Common use of JSC Functions and Powers Clause in Contracts

JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JSC will include: (i) overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s); (ii) approving Product Adjustments; (iii) approving the development of Pathogen Combination Products; (iv) updating the initial COVID R&D Plan to include the further Development work; (v) discussing and agreeing the Development budgets under the COVID R&D Plan(s); (vi) the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines; (vii) receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development of the respective COVID Product; (viii) exchanging Development Data and other technical information; (ix) discussing and agreeing on the entry of supply agreements that provide for the supply of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories; (x) discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product; (xi) creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub- committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply. (xii) serving as a forum where each Party shall inform the other Party of any material feedback received from Regulatory Authorities in relation to any COVID Product; (xiii) informing on material regulatory filings and regulatory interactions related to the COVID Products; (xiv) discussing and deciding on whether to Develop (temporarily or completely) several different COVID Products in parallel, and if several COVID Products are developed in parallel, decide on whether the Development will be completed only for one or for more than one COVID Product; (xv) fostering the collaborative relationship between the Parties; (xvi) discussing and agreeing, and reviewing no more than once each Calendar Year, the rate payable for distribution costs comprised in the COGS, taking into account possible cost savings, efficiency savings or increases in the underlying costs; (xvii) resolving disputes between the Parties; and (xviii) such other functions as assigned to it under this Agreement or as agreed by the Parties. If the JSC establishes a sub-committee in accordance with this Section 7.3, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee. The Parties shall, within the JSC, in good faith evolve the composition and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the COVID Products. Neither Party shall make its consent (whereby either Party may give or withhold its consent in its sole discretion) subject to a change of the financial model for the Development, Manufacturing and Commercialization of COVID Products set forth in this Agreement or on the payment by the other Party of any additional consideration under this Agreement (although, for clarity, any costs incurred by the other Party in respect of obtaining a license to any In-Licensed IP shall be taken in account in the calculation of Net Profits, as set forth in this Agreement).

Appears in 1 contract

Samples: Covid Collaboration and License Agreement

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JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JSC will include: (i) overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s);, including deciding the strategy for the Manufacturing and supply of clinical materials, as referred to in Section 5.1; ​ (ii) approving Product Adjustments;; ​ (iii) approving the development of Pathogen Combination Products;; ​ ​ ​ ​ ​ (iv) updating the initial COVID R&D Plan to include the further Development work;; ​ (v) discussing and agreeing the Development budgets under the COVID R&D Plan(s);; ​ (vi) the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines;; ​ (vii) receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development of the respective COVID Product;; ​ (viii) exchanging Development Data and other technical information;; ​ (ix) discussing and agreeing on the entry of supply agreements that provide for the supply of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories;; ​ (x) discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product;; ​ (xi) creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub- sub-committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply. (xii) serving as a forum where each Party shall inform the other Party of any material feedback received from Regulatory Authorities in relation to any COVID Product;; ​ (xiii) informing on material regulatory filings and regulatory interactions related to the COVID Products;; ​ (xiv) discussing and deciding on whether to Develop (temporarily or completely) several different COVID Products in parallel, and if several COVID Products are developed in parallel, decide on whether the Development will be completed only for one or for more than one COVID Product;; ​ (xv) fostering the collaborative relationship between the Parties;; ​ (xvi) discussing and agreeing, and reviewing no more than once each Calendar Year, the rate payable for distribution costs comprised in the COGS, taking into account possible cost savings, efficiency savings or increases in the underlying costs;; ​ (xvii) resolving disputes between the Parties; andand ​ (xviii) such other functions as assigned to it under this Agreement or as agreed by the Parties. If the JSC establishes a sub-committee in accordance with this Section 7.3, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee. ​ ​ ​ ​ ​ The Parties shall, within the JSC, in good faith evolve the composition and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the COVID Products. Neither Party shall make its consent (whereby either Party may give or withhold its consent in its sole discretion) subject to a change of the financial model for the Development, Manufacturing and Commercialization of COVID Products set forth in this Agreement or on the payment by the other Party of any additional consideration under this Agreement (although, for clarity, any costs incurred by the other Party in respect of obtaining a license to any In-Licensed IP shall be taken in account in the calculation of Net Profits, as set forth in this Agreement).. ​

Appears in 1 contract

Samples: Covid Cla Amendment and Restatement Agreement (CureVac N.V.)

JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions responsibilities of the JSC will includeshall be as follows: (i) overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s); (ii) approving Product Adjustments; (iii) approving the development of Pathogen Combination Products; (iv) updating the initial COVID R&D Plan to include the further Development work; (v) discussing encouraging and agreeing the Development budgets under the COVID R&D Plan(s); (vi) the resolution and approval of any issue and recommendation from facilitating communication between the Parties with respect to the modification Development and Commercialization of Licensed Products; (ii) providing a forum for the Parties to discuss and mutually agree on the overall strategy and priorities for Development of Licensed Products in the Field in the Territory and to assist Company in coordinating Development activities outside Territory; (iii) providing a forum for the Parties to discuss and mutually agree on an initial Development Plan (prepared as described in Section 5.2) and updates or amendments, as appropriate, to the Development Plan; (iv) providing a forum for the Parties to discuss the conduct of any Combination Trial; (v) monitoring the progress of the COVID R&D Plan(sDevelopment of Licensed Products against the Development Plan and each Party’s diligence in carrying out its responsibilities thereunder; (vi) providing a forum for the Parties to discuss the Commercialization Plan (prepared as described in Section 6.2), including but not limited to modifications of the budget and timelines; (vii) receiving written reports or presentations from GSK and CureVac of their respective monitoring the progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development Commercialization of Licensed Products against the respective COVID ProductCommercialization Plan and each Party’s diligence in carrying out its responsibilities thereunder; (viii) exchanging Development Data and other technical information; (ix) discussing and agreeing on the entry of supply agreements that provide establishing projected timelines for the supply performance of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories Development and the CureVac Territories; (x) discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product; (xi) creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub- committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply. goals (xii) serving as a forum where each Party shall inform the other Party of than any material feedback received from Regulatory Authorities in relation to any COVID Product; (xiii) informing on material regulatory filings and regulatory interactions related to the COVID Products; (xiv) discussing and deciding on whether to Develop (temporarily or completely) several different COVID Products in parallel, and if several COVID Products are developed in parallel, decide on whether the Development will be completed only for one or for more than one COVID Product; (xv) fostering the collaborative relationship between the Parties; (xvi) discussing and agreeing, and reviewing no more than once each Calendar Year, the rate payable for distribution costs comprised in the COGS, taking into account possible cost savings, efficiency savings or increases in the underlying costs; (xvii) resolving disputes between the Parties; and (xviii) such other functions as assigned to it under this Agreement or as agreed by the Parties. If the JSC establishes a sub-committee in accordance with this Section 7.3, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee. The Parties shall, within the JSC, in good faith evolve the composition and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the COVID Products. Neither Party shall make its consent (whereby either Party may give or withhold its consent in its sole discretion) subject to a change of the financial model for the Development, Manufacturing and Commercialization of COVID Products set forth in this Agreement or on the payment by the other Party of any additional consideration under this Agreement (although, for clarity, any costs incurred by the other Party in respect of obtaining a license to any In-Licensed IP shall be taken in account in the calculation of Net Profits, as timelines expressly set forth in this Agreement); provided, however, that to the extent such timelines are not met by Licensee in a certain region or country, the JSC shall discuss in good faith to decide (A) whether to modify the timelines for such Development activities in such region or country, or (B) how to address any unmet timelines. (ix) establishing subcommittees on an as-needed basis, and overseeing the activities of all subcommittees, and attempting to resolve disputes or disagreements arising in all such subcommittees; and (x) carrying out the other duties and responsibilities described for it in this Agreement.

Appears in 1 contract

Samples: License Agreement (Immunomedics Inc)

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JSC Functions and Powers. The JSC will be responsible generally for facilitating shall manage the activities of the Parties as set forth in this Section 4.5, unless otherwise mutually agreed in writing by the Parties’ interactions under . Notwithstanding anything to the contrary contained in this Agreement, the JSC shall not have right to amend this Agreement or make any decision or require either Party to take any action that conflicts with the terms of this Agreement or that would impose, without reimbursement, additional financial and specifically for overseeing other obligations on either Party, unless mutually agreed to by the Development, Manufacture and Commercialization of the COVID ProductsParties. The JSC has (i) no jurisdiction shall encourage and facilitate the collaborative relationship and information exchange between the Parties in order to make any amendments to this Agreementassist each Party in fulfilling its obligations hereunder, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JSC will includeshall in particular: (i) overseeing monitor the Development progress of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s)Parties carrying out their responsibilities hereunder; (ii) approving Product Adjustmentsdetermine the physician education with respect to the Commercial Assay; (iii) approving discuss and coordinate Pfizer’s planning and decision making process for initiating the development of Pathogen Combination ProductsAdditional Facility or the Pfizer Facility; (iv) updating discuss and monitor access and reimbursement issues throughout the initial COVID R&D Plan to include the further Development workTerritory; (v) discussing address regulatory matters and agreeing the Development budgets under the COVID R&D Plan(s)issues and coordinate contacts with Regulatory Authorities; (vi) discuss the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines;Monogram Trademarks; and (vii) receiving written reports or presentations from GSK and CureVac perform such other functions as appropriate to further the purposes of their respective progress with this Agreement as mutually determined by the further Development of each COVID Product summarizing their Development activities and the results thereof with Parties. With respect to the applicable COVID Product availability of Commercial Assays in countries in the Ex-US Territory pursuant to Section 3.1, the JSC shall also: (i) discuss, coordinate, approve and discuss at meetings monitor plans regarding the status, progress, and results availability of the Development of the respective COVID ProductCommercial Assays; (viiiii) exchanging Development Data determine and other technical informationapprove the infrastructure required to support the availability of Commercial Assays, including the associated budget; (ixiii) discussing and agreeing on the entry of supply agreements that provide for the supply of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories; (x) discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product; (xi) creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub- committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply. (xii) serving as a forum where each Party shall inform the other Party of any material feedback received from Regulatory Authorities in relation to any COVID Product; (xiii) informing on material regulatory filings and regulatory interactions related to the COVID Products; (xiv) discussing and deciding on determine whether to Develop (temporarily or completely) several different COVID Products use couriers and/or consolidation laboratories in parallela country, select such couriers and/or consolidation laboratories, approve contracts with such couriers and/or consolidation laboratories and if several COVID Products are developed in parallel, decide on whether the Development will be completed only for one or for more than one COVID Product; (xv) fostering the collaborative relationship between the Parties; (xvi) discussing and agreeing, and reviewing no more than once establish Consolidator Performance Standards applicable to each Calendar Year, the rate payable for distribution costs comprised in the COGS, taking into account possible cost savings, efficiency savings or increases in the underlying costs; (xvii) resolving disputes between the PartiesEx-US Country; and (xviiiiv) such other functions as assigned to it under this Agreement or as agreed by the Parties. If the JSC establishes a sub-committee in accordance with this Section 7.3approve all budgets, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee. The Parties shall, within the JSC, in good faith evolve the composition contracts and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the COVID Products. Neither Party shall make its consent (whereby either Party may give or withhold its consent in its sole discretion) subject to a change of the financial model staffing requirements for the DevelopmentEx-US Infrastructure Costs and Ex-US Operating Costs. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Manufacturing and Commercialization of COVID Products set forth in this Agreement or on the payment by the other Party of any additional consideration under this Agreement (althoughMARKED BY BRACKETS, for clarityHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, any costs incurred by the other Party in respect of obtaining a license to any In-Licensed IP shall be taken in account in the calculation of Net Profits, as set forth in this Agreement)AS AMENDED.

Appears in 1 contract

Samples: Collaboration Agreement (Monogram Biosciences, Inc.)

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