“Fully–Burdened Manufacturing Costs” means: the costs of all raw materials and labor used or consumed in such manufacture, packaging costs and expenses, shipping, handling, and delivery costs related to delivery of CAMB, quality assurances and quality control related expenses and all overhead amounts allocable to such manufacturing and delivery (including without limitation amortized capital equipment costs) provided that: (1) all of the foregoing shall be calculated in accordance with US GAAP, (ii) BDSI shall, notwithstanding anything to the contrary in the Agreement, use commercially reasonable efforts to minimize Fully–Burdened Manufacturing Costs.
2. RESEARCH AND DEVELOPMENT PROGRAM
2.4 BDSI’s Performance of the R&D Plan
(c) Clinical Product Supply. BDSI will manufacture and make available to DNDi samples of CAMB in such quantities as shall be necessary for DNDi to conduct its activities under the R&D Plan. Such samples will be subject to the provisions of Section 2.6 below and sold by BDSI to DNDi at a price to be agreed between the Parties once agreement on clinical trial protocols have been reached by the JRC. DNDi and BDSI management will base the cost of clinical trial materials on the cost of the raw materials necessary for the production of CAMB and agree to a reasonable and sufficient additional cost to cover BDSI’s internal costs or the costs of using an external manufacturer. DNDi acknowledges (a) any or all of BDSI’s supply obligations hereunder can be supplied by Third Party subcontractors which will provide the necessary staff, equipment, instruments, raw materials and facilities to carry out BDSI’s manufacturing obligations, (b) BDSI will remain responsible for the conduct of all of its obligations under this Agreement, including those conducted by such Third Party subcontractors and DNDi will have no responsibility for managing such activities or such subcontractors, (c) BDSI will keep the JRC informed of any Third Party subcontractor which BDSI engages to perform its obligations under this section of the Agreement.
5. FINANCIAL TERMS
5.1 No Payment or Financial Contribution. Except as specifically set out in this Agreement, neither Party shall make any payment or pay any financial contribution to the other Party and each Party will bear all expenses it will incur for the performance of its own obligations under or in connection with this Agreement.
5.2 Funding of Clinical trials; Fees and Duties. DNDi will be solely responsible and pay for (a) all costs related to the clinical trials to be conducted upon CAMB to assess its efficacy in the Field as part of the R&D Plan and (b) all taxes, fees, duties and payments to any Governmental Authority in connection with the Regulatory Approvals and the Distribution Through the Public Sector in the Territory.
5.3 Product Supply. BDSI will, other than the clinical trial supplies as discussed in section 2.4, supply CAMB to DNDi at the following prices: Fully–Burdened Manufacturing Cost increased by a margin not exceeding *** for all supplies of CAMB for use in the Field and Distribution Through the Public Sector in the Territory. Once BDSI receives a first approval for CAMB, BDSI shall supply CAMB to DNDi at BDSI’s Fully–Burdened Manufacturing Costs increased by a margin not exceeding *** for all supplies of CAMB for use in the Field and Distribution Through the Public Sector in the Territory. BDSI and DNDi agree that the cost for lot failures, batch failures, or other quality control or productions failures (collectively “failures”) will be shared equally between the parties and BDSI shall keep all the necessary records to document failures and allocate costs accordingly.