Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. The Parties hereby establish a joint development committee (the “JDC”), to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview. (a) Responsibilities of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iii) review and monitor progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time.

Joint Development Committee. The As of the Effective Date, the Parties hereby establish have established a joint development Development, Medical Affairs, and regulatory committee (the “Joint Development Committee” or the “JDC”), composed of up to [ * ] representatives of each Party, to monitor and coordinate the Development of, and Medical Affairs Activities connected with, the Compound and Products at the operational level. Each JDC representative shall have knowledge and expertise in the clinical development of products similar to the Products. The JDC shall in particular: (a) coordinate and oversee monitor the Development activities of the Parties under the GDP and oversee implementation of the GDP, and report to the JEC on all significant Development activities in the Collaborator Territory; (b) provide a forum for and facilitate communications between the Parties with respect to the Development of Products in the Collaborator Territory and the Exelixis Territory, including sharing of Development information and Data in accordance with Section 4.7; (c) review and approve for the Collaborator Territory Clinical Trial protocols, including investigator-initiated and cooperative group clinical trial plans and protocols, and statistical analysis plans for Clinical Trials (and any amendments thereto); (d) define areas of permissible scientific and medical inquiry and parameters for Phase 4 Clinical Trials in the Collaborator Territory; (e) review Data resulting from Clinical Trials to determine if progression to additional Clinical Trials or submission of Regulatory Filings in the Collaborator Territory is warranted in terms of regulatory and scientific point of view; (f) review and recommend amendments to the GDP (including the Development Budget) and propose the recommendation to JEC; (g) provide a forum for Exelixis to provide Collaborator with a status report, at each regularly-scheduled meeting of the JDC, of any significant potential or proposed change(s) in any of Exelixis’ or its other Product licensee’s Development plans and activities that may [ * ] = 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. result in or require an amendment to the GDP, including any global clinical trial or study of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority which Collaborator may wish to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview.participate; (ah) Responsibilities review the status of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3Product manufacturing and supply activities and strategies associated with Development; (i) the general strategy provide a forum for evaluation of Japanese regulatory actions, communications and budget submissions for the Development Compound and Products under the GDP, and pharmacovigilance and safety matters worldwide; (j) establish joint working groups (such as clinical, regulatory and safety working groups) as it deems necessary or appropriate to oversee the day-to-day management of different aspects of the Product, including Development work under the GDP; (k) oversee and coordinate the material Medical Affairs Activities for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit Ball indications, which shall be reviewed subject to a Medical Affairs portion of the GDP and updated [***] may be coordinated through a Medical Affairs working group established and overseen by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 BudgetJDC; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iiil) review and monitor progress of the Development activities (including any coordinate decisions related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific research or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territorynew indications, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territorycharacterization, and Development of [ * ] (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(eif any); and (xim) have perform such additional responsibilities other functions as may be assigned appropriate to further the purposes of this Agreement with respect to the JDC pursuant Development of Products, including endeavoring to this Agreement resolve any disputes between the Parties arising from the deliberations of the JDC, or as may be mutually agreed upon otherwise directed by the Parties in writing from time to timeJEC.

Joint Development Committee. The Parties hereby establish shall form a joint development committee team (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Advaxis and Incyte (not to coordinate exceed three (3) each), which shall have responsibility for coordinating all regulatory and oversee other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the Development “Project Manager”) who shall be responsible for ensuring clear and responsive communication between the Parties and the effective exchange of information, serving as the Product in primary point of contact for any issues arising under this Agreement, implementing and coordinating activities, and facilitating the Norgine Territory before Regulatory Approval thereinexchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives meet as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] soon as practicable after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to Date and then no less than once each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview. (a) Responsibilities of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”)Calendar Quarter, and agreeing to more often as reasonably considered necessary at the Phase 3 Budget; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by request of either Party that such Party believes present with reasonable notice, to provide an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iii) review and monitor update on progress of the Development activities (including any related clinical trials Study and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions make decisions regarding the conduct of the Development Plan; Study and any modifications to the Protocol and Budget. Five (iv5) review business days prior to any such meeting, the Incyte Project Manager shall provide an update in writing to the Advaxis Project Manager, which update shall contain information about overall Study progress, recruitment status, interim analysis (if results are available), final analysis and approval other information relevant to the conduct of the protocol Study. The JDC will attempt to reach decisions by consensus, except that Advaxis will determine in its sole discretion the dose and dosing regimen for the Advaxis Compound and Incyte will determine in its sole discretion the dose and dosing regimen for the Incyte Compound. When consensus is not achieved on any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect matter, the matter will be escalated to the Products Incyte CEO and the EVP CMO Advaxis or his/her nominee for resolution, provided however that (including discussing coordination of such activities 1) in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of event that the Product; (vii) discuss such other information relating matter relates solely to the Products that is reasonably requested by either Party; Advaxis Compound, Advaxis shall have final decision-making authority and (viii2) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in event that the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and (xi) have such additional responsibilities as may be assigned matter relates solely to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to timeIncyte Compound, Incyte shall have final decision-making authority.

Joint Development Committee. The Parties hereby shall establish a joint development committee Joint Development Committee (the “JDC”), to coordinate and oversee the Development ) promptly upon commencement of the Product in Co-Detail Term for the Norgine Territory before Regulatory Approval thereinfirst Co-Detail Product, if any. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson purpose of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall alternate between terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt of the Parties on an annual basisfirst Marketing Approval for such Co-Detail Product by a Party; and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice Subject to the other Party. The initial representatives and chair terms of the JDC shall be established within [***] after Joint Development and Co-Detail Agreement(s), the Effective Date. The chairJDC’s specific responsibilities are as follows: 4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, in conjunction including with the Alliance Managersrespect to which indications, shall have the responsibility markets and populations to call meetings, circulate meeting agendas at least [***] prior pursue and matters with respect to life cycle management; 4.7.2 Reviewing and discussing each regular JDC meeting, draft minutes for each JDC meeting initial Joint Development and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form subCo-teams or subcommittees Detail Plan and Joint Development and Co-Detail Budget and any updates to address any of the issues within its purview.foregoing plans or budgets; (a) Responsibilities 4.7.3 Overseeing the execution of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy development activities pursuant to each Joint Development and budget for the Development of the ProductCo-Detail Plan, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant adherence to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed associated Joint Development and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Co-Detail Budget; (ii) alignment on protocol 4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical TrialCo-Detail Product; (iii) review and monitor 4.7.5 Reviewing progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities reports with respect to the development of Co-Detail Products (including discussing coordination of such activities in the Parties’ respective territories)under a Joint Development and Co-Detail Agreement; (vi) review 4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to the conduct of any scientific or safety concerns of development activities under a Party which such Party reasonably believes might impact such Party’s Joint Development of the Product;and Co-Detail Agreement; and (vii) discuss 4.7.7 Fulfilling such other information relating responsibilities as may be allocated to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations JDC under this Agreement, including a Joint Development and Co-Detail Agreement, or by mutual written agreement of the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to timeParties.

Joint Development Committee. (i) The Parties hereby establish a joint development committee (.1-DC will have the “JDC”), to coordinate responsibility for the overall coordination and oversee oversight of the Development of the Product Products in the Norgine Field in the Licensed Territory before Regulatory Approval thereinin accordance with the applicable Development Plan and oversight of the Development of any Product under a Collaboration Plan. The JDC As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall consist of [***] designate its initial two (2) representatives on the JDC. Company shall appoint a person from each Party. The Parties shall ensure that each of their among its representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives serve as the initial chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair JDC: (A) calling meetings of the JDC JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; and (C) preparing and circulating an agenda for the upcoming meeting; provided that the chairperson shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address include any of the issues within its purviewagenda items proposed by Licensee. (aii) Responsibilities of the JDC. The JDC shall have the following responsibilitiesresponsibility for: ACTIVE/105730326.3 (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines flow and transfer of information between the Product presents an unacceptable risk Parties related to patients participating in the Pivotal Clinical Trial; provided that any decision each of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iii) review and monitor progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget, any Collaboration Plan, and facilitating discussions regarding the conduct of the Development Plan; (iv) review any Collaboration Budget pursuant to 5.2, 5.3 and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory5.5, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, respectively; (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in overseeing, reviewing and coordinating the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territoriesField in Licensed Territory; ACTIVE/105730326.3 (xC) coordinate overseeing, reviewing and coordinating Medical Affairs Activities with respect to each Product in the sharing Field in the Licensed Territory; (D) reviewing and exchange approving the Development Plan, Development Plan Budget, Medical Affairs Plan, Medical Affairs Plan Budget and all amendments thereto; (E) reviewing and approving each Collaboration Proposal; (F) developing, reviewing, and approving each Collaboration Plan and Collaboration Budget and all amendments thereto; (G) overseeing, reviewing and coordinating the conduct of information necessary or useful for each Party to perform its obligations under this AgreementCollaboration Plan; and (H) as applicable, including reviewing the information exchanged pursuant to Sections 3.1(d) other Development activities and 3.1(e); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon Medical Affairs Activities being conducted by the Parties in writing from time to timeParties.

Joint Development Committee. The Parties hereby (a) No later than its initial meeting, the JSC shall establish a joint development Development committee (the “Joint Development Committee” or “JDC”)) which shall hold its initial meeting within fifteen (15) days of its establishment. At its first meeting, to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of shall: (i) [***] representatives from each Party], and (ii) review, modify as necessary and recommend for approval to the JSC a Development Plan (including the Development Budget). The Parties Illustrative Development Plan/Budget is an illustrative indication of the activities and the budget to be considered and addressed in the first Development Plan and shall ensure that each of their representatives not be binding on the JDC shall have knowledge and on-going familiarity with Parties, the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to JSC or the JDC. AMAG shall designate [***] of Following its representatives as the initial chairperson of the JDC. The chairperson of meeting, the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chairwill meet in person, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas by teleconference or by video- teleconference at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview. (a) Responsibilities of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated per [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iii) review and monitor progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***];. (ixb) serve Without limiting the foregoing, the JDC shall be responsible for: (i) reviewing, consulting with the Parties on and modifying (as appropriate) the first forum Development Plan including the Development Budget; (ii) recommending the Development Plan including the Development Budget (as modified) for discussing disputes or disagreements resulting from, arising out approval by the JSC; (iii) communicating with the JCC regarding the interrelationship between Development activities and potential Commercialization; (iv) reviewing and monitoring the activities and progress against the Development Plan; (v) reviewing and monitoring the costs and expenses of or Development against the Development Budget; (vi) finalizing the Product specifications for inclusion in relation to Development or Manufacture the Regulatory Filings for the Territory and Regulatory Approvals and Pricing and Reimbursement Approvals for the Territory; and (vii) communicating with the Parties regarding all of the Products in foregoing. For the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate avoidance of doubt, the sharing CRO used for Clinical Trials shall be selected by Coherus, and exchange of information necessary or useful for each Party such selection shall not be subject to perform its obligations the dispute escalation process under this Agreement, including the information exchanged pursuant to Sections Section 3.1(d) and 3.1(e(Decision-Making; Deciding Vote); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time.

Joint Development Committee. The (a) Within [***] following the Effective Date, the Parties hereby will establish a joint development committee Joint Development Committee (the “Joint Development Committee” or “JDC”)) which will have responsibility to manage, to coordinate direct and oversee all Development activities relating to the Selected Molecules, Designated ARC Molecules and Development Molecules, including those activities set out in the Development Plan, and the following: (i) managing, directing and overseeing all activities under the Development Plan; (ii) providing a forum to facilitate the resolution of issues between the Parties; (iii) identifying materials or resources to be accessed from Third Parties; (iv) [***] (v) reviewing and approving or rejecting proposed modifications to the Budget; (vi) selecting the initial SM2 from among the Designated ARC Molecules; (vii) reviewing and approving or rejecting proposed modifications to the Development Plan in a timely manner and circulating copies of each revised or updated version to the Parties; (viii) monitoring progress of the Product Development Plan, including monitoring Xxxxxxxx’x compliance with its obligations under same, including the accomplishment of key objectives and milestones; (ix) circulating to each representative of the JDC, at least [***], a summary report (in such form and format as determined by the JDC) of the Development Program activities performed in the Norgine Territory before Regulatory Approval therein. The JDC shall consist previous Calendar Quarter; (x) identifying and maintaining a list of [***] representatives from each Party. The Parties shall ensure that each for purposes of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview. (a) Responsibilities of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 BudgetSection 7.1; (iixi) alignment on protocol appointing and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that overseeing such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of subcommittees as the JDC with respect to suspension or termination of the Pivotal Clinical Trial deems appropriate for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial;carrying out activities under this Agreement; and (iiixii) review and monitor progress of the Development activities (including any related clinical trials and any carrying out such other material results thereunder) and the Parties’ activities under the Development Plan, including serving duties as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect are specifically assigned to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations JDC under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time. (b) The JDC will be comprised of [***] representatives of each Party, with each Party having at least [***] representatives on the JDC at all times. Each representative (or any alternate to such representative) will be an employee or consultant of the applicable Party or one of its Affiliates having expertise appropriate for the function and purpose of the JDC and to address all strategic questions which the JDC is reasonably expected to deal in accordance with this Agreement. Each Party may replace its representatives on the JDC from time to time in its discretion with prior written notice to the other Party. All members of the JDC will be subject to written confidentiality obligations commensurate in scope to the provisions of Article 7. Non-voting observers who are subject to written confidentiality obligations commensurate in scope to the provisions of Article 7 may be invited to JDC meetings, as mutually agreed by the Parties’ JDC representatives. (c) Xxxxxxxx will appoint the chair of the JDC (the “JDC Chair”), who will be responsible for coordinating meetings of the JDC and preparing an agenda for each such meeting (which will include any agenda items proposed by either Party). The JDC Chair will have no greater authority on the JDC than any other representative. (d) The JDC will oversee execution of the Development Plan and Development of the Molecules. The JDC’s oversight responsibilities will continue for each Molecule until the end of the Development Term for such Molecule. The JDC will be dissolved upon expiration of the Development Period.

Joint Development Committee. The Parties hereby establish (a) Each Member shall appoint four (4) members of a joint development oversight and management committee (the “Joint Development Committee” or “JDC”). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives serve as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between through the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair first anniversary of the JDC Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall be established within [***] after serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The chairinitial JDC members and the chairperson are identified in Annex A hereto. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, in conjunction with the Alliance ManagersMARKED BY BRACKETS, shall have the responsibility to call meetingsHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purviewAS AMENDED. (ab) Responsibilities Subject to the oversight of the JDC. The JEC, the JDC shall have the following responsibilitiespowers and duties: ACTIVE/105730326.3 to (i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget; (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iiix) review and monitor progress propose to the JEC for its approval each annual update of the Development activities Plan and Development Budget and (including any related clinical trials y) review and any other material results thereunder) approve each interim update of the Development Plan and Development Budget, in each case proposed pursuant to Section 3.7; to oversee and coordinate the Parties’ activities under the Development Plan; to oversee and manage matters relating to clinical supply of the Combination Product, including serving as a forum including, without limitation, Manufacturing requirements, inventory projections and inventory control; with the Alliance Managers, (x) to assist in coordinating scientific interactions between the Parties during the course of implementing the Development Plan and (y) to facilitate the exchange among the Parties of data, information, materials and results relating to clinical manufacturing, clinical trials, and communications and filings with Regulatory Authorities for exchanging the Combination Product (in each case solely to the extent that such data, information and facilitating discussions regarding materials are required to be exchanged among the conduct of the Development Plan; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities Parties, or with respect to which one Member Party has the Products (including discussing coordination of such activities in right to gain access from the Parties’ respective territories); (vi) review of any scientific other Member Party or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine TerritoryJV, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***]; (ix) serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories; ACTIVE/105730326.3 (x) coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and (xi) have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or the Operating Agreement); to oversee regulatory matters for the JV, including, without limitation, approving all Combination Product Regulatory Documentation to the extent required pursuant to Section 3.4, overseeing Gilead’s activities as the JV’s liaison with Regulatory Authorities in the Territory, and overseeing the activities conducted pursuant to the SDEA and other pharmacovigilance and safety reporting; to oversee the Member Parties’ activities pursuant to their respective Supply Agreements and to oversee and coordinate with the JCC with respect to matters relating to the monitoring of Manufacturing capacity, forecasts and orders for the active pharmaceutical ingredients of the Combination Product; to resolve disputes between the Member Parties with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the other Member Party with access to certain of such Member Party’s records, documentation and data; to oversee medical affairs and medical communications activities; to review and approve or reject proposals for Phase IV clinical studies of the Combination Product; to provide updates on the JDC’s activities and achievements to the JEC each Calendar Quarter; and to perform such other functions as the Member Parties may be mutually agreed upon by the Parties agree in writing from time to time.

Joint Development Committee. The Within [****] after the Effective Date, the Parties hereby shall establish a joint development committee (the “Joint Development Committee” or “JDC”), to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC which shall consist of [****] representatives from each Party. The Parties shall ensure that of the Parties, each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement requisite experience and the activities hereunder, and shall be of suitable seniority and possess the authority to enable such person to make decisions reserved on behalf of the Parties with respect to the issues falling within the jurisdiction of the JDC. AMAG shall designate From time to time, each Party may substitute [****] of its representatives as the initial chairperson of the JDC. The chairperson of to the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [****] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least appoint [****] prior of its representatives to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form subserve as a co-teams or subcommittees to address any of the issues within its purview. (a) Responsibilities chairperson of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3 (i) the general strategy , and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [****] by the JDC (as amended may change its appointed co-chairperson from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget;time upon written notice [****]. The JDC shall: (ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial; (iii) review and monitor progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving 7.1.1 serve as a forum for exchanging information discussing and facilitating discussions regarding coordinating Development of Licensed Products for use in the Licensed Field in the United States and discussing Development of Licensed Products for use in the Licensed Field in the Royalty Territory, including by overseeing the conduct of the Development Planactivities as set forth in Section 3.1 and reviewing Development reports as set forth in Section 3.4.2; (iv) review and approval of the protocol for any Regulator-Requested Trial; (v) review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories); (vi) review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product; (vii) discuss such other information relating to the Products that is reasonably requested by either Party; (viii) discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than 7.1.2 [****]; (ix) serve 7.1.3 [****]; 7.1.4 develop and determine whether to approve any amendment to the Development Plan and corresponding Budget as the first forum for discussing disputes or disagreements resulting fromset forth in Section 3.2.2 or, arising out of or in relation to Development or Manufacture of the Products in if applicable, 3.3.2; 7.1.5 review and discuss the Parties’ respective territories; ACTIVE/105730326.3regulatory activities in the United States, including any updates regarding any material, non-recurring submissions and filings (e.g., INDs, BLAs, major supplements or amendments to the foregoing, material labeling supplements, Regulatory Authority meeting requests and core data sheets and filings related to new Indications and proposed labeling) that PARTNER proposes to submit or has submitted to any Regulatory Authority in the United States; (x) coordinate the sharing and exchange of information necessary or useful for each Party 7.1.6 [****]; 7.1.7 conduct responsibilities delegated to perform its obligations another Joint Committee under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e)Agreement if such Joint Committee is not yet formed; and (xi) have 7.1.8 perform such additional responsibilities other functions as may be assigned to the JDC pursuant to this Agreement are set forth herein or as may be mutually agreed upon by the Parties may mutually agree in writing from time to timewriting, except where in conflict with any provision of this Agreement.