Common use of Development Plan Clause in Contracts

Development Plan. (a) The initial Development plan for the Development of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the “Development Plan”). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimates. (b) On no less than an annual basis, the JSC shall review the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes. (c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Development Plan. (a) The initial Development plan Parties’ respective responsibilities for the Development of Product the Collaboration Compounds and the Products are set forth in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Initial Indications is Development of Product(s), attached hereto to this Agreement as Exhibit B (as amended A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to this AgreementRule 406 of the Securities Act of 1933, the “Development Plan”)as amended. financial and commercial factors. The Development Plan shall includeallocate Development activities between the Parties, based on the following principles: (ai) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in Product(s) comprising the Territory Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until Regulatory Approval of such Product [*] for such indicationProduct; (eiii) an estimated timeline Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of activities; and (f) FTE estimates. (b) On no less than an annual basis, the JSC shall review the Development Plan and recommend any amendments or changes Activities according to the Development Plan and approve any such amendments or changes. (c) The within the Development Budget. In the course of Products shall be conducted by Parties pursuant fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to timeconduct certain specific Development activities, and (d) the equivalent Applicable Laws other Party shall have the Territoryright to accept or reject such request, each as may be amended at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and applicable from time to time and experts worldwide, including participation in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjectsadvisory board meetings.

Development Plan. The Development of the Compound and Products under this Agreement (a) The initial including the development of the Compound and any Product as a combination product or combination therapy with another product and/or therapy), including Independent Work and Licensee Only Development Work, shall be conducted only pursuant to a comprehensive written global Development plan for (the “Global Development Plan” or “GDP”), which shall be incorporated by reference as part of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the “Development Plan”). The Development Plan GDP shall include: set forth the timeline and details (aincluding line of therapy, tumor type, primary endpoints, approximate patient size, combination agents and comparator agents) of all indications of Products then being pursued; (b) a description of the preclinical and clinical Development activities to be conducted by each Party the Parties as necessary to generate Data sufficient to meet the common requirements of both the EMA and FDA for MAA Approval of the Compound and Products for RCC, HCC, and other indications agreed upon by the Parties. The GDP may also include any other Development activities approved by the JSC, including parameters for permissible scientific inquiry in Phase 4 Clinical Trials. The GDP will include Clinical Trials that the Parties are committed to conducting (unless modification is required by a Regulatory Authority or any local or regional IRB/ethics committee, or is reasonably necessary to protect patient safety) as well as Clinical Trials that will be decided by the JDC and JSC based on Data and results obtained after the Effective Date and the relevant deliverables; (c) all relevant decision points to continue Parties’ review of the future competitive landscape. The GDP shall include a coordinated Development and regulatory strategy, including the Parties’ respective roles in the Development of the registration dossier and Regulatory Filings for the Products and the countries in which Development of the Products will occur. The GDP shall also set forth the detailed budget of the anticipated costs for such Development activities (the “Development Budget”) on a study-by-study or Clinical Trial-by-Clinical Trial basis. As of the Effective Date, the Parties have agreed upon an initial GDP and Development Budget, attached to this Agreement as Exhibit D. If the terms of the GDP contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. From time to time during the Term (at least on [ * ] basis), the JDC shall prepare updates and amendments, as appropriate, to the then-current GDP, including budgets, and shall submit such updates and amendments to the JSC for review and approval before such updates and amendments are adopted. If upon the determination by the JDC as reviewed and approved by the JSC, any pre-clinical, or Clinical Trials not included in the GDP (i) are required in order to obtain and/or maintain MAA Approval for a Product in an indication; the EU and in one or all the countries of the Exelixis Territory, or (dii) a budget for are otherwise recommended by the Development activities to be conducted EMA or the FDA in the Territory with respect to Products EU and in one or all of the Territory until Regulatory Approval countries of such Product for such indication; (e) an estimated timeline for the performance of activities; Exelixis Territory, then the JDC shall review and (f) FTE estimates. (b) On no less than an annual basis, recommend and the JSC shall review the Development Plan and recommend any amendments or changes approve an amendment to the Development Plan GDP [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and approve any filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. reflecting such amendments or changes. (c) additional studies, including associated budget. The Development costs of Products such additional studies shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed borne by the FDA Parties as defined provided in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human SubjectsSection 4.5(a), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Development Plan. The Development of the Compound and Products under this Agreement (a) The initial including the development of the Compound and any Product as a combination product or combination therapy with another product and/or therapy), including Independent Work and Licensee Only Development Work, shall be conducted only pursuant to a comprehensive written global Development plan for (the “Global Development Plan” or “GDP”), which shall be incorporated by reference as part of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the “Development Plan”). The Development Plan GDP shall include: set forth the timeline and details (aincluding line of therapy, tumor type, primary endpoints, approximate patient size, combination agents and comparator agents) of all indications of Products then being pursued; (b) a description of the preclinical and clinical Development activities to be conducted by each Party the Parties as necessary to generate Data sufficient to meet the common requirements of both the EMA and FDA for MAA Approval of the Compound and Products for RCC, HCC, and other indications agreed upon by the Parties. The GDP may also include any other Development activities approved by the JSC, including parameters for permissible scientific inquiry in Phase 4 Clinical Trials. The GDP will include Clinical Trials that the Parties are committed to conducting (unless modification is required by a Regulatory Authority or any local or regional IRB/ethics committee, or is reasonably necessary to protect patient safety) as well as Clinical Trials that will be decided by the JDC and JSC based on Data and results obtained after the Effective Date and the relevant deliverables; (c) all relevant decision points to continue Parties’ review of the future competitive landscape. The GDP shall include a coordinated Development and regulatory strategy, including the Parties’ respective roles in the Development of the registration dossier and Regulatory Filings for the Products and the countries in which Development of the Products will occur. The GDP shall also set forth the detailed budget of the anticipated costs for such Development activities (the “Development Budget”) on a study-by-study or Clinical Trial-by-Clinical Trial basis. As of the Effective Date, the Parties have agreed upon an initial GDP and Development Budget, attached to this Agreement as Exhibit D. If the terms of the GDP contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. From time to time during the Term (at least on [ * ] basis), the JDC shall prepare updates and amendments, as appropriate, to the then-current GDP, including budgets, and shall submit such updates and amendments to the JSC for review and approval before such updates and amendments are adopted. If upon the determination by the JDC as reviewed and approved by the JSC, any pre-clinical, or Clinical Trials not included in the GDP (i) are required in order to obtain and/or maintain MAA Approval for a Product in an indication; the EU and in one or all the countries of the Exelixis Territory, or (dii) a budget for are otherwise recommended by the Development activities to be conducted EMA or the FDA in the Territory with respect to Products EU and in one or all of the Territory until Regulatory Approval countries of such Product for such indication; (e) an estimated timeline for the performance of activities; Exelixis Territory, then the JDC shall review and (f) FTE estimates. (b) On no less than an annual basis, recommend and the JSC shall review the Development Plan and recommend any amendments or changes approve an amendment to the Development Plan and approve any GDP reflecting such amendments or changes. (c) additional studies, including associated budget. The Development costs of Products such additional studies shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed borne by the FDA Parties as defined provided in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human SubjectsSection 4.5(a), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Development Plan. 24 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (a) The initial Development of the Compound and Products under this Agreement (including the development of the Compound and any Product as a combination product or combination therapy with another product and/or therapy), including Independent Work and Local Development Work, shall be conducted only pursuant to a comprehensive written global Development plan for which shall be updated at least [ * ] through the Development of Product for JDC subject to the Initial Indications is attached hereto as Exhibit B JEC’s approval during the Term (as amended from time to time pursuant to this Agreement, the “Global Development Plan” or “GDP”). The GDP shall be incorporated by reference as part of this Agreement. As of the Effective Date, the Parties have agreed upon an initial GDP, including an initial Development Plan Budget, attached to this Agreement as Exhibit 4.2. If the terms of the then-current GDP contradicts, or creates inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall include: (a) all indications of Products then being pursued; govern. (b) a description The GDP shall set forth the timeline and details (including line of the therapy, tumor type, primary endpoints, approximate patient size, combination agents, and comparator agents) of all preclinical and clinical Development activities to be conducted by each Party the Parties as necessary to generate Data sufficient to meet the common requirements of both the FDA and PMDA for MAA Approval of the relevant deliverablesCompound and Products for RCC (1st line and 2nd line), HCC (2nd line), and other indications agreed upon by the Parties. The GDP shall also include (i) any other Development activities approved by the JDC, including parameters for permissible scientific inquiry in Phase 4 Clinical Trials or Expanded Access Program; (cii) all relevant decision points Clinical Trials that the Parties are committed to continue Development of a Product in an indicationconducting; (diii) any modification to the Clinical Trials set forth in GDP that will be decided by the JDC based on requirement from a budget for the Development activities Regulatory Authority or any local or regional IRB (Institutional Review Board)/ethics committee or reasonably necessary to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activitiesprotect patient safety; and (fiv) FTE estimates. Clinical Trials that will be decided by the JDC based on Data and results obtained after the Effective Date and the Parties’ review of the future competitive landscape. The GDP shall include a coordinated Development and regulatory strategy, including the Parties’ respective roles in the Development of the registration dossier and Regulatory Filings for the Products and the countries in which Development of the Products will occur. The GDP shall also set forth the detailed budget of the anticipated costs for such Development activities (bthe “Development Budget”) On no less than an annual on a study-by-study or Clinical Trial-by-Clinical Trial basis. For clarity, the JSC Development Budget shall review the not include any Development Plan and recommend any amendments Costs associated with Collaborator Local Development Work or changes to the Exelixis Local Development Plan and approve any such amendments or changesWork. (c) The Development of Products shall be conducted If upon the determination by Parties pursuant the JDC, any modification to good the then-current GDP, including any non-clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth or Clinical Trials not included in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined GDP, (i) is required in 21 C.F.R. Part 58, or the equivalent Applicable Laws order to obtain and/or maintain MAA Approval for a Product in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for Collaborator Territory or in one or more of the design, conduct, performance, monitoring, auditing, recording, analyses and reporting countries of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Exelixis Territory, (bii) is otherwise recommended or suggested by the Declaration of Helsinki (2004) as last amended at PMDA in the 52nd World Medical Association Collaborator Territory or the FDA or other Regulatory Authority in October 2000 and any further amendments or clarifications theretothe Exelixis Territory, (ciii) U.S. Code is required by any local or regional IRB/ethics committee or (iv) is reasonably deemed necessary to protect patient safety, then the JDC shall prepare an amendment to the GDP reflecting such required, recommended or suggested modification, including associated Development Budget. The costs of Federal Regulations Title 21, Parts 50 (Protection of Human Subjectssuch additional studies shall be borne by the Parties as provided in Section 4.5(a), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Development Plan. (a) The initial Development development plan for governing the conduct of Development of the Existing Licensed Product for in BPH in the Initial Indications Territory is attached hereto as Exhibit B SCHEDULE 4.1 (as amended from time to time pursuant to this Agreement, the “Development Plan”"DEVELOPMENT PLAN"). The Parties contemplate that the activities set forth in the Development Plan shall include: are the primary Development activities required to obtain NDA Approval of the Existing Licensed Product for BPH in the Territory (such NDA Approval, whether it covers BPH only or BPH and other indications, the "INITIAL APPROVAL"). As of the Execution Date, Licensor is conducting certain Phase IIIA Clinical Studies described in the Development Plan for the Existing Licensed Product for BPH in the Territory. On or before the Execution Date, Licensor has made available to Licensee (a) all indications Clinical Data with respect to the Licensed Products for use in the Field generated by or on behalf of Products then being pursued; Licensor, its Affiliates or any of its licensees existing as of the Execution Date, including all Clinical Study results and resultant data analyses, (b) a description all regulatory submissions made to the FDA by or on behalf of Licensor or its Affiliates with respect to Licensed Products in the Development activities to be conducted by each Party Field and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget protocols for the Development activities to be conducted in the Territory any ongoing Clinical Studies and proposed designs for any anticipated Clinical Studies with respect to Products any Licensed Product in the Territory until Regulatory Approval Field. Subject to the terms and conditions of such Product this Agreement and in accordance with the Development Plan, Licensor shall have the responsibility, at its sole expense, for such indicationperforming all activities set forth in the Development Plan; (e) an estimated timeline for PROVIDED, HOWEVER, that the performance of activities; and (f) FTE estimates. (b) On no less than an annual basis, the JSC shall review Open Label Extension Study set forth in the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes. (c) The Development of Products shall be conducted by Parties - 20 - Licensor at Licensee's expense for Development Costs, pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”)the provisions of Section 4.4 below. GLP means all applicable Good Laboratory Practice standardsFor the avoidance of doubt, including, as applicable, as set forth Licensor shall have no right to conduct any Development in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws Field in the Territory, each as may be amended and applicable from time Territory except pursuant to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjectsthis Section 4.1.

Development Plan. (a) The initial All Development of the Licensed Viruses and Licensed Products by or on behalf of Newsoara under this Agreement (except for the NSCLC Multi-Center Trial, which shall be conducted pursuant to Section 4.1.5 (Clinical Trial for Indication of NSCLC)) shall be conducted pursuant to a comprehensive written Development plan for that sets forth the Development timeline, budget and other details of Product for all clinical and regulatory activities to be conducted by or on behalf of Newsoara to obtain Regulatory Approval of the Initial Indications is attached hereto as Exhibit B Licensed Products in the Field in the Territory (as amended from time to time pursuant to this Agreement, the “Development Plan”). The As of the Effective Date, Newsoara has proposed an initial Development Plan, which is attached hereto as Schedule 4.1.4 (Development Plan Proposal); after the Effective Date, the JSC will meet and review the Development Plan Proposal in accordance with Article 3. From time to time, [***], Newsoara shall propose updates or amendments to the Development Plan in consultation with Genelux and submit such proposed updated or amended plan to the JSC for review, discussion, and approval. Once approved by the JSC, the updated or amended Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimatesbecome effective. (b) On no less than an annual basis, the JSC shall review The Parties contemplate that the Development Plan of the Licensed Viruses and recommend any amendments or changes to Licensed Products in the Field in the Territory shall initially be focused on the Development Plan of Olvi-Vec. Therefore, Newsoara agrees that the technology transfer and approve any such amendments or changesmaterial supply under Sections 4.1.1 (Technology Transfer) and 4.1.2 (Material Supply) shall initially be limited to those related to Olvi-Vec, and technology transfer and material supply for other Licensed Virus(es) shall be provided only in accordance with Section 4.1.4(c) below. (c) The Development Upon Newsoara’s request, Genelux shall provide Newsoara with access to its database that contains all data and results Controlled by Genelux and related to the Licensed Viruses in Genelux’s library of Products Oncolytic Viruses. After reviewing such data, through the JSC, the Parties shall discuss and agree on an initial screening protocol, which may include screening of the virus library to be conducted by Genelux or by a mutually agreed Third Party laboratory, at Newsoara’s cost and expense, and may include a visiting scientist from Newsoara. Newsoara then shall prepare an update to the Development Plan that includes such mutually agreed screening protocol and further Development of Licensed Viruses selected from such screening work. Based on such updated Development Plan, the Parties pursuant shall discuss and agree on the number of viruses in Genelux’s library to good clinical practices (“GCP”) and good laboratory practices (“GLP”)be transferred to Newsoara on an annual basis, which shall be based on mutual capacity of the Parties. GLP means all applicable Good Laboratory Practice standardsFor clarity, including, as applicable, as set forth Newsoara’s final decision-making authority in the then current good laboratory practice standards promulgated or endorsed by JSC shall not apply to the FDA as defined in 21 C.F.R. Part 58, or decision on the equivalent Applicable Laws in screening protocol and the Territory, each as may number of viruses to be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to timetransferred, and (d) Genelux shall not be required to transfer the equivalent Applicable Laws the Territory, each as may be amended and applicable from time entire virus library to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjectsNewsoara.

Development Plan. Subject to and in accordance with this Article 4 (a) Development), each Party shall be responsible for, and shall use Commercially Reasonable Efforts to, complete the Development activities allocated to such Party in the Development Plan in accordance with the timelines set forth therein. The initial Development plan for the Development of Product for the Initial Indications is Plan, attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the “Development Plan”). The , and each subsequent Development Plan shall include: include (a) all indications of Products then being pursued; (bi) a description of the reasonably detailed and written plan for any Development activities and Clinical Trials to be conducted by each Party or on Epirus’s behalf in order to obtain Regulatory Approval to market the Licensed Products in the Field in a harmonized clinical development program for the [***] as well as a plan for regulatory activities in such countries (it being agreed and understood that (x) the relevant deliverables; Regulatory Approval timeline under such Plan shall not be adversely impacted as a result of [***] being included therein, (cy) all relevant decision points any separate [***] or otherwise outside of the Territory shall not be part of the [***] hereunder and shall be solely for [***] and (z) Partner shall be entitled to continue reference to the resulting [***] and/or ex-Territory. data solely for use in the Territory) (“Global Development of a Product in an indication; Activities”), (dii) a budget reasonably detailed and written plan for the any Development activities and Clinical Trials to be conducted in order to obtain Regulatory Approval to market the Territory with respect to Licensed Products in the Field in any country in the Territory until that are not Global Development Activities as well as a plan for regulatory activities with the EMA and other Regulatory Approval of such Product for such indication; Authorities in the Territory (ethe “Local Development Activities”) an estimated timeline and (iii) a rolling five (5)-year budget for the performance of activities; Global Development Activities and the Local Development Activities (f) FTE estimates. (b) On no less than an annual basisthe “Development Budget”). During the Term, the JSC JMC shall review the Development Plan and recommend any amendments or changes prepare updates to the Development Plan and approve Development Budget on an annual basis, or more frequently as determined by the JMC ; provided, however, that any such amendments or changes. (c) The increases to the Development Budget in excess of Products shall be conducted [***] of the most recent Development Budget approved by Parties the JMC without Epirus’s use of its deciding vote pursuant to good clinical practices Section 3.2.3(c) (“GCP”Matters Reserved for Epirus) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in shall require approval of Partner’s representative on the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjectsJMC.

Development Plan. (a) The initial All Development plan of the Specialty Product in and for the Development of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time Territory shall be conducted pursuant to this Agreementa written development plan which sets forth the timeline and details of all non-clinical and clinical studies, regulatory affairs strategy and activities and other Development activities to be conducted by or on behalf of a Party or its Affiliate in connection with obtaining and maintaining Regulatory Approvals in the Territory (the “Development Plan”). The As soon as practicable after the Effective Date, the JDC shall discuss and prepare, and the JSC shall approve, the initial Development Plan pursuant to Section 3.3. From time to time (at least on an annual basis), the JDC shall include: (a) all indications of Products then being pursued; (b) a description prepare amendments and updates, as appropriate, to the then-current Development Plan, and shall submit such amendments and updates to the JSC for review, discussion and approval pursuant to Section 3.3. If the terms of the Development activities Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. For more clarity, the special considerations and commonly accepted industry standards or practices with regard to the Development in China shall be conducted by specifically and duly taken into account in discussing, preparing and approving the Development timelines of the Development Plan. . Under the oversight of the JDC, each Party or its Affiliate shall conduct Development activities in and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Territory in accordance with, and as assigned to such Party under, the Development Plan, in good scientific manner, and in compliance with all Applicable Laws, including applicable national and international guidelines such as ICH, GCP, GLP and GMP. Without limiting the foregoing, each Party shall use Commercially Reasonable Efforts to accomplish the Development work assigned to such Party under each Development Plan in accordance with the timelines specified therein. In the event Licensee, prior to receipt of the first Regulatory Approval in the Territory, discontinues all or substantially all Development activities to be conducted set forth in the Territory Development Plan for a period of three (3) consecutive months, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control (such as due to Regulatory Authority requirements or delays), then, without prejudice or limitation to Teva’s other termination rights hereunder, Teva shall have the right in its sole discretion, upon thirty (30) days’ written notice to Licensee, to terminate this Agreement with respect to Products the given Specialty Product, provided however, that Teva has called for the consultation(s) on such Development discontinuation but both Parties are still unable to reach a solution within three (3) months as from the date of the first consultation. For the avoidance of doubtExcept as stated in the Territory until Regulatory Approval foregoing, the termination right set forth in this Section 4.3 is not intended in any manner to inform or restrict Teva’s other termination rights hereunder in any manner or degree, or set any threshold by which such other termination rights are to be judged or characterized, except that such Development discontinuance is caused by the reasons imputable to Teva (such as Teva’s delay in its responsible Development or other breach of such Product this Agreement), in which case the termination right set forth in this Section 4.3 shall not be applicable or enforced, and both Parties shall, at the reasonable request of Licensee, be obligated to renegotiate on the affected Development timelines and regulatory approvals milestones in good faith. Each Party may perform Development work for such indication; (e) an estimated timeline which it is responsible under the Development Plan through one or more subcontractors or consultants, provided that the contracting Party shall remain responsible for any obligations that have been delegated or subcontracted to any subcontractor, and shall be responsible for the performance of activities; and (f) FTE estimates. (b) On no less than an annual basisits subcontractors. Upon reasonable notice during regular business hours, the JSC shall review the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes. (c) The Development of Products Teva shall be conducted by Parties pursuant entitled to good clinical practices (“GCP”) audit such Licensee subcontractors at Teva’s sole cost and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to timeexpense, and (d) the equivalent Applicable Laws the Territory, each as may Licensee shall be amended and applicable from time obligated to time and include such audit right of Teva in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjectsits agreements with such subcontractors.

Development Plan. (ai) The initial Development plan for the Development of Product for the Initial Indications Plan is attached hereto as Exhibit B (as amended from time to time pursuant to this AgreementSchedule ‎1.49, the “Development Plan”). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of and sets forth the Development activities to be conducted undertaken by each Party or on behalf of Scynexis with respect to the Compounds and the relevant deliverables; Products in the Field in the GSK Territory. The Parties shall, on an as reasonably needed basis and through the JDC, review and discuss proposed amendments to the then-current Development Plan, including any modifications that are required as a result of any request or requirement of the FDA or any other Regulatory Authority. The Parties acknowledge and agree that (cA) without limiting Section ‎3.2(g) and notwithstanding anything else in this Agreement to the contrary, GSK shall have final decision-making authority with respect to any such proposed amendment to the Development Plan to increase the number of patients involved in the MARIO Study or to increase the scope of data safety monitoring for any Clinical Trial included in the Development Plan, provided that GSK shall [***], and (B) notwithstanding Section ‎3.2(g), any such proposed amendment to the Development Plan to materially change (1) the scope or timeline of activities under the Development Plan (including the addition of any new Clinical Trial or termination or cessation of any existing Clinical Trial), (2) the overall budget of the Development Plan, (3) the allocation between the Parties of responsibility for activities under the Development Plan, or (4) the general approach, inclusion criteria, dosing regimen or endpoints set forth in the protocol for any Clinical Trial included in the Development Plan, shall require the mutual written agreement of the Parties. Scynexis shall make available to GSK any and all relevant decision points results, raw (to continue Development the extent in Scynexis’s or any of a Product in an indication; (dits Affiliates’ possession or reasonably available to Scynexis or any of its Affiliates) a budget for and analyzed data, and information arising from the Development activities performed by Scynexis pursuant to be conducted the Development Plan in the Territory accordance with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimatesSection ‎4.1(c). (bii) On no less than an annual basisSubject to the terms and conditions of this Agreement, Scynexis (A) will be solely responsible, at its cost and expense, for the JSC shall review conduct of the Development activities set forth in the Development Plan, (B) will perform such Development activities in accordance with this Agreement (including Section ‎4.1(a)(iv) below) and the Development Plan and recommend in accordance with all Laws and GCP, in each case to the extent applicable, and (C) shall commit such resources (including all Personnel, facilities, equipment and materials) as are reasonably available to Scynexis and its Affiliates and necessary to comply with such foregoing obligations. Xxxxxxxx acknowledges and agrees that Xxxxxx shall conduct Development activities set forth in the Development Plan solely to the extent expressly set forth in the Clinical Trial Participation Agreement between Xxxxxxxx and Hansoh (as such agreement exists as of the Execution Date) unless the Development Plan is amended in accordance with this Agreement to expand the Development activities conducted by Xxxxxx and Xxxxxx agrees to conduct such additional activities. (iii) GSK will provide input and advise on the Development Plan and oversee implementation of the Development Plan by Xxxxxxxx through the JDC, including with respect to clinical trial design, statistical analysis and pharmacology matters. (iv) Xxxxxxxx’s and its Affiliates’ performance of activities set forth in the Development Plan shall be conducted in a professional and workmanlike manner by competent and qualified individuals who possess the training, education, experience and skill reasonably necessary to perform such activities. Scynexis shall use Commercially Reasonable Efforts to comply with the estimated timelines for completing the activities set forth in the Development Plan or any amendments portion thereof. Notwithstanding anything to the contrary in this Agreement, either Party may cease performance of any activities set forth in the Development Plan to the extent such activities would (a) violate any requirements of or changes recommendations by any applicable Regulatory Authority or any applicable data and safety monitoring board or similar committee, (b) in such Party’s reasonable belief, pose a safety risk to human subjects, or (c) based on such Party’s good faith determination, violate applicable Law or infringe or violate any intellectual property rights of any Third Party, provided that such Party shall, in each case, notify the other Party promptly in writing of the potential for such cessation of such activities immediately, and the Parties shall discuss in good faith reasonable steps that such Party should take with respect to such Development activities to mitigate or resolve such concern, including any amendment to the Development Plan and approve any such amendments or changes. if necessary (c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standardsit being understood that, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by event such cessation is due to such Party’s reasonable belief that such activities pose a safety risk, the FDA as defined Parties shall cooperate and determine the appropriate actions to be taken in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjectsa timely manner), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Development Plan. Within ninety (a90) The initial Development plan days after the receipt by Otsuka of ISTA's pre-clinical data and clinical data summarized in final clinical study reports for the Development of Product for the Initial Indications is attached hereto as Exhibit B treatment of vitreous hemorrhage (as amended including all such data from time each completed phase I, phase II and phase III clinical study, and all such data from each clinical pivotal study, all of which shall be in English), Otsuka shall submit to time pursuant to this AgreementISTA for approval, Otsuka's written plan for completing the clinical development (and associated pre-clinical effort) of, and obtaining Regulatory Approval for marketing, sale and use of, the “Development Plan”). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory for the treatment of vitreous hemorrhage (or subsequently for another indication within the Field as the Parties may agree to) ("Development Plan"); such approval not to be unreasonably delayed or withheld. ISTA shall provide Otsuka with the above referenced pre-clinical and clinical data summarized in the final clinical study reports for the Product no later than the date on which ISTA first files the clinical section of its New Drug Application for Vitrase(R) with the FDA. Except with respect to Products revisions expressly identified to ISTA, Otsuka shall prepare the initial Development Plan for the Product based on the protocols used by ISTA in conducting the clinical studies on Vitrase(R) in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline United States for the performance treatment of activities; vitreous hemorrhage (or subsequently for another indication in the Field as the Parties may agree to), and (f) FTE estimates. (b) On no less than an annual basisshall submit such Development Plan to ISTA for approval, the JSC such approval not to be unreasonably withheld or delayed. Otsuka shall review revise the Development Plan to incorporate ISTA's comments with respect to any clinical study protocols before Otsuka files its first Regulatory Filing with MHLW that contains the detailed clinical trial protocols or proposals for the Product. After Otsuka files its first Regulatory Filing with MHLW that contains the detailed clinical protocols or proposals for the Product, Otsuka will submit proposed material updates and recommend changes to the clinical trial protocols that were not requested by MHLW to ISTA for approval, such approval not to be unreasonably withheld or delayed, and Otsuka will revise the Development Plan to incorporate ISTA's comments. After Otsuka files its first Regulatory Filing with MHLW that contains the detailed clinical protocols or proposals for the Product, Otsuka will submit proposed material updates and changes to the clinical trial protocols that were requested by MHLW to ISTA for comment. In any amendments or event, Otsuka shall submit proposed updates and changes to the Development Plan and approve any such amendments or changesto ISTA at least annually. (c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.