Common use of Responsibilities of the Joint Development Committee Clause in Contracts

Responsibilities of the Joint Development Committee. Each Party shall keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided in the last sentence of this Section 2.4 with respect to Sponsor-Funded Studies, the JDC shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Study: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a); (b) overseeing the activities of the Parties with respect to a Combined Therapy Study, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy Study; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budget) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy Study, and reviewing the strategy for and results of medical monitoring and site audits; (e) reviewing and approving the Protocol and any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review); (f) approving any immunogenicity analysis for the Combined Therapy, including the protocol and entity to do the analysis; (g) approving the Bioanalysis Plan and any amendments to the Bioanalysis Plan; [*] = 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. (h) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study and, to the extent they are inconsistent with the Protocol, approving such proposed communications and communication strategies (with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review); (i) approving any IND, or IND amendment, submitted for the Combined Therapy Study after the Effective Date, as well as reviewing substantive submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] of such IND and submissions being presented to the JDC for review); (j) reviewing any substantive Combined Therapy Study Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within [*] of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for review); (k) reviewing and approving any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement) to Study Sites or IRBs relating to patient safety or termination/cessation of the Combined Therapy Study (with such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approval); (l) appointing working teams that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy Study; (m) determining the quantities of Compugen Compound and BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary for the Combined Therapy Study and coordinating the supply of such quantities by the respective Party in accordance with Article 4; (n) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of the Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan, with such review to be completed within [*] following such proposed additional analyses being presented to the JDC for review; (o) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.9, so long as the JDC remains in force and effect; (p) approving the CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c), with such approval to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study); (q) subject to Section 2.1(d), reviewing and approving the template ICF, template CRF and template Site Agreement to be used in the Combined Therapy Study (with such review to be completed within [*] following Compugen providing to the JDC a draft of the applicable template for review); [*] = 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. (r) approving the final clinical study report (and final statistical analysis in accordance with the Statistical Analysis Plan) for the Combined Therapy Study; (s) reviewing and approving a plan for the periodic sharing of Study Data among the Parties as described in Section 5.1(a)(xv); (t) reviewing and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5; and (u) discussing any other topics or issues relating to the Combined Therapy Study that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to the amendments, communications, submissions and other activities as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studies.

Responsibilities of the Joint Development Committee. Each Party shall keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided in the last sentence of this Section 2.4 below with respect to Sponsor-Funded Studies, the JDC shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Study: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, Plan in accordance with Section 2.1(a); (b) overseeing the activities of the Parties with respect to a Combined Therapy Study, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy Study; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budget) exceeds [*] 110% of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy Study, and reviewing the strategy for and results of medical monitoring and site audits; (e) reviewing and approving the Protocol Protocol; (f) reviewing and approving any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Checkmate Compound (and/or other therapeutic agent or therapy[***], as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] ten (10) Business Days following presentation of the proposed amendment to the JDC for review); (fg) approving any immunogenicity analysis for the Combined Therapy, including the protocol and entity to do the analysis; (gh) approving the Bioanalysis Plan and any amendments to the Bioanalysis Plan; [*] = 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.; (hi) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study and, to the extent they are inconsistent with the Protocol, approving such proposed communications and communication strategies (with such review to be completed within [*] ten (10) Business Days of such proposed communication strategies and communications being presented to the JDC for review); (ij) approving any IND, or IND amendment, amendment submitted for the Combined Therapy Study after the Effective DateStudy, as well as reviewing substantive submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND amendment in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] ten (10) Business Days of such IND amendment and submissions being presented to the JDC for review); (jk) reviewing any substantive Combined Therapy Study Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within [*] ten (10) Business Days of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for review); (kl) reviewing and approving any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement) to Study Sites or IRBs relating to patient safety or termination/cessation of the Combined Therapy Study (with such review to be completed within [*] ten (10) Business Days of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] twenty-four (24) hours without JDC approval); (lm) as agreed by the JDC, appointing working teams that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy Study; (m) determining the quantities of Compugen Compound and BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary for the Combined Therapy Study and coordinating the supply of such quantities by the respective Party in accordance with Article 4; (n) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of the Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan, with such review to be completed within [*] ten (10) Business Days following such proposed additional analyses being presented to the JDC for review; (o) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.9, so long as the JDC remains in force and effect; (p) approving the preliminary CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c), with such approval to be completed within [*] ten (10) Business Days after presentation of proposed changes to the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study)withheld; (q) subject to Section 2.1(d), reviewing and approving the template ICF, template CRF and template Site Study Agreement to be used in the Combined Therapy Study (with such review to be completed within [*] ten (10) Business Days following Compugen the Sponsoring Party providing to the JDC a draft of the applicable template for review); [*] = 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.; (r) reviewing and approving the final clinical study report (and final statistical analysis in accordance with the Statistical Analysis Plan) for the Combined Therapy Study;Study [***] (s) reviewing review and approving approve a plan for the periodic sharing of Study Data among the Parties as described in Section 5.1(a)(xv5.1(a)(xiv); (t) reviewing and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5; and (u) discussing any other topics or issues relating to the Combined Therapy Study that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to the amendments, communications, submissions and other activities as set forth above that are non‑substantive non-substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studies.Studies.1

Responsibilities of the Joint Development Committee. Each Party shall use Commercially Reasonable Efforts to keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided The JDC (or in the last sentence absence of this Section 2.4 with respect to Sponsora formal JDC meeting the Co-Funded Studies, the JDC Chairs) shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Studyfollowing: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a); (b) overseeing the activities of the Parties with respect to a Combined the Combination Therapy StudyTrials, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy StudyTrials; (b) prior to or contemporaneously with the approval of each Protocol, preparing (through the Finance Representatives of the Parties), discussing and approving a budget for each Combined Therapy Trial, and approving any material amendments to any previously approved budget, including reviewing and approving any costs for a given budget of a Combined Therapy Trial that are reasonably anticipated to be greater than ten percent (10%) of the JDC-approved budget; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies reviewing (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budgeti) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy StudyTrial, (ii) the proposed plan for medical monitoring and reviewing site audits (with BioXcel to take comments of the strategy for JDC members to such proposed plan into account) and (iii) the results of such medical monitoring and site audits; (d) reviewing and approving with respect to each Combined Therapy Trial (i) the applicable Protocol and the Statistical Analysis Plan, and any proposed substantive amendment thereto and (ii) the CRO Agreement(s) and, to the extent provided in Section 2.4(o), proposed material amendments thereto; (e) reviewing and approving the Protocol and any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review); (f) approving any immunogenicity analysis for the each Combined TherapyTherapy Trial, including the protocol and entity Entity to do the analysis; (f) reviewing and approving any Bioanalysis Plan not set forth in the Protocol, and any material amendments thereto; (g) approving the Bioanalysis Plan reviewing and any amendments providing timely comments to the Bioanalysis Plan; [*] = 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. (h) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study Trials and, to the extent they are inconsistent with the Protocolif applicable, approving such proposed communications and communication strategies (with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review)strategies; (ih) approving any IND, or IND amendment, submitted for the a Combined Therapy Study after the Effective DateTrial, as well as reviewing substantive material submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] of such IND and submissions being presented to the JDC for review)5; (ji) reviewing any substantive Combined Therapy Study Trial Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within ; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[*] of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for review);**]”. 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 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (kj) reviewing and approving any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject to Section 2.6(d), agreeing on the Pharmacovigilance Agreement) final list of proposed clinical trial sites pursuant to Study Sites Section 2.6(d), and agreeing on communications to clinical trial sites or IRBs relating to patient safety or early termination/cessation of the a Combined Therapy Study (with such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approval)Trial; (lk) appointing working teams teams, including a clinical execution working team, to be made up of an equal number of representatives from each Party, that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy StudyTrials, and delegating certain decision-making authority to such working teams; (ml) determining the quantities of Compugen BioXcel Compound, Nektar Compound, CPI Compound and BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary for the Combined Therapy Study Trials within a sufficient minimum lead time and coordinating the supply of such quantities by the respective Party in accordance with Article 44 and the Supply Agreement; (nm) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of of, or that include, the Combined Therapy Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan; provided that, with for clarity, such review and approval shall not apply to be completed within [*] following such proposed additional analyses being presented to by a Party of the JDC monotherapy data for reviewits own Compound from a Combined Therapy Trial; (on) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.98.5 that are not described in the Protocol and ICF, so long as the JDC remains in force and effect; (o) for any CROs or Third Party contactors engaged after the Effective Date, reviewing and approving (1) the selection of any such CRO and Third Party contractor (other than individuals in a Party’s workforce who are engaged on an independent contractor basis) that has a material role in each Combined Therapy Trial pursuant to Section 2.6(d) and (2) the terms of any such CRO contract or pharmacovigilance contract (“CRO Agreement”) with a Third Party; (p) reviewing and approving the CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c)template ICF form, with such approval template case report form and template clinical site study agreement to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study)used in a given Combined Therapy Trial; (q) subject reviewing and approving any changes that clinical sites or IRBs propose to Section 2.1(d)the risk sections of any ICF describing adverse effects of the Nektar Compound, either alone or in combination with the BioXcel Compound and/or the CPI Compound; (r) reviewing and approving the template ICF, template CRF and template Site Agreement to be used countries in the which each Combined Therapy Study (with such review to Trial will be completed within [*] following Compugen providing to the JDC a draft of the applicable template for review); [*] = 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 1934conducted, as amended.set forth in Section 2.6(d); (rs) approving the final clinical study trial report (and and/or final statistical analysis in accordance with the Statistical Analysis Plan) for the from each Combined Therapy Study; (s) reviewing Trial; and approving a plan for the periodic sharing of Study Data among the Parties as described in Section 5.1(a)(xv);CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE 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 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (t) reviewing and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5; and (u) discussing any other topics or issues relating to the Combined Therapy Study Trials that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to at the amendments, communications, submissions and other activities as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studiesworking team level.

Responsibilities of the Joint Development Committee. Each Party The Joint Development Committee shall keep be responsible for overseeing the JDC informed about activities performed by that Party hereunderentire collaboration between SkyePharma and Enzon under this Agreement, including both the Development Program and all commercialization activities. Except as otherwise provided in Without limiting the last sentence of this Section 2.4 with respect to Sponsor-Funded Studiesforegoing, the JDC shall be responsible perform the following functions: 3.2.1 determine and revise the overall strategy for the following with respect to Development Program; 3.2.2 annually determine the Annual Operating Plan and Budget for each Combined Therapy StudyCompound and Product, and for clarity will have no authority with respect revise same from time to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Study: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a)time as needed; (b) overseeing the activities 3.2.3 determine target indications for each Compound and Product, and revise same from time to time as needed; 3.2.4 determine and revise multi-year expense forecasts and projected financial results of the Parties with respect to a Combined Therapy Study, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy Studyunder this Agreement; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies (or any changes 3.2.5 evaluate progress and provide direction to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budget) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy Study, and reviewing the strategy for and results of medical monitoring and site audits; (e) reviewing and approving the Protocol and any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review); (f) approving any immunogenicity analysis for the Combined Therapy, including the protocol and entity to do the analysis; (g) approving the Bioanalysis Plan and any amendments to the Bioanalysis Plan; [*] = 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. (h) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study and, to Development Program and any commercialization activities undertaken by the extent they are inconsistent with the Protocol, approving such proposed communications and communication strategies (with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review)Parties; 3.2.6 determine, the selection of (i) approving any INDCompounds on which to focus collaborative development efforts, or IND amendment(ii) criteria to be met to demonstrate “proof-of-concept” for such Compounds in the target patient populations, submitted (iii) indications for the Combined Therapy Study after the Effective Date, as well as reviewing substantive submissions which each Compound is to be developed (with the reporting of Safety Information from the Combined Therapy Study being subject which determination may include adjustments to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] of such IND and submissions being presented to the JDC for review); (j) reviewing any substantive Combined Therapy Study Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within [*] of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for review); (k) reviewing and approving any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement) to Study Sites or IRBs relating to patient safety or termination/cessation respective responsibilities of the Combined Therapy Study (Parties, and corresponding financial arrangements between the Parties, with respect to such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approvalindication(s); (l) appointing working teams that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy Study; (m) determining the quantities of Compugen Compound and BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary (iv) other development criteria to be met for the Combined Therapy Study and coordinating the supply of such quantities by the respective Party in accordance with Article 4continued development; (n) reviewing and approving3.2.7 determine which pre-clinical studies, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of the Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan, with such review to be completed within [*] following such proposed additional analyses being presented to the JDC for review; (o) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.9, so long as the JDC remains in force and effect; (p) approving the CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c), with such approval to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for reviewclinical trials, and where such approval by toxicology studies are necessary or desirable to meet the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study); (q) subject to Section 2.1(d), reviewing and approving the template ICF, template CRF and template Site Agreement to be used in the Combined Therapy Study (with such review to be completed within [*] following Compugen providing to the JDC a draft requirements of the applicable template Regulatory Authorities for the Registration of the Products in the countries of interest in the Territory; 3.2.8 review); [*] = Certain confidential information contained , approve and determine ownership of all INDs, Registration Applications, Registrations and other regulatory filings and approvals for the Compounds and Products on a Compound/Product by Compound/Product basis: 3.2.9 evaluate data on all Compounds and Products under development; 3.2.10 review and approve activities related to manufacturing and the identification of manufacturer(s) in this document, marked by brackets, has been omitted and filed separately connection with the Securities development and Exchange Commission pursuant to Rule 24b-2 commercialization of Compounds and Products; 3.2.11 select and determine ownership of the Securities Exchange Act of 1934trademarks, as amended. (r) approving trade names and logos under which each Product shall be marketed and sold in each country in the final clinical study report (and final statistical analysis in accordance with the Statistical Analysis Plan) for the Combined Therapy StudyTerritory; (s) reviewing 3.2.12 decide whether and approving a plan for the periodic sharing of Study Data among how to institute Infringement actions against Third Parties based on any Compound or Product being developed or commercialized by the Parties as described in Section 5.1(a)(xv)under this Agreement; (t) reviewing 3.2.13 review and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5approve “go/no-go” decisions and recommendations; and (u) discussing any 3.2.14 perform such other topics or issues relating responsibilities as may be assigned to the Combined Therapy Study that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect Joint Development Committee pursuant to specific matters to JDC subteams. With respect to the amendments, communications, submissions and other activities this Agreement or as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect mutually agreed upon by the Parties from time to specific Sponsor-Funded Studies, as described in a Study Plan for such Studiestime.

Responsibilities of the Joint Development Committee. Each Party shall use Commercially Reasonable Efforts to keep the JDC informed about activities performed by that Party hereunderunder the Development Program. Except as otherwise provided The JDC will be responsible for the overall oversight of the Development Program. The JDC (or in the last sentence absence of this Section 2.4 with respect to Sponsora formal JDC meeting the Co-Funded Studies, the JDC Chairs) shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Studyfollowing: (ai) establishing and approving each Study Planoverseeing the Development Program, including approving the Joint Development Plan and any amendments to such Study Plan, in accordance with Section 2.1(a)Material Amendments thereto; (bii) overseeing the activities of the Parties with respect to a Combined Therapy Studythe Collaboration Studies, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Collaboration Studies; (iii) approving the annual, high-level Development Budget for each Collaboration Study (as reviewed and provided by the JFC to the JDC), including reviewing and approving any costs for a given budget of a Collaboration Study that are reasonably anticipated to be greater than [***] of the JDC-approved budget; (iv) determining the Lead Party (and any secondary study sponsor and operational responsibilities of such sponsor) and Diligence Date for each Combined Therapy Collaboration Study; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budget) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (dv) reviewing (A) the progress of each Combined Therapy Collaboration Study, (B) the proposed plan for medical monitoring and reviewing site audits and (C) the strategy for and results of such medical monitoring and site audits; (evi) reviewing and approving with respect to each Collaboration Study (A) the applicable Protocol and the Statistical Analysis Plan, and any proposed substantive amendment thereto and (B) the CRO Agreement(s) and proposed material amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review)thereto; (fvii) reviewing and approving any immunogenicity analysis for the each Combined TherapyTherapy Collaboration Study, including the protocol and entity Person to do the analysis; (gviii) reviewing and approving the any Bioanalysis Plan not set forth in the Protocol, and any material amendments to the Bioanalysis Plan; [*] = 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.thereto; (hix) reviewing substantive and providing timely comments to proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study Collaboration Studies and, to the extent they are inconsistent with the Protocolif applicable, approving such proposed communications and communication strategies (with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review)strategies; (ix) approving any IND, or IND amendment, submitted for the a Combined Therapy Study after the Effective DateCollaboration Study, as well as reviewing substantive material submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions 10 (with such review to be completed within [*] of such IND and submissions being presented to the JDC for reviewGlobal Regulatory); (jxi) reviewing any substantive Combined Therapy Collaboration Study Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof 10 (with such review to be completed within [*] of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for reviewGlobal Regulatory); (kxii) reviewing and approving any substantive communications (with Regulatory Documentation from any Combined Therapy Independent Study, or portions thereof, that relate to the reporting use of Safety Information from the Nektar Compound in the Combined Therapy Study being Therapy, in accordance with Article 10 (Global Regulatory); (xiii) subject to Section 3.4(c), agreeing on the Pharmacovigilance Agreement) final list of proposed clinical trial sites pursuant to Study Sites Section 3.4(c), and agreeing on communications to clinical trial sites or IRBs relating to patient safety or early termination/cessation of the Combined Therapy Study (with such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approval)Collaboration Study; (lxiv) appointing working teams teams, to be made up of representatives from each Party, that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, Protocols, patient safety and regulatory issues that arise in the course of a study under the Combined Therapy StudyJoint Development Plan, and delegating certain decision-making authority to such working teams; (mxv) determining the quantities of Compugen Compound and Nektar Assets, BMS Compound (andAssets, as applicable, another therapeutic agent or therapy), Third Party Asset and any co-medications, necessary for the Combined Therapy Study Collaboration Studies within a sufficient minimum lead time and coordinating the supply of such quantities by the respective Party in accordance with Article 45 and the Supply Agreements; (nxvi) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of of, or that include, the Collaboration Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan; provided that, with for clarity, such review and approval shall not apply to be completed within [*] following such proposed additional analyses being presented to by a Party of the JDC monotherapy data for reviewits own Single Agent Compound (other than the Nektar Compound, in the case of Nektar); (oxvii) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.911.8 that are not described in the Protocol and ICF, so long as the JDC remains in force and effect; (pxviii) approving the CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c), with such approval to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded StudyCROs or Third Party contractors engaged after the Effective Date, reviewing and approving (A) the selection of any such CRO and Third Party contractor (other than individuals in a Party’s workforce who are engaged on an independent contractor basis) that has a material role in each Collaboration Study pursuant to Section 3.4(c) and (B) the terms of any such CRO contract or pharmacovigilance contract (“CRO Agreement”); (qxix) subject to Section 2.1(d), reviewing and approving the template ICFICF form, template CRF case report form and template Site Agreement clinical site study agreement to be used in a given Collaboration Study; (xx) reviewing and approving the Combined Therapy countries in which each Collaboration Study (with such review to will be completed within [*] following Compugen providing to the JDC a draft of the applicable template for review); [*] = 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 1934conducted, as amended.set forth in Section 3.4(a); (rxxi) approving the final clinical study trial report (and and/or final statistical analysis in accordance with the Statistical Analysis Plan) for the Combined Therapy from each Collaboration Study; (sxxii) reviewing and approving for each Collaboration Study, delegating to the Lead Party certain decision-making authority in relation to certain JDC responsibilities, in each case that do not constitute Material Amendments or any matters for which a plan for the periodic sharing of Study Data among the Parties as described in Party has final decision-making authority under Section 5.1(a)(xv)3.8; (txxiii) subject to any Third Party limitations in respect of Confidential Information, reviewing and approving a joint publication plan for Combined Therapy Studies, as described in discussing progress reports relating to the Independent Studies and activities performed by either Party pursuant to Section 9.53.9; and (uxxiv) discussing any other topics or issues relating to the Combined Therapy Study Collaboration Studies that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to at the amendments, communications, submissions and other activities as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studiesworking team level.

Responsibilities of the Joint Development Committee. Each Party shall keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided in the last sentence of this Section 2.4 with respect to Sponsor-Funded Studies, the The JDC shall be responsible for for: (i) The constitution of the following with respect to Joint Clinical Study Working Group (as defined below) and the establishment of such other subcommittees and working groups as the JDC decides is necessary. (ii) Overseeing the activities of, and providing guidance and directives to, the Joint Clinical Study Working Group and resolving any disputes arising at the Joint Clinical Study Working Group level. (iii) Reviewing the regulatory strategy regarding each Combined Therapy Study, and for clarity will have no authority with respect Trial. (iv) Resolving any disputes between the Parties relating to any aspect execution of the following relating solely Combined Therapy Trials. (v) Consulting and reviewing in relation to the Monotherapy Arm overall management of the CGEN Phase 1 Study:Combined Therapy Trials and on all significant matters relating to the Combined Therapy Trials. (avi) establishing Monitoring the nature, progress and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a)results of the Combined Therapy Trials; (bvii) overseeing the activities of the Parties with respect to a Combined Therapy Study, Selecting and providing a forum for the Parties to discuss, monitor approving independent data monitoring committees and coordinate all activities and communications regarding the Combined Therapy Studyindependent radiologic reviews; (cviii) approving a Budget for Approving the Study Costs in connection with Jointly-Funded Studies Protocols (or including any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the BudgetStatistical Analysis Plan) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy Study, and reviewing the strategy for and results of medical monitoring and site audits; (e) reviewing and approving the Protocol and any proposed amendments to thereto for the Protocol Combined Therapy Trials together with a budget for each Combined Therapy Trial (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety Shared Costs) and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review)material amendments thereto; (fix) approving any immunogenicity analysis for the Combined Therapy, including the protocol and entity to do the analysis; (g) approving Approving the Bioanalysis Plan and any amendments to thereto; (x) Monitoring the Bioanalysis Plankey milestones of each Combined Therapy Trial proposed by the Joint Clinical Study Working Group; [*[ * ] = 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. (hxi) reviewing substantive proposed Approving the final clinical trial report (and/or final statistical analysis in accordance with the Statistical Analysis Plan) from each Combined Therapy Trial; (xii) Approving the material communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study andTrials, and to the extent they are inconsistent with the Protocolreasonably possible, approving such proposed communications and communication strategies (timing for scheduled meetings with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review)any Regulatory Authority; (ixiii) approving Approving any IND, or IND amendment, submitted for the Combined Therapy Study after the Effective Date, as well as reviewing substantive submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] of such IND submitted to a Regulatory Authority and submissions being presented to the JDC for review)any material amendments thereto; (jxiv) reviewing any substantive Discussing additional Combined Therapy Study Regulatory DocumentationTrials of the BMS Compound(s) with the Exelixis Compound, provided that no Party shall be obligated to collaborate with the other Party or portions thereof, that relate agree on terms with the other with respect to any additional clinical trials pursuant to this Section 2.3(c)(xii); and (xv) Discussing whether any pre-clinical studies are needed to explore or support any clinical trial for the Combined Therapy, in accordance with Article 5, and, to especially for clinical trials for indications other than those for the extent they are inconsistent with Initial Trials. In the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within [*] of such proposed Combined Therapy Study Regulatory Documentation being presented to event the JDC for review); (k) reviewing and approving determines that any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject pre-clinical study is needed to the Pharmacovigilance Agreement) to Study Sites explore or IRBs relating to patient safety or termination/cessation of the Combined Therapy Study (with such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approval); (l) appointing working teams that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review support any clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy Study; (m) determining the quantities of Compugen Compound and BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary trial for the Combined Therapy Study and coordinating Therapy, any such pre-clinical study will only be conducted if the supply Parties enter into a separate agreement for the conduct of such quantities by the respective Party in accordance with Article 4; (n) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of the Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan, with such review to be completed within [*] following such proposed additional analyses being presented to the JDC for review; (o) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.9, so long as the JDC remains in force and effect; (p) approving the CRO/Study Site List for Jointlypre-Funded Studies in accordance with Section 2.1(c), with such approval to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study); (q) subject to Section 2.1(d), reviewing and approving the template ICF, template CRF and template Site Agreement to be used in the Combined Therapy Study (with such review to be completed within [*] following Compugen providing to the JDC a draft of the applicable template for review); [*] = 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 amendedclinical study. (r) approving the final clinical study report (and final statistical analysis in accordance with the Statistical Analysis Plan) for the Combined Therapy Study; (s) reviewing and approving a plan for the periodic sharing of Study Data among the Parties as described in Section 5.1(a)(xv); (t) reviewing and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5; and (u) discussing any other topics or issues relating to the Combined Therapy Study that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to the amendments, communications, submissions and other activities as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studies.

Responsibilities of the Joint Development Committee. Each Party shall use Commercially Reasonable Efforts to keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided The JDC (or in the last sentence absence of this Section 2.4 with respect to Sponsora formal JDC meeting the Co-Funded Studies, the JDC Chairs) shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Studyfollowing: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a); (b) overseeing the activities of the Parties with respect to a Combined the Combination Therapy StudyTrials, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy StudyTrials; (b) approving a budget for each Combined Therapy Trial and any material amendments thereto, including reviewing and approving any costs for a given budget of a Combined Therapy Trial that are reasonably anticipated to be greater than [***] of the JDC-approved budget; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies reviewing (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budgeti) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy StudyTrial, (ii) the proposed plan for medical monitoring and reviewing site audits (with Nektar to take comments of the strategy for JDC members to such proposed plan into account) and (iii) the results of such medical monitoring and site audits; (d) reviewing and approving with respect to each Combined Therapy Trial (i) the applicable Protocol and the Statistical Analysis Plan, and any proposed substantive amendment thereto and (ii) the CRO Agreement(s) and, to the extent provided in Section 2.4(o), proposed material amendments thereto; (e) reviewing and approving the Protocol and any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review); (f) approving any immunogenicity analysis for the each Combined TherapyTherapy Trial, including the protocol and entity Entity to do the analysis; (f) reviewing and approving any Bioanalysis Plan not set forth in the Protocol, and any material amendments thereto; (g) approving the Bioanalysis Plan reviewing and any amendments providing timely comments to the Bioanalysis Plan; [*] = 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. (h) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Combined Therapy Study Trials and, to the extent they are inconsistent with the Protocolif applicable, approving such proposed communications and communication strategies (with such review to be completed within [*] of such proposed communication strategies and communications being presented to the JDC for review)strategies; (ih) approving any IND, or IND amendment, submitted for the a Combined Therapy Study after the Effective DateTrial, as well as reviewing substantive material submissions (with the reporting of Safety Information from the Combined Therapy Study being subject to the Pharmacovigilance Agreement (e.g. SAE reports and Investigator Notification Letters)) to any such IND in accordance with Article 5 and, to the extent they are inconsistent with the Protocol, approving such submissions (with such review to be completed within [*] of such IND and submissions being presented to the JDC for review)5; (ji) reviewing any substantive Combined Therapy Study Trial Regulatory Documentation, or portions thereof, that relate to the Combined Therapy, in accordance with Article 5, and, to the extent they are inconsistent with the Protocol, approving such Combined Therapy Study Regulatory Documentation, or portions thereof (with such review to be completed within [*] of such proposed Combined Therapy Study Regulatory Documentation being presented to the JDC for review); (kj) reviewing and approving any substantive communications (with the reporting of Safety Information from the Combined Therapy Study being subject to Section 2.6(d), agreeing on the Pharmacovigilance Agreement) final list of proposed clinical trial sites pursuant to Study Sites Section 2.6(d), and agreeing on communications to clinical trial sites or IRBs relating to patient safety or early termination/cessation of the a Combined Therapy Study (with such review to be completed within [*] of such proposed communication being presented to the JDC for review, provided that if time is of the essence to protect patient safety, the medical monitors appointed by each Party shall have the authority to develop and enact a strategy for disseminating information to IRBs within [*] without JDC approval)Trial; (lk) appointing working teams teams, including a clinical execution working team, to be made up of an equal number of representatives from each Party, that will hold telephone discussions at a mutually agreed-upon reasonable frequency to review clinical development, patient safety and regulatory issues that arise in the course of the Combined Therapy StudyTrials, and delegating certain decision-making authority to such working teams; (ml) determining the quantities of Compugen Compound and Nektar Compound, BMS Compound (and, as applicable, another therapeutic agent or therapy), and any co-medications, necessary for the Combined Therapy Study Trials within a sufficient minimum lead time and coordinating the supply of such quantities by the respective Party in accordance with Article 44 and the Supply Agreement; (nm) reviewing and approving, in advance, any and all proposed amendments to the Statistical Analysis Plan, including additional analyses of of, or that include, the Combined Therapy Study Data proposed to be conducted by either Party that are not included in the Statistical Analysis Plan; provided that, with for clarity, such review and approval shall not apply to be completed within [*] following such proposed additional analyses being presented to by a Party of the JDC monotherapy data for reviewits own Compound from a Combined Therapy Trial; (on) reviewing and approving use of any Samples beyond the Bioanalysis Plan, in accordance with Section 8.98.5 that are not described in the Protocol and ICF, so long as the JDC remains in force and effect; (o) for any CROs or Third Party contactors engaged after the Effective Date, reviewing and approving (1) the selection of any such CRO and Third Party contractor (other than individuals in a Party’s workforce who are engaged on an independent contractor basis) that has a material role in each Combined Therapy Trial pursuant to Section 2.6(d) and (2) the terms of any such CRO contract or pharmacovigilance contract (“CRO Agreement”) with a Third Party; (p) reviewing and approving the CRO/Study Site List for Jointly-Funded Studies in accordance with Section 2.1(c)template ICF form, with such approval template case report form and template clinical site study agreement to be completed within [*] after presentation of the list or proposed changes thereto to the JDC for review, and where such approval by the JDC shall not be unreasonably withheld (it being understood that the JDC does not have the right to approve the CRO/Study Site List for any Sponsor-Funded Study)used in a given Combined Therapy Trial; (q) subject to Section 2.1(d), reviewing and approving the template ICF, template CRF and template Site Agreement to be used countries in the which each Combined Therapy Study (with such review to Trial will be completed within [*] following Compugen providing to the JDC a draft of the applicable template for review); [*] = 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 1934conducted, as amended.set forth in Section 2.6(d); (r) approving the final clinical study trial report (and and/or final statistical analysis in accordance with the Statistical Analysis Plan) for the from each Combined Therapy Study; (s) reviewing and approving a plan for the periodic sharing of Study Data among the Parties as described in Section 5.1(a)(xv); (t) reviewing and approving a joint publication plan for Combined Therapy Studies, as described in Section 9.5Trial; and (us) discussing any other topics or issues relating to the Combined Therapy Study Trials that either Party requests that cannot be resolved by any JDC subteam. The JDC may delegate its responsibilities with respect to specific matters to JDC subteams. With respect to at the amendments, communications, submissions and other activities as set forth above that are non‑substantive matters, the Sponsoring Party will keep the Other Party informed and updated (through the medical monitor and other designees of the JDC) in a timely manner, so that if the Other Party has any concerns or disagreements regarding such matters, the matter can be escalated to the JDC for review. The Parties agree that the JDC has the sole right to approve any matters that specifically require JDC approval under this Section 2.4, and neither Party will have final decision-making authority with respect to those matters. Notwithstanding the foregoing, the specific responsibilities and authority granted to the JDC may be circumscribed with respect to specific Sponsor-Funded Studies, as described in a Study Plan for such Studiesworking team level.