Master Alliance Provisions Guide (MAPGuide)

DNDi Template Development Collaboration and License Agreement

  • Equitable Access | Affordable pricing

<p>&#8220;<strong>Affordable Basisstrong>&#8221; shall mean pricing a Product at the lowest sustainable level which may include only:p>
<p style=”paddingleft: 40px;”>a) full production costs, as optimised without compromising the quality of the Product; andp>
<p style=”paddingleft: 40px;”>b) direct distribution costs, andp>
<p style=”paddingleft: 40px;”>c) a reasonable margin, not to exceed &lt; to be completed &gt; percent of the foregoing costs, for the selling Party.p>
<p class=”p1“><span style=”textdecoration: underline;”><strong>3. DEVELOPMENT AND DISTRIBUTION PROGRAMstrong>span>p>
<p><strong>3.5strong> During the Term, each Party shall use <a href=”#kt“>Reasonable Effortsa> to conduct, advance and complete the activities assigned to it in a timely way and as soon as reasonably practical, including devoting such employees/consultants/CSPs with sufficient skills and experience, and facilities and equipment as are reasonably necessary to complete its obligations under the Collaboration Plans. In particular, the Parties shall use Reasonable Efforts to develop, obtain <a href=”#kt“>Regulatory Approvala>(s) for and, following <a href=”#kt“>Marketing Authorisationa>, use all Reasonable Efforts to provide an adequate supply of Product on an Affordable Basis in the Field in the Territory and provide a strong supply network to support such distribution.p>
<p class=”p1“><span style=”textdecoration: underline;”><strong>9. MANUFACTURE AND SUPPLYstrong>span>p>
<p><em>Manufacture of the Product.em>p>
<p><strong>9.5strong> Partner shall undertake Reasonable Efforts to optimize the manufacture of the Product, so as to make possible a final price ensuring the widespread use of the Product consistent with the Access and Implementation Plan. Partner commits to pass on any significant reduction in the production costs of such materials to the benefit of the sale price.p>
<p><em>Product Distribution and Pricing.em>p>
<p><strong>9.6strong> Partner shall be responsible for the distribution, either directly or through any Third Party it may appoint, of the Product in accordance with this Agreement. Following receipt of the applicable Marketing Authorisation, Partner shall make the Product available in the Territory on an Affordable Basis.p>
<p><strong>9.7strong> In the event that the Product is not achieving the Access and Implementation Plan, which may be attributable to the price of the Product, then DNDi may request and Partner shall disclose to DNDi the composition of the price of the Product, including any allowed Third Party or Affiliate margin and cost markup, so that the Parties can resolve the elements of pricing in good faith.p>
<p><strong>9.8strong> Partner shall transfer manufacturing technology in full to one or more Third Party manufacturers if such transfer reduces the cost of the Product in accordance with a technology transfer plan mutually agreed upon by the Parties which shall include, at a minimum the terms attached hereto as <a href=”” target=”_blankrel=”noopener“>Annex 6a>, provided that (i) such Third Party manufacturersquality standards meets <a href=”#kt“>Good Manufacturing Practicea>; and (ii) the transfer will not delay access to the Product in the Territory.p>
<p><em>Price Audit and Adjustmentem>p>
<p><strong>9.9strongDNDi may mandate an independent and experienced auditor to verify the conformity of Partners current prices of the Product with the Affordable Basis definition. Partner undertakes to provide the independent auditor with all relevant data, methods and information that are required to allow the independent auditor to carry out its mandate. The conclusion of the independent auditor will be binding on the Parties. The fees and expenses of such auditor shall be paid by DNDi, unless the examination results in a determination that the current price of the Product was overstated by more than ten percent (10%) for the period examined, in which case Partner shall pay the fees and expenses of such auditor.p>