General Questions. FAQ New Biomarkers for HIV Incidence Measurement

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General Questions Q. How much are the potential grants? A. The foundation is willing to invest up to a total of $3M for establishing proof of concept of a novel biomarker, or set of biomarkers, for the measurement of HIV incidence. Individual proposals are eligible for up to $1M in total cost and should clearly identify decisions and endpoints that fit within the timeframe of 36 months. The foundation reserves the right to award a grant amount lower than what is proposed. Q. How many awards will be funded? A. The foundation plans to fund three to five proposals. It is likely that the total amount available for awards ($3 million) will be split between the number of grant recipients, with varying award amounts based on project scope and timing. Q. Is this grant program part of Grant Challenges Explorations? A. No. Unlike Grant Challenges Explorations, this solicitation opportunity is not ongoing; the application deadline for New Biomarkers for HIV Incidence Measurement is May 18, 2012, after which time applications will no longer be accepted. Grand Challenges Explorations grants are solicited and awarded multiple times per year, with each funding round addressing a few specific topics. Proposals for Round 9 are currently being accepted at www.grandchallenges.org/explorations through Tuesday, May 15, 2012. The Explorations program targets smaller projects that are at an earlier stage of discovery. Q. Will you provide guidance on an application before I submit it? A. We cannot provide individual guidance on ideas before submission. After submission, however, we may ask follow up questions once the concept has been evaluated by our review panel. Due to the high volume of applications, we will not be able to provide individualized feedback to each applicant. Q. How can I access samples to use in testing my idea? A standardized set of samples forming development and qualification panels will be made available to funded investigators upon request. These will include blood products, urine, oral fluid, hair, and stool. Descriptions of the panels and instructions for access can be found at http://www.incidenceestimation.com/page/the-cephia-repository. Q. Who can I contact if I have a question? A. Please submit your questions to HIVDiagnostics@gatesfoundation.org. Questions will be routed to the appropriate foundation staff person for response. Page 1 of 6

Application Process Q. Is there a specific format for the application? A. Yes, please download and use the LOI Application Form for your submission. Please review the Letter of Inquiry instructions and complete the application in accordance with the rules and guidelines for the request. Instructions can be found at: https://unison.gatesfoundation.org/applicant/_layouts/portal/applicants/applicationform.as px?requestid=c32b760b 0872 e111 bafd 0019b9f2848b Q. Do I have to submit my proposal using the Online Application Tool? A. Yes, all applications must be submitted through the Online Application Tool. Under exceptional circumstances, we will consider accepting submissions from those unable to use the online tool. Please contact HIVDiagnostics@gatesfoundation.org if you have any questions or feel you will be unable to submit through the Online Application Tool. Q. Can one institution submit multiple LOIs? A. Yes, multiple submissions from an institution are allowed. Q. Is it possible to have multiple applicants on a proposal? A. The foundation welcomes collaborations and formation of consortiums within a single application. Applicants, however, need to elect a Principal Investigator who will serve as the primary contact for the team. Collaborations will have to be set up by the proposer, as this will not be done by the foundation. Q. What amount of indirect cost is available? Do you accept my U.S. organization s federally negotiated indirect cost rate? The foundation allows indirect cost within certain guidelines at the following rates: 0% for governmental agencies, other private foundations, and for profit organizations Up to maximum of 10% for U.S. universities and U.S community colleges Up to maximum of 15% for all other non governmental organizations (NGOs), international organizations and non U.S. universities Further details of the foundation indirect cost policy can be found here: http://www.gatesfoundation.org/grantseeker/documents/indirect_cost_policy.pdf Q. I submitted my LOI but did not receive a confirmation. How would I know if my proposal went through? A. You will be prompted by our system if you have not completed all required fields. Once it goes through, the page will refresh and an onscreen confirmation will be displayed. Our system will also send an email confirmation when you submit your LOI application. Please check your junk mail folder if you have not received it in your inbox. If you do not receive a Page 2 of 6

confirmation, please feel free to contact HIVDiagnostics@gatesfoundation.org for verification that your application was received. Review Process Q. What is the review process? A. LOIs will be reviewed by a panel of foundation and non foundation staff using the Evaluation Criteria described in the Rules and Guidelines document. In July 2012, the foundation will invite a select number applicants to submit full proposals by August 2012. These time periods are subject to change if the volume of applications exceeds the number expected and thus requires additional time for processing and evaluation. All applicants will be notified by email in a timely manner of any change to the dates for notification and proposal deadline. Due to expected high volumes, the foundation will not be able to provide individual feedback for LOIs not selected to submit full proposals. The foundation may use external reviewers to assess the merit of proposals; final selection decisions will be made by the foundation. Q. Will my idea be treated as confidential during the review process? A. The foundation has put in place policies and procedures to restrict public dissemination of grant application materials including, when possible, having external reviewers sign confidentiality agreements and requiring that reviewers destroy or return to the foundation all copies of information acquired or created during the course of performing a review. Application Schedule Q. When will I know if my LOI has been selected? A. The foundation will communicate to all applicants by July 2012, although this timeframe may change depending on the number of applications. You will either receive information that your proposal has not been selected for further consideration or you will receive information on how to submit a full proposal. All applicants will be notified in a timely manner of any change to the notification schedule. Please refer to the Rules and Guidelines document for the full schedule of events. Q. When will invitations be issued to submit full proposals? Invitations to submit full proposals will be issued in July 2012. If you are selected to submit a full proposal, an email invitation will provide you with an access code and will include a link to our application portal to download the proposal templates and relevant materials. Please refer to the Rules and Guidelines document for the full schedule of events. Page 3 of 6

Grant Terms and Conditions Q. Do you publish or publicly disseminate proposals or grant applications materials? A. The foundation does not publicly disseminate or "publish" proposals or supporting information related to a grant application. For IRS compliance reasons we are required to publish a list of grants that we have made. We do not publish the full proposal or any supporting materials; however, we provide a general description of the grant on our website at www.gatesfoundation.org. These brief descriptions are also made available in press releases and other marketing materials. Q. Who will own the rights to technologies created by the grants? What is being done to ensure access for developing countries? A. In general, the investigators will own the rights to any technologies they invent. They are, however, required to use these rights to help ensure that any tools or knowledge created will be made available and affordable in the developing world. Agreement to this principle is a condition of receiving a grant. Q. How is intellectual property handled? A. We respect the intellectual property (IP) of our grantees, but we ask them to structure their IP in a way that allows the developing world to access their drugs, vaccines, diagnostics, or any other health interventions at an affordable price. Our Global Access Objectives aspire to ensure that the poorest of the poor have access to any knowledge or products that we fund. We do not provide a blueprint for exactly how this should be done. Instead, we leave that to our partners. Please see LOI Instructions for a full description of the Global Access Objectives. Technical Support Q. I have already created an account for the Grand Challenges Explorations (GCE portal) or Clinical Studies Tracker. Do I need to create another account? A. No. You can sign in with the same email address and password that you have used on those sites. Q. I cannot log in. Where do I get my temporary password? A. When you first create an account, a temporary password is sent to the email address you have provided. If the email does not appear in your inbox, please check your Junk Mail folder or with your system administrator. Sometimes emails are blocked by an enterpriselevel spam filter. When you first log in using your temporary password, you will be prompted to change your password. If you need further assistance, please email HIVDiagnostics@gatesfoundation.org. Page 4 of 6

Q. What if I forgot my password? If you forget your password, click on the I forgot my password link on the login page, and you will be asked the security question you supplied when you first created your account. When you answer the question correctly, a temporary password will be emailed to you. Sign in with your temporary password and then create a new one when prompted to do so. If you forgot your password and cannot answer your security question, please email the specifics of your problem to HIVDiagnostics@gatesfoundation.org and provide the user email address to which the temporary password will be sent. Q. I have tried to log in multiple times, and I am now locked out of the system. What next? A. If you have entered the wrong password 10 times, you can either wait 20 minutes before trying to sign in again or click the I forgot my password link. Q. The application tool is not loading for me. What can I do to fix this? A. If other websites load normally, we might be performing maintenance on our site. Wait at least one hour and try the site again. If the issue persists, please email the specifics of your problem to HIVDiagnostics@gatesfoundation.org. Please note that you will not be able to access the application tool using Microsoft Internet Explorer 3 or 4. Check your browser settings to enable Java Script and cookies. Q. Will my data be lost if I navigate away from this site? A. The application tool will back up data entered into fields in real time as long as you are connected to the Internet. You will be logged out after one hour of inactivity. Any changes or work not saved will be lost. Q. Where can I report broken web links? A. Please notify HIVDiagnostics@gatesfoundation.org so that we can repair them. Q. Am I able to edit my profile and letter of inquiry once submitted? A. No, once you have uploaded your documents and submitted the materials on the "Review & Submit" tab in the Unison application portal, you cannot edit your document. We encourage applicants not to upload until they have edited and completed their application. Q. I am having trouble uploading my application file. What should I do? A. Your document must be saved with one of the following extensions: *.pdf, *.doc, or *.docx. If you are having issues, please be aware that the site does not accept the following file extensions:.ade,.adp,.app,.bas,.bat,.chm,.class,.cmd,.com,.cpl,.crt,.dll,.exe,.fxp,.hlp,.hta,.ins,.isp,.jse,.lnk,.mda,.mdb,.mde,.mdt,.mdw,.mdz,.msc,.msi,.msp,.mst,.ops,.pcd,.pif,.prf,.prg,.reg,.scf,.scr,.sct,.shb,.shs,.url,.vb,.vbe,.vbs,.wsc,.wsf, and.wsh. Otherwise, try recreating your document using Microsoft Word, Adobe Acrobat, or Word Pad and uploading again. Page 5 of 6

Q. I am asked to log in when opening the Application Form. What should I enter? A. This is an issue with some versions of Microsoft Office. Click Cancel and the application form will open for you. Q. Who can I contact for website related issues? A. Please email the specifics of your problem to HIVDiagnostics@gatesfoundation.org. Criteria for Selection Q. I am not presently employed by an organization. May I still apply? A. In order to apply, you must be affiliated with an organization. Q. Am I eligible to apply if I work for the private sector? Yes, we are accepting applications from Principal Investigators at both private and public organizations. Q. Am I eligible to apply if my organizations is outside the United States? A. Yes. There is no geographical restriction for applicants. We encourage applicants worldwide to submit LOIs. Please note that all applications must be written in English. Q. Why wasn t my LOI selected? A. Given the size and nature of the program, we are not able to provide individualized feedback to each applicant. All LOIs will be reviewed using the Evaluation Criteria outlined in the Rules and Guidelines document. Generally, applications are not funded due to one of the following reasons: 1) It presents an idea that is explicitly excluded from consideration for funding. For more information, please see the Rules and Guidelines document. 2) It is not complete. Applications that do not contain a coherent idea, design or description of the work to be performed are not considered for funding. 3). The proposal does not describe how the idea offers a creative approach to the problem and how it varies from current or conventional approaches. 4) It does not clearly outline or describe the specific objective(s) to be accomplished within the time period of the proposed project. 5) Costs do not correspond to the value added of the proposed grant. Page 6 of 6