MAPGuideⓇ
Equitable Access Toolkit
Approaches to Affordable Pricing Commitments in Funding Agreements
Product pricing is a complex topic requiring consideration of the market dynamics and incentives specific to the product, for example the level of competition, the price at which manufacturing is sustainable, expected supply volumes, and the availability of advance purchase commitments. This commentary focuses on the provisions in funding agreements that can be used to support the achievement of an affordable price for subsequent procurement agreements, but it is not intended to provide a comprehensive assessment of the complexities of pricing negotiations or the potential impact of national laws and regulations on product pricing.
As illustrated below, funding agreement provisions intended to support affordability can take a number of different forms. The available options are not always mutually exclusive, but their suitability can depend on the context of a specific agreement. In addition to agreement context, it is important that funders take into account likely procurement pathways and the affordability requirements of the likely purchasers of the end product. These considerations can be supported through the development of access roadmaps.
1. Fixed pricing obligations
Fixed pricing obligations are those that set a specific price threshold, for example a maximum absolute price cap, a maximum percentage mark-up over the cost of goods (“COGS”) (also referred to as “cost plus” or “COGS+”), an obligation to sell a product at no profit, or a combination of a COGS-based formula with a “not to exceed” price. Fixed pricing provisions may also require funded developers or manufacturers to match the price of comparable products, or apply tiered pricing frameworks. Some considerations for the application of these different approaches are set out below:
Price caps
The feasibility of using price cap provisions is dependent on the context of the agreement. This approach is more likely to be acceptable to the funded partner if the expected cost of manufacturing the product is already known; it is therefore unlikely to be appropriate for agreements funding early stage research and development. An example of a context in which a price cap might be applied is an agreement for development of a substitutable medical product (for example, generic drugs), for which reference prices are available.
There are a number of potential challenges associated with the use of a specified price cap in a funding agreement. For example:
- A funded partner may interpret a “maximum” price as “the” price at which it is required to supply the product, even if it is actually able to sustain a lower price. Lower pricing may particularly be possible over time as manufacturing efficiencies and economies of scale are achieved.
- Agreements that require specified prices will need expert legal review to consider potential conflicts with applicable competition laws.
- A maximum price to be charged to a procurement agency does not guarantee the final price to a patient or end user of a product. For example, freight and distribution costs, as well as ongoing service and maintenance requirements for diagnostics and devices, can add significant extra costs for end users.
- Maximum prices need to be sustainable. The caps set in funding agreement provisions therefore need to align with both the prices that purchasers are willing and able to pay, and the minimum margin needed for the funded partner to be willing and able to continue supplying the product.
Cost plus and no profit/no loss pricing
Cost plus and no profit/no loss pricing provisions are often used in funding agreements as a mechanism for balancing affordability and sustainability. These provisions can potentially be used in a broader range of agreements than price caps as they do not require knowledge of final COGS or a reference price. However, the success of these pricing frameworks is dependent on the COGS achieved and does not guarantee that the price of the product will be affordable for the intended purchasers.
COGS-based pricing requirements need to be supported by a number of related provisions and definitions, including:
- A definition stating the types of cost to be included in the calculation of COGS or manufacturing costs that will form the basis of the agreed product price. COGS definitions are sometimes tied to accounting principles (for example, “as calculated under U.S. GAAP”), but other agreements separately list the cost categories that may be included in the COGS calculations as accounting standards may not address all of the considerations relevant to the specific goals of affordability and appropriate returns to support sustainability. Further details are set out in the Gates Foundation’s Production Economics for Vaccines handbook.
- A requirement for the developer to make efforts to minimize COGs and be as cost efficient as possible. Without such a provision, a developer may lack an incentive to reduce their cost base over time and pass through efficiencies in its product pricing.
- Reporting requirements to provide a funder with sufficient information to assess the likely impact of anticipated COGS on affordability and the funded partner’s efforts to reduce COGS.
- Audit rights that enable a funder to verify that the final price of the product has been calculated in accordance with the agreement. COGS calculations are complex and commercially sensitive, and funders should periodically exercise their audit rights, either on their own or using an independent auditor, to verify that the developer’s calculations are in line with their expectations.
Examples from the MAPGuide
Price caps
[Developer] will ensure that it or its manufacturing and/or commercial partner(s) sell the Product: (i) at a maximum price of USD XXX (XXX United States dollars) per Test Unit (based on EXW) and a maximum price of USD XXX (XXX United States dollars) per Instrument Unit, which shall apply to Eligible Purchasers (collectively, the “Affordable Price”) in the Territory. […] The Affordable Price does not include (i) freight and insurance charges to the country destination from the XYZ site of shipment; nor (ii) import duties into the final destination country. Regarding the freight charges, XYZ shall negotiate directly with the purchaser a mutually agreed cost, retaining at all times the requirement to minimise such a cost, in accordance with Global Access requirements.
Related definitions:
- “Ex Works” or “EXW” shall have the meaning under INCOTERMS 2020 and shall be based on [Developer] COGs.
- “COGS” or “Manufacturing Cost of Goods Sold” means all of the direct costs such as labor, material, and allocated overhead costs in a Product manufacture as detailed in Schedule [x] “Cost Analysis”, and excluding research and development costs, sales and marketing costs, as well as selling, general, and administrative expenses.
Source: taken from sample terms and conditions for FIND project investment agreements. Partner types: PDP, industry; Product type: diagnostics; Development stage at signature: project-dependent. Read in context.
The Company will make available in Developing Countries all Products developed and commercialized pursuant to a Project (i) at or below the price set forth in the applicable TPP and (ii) in quantities meeting or exceeding those set forth in the applicable statement of work (or other applicable global access agreements between the [Funder] and the Company), provided that if the Fully Loaded Costs exceed the price set forth in the applicable TPP then the Company will make such Product available at the Fully Loaded Costs, unless the parties mutually agree otherwise.
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and BioNTech (Developer) signed in relation to a USD $55 million investment in BioNtech by the Foundation. Partner types: philanthropic funder, industry; Product type: products for the prevention or treatment of TB and HIV; Development stage at signature: preclinical. Read in context.
Upon WHOPQ, and in compliance with applicable laws and regulations, [Developer] will offer and provide to Public Sector Purchasers the Aggregate Minimum Supply at the Annual Minimum Supply (as set forth in section [x]) of the Released Product for Maternal Immunization in the Developing Countries at a maximum price as reflected in Table A:
TABLE A
“Price Commitment” is equal to the [**] Costs (as adjusted from time to time under this section [x]) plus [**] mark-up but provided always that such price does not exceed: [**] per Dose (USD) herein after the “[**]”
The Parties acknowledge and agree that (1) the [**] described in Table A above is based on principle assumptions about [Developer] future manufacturing efficiencies at the time of WHOPQ as set forth on Appendix C attached hereto and incorporated by reference herein, and (2) to the extent that actual results differ from such Appendix C principal assumptions, then the Parties shall take such factors causing differing results into account and will thereafter adjust such [**] pursuant to Section [x].
Notwithstanding Table A, within three (3) months prior to the estimated date for WHOPQ, and unless otherwise agreed by the Parties, at every third anniversary thereafter, coinciding with UNICEF tenders, the Parties shall, in good faith, discuss applicable adjustments to the Price Commitment (whether upwards or downwards) to proportionately, fairly, and reasonably reflect the factors set forth in Appendix C, including the impact on such factors caused by external or internal circumstances, including inflation, currency fluctuations, efficiencies of scale, product demand and yield improvements. […]
Notwithstanding section [x] above, in the event that [Developer] sells Released Product for Maternal Immunization to a Public Sector Purchaser in any country (whether a Developing Country or a Developed County) at a lower than the Price Commitment in subsection [x] above, [Developer] will promptly offer such Released Product for sale at such lower price to any Developing Countries in which the sale, use or marketing of Released Product is authorized by WHOPQ or applicable country registrations. [Developer] will promptly notify the [Funder] of any price decrease of the Released Product for Maternal Immunization.
Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.
Cost plus and no profit/no loss pricing
The [Developer] shall make [products] available to non-profit organizations and public-sector purchasers in Target Countries (“Global Health Purchasers”) at a price of no more than 30% above the [Developer]’s COGS, in Low-Income Countries and in Low-Middle-Income Countries, if approved by the Global Access Committee […]
Related definitions: “Global Access Committee” refers to a joint steering committee to oversee the [Developer]’s efforts in Target Countries. The Global Access Committee shall be comprised of up to four (4) members: (i) one individual appointed by the [Developer]; (ii) one individual appointed by the Investor (the “AXA IM Prime Impact Fund Appointee”); and (iii) up to two additional individuals unaffiliated with the [Developer] or the Investor, and appointed upon mutual agreement of the [Developer] and the Investor.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.
COGS +25% cap with tiered pricing framework: The Company shall use its reasonably diligent endeavors to make the Global Access Products accessible to most people in need in the Target Countries, to the extent such access can be achieved on terms that are commercially reasonable for the Company. For the avoidance of doubt, the Company agrees that the maximum price of Global Access Products in the Target Countries will be capped at cost of sales plus 25%. In no event shall the Company be obligated to sell the Global Access Products at a loss.
[…]
The Company shall make the Global Access Products available to both public and private purchasers in the Target Countries at a reasonable volume that is sufficient to meet the demands of non-profit organization and public-sector purchasers in accordance with a tiered pricing framework that is commercially reasonable for the Company, in the opinion of the Company and Adjuvant, acting reasonably, and that reflects the needs, including price sensitivity, of low-income patients in the Target Countries. The tiered pricing framework shall include pricing based on the type of buyer (public or private) and the geographic location of such buyer.
Source: taken from a global health agreement between Adjuvant Global Health Technology Fund (Funder) and AN2 Therapeutics (Developer) signed in connection with a USD $7 million share purchase by Adjvant. Partner types: impact investor, industry; Product type: melioidosis and tuberculosis therapeutic (Epetraborole); Development stage at signature: preclinical. Read in context.
During the Commitment Period, the Company will supply the [product] to Purchasers at a price not to exceed COGS plus ten percent (10%).
Source: taken from a letter agreement between the Gates Foundation (Funder) and Amyris (Developer) signed in connection with a USD $5 million stock purchase by the Gates Foundation. Partner types: philanthropic funder, industry; Product type: input material for malaria therapeutics (artemisinic acid and amorphadiene for use in artemisinin-based combination therapies (ACTs)); Development stage at signature: licensed product. Read in context.
2. “Soft” pricing obligations
A soft pricing obligation is one that requires a product developer to make best or reasonable efforts to achieve an affordable price for the final product, but without setting any specific parameters on what this price should be. Funding agreements often include soft pricing obligations that recognize the need for a price that is both affordable for the populations in need of a product and commercially sustainable for the developer in order to promote long-term and widespread access to the product. Soft pricing obligations may also require funded developers to apply tiered pricing frameworks or supply the funded product to certain purchasers at a preferential price.
The nature of soft pricing obligations means that they are more straightforward for an early-stage developer to pass through in future partnering agreements for later-stage development and/or commercialization of a funded product. However, without a quantified expected price or clear standard for determining what is “affordable”, these obligations are subjective, which means they could be difficult to enforce in the event of a dispute.
One approach to affordable pricing that funders can consider, particularly when funding early stage development, is to include a high level affordable pricing provision funding agreements along with a requirement to develop more detailed pricing commitments when certain stages of product development are reached. These more detailed commitments can be documented in an evolving access plan that is annexed to the funding agreement.
Examples from the MAPGuide
[Funder] is committed to achieving equitable access to the results of all [Funder]-supported programmes pursuant to the “Equitable Access Policy” referenced in [Funder’s] Third Party Code. Equitable Access means that a Project Vaccine is available first to populations at risk when and where they are needed at affordable prices. For clarity, it is [Funder’s] intention that the price of a Project Vaccine shall be commercially sustainable to the manufacturer. […] The Parties acknowledge that the price of the Project Vaccine is critical to achieving Equitable Access during the Pandemic Period. Accordingly, [Developer] agrees that its pricing shall be reasonable to achieve Equitable Access for populations in need of a Project Vaccine as well as an appropriate return on investment for vaccine manufacturers that make on-going supply commercially sustainable. The Parties acknowledge that the availability of pandemic insurance […] shall be a relevant cost factor in Equitable Access. For clarity, the purchase of Project Vaccine by the Global Allocation Body or by any other purchasing agent(s) designated by [Funder] shall be considered to have satisfied the pricing requirements for Equitable Access.
Source: taken from a development funding agreement for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase I clinical trials. Read in context.
[T]he 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 (“Affordable Price”). 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.
Source: taken from the sample terms and conditions for Unitaid (Funder) funding for Recipients (Developer) under the UnitaidExplore program. Partner types: non-profit funder, industry; Product type: innovations with transformative potential for public health in LMICs; Development stage at signature: multiple. Read in context.
The price of Product for Distribution Through the Public Sector in Malaria-Endemic Countries should be affordable within the context of similar anti-malarial medicines that are registered in those countries for the same sector, and preferential compared to the price for Distribution Through the Private Sector, it being understood that [Funder] does not expect the term “affordable” to mean that the price for Distribution Through the Public Sector be lower than COGS plus cost of delivery.
Source: an extract of language used in MMV (PDP) development agreements. Partner types: PDP, industry; Product type: malaria therapeutics; Development stage at signature: early- through late-stage development.
[Funder] is committed to achieving equitable access to the outputs of all [Funder]-supported programmes, including access to all applicable Project Results in accordance with this Agreement, pursuant to [Funder]’s “Equitable Access” Policy. Equitable Access to [disease] vaccines means the regular supply of the Product(s) to public health systems in all Non-Traveler’s Market Countries that have a demand for the vaccines at an affordable price (as outlined in Clause [x]) and, in the context of an Outbreak or Increased Outbreak Preparation Need means that appropriate vaccines are first available to populations in the Affected Territory when and where they are needed, including to end an Outbreak or curtail an epidemic, regardless of ability to pay. Consistent with [Funder]’s Equitable Access Policy, [Funder] is also committed to supporting Equitable Access so that the economics are sustainable to the manufacturer.
The initial plan to support such Equitable Access commitment is set out in Annex E (the “Equitable Access Plan”); and the Equitable Access Plan shall be reviewed by the JMAG and/or the Equitable Access Group after it is established in accordance with Clause [x] no less than every [***] and shall take into account, as applicable, changes in COGs over time, production yield and volume and production economics. The Equitable Access Plan shall be updated throughout the Term to reflect such reviews or as otherwise agreed between the Parties. A significantly more detailed Equitable Access Plan shall be agreed promptly after the Equitable Access Group is established. Each Partner will keep [Funder] fully and regularly informed of its adherence to the Equitable Access Plan and its progress, or lack thereof, in meeting its objectives.
Source: taken from a USD $38.4 million funding agreement between CEPI (Funder) and the University of Oxford and Barinthus Biotherapeutics (Developers). Partner types: non-profit funder, industry/academic institution; Product type: MERS vaccine; Development stage at signature: early stage development. Read in context.
3. “Indirect” obligations
A number of other provisions can be included in funding agreements in parallel with fixed and/or soft pricing obligations to support the achievement of an affordable price and ensure that the commercial value that a developer derives from a funded product is equitably shared. These provisions include:
Alternative manufacturers
Affordable pricing obligations can be supported by a requirement to conduct a technology transfer to a regional manufacturer who can manufacture the product at a lower cost. This requirement could be triggered either when a certain milestone is reached (e.g. first regulatory approval, or entering a certain clinical trial stage), or only if the developer is unable to manufacture and supply the product at an affordable price itself.
This approach can be complemented by programs that establish connections with, and provide capacity strengthening investment for, a network of potential alternative manufacturers that would be willing and able to deliver the product at an affordable price. The use of access roadmaps can support the coordination of such programs with relevant stakeholders.
Benefits sharing
While not having a direct impact on the product price, a requirement for funded partners to share a portion of any commercial benefits generated from funded products, technologies, or projects can extend the public benefit impact of public or philanthropic funding. These requirements may be a higher negotiating priority for funders when there are clear pathways for a funded partner to generate substantial commercial returns, for example through sales of the funded product or derivative products in high income markets, or award of a priority review voucher.
Commercial benefits sharing provisions may provide for returns to be made directly back to the funder or to another non-profit cause in the form of cash payments (for example milestone payments, or a revenue sharing agreement) or in-kind contributions (for example, product donations or time commitments for a developer’s employees to support a different project).
Funding agreements may include detailed benefit sharing mechanisms in circumstances where there is reasonable certainty over when and how commercial returns may be generated. Alternatively, agreements may provide for good faith negotiation of how benefits will be shared if and when they arise.
Examples from the MAPGuide
Alternative Manufacturers
If the [Funder] determines, in consultation with the Progress Review Group, […] that working with a third–party manufacturer (“TPM”) is reasonably necessary to achieve the price and volume commitments described below, the [Developer] will agree to license and transfer the necessary technology and other intellectual property to such TPM (subject to such TPM entering into reasonable agreements with the [Developer] with respect to confidentiality and use of the technology and licenses solely for the purposes contemplated herein) in order to allow the production of Products for the Developing Countries. The [Funder] will be responsible for the reasonable costs payable for the license and technology transfer of the necessary intellectual property to such TPM.
Source: taken from a strategic relationship agreement between the Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb (staphylococcus aureus); Development stage at signature: discovery. Read in context.
If the [Developer] 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 [Developer] 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 [Developer] to third parties who may be of assistance in the establishment of a secondary manufacturing facility, (c) audit the [Developer’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 [x].
Source: taken from an anonymised product development funding agreement. Read in context.
To facilitate achievement of the [equitable access] conditions set out in Clauses [x], [Developer] has agreed to transfer its technology to an LMIC manufacturer […] [Developer] will, within [***] of the signature date of this Agreement, […], sign a Sub-Awardee agreement with an LMIC manufacturer, which […] shall obligate such LMIC manufacturer to manufacture the Product for regular supply in all Non-Traveler’s Market Countries that have a demand for Product and to supply the Product to Non-Traveler’s Market Countries under the conditions of [affordable price clause]. Prior to signing such Sub-Awardee agreement with an LMIC manufacturer and prior to completion of technology transfer to enable such LMIC manufacturer to manufacture and supply the Product to Non-Traveler’s Market Countries, [Developer] shall fulfill manufacturing and supply obligations for Non-Traveler’s Market Countries as set out in the IPDP [integrated product development plan].
Source: taken from a USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context. The requirement for an LMIC manufacturer was subsequently met through the signature of an agreement with Instituto Butantan.
Benefits sharing
The Parties shall agree in good faith how such Commercial Benefits (if any) are to be managed in a fair, equitable and proportionate manner, taking account the financial contribution of each of the Parties to the Background Technology and Project Technology being exploited, the public and philanthropic nature of the [Funder] funding, any other non-repayable public or philanthropic financial contribution to the foregoing, the public benefit derived from the Commercial Use, and any private or ancillary benefit that may arise. The Parties shall execute a separate agreement implementing their good faith agreement on how such Commercial Benefits are to be managed in a fair, equitable and proportionate manner as of the Effective Date of this Agreement. For the avoidance of doubt, Commercial Benefits generated outside the Field and […] will not be shared between the Parties.
Related definitions: “Commercial Benefits” means any economically quantifiable benefits that arise from the commercial exploitation of the Project Results other than in preparation for or in response to an Outbreak or Increased Outbreak Preparation Need. Examples of Commercial Benefits include the commercial licensing of Project IP, receipt of government-granted incentives such as Priority Review Vouchers and revenue from the commercialization of combination, derivative or follow-on products (including antibody products, assays and vaccines) or application of production technology.
Source: taken from a USD $34 million funding agreement between CEPI (Funder) and CureVac (Developer). Partner types: philanthropic funder, industry; Product type: mRNA platform technology; Development stage at signature: preclinical. Read in context.
[Commercial partner] shall pay to [Funder] the following percentage of each of Net Sales and Net Income received during the Royalty Term: [***]
[Commercial partner] shall pay [Funder] the following percentages of Net Revenue: [***].
[Commercial partner] shall pay to [Funder] [***] of any PRV Proceeds received during the Royalty Term.
[…]
If any Net Income or Net Revenue is received as non-cash consideration, [Commercial partner] shall, at [Commercial partner]’s discretion, either: (i) transfer a percentage of such non cash consideration into the name of [Funder] to satisfy [Commercial partner]’s obligation under Clause [x]; or (ii) transfer cash to [Funder] calculated based on applying the applicable percentage set out in Clause [x] to the cash value of such Net Income or Net Revenue at the time such non-cash consideration was received by [Commercial partner], with either Party having the right to refer the determination of the cash value of such non-cash consideration to a mutually agreed independent expert for determination if the Parties do not agree on such cash value.
[Academic partner] will promptly notify [Funder] of any Commercial Benefits it receives. Promptly after receipt of such notification, [Academic partner] and [Funder] shall enter into a revenue share agreement detailing the share of Commercial Benefits that will be allocated to [Funder].
The share of Commercial Benefits received by [Funder] shall be proportionate to the added value of [Funder]’s funding under this Agreement, taking into account all relevant factors, including the amount of funding by [Funder] and the results of such funding. Without prejudice to the foregoing, [Funder] does not require a share of Commercial Benefits received from the exploitation of the Project Results for the benefit of LMICs, including technology transfer to manufacturers or service providers who are engaged specifically to assist in making vaccines available to LMICs.
Related definitions: “Commercial Benefits” means any economically quantifiable benefits that arise from: (i) the exploitation of the Project Vaccine, or (ii) the exploitation of the Project Intellectual Property or Project Results.
Source: taken from a USD $34.8 million funding agreement between CEPI (funder) and the University of Oxford (academic partner) and Barinthus Biotherapeutics (commercial partner). Partner types: non-profit funder, industry/academic institution; Product type: MERS vaccine; Development stage at signature: early stage development. Read in context.
[Funder] has agreed the following revenue sharing scheme which applies to all Grant Terms and Conditions of Funding:
Cumulative income £0 – £100k
- Maximum translation fee: 10%
- Remaining net amount: 90%
- Remaining distribution: 50% host institution; 50% [Funder]
Cumulative income £100k +
- Maximum translation fee: 5%
- Remaining net amount: 95%
- Remaining distribution: 50% host institution; 50% [Funder]
[Funder] expects that these recommendations form the basis for negotiations around any potential revenue sharing agreements because of IP exploitation. It is anticipated that any organisation that has been responsible for the exploitation (e.g. the TTO) will deduct the direct costs that have been incurred as a result of the exploitation e.g. patent costs or proof-of-concept funds ahead of the distribution. […]
Source: taken from the standard grant terms and conditions for GOSH Charity (Funder). Read in context. Partner types: philanthropic funder, academic institution, non-profit research institution; Product type: products for prevention, diagnosis, prognosis, or treatment of rare or complex paediatric diseases; Development stage at signature: early stage R&D. Read in context.
What are the opportunities for refining the pricing commitments as product development progresses?
To which markets and product indications do pricing commitments apply? Are the pricing requirements restricted to a certain period of time?
What are the requirements to make the product available for purchase for use in the relevant markets?
How can a funder verify compliance with pricing commitments?
What happens if the funded partner does not or cannot comply with its pricing commitments?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.