Document:

ex10-46.htm

 EXHIBIT 10.46 

 Notice of Award 

 Issue Date: 06/22/2009 

 SMALL BUSINESS INNOVATION RESEARCH PROG 

 Department of Health and Human Services 

 National Institutes of Health 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Grant Number: 2R44DA018515-02 

 Principal Investigator(s): 

 Ralph Snodgrass, PHD 

 Project Title: Clinical Development of 4-Cl-KYN to Treat Pain 

 Rice, Franklin 

 EVP Finance and Administration  

 384 Oyster Point Blvd #8 

 South San Francisco, CA 94080 

 Budget Period: 07/01/2009 - 06/30/2010 

 Project Period: 07/01/2004 - 06/30/2011 

 Dear Business Official: 

 The National Institutes of Health hereby awards a grant in the amount of $2,469,281 (see "Award Calculation" in Section I and "Terms and Conditions" in Section III) to VISTAGEN THERAPEUTICS, INC. in support of the above referenced project. This award is pursuant to the authority of 42 USC 241 42 CFR PART 52 15 USC 638 and is subject to the requirements of this statute and regulation and of other referenced, incorporated or attached terms and conditions. 

 Acceptance of this award including the "Terms and Conditions" is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system. 

 Each publication, press release or other document that cites results from NIH grant-supported research must include an acknowledgment of NIH grant support and disclaimer such as "The project described was supported by Award Number R44DA018515 from the National Institute On Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute On Drug Abuse or the National Institutes of Health." 

 Award recipients are required to comply with the NIH Public Access Policy. This includes submission to PubMed Central (PMC), upon acceptance for publication, an electronic version of a final peer-reviewed, manuscript resulting from research supported in whole or in part, with direct costs from National Institutes of Health. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. For additional information, please visit http://publicaccess.nih.gov/. 

    

    

    

 

 Award recipients must promote objectivity in research by establishing standards to ensure that the design, conduct and reporting of research funded under NIH-funded awards are not biased by a conflicting financial interest of an Investigator. Investigator is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of NIH-funded research or proposed research, including the Investigator's spouse and dependent children.  Awardees must have a written administrative process to identify and manage financial conflict of interest and must inform Investigators of the conflict of interest policy and of the Investigators' responsibilities. Prior to
expenditure of these awarded funds, the Awardee must report to the NIH Awarding Component the existence of a conflicting interest and within 60 days of any new conflicting interests identified after the initial report. Awardees must comply with these and all other aspects of 42 CFR Part 50, Subpart F. These requirements also apply to subgrantees, contractors, or collaborators engaged by the Awardee under this award. The NIH website http://grants.nih.gov/grants/policy/coi/index.htm provides additional information. 

 If you have any questions about this award, please contact the individual(s) referenced in Section IV. 

 Sincerely yours, 

 Pamela G. Fleming 

 Grants Management Officer 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Additional information follows 

 NIH NGA R | Version: 369 - 05/26/2009 10:57:35 | Generated on: 06/22/2009 00:25:04 

    

    

    

 SECTION I – AWARD DATA – 2R44DA018515-02 

	
 Award Calculation (U.S. Dollars) 

	    	    
	
 Salaries and Wages 

	    	
 $70,390 

	
 Fringe Benefits 

	    	
 $16,894 

	
 Consultant Services 

	    	
 $24,000 

	
 Supplies 

	    	
 $829,280 

	
 Consortium/Contractual Cost 

	    	
 $960,949 

	    	    	    
	    	    	    
	
 Federal Direct Costs 

	    	
 $1,901,513 

	
 Federal F&A Costs 

	    	
 $406,226 

	
 Approved Budget 

	    	
 $2,307,739 

	
 Fee 

	    	
 $161,542 

	
 Federal Share 

	    	
 $2,469,281 

	
 TOTAL FEDERAL AWARD AMOUNT 

	    	
 $2,469,281 

	    	    	    
	
 AMOUNT OF THIS ACTION (FEDERAL SHARE) 

	    	
 $2,469,281 

 SUMMARY TOTALS FOR ALL YEARS 

	
 YR 

	
 THIS AWARD 

	
 CUMULATIVE TOTALS 

	
 2 

	
 $2,469,281 

	
 $2,469,281 

	
 3 

	
 $1,714,903 

	
 $1,714,903 

 Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project. 

 Fiscal Information:

	
 CFDA Number: 

	
 93.279 

	
 EIN: 

	
 1943301660A1 

	
 Document Number: 

	
 RDA018515B 

	
 Fiscal Year: 

	
 2009 

	
 IC 

	
 CAN 

	
 2009 

	
 2010 

	
 DA 

	
 8742672 

	
 $2,469,281 

	
 $1,714,903 

 Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project. 

 NIH Administrative Data: 

 PCC:  MF/AP1  /  OC:  414B  /  Processed:  PFLEMING 06/18/2009 

 SECTION II – PAYMENT/HOTLINE INFORMATION – 2R44DA018515-02 

 For payment and HHS Officer of Inspector General Hotline information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm 

    

    

    

 

 SECTION III – TERMS AND CONDITIONS – 2R44DA018515-02 

 This award is based on the application submitted to, and as approved by, NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following: 

	
 a.   

	
 The grant program legislation and program regulation cited in this Notice of Award. 

	
 b.   

	
 Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts. 

	
 c.   

	
 45CFR Part 74 or 45 CFR Part 92 as applicable. 

	
 d.   

	
 The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period. 

	
 e.   

	
 This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW. 

	   	   

 (See NIH Home Page at ‘http://grants.nih.gov/grants/policy/awardconditions.htm’ for certain references cited above.) 

 An unobligated balance may be carried over into the next budget period without Grants Management Officer prior approval. 

 This grant is subject to Streamlined Noncompeting Award Procedures (SNAP). 

 In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. 

 For more information, see NOT-OD-08-033 and the Public Access website: 

 http://publicaccess.nih.gov/ 

 Treatment of Program Income: 

 Additional Costs 

 SECTION IV – DA Special Terms and Conditions – 2R44DA018515-02 

 PAYMENT INFORMATION: The awardee organization will receive information and forms from the Division of Payment Management of the Department of Health and Human Services regarding requests for cash, manners of payment, and associated reporting requirements. Payment may be made on a cost-reimbursement or advance basis. Cost reimbursements may be requested monthly, quarterly or at other periodic intervals. Advance payments may be requested on a monthly basis only. The telephone number for the Payment Management System Office is 1-877-614-5533. The Division of Payment Management website is: http://www.dpm.psc.gov/ 

 INTELLECTUAL PROPERTY RIGHTS: Normally, the awardee organization retains the principal worldwide patent rights to any invention developed with United States Government support. Under Title 37 Code of Federal Regulations Part 401, the Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain circumstances, and requires that anyone exclusively licensed to sell the invention in the United States must normally manufacture it substantially in the United States. 

 Rights and obligations related to inventions created or reduced to practice as a result of this award are detailed in 35 U.S.C. 205 and 37 CFR Part 401. These inventions must be reported to the Extramural Invention Reporting and Technology Resources Branch, OPERA, NIH, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20892-7750, (301) 435-1986. For additional information, access the NIH link on the Interagency Edison web site (www.iedison.gov) which includes an electronic invention reporting system, reference information and the text to 37 CFR 401. 

 

 To the extent authorized by 35 U.S.C., Section 205, the Government will not make public any information disclosing an NIH-supported invention for a 4-year period to allow the awardee organization a reasonable time to file a patent application, nor will the Government release any information that is part of that patent application.

 When purchasing equipment or products under this SBIR award, the grantee shall use only American-made items, whenever possible. 

 

 The fee provided as part of this Notice of Grant Award is in addition to direct and facilities and administrative costs. The fee is to be drawn down from the DHHS Payment Management System in increments proportionate to the draw down of costs. 

 

    

    

    

 

 Allowable costs conducted by for-profit organizations will be determined by applying the cost principles of Contracts with Commercial Organizations set forth in 48 CFR, Subpart 31.2. 

 The Code of Federal Regulations (Title 45 Part 74.26) stipulates that a commercial organization is subject to audit requirements for a non-federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is an HHS grant or subgrant. Therefore, the organization must have one grant or subgrant in order to be required to obtain a non-federal audit, but other HHS awards are included in the threshold calculations and the scope of the audit. (See threshold calculation examples, http://oamp.od.nih.gov/dfas/faqexamples.html.) 

 All grantees must acknowledge funding received from the National Institute on Drug Abuse at the National Institutes of Health when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with NIDA money. (NIH Grants Policy Statement, Part II, Page 114- Rights in Data (Publication and Copyrighting), December 2003). 

 In conjunction with this requirement, in order to most effectively disseminate research results, advance notice should be given to NIDA that research finds are about to be published so that we may coordinate accurate and timely release to the media. This information will be embargoed until the publication date. Any press notification should be coordinated with the NIDA Press Officer who can be reached at (301) 443-6245. 

 We strongly encourage all of our grantees to register in the eRA Commons. The eRA Commons provides grantees with the ability to electronically submit; e-SNAP applications, No cost extensions, Just in Time documents, Financial Status Reports, Final Progress Reports, and allows grantees to register to become e-mail enabled to receive Notice of Grant Awards (NGA). 

 STAFF CONTACTS 

 The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail. 

 Grants Management Specialist:  Catherine Mills 

 Email:  cmills@nida.nih.gov   Phone:  301-443-6710   Fax:  301-594-6849 

 Program Official: Amrat Patel 

 Email:  ap79g@nih.gob   Phone:  301-443-8476 

 SPREADSHEET SUMMARY 

 GRANT NUMBER:  2R44DA018515-02 

 INSTITUTION:  VISTAGEN THERAPEUTICS, INC. 

	
 Budget 

	
 Year 2 

	
 Year 3 

	
 Salaries and Wages 

	
 $70,390 

	
 $72,400 

	
 Fringe Benefits 

	
 $16,894 

	
 $17,376 

	
 Consultant Services 

	
 $24,000 

	
 $16,068 

	
 Supplies 

	
 $829,280 

	
 $555,203 

	
 Consortium/Contractual Cost 

	
 $960,949 

	
 $677,247 

	
 FEE 

	
 $161,542 

	
 $112,190 

	
 TOTAL FEDERAL DC 

	
 $1,901,513 

	
 $1,338,294 

	
 TOTAL FEDERAL F&A 

	
 $406,226 

	
 $264,419 

	
 TOTAL COST 

	
 $2,469,281 

	
 $1,714,903 

 

	
 Facilities and Administrative Costs 

	
 Year 2 

	
 Year 3 

	
 F&A Cost Rate 1 

	
 40% 

	
 40% 

	
 F&A Cost Base 1 

	
 $1,015,564 

	
 $661,047 

	
 F&A Costs 1 

	
 $406,226 

	
 $264,419 

 

    

    

    

 

 Notice of Award 

 Issue Date:  07/19/2010 

 SMALL BUSINESS INNOVATION RESEARCH PROG 

 Department of Health and Human Services 

 National Institutes of Health 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Grant Number: 3R44DA01815-03S1 

 Principal Investigator(s): 

 Ralph Snodgrass 

 Project Title:  Clinical Development of 4-CI-KYN to Treat Pain 

 Rice, Franklin 

 EVP Finance and Administration 

 384 Oyster Point Blvd #8 

 South San Francisco, CA  94080 

 Award e-mailed to:  rsnodgrass@vistagen.com 

 Budget Period:  07/01/2010 – 06/30/2011 

 Project Period:  07/01/2004 – 06/30/2011 

 Dear Business Official: 

 The National Institutes of Health hereby awards a grant in the amount of $419,898 (see "Award Calculation" in Section I and "Terms and Conditions" in Section III) to VISTAGEN THERAPEUTICS, INC. in support of the above referenced project. This award is pursuant to the authority of 42 USC 241 42 CFR PART 52 15 USC 638 and is subject to the requirements of this statute and regulation and of other referenced, incorporated or attached terms and conditions. 

 Acceptance of this award including the "Terms and Conditions" is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system. 

 Each publication, press release or other document that cites results from NIH grant-supported research must include an acknowledgment of NIH grant support and disclaimer such as "The project described was supported by Award Number R44DA018515 from the National Institute On Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute On Drug Abuse or the National Institutes of Health." 

 Award recipients are required to comply with the NIH Public Access Policy. This includes submission to PubMed Central (PMC), upon acceptance for publication, an electronic version of a final peer-reviewed, manuscript resulting from research supported in whole or in part, with direct costs from National Institutes of Health. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. For additional information, please visit http://publicaccess.nih.gov/. 

 

    

    

    

 

 Award recipients must promote objectivity in research by establishing standards to ensure that the design, conduct and reporting of research funded under NIH-funded awards are not biased by a conflicting financial interest of an Investigator. Investigator is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of NIH-funded research or proposed research, including the Investigator's spouse and dependent children. Awardees must have a written administrative process to identify and manage financial conflict of interest and must inform Investigators of the conflict of interest policy and of the Investigators' responsibilities. Prior to expenditure of
these awarded funds, the Awardee must report to the NIH Awarding Component the existence of a conflicting interest and within 60 days of any new conflicting interests identified after the initial report. Awardees must comply with these and all other aspects of 42 CFR Part 50, Subpart F. These requirements also apply to subgrantees, contractors, or collaborators engaged by the Awardee under this award. The NIH website http://grants.nih.gov/grants/policy/coi/index.htm provides additional information. 

 If you have any questions about this award, please contact the individual(s) referenced in Section IV. 

 Sincerely yours, 

 Pamela G. Fleming 

 Grants Management Officer 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Additional information follows 

 

    

    

    

 

 SECTION I – AWARD DATA – 3R44DA018515-03S1 

	
 Award Calculation (U.S. Dollars) 

	    	    
	
 Travel Costs 

	    	
 $12,500 

	
 Consortium/Contractual Cost 

	    	
 $354,255 

	    	    	    
	    	    	    
	
 Federal Direct Costs 

	    	
 $366,755 

	
 Federal F&A Costs 

	    	
 $25,673 

	
 Approved Budget 

	    	
 $392,428 

	
 Fee 

	    	
 $27,470 

	
 Federal Share 

	    	
 $419,898 

	
 TOTAL FEDERAL AWARD AMOUNT 

	    	
 $419,898 

	    	    	    
	
 AMOUNT OF THIS ACTION (FEDERAL SHARE) 

	    	
 $419,898 

 SUMMARY TOTAL FEDERAL AWARD AMOUNT YEAR (3) 

	
 GRANT NUMBER 

	
 TOTAL FEDERAL AWARD AMOUNT 

	
 3R44DA018515-03S1 

	
 $419,898 

	
 5R44DA018515-03 

	
 $1,714,903 

	
 TOTAL 

	
 $2,134,801 

 SUMMARY TOTALS FOR ALL YEARS 

	
 YR 

	
 THIS AWARD 

	
 CUMULATIVE TOTALS 

	
 3 

	
 $419,898 

	
 $2,134,801 

 Fiscal Information:

	
 CFDA Number: 

	
 93.279 

	
 EIN: 

	
 1943301660A1 

	
 Document Number: 

	
 RDA018515B 

	
 Fiscal Year: 

	
 2010 

	
 IC 

	
 CAN 

	
 2010 

	
 DA 

	
 8742672 

	
 $419,898 

 NIH Administrative Data: 

 PCC:  MF/AP1  /  OC:  414C  /  Processed:  PFLEMING 07/14/2010 

 SECTION II – PAYMENT/HOTLINE INFORMATION – 3R44DA018515-03S1 

 For payment and HHS Office of Inspector General Hotline information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm 

 

    

    

    

 

 SECTION III – TERMS AND CONDITIONS – 3R44DA018515-03S1 

 This award is based on the application submitted to, and as approve d by, NIH on the above titled project and is subject to the terms and conditions incorporated either directly or by reference in the following: 

	
 a.   

	
 The grant programs legislation and program regulation cited in this Notice of Award. 

	
 b.   

	
 Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts. 

	
 c.   

	
 45 CFR Part 74 or 45 CFR Part 92 as applicable. 

	
 d.   

	
 The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period. 

	
 e.   

	
 This award notices, INCLUDING THE TERMS AND CONDITIONS CITED BELOW. 

 (See NIH Home Page at ‘http://grants.nih.gov/grants/policy/awardconditions.htm’ for certain references cited above.) 

 An unobligated balance may be carried over into the next budget period without Grants Management Officer prior approval. 

 This grant is subject to Streamlined Noncompeting Award Procedures (SNAP). 

 In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. 

 For more information, see NOT-OD-08-033 and the Public Access website: 

 http://publicaccess.nih.gov/ 

 This award represents the final year of the competitive segment for this grant. Therefore, see the NIH Grants Policy Statement (12/1/2003 version) for closeout requirements at: 

 http://grants.nih.gov/ grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600151. 

 A final Financial Status Report (FSR) (SF 269) must be submitted through the eRA Commons (Commons) within 90 days of the expiration date; see NIH Guide Notice NOT-OD-07-078 for additional information on this electronic submission requirement. The final FSR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FSR and the Payment Management System's (PMS) Federal Cash Transaction Report (SF-272). 

 Furthermore, unless an application for competitive renewal is submitted, additional grant closeout documents consisting of a Final Invention Statement and Certification form (HHS 568), (not applicable to training, construction, conference or cancer education grants) and a final progress report must also be submitted within 90 days of the expiration date. 

 NIH also strongly encourages electronic submission of the final progress report and the final invention statement through the Closeout feature in the Commons. If the final progress report and final invention statement are not submitted electronically, copies of the HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm. 

 Submissions of the final progress report and HHS 568 may be e-mailed as PDF attachments to the NIH Central Closeout Center at: deascentralized@od.nih.gov 

 Paper submissions of the final progress report and the HHS 568 may be faxed to the NIH Central Closeout Center at 301-480-2304 or mailed to the NIH Central Closeout Center at the following address: 

 NIH/OD/OER/DEAS 

     Central Closeout Center 

     6705 Rockledge Drive, Room 2207 

 Bethesda, MD 20892-7987 (for regular or U.S. Postal Service Express mail) 

 Bethesda, MD 20817 (for other courier/express mail delivery only) 

 

    

    

    

 

 The final progress report should include, at a minimum, a summary of progress toward the achievement of the originally stated aims, a list of significant results (positive and/or negative), a list of publications and the grant number. If human subjects were included in the research, the final progress report should also address the following: 

 • Report on the inclusion of gender and minority study subjects (using the gender and minority Inclusion Enrollment Form as provided in the PHS 2590 and available at http ://grants.nih.gov/grants/forms.htm). 

 • Where appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children (see "Public Policy Requirements and Objectives-Requirements for Inclusiveness in Research Design-Inclusion of Children as Subjects in Clinical Research" in the PHS 398 at URL  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm#_Toc54600090) 

 • Describe any data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information resulting from the research that is available to be shared with other investigators and how it may be accessed. 

 Note, if this is the final year of a competitive segment due to the transfer of the grant to another institution, then not all the requirements stated above are applicable. Specifically a Final Progress Report is not required. However, a final FSR is required and should be submitted electronically as noted above. In addition, if not already submitted, the Final Invention Statement is required and should be sent directly the assigned Grants Management Specialist. 

 Treatment of Program Income: 

 Additional Costs 

 SECTION IV – DA Special Terms and Conditions – 3R44DA018515-03S1 

 This award provides supplemental funds of $419,898 Total Costs ($366,755 Direct Costs, $25,673 F&A Costs and $27,470 Fixed Fee) for the purpose of covering the unanticipated FDA mandated changes. These funds are restricted for stated purpose, in request dated 12/8/2009, from H. Ralph Snodgrass, President and CSO, VistaGen Therapeutics, Inc. and may not be used for any other purpose, without Grants Management Branch, NIDA approval. 

 This award is subject to the current Data Safety Monitoring Plan (DSMP) submitted and previously approved by NIDA. Any changes in the DSMP must be reviewed and approved by the Program Official. If changes are approved, the approval will be reflected on the Notice of Grant Award. If changes are not approved, the Principal Investigator must revise the DSMP to the satisfaction of the Program Official. The Principal Investigator must provide a DSMP for any new trial that is to be conducted under this grant. 

 This award includes funds awarded for consortium activity with Cambridge Major Labs, Pharmatek, AvivoClin, MicroConstants, and Cato Research. Consortiums are to be established and administered as described in the NIH Grants Policy Statement (NIH GPS). The referenced section of the NIH Grants Policy Statement is available at http://grants1 .nih.gov/grants/policy/nihgps_2003/ NIHGPS_Part12.htm#_Toc54600251, pages 224-227. 

 INTELLECTUAL PROPERTY RIGHTS: Normally, the awardee organization retains the principal worldwide patent rights to any invention developed with United States Government support. Under Title 37 Code of Federal Regulations Part 401, the Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain circumstances, and requires that anyone exclusively licensed to sell the invention in the United States must normally manufacture it substantially in the United States. 

    

    

    

 

 Rights and obligations related to inventions created or reduced to practice as a result of this award are detailed in 35 U.S.C. 205 and 37 CFR Part 401. These inventions must be reported to the Extramural Invention Reporting and Technology Resources Branch, OPERA, NIH, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20892-7750, (301) 435-1986. For additional information, access the NIH link on the Interagency Edison web site (www.iedison.gov) which includes an electronic invention reporting system, reference information and the text to 37 CFR 401. 

 To the extent authorized by 35 U.S.C., Section 205, the Government will not make public any information disclosing an NIH-supported invention for a 4-year period to allow the awardee organization a reasonable time to file a patent application, nor will the Government release any information that is part of that patent application. 

 When purchasing equipment or products under this SBIR award, the grantee shall use only American-made items, whenever possible. 

 The fee provided as part of this Notice of Grant Award is in addition to direct and facilities and administrative costs. The fee is to be drawn down from the DHHS Payment Management System in increments proportionate to the draw down of costs. 

 Allowable costs conducted by for-profit organizations will be determined by applying the cost principles of Contracts with Commercial Organizations set forth in 48 CFR, Subpart 31.2. 

 The Code of Federal Regulations (Title 45 Part 74.26) stipulates that a commercial organization is subject to audit requirements for a non-federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is an HHS grant or subgrant. Therefore, the organization must have one grant or subgrant in order to be required to obtain a non-federal audit, but other HHS awards are included in the threshold calculations and the scope of the audit. (See threshold calculation examples, http://oamp.od.nih.gov/dfas/faqexamples.html.) 

 All grantees must acknowledge funding received from the National Institute on Drug Abuse at the National Institutes of Health when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with NIDA money. (NIH Grants Policy Statement, Part II, Page 114- Rights in Data (Publication and Copyrighting), December 2003). 

 In conjunction with this requirement, in order to most effectively disseminate research results, advance notice should be given to NIDA that research finds are about to be published so that we may coordinate accurate and timely release to the media. This information will be embargoed until the publication date. Any press notification should be coordinated with the NIDA Press Officer who can be reached at (301) 443-6245. 

 We strongly encourage all of our grantees to register in the eRA Commons. The eRA Commons provides grantees with the ability to electronically submit; e-SNAP applications, No cost extensions, Just in Time documents, Financial Status Reports, Final Progress Reports, and allows grantees to register to become e-mail enabled to receive Notice of Grant Awards (NGA). 

 NIDA has an interest in supporting HIV/AIDS and infectious disease research. The purpose of this support is to develop effective prevention, treatment, and service strategies for drug abusing youth and adults. To that end, awardees conducting HIV/AIDS research are encouraged to make every effort to incorporate scientific questions related to HIV/AIDS and other infectious diseases into research protocols. Principal Investigators will be required to provide information related to the development of research in this area in annual progress reports to allow NIDA to assess progress regarding HIV/AIDS research. 

 

    

    

    

 

 STAFF CONTACTS 

 The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail. 

 Grants Management Specialist: Diana Haikalis 

 Email: dh84m@nih.gov  Phone: (301) 435-1373  Fax: (301) 594-6849 

 Program Official: Amrat Patel 

 Email: ap79g@nih.gov  Phone: (30l) 443-8476 

 SPREADSHEET SUMMARY 

 GRANT NUMBER: 3R44DA018515-03S1 

 INSTITUTION: VISTAGEN THERAPEUTICS, INC. 

	
 Budget 

	
 Year 3 

	
 Travel Costs 

	
 $12,500 

	
 Consortium/Contractual Cost 

	
 $354,255 

	
 FEE 

	
 $27,470 

	
 TOTAL FEDERAL DC 

	
 $366,755 

	
 TOTAL FEDERAL F&A 

	
 $25,673 

	
 TOTAL COST 

	
 $419,898 

	    
	
 Facilities and Administrative Costs 

	
 Year 3 

	
 F&A Cost Rate 1 

	
 7% 

	
 F&A Cost Base 1 

	
 $366,755 

	
 F&A Costs 1 

	
 $25,673 

 

    

    

    

 

 Notice of Award 

 Issue Date:  08/09/2011 

 SMALL BUSINESS INNOVATION RESEARCH PROG 

 Department of Health and Human Services 

 National Institutes of Health 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Grant Number:  5R44DA01815-03 REVISED 

 Principal Investigator(s): 

 Ralph Snodgrass, PHD 

 Rice, Franklin 

 EVP Finance and Administration 

 384 Oyster Point Blvd #8 

 South San Francisco, CA  94080 

 Award e-mailed to:  rsnodgrass@vistagen.com 

 Budget Period:  07/01/2010 – 06/30/2010 

 Project Period:  07/01/2001 – 06/30/2012 

 Dear Business Official: 

 The National Institutes of Health hereby revises this award (see "Award Calculation" in Section I and "Terms and Conditions" in Section III) to VISTAGEN THERAPEUTICS, INC. in support of the above referenced project. This award is pursuant to the authority of 42 USC 241 42 CFR PART 52 15 USC 638 and is subject to the requirements of this statute and regulation and of other referenced, incorporated or attached terms and conditions. 

 Acceptance of this award including the "Terms and Conditions" is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system. 

 Each publication, that cites results from NIH grant-supported research must include an acknowledgment of NIH grant support and disclaimer such as "The project described was supported by Grant Number R44DA018515 from the National Institute On Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute On Drug Abuse or the National Institutes of Health." Prior to issuing a press release concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination. 

 Award recipients are required to comply with the NIH Public Access Policy. This includes submission to PubMed Central (PMC), upon acceptance for publication, an electronic version of a final peer-reviewed, manuscript resulting from research supported in whole or in part, with direct costs from National Institutes of Health. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. For additional information, please visit http://publicaccess.nih.gov/. 

 

    

    

    

 

 Award recipients must promote objectivity in research by establishing standards to ensure that the design, conduct and reporting of research funded under NIH-funded awards are not biased by a conflicting financial interest of an Investigator.  Investigator is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of NIH-funded research or proposed research, including the Investigator's spouse and dependent children. Awardees must have a written administrative process to identify and manage financial conflict of interest and must inform Investigators of the conflict of interest policy and of the Investigators' responsibilities. Prior to
expenditure of these awarded funds, the Awardee must report to the NIH Awarding Component the existence of a conflicting interest and within 60 days of any new conflicting interests identified after the initial report. Awardees must comply with these and all other aspects of 42 CFR Part 50, Subpart F. These requirements also apply to subgrantees, contractors, or collaborators engaged by the Awardee under this award. The NIH website http://grants.nih.gov/grants/policy/coi/index.htm provides additional information. 

 If you have any questions about this award, please contact the individual(s) referenced in Section IV. 

 Sincerely yours, 

 Diana Haikalis 

 Grants Management Officer 

 NATIONAL INSTITUTE ON DRUG ABUSE 

 Additional information follows 

 SECTION I – AWARD DATA – 5R44DA018515-03 REVISED 

	
 Award Calculation (U.S. Dollars) 

	    	    
	
 Salaries and Wages 

	    	
 $72,400 

	
 Fringe Benefits 

	    	
 $17,376 

	
 Personnel Costs (Subtotal) 

	    	
 $89,776 

	
 Consultant Services 

	    	
 $16,068 

	
 Supplies 

	    	
 $555,203 

	
 Consortium/Contractual Cost 

	    	
 $677,247 

	    	    	    
	    	    	    
	
 Federal Direct Costs 

	    	
 $1,338,294 

	
 Federal F&A Costs 

	    	
 $264,419 

	
 Approved Budget 

	    	
 $1,602,713 

	
 Fee 

	    	
 $112,190 

	
 Federal Share 

	    	
 $1,714,903 

	
 TOTAL FEDERAL AWARD AMOUNT 

	    	
 $1,714,903 

	    	    	    
	
 AMOUNT OF THIS ACTION (FEDERAL SHARE) 

	    	
 $0 

 

    

    

    

 

 SUMMARY TOTAL FEDERAL AWARD AMOUNT YEAR (3) 

	
 GRANT NUMBER 

	
 TOTAL FEDERAL AWARD AMOUNT 

	
 3R44DA018515-03 

	
 $1,714,903 

	
 5R44DA018515-03S1 

	
 $419,898 

	
 TOTAL 

	
 $2,134,801 

 SUMMARY TOTALS FOR ALL YEARS 

	
 YR 

	
 THIS AWARD 

	
 CUMULATIVE TOTALS 

	
 3 

	
 $1,714,903 

	
 $2,134,801 

 Fiscal Information:

	
 CFDA Number: 

	
 93.279 

	
 EIN: 

	
 1943301660A1 

	
 Document Number: 

	
 RDA018515B 

	
 Fiscal Year: 

	
 2010 

	
 IC 

	
 CAN 

	
 2010 

	
 DA 

	
 8742672 

	
 $1,714,903 

 NIH Administrative Data: 

 PCC:  MF/AP1   /   OC:  414E   /   Processed:  HAIKALIS 08/08/2011 

 SECTION II – PAYMENT/HOTLINE INFORMATION – 5R44DA018515-03 REVISED 

 For payment and HHS Office of Inspector General Hotline Information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm 

 SECTION III – TERMS AND CONDITIONS – 5R44DA01815-03 REVISED 

 This award is based on the application submitted to, and as approve d by, NIH on the above titled project and is subject to the terms and conditions incorporated either directly or by reference in the following: 

	
 a.   

	
 The grant programs legislation and program regulation cited in this Notice of Award. 

	
 b.   

	
 Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts. 

	
 c.   

	
 45 CFR Part 74 or 45 CFR Part 92 as applicable. 

	
 d.   

	
 The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period. 

	
 e.   

	
 This award notices, INCLUDING THE TERMS AND CONDITIONS CITED BELOW. 

 (See NIH Home Page at ‘http://grants.nih.gov/grants/policy/awardconditions.htm’ for certain references cited above.) 

 An unobligated balance may be carried over into the next budget period without Grants Management Officer prior approval. 

 This grant is subject to Streamlined Noncompeting Award Procedures (SNAP). 

 In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. 

 For more information, see NOT-OD-08-033 and the Public Access website:  http://publicaccess.nih.gov/ 

 This award provides support for one or more clinical trials.  By law (Title VIII, Section 801 of Public Law 110-85), the “responsible party” must register “applicable clinical trials” on the Clinical Trials.gov Protocol Registration System Information Website.  NIH Encourages registration of all trials whether required under the law or not.  For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

 

    

    

    

 

 This award represents the final year of the competitive segment for this grant.  Therefore, see the NIH Grants Policy Statement Section 8.6 Closeout for closeout requirements at:  http://grants.nih.gov/grants/policy#gps. 

 A final Federal Financial Report (FFR) (SF 425) must be submitted through the eRA Commons (Commons) within 90 days of the expiration date; see the NIH Grants Policy Statement Section 8.6.1 Financial Reports, http://grants.nih.gOv/grants/policy/#gps, for additional information on this submission requirement. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the
Payment Management System's (PMS) cash transaction data. 

 A Final Invention Statement and Certification form (HHS 568), (not applicable to training, construction, conference or cancer education grants) must be submitted through the eRA Commons (Commons) within 90 days of the expiration date. 

 Furthermore, unless an application for competitive renewal is submitted, a final progress report must also be submitted within 90 days of the expiration date. Institute/Centers may accept the progress report contained in competitive renewal (type 2) in lieu of a separate final progress report. Contact the awarding IC for IC-specific policy regarding acceptance of a progress report contained in a competitive renewal application in lieu of a separate final progress report. 

 NIH strongly encourages electronic submission of the final progress report and the final invention statement through the Closeout feature in the Commons. If the final progress report and final invention statement are not submitted through the Commons, a copy can be emailed or sent to the contacts listed below. Copies of the HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm. 

 Submissions of the final progress report and HHS 568 may be e-mailed as PDF attachments to the NIH Central Closeout Center at: DeasCentralized@.od.nih.gov. 

 Paper submissions of the final progress report and the HHS 568 may be faxed to the NIH Central Closeout Center at 301-480-2304 or mailed to the NIH Central Closeout Center at the following address: 

 NIH/OD/OER/DEAS 

 Central Closeout Center 

 6705 Rockledge Drive, Room 2207 

 Bethesda, MD 20892-7987 (for regular or U.S. Postal Service Express mail) 

 Bethesda, MD 20817 (for other courier/express mail delivery only) 

 The final progress report should include, at a minimum, a summary of progress toward the achievement of the originally stated aims, a list of significant results (positive and/or negative), a list of publications and the grant number. If human subjects were included in the research, the final progress report should also address the following: 

 Report on the inclusion of gender and minority study subjects (using the gender and minority Inclusion Enrollment Form as provided in the PHS 2590 and available at http://grants.nih.gov/grants/forms.htm). 

 Where appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children (see NIH Grants Policy Statement Section 4.1.15.7 Inclusion of Children as Subjects in Clinical Research at URL http://grants.nih.gOv/grants/policy/#gps). 

 Describe any data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information resulting from the research that is available to be shared with other investigators and how it may be accessed. 

 

 Any other specific requirements set forth in the terms and conditions of the award must also be addressed in the final progress report. 

 

    

    

    

 

 Note, if this is the final year of a competitive segment due to the transfer of the grant to another institution, then not all the requirements stated above are applicable. Specifically a Final Progress Report is not required. However, a final FFR is required and should be submitted electronically as noted above. In addition, if not already submitted, the Final Invention Statement is required and should be sent directly the assigned Grants Management Specialist. 

 Treatment of Program Income: 

 Additional Costs 

 SECTION IV – DA Special Terms and Conditions – 5R44DA018515-03 REVISED 

 REVISED AWARD:  The purpose of this revision is to change the budget and project period end-dates from 06/30/11 to 06/30/12 in accordance with the letter of 08/04/11 from H. Ralph Snodgrass, Ph.D., and Franklin Rice, M.B.A./VistaGen. This revision supersedes the NoA issued 06/26/10. 

 This award includes funds awarded for consortium activity with Cambridge Major Labs, Pharmatek, AvivoClin, MicroConstants, and Cato Research in the amount of $677,247. Consortiums are to be established and administered as described in the NIH Grants Policy Statement (NIH GPS). The referenced section of the NIH Grants Policy Statement is available at http://grants1.nih.gOv/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600251, pages 224-227. 

 INTELLECTUAL PROPERTY RIGHTS: Normally, the awardee organization retains the principal worldwide patent rights to any invention developed with United States Government support. Under Title 37 Code of Federal Regulations Part 401, the Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain circumstances, and requires that anyone exclusively licensed to sell the invention in the United States must normally manufacture it substantially in the United States. 

 Rights and obligations related to inventions created or reduced to practice as a result of this award are detailed in 35 U.S.C. 205 and 37 CFR Part 401. These inventions must be reported to the Extramural Invention Reporting and Technology Resources Branch, OPERA, NIH, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20892-7750, (301) 435-1986. For additional information, access the NIH link on the Interagency Edison web site (www.iedison.gov) which includes an electronic invention reporting system, reference information and the text to 37 CFR 401. 

 To the extent authorized by 35 U.S.C, Section 205, the Government will not make public any information disclosing an NIH-supported invention for a 4-year period to allow the awardee organization a reasonable time to file a patent application, nor will the Government release any information that is part of that patent application. 

 When purchasing equipment or products under this SBIR award, the grantee shall use only American-made items, whenever possible. 

 The fee provided as part of this Notice of Grant Award is in addition to direct and facilities and administrative costs. The fee is to be drawn down from the DHHS Payment Management System in increments proportionate to the draw down of costs. 

 Allowable costs conducted by for-profit organizations will be determined by applying the cost principles of Contracts with Commercial Organizations set forth in 48 CFR, Subpart 31.2. 

 The Code of Federal Regulations (Title 45 Part 74.26) stipulates that a commercial organization is subject to audit requirements for a non-federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is an HHS grant or subgrant. Therefore, the organization must have one grant or subgrant in order to be required to obtain a non-federal audit, but other HHS awards are included in the threshold calculations and the scope of the audit. (See threshold calculation examples, http://oamp.od.nih.gov/dfas/faqexamples.html.) 

 

    

    

    

 

 This award represents the final year of the competitive segment (Phase I or Phase II) for this grant. Therefore, see the NIH Grants Policy Statement, December 2003, Part II, http://grants.nih.gOv/grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600151, pages 139-141, a Financial Status Report (SF 269) must be submitted within 90 days of the expiration date. In addition, unless an application for competitive renewal is
funded, grant closeout documents consisting of a Final Invention Statement (HHS 568), and a final progress report must also be submitted within 90 days of the expiration date. The Financial Status Report and Final Invention Statement are available at: http://grants.nih.gov/grants/forms.htm 

 There is no ?form page? for a Final Report. The Final Progress Report may be typed on plain white paper (or you may use the PHS 398 Continuation Page). The recommended length for the narrative portion is 10 pages. 

 

 {Include the next paragraph on Phase I only} 

 

 Phase I grantees that (1) do not intend to seek Phase II support or (2) are not prepared to submit a Phase II application within four months following the expiration of the Phase I budget period, must submit a final report of their Phase I effort. Otherwise, the Phase I Final Report is a part of the Phase II application. 

 The format for the Final Report is as follows: 

	
 1.   

	
 State the beginning and ending dates for the period covered by the SBIR/STTR Phase I/Phase II) grant. 

	
 2.   

	
 List all key personnel who have worked on the project during that period, their titles, dates of service, and number of hours devoted to the project. 

	
 3.   

	
 Summarize the specific aims of the Phase I grant. 

	
 4.   

	
 Provide a succinct account of published and unpublished results, indicating progress toward their achievement. Summarize the importance of the findings. Discuss any changes in the specific aims since the project was initiated. Include the Inclusion Enrollment Report with the final enrollment data for clinical research (MS Word or PDF). 

	
 5.   

	
 List titles and complete references to publications, and manuscripts accepted for publication, if any, that resulted from the project?s effort. Submit five copies of such items, except patent and invention reports, as an Appendix. 

	
 6.   

	
 List patents, copyrights, trademarks, invention reports and other printed materials, if any, that resulted from the project or describe patent status, trade secrets or other demonstration of IP protection. 

	
 7.   

	
 Describe the technology developed from this SBIR/STTR, its intended use and who will use it. 

	
 8.   

	
 Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). 

	
 9.   

	
 If applicable, describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND studies, filed an 1ND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved). 

	
 10.   

	
 Describe how your company has benefited from the program and/or the technology developed (e.g., firm's growth, follow-on funding, increased technical expertise, licensing agreements, spin-off companies, public offering [include stock exchange and symbol]). 

	
 11.   

	
 List of the generic and/or commercial name of product, process, or service, if any, that resulted from SBIR/STTR funding. If applicable, indicate the number of products sold. 

	
 12.   

	
 Provide the current number of employees (total full time equivalents [FTEs]). 

 If human subjects were included in the research, the final progress report should also address the following: 

	
 -   

	
 Report on the inclusion of gender and minority study subjects (using the gender and minority inclusion table as provided in the PHS 2590) 

	
 -   

	
 Where appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children (see Public Policy Requirements and Objectives Requirements for Inclusiveness in Research Design Inclusion of Children as Subjects in Clinical Research in the PHS 398 at URL http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm#_Toc54600090) 

	
 -   

	
 Describe any data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information resulting from the research that is available to be shared with other investigators and how it may be accessed. 

 The Final Progress Report and Final Invention Statement should be submitted in an electronic format. 

    

    

    

 

 If the grantee institution is registered to do business in the NIH Commons, all required documents should be submitted electronically. The Final Progress Report (FPR) and the Final Invention Statement (FIS) should be submitted electronically through the NIH Commons available at https://commons.era.nih.gov/commons/. 

 If electronic submission is not feasible, you may fax your documents to our central fax gateway at 301-480-2304. 

 If the grantee institution is registered to do business in the NIH Commons, the Financial Status Report (FSR) should be submitted electronically through the NIH Commons available at https://commons.era.nih.gov/commons/. Additional information on electronic submission of FSRs is available at the Commons Homepage or by contacting the eRA Helpdesk at:  commonsd@od.nih.gov or (866) 504-9552. 

 If electronic submission is not feasible, paper submission of the Financial Status Report may be mailed to: 

 Government Accounting Branch 

 Office of Financial Management 

 National Institutes of Health 

 2115 East Jefferson Street, MSU 8500 

 Ste. 4B432 

 Bethesda, MD  20892-8500 (Rockville, MD  20852 – Use for FedEx, UPS and other courier services) 

 This award is subject to the current Data Safety Monitoring Plan (DSMP) submitted and previously approved by NIDA. Any changes in the DSMP must be reviewed and approved by the Program Official. If changes are approved, the approval will be reflected on the Notice of Grant Award. If changes are not approved, the Principal Investigator must revise the DSMP to the satisfaction of the Program Official. The Principal Investigator must provide a DSMP for any new trial that is to be conducted under this grant. 

 The FDA Modernization Act of 1977 requires that NIH (and companies and universities) register all drug trials for serious or life threatening conditions. The NIH policy is that all NIH supported clinical trials will be registered regardless of whether or not the trial involves serious or life threatening conditions. 

 It is the responsibility of the Principal Investigator and the grantee organization to identify whether or not this funded research project must be registered. You are required to use the following definition in determining whether this research is/is not a clinical trial. 

 The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits these criteria of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be
considered to be a clinical trial if the test will be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects. 

 If this award is to support research that meets the NIH definition of a clinical trial above, please visit the following URL: <http://prsinfo.clinicaltrials.gov/> to register this award. 

 This award provides support for one or more NIH defined Phase III Clinical Trials. The NIH Policy for research support as an NIH Phase III Clinical Trial has been updated in Section III.B of the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research? Updated August 1, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-048.html). A description of plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups must be included in clinical trial protocols and the results of the subset analyses must be reported to NIH in the annual progress reports, competitive Renewal Applications
(Contract Renewals/Extensions), and in the required Final Progress Report, as stated in Section III.B of the Guidelines. However, as this award is part of NIDA?s Clinical Trials Network, which will have a lead investigator for each protocol, only that lead investigator will be responsible for implementing the requirement for any given protocol.. Nonetheless, each P.I. will still be responsible for providing the minority/gender figures for subjects enrolled under his/her node. 

 All grantees must acknowledge funding received from the National Institute on Drug Abuse at the National Institutes of Health when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with NIDA money. (NIH Grants Policy Statement, Part II, Page 114- Rights in Data (Publication and Copyrighting), December 2003). 

 

    

    

    

In conjunction with this requirement, in order to most effectively disseminate research results, advance notice should be given to NIDA that research finds are about to be published so that we may coordinate accurate and timely release to the media. This information will be embargoed until the publication date. Any press notification should be coordinated with the NIDA Press Officer who can be reached at (301) 443-6245. 

 We strongly encourage all of our grantees to register in the eRA Commons. The eRA Commons provides grantees with the ability to electronically submit; e-SNAP applications, No cost extensions, Just in Time documents, Financial Status Reports, Final Progress Reports, and allows grantees to register to become e-mail enabled to receive Notice of Grant Awards (NGA). 

 NIDA has an interest in supporting HIV/AIDS and infectious disease research. The purpose of this support is to develop effective prevention, treatment, and service strategies for drug abusing youth and adults. To that end, awardees conducting HIV/AIDS research are encouraged to make every effort to incorporate scientific questions related to HIV/AIDS and other infectious diseases into research protocols. Principal Investigators will be required to provide information related to the development of research in this area in annual progress reports to allow NIDA to assess progress regarding HIV/AIDS research. 

 STAFF CONTACTS 

 The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail. 

 Grants Management Specialist:  Diana Haikalis 

 Email:  dh84m@nih.gov   Phone:  301-435-1373   Fax:  301-594-6849 

 Program Official:  Amrat Patel 

 Email:  ap79g@nih.gov   Phone:  301-443-8476 

 SPREADSHEET SUMMARY 

 GRANT NUMBER:  5R44DA01815-03 REVISED 

 INSTITUTION:  VISTAGEN THERAPEUTICS, INC. 

	
 Budget 

	
 Year 3 

	
 Salaries and Wages 

	
 $72,400 

	
 Fringe Benefits 

	
 $17,376 

	
 Personnel Costs (Subtotal) 

	
 $89,776 

	
 Consultant Services 

	
 $16,068 

	
 Supplies 

	
 $555,203 

	
 Consortium/Contractual Cost 

	
 $677,247 

	
 FEE 

	
 $112,190 

	
 TOTAL FEDERAL DC 

	
 $1,338,294 

	
 TOTAL FEDERAL F&A 

	
 $264,419 

	
 TOTAL COST 

	
 $1,714,903 

	    
	
 Facilities and Administrative Costs 

	
 Year 3 

	
 F&A Cost Rate 1 

	
 40% 

	
 F&A Cost Base 1 

	
 $661,047 

	
 F&A Costs 1 

	
 $264,419 

 

 Exhibit 10.46 

 Issue date 6/22/09ex10-47.htm

 EXHIBIT 10.47 

 SIGN AND RETURN THIS PAGE TO CIRM    RT1-01012-1 

 NOTICE OF GRANT AWARD – CIRM RFA-08-02:  Tools & Technologies 

 California Institute for Regenerative Medicine 

 Issue Date:  April 1, 2009 

	
 Grant Number: 

	
 RT1-01012-1 

	
 Budget Period: 

	
 Annual as of 4/1/2009 

	
 Grantee Name: 

	
 VistaGen Therapeutics, Inc. 

	    	    
	
 Grantee ID: 

	
 PR-Y0002A-SF 

	
 Project Period Start: 

	
 4/1/2009 

	
 Principal Investigator: 

	
 Dr. Kristina C. Bonham 

	
 Project Period End: 

	
 3/31/2011 

	
 Project Title: 

	
 Development of an hES Cell-Based Assay System for Hepatocyte Differentiation Studies and Predictive Toxicology Drug Screening 

	
 Authorized Organizational Official and Address: 

 Ralph Snodgrass, PhD 

 CEO 

 VistaGen Therapeutics, Inc. 

 384 Oyster Point Blvd #8 

 South San Francisco, CA  94080 

	    	
 Official and Address to Receive Payments: 

 Cell Biology 

 Attn:  Kristina Bonham, PhD 

 VistaGen Therapeutics, Inc. 

 384 Oyster Point Blvd #8 

 South San Francisco, CA  94080 

 The California Institute for Regenerative Medicine (CIRM) hereby awards a grant in the amount of $971,558 to be disbursed over a total period of 2 years to VistaGen Therapeutics, Inc. (Grantee ID PR-Y0002A-SF) in support of the above referenced project. This award is pursuant to the California Stem Cell Research and Cures Act (Health and Safety Code section 125290.10 et. seq.) and is subject to terms and conditions referenced below. (Capitalized terms are defined in the CIRM Grants Administration
Policy for Academic and Non-Profit Institutions (GAP), a copy of which may be found on the CIRM website at: http://www.cirm.ca.aov/reg/pdf/req100500 policv.pdf.) 

 

 In accepting this Grant, the Grantee warrants to CIRM that any funds expended underthe award will be for the purposes set forth in the approved application and agrees to comply with all applicable CIRM regulations. See Item II (page 3) below. 

 To accept this Grant, the Principal Investigator and Authorized Organizational Official must sign and return this Notice of Grant Award (NGA) to CIRM within 45 days of the issue date. Payment will be issued only after the signed NGA is received by CIRM. Grant funds will be sent to the organization's address listed above under Official and Address to Receive Payments unless an updated address is provided in the box below. If the applicant cannot accept the award, including the legal obligation to perform in accordance with the provisions of this NGA, it should notify CIRM immediately. 

 If you have any questions about this award, please contact the CIRM staff referenced on page 3. 

	
 /s/ Marie Csete 

 Marie Csete, MD, Ph.D. 

 Chief Scientific Officer 

 California Instituted for Regenerative Medicine 

	
 Updated Address to Receive Payments: 

 

 

 AWARD ACCEPTANCE:  The Principal Investigator and Authorized Organizational Official must sign below and return the entire NGA to CIRM to accept the Grant award. 

	    	
 Principal  Investigator 

	
 Authorized Organizational Official 

	
 Name 

	
 Dr. Kristina C. Bonham 

	
 Ralph Snodgrass, PhD 

	
 Signature 

	
 /s/ Kristina C. Bonham 

	
 /s/ H. Ralph Snodgrass 

	
 Date 

	
 4/8/09 

	
 4/7/09 

 

 SIGN AND RETURN TO CIRM 

    

    

    

 

 RT1-01012-1 

 NOTICE OF GRANT AWARD 

 California Institute for Regenerative Medicine 

 

 I. AWARD DATA: 

 AWARD DETAIL (U.S. Dollars): 

	    	
 Year l 

	
 Year 2 

	
 Direct Project Costs 

	    	    
	
 Personnel (Non -Trainee) Costs 

	
 $252,001 

	
 $253,127 

	
 Trainee Costs 

	    	    
	
 Travel 

	
 $9,800 

	
 $10,000 

	
 Supplies 

	
 $30,000 

	
 $28,800 

	
 Equipment 

	
 $ 0 

	
 $ 0 

	
 Consultants/Subcontracts 

	
 $8,000 

	
 $8,000 

	
 Total Project Costs 

	
 $299,801 

	
 $299,927 

	
 Facilities Costs 

	    	    
	
 Facilities Costs - Category A 

	
 $ 52,465 

	
 $ 52,487 

	
 Facilities Costs - Category B 

	
 $ 52,465 

	
 $ 52,487 

	
 Indirect Costs 

	    	    
	
 Indirect Costs 

	
 $80,946 

	
 $80,980 

	
 APPROVED BUDGET TOTAL 

	
 $485,677 

	
 $485,881 

 QUARTERLY INSTALLMENTS ON GRANT PAYMENTS 

 Payments will be made in quarterly installments, issued at the beginning of each quarter.  Quarters will be tied to the project start date.  The final quarterly installment will be held until completion of Close-Out. 

 *Any interest accrued by the Grantee from the Grant payment must be used for the CIRM Tools & Technologies Program. 

 PROGRESS REPORTS SCHEDULE 

	    	
 Year 1 

	
 Year 2 

	
 Programmatic Report 

	
 2/1/2010 

	
 2/1/2011 

	
 Financial Report 

	
 7/1/2010 

	
 7/1/2011 

	
 Close-Out Report 

	
 n/a 

	
 7/1/2011 

    

    

    

 

 RT1-01012-1 

 NOTICE OF GRANT AWARD 

 California Institute for Regenerative Medicine 

 II. TERMS AND CONDITIONS 

 This award is based on the application submitted to CIRM, and as approved by the Independent Citizens' Oversight Committee (ICOC) on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following: 

	
 A.   

	
 The California Stem Cell Research and Cures Act (Health and Safety Code Section 125290.10 et. seq.) and regulations adopted by the ICOC. 

	
 B.   

	
 The CIRM Interim Grants Administration Policy for For-Profit Organizations (Title 17, California Code of Regulations, Section 100501), CIRM Grants Administration Policy for Academic and Non-Profit Institutions (Title 17,  California Code of Regulations, Section 100500), CIRM Intellectual Property Policy and Revenue Sharing Requirements for For-Profit Organizations, the CIRM Medical and Ethical Standards Regulations (Title 17, California Code of Regulations, Sections 100010-1000110),
CIRM Use of Fetal Tissue (Title 17, California Code of Regulations, Section 10085), and any subsequently adopted applicable regulations. 

 

	
 C.   

	
 The terms and requiremenets detailed in RFA 08-02: CIRM Tools and Technologies Awards. 

 

	
 D.   

	
 Grantee shall not commence work on the K117 hESC line until approval to use this line is granted by the institution’s SCRO committee and documentation of that verifies such approval has been received by CIRM. 

 

	
 E.   

	
 The timing of the distribution of funds pursuant to this grant shall be contingent upon the availability of funds in the California Stem Cell Research and Cures Fund in the State Treasury, as determined by CIRM in its sole discretion. 

 Please check the following website for updated policy documents: http://www.cirm.ca.qov/req/ 

 III. CIRM CONTACTS: 

 Andrew McFarland, Grants Management Specialist 

 Phone:  (415) 396-9126   Email:  amcfarland@cirm.ca.gov   Fax:  (415) 396-9141 

 Sohel Talib, PhD, Scientific Program Officer 

 Phone:  (415) 396-9137   Email:  stalib@cirm.ca.gov   Fax:  (415) 396-9141 

 The CIRM home page is at http://www.cirm.ca.gov 

 CIRM Mailing Address: 

 California Institute for Regenerative Medicine 

 Attn:  Andrew McFarland, Grants Management Specialist 

 210 King Street 

 San Francisco, CA  94107 

 

    

    

    

 

 RT1-01012-1  

 Budget Adjustments  

 Note 1:  None    

 Note 2:    

 Note 3: 

 

	   	
 Year 1 Requested Amount 

	 Year 1 Approved Budget 	 Year 2 Requested Amount 	 Year 2 Approved Budget 	  Year 2 Expenditure Report 	 Total Approved Budget 

 Exhibit 10.47

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