Provision Language
Definitions
“Affordable Price” means the maximum price at which a Final Product may be offered for sale in the Territory, reflective of the lowest, sustainable, competitive price level for a Final Product, to be agreed upon between Unitaid and UW in accordance with the terms of the Unitaid Agreement and notified by UW to MPP as soon as reasonably possible.
“Minimum Supply Targets” means any targets agreed between Unitaid and UW in accordance with the terms of the Unitaid Agreement in relation to minimum production capacity, minimum annual production volumes, maximum order lead time for delivery and/or minimum order quantity for a Final Product, each for the benefit of the Public Sector in the Territory.
Background
I. MPP is a non– profit organisation with a mission to improve the health of people living in the developing world by increasing access to quality, safe, efficacious and affordable medicines by facilitating access to intellectual property on those medicines.
II. UW is the exclusive holder of rights to long–acting injectable technologies (“LAI”) which may provide efficacious exposure to drugs relevant to the human immunodeficiency virus (“HIV”) for an extended period of time, and therefore may help reduce the associated costs of treatment and improve adherence and retention in care. Under agreement with Unitaid (the “Unitaid Agreement”), UW is obligated to license this technology to MPP in order to maximise impact and to reach as many people living with HIV as possible. Both Parties acknowledge that the key objective of this Agreement is to ensure that Licensed Products are made widely available as quickly as possible and on a continuing basis, at an affordable and sustainable price, to the Public Sector of Low– and Middle–Income countries and in sufficient quantities to meet the needs of those countries (the “Access Objective”). UW acknowledges that in High Income Countries (“HICs”), access to drugs in low income groups can also be a challenge and UW’s licensing strategy for HICs aims to be socially responsible.
III. The rights afforded under this Agreement will allow MPP to enter into sub–licensing agreements with third parties, such as funders, product development partnerships, and pharmaceutical manufacturers and distributors to develop and manufacture long–acting formulations of specified pharmaceutical products for public health purposes under the rights described in this Agreement.
IV. The intent of this Agreement is to provide access to Licensed Technology, and not to create any non–intellectual property–related barriers.
3. Right To Sub–License To MPP Licensees
3.1. MPP may grant sub–licences and may disclose to MPP Licensees only such of the Confidential Information as is necessary for the exercise of the rights sub–licensed, subject in each case to the following conditions: […]
3.1.3. MPP will not enter into Development Agreements or Commercialisation Agreements for Licensed Products prior to agreement between UW and Unitaid on the Specific Access Commitments for such Licensed Products[.]
3.2 MPP agrees to monitor compliance of each MPP Licensee. Such monitoring shall include:
3.2.1 reviewing with all reasonable skill and care any reports provided to MPP by the MPP Licensee under the relevant sections of the Sub–Licence Agreement;
3.2.2 fully exercising the audit right set out in the Sub–Licence Agreement(s) as soon as MPP has reasonable cause to believe (or as soon as UW and MPP have agreed that they have reasonable cause to believe) an audit is necessary.
3.3 If MPP becomes aware of any act or omission of an MPP Licensee which constitutes a breach of the relevant Sub–Licence Agreement, then MPP shall notify UW immediately and (i) if the breach is capable of correction and does not give rise to an immediate right of termination under the Sub–Licence Agreement, direct the relevant MPP Licensee in writing to cure the breach, with a simultaneous copy of that writing to UW; and (ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the Sub–Licence Agreement, and in each case if so requested by UW, procure the termination of the relevant Sub–Licence Agreement in accordance with its terms.
Schedule 4: Commercialisation Agreement Term Sheet
2. Access Commitments: Commercialisation Partner will ensure that Licensed Products are made available in accordance with the following specific access commitments (the “Specific Access Commitments”):
a. Price Commitment: the Licensed Products will be made available to the Public Sector and in the Private Sector in the Territory at a price which is no more than the Affordable Price.
b. Purchase by Public Sector: Commercialisation Partner shall make best efforts to ensure that the Final Product can be purchased by the Public Sector in the Territory through relevant governmental or international procurement mechanisms including, without limitation, Global Fund, PEPFAR and the Global Drug Facility (“GDF”). The said efforts shall include without limitation responding to tenders launched by such procurement mechanisms.
c. Supply Commitment: the Licensed Products will be made available in a timely manner and in sufficient quantities to meet the needs of the Public Sector in the Territory, including in accordance with any Minimum Supply Targets, and shall prioritise delivery of firm orders from the Public Sector over firm orders from the Private Sector.
d. Registration Commitment: the Licensed Products will be registered in certain priority countries as designated by MPP, upon agreement with Unitaid to determine the registration plan and timeline.
e. QA Commitment: the Licensed Products will be developed in accordance with appropriate quality standards and Commercialisation Partners will seek approval or a positive recommendation for Licensed Products from the WHO Prequalification Programme (PQ), Global Fund/Unitaid Expert Review Panel (ERP), US FDA and/or another WHO Listed Regulatory Authority as agreed between MPP and the Commercialisation Partner.
3. Manufacturing Commitment: Commercialisation Partner will make commercially reasonable efforts to manufacture Licensed Products at the lowest possible cost and will pass on any significant reduction in the production and distribution costs of the Licensed Products to the benefit of the sale price offered to both the Public Sector and the Private Sector.
11. Reporting: Within 10 business days following the end of each calendar quarter, Commercialisation Partner will be required to provide MPP and UW with a quarterly written report setting forth in relation to that quarter (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product and (e) the Licensed Products (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under the Commercialisation Agreement during such agreement quarter, on a country–by–country basis; (f) any scientific discoveries or Know–how developed related to the Licensed Technology. MPP and Licensee will agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. MPP will agree that information contained in quarterly and other such reports shall be treated as confidential; provided, however, that such information may be shared with UW and Unitaid; and that aggregated data may be publicly disclosed by MPP.
12. Audit: Commercialisation Partner will permit MPP and UW, individually or together, through a certified public accountant to: (i) inspect and audit the performance of, and compliance with, the Commercialisation Agreement and the applicable laws; and (ii) inspect and audit all documents and other records relating to the performance of the Commercialisation Agreement. Commercialisation Partner will cooperate with and provide all reasonable assistance to MPP or UW. MPP or UW will provide Commercialisation Partner with a commercially reasonable period of notice of the proposed audit. MPP and UW, each individually, agree that such audits will not be conducted more than once in any 12–month period, unless the prior audit has shown evidence of the failure of Licensee to perform in compliance with the Commercialisation Agreement or applicable laws. If any audit reveals a discrepancy of more than 5% to the detriment of UW and/or MPP, Commercialisation Partner will reimburse MPP or UW for the cost of that audit. The result of the audit will be binding, and in the event that the audit reveals a failure to comply with the Price Commitment, the Commercialisation Partner will implement any adjustment to the Affordable Price deemed required by MPP or UW as a result of the audit.