Provision Language
Definitions
“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.
“GHSI” means the Global Health Security Initiative, an informal, international partnership among like–minded countries to strengthen health preparedness and response globally to threats of biological, chemical, radio–nuclear terrorism (CBRN) and pandemic influenza.
“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.
“Investigational Stockpile” means a quantity of doses of the Product adequate for the planned Clinical Trials in the Development Plan or as described in a Work Phase Statement which is manufactured and stored according to GMP, where the Product has been approved for use in clinical trials in humans, which has not received Marketing Approval.
“Pivotal Trial” means a pivotal human clinical trial in any country the results of which could be used or is intended to be used to establish safety and efficacy of a Product sufficient to provide the basis for an application for a Marketing Approval submitted to the European Medicines Agency, or any successor authority, or other Approved Regulatory Authority.
“Secondary Manufacturer” means a manufacturer capable of Manufacturing the Product and regulated by and meeting the standards of either (i) an Approved Regulatory Authority or (ii) another Regulatory Authority acceptable to FUNDER in its sole discretion.
Whereas:
FUNDER is a public–private not–for–profit organization including civil and philanthropic organisations formed to:
i. fund, co–fund, co–ordinate and support the development of new vaccines with chosen partners to prevent and contain infectious disease epidemics;
ii. work with its partners and relevant agencies to ensure the vaccines developed are provided to all populations who need them on an equitable basis;
iii. work with its partners and relevant agencies to ensure adequate stockpiles and manufacturing capacity of vaccines developed for epidemic situations;
((i), (ii) and (iii) together, the “FUNDER Mission”).
2. Partnering and Collaboration
[…]
2.2 FUNDER Mission. Both Parties acknowledge and agree that:
2.2.1. they are entering into this Agreement with the intention to further the FUNDER Mission by developing a vaccine for a disease with epidemic potential to address global health concerns;
2.2.2. markets for vaccines with epidemic potential are very unusual in that successful vaccines may never be used and, if they are used, the demand for such vaccines may be erratic, unpredictable and unlikely to be at a sufficient level to allow manufacturers to be able to benefit from larger economies of scale;
2.2.3. the Product is being developed using FUNDER’s public and philanthropic funds and may be a product that would otherwise be uneconomic to develop due to disease epidemiology and other factors; and
2.2.4. the most significant benefits anticipated to arise from this Agreement will be public healthcare benefits. Neither Party is entering into this Agreement in anticipation of receiving significant commercial benefits from the exploitation of the Product in the Affected Territory.
3. Contributions & Work Phases
[…]
3.2. Partner Obligations. The Partner shall:
3.2.1. before an Outbreak, […]
(iii) use its Reasonable Efforts either to establish directly or to enter into an agreement with FUNDER, a Public Sector Agency or another third party, for supply of Product into an Investigational Stockpile before the first subject receives the first dose in a Phase II Clinical Trial and perform the related obligations detailed at Clause 8.4;
6. Development and Regulatory Activities
[…]
6.2 Development Plan. A draft [] Development Plan is attached hereto as Schedule 6. A Development Plan that specifies all the Development activities to be performed in the Development of the Product shall be finalized by the Partner and submitted to the JMAG for its approval within six (6) weeks of the Effective Date. The Development Plan is to be considered by the JMAG at its next meeting after such submission and must be approved by the JMAG as soon thereafter as is reasonable under the circumstances. It is recognised that the Development Plan will need to be amended, expanded, altered and refined over time as more information becomes available and include details relevant to the stage of the Product’s development. The Partner shall update the Development Plan on an ongoing basis to ensure that this remains fit for purpose and proposed amendments to the Development Plan shall be reviewed and approved at the next JMAG meetings. The Development Plan shall set out, where appropriate:
6.2.1. the planned location, volume and capacity of Investigational Stockpiles of the Product and the plans for maintenance and replenishment of such Investigational Stockpiles taking account of any frameworks developed by the Medical Countermeasures Task Force, GHSI or another relevant Public Sector Agency;
6.2.2. resource mobilisation plans for conducting Pivotal Trials of Product in the event of an Outbreak or Increased Outbreak Preparation Need in the Affected Territory taking account of any frameworks developed by the Medical Countermeasures Task Force, GHSI or another relevant Public Sector Agency;
6.2.3. a manufacturing plan clarifying volume and capacity, including any plans to reserve capacity, to produce investigational doses of Product for use in the Field in the event of an Outbreak or Increased Outbreak Preparation Need in the Affected Territory;
6.2.4. details of the Outbreak Response Activities;
6.2.5. plans to engage manufacturing partners and Secondary Manufacturers if required to meet the volume and cost targets set out in Clause 8 , including any plans to reserve capacity, or to mitigate anticipated risks;
6.2.6. plans to engage with Public Sector Agencies including procurement agencies for Investigational Stockpiles;
6.2.7. the strategy to keep the cost of goods of investigational doses of Product as low as possible in line with the methodology to determine pricing obligations set out in FUNDER Equitable Access Policy;
6.2.8. plan for engagement with Regulatory Authorities; and
6.2.9. the strategy to best facilitate timely and sustainable equitable access to the Product in the Affected Territory in the event of an Outbreak or Increased Outbreak Preparation Need.
6.3 Regulatory. Subject to the provisions of Clauses 9 and 15, the Partner shall be responsible for developing the regulatory strategy for the Product for review and approval by the JMAG. Such strategy shall include the strategy with respect to any data, market or other regulatory exclusivity periods that may be applicable to Product in the Affected Territory or a territory served by an Approved Regulatory Agency. The Partner shall use Reasonable Efforts to file for, obtain and maintain IND or a CTA for the Product in both a territory served by an Approved Regulatory Agency and the Affected Territory, and Marketing Approval for the Product in the Field in such countries in the Affected Territory.
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.