments thereto; including allocating related medical affairs responsibilities between the Parties; (Ef) reviewing and approving each Collaboration Proposal; (F) developinguntil formation of the JMAC, reviewing, and approving each Collaboration Plan and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of each Collaboration Plan; and (H) as applicable, reviewing the other Development oversee medical education activities and Medical Affairs Activities being conducted by establish a joint review process for medical affairs materials, including disease state awareness, medical education and other non-promotional materials; (g) establish joint subcommittees, as appropriate, to carry out its functions; and (h) perform such other functions as may be appropriate to further the Partiespurposes of this Agreement with respect to the Development of Tirasemtiv and Product.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)