Provision Language
<p><em><strong>Definitionsstrong>em>p>
<p class=”p1“>“<strong>LMICsstrong>” means those countries defined by the World Bank as having “low–income economies”, “lower middle–income economies” or “upper middle–income economies” as may be amended from time to time.p>
<p><span style=”text–decoration: underline;”><strong>3. Access to Health Productsstrong>span>p>
<p>The Recipient acknowledges that the objective of the Project is to ensure that the Health Products are made widely available, as quickly as possible and on a continuing basis, at an affordable and sustainable price, to the <a href=”#kt“>Public Sectora> seeking to supply them to <a href=”#kt“>LMICsa> and in sufficient quantities to meet the needs of LMICs (the “<em><strong>Access Objectivestrong>em>”). The Recipient will make best efforts to ensure that the Health Products are developed and commercialised in a manner which is consistent with the Access Objective. In furtherance of the Access Objective, the Recipient will ensure that the Health Products are made available in accordance with the following commitments (“<em><strong>Access Commitmentsstrong>em>”):p>
<p style=”padding–left: 25px;”>(i) “<strong>Price Commitmentstrong>” – the Health Products will be offered for sale to the Public Sector seeking to supply them to LMICs at a price which is no more than the lowest sustainable competitive price level (“<em><strong>Affordable Pricestrong>em>”). The Affordable Price will cover: (a) the cost of raw materials, labour and other manufacturing costs incurred in manufacturing the Health Product (including assembly); (b) the actual distribution costs incurred in the marketing, promotion, offering for sale, importing for sale, exporting for sale, distribution and sale of the Health Product; and (c) a reasonable mark–up not to exceed the mark–up set out in the Commercialisation Plan attached to this Agreement to help ensure the economic sustainability of the production and distribution;p>
<p style=”padding–left: 25px;”>(ii) “<strong>Supply Commitmentstrong>” – the Health Products will be made available in a timely manner and in sufficient quantities to meet the demands of the Public Sector seeking to supply them to the target countries listed in the Commercialisation Plan (“<em><strong>Target Countriesstrong>em>”). The Recipient will supply the Health Products to the Target Countries in accordance with the minimum annual volume target set out in the Commercialisation Plan (“<em><strong>Minimum Supply Targetstrong>em>”). In addition to the Minimum Supply Target for the Target Countries, the Recipient will make best efforts to ensure that the Health Products are available in sufficient quantities to meet the demands of the Public Sector in all LMICs which are not Target Countries;p>
<p style=”padding–left: 25px;”>(iii) “<strong>QA Commitmentstrong>” – the Health Products will be developed in accordance with appropriate quality standards and, when appropriate, approval will be obtained from the US FDA and/or another <a href=”#kt“>Stringent Regulatory Authoritya> or WHO Listed Regulatory Authority; andp>
<p style=”padding–left: 25px;”>(iv) “<strong>Registration Commitmentstrong>” – the Health Products will be registered for commercial use, if, as and where required, in the Target Countries in accordance with a timeline to be agreed between Unitaid and the Recipient (“<em><strong>Registration Timelinestrong>em>”).p>
<p>The Recipient will ensure that it secures appropriate commitments from all Commercialisation Partners and includes appropriate terms and conditions in all Commercialisation Agreements in order to ensure compliance with the Access Commitments. Such commitments, terms and conditions will require that Commercialisation Partners (as relevant and appropriate): (i) legally commit to and comply with the Access Commitments; and (ii) agree that compliance with the Access Commitments will be subject to audit by an independent firm of accountants at any time. The result of the audit will be binding, and such Commercialisation Partner should agree to implement any adjustments which are necessary as a result of the audit.p>
<p>The commitments set out in this Section 3 (Access to Health Products) will remain in force and effect for a period of ten (10) years from the date of first commercialisation of the Health Products in the Target Countries (“<em><strong>Access Enforceability Periodstrong>em>”). The Recipient will ensure that the terms and conditions included within Commercialisation Agreements will remain in force and effect for an identical period.p>
