Common use of Formation; Composition Clause in Contracts

Formation; Composition. Within […***…] days after the Effective Date, the Parties shall establish a joint development committee (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, Molecules and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within 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. Either Party may invite non-members to participate in the discussions and meetings of the JDC 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 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, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

Appears in 2 contracts

Sources: 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 development 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 Development Committee” or “JDCJMAC), which shall have the responsibilities set forth in Section 1.2(b). Each Party shall initially appoint three (3) [*] representatives to the JDCJMAC, with each representative having knowledge and expertise in the development of compounds, Molecules and working with products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within such 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. Either Party The JMAC may invite non-members to participate in the discussions and meetings of the JDC 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 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 JDCJMAC 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

Sources: 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, Molecules compounds and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Licensed Products and having sufficient seniority within such 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. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JDC 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 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 JDCJDC 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

Sources: 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 development communications review committee (the “Joint Development Communication Review Committee” or “JDCJCRC), which shall have the responsibilities set forth in Section 1.2(b) 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, Molecules and communications related to products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within 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. Either Party may invite non-members to participate in the discussions and meetings of the JDC JCRC 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 JDCJCRC. The JDC JCRC 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 JDCJCRC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JCRC representatives.

Appears in 2 contracts

Sources: 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 development commercialization committee (the “Joint Development Commercialization Committee” or “JDCJCC), which shall have the responsibilities set forth in Section 1.2(b)) 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, Molecules and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within 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. Either Party may invite non-members to participate in the discussions and meetings of the JDC 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 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 JDCJCC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC JCC representatives.

Appears in 2 contracts

Sources: 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 development 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 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, Molecules and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within such 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; by[*] 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. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JDC 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 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 JDCJDC 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

Sources: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within [***] days after the Effective Date, the Parties shall establish a joint development 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 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, Molecules compounds and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules Compounds and Optioned Licensed Products and having sufficient seniority within such 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; time, 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. 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 JDC 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 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 JDCJDC 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

Sources: Collaboration Agreement (Blueprint Medicines Corp)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a joint development 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 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, Molecules and products similar to the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within such 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. Either Party The JDC may invite non-members to participate in the discussions and meetings of the JDC 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 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 JDCJDC 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

Sources: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, but no later than the earlier of (i) eighteen (18) months prior to the date of the expected First Commercial Sale of the Product in the U.S. and (ii) six (6) months prior to the projected date of submission of the first NDA for the Product in the U.S., the Parties shall establish a joint development committee to oversee Commercialization of Products in the Territory and in China (the “Joint Development Committee” or “JDCJCC”), which shall have and prior thereto, the JSC will be responsible for all JCC responsibilities except for the specific responsibilities it delegates to the Core JPT as set forth out in Section 1.2(bSchedule G(b). Each Party shall initially appoint three (3) representatives of such Party or its Affiliate to the JDC, with each JCC at its inception. Each representative having appointed to the JCC shall have knowledge and expertise in relevant aspects of the development commercialization of compoundssmall molecule pharmaceutical products, Molecules and products similar to including in the Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within such the applicable Party or its Affiliate to make decisions arising within with the scope of the JDCJCC’s responsibilities. The JDC JCC may change its size from time to time if agreed by consensus among mutual consent of its members; , provided that the JDC JCC shall consist at all times of an equal number of representatives of each of Galapagos FibroGen and GileadAstraZeneca. Each Party may replace its JDC JCC representatives at any time upon written notice to the other Party. Either Party The JCC 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 JCC, 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 JDCJCC. The JDC JCC shall have a chairpersonchairman, 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 […***…]AstraZeneca. The role of the chairperson chairman shall be to convene and preside at meetings of the JDC, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.JCC,

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Fibrogen Inc)

Formation; Composition. Within [***…] days after the Effective Date, the Parties shall establish a joint development 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 Development Committee” or “JDC”), which provided that primary responsibility for coordinating CMC Development shall have be with the responsibilities set forth in Section 1.2(b)JMC. 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 Galapagos Molecules, Galapagos Products, Optioned Molecules and Optioned Products and having sufficient seniority within such 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 mutual consent of its members; , provided that the JDC shall consist at all times of an equal number of representatives of each of Galapagos Medivation and GileadPartner. Each Party may replace its 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 JDC 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 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 GileadPartner. The initial chairperson shall be selected by […***…]Medivation. The role of the chairperson shall be to convene and preside at meetings of the JDC, 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 JDC representatives.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a joint development 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 Development Committee” or “JDC”)) and prior thereto, which shall have the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to the Core JPT as set forth out in Section 1.2(bSchedule 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 compoundssmall molecule pharmaceutical products, Molecules and products similar to including in the Galapagos Molecules, Galapagos Products, Optioned Molecules and 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 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. 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 JDC 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 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 […***…]▇▇▇▇▇▇▇▇ and one selected by AstraZeneca. The role of the chairperson co- chairmen shall be to convene and preside at meetings of the JDC, 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

Sources: License, Development and Commercialization Agreement

Formation; Composition. Within […***…] days after At a time determined by the Effective DateJSC, the Parties shall establish a joint development 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 Development Committee” or “JDC”)) and prior thereto, which shall have the JSC will be responsible for all JDC responsibilities except for the specific responsibilities it delegates to the Core JPT as set forth out in Section 1.2(bSchedule 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 compoundssmall molecule pharmaceutical products, Molecules and products similar to including in the Galapagos Molecules, Galapagos Products, Optioned Molecules and 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 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. 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 JDC 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 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, 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

Sources: License, Development and Commercialization Agreement (Fibrogen Inc)