Formation; Composition. Each Party will initially appoint [***] representatives to the JCC, with each representative having knowledge and expertise in the commercialization of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JCC’s responsibilities. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC will consist at all times of an equal number of representatives of each of Surface and Novartis. Each Party may replace its JCC representatives at any time upon written notice to the other Party. The JCC may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this Agreement. The JCC will be co-chaired, with one chairperson designated by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 3 contracts
Sources: Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.)
Formation; Composition. Promptly following the designation of a Product Candidate, the Parties shall establish a Joint Marketing Committee for such Product Candidate and Products containing such Product Candidate (each, a “JMC”). The Parties contemplate that there will be a separate JMC for each Product Candidate. Each Party will shall initially appoint [***] three (3) representatives to the JCCeach JMC, with each representative having knowledge and expertise in the commercialization of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within with the scope of the JCCsuch JMC’s responsibilities. The JCC Each JMC may change its size from time to time by mutual consent of its members, provided that the JCC will such JMC shall consist at all times of an equal number of representatives of each of Surface Reata and Novartis▇▇▇▇▇▇. Each Party may replace its JCC representatives at any time upon written notice to the other Party. The JCC JMC 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 JCCsuch JMC, provided that such participants are involved in activities related to Product Candidates or Products and shall have no voting authority at on such JMC. Each JMC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Reata or ▇▇▇▇▇▇. The initial chairperson for the JCC JMC for the first Product Candidate shall be selected by ▇▇▇▇▇▇, and are bound under written obligation of confidentiality no less protective the initial chairperson for the JMC for the second Product Candidate shall be selected by Reata, with the initial chairperson for JMC for each later Product Candidate to be selected by alternating Parties. The role of the Parties’ Confidential Information than chairperson shall be to convene and preside at meetings of the applicable JMC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those set forth in this Agreementheld by the other JMC representatives. Each JMC shall have a vice chairperson, who shall serve for a term of one year (and who then shall serve as chairperson), and who shall be selected alternately, on an annual basis, by ▇▇▇▇▇▇ or Reata. The JCC will initial vice chairperson for the JMC for the first Product Candidate shall be co-chairedselected by Reata, and the initial chairperson for the JMC for the second Product Candidate shall be selected by ▇▇▇▇▇▇, with one the initial chairperson designated by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for JMC for each meeting are set and achievedlater Product Candidate to be selected by alternating Parties. Responsibility for running each meeting The role of the JCC will alternate between vice chairperson shall be to consult with and assist the chairpersons from meeting-to-meeting, with Novartischairperson in the carrying out of the chairperson’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDduties.
Appears in 2 contracts
Sources: Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc)
Formation; Composition. Each Party will initially appoint No later than after [***] after the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) comprised of an equal number of representatives to the JCC, from each Party (or appointed representatives of any Affiliate of such Party) with each representative having knowledge and expertise in the commercialization of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JCCJSC’s responsibilities. The JCC JSC may change its size from time to time by mutual consent of its members, provided that the JCC JSC [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed. will consist at all times of an equal number of representatives of each of Surface HFB and NovartisFibroGen. Each Party may replace its JCC JSC representatives at any time upon written notice to the other Party. The JCC If agreed by the JSC on a case-by-case basis, the JSC may invite non-members to participate in the discussions and meetings of the JCCJSC, provided that such participants will have no voting authority at the JCC JSC and are bound under by written obligation obligations of confidentiality no less confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties’ Confidential Information than Parties as those set forth in this Agreement. The JCC JSC will be co-chairedchaired by an HFB representative prior to the first Option Exercise Date with respect to any Option Program, with one chairperson designated and thereafter by Surface and [***] designated by Novartisa representative of FibroGen (each, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieveda “Chairperson”). Responsibility for running each meeting The role of the JCC Chairperson will alternate between be to convene and preside at meetings of the chairpersons from meeting-to-meeting, JSC. The Chairperson will have no additional powers or rights beyond those held by the other JSC representatives. The Alliance Managers will work with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDChairperson to prepare and circulate agendas and to ensure the preparation of minutes.
Appears in 1 contract
Sources: Exclusive License and Option Agreement (Fibrogen Inc)
Formation; Composition. Each Party will initially appoint Within [***] of the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) comprised of [***] qualified representatives to the JCC, from each Party (or appointed representatives of any Affiliate of such Party) with each representative having knowledge and expertise in the commercialization of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JCCJSC’s responsibilities. The JCC JSC may change its size from time to time by mutual consent of its membersthe Parties, provided that the JCC JSC will consist at all times of an equal number of representatives of each of Surface Mabwell and NovartisDisc. If a representative from either Party is unable to attend or participate in a JSC meeting, the Party who designated that representative may designate a substitute JSC representative for the meeting in its sole discretion upon prior written notice to the other Party. Representation by proxy shall not be allowed. A quorum of the JSC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Each Party may replace its JCC JSC representatives at any time upon written notice to the other Party. The JCC JSC may invite non-members to participate in the discussions and meetings of the JCCJSC, provided that such participants will have no voting authority at the JCC JSC and are bound under written obligation shall be Representatives of the inviting Party, for clarity all such non-members shall be subject to restrictions regarding the confidentiality and non-use of Confidential Information no less protective of restrictive than the Parties’ Confidential Information than those provisions set forth in this AgreementSection 8. The JCC JSC will be co-chaired, with chaired by one chairperson designated of the representatives (“Chairperson”) and will rotate between and appointed by Surface and the Parties every [***] designated by Novartisduring the Term, whose responsibilities provided that the first Chairperson of JSC will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achievedbe a representative of Disc. Responsibility for running each meeting The role of the JCC Chairperson will alternate between be to convene and preside at meetings of the chairpersons from meeting-to-meeting, JSC. The Chairperson will have no additional powers or rights beyond those held by the other JSC representatives. The Alliance Managers will work with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDChairperson to prepare and circulate agendas and to ensure the preparation of minutes.
Appears in 1 contract
Formation; Composition. At a time determined by the JSC, 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 committee to oversee Commercialization of Products in the Territory and in China (the “JCC”), 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 out in Schedule G(b). Each Party will initially shall appoint [***] three (3) representatives of such Party or its Affiliate to the JCC, with each JCC at its inception. Each representative having appointed to the JCC shall have knowledge and expertise in relevant aspects of the commercialization of products similar to small molecule pharmaceutical products, including in the Regional Licensed Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within the applicable Party or its Affiliate to make decisions arising within with the scope of the JCC’s responsibilities. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC will shall consist at all times of an equal number of representatives of each of Surface FibroGen and NovartisAstraZeneca. Each Party may replace its JCC representatives at any time upon written notice to the other 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 JCC, provided that such participants shall have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this AgreementJCC. The JCC will shall have a chairman, who shall be co-chaired, with one chairperson designated selected by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achievedAstraZeneca. Responsibility for running each meeting The role of the chairman shall be to convene and preside at meetings of the JCC, but the chairman shall have no additional powers or rights beyond those held by the other JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDrepresentatives.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement
Formation; Composition. Within [*] days after the Effective Date, the Parties shall establish a committee to oversee and manage the Regulatory Approval of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the regulatory activities of the Parties (the “JRC”). Each Party will shall initially appoint [***] three (3) representatives to the JCCJRC, with each representative having knowledge and expertise in the commercialization obtaining and maintaining Regulatory Approvals of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within with the scope of the JCCJRC’s responsibilities. The JCC JRC may change its size from time to time by mutual consent of its members, provided that the JCC will JRC shall consist at all times of an equal number of representatives of each of Surface Medivation and NovartisPartner. Each Party may replace its JCC JRC representatives at any time upon written notice to the other Party. The JCC JRC 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 JCCJRC, provided that such participants are involved in activities related to Collaboration Molecules or Products and shall have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this AgreementJRC. The JCC will JRC shall have a chairperson, who shall serve for a term of one year, and who shall be co-chairedselected alternately, with one chairperson designated on an annual basis, by Surface and [***Medivation or [ * ] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. = CERTAIN CONFIDENTIAL PORTIONS OF INFORMATION CONTAINED IN THIS EXHIBIT WERE DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER 24B-2 OF THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED.
Appears in 1 contract
Formation; Composition. At a time determined by the JSC, 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 committee to oversee Commercialization of Products in the Territory and in China (the “JCC”), 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 out in Schedule G(b). Each Party will initially shall appoint [***] three (3) representatives of such Party or its Affiliate to the JCC, with each JCC at its inception. Each representative having appointed to the JCC shall have knowledge and expertise in relevant aspects of the commercialization of products similar to small molecule pharmaceutical products, including in the Regional Licensed Products area of chronic kidney disease or cardiovascular or metabolic disorders and having sufficient seniority within the applicable Party or its Affiliate to make decisions arising within with the scope of the JCC’s responsibilities. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC will shall consist at all times of an equal number of representatives of each of Surface FibroGen and NovartisAstraZeneca. Each Party may replace its JCC representatives at any time upon written notice to the other 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 JCC, provided that such participants shall have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this AgreementJCC. The JCC will shall have a chairman, who shall be co-chaired, with one chairperson designated selected by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achievedAstraZeneca. Responsibility for running each meeting The role of the chairman shall be to convene and preside at meetings of the JCC, but the chairman shall have no additional powers or rights beyond those held by the other JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDrepresentatives.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Fibrogen Inc)
Formation; Composition. As of the Amendment No. 3 Execution Date, in lieu of the JSC, which is disbanded as of the Amendment No. 3 Execution Date, the Parties hereby establish a joint executive committee (the “Joint Executive Committee” or “JEC”), which shall have the responsibilities set forth in Section 2.1(b). Each Party will initially may appoint [***] up to four (4) representatives to the JCCJEC, with each representative having knowledge all of whom shall have sufficient seniority, experience and expertise in the commercialization of products similar to the Regional Licensed Products 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 JCCJEC’s responsibilities, and no JEC representative shall be a member of any other Committee during any period when such representative is a member of the JEC. As of the Amendment No. 3 Execution Date, (i) Gilead hereby appoints its Chief Financial Officer (CFO) or such CFO’s delegate with the appropriate decision-making authority, its Chief Medical Officer (CMO) or such CMO’s delegate with the appropriate decision-making authority, its Chief Commercial Officer (CCO) or such CCO’s delegate with the appropriate decision-making authority and its Executive Vice President for Pharmaceutical Development and Manufacturing or their delegate with the appropriate decision-making authority, and (ii) Arcus hereby appoints its Chief Executive Officer (CEO) or such CEO’s delegate with the appropriate decision-making authority, its Chief Operating Officer (COO) or such ▇▇▇’s delegate with the appropriate decision-making authority, and up to two (2) additional representatives as appointed by its CEO, in each case, as representatives to the JEC of such Party. The JCC JEC may change its size from time to time if agreed by mutual consent of consensus among its members, ; provided that the JCC will JEC may consist at all times of an equal unequal number of representatives of each of Surface Arcus and NovartisGilead. Each Party may replace its JCC JEC representatives at any time upon written notice to approval of the other Party, such approval not to be unreasonably conditioned, withheld or delayed. The JCC Either Party may invite non-members to participate in the discussions and meetings of the JCCJEC 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 (1) be subject to confidentiality obligations at least as stringent as those set forth in ARTICLE XIII and (2) have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this AgreementJEC. The JCC will be co-chaired, with one JEC shall have a chairperson designated by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDThe role of the chairperson shall be to (x) convene and preside at meetings of the JEC and (y) [***].
Appears in 1 contract
Sources: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)
Formation; Composition. Each Party will initially appoint 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 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 Regional Licensed Arcus Molecules, Arcus Products, Optioned Molecules and 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 JCCJDC’s responsibilities, and each JDC representative shall not be a member of any other Committee during any period when such representative is a member of the JDC. The JCC JDC may change its size from time to time if agreed by mutual consent of consensus among its members, ; provided that the JCC will JDC shall consist at all times of an equal number of representatives of each of Surface Arcus and NovartisGilead. Each Party may replace its JCC JDC representatives at any time upon written notice to approval of the other Party, such approval not to be unreasonably conditioned, withheld or delayed. The JCC Either Party may invite non-members to participate in the discussions and meetings of the JCCJDC 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 JCC JDC. The JDC shall have a chairperson, who shall serve for a term of one (1) year, and are bound under written obligation of confidentiality no less protective who shall be selected alternately, on an annual basis, by Arcus or Gilead. The role of the Parties’ Confidential Information than chairperson shall be to convene and preside at meetings of the JDC, but the chairperson shall have no additional powers or rights beyond those set forth in held by the other JDC representatives; provided, however, that for clarity this sentence shall not be interpreted to deprive a Party of its final decision-making authority under this Agreement. The JCC will be co-chaired, with one chairperson designated by Surface and Within [***] designated by NovartisBusiness Days after the Amendment No. 3 Execution Date, whose responsibilities each Party will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achievedmake any changes to its JDC representatives as required to adhere to this clause (b) as revised in Amendment No. Responsibility for running each meeting of the JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]3.”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 1 contract
Sources: Option, License and Collaboration Agreement (Arcus Biosciences, Inc.)