Common use of Formation and Purpose Clause in Contracts

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following In order to oversee, review and coordinate the Effective Dateactivities of the Parties under this Agreement, Pfenex and Hospira will form an executive steering committee promptly after the Signature Date (the “Executive Steering Committee”), whose initial members are listed in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement. The Executive Steering Committee shall, in accordance with the procedures set forth in Section 7.4, (a) review and comment on the development, manufacture and commercialization of Product, including the Development Plan, the Parties shall confer Technical Transfer Plan, and then create any clinical protocols for the Committees listed in conduct of the chart belowComparative Clinical Study, (b) consult with Hospira regarding Hospira’s plan for seeking Regulatory Approval, (c) review and approve any modifications or amendments to the Development Plan, (d) review and approve the clinical protocols for the conduct of the Comparative Clinical Study and any modifications or amendments thereto, (e) review and approve the Technical Transfer Plan and any modifications or amendments thereto, (f) review and comment on the IP Strategy and any modifications or amendments thereto, (g) serve as a forum for discussion for matters relating to the development, manufacture and commercialization of Product, (h) establish an estimated budget for Regulatory Approval Costs to be paid by Hospira for each calendar year by October 31st of the prior calendar year, (i) establish one or more working committees, which shall have include a product development working committee, a manufacturing working committee and other working groups, committees and subcommittees as may be established by mutual consent of Pfenex and Hospira (each, a “Working Committee”), and (j) performing such other duties as are specifically assigned to the purpose indicated Executive Steering Committee in this Agreement. The Executive Steering Committee shall be the chart. To primary forum for Pfenex and Hospira to communicate with one another regarding the extent that after conferring both Parties agree that a given Committee need not be created until a later dateplans for, and progress of, the Parties may agree to defer the creation development and commercialization of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, Product as well as approve budgets for such projectsany associated problems. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets Confidential treatment has been requested with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoingomitted portions.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Fibroblast Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Fibroblast Program. Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Fibroblast Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Fibroblast Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Fibroblast Program; review and approve itemized budgets with respect to the foregoing. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Bacteriophage Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plansplans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Bacteriophage Program. Regulatory Committee (“RC”) Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Ampliphi Products under the Bacteriophage Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Bacteriophage Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Anti-Infectives Bacteriophage Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Lantibiotics Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Lantibiotics Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Lantibiotics Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Lantibiotics Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Lantibiotics Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Lantibiotics Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Lantibiotics Program. Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Lantibiotics Program; review and approve itemized budgets with respect to the foregoing. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Lantibiotics Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Lantibiotics Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Melioidosis Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plansplans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Melioidosis Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRCRC”) Review and approve all research and development plansplans and projects, including but not limited to clinical projects and projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Soligenix Products under the Anti-Infectives Melioidosis Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Melioidosis Program. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Anti-Infectives Melioidosis Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Fibroblast Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Fibroblast Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Fibroblast Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Fibroblast Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Fibroblast Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and promptly schedule a meeting of such Committee within one (1) montha reasonable time. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Probiotics Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Probiotics Program. CONFIDENTIAL TREATMENT REQUESTED BY INTREXON CORPORATION EXECUTION COPY CONFIDENTIAL Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plansplans and projects, including clinical projects and projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval under the Anti-Infectives Probiotics Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Probiotics Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Probiotics Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later datenon-JSC and non-IPC Committee, the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plansplans and projects, including clinical projects and publicationsprojects, associated with any regulatory approvals, review all associated publications (in conjunction with the IPC), and all regulatory filings and correspondence relating to pursuing regulatory approval of Collaboration Products under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Ophthalmic Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plansplans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Ophthalmic Program. Regulatory Approval Committee (“RC”) Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new JV Products under the Ophthalmic Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Ophthalmic Program. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Ophthalmic Program; review and approve itemized budgets with respect to the foregoing. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following In order to oversee, review and coordinate the activities of the Parties under this Agreement, NRx and Alvogen will form an executive steering committee upon the Effective Date, Date (the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart“Executive Steering Committee”). To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint The Executive Steering Committee shall, in accordance with the procedures set forth in ‎Section 7.4, (“JSC”a) Establish projects for the Anti-Infectives Program and establish the prioritiesreview, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistrycomment on, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistryany updates, manufacturingmodifications or amendments to the Development Plan, (b) review, comment on, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all any material research and development plans(including pre-clinical and clinical trial activities and statistical design) activities of Product in the Field in the Territory, clinical projects and publications(c) review, comment on, and approve any regulatory filings and correspondence under affairs, regulatory strategy, or regulatory activities with respect to Product in the Anti-Infectives Program; Field in the Territory, including filing the NDA with the FDA, (d) review and approve itemized budgets comment on Commercialization of Product in the Field in the Territory, (e) review and comment on the creation and implementation of strategies related to the NRx Patents and Patents of Third Parties, in each case with respect to the foregoing. Prosecution and Maintenance of Patents claiming Product Inventions and the enforcement thereof, development (including obtaining NDA Approval) and Commercialization Committee of Product in the Territory (collectively, “CCIP Strategy”), (f) Establish project plans and review and approve activities and budgets serve as a forum for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect discussion of matters relating to the foregoingdevelopment, manufacturing and Commercialization of Product in the Territory, (g) establish one or more working committees and subcommittees as may be established by mutual consent of NRx and Alvogen (each, a “Working Committee”), and (h) perform such other duties as are specifically assigned to the Executive Steering Committee in this Agreement. The Executive Steering Committee shall be the primary forum for NRx and Alvogen to communicate with one another regarding the plans for, and progress of, the development and Commercialization of Product in the Territory.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Bacteriophage Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plansplans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Bacteriophage Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRCRC”) Review and approve all research and development plansplans and projects, including clinical projects and projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Ampliphi Products under the Anti-Infectives Bacteriophage Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Bacteriophage Program. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Anti-Infectives Bacteriophage Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and promptly schedule a meeting of such Committee within one (1) montha reasonable time. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Probiotics Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Probiotics Program. CONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC. EXECUTION COPY CONFIDENTIAL Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plansplans and projects, including clinical projects and projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval under the Anti-Infectives Probiotics Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Probiotics Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Probiotics Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated CONFIDENTIAL in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee Subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Approval Committee (“CRCRAC”) Review and approve all research and development plansplans and projects, including clinical projects and projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval under the Anti-Infectives Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization Commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval under the Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Program; review and approve itemized budgets with respect to the foregoing. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below, each of which . Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that to not create a given Committee need not be created until a later date(other than the JSC and the IPC), the Parties may agree to defer the creation of the such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) monthCommittee. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Melioidosis Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plansplans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Melioidosis Program. Regulatory Committee (“RC”) Review and approve all research and development plans and projects, including but not limited to clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Soligenix Products under the Melioidosis Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Melioidosis Program. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Melioidosis Program; review and approve itemized budgets with respect to the foregoing. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following In the Effective Dateevent BioLife exercises the option under Section 5.1 during the Option Period, the Parties shall promptly thereafter confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives SMA Therapeutics Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives SMA Therapeutics Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives SMA Therapeutics Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives SMA Therapeutics Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives SMA Therapeutics Program; review and approve itemized budgets with respect to the foregoing.

Formation and Purpose. Promptly following For the Effective Datepurpose of establishing a thorough and effective co-operation and communication between them during the term of this Agreement, within thirty (30) days after the Original Execution Date the Parties shall confer establish a “Joint Steering Committee” or “JSC” in accordance with this Section 6.1 to exchange information relating to the Development and then create the Committees listed Commercialization of the Licensed Products, as further described in this Section 6.1 or otherwise set forth in this Agreement, and, among other things, to facilitate the flow of information with respect to Development activities being conducted for the Licensed Products and Clinical Studies and Post Approval Studies for the Licensed Products conducted under the Development Plans. Each Party shall designate its initial members of the JSC within thirty (30) days after the Original Execution Date by written notice to the other Party. 6.1.2 Specific Responsibilities of the JSC. At its meetings, the JSC shall, consistent with the terms and conditions of this Agreement, (a) review the Development Plans and, during the Co-Promotion Period, approve the Americas/Europe Development Plan for the United States and Europe and the Development Budget (including all amendments), (b) monitor the Licensee’s progress toward the objectives and timelines set forth in the chart belowDevelopment Plans and the Commercialization Plans and, each during the Co-Promotion Period, the progress of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that towards those objectives with respect to the Americas/Europe Development Plan and the Americas/Europe Commercialization Plan, (c) review the Commercialization Plans and, during the Co-Promotion Period, approve the Americas/Europe Commercialization Plan for Europe, (d) undertake and/or approve such other matters as are specifically provided for the JSC under this Agreement, and (e) serve as a given Committee need not be created until a later date, forum for communication between the Parties may agree and to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, resolve issues as well as approve budgets for such projects. Approve all subcommittee projects and plansmutually agreed. The JSC shall establish budgets not less than on create, when advisable, subcommittees such as, for example, a quarterly basis. Chemistryjoint development committee and/or a joint manufacturing committee, Manufacturing comprised of representatives of each Party having qualifications and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant experience relevant to a request for confidential treatment under Rule 24b-2 productive dialogue on the subject matter of the Securities Exchange Act of 1934, as amendedeach such subcommittee. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect All such subcommittees shall report to the foregoingJSC. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.6.2