“Affected Territory” means the geographic area of any country (i) where there is an Outbreak or (ii) for which there is an Increased Outbreak Preparation Need or (iii) the Parties otherwise agree in writing and in each case, including healthcare workers providing healthcare in such a country regardless of their home country.
“Field” means the disease area relevant for the project.
“Increased Outbreak Preparation Need” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates in the Field, Funder determines, in its sole discretion, that there is a heightened need for the Product;
“Market” means, in relation to a Product, importing, exporting, marketing, selling, promoting, distributing or otherwise utilising or commercially exploiting the Product or licensing the right to do so or offering to do the any of the foregoing as well as any variations, licenses, or post-marketing obligations pursuant thereto.
8. Access to and Supply of Product
8.1 Funder Policy. Partner acknowledges and understands the Funder Equitable Access Policy and agrees to comply with such policy as it applies to the Product. In accordance with that policy, Partner shall provide the following then current information to Funder in accordance with Clause 3.5.2 (Agreeing Work Phase Statement):
8.1.1 Progress report on the scale-up of the Manufacturing process to fulfil the requirement of an Approved Regulatory Authority for the grant of Marketing Approval for the Product or plans to do that same and a good faith estimate of the number of doses of Product such scaled-up Manufacturing process will be capable of producing in each year of manufacture and by when such volume will be achieved; and
8.1.2 A good faith estimate of Cost of Goods for the Product for (i) the Investigational Stockpile and (ii) additional doses of the Product together with any information that would impact the cost of the Product.
8.2 Volume. If the Partner has not developed a Manufacturing process for the Product which meets the estimated capabilities disclosed under Clause 8.1 by [date], (i) the Partner shall provide Funder with full details of the obstacles to meeting such requirement and all related Data within ten (10) Business Days after such date; (ii) Funder may at its sole discretion (i) grant an extension of time and require the Partner to consult with experts in the field approved by Funder or (b) exercise its step-in rights under Clause 9.
8.3 Cost of Goods. If the Partner has not developed a Manufacturing process for the Product which will maintain the Cost of Goods for the Product at a level Public Service Agencies agree is affordable for use in the Affected Territories by [date], (i) the Partner shall provide Funder with the Cost of Goods and supporting Data and (ii) Funder may in its sole discretion, (a) participate in the negotiations with the Public Services Agency(ies), (b) facilitate introductions for the Partner to third parties who may be of assistance in the establishment of a secondary manufacturing facility, (c) audit the Partner’s Cost of Goods (and may use a reputable accounting firm to do so in its behalf), or (d) exercise its step-in rights under Clause 9.
8.4 Access to Product.
8.4.1 Within [timing] the Partner shall deliver to Funder a Marketing Plan which will describe the Partner’s planned activities to make the Product available for stockpile in accordance with the definition of “Market” or otherwise in preparation for an Outbreak or Increased Outbreak Preparation Need.
8.4.2 Partner shall ensure that the first [w%] of doses of Product Manufactured in the first [v] years after scale-up shall be provided as directed in writing by Funder in accordance with the Funder Equitable Access Policy.
8.5 Updates to Marketing Plan. The Partner shall review and, where appropriate, update the marketing plan at least once every calendar year and will deliver to Funder, not less than one (1) month prior to the commencement date of the revised marketing plan, the revised marketing plan together with an update on the implementation of the marketing plan.