Common use of Formation; Composition Clause in Contracts

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”) to oversee Commercialization of Optioned Products. Each Party shall initially appoint three (3) representatives to the JCC, with each representative having knowledge and expertise in the commercialization of products similar to the Optioned Products and having sufficient seniority within such Party to make decisions arising within the scope of the JCC’s responsibilities. The JCC may change its size from time to time if agreed by consensus among its members; provided that the JCC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JCC representatives at any time upon written notice to the other Party. Either Party may invite non-members to participate in the discussions and meetings of the JCC provided notice is given to the other Party 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 JCC. The 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 JCC, but the chairperson shall have no additional powers or rights beyond those held by the other JCC representatives.

Appears in 2 contracts

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

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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 “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of compounds and products similar to the Optioned Licensed Products and having sufficient seniority within such the applicable Party to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its members; , provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos and Gilead. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC JDC representatives.

Appears in 2 contracts

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

Formation; Composition. Within [***…] days after the Effective Date], the Parties shall establish a joint commercialization committee to oversee and manage the Medical Affairs Activities with respect to Product(s) in the Shared Territory in accordance with the Joint Medical Affairs Plan(s) for such Product(s) and to coordinate the regulatory activities of the Parties with respect to such activities (the “Joint Commercialization Committee” or “JCCJMAC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) [*] representatives to the JCCJMAC, with each representative having knowledge and expertise in the commercialization of working with products similar to the Optioned Products and having sufficient seniority within such the applicable Party to make decisions arising within with the scope of the JCCJMAC’s responsibilities. The JCC JMAC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JCC JMAC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JCC JMAC representatives at any time upon written notice to the other Party. Either Party The JMAC may invite non-members to participate in the discussions and meetings of the JCC JMAC, provided notice is given to the other Party and that such non-members participants 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 JCCJMAC. The JCC 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 JCCJMAC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC 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 commercialization committee to coordinate the Development activities (including the related regulatory activities) of the Parties related to the Development of Licensed Compound in accordance with the Joint Development Plan (the “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) [**] representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of compounds and products similar to Licensed Compound and the Optioned Licensed Products and having sufficient seniority within such the applicable Party to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its memberstime; provided provided, that the JCC 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 JCC JDC representatives with a qualified employee of such Party at any time upon written notice to the other Party. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JCC provided notice is given to the other Party and JDC; provided, that such non-members participants 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 JCCJDC and shall be bound by the confidentiality obligations no less stringent than those provided in this Agreement. The JCC 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 JCC, but co-chairpersons to prepare and circulate agendas and to ensure the chairperson preparation of minutes. The co-chairpersons shall have no additional powers or rights beyond those held by the other JCC JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Arvinas, Inc.)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint commercialization development committee (the “Joint Commercialization Development Committee” or “JCCJDC) to oversee Commercialization of Optioned Products), which shall have the responsibilities set forth in Section 2.2(b). Each Party shall initially appoint three (3) representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of Molecules and products similar to the Arcus Molecules, Arcus Products, Optioned Molecules and Optioned Products and having sufficient seniority within such Party to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its members; provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos Arcus and Gilead. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either Party may invite non-members to participate in the discussions and meetings of the JCC provided notice is given to JDC with the other Party Party’s prior approval, such 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 JCCJDC. The JCC 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 JCCJDC, but the chairperson shall have no additional powers or rights beyond those held by the other JCC JDC 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 commercialization committee to oversee Development of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) [*] representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of products similar to the Optioned Products and having sufficient seniority within such the applicable Party to make decisions arising within with the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its members; [*] of [*], provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC 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 At a time determined by the Effective DateJSC, the Parties shall establish a joint commercialization committee to oversee Development of Product(s) in the Territory and in China in accordance with the Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to oversee Commercialization of Optioned Productsthe 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 JCC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the commercialization development of products similar to small molecule pharmaceutical products, including in the Optioned Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within such the applicable Party or Affiliate to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either 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 JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JCC 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 At a time determined by the Effective DateJSC, the Parties shall establish a joint commercialization committee to oversee Development of Product(s) in the Territory and in China in accordance with the Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to oversee Commercialization of Optioned Productsthe 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 JCC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the commercialization development of products similar to small molecule pharmaceutical products, including in the Optioned Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within such the applicable Party or Affiliate to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either 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 JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JCC JDC representatives. Each Party shall appoint a secretariat to the JDC.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement

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Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a joint commercialization committee to oversee Development of Product(s) in the Territory and in China in accordance with the Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC”) and prior thereto, the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to oversee Commercialization of Optioned Productsthe 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 JCC, with each JDC at its inception. Each representative having appointed to the JDC shall have knowledge and expertise in relevant aspects of the commercialization development of products similar to small molecule pharmaceutical products, including in the Optioned Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within such the applicable Party or Affiliate to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either 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 JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC, but the chairperson they shall have no additional powers or rights beyond those held by the other JCC JDC representatives. Each Party shall appoint a secretariat to the JDC.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Fibrogen Inc)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint commercialization committee to coordinate the Development activities of the Parties related to the Development of the Lead Compound 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 “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) [***] representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of compounds and products similar to the Optioned Compounds and Licensed Products and having sufficient seniority within such the applicable Party to make decisions arising within the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its members; time, provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos BPM and GileadRoche. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either 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 JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Blueprint Medicines Corp)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a joint commercialization committee to oversee Development of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products), provided that primary responsibility for coordinating CMC Development shall be with the JMC. Each Party shall initially appoint three (3) representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of products similar to the Optioned Products and having sufficient seniority within such the applicable Party to make decisions arising within with the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadPartner. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either 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 JCC JDC, provided notice is given that such participants are involved in activities related to the other Party Collaboration Molecule or Products 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 JCCJDC. The JCC 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 GileadPartner. The initial chairperson shall be selected by […***…]Medivation. The role of the chairperson shall be to convene and preside at meetings of the JCCJDC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a joint commercialization committee to oversee Development of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “Joint Commercialization Committee” or “JCCJDC) to oversee Commercialization of Optioned Products). Each Party shall initially appoint three (3) [*] representatives to the JCCJDC, with each representative having knowledge and expertise in the commercialization development of products similar to the Optioned Products and having sufficient seniority within such the applicable Party to make decisions arising within with the scope of the JCCJDC’s responsibilities. The JCC JDC may change its size from time to time if agreed by consensus among its members; by[*] of [*], provided that the JCC JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadAstellas. Each Party may replace its JCC JDC representatives at any time upon written notice to the other Party. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JCC JDC, provided notice is given to the other Party and that such non-members participants 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 JCCJDC. The JCC 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 JCCJDC and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC JDC representatives.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

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