BIRAC-Wellcome Trust Joint Call in Translational Medicine

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BIRAC-Wellcome Trust Joint Call in Translational Medicine Preliminary Application Form BIRAC and WELLCOME TRUST DATA PROTECTION STATEMENT 1. This statement is a fair processing notice under the United Kingdom s Data Protection Act 1998 and the Indian Information Technology Act 2000 and The Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 (together, the Acts ) and sets out what BIRAC and/or the Wellcome Trust (together, the Funders ) will do with the information that they collect from you during the grant/award application process and throughout the life of the grant/award (including all information relating to the grant/award application and, as applicable, any subsequent grant/award made). 2. Information (including personal data as defined under the Acts) that you supply to the Funders including any application and progress or update report, may be used by the Funders to process applications and administer grants/awards, for the purposes of audit and evaluation and to monitor the fairness and trends in application decisions. Your information may be disclosed for these purposes by the Funders only to individuals and organisations connected with one or more of the Funders, including their respective funding partners (including in the case of BIRAC, the Department of Biotechnology, Government of India) external peer reviewers and external committee members. You information may also be shared with selected third parties for the purposes of independent audit, evaluation and assessment of activities funded by the grant/award and their outputs and outcomes. Some of the individuals, organisations and third parties with whom the Funders may share the information may be based outside of India and/or the European Economic Area. All personal data will be stored and used by or on behalf of the Funders in accordance with the Acts. 3. The Funders may anonymise your personal data and use it for research and statistical purposes. 4. The Funders may publish details of successful grants/awards and their outputs, including your name, employing organisation, project title, a summary of the grant/award and its value and, in the case of grants/awards funding research, scientific/academic abstracts and lay summaries of research (e.g. via the internet or via publicly accessible databases or other publications), some of which may be accessible outside the EEA and India. 5. The Funders may contact you about their activities and events, or to help inform or evaluate these activities and events, the Funders application processes and policy work. 6. The Wellcome Trust has a more general Privacy Statement on its website at www.wellcome.ac.uk. Please contact the Wellcome Trust Data Protection Compliance Officer by email at dataprotection@wellcome.ac.uk or by post at: The Wellcome Trust, 215 Euston Road, London NW1 2BE if you have any queries about the use of your personal data by The Wellcome Trust. 7. Please contact BIRAC at [insert contact details] if you have any queries about the use of your personal data by BIRAC. 8. The Funders may amend this Statement from time to time. Any material changes in how the Funders collect, use or share your personal data will be posted on the Funders respective websites at: www.wellcome.ac.uk and www.birac.nic.in.

Applicant Undertakings: 1. I confirm that I (and all those providing personal information in the application) have read and understood the BIRAC and Welcome Trust Data Protection Statement. 2. To the best of my knowledge, the information provided in this application is accurate and complete and I agree to inform the Funders of any material changes to this information during the period of the grant/award. 3. I have read the conditions under which grants/awards are made and agree to abide by the conditions should a grant/award be made. 4. The necessary facilities will be made available to conduct the research/activities funded by Funders grant/award, and will continue to be made available for the duration of the grant/award (applicable to Heads of Department, Sponsors, Research Sponsors and Organisation Administration Department approvers). Signature of Principal Applicant Date: Signature of Coapplicant (1) Date: Signature of Coapplicant (2) Date: Signature of Coapplicant (3) Date:

[To be printed on the headed notepaper of the Administering Organisation or its Technology Transfer Group (if an independent organisation) or the Company] [BIRAC addressee and address] The Grants Adviser (Technology Transfer) Grants Management Department Wellcome Trust Gibbs Building, 215 Euston Road London NW1 2BE [Date] Dear Sirs Application to the BIRAC-Wellcome Trust Joint-Call Funding Committee: [Name and Title of Principal Investigator], [Name of Administering Organisation or Company], [ Title of Project ] 1. I confirm our agreement to participate as an Applicant on the above named BIRAC-Wellcome Trust Joint-Call Funding Committee application and to take responsibility for the information provided in the Commercial Matters sections of this. 2. I confirm that I (and all those providing personal information in the application) have read and understood the BIRAC and Welcome Trust Data Protection Statement. 3. To the best of my knowledge, the information provided in this application is accurate and complete and I agree to inform the Funders of any material changes to this information during the period of the grant/award. 4. I have read the conditions under which grants/awards are made and agree to abide by the conditions should a grant/award be made. 5. The necessary facilities will be made available to conduct the research/activities funded by Funders grant/award, and will continue to be made available for the duration of the grant/award (applicable to Heads of Department, Sponsors, Research Sponsors and Organisation Administration Department approvers). Yours faithfully Signature: Name: Job Title: Organisation: Date of Signature: [Signed by Head Technology Transfer Office or Group on behalf of Administering Organisation or its Technology Transfer Group if independent or if the University does not have a TTO, a person duly authorised to sign on behalf of University or Institution]* [Signed by Business Officer on behalf of [Name of Company]]* (*Please delete as applicable)

BIRAC and WELLCOME TRUST DATA PROTECTION STATEMENT 9. This statement is a fair processing notice under the United Kingdom s Data Protection Act 1998 and the Indian Information Technology Act 2000 and The Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 (together, the Acts ) and sets out what BIRAC and/or the Wellcome Trust (together, the Funders ) will do with the information that they collect from you during the grant/award application process and throughout the life of the grant/award (including all information relating to the grant/award application and, as applicable, any subsequent grant/award made). 10. Information (including personal data as defined under the Acts) that you supply to the Funders including any application and progress or update report, may be used by the Funders to process applications and administer grants/awards, for the purposes of audit and evaluation and to monitor the fairness and trends in application decisions. Your information may be disclosed for these purposes by the Funders only to individuals and organisations connected with one or more of the Funders, including their respective funding partners (including in the case of BIRAC, the Department of Biotechnology, Government of India) external peer reviewers and external committee members. You information may also be shared with selected third parties for the purposes of independent audit, evaluation and assessment of activities funded by the grant/award and their outputs and outcomes. Some of the individuals, organisations and third parties with whom the Funders may share the information may be based outside of India and/or the European Economic Area. All personal data will be stored and used by or on behalf of the Funders in accordance with the Acts. 11. The Funders may anonymise your personal data and use it for research and statistical purposes. 12. The Funders may publish details of successful grants/awards and their outputs, including your name, employing organisation, project title, a summary of the grant/award and its value and, in the case of grants/awards funding research, scientific/academic abstracts and lay summaries of research (e.g. via the internet or via publicly accessible databases or other publications), some of which may be accessible outside the EEA and India. 13. The Funders may contact you about their activities and events, or to help inform or evaluate these activities and events, the Funders application processes and policy work. 14. The Wellcome Trust has a more general Privacy Statement on its website at www.wellcome.ac.uk. Please contact the Wellcome Trust Data Protection Compliance Officer by email at dataprotection@wellcome.ac.uk or by post at: The Wellcome Trust, 215 Euston Road, London NW1 2BE if you have any queries about the use of your personal data by The Wellcome Trust. 15. Please contact BIRAC at [insert contact details] if you have any queries about the use of your personal data by BIRAC. 16. The Funders may amend this Statement from time to time. Any material changes in how the Funders collect, use or share your personal data will be posted on the Funders respective websites at: www.wellcome.ac.uk and www.birac.nic.in.

PART 1 PRELIMINARY APPLICATION FORM Principal Applicant Surname Forename(s) Title Position Employing organisation Contact address Phone Mobile Fax email Company name and address or department name and address at administering organisation, where different from principal applicant s employing organisation: Is this a joint application*? *A joint application is where two (or more) organisations will administer funds or if funding payments are to be made in more than one currency. If this is the case or you think this is likely, you need to answer yes to the joint applications question in the preliminary application form. This option is only available at this stage.

Coapplicant(s) Surname Forename(s) Title Position Employing organisation Contact Address Phone Mobile Fax Email Technology Transfer Officer/Business Officer Surname Forename(s) Title Employing organisation Contact address Email address Phone number Mobile Fax Q1 Proposed project title: (no more than 233 characters, including spaces) Q2 Please provide a summary of the technology to be further developed (no more than 200 words) Q3 Summarise your research aim and how the proposed project will address the unmet healthcare needs in India and potentially other markets. State the intended target population(s) and estimate size (no more than 300 words) Q4 (a) Please give details of key points of validation attained to date (no more than 400 words) (b) Please give details of the current stage of development of the technology (no more than 200 words)

(c) Please give details of any other relevant background information (no more than 200 words) Q5 (a) Provide details of the plan of investigation proposed to be funded by the Trust, including: (i) the specific aims and objectives, (ii) at least three milestones for the Trust-funded component during the course of the project (funding may be dependent on achieving milestones), and (iii) details regarding what other funds (if any) are contributing to related project tasks. Please also describe how the project will be managed to deliver the milestones and key objectives, describing the in-house expertise and any other expertise that needs to be accessed externally. (no more than 1,400 words)

(b) Provide a Gantt chart or similar graphical overview of the tasks to be undertaken, their sequence and duration for the entire project including those (marked separately) that will be undertaken in parallel but without Trust funding (if applicable) and key development steps after Trust funding.

Q6 Affordability Please explain how you would ensure that the project / healthcare solution will be made affordable to the maximum number of targeted patient populations in India and potentially other developing world markets. (no more than 250 words) Q7 Commercial Matters (a) Patent information Application number: Priority date: Inventors: Applicant: Ownership (including assignees) Funding source: Title (b) How do these patent(s) or patent application(s) relate to the proposal? (no more than 700 words) (c) Describe any freedom to operate issues that have been identified or that might arise and how these will be or have been addressed. Listing any IP from third parties that is subject to licence. Include the type and date of any searches that have been conducted. (no more than 350 words) (d) Describe any new intellectual property filings that are anticipated arising from this project including how these inventions will be managed. (no more than 350 words) (no more than 350 words) Q8 Please describe any competitors and competing technologies being developed or that have been marketed, In addition, please provide a description of the competitive advantage of this technology over currently accepted methods. (no more than 350 words) Q9 Please describe the route by which the proposed healthcare solution or innovation can be made available to, or widely adopted by, the target population(s) (no more than 250 words) Q10 Please describe why, at the end of Trust funding, the technology will be attractive for followon investment, commercial exit and/or adoption and how this will be achieved (no more than 350 words) Q11 Please identify any third parties that would be interested in such technology and any approaches made to them to date (no more than 350 words)

Q12 (a) Please provide an approximate budget for the project. Please state currency used (no more than 200 words) (b) State period for which support is sought (number of months) Q13 Please provide justification for your request for funding from the Wellcome Trust (no more than 200 words) Q14 If this is a resubmission of a project previously submitted to the Technology Transfer Division, please provide details of the key differences between that application and the current proposal. (no more than 500 words) Q15 For company applicants, please provide details on the number of employees and indicate if they are full time or part time, whether your company has publicly tradable shares, the stock exchange(s) where it is listed and the total market capitalisation. (no more than 200 words) Q16 Additional Information If you wish to provide additional information, up to a maximum of 5 A4 pages of supporting information can be attached. Please note that anything submitted over this limit will be deleted.