Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities: 2.2.3.1. review and discuss the Research by the Parties with respect to the T1 Antibody Candidates and Option Target Antibody Candidates, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; 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. 2.2.3.2. review and discuss the Development of Regional Antibody Candidates; 2.2.3.3. review and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities; 2.2.3.4. review, discuss and oversee Manufacturing for the T1 Antibody Candidates and Option Antibody Candidates, including the supply chain for Antibody Candidates; 2.2.3.5. facilitate the flow of information between the Parties with respect to T1 Antibody Candidates, Regional Antibody Candidates, Global Antibody Candidates and Licensed Products; 2.2.3.6. review and discuss reports from the JRC, JDC and JCC, and provide guidance thereto and direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan, and, in each case, all amendments thereto; 2.2.3.7. review and discuss the entry of any Collaboration In-Licenses with respect to the Research, Development, Manufacture or Commercialization of any Antibody Candidates or Licensed Products; 2.2.3.8. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory; 2.2.3.9. review and facilitate discussion of proposed publications and resolve disputes with respect thereto taking into consideration Section 11.2.1; 2.2.3.10. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee; 2.2.3.11. establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and 2.2.3.12. perform such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties or as expressly provided in this Agreement. 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.

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities:, provided, however that the following will not apply with respect to the Development or Commercialization of any Reversion Product (except as otherwise expressly provided): 2.2.3.1. (i) oversee the activities of the Parties under this Agreement; (ii) review, discuss and approve the selection of the A3 Antigen and any Replacement Antigen; (iii) for each Collaboration Antigen, review, discuss and approve the selection of the SGI Antibodies for each Research Candidate; (iv) for each Collaboration Antigen, review, discuss and approve the selection of the Development Candidate for Development in accordance with Section 2.5; (v) for each Collaboration Antigen, review, discuss and approve the selection of the Product for Commercialization in accordance with Section 2.6; (vi) review and discuss the Research, Development and Commercialization of Research by the Parties with respect to the T1 Antibody Candidates, Development Candidates and Option Target Antibody Candidates, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; 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. 2.2.3.2. review and discuss the Development of Regional Antibody Candidates; 2.2.3.3. review and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities; 2.2.3.4. (vii) review and discuss the Manufacture of ACTR T-cells and the SGI Antibodies for use in Research Candidates, Development Candidates and Products, including any applicable Third Party intellectual property; (viii) review and discuss the supply chain for Research Candidates, Development Candidates and Products; (ix) subject to Section 10.7, review, discuss and oversee Manufacturing for determine whether the T1 Antibody planned activities or product features under this Agreement with respect to Research Candidates, Development Candidates and Option Antibody Candidates, including the supply chain for Antibody CandidatesProducts may require or benefit from a license under Patents or Know-How of Third Parties; 2.2.3.5. (x) review, discuss and determine the allocation of any Third Party Payments between the Parties in the Shared Territory; provided that the JSC may determine that such Third Party Payment constitutes Development Costs or Joint Commercialization Costs, as applicable, and should be shared by the Parties pursuant to the profit sharing mechanism under this Agreement; (xi) facilitate the flow of information between the Parties with respect to T1 Antibody Research Candidates, Regional Antibody Candidates, Global Antibody Development Candidates and Licensed Products; 2.2.3.6. (xii) review and discuss reports from the JRC, JDC and JCC, JCC and provide guidance thereto and thereto, direct the activities of such Committees, and review and approve all each Research Plans and each RLP Plan, Early Clinical Development Plan, Late Clinical Development Plan and Joint Commercialization Plan and, in each casethe case of all plans, all amendments thereto; 2.2.3.7. review (xiii) decide whether and discuss when to initiate or discontinue any Voluntary Phase 4 Clinical Trial or Supplemental Trials, provided no Party will be required to include a Supplemental Trial in the entry of any Collaboration In-Licenses with respect Late Clinical Development Plan or a Voluntary Phase 4 Clinical trial in the Joint Commercialization Plan absent JSC agreement (and for clarity without escalation to the Research, Development, Manufacture Executive Officers or Commercialization of any Antibody Candidates or Licensed Productsarbitration under Article 17); 2.2.3.8. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory; 2.2.3.9. review and facilitate discussion of proposed publications and resolve disputes with respect thereto taking into consideration Section 11.2.1; 2.2.3.10. (xiv) attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee; 2.2.3.11. (xv) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and 2.2.3.12. (xvi) perform such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties or as expressly provided in this Agreement. 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.

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities: 2.2.3.1. review discuss, prepare and discuss approve amendments to the Research by the Parties with respect to the T1 Antibody Candidates and Option Target Antibody Candidates, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; 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.Plan, 2.2.3.2. review review, discuss and oversee the conduct of the Research Programs, 2.2.3.3. review, discuss and oversee the Development of Regional Antibody Candidates;Licensed Antibodies, including to discuss a plan for the Development of backups to the lead Regional Licensed Antibodies, 2.2.3.32.2.3.4. review, discuss and oversee the Commercialization of Regional Licensed Products and any other ongoing related activities, including approving the Commercialization Plans submitted by the JCC, 2.2.3.5. review and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities;, 2.2.3.42.2.3.6. review, discuss and oversee the Manufacturing for the T1 Antibody Candidates and Option Antibody CandidatesLicensed Antibodies (other than Fc Licensed Antibodies), including the supply chain for Antibody Candidates;chain, 2.2.3.52.2.3.7. facilitate the flow of information between the Parties with respect to T1 Antibody Candidates, Regional Antibody Candidates, Global Antibody Candidates Licensed Antibodies and Licensed Products;, 2.2.3.62.2.3.8. review and discuss reports from the JRC, JDC and JCC, and provide guidance thereto and thereto, direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan and OLP Development Plan, and, in each case, all amendments thereto;, 2.2.3.72.2.3.9. review review, discuss and discuss approve the entry of into any Collaboration In-Licenses with respect to the Research, Development, Manufacture or Commercialization of any Antibody Candidates or Regional Licensed Antibodies, Regional Licensed Products;, Optioned Licensed Antibodies and Licensed Products, 2.2.3.82.2.3.10. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory;Products, 2.2.3.92.2.3.11. review and facilitate discussion of proposed publications and resolve disputes with respect thereto taking into consideration pursuant to Section 11.2.1;, 2.2.3.102.2.3.12. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee;, 2.2.3.112.2.3.13. establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; , and 2.2.3.122.2.3.14. perform such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties or as expressly provided in this Agreement. 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.

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities:responsibilities set forth in the subsections of this Section 3.2.2 with respect to any Product that Pieris co-Develops or co-Commercializes and has not opted out of co-Developing or co-Commercializing or so long as Pieris has an unexpired CoDev Option with respect to such Product. For the avoidance of doubt, if Pieris does not exercise its CoDev Option for a given Product, then after the expiration of the time period for Pieris to exercise such CoDev Option, where Pieris does not excise such Option or if Pieris opts out of co-Developing such Product, the JSC shall no longer have such responsibilities with respect to such Product, which shall fall to AstraZeneca alone. 2.2.3.13.2.2.1. Agree upon a Target for each Collaboration Product and prepare an initial Collaboration Product Development Plan in connection with each of the four (4) Collaboration Products; 3.2.2.2. review and discuss the Research by Lead Product Development Plan and the Parties with respect to the T1 Antibody Candidates Collaboration Product Development Plans and Option Target Antibody Candidatesapprove all modifications, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; 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. 2.2.3.2. review amendments and discuss the Development of Regional Antibody Candidatessupplements thereto; 2.2.3.33.2.2.3. review and discuss the Commercialization of Regional Licensed Lead Product and the CoDev Products and any other ongoing related activities; 2.2.3.43.2.2.4. review, discuss and oversee Manufacturing for the T1 Antibody Candidates Lead Product and Option Antibody Candidates, including the supply chain for Antibody CandidatesCoDev Products; 2.2.3.53.2.2.5. facilitate the flow of information between the Parties with respect to T1 Antibody Candidatesthe Research, Regional Antibody CandidatesDevelopment, Global Antibody Candidates Manufacture and Licensed Commercialization of the Products; 2.2.3.63.2.2.6. establish subcommittees (in addition to the Joint Development Committee) as it deems necessary to achieve the objectives and intent of this Agreement; 3.2.2.7. review and discuss reports from any subcommittee of the JRC, JDC and JCCJSC, and provide guidance thereto and direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan, and, in each case, all amendments theretosubcommittee; 2.2.3.73.2.2.8. review and discuss the entry of any Collaboration Innecessary or useful in-Licenses licenses with respect to the Research, Development, Manufacture or Commercialization of Lead Product or any Antibody Candidates or Licensed CoDev Products; 2.2.3.83.2.2.9. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Lead Product, the CoDev Products in and the TerritoryAZ Dev Products until Lead Candidate; 2.2.3.93.2.2.10. review and facilitate discussion of proposed publications relating to the Lead Product, the CoDev Products, and the and the AZ Dev Products until Lead Candidate and resolve disputes with respect thereto taking into consideration and at all times abiding by the requirements of Section 11.2.111; 2.2.3.103.2.2.11. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or within any other subcommittee; 2.2.3.113.2.2.12. establish such additional joint subcommittees as it deems necessary share all data related to achieve the objectives Research, Development and intent Manufacture of this AgreementLead Product, the CoDev Products, and the AZ Dev Products (but only until Lead Candidate for the AZ Dev Products); 3.2.2.13. discuss and agree upon a communication strategy for Data generated during Development of the Lead Product and the Collaboration Product including participation and messaging at scientific congresses and meetings; 3.2.2.14. review and approve of the Development Plans including associated budgets; and 2.2.3.123.2.2.15. perform such other functions as appropriate, and direct each other Committee any subcommittee to perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties or as expressly provided in this Agreement. 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.

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities: 2.2.3.1. review and discuss the Research by the Parties with respect to the T1 Antibody Candidates and Option Target Antibody Candidates, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; 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.; 2.2.3.2. review and discuss the Development of Regional Antibody Candidates; 2.2.3.3. review and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities; 2.2.3.4. review, discuss and oversee Manufacturing for the T1 Antibody Candidates and Option Antibody Candidates, including the supply chain for Antibody Candidates; 2.2.3.5. facilitate the flow of information between the Parties with respect to T1 Antibody Candidates, Regional Antibody Candidates, Global Antibody Candidates and Licensed Products; 2.2.3.6. review and discuss reports from the JRC, JDC and JCC, and provide guidance thereto and direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan, and, in each case, all amendments thereto; 2.2.3.7. review and discuss the entry of any Collaboration In-Licenses with respect to the Research, Development, Manufacture or Commercialization of any Antibody Candidates or Licensed Products; 2.2.3.8. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory; 2.2.3.9. review and facilitate discussion of proposed publications and resolve disputes with respect thereto taking into consideration Section 11.2.1; 2.2.3.10. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee; 2.2.3.11. establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and 2.2.3.12. perform such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties or as expressly provided in this Agreement. 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.

Specific Responsibilities. In addition to its overall responsibility for monitoring Development, Regulatory Approval and providing strategic oversight with respect to the Parties’ activities under this AgreementManufacturing, the JSC will shall, in particular have particular, be responsible in both the following responsibilitiesTerritory and the Retained Territory for: 2.2.3.1. review (i) reviewing on-going Development activities including those referred to in Section 2.1(d); (ii) reviewing cost sharing in accordance with Section 2.1(d) and discuss the Research by making recommendations thereon to the Parties with respect for their approval; (iii) reviewing and making recommendations to the T1 Antibody Candidates Parties for their approval regarding the Manufacturing plans and Option Target Antibody Candidates, including whether a Technical Failure has occurred supply chain strategy in accordance with respect the provisions of Article 7; (iv) reviewing and making recommendations to Option Target Antibody Candidatesthe Parties for their approval regarding the regulatory strategy for obtaining Regulatory Approvals; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. A COMPLETE VERSION OF THIS EXHIBIT ALL SUCH OMITTED MATERIAL 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 AMENDED17 C.F.R. SECTIONS 200.80(B)(4) AND 240.24B-2. 2.2.3.2. review (v) reviewing and discuss making recommendations to the Development of Regional Antibody CandidatesParties for their approval regarding the Patent and Product Trademark filing and prosecution strategy; 2.2.3.3. review (vi) reviewing and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities; 2.2.3.4. review, discuss and oversee Manufacturing for the T1 Antibody Candidates and Option Antibody Candidates, including the supply chain for Antibody Candidates; 2.2.3.5. facilitate the flow of information between making recommendations to the Parties with respect to T1 Antibody Candidates, Regional Antibody Candidates, Global Antibody Candidates and Licensed Products; 2.2.3.6. review and discuss reports from for their approval regarding the JRC, JDC and JCC, and provide guidance thereto and direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan, and, in each case, all amendments thereto; 2.2.3.7. review and discuss the entry of any Collaboration In-Licenses with respect to the Research, Development, Manufacture or Commercialization of any Antibody Candidates or Licensed Products; 2.2.3.8. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory; 2.2.3.9. review and facilitate discussion of proposed publications and resolve disputes line with respect thereto taking into consideration Section 11.2.1; 2.2.3.10. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee; 2.2.3.11. establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement11.3; and 2.2.3.12. perform (vii) performing such other functions as appropriate, and direct each other Committee to perform such other functions as appropriate, appropriate to further the purposes of the collaboration, consistent with this Agreement, in each case and such other responsibilities as may be agreed in writing by the Parties or as expressly provided in this Agreement. 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 1933writing from time to time; in the case of each subparagraph (i)-(vii), AS AMENDEDconsistent with the activities and Clinical Plan Development Costs set out in the Clinical Development Plan and with the activities and Manufacturing Costs set out in the Manufacturing Plan; and (viii) reviewing, sharing and discussing (with each Party taking into consideration the other’s reasonable points and comments) Commercialization strategies, Commercialization plans, branding, including global brand strategies, Product positioning, advertising and promotional material, Product claims, Investigator Initiated Trials, communication, life cycle management (Phase 3b/4 trials) and other Commercialization matters.