Common use of Formation; Composition Clause in Contracts

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDC”). Each Party shall initially appoint three (3) representatives to the JDC, with each representative having knowledge and expertise in the development of compounds and products similar to the Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its members, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Galapagos Nv), License and Collaboration Agreement (Galapagos Nv)

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Formation; Composition. Within [***…] days after the Effective Date], the Parties shall establish a committee to oversee Development of Licensed and manage the Medical Affairs Activities with respect to Product(s) in the Shared Territory in accordance with the Development Joint Medical Affairs Plan(s) for the same such Product(s) and to coordinate the Development regulatory activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties with respect to such activities (the “JDCJMAC”). Each Party shall initially appoint three (3) [*] representatives to the JDCJMAC, with each representative having knowledge and expertise in the development of compounds and working with products similar to the Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within with the scope of the JDCJMAC’s responsibilities. The JDC JMAC may change its size from time to time if agreed by consensus among mutual consent of its members, provided that the JDC JMAC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JDC JMAC representatives at any time upon written notice to the other Party. The JDC JMAC may invite non-members to participate in the discussions and meetings of the JDCJMAC, provided that such participants shall have no voting authority at the JDCJMAC. The JDC JMAC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Medivation or GileadAstellas. The initial chairperson shall be selected by […***…]Medivation. The role of the chairperson shall be to convene and preside at meetings of the JDC JMAC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JMAC representatives.

Appears in 2 contracts

Samples: Collaboration Agreement (Medivation, Inc.), Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a joint development committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “Joint Development Committee” or “JDC”), which shall have the responsibilities set forth in Section 1.2(b). Each Party shall initially appoint three (3) representatives to the JDC, with each representative having knowledge and expertise in the development of compounds compounds, Molecules and products similar to the Licensed Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDC, JDC provided that notice is given to the other Party and such participants non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 2 contracts

Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a joint communications review committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDCJoint Communication Review Committee” or “JCRC) to oversee publications and other public communications related to Optioned Programs (including Optioned Molecules and Optioned Products). Each Party shall initially appoint three (3) representatives to the JDCJCRC, with each representative having knowledge and expertise in the development of compounds and communications related to products similar to the Licensed Optioned Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDCJCRC’s responsibilities. The JDC JCRC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC JCRC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JDC JCRC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDC, JCRC provided that notice is given to the other Party and such participants non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDCJCRC. The JDC JCRC shall have a Option, License and Collaboration Agreement chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJCRC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JCRC representatives.

Appears in 2 contracts

Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a joint commercialization committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDCJoint Commercialization Committee” or “JCC)) to oversee Commercialization of Optioned Products. Each Party shall initially appoint three (3) representatives to the JDCJCC, with each representative having knowledge and expertise in the development commercialization of compounds and products similar to the Licensed Optioned Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDCJCC’s responsibilities. The JDC JCC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC JCC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JDC JCC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDC, JCC provided that notice is given to the other Party and such participants non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDCJCC. The JDC JCC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJCC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JCC representatives.

Appears in 2 contracts

Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall will establish a committee to oversee the identification, Research and Development of Licensed Product(sResearch Candidates, Development Candidates and Products (but not Reversion Products) in the Territory in accordance with the Research Plan(s), Early Clinical Development Plan(s) and Late Clinical Development Plan(s) for the same and to coordinate the Research and Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”). Each Party shall will initially appoint three (3) [***] representatives to the JDC, with each representative having knowledge and expertise in the development Research and Development of compounds and products similar to the Licensed Research Candidates, Development Candidates and Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its memberstime, provided that the JDC shall will consist at all times of an equal number of representatives of each of Galapagos Unum and GileadSGI. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall will have a chairperson, who shall will serve for a term of one (1) year[***], and who shall will be selected alternately, on an annual basis, by Galapagos Unum or GileadSGI. The initial chairperson shall will be selected by […***…]Unum. The role of the chairperson shall will be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have has no additional powers or rights beyond those held by the other JDC representatives.

Appears in 2 contracts

Samples: Collaboration Agreement (Unum Therapeutics, Inc.), Collaboration Agreement (Unum Therapeutics, Inc.)

Formation; Composition. Within [***] days after the Effective Amendment No. 3 Execution Date, the Parties shall establish a joint finance committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDCJoint Finance Committee” or “JFC), which shall have the responsibilities set forth in Section 2.11(b). Each Party shall initially appoint three one (31) representatives representative to the JDCJFC, with each representative having all of whom shall have knowledge and expertise in the development of compounds finance and products similar to the Licensed Products shall be at sufficient seniority, experience and having sufficient seniority authority within the applicable such Party to make act on behalf of and bind such Party with respect to decisions arising within the scope of the JDCJFC’s responsibilities, and each JFC representative shall not be a member of any other Committee during any period when such representative is a member of the JFC. As of the Amendment No. 3 Execution Date, Gilead hereby appoints [***], and Arcus hereby appoints [***], in each case, as representatives to the JFC of such Party. The JDC JFC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC JFC shall consist at all times of an equal number of representatives of each of Galapagos Arcus and Gilead. Each Party may replace its JDC JFC representatives at any time upon written notice to approval of the other Party, such approval not to be unreasonably conditioned, withheld or delayed. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDCJFC with the other Party’s prior approval, provided that such participants approval not to be unreasonably conditioned, withheld or delayed and such non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDCJFC. The JDC shall have a chairpersonFor purposes of this Agreement, who the JFC representative of each Party shall serve for a term as the Finance Officer of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representativessuch Party under Section 9.11(b).

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Joint Development Plan(s) for the same such Product(s) and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”). Each Party shall initially appoint three (3) [*] representatives to the JDC, with each representative having knowledge and expertise in the development of compounds and products similar to the Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within with the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its membersby[*] of [*], provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Medivation or GileadAstellas. The initial chairperson shall be selected by […***…]Medivation. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory and in China in accordance with the Development Plan(s) for the same such Product(s) and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to the Core JPT as set out in Schedule G(a). Each Party shall initially appoint three (3) representatives of such Party or its Affiliates to the JDC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the development of compounds and products similar to small molecule pharmaceutical products, including in the Licensed Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within the applicable Party or Affiliate to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among mutual consent of its members, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairpersontwo (2) co-chairmen, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]XxxxxXxx and one selected by AstraZeneca. The role of the chairperson co- chairmen shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JDC representatives. Each Party shall appoint a secretariat to the JDC.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a committee to oversee coordinate the Development activities (including the related regulatory activities) of the Parties related to the Development of Licensed Product(s) in the Territory Compound in accordance with the Joint Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Plan (the “JDC”). Each Party shall initially appoint three (3) [**] representatives to the JDC, with each representative having knowledge and expertise in the development of compounds and products similar to Licensed Compound and the Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its memberstime; provided, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos and GileadParty. Each Party may replace any of its JDC representatives with a qualified employee of such Party at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC; provided, provided that such participants shall have no voting authority at the JDCJDC and shall be bound by the confidentiality obligations no less stringent than those provided in this Agreement. The JDC shall have a chairpersontwo (2) co-chairpersons, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]from each Party. The role of the chairperson co-chairpersons shall be to convene and preside at meetings of such JDC. The Alliance Manager shall work with the JDC co-chairpersons to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson . The co-chairpersons shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Arvinas, Inc.)

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory and in China in accordance with the Development Plan(s) for the same such Product(s) and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to the Core JPT as set out in Schedule G(a). Each Party shall initially appoint three (3) representatives of such Party or its Affiliates to the JDC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the development of compounds and products similar to small molecule pharmaceutical products, including in the Licensed Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within the applicable Party or Affiliate to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among mutual consent of its members, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairpersontwo (2) co-chairmen, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]FibroGen and one selected by AstraZeneca. The role of the chairperson co-chairmen shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JDC representatives. Each Party shall appoint a secretariat to the JDC.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Fibrogen Inc)

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Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss Parties related to the Development and Manufacture of Licensed the Lead Compound and Licensed Products in accordance with the Development Plan and, subject to Section 3.13, the Development of a Second Generation RET Compound or a Lead Backup in accordance with a Second Generation Research Plan (the “JDC”). Each Party shall initially appoint three (3) [***] representatives to the JDC, with each representative having knowledge and expertise in the development of compounds and products similar to the Compounds and Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its memberstime, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos BPM and GileadRoche. Each Party may replace its JDC representatives at any time upon written notice to the other Party. In addition, JDC members may be represented at any meeting by another person designated by the absent member who has the required expertise (which such designee shall have voting authority at the JDC for the applicable meeting). The JDC may invite non-members to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and chairperson who shall be selected alternately, on an annual basis, by Galapagos BPM or GileadRoche. The initial chairperson shall be selected by [***]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Blueprint Medicines Corp)

Formation; Composition. Within No later than [***] days after months prior to the Effective Dateanticipated first commercial launch in the Shared Territory of the first Joint Product (or by such other date as mutually agreed by the Parties), the Parties shall establish a joint commercialization committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDCJoint Commercialization Committee” or “JCC)) to oversee Commercialization of Joint Products in the Shared Territory. Each Party shall initially appoint three (3) representatives to the JDCJCC, with each representative having knowledge and expertise in the development commercialization of compounds and products similar to the Licensed Joint Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDCJCC’s responsibilities. The JDC JCC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC JCC shall consist at all times of an equal number of representatives of each of Galapagos Arcus and Gilead. Each Party may replace its JDC JCC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDCJCC with the other Party’s prior approval, provided that such participants approval not to be unreasonably conditioned, withheld or delayed and such non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDCJCC. The JDC JCC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by [***]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJCC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JCC representatives.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint development committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “Joint Development Committee” or “JDC”), which shall have the responsibilities set forth in Section 2.2(b). Each Party shall initially appoint three (3) representatives to the JDC, with each representative having knowledge and expertise in the development of compounds Molecules and products similar to the Licensed Arcus Molecules, Arcus Products, Optioned Molecules and Optioned Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos Arcus and Gilead. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDCJDC with the other Party’s prior approval, provided that such participants approval not to be unreasonably conditioned, withheld or delayed and such non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Arcus or Gilead. The initial chairperson shall be selected by [***]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory and in China in accordance with the Development Plan(s) for the same such Product(s) and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to the Core JPT as set out in Schedule G(a). Each Party shall initially appoint three (3) representatives of such Party or its Affiliates to the JDC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the development of compounds and products similar to small molecule pharmaceutical products, including in the Licensed Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within the applicable Party or Affiliate to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among mutual consent of its members, provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairpersontwo (2) co-chairmen, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos or Gilead. The initial chairperson shall be selected by […***…]FibroGen and one selected by AstraZeneca. The role of the chairperson co- chairmen shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JDC representatives. Each Party shall appoint a secretariat to the JDC.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint development committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “Joint Development Committee” or “JDC”), which shall have the responsibilities set forth in Section 2.2(b). Each Party shall initially appoint three (3) representatives to the JDC, with each representative having knowledge and expertise in the development of compounds Molecules and products similar to the Licensed Assembly Molecules and Assembly Products and having sufficient seniority within the applicable such Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos Assembly and Gilead. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDCJDC with the other Party’s prior approval, provided that such participants approval not to be unreasonably conditioned, withheld or delayed and such non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XVII and (ii) have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Assembly or Gilead. The initial chairperson shall be selected by [***]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJDC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Assembly Biosciences, Inc.)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Joint Development Plan(s) for the same such Product(s) and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products Parties (the “JDC”). Each Party shall initially appoint three (3) [*] representatives to the JDC, with each representative having knowledge and expertise in the development of compounds and products similar to the Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within with the scope of the JDC’s responsibilities. The JDC may change its size from time to time if agreed by consensus among its members[*] of [*], provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC, provided that such participants shall have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Medivation or GileadAstellas. The initial chairperson shall be selected by […***…]Medivation. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives. [*] = 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.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint manufacturing committee to oversee Development of Licensed Product(s) in the Territory in accordance with the Development Plan(s) for the same and to coordinate the Development activities of the Parties, and review and discuss the Development and Manufacture of Licensed Compound and Licensed Products (the “JDCJoint Manufacturing Committee” or “JMC) to oversee Manufacturing related to Optioned Programs (including Optioned Molecules and Optioned Products). Each Party shall initially appoint three (3) representatives to the JDCJMC, with each representative having knowledge and expertise in the development clinical and commercial Manufacture of compounds and products similar to the Licensed Optioned Products and having sufficient seniority seniority, experience and authority within the applicable such Party to make act on behalf of and bind such Party with respect to decisions arising within the scope of the JDCJMC’s responsibilities, and each JMC representative shall not be a member of any other Committee during any period when such representative is a member of the JMC. The JDC JMC may change its size from time to time if agreed by consensus among its members, ; provided that the JDC JMC shall consist at all times of an equal number of representatives of each of Galapagos Arcus and Gilead. Each Party may replace its JDC JMC representatives at any time upon written notice to approval of the other Party, such approval not to be unreasonably conditioned, withheld or delayed. The JDC Either Party may invite non-members to participate in the discussions and meetings of the JDC, JMC provided that notice is given to the other Party and such participants non-members shall (i) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (ii) have no voting authority at the JDCJMC. The JDC JMC shall have a chairperson, who shall serve for a term of one (1) year, and who shall be selected alternately, on an annual basis, by Galapagos Arcus or Gilead. The initial chairperson shall be selected by […***…]. The role of the chairperson shall be to convene and preside at meetings of the JDC and to ensure the preparation of minutesJMC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JMC representatives.

Appears in 1 contract

Samples: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)

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