Common use of Specific Responsibilities of the JSC Clause in Contracts

Specific Responsibilities of the JSC. In addition to its overall responsibilities described in Section 2.4.1, and subject to the provisions of Section 2.7.3 and Article 6, the JSC shall, in particular: (a) select which Party and/or Third Party(ies) to engage for the Manufacture and supply of Collaboration Products and components thereof (“Third Party Manufacturers”), oversee auditing of Third Party Manufacturers, and approve contracts governing such Manufacture and supply; (b) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Collaboration Products and for worldwide supply of Collaboration Products; (c) jointly develop a Manufacturing strategy for the US Territory and the ROW Territory to enable development and licensure of manufacturing processes and facilities for Collaboration Products that includes all aspects of Manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, test methods and process validation studies, stability studies and Manufacturing plans and forecasts and the implementation of Manufacturing Improvements; (d) determine Manufacturing plans and budgets, including timelines and inventory strategies, and allocate responsibilities for and oversee the implementation of such plans in accordance with this Agreement; (e) oversee and approve process development plans prior to the Manufacture of registration batches of Collaboration Products; (f) oversee and approve plans to support Manufacture of commercial supply of Compound and Collaboration Products; (g) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Collaboration Products; (h) review and coordinate the drafting and contents of the Chemistry, Manufacturing and Controls section of a Drug Approval Application for Collaboration Products; (i) review and approve technology transfer plans for any changes in Manufacturing sites, testing sites, and responsibilities in the supply chain for Collaboration Products, it being understood that decisions regarding the selection of which of a Party’s own Manufacturing and testing sites shall be used to manufacture any component of a Collaboration Product, if a Party Manufactures any component of a Collaboration Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; (j) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Collaboration Products; (k) ensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Marketing Plan for the US Territory, and the corresponding plans for the ROW Territory, as well as inventory levels for Collaboration Products; (l) review quality-related issues concerning the Collaboration Products or any component thereof; and (m) review and approve compliance plans whereby the Parties prepare for or participate in a Governmental Authority inspection of the Manufacturing or testing site of the Compound.

Specific Responsibilities of the JSC. In addition to its overall responsibilities described in Section 2.4.12.3.1, and subject to the provisions of Section 2.7.3 2.6.1 and Article 65, the JSC shall, in particular: (a) select which Party and/or Third Party(ies) to engage for the Manufacture and supply of Collaboration Products and components thereof (“Third Party Manufacturers”), oversee auditing of Third Party Manufacturers, and approve contracts governing such Manufacture and supply; (b) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Collaboration Products and for worldwide supply of Collaboration Products; (c) jointly develop a Manufacturing strategy for the US Territory and the ROW Territory to enable development and licensure of manufacturing processes and facilities for Collaboration Products that includes all aspects of Manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, test methods and process validation studies, stability studies and Manufacturing plans and forecasts and the implementation of Manufacturing Improvements; (d) determine Manufacturing plans and budgets, including timelines and inventory strategies, and allocate responsibilities for and oversee the implementation of such plans in accordance with this Agreement; (e) oversee and approve process development plans prior to the Manufacture of registration batches of Collaboration Products; (f) oversee and approve plans to support Manufacture of commercial supply of Compound and Collaboration Products; (g) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Collaboration Products; (h) review and coordinate the drafting and contents of the Chemistry, Manufacturing and Controls section of a Drug Approval Application for Collaboration Products; (i) review and approve technology transfer plans for any changes in Manufacturing sites, testing sites, and responsibilities in the supply chain for Collaboration Products, it being understood that decisions regarding the selection of which of a Party’s own Manufacturing and testing sites shall be used to manufacture any component of a Collaboration Product, if a Party Manufactures any component of a Collaboration Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; (j) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Collaboration Products; (k) ensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Marketing Plan for the US Territory, Territory and the corresponding plans for the ROW Territory, as well as inventory levels for Collaboration Products; (l) review quality-related issues concerning the Collaboration Products or any component thereof; and (m) review and approve compliance plans whereby the Parties prepare for or participate in a Governmental Authority inspection of the Manufacturing or testing site of the Compound.

Specific Responsibilities of the JSC. In addition to its overall responsibilities described in Section 2.4.1, responsibility for monitoring and subject providing a forum to discuss the provisions of Section 2.7.3 and Article 6Parties’ activities under this Agreement, the JSC shall, shall in particular: (ai) select which Party and/or Third Party(ies) to engage for the Manufacture and supply of Collaboration Products and components thereof (“Third Party Manufacturers”)discussing, oversee auditing of Third Party Manufacturersfacilitating, and approve contracts governing such Manufacture and supplycoordinating the exchange of information between the Parties; (bii) delineate requirements managing and responsibilities for development overseeing the transfer of the BIO FS Product Technology (and, as applicable, the BIO External Product Interface Technology) and licensure Manufacturing Technology to Acutus pursuant to the terms of manufacturing processes and facilities for Collaboration Products and for worldwide supply of Collaboration Products; (c) jointly develop a Manufacturing strategy for the US Territory and the ROW Territory this Agreement, to enable development and licensure of manufacturing processes and facilities for Collaboration Products that includes all aspects of Manufacture and releaseAcutus to exercise its Development, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, test methods and process validation studies, stability studies and Manufacturing plans and forecasts and the implementation of Manufacturing Improvements; (d) determine Manufacturing plans and budgets, including timelines and inventory strategiesManufacture, and allocate responsibilities for and oversee the implementation of such plans in accordance with Commercialization rights under this Agreement; (eiii) oversee managing and approve process development plans prior overseeing the transfer of Development Data from Acutus to the Manufacture BIO Parties to enable the BIO Parties to seek Marketing Authorization Approval for the FS Product Line (including any individual product contained therein) and External Products, in each case in any country in the Territory outside the US and the EU; (iv) discussing and reviewing FS Product Line and External Product Development strategies useful or necessary to obtain Marketing Authorization Approval from the Regulatory Authorities for the FS Product Line and External Products (including any individual product contained therein) in the Territory (including the strategy, design and progress of registration batches of Collaboration any Clinical Trials in support thereof), including discussing and reviewing how data from Clinical Trials will be transferred between the Parties to support application for Marketing Authorization Approval for FS Product Line and the External Products; (fv) oversee establishing a plan for Development of the FS Product Line and approve plans to support Manufacture plan for obtaining Marketing Authorization Approval of commercial supply External Products for use with the FS Product Line (a “Development Plan”), which first draft of Compound such Development Plan shall be prepared by Acutus and Collaboration Productssuch Development Plan shall then be discussed, finalized and approved by the JSC no later than 30 September 2019, and reviewing and approving amendments thereto; (gvi) review quality assurance effortsdiscussing and reviewing any applicable Commercialization Plan by a Party prior to First Commercial Sale as well as Commercialization strategies for the FS Product Line in the Field in the Territory; provided, including but not limited that for clarity, neither Party shall be obliged to those efforts with respect to the establishment of specifications and quality standards for Collaboration Productsreport detailed sales data or pricing; (hvii) review discussing and coordinate the drafting reviewing strategies and contents plans for Manufacture and supply of the ChemistryFS Product Line by Acutus to the BIO Parties, Manufacturing and Controls section the BIO Parties’ Manufacture and supply to Acutus of a Drug Approval Application for Collaboration the FS Electronic Products and External Products, in each case consistent with the terms of the Manufacture and Supply Agreement; (iviii) review resolution of matters presented to it and approve technology transfer plans for disputes raised to it by any changes in Manufacturing sites, testing sites, and Subcommittee that is within the scope of responsibilities in delegated to the supply chain for Collaboration Products, it being understood that decisions regarding respective Subcommittee by the selection of which of a Party’s own Manufacturing and testing sites shall be used to manufacture any component of a Collaboration Product, if a Party Manufactures any component of a Collaboration Product pursuant to JSC under this Agreement or any related supply agreement, shall remain and subject to the decision-making processes set forth in the sole control of such Party; (j) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Collaboration Products; (k) ensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Marketing Plan for the US Territory, and the corresponding plans for the ROW Territory, as well as inventory levels for Collaboration Products; (l) review quality-related issues concerning the Collaboration Products or any component thereofSection 3.4; and (mix) review performing such other functions as appropriate, and approve compliance plans whereby directing each Subcommittee to perform such other functions as appropriate, to further the Parties prepare for or participate purposes of this Agreement, in a Governmental Authority inspection of each case as mutually agreed in writing by the Manufacturing or testing site of the CompoundParties.