Request for Proposal: Market Managers for HIV Prevention and HIV Treatment and Diagnostics Opens: March 16, 2015 Submission Deadline: April 23, 2015 Overview Introduction The Bill & Melinda Gates Foundation (the “Foundation”), through this Request for Proposals (RFP), invites initial proposals (“Concepts”) from qualified organizations (“Applicants”) interested in receiving grant support to take on the role(s) of a Market Manager for HIV Prevention and/or a Market Manager for HIV Treatment and Diagnostics for priority prevention, treatment and diagnostic products; and to facilitate the launch and sustained uptake of these products to reach those most in need in high-burden countries. From the submitted Concepts, one or more Applicants will be invited to submit a full proposal, a small number of which will be competitively selected to receive a final grant award. Background The uptake and coverage rates of prevention, treatment and diagnostic products for HIV are part of a broader pattern that has become common in global health. Historically, global health interventions, particularly in developing countries, have seen low and slow uptake despite both technological superiority and burden of disease. In addition to antiretrovirals (ARVs) for HIV treatment, good examples include molecular diagnostic testing for tuberculosis, artemisinin combination therapies (ACTs) for malaria, amoxicillin dispersible tablets for childhood pneumonia, and oral rehydration salts (ORS) for diarrhea—all technically superior products that took more than 15 years to achieve only modest coverage rates. In order to ensure that prevention, diagnosis and treatment products reach developing countries and their citizens, new strategies are needed. Despite significant decreases in the last decade, HIV continues to be one of the leading causes of death worldwide, and that burden has fallen disproportionately on the poor and developing country citizens. Though deaths from HIV/AIDS have declined, over 33 million people today are still living with the disease, and new infections still outpace the number of people getting new access to treatment by 150%. The majority of HIV cases are in the developing world, and in particular among the poorest and most disadvantaged in those countries. There is also a significant population of people living with HIV who are co-infected with other life-altering illnesses, such as tuberculosis and hepatitis. Although effective prevention, testing and treatment options are available for HIV, many people (particularly the poor and developing country citizens) are not getting effective prevention or treatment services. About half of all people diagnosed with HIV do not receive appropriate treatment or do not follow up with treatment once they begin, and nearly two million people are newly infected each year. In addition, many people at risk for contracting HIV do not know their HIV status and do not use sufficient prevention methods, putting both themselves and others at risk. In order to ensure that everyone in need of HIV drugs, or a reliable way to get testing or prevention methods, has access to care, new approaches are needed. HIV is one of the highest priorities for the Foundation. The goal of the Foundation’s HIV strategy is to accelerate the decline of the global burden and incidence of HIV infection by ensuring development and use of impactful prevention and treatment interventions. Defeating HIV requires a multi-faceted approach that includes prevention, diagnosis and treatment, and the development of vaccines and immunologic interventions. The Foundation’s HIV program has a global focus, with efforts concentrated in the poorest countries with the highest burden of HIV, where Foundation resources will likely have the most impact. For HIV prevention, the Foundation’s goal is to ensure the development and efficient use of prevention interventions to maximize the reduction of new infections. For those already infected, the Foundation’s treatment strategy goal is to ensure the development and efficient use of treatment to maximize lives saved, of which testing and linkage to care is a cornerstone. In recent years, HIV control efforts have reduced both the number of deaths and the number of new infections. There have been promising technological advances in both first and second line anti-retroviral (ARV) treatments for HIV, with more under development. There has also been the development of rapid, accurate and low-cost diagnostic tools that Page 1 of 9 © 2014 Bill & Melinda Gates Foundation can be used in low resource settings that have the potential to help HIV-positive people get the care they need faster and reduce transmission. New pipeline prevention technologies, including long-acting injectables, oral preventatives, vaginal inserts and advances in condom technology, will also increase the ability to prevent HIV. However, there are concerns that technological advances alone will not curb the spread of HIV, particularly among the poor and those in developing countries. To date, uptake and coverage rates have not kept up with these advances, resulting in millions of people in developing countries not using preventive measures, unaware of their condition, or on sub-optimal or no treatment for the disease. Rapid tests for diagnosis of infection remain complex and associated with high rates of user errors. For example, point-of-care CD4 tests for HIV diagnosis are available, yet have not achieved high rates of adoption in areas of greatest need. Viral load measurement, necessary for ongoing monitoring of HIV treatment, is still not widely available in many low resource settings. Similarly, despite being the only effective treatment for HIV and having the potential to drastically improve quality of life for HIV-positive people, first- and second-line ARVs are used in little more than half of HIV cases. In particular, East and Southern Africa also still see high rates of HIV transmission because methods (e.g. consistent condom use, reduction in high-risk behaviors such as multiple, concurrent sexual partners, and use of treatment as prevention) for preventing the spread of the disease have not been widely adopted. Lack of coordination, inefficiencies in data collection and information sharing, and a product—rather than portfolio—focus are just a few of the reasons that coverage has not been achieved. The coverage of prevention, diagnostic and treatment products will also need to improve dramatically in order to reach current prevention and treatment targets. Goal The purpose of this RFP is to solicit Concepts from qualified organizations seeking support to take on the role of Market Manager for HIV Prevention and/or HIV Treatment and Diagnostics as a way to accelerate access prevention and care for people with or at risk of contracting or spreading HIV in developing countries. In general terms, a Market Manager is an entity, likely a team within a larger organization, which has responsibility, ability and accountability to plan, coordinate, and execute critical path activities in partnership with manufacturers and other stakeholders in order to drive effective coverage of interventions that will benefit those in developing countries. Market Managers will perform three main functions to drive uptake: coordinate and share market insights and analytics with the Foundation; assist with overall strategy setting; and provide portfolio-level delivery capacity in collaboration with manufacturing partners. The success of any grant made under this RFP will be judged based upon the Market Manager’s success in hitting targets developed together with the Foundation for uptake of products that further the Foundation’s programmatic objectives within a particular therapeutic area. The Foundation is also considering a pay-forperformance scheme that would reward grantees for exceeding coverage targets, and will explore this idea further with any Applicants invited to develop a full proposal. Scope and Approach The Market Manager role is the result of a comprehensive analysis of the root causes leading to the slow introduction and low uptake of many technically superior and critical devices, drugs and diagnostics in the developing world. Slow introduction and low uptake can be caused by many factors, but some of the most common in developing country health markets are inappropriate product design, inefficient launch planning/execution, and reliance on systems that do not rapidly accommodate innovation. Other causes can include technology designs that are not optimized for impact, partners playing outside their strengths/comfort zones, and having different partners engage at different stages of the development process, leading to lack of knowledge transfer. Although there are many symptoms, the root causes are often fundamental inefficiencies for product adoption in resource-limited settings. The following describes potential services or roles where a Market Manager could add value. The actual role of the Market Manager will depend on the specific treatment area, as well as their pipeline and focus countries. Page 2 of 9 Oversight & Coordination (required) – This is the essential role on which other services depend. Potential activities are listed below, but Applicants are strongly encouraged to propose targets based on outcomes/increased coverage rather than inputs/activities. The role described below can also add value for interventions already existing in the market. o Assessing current market state: Coverage/market share of relevant intervention(s); regulatory/registration pathways for pipeline products; global and country policy guidance; assessment of political will and country capacity for implementation in target countries; financial forecasting including both probable commitment of country resources and projections of manufacturing costs; medium-term demand; product pipeline; current and future predicted market prices; and supply capacity; © 2014 Bill & Melinda Gates Foundation o Developing and coordinating delivery activities: Identifies actors (e.g. suppliers, global agencies, implementers, etc.) responsible to drive coverage; works together with stakeholders to clarify roles and responsibilities; coordinates activities across actors; and tracks the progress of various stakeholders against agreed-upon roles and targets; o Tracking and reporting progress: Tracking trends in coverage/use across public and private markets and ensuring provider/user feedback is translated into next generation products; o Troubleshooting: Identifies when activities are off-track or bottlenecks emerge and flexes to address problem - either by managing directly or by assigning responsibility to a better placed actor; o Communications: Being a go-to resource on issue and sharing progress transparently. Go-to-Market Strategic Planning – Planning operational activities to drive roll-out and assign roles/responsibilities to execute (primarily in countries with product adoption) including: o Building evidence to accelerate global and country policy-making decisions; o Identifying first wave countries and building launch plans/operational research/financing strategies/etc. to pave the way; o Ensuring timely registration and inclusion in procurement tenders; o Facilitating an appropriate ecosystem for impact, including ensuring technical guidance in place, training programs are developed and active and stakeholders are prepared to adopt the intervention; etc. o Acting as a commercial partner with product developers – actual service delivery may be implemented by others. Market Research/Insights – Leveraging knowledge from partners across countries (developed via its Market Oversight & Coordination role) to advise product development and design/Target Product Profile (TPP) decisions. Pre-launch Market Testing – The same network aforementioned could also be leveraged to test products with later design lock-in (e.g. diagnostics), brainstorm program designs, and assess acceptability among key opinion leaders/stakeholders/users. Manufacturing Strategy Support – Translating demand forecasts to inform manufacturing strategies. Regulatory Strategy Support – Where there are multiple products being managed by different development partners over time, ensure lessons are transferred from one candidate to the next in pursuing quality assurance. In-country Registration Support – Where either the registration pathway is not clear or the manufacturer lacks interest to register in certain geographies, identify local partners to facilitate registration (as often depends upon local networks). Market Intelligence and Market Dynamics – Monitor global trends in the marketplace to proactively identify challenges in market economics and bring in market dynamic partners to address challenges in pricing, forecasting and supplier capacity. Implementation Knowledge Sharing – Once a product is launched, take lessons and tools from increasing coverage in one country and share with partners in other geographies, as well as across products. Potential Market Manager Roles across Product Development Lifecycle Page 3 of 9 © 2014 Bill & Melinda Gates Foundation The Market Manager is designed to respond to this need for the kind of consolidated oversight and close partnership that can address many of these challenges. Often, delivery strategies are based around products, not portfolios, resulting in duplication, competition and/or lack of coordination among complementary products. This fragments activities among actors and products, rather than facilitating coordination, collaboration and ownership over a portfolio of related products. For example, there is currently a lack of an efficient means to gain insights from different but related products early and use these to inform the design, development and delivery of multiple products. Similarly, both commercialization and deep country expertise are necessary to launch and grow a product in a target geography, but more often than not the responsibility of different stages of product delivery are divided up between different partners, resulting in duplicated effort and loss of valuable knowledge. The Market Manager would ideally provide a single consistent delivery partner across the different stages of product development, ensuring information is updated, shared and of a high quality. While it is important that a Market Manager have some capability in all of the above areas, the needs of different therapeutic areas lend themselves to different capacities required. In the HIV prevention space, the critical gaps appear to be: Coordination and Ownership. The largest need is for a body to serve as both a coordinating mechanism among different stakeholders and as the overall steward of the space, who, in partnership with manufacturers, is able to make the impartial, evidence-based decisions about product development, launch and scale needed to track and achieve the ultimate goal of increased HIV prevention. The Market Manager will not seek to duplicate work that is already being done by manufacturers, commercial partners, or other stakeholders; Coordination and Oversight that will allow manufacturers to share information about product demand and combine and streamline approaches to regulatory processes both globally and in-country, and will also track uptake of key products. In the prevention space, the greatest needs are in the sharing of regulatory and market data among products, as well as target-setting for individual products; Go-to-Strategic Planning to provide specialized late stage product launch and supplier strategy assistance to manufacturing partners, with view into other players’ future demand generation plans. Uptake planning, with a particular a focus on adoption and adherence, is needed for several prevention products that are currently under development, but which will be new product classes and thus require extra support; Scale Up and Coverage Tracking in the medium term at both the global and country level for prevention products that are currently in the market. For HIV prevention, due to the number of technologies in the early in the pipeline, targets will likely need to be highly product-specific. The Foundation plans on working with the Market Manager grantee in the proposal and post-award phases to set these targets for priority products and countries, with the Market Manager in the lead. As per the Response Guidelines below, the Foundation would like Applicants to include ideas on appropriate targets in their Concepts. An illustrative example of the kinds of targets the Foundation would like to see the Market Manager propose is: “Contribute to # of individuals using PrEP effectively: 10K adolescent women in RSA by 2015 and 200K high risk individuals in sub-Saharan Africa by 2019”. In the HIV treatment and diagnostics space, the critical gaps appear to be: Coordination and Ownership. The largest need is for a body to serve as both a coordinating mechanism among different stakeholders. For HIV treatment and diagnostics, in particular, the greatest need is for coordination between the treatment and diagnostics players to ensure that complementary products are optimally launched. The Market Manager will also serve as the overall steward of the space, who is able to work with stakeholders to make the impartial, evidence-based decisions about product development, launch and scale needed to track and achieve the ultimate goal of increased HIV treatment; Coordination and Oversight that will allow manufacturers to share information about product demand and combine and streamline approaches to regulatory processes both globally and in-country. For diagnostics, the biggest opportunities is increasing placement and market data (especially on uptake), and a proactively sharing lessons learned within and across organization(s). Go-to Strategic Planning to provide specialized late stage product launch and supplier strategy assistance, with view into other players’ future demand generation plans. Currently, there are limited or uncoordinated launch or uptake strategies for key diagnostics and drugs, and the size and timing of demand generation is uncertain. The Market Manager could also serve as a resource for trouble-shooting as products face challenges in introduction. Page 4 of 9 © 2014 Bill & Melinda Gates Foundation HIV-TB Integration. There are significant opportunities for HIV and TB linkage, particularly on the diagnostics side. Given the high rates of HIV-TB co-infection in some countries, this could be an area that the Market Manager would explore. The Foundation plans on working with the Market Manager grantee in the proposal and post-award phases to set targets for products that further Foundation programmatic objectives and priority countries, with the Market Manager in the lead. As per the Response Guidelines below, the Foundation would like Applicants to include ideas on appropriate targets in their Concepts. While the focus of the Foundation HIV strategy is global, the greatest short-term gains in treatment coverage will likely be in high burden countries in East and Southern Africa. The HIV team at the Foundation would therefore be the most interested in plans to use the Market Manager to make progress on the following in a few high-burden countries: Median CD4 at initiation % of patients with CD4>200 at initiation % of patients virally suppressed Average cost per patient linked Pre-ART cost per patient year (cost/ppy) ART cost/ ppy 1st line ARV cost/ ppy 2nd line ARV cost/ ppy The Foundation would also be interested in proposals to track indicators similar to the following, even if attributable impact is not measured: Number of HIV tests conducted Number of patients on 1st line ART Number of patients on 2nd line ART Number of VL tests conducted Prevalence of resistance However, it is important to note that these lists are only indicative of the Foundation’s preliminary analysis in these areas. The Foundation recognizes that often its partners have different knowledge based upon their experience in the field, and the Foundation encourages Applicants to respond to the Concept questions below based upon their own knowledge of the different therapeutic areas and their markets. The Foundation also expects priorities to change over time, and are looking for Applicants who have a clear outlook on the first year or two but are willing to be flexible and adaptable in the future in order to “do what it takes” to achieve coverage targets. Ultimately, the success of the Market Manager grantee will be evaluated based upon reaching coverage outcomes, rather than completing activities or process milestones. The anticipated grant period is 5-7 years contingent on a successful mid-point evaluation, although Applicants are welcome to suggest alternative grant periods in line with the proposed approach. Rules & Guidelines Eligibility Funding Criteria The ideal Applicant for this work will have the following qualifications: Page 5 of 9 501(c)(3) organization status or certified international equivalent; Success in meeting organizational and client goals; Demonstrated expertise in the therapeutic area of HIV, and knowledge of existing and pipeline products related to the product areas addressed in its Concept; Good relationships with key stakeholders in the HIV space, including funders, procurers, regulatory bodies, manufacturers/Product Development Partners, delivery agencies and suppliers; © 2014 Bill & Melinda Gates Foundation Good relationships with ministries of health in countries with a high burden of HIV; Country-level presence, network or deep understanding of local context in countries with a high HIV burden; Success building and maintaining relationships among different stakeholders with varied goals; Be, and be perceived as, unbiased towards any particular HIV product; Demonstrated understanding of the nuances and complexities of the HIV product landscape and delivery challenges in high-burden countries; Extensive experience with product commercialization and scale up, or demonstrated ability to manage and conduct product commercialization via sub-contracts or partnerships; The capacity to administer and manage sub-contracts as needed; An organizational strategic vision and leadership support that includes expanding into the Market Manager space. Organizations receiving grants must to comply with Foundation requirements for submission of narrative and financial reports in addition to periodic information needed for overall project performance monitoring and management. This Concept is intended to solicit initial Concepts no longer than 10 pages responding to the questions laid out in the submission guidelines from organizations with existing experience in both the therapeutic area of interest and in product commercialization, as well as an organizational interest in growing into the Market Manager role beyond the period of any awarded grant. This document is intended to gather responses to key questions from interested parties, after which a small number of those parties will be invited to complete a full proposal. Exclusion Criteria Due to potential conflicts of interest, the Foundation is not soliciting Concepts from for-profit organizations or organizations with a financial or reputational stake in particular in market or pipeline HIV products. The Foundation is also not accepting concepts from unaffiliated individuals. Due to the Foundation’s status as a public charity, proposals including work in countries under active OFAC sanctions will not be considered for funding. Evaluation Criteria The Foundation’s relevant internal experts and external reviewers will evaluate submitted Concepts with regard to the following criteria: Overall approach; coherence and relevance of proposed work plan; Capacity of the Applicant to deliver on the proposed objectives; Relevant experience, including previous subject matter and geographic experience, as stated in the Response Requirements below; Relevant capacity and capabilities; Reputation for completing similar work; Connections with stakeholders in the HIV space; Organizational culture; Estimated costs of the services; Adherence to guidelines set forth in this document; Additional evaluation criteria the Foundation considers relevant to the specific services in question. The relative weighting and priority of these criteria will be at the Foundation’s discretion. The Foundation will share the criteria and weighting with Applicants who are invited to submit a full proposal. Budget Expectations Applicants should submit an estimated high-level budget that includes proposed spending in major cost categories and an estimated project timeline. Budgets should be organized into the following cost categories: personnel; required travel; consultants; capital equipment; other direct costs; and sub-awards (including sub-grants or sub-contracts). Applicants whose Concepts are selected will be asked to submit a more fully developed budget in a standard Foundation format. All budgets must be in compliance with the Foundation’s indirect cost policy: http://www.gatesfoundation.org/grantseeker/Documents/Indirect_Cost_Policy.pdf. Page 6 of 9 © 2014 Bill & Melinda Gates Foundation Activities & Timeline March 16, 2015: Request announced. April 13, 2015 – 2:00PM (PST): Deadline for clarifying questions. April 24, 2015 – 2:00PM (PST): Deadline for submitting Concepts. June 5, 2015: Finalists notified, full proposals requested. September 23, 2015 (anticipated): Awards announced. How to Submit a Concept Response Requirements For the purpose of this RFP, the Foundation requests that the Applicants focus their Concepts on addressing the following questions. Concepts should be no longer than 10 pages in length, excluding any supporting documentation that is uploaded separately. The Foundation will then ask any Applicants selected to move forward to develop a more detailed proposal that outlines their approach and budget more fully. Questions for Applicants: Why is your organization interested in taking on this role? How does it fit with the vision of your institution moving forward? What is your experience in this particular therapeutic area? What is your experience and your current capacity/partnerships in high-burden HIV countries? Do you see any potential conflicts in playing this role given involvement in other projects or associations with specific products? When you look out over the next five years, what do you think will be the key issues the organization will need to address? If you assume your organization acts as the Market Manager on the key issues outlined above, what would you propose the Foundation hold you accountable for to demonstrate progress against the aforementioned issues? And what are the type of activities you project will be necessary to achieve these results? Would your organization consider a pay-for-performance model that covered operating costs but offered bonuses for achieving additional coverage targets? If so, how might that be structured? How would you approach picking target countries and what criteria might you use? What estimated resources (human and financial) do you think would be required to pursue the results and activities listed in this RFP? o Regarding human resources – what type of people and skills do you think would be necessary? How would you structure the team? o Regarding financial resources – what factors might increase or decrease the financial requirements? What will be the key internal (i.e. organizational capacity/culture/structure) factors that enable an organization to be successful or not in this role? What will the organization need from the Foundation to play this role effectively? What external factors are the biggest risks and with what potential implications (expectation-wise, financial, other)? Why do you think your organization is capable of playing the Market Manager role successfully? What unique capabilities does your firm have that are relevant for this project? In addition to answering the above, Applicants should also include the following: Three references who can address at least one of the following about individuals who are likely to be in the proposed team: o How they have managed projects that have either struggled or failed o How they have managed resources (human and financial) o How they interact with key stakeholders (host governments, product developers, key policy makers) Proposed organizational structure of Applicant’s team and its place in the Applicant’s overall organization, and/or of any partnership arrangements; Page 7 of 9 © 2014 Bill & Melinda Gates Foundation Basic profiles of team members and key hires or relationships necessary to achieve success. Note that CVs are not required, but if you choose to include them, you can upload them separately. They will not count against the 10 page limit for Concepts; High-level budget that includes proposed spending in major cost categories such as professional fees, travel, expenses, etc., and proposed, high-level project timeline. Please adhere to the instructions when responding to this RFP. All questions must be answered completely in order for Applicant to be considered for this RFP. Submission Instructions Please submit an electronic copy of your Concept response (no more than 10 pages in Microsoft Word or Adobe PDF format) through the application portal for this RFP under Opportunities on gatesfoundation.org. Additional materials, such as collateral brochures, white papers and case studies that you reference in your Concept can be uploaded electronically as additional documents on the web portal. Electronic copies of documents are preferred, but any hard copy materials can be mailed to: Bill & Melinda Gates Foundation Attention: Alexa Bednarz, Integrated Delivery PO Box 23350 Seattle, WA 98102 Help Contact(s) All communication relating to the RFP, including questions and clarifications, should be submitted via email to the Foundation at marketmanagers@gatesfoundation.org. Please do not contact individual Foundation employees regarding this RFP, as that may be grounds for disqualification. The Foundation team will respond to questions with four business days. All answers to content questions and clarifications will be distributed to all Applicants. More Information FAQ Who can participate? This is an open solicitation. However, due to potential conflicts of interest, the Foundation is not soliciting proposals from for-profit organizations or organizations with a financial or reputational stake in particular in market or pipeline HIV products. We are also not accepting concepts from unaffiliated individuals. Employees of the Foundation and their respective immediate families cannot participate. Will I receive any compensation for submitting? You will not receive any compensation for your submission even if it is used by the Foundation or third parties in any way. Can I submit a Concept addressing more than one Market Manager role? Yes, the Foundation is open to receiving Concepts combining any of the open calls for Market Managers. If your plan to address more than one area, indicate this clearly in the Concept. What will the Foundation do with my submission? The Foundation will review all submissions. The Foundation may also share your submission, or ideas contained within it, with external reviewers involved in this RFP. With this in mind, please ensure that any materials you provide under this solicitation are your own, and understand that the Foundation and others will have a right to view your submission, upon delivery, for noncommercial purposes under the scope of this RFP. Key Terms & Conditions A. Disclosure Notice To help the Foundation with its review of RFP responses, the Foundation may disclose proposals, documents, communications, and associated materials submitted to the Foundation in response to this RFP (collectively, “Submission Materials”) to its employees, contingent workers, consultants, independent subject matter experts, and potential co-funders. Please carefully consider the information included in the Submission Materials. If you (the “Applicant”) have any doubts about the wisdom of disclosure of confidential or proprietary information, the Foundation recommends you consult Page 8 of 9 © 2014 Bill & Melinda Gates Foundation with your legal counsel and take any steps you deem necessary to protect your intellectual property. You may wish to consider whether such information is critical for evaluating the submission or if more general, non-confidential information may be adequate as an alternative for these purposes. Notwithstanding the Applicants characterization of any information as being confidential, the Foundation the Foundation is under no obligation to treat such information as confidential. B. Disclaimer This RFP is not an offer to contract or award grant funds. The Foundation assumes no responsibility for the Applicants cost to respond to this RFP. All responses generated by this RFP become the property of the Foundation. C. Release and Verification In exchange for the opportunity to be awarded a grant or contract, the Applicant agrees that the Foundation may, in its sole discretion: (1) amend or cancel the RFP, in whole or in part, at any time; (2) extend the deadline for submitting responses; (3) determine whether a response does or does not substantially comply with the requirements of the RFP; (4) waive any minor irregularity, informality or nonconformance with the provisions or procedures of the RFP; (5) issue multiple awards; (6) share responses generated by this RFP with Foundation staff, consultants, contingent workers, subject matter experts, and potential co-funders; and (7) copy the responses. Applicant agrees not to bring a legal challenge of any kind against the Foundation relating to the Foundation’s selection and award of a grant or contract arising from this RFP. Applicant represents that it has responded to the RFP with complete honesty and accuracy. If facts provided in Applicant’s response change, Applicant will supplement its response in writing with any deletions, additions or changes within ten days of the changes. Applicant will do this, as necessary, throughout the selection process. Applicant understands that any material misrepresentation, including omissions, may disqualify it from consideration for a grant or contract award. By responding to this RFP, you are representing: (i) that you have authority to bind the named Applicant to the terms and conditions set forth above, without amendment; and (ii) that you agree to be bound by them. D. Global Access and Intellectual Property Intellectual property (IP) rights and the management of IP rights are likely to play an important role in achieving the goals of this project. To this end, the Foundation requires that, even at this stage, all Applicants seriously consider their willingness to submit a response in compliance with the Foundation’s response requirements, a portion of which may ask for certain information and intentions regarding intellectual property concerns and Global Access. Specifically, the Foundation requires that; You will conduct and manage the Project and the Funded Developments in a manner that ensures Global Access. Your Global Access commitments will survive the term of the Agreement. “Funded Developments” means the products, services, processes, technologies, materials, software, data, other innovations, and intellectual property resulting from the Project (including modifications, improvements, and further developments to Background Technology). “Background Technology” means any and all products, services, processes, technologies, materials, software, data, or other innovations, and intellectual property created by You or a third party prior to or outside of the Project used as part of the Project. “Global Access” means: (a) the knowledge and information gained from the Project will be promptly and broadly disseminated; and (b) the Funded Developments will be made available and accessible at an affordable price (i) to people most in need within developing countries, or (ii) in support of the U.S. educational system and public libraries, as applicable to the Project. The Foundation will be selecting Applicants based on the conclusion that their technologies and expertise will be most appropriate for the success of this RFP. As part of the Foundation’s review and evaluation of each response, the Foundation will conduct due diligence with respect to each Applicant’s ability and commitment to manage intellectual property in a manner consistent with the stated scientific and charitable goals of the Foundation. Due diligence activities may include inquiry into an Applicant’s: 1) Freedom to operate (FTO) and ability to freely use and acquire needed background technology; 2) Commitment to promote the utilization, commercialization and availability of Funded Developments for public benefit The Foundation encourages you to include this information in your response. About the Bill & Melinda Gates Foundation Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. We work with partner organizations worldwide to tackle critical problems in four program areas. Our Global Development Division works to help the world’s poorest people lift themselves out of hunger and poverty. Our Global Health Division aims to harness advances in science and technology to save lives in developing countries. Our United States Division works to improve U.S. high school and postsecondary education and support vulnerable children and families in Washington State. And our Global Policy, Advocacy & Communications Division seeks to build strategic relationships and promote policies that will help advance our work. Our approach to grantmaking emphasizes collaboration, innovation, risk-taking, and, most importantly, results. To learn more about the Foundation's work, visit www.gatesfoundation.org. Page 9 of 9 © 2014 Bill & Melinda Gates Foundation