DATE: TO: THROUGH: FROM: SUBJECT: National Institutes of Health Office of intramural Research April 21,2015 Richard U. Rodriguez Acting Director, NIH Of?ce of Technology Transfer (OTT) Director, DTDT, Susan Ann, Chief, Infectious Diseases and Medical Engineering Branch. DTDT, OTT Kevin W. Chang. PILD. Senior Licensing and Patcnting Manager, IDME, DTDT, OTT Final Determination: Regarding license application for a Stan-Up Exclusive Patent License Agreement (A-OZ from Virotas Biopharmaeeuticals, LLC for: Ed? 1-20I4l0 Patent Family, entitled ?Use of and Its Related AnaIOgs? U.S. Provisional Patent App]. No. 6 U909, 414 (HHS Ref. No. 1-20 MID-US-O I) filed November 27, 2013 International PCT Appl. No. (HHS Ref. No. 13?01 ?led November 20, 2014 Taiwanese Patent Appl. n. (HHS Ref. No. ?led November 26, 2014 US. Provisional Patent Appl. No. 6210] 1,462 HHS Ref. No. E-l fat-20] filed June 20M Inventorls): 1) E411 1?2014?) Patent Family lake Liang (NIDDK), Shanshan He (NIDDK), Zongyi (NIDDK), Wei Zhang (NCATS), Noel T. Southall (NCATS), Juan Marugan (NCATS). Xin Hu (NCATS), Jiangbo Xian (NCATS). and Marc Ferrer-Alegre (NCATS) 2) Patent Family Jake Liang Shanshan He (NIDDK). Zongyi Hu (NIDDK), Wei Zhang (NCATS), Noel T. Southall (NCATS), Juan Mamgan (NCATS), Xin Hu (NCATS), Jiangbo Xian (NCATS), Marc Ferrer?Alegre (NCATS), Kevin J. Frankowski (University of Kansas), Frank J. Schoenen (University of Kansas), and Kelin Li (University of Kansas) CONFIDENTIAL Final lord-0212015 Biophaitnaccuualx. Page 3 Ul 3 FINAL DETERMINATION Virutas tVirotuK hereafter) submitted it license application for cxclusiw commercial license, pursuant to initiative program tor the above referenced atcnt a i \lications on October 9. 201-preliminary meeting was held on March 20. 3015 and there were no from either members of OTT or the to moving forward with the start-up. ex?ctusixe license. ?llie intent to grant the cxcluxive license was pithtiuhed in the March ltti? issue of the Federal Register (vol. Sf). HO it), pg, l??xX?h for public comment. During the comment )eritid commentx (attached) were. received. One was received from a private Citizcn and the other comment was received from Knowledge Ecology International and .itizen. No license applications were submitted with the. comments. . two TECHNOLOGY The \?th majorin of people infected with Hepatitis will have chronic infection Over decades. this can lead to liver diseaw and liver cancer. In fact. HCV infection is currently the leading causc of liver transplants the Several new drugs have recently come into the market that have changed the treatment paradigm. Howetet: the effectiveness of these new drugs can var) depending.) on the genotype Additionally, the high costs of these new therapeutics may be a barrier to particularly in deteloping countries. Thus. there is .still the need for additional new tlzerapetiticx against The subject lt?Ci?t?OiUgl?b are amall molecule compounds for the treatment of infection identified using a novel cell-haQed high throughput asmy. The compounds disclosed in 0 1 Zl'llr-l the derivatives or that Show potent antiriral properties against HCV. in already on the market for the treatment of allergic tcactionx. has used in humam. and has excellent safety pro?le with known pharmaceutical prupertiex. 'lhe compounds in 13-10 1 -20 4/0 are additional lietei?m?yclic compounds that were also found to have anti-HCV? activity. In t't'rm data for the subject technologies are availahlc 'l'he. CONFIDENTIAL Fiml Dru-[mi mini Iii!" 2013? Biupimi'mugculix?hlx. LLC Page MW 3 Nihich can potentially used in combination with caidi and Mimi AND PLAN NEXT STEP THE LICENSING PROCESS Barring any l'iuili NIDDK will ncgut?alc stall?up. cu'lmiw ill] (or the subject applicatiom. SIGNATURE Richard u. Rodr guez ?3 - i i Dale: Richard U, Rodriguez Acting Director. NIH. Directoi. DTDT. cc; Anita Aznaig MDDK Lili P?l'iillil. APPENDIX EX ROYALTY REPORT Required royalty report info rmation includes: OTT license reference nurrber 0 Reporting period 0 Catalog number and units sold ol each Licensed Product (domestic and foreign) - Gross Sa es per catalog numbe' per country Total Gross Sales - Itemized deductions from Gross Sales 0 Total Net Sales Earned Royalty Rate and associated caleulations 0 Gross Earned Royalty Adjustments fer Vlinimum Annual Royalty (MAR) and other creditable payments made 0 Net Earned Royalty due Example Catalog Number Product Name Country Unlts Sold Gross Sales is; 1 A US 250 62.500 1 A UK 32 16,500 1 A France 25 15.625 57,125 4 US 12 1,500 Total Gross Sales 153,750 Less Deductions. Freight 3.000 Retums 7,000 Total Net Sales 143,250 Royalty Rate 8% Royalty Due 11,460 Less Creditable Payments 10,000 Net Royalty Due 1,460 NIH Star Jp Patent Licczixu Alil?t?t'lrt'mufti lmi M11131 00 soil tLpdutcd a-zmz) Past: 2mm APPENDIX (2 OPTIONS 'l'lie License Nimber MUST appear on payments. reports and correspondence. Automated (flearing House (Mill) for payments through banks only The encourages its licensees to submit eicc?tmtlic funds transfer payments through the Automated Clearing House (AC 1). Submit your ACll payment through the US. Treasury web site located at: locate the Royalty Payment Page" through the HHS link in the Pay-gov "Agency List". Electronic Funds Wire Transfers The following account information is provzded for Wll?c payments. Ir. order to process payment vm Electronic Funds Wire Transfer sender MUST supply the following information within the transmission: Drawn on a US. bank account via should be sent directly to the following account: Bene?ciary Account: Federal Reserve Bank of New York or TREAS NYC Bank: Federal Reserve Banlt ofNew York 02 Account Number: 750800? Bank Address: 33 Liberty Street. New York. NY ?1045 Payment Details: Number XX) Name ofthe Licensee Drawn on a foreign bank account should be sent directly to the liilluwiitg account. Payment inmt he sent in Dollars wing the folluuing Bene?ciary Account: Federal Reserve Bank of New or Bank: (?Itihnnk NA (New York) SWIFT Code: CITIUSSJ Account Number: 36838868 Bank Address: 388 Greenwich Street. New York. NY 10013 Payment (l .mc 7012 NIH 750800? License Number Name of the Licensee Detail el?Charges (line "flat; Charge Our (5) CONFIDENTIAL Start-l lp Pnu-nl icenw Agreementfir-imi- I Checks All checks should made payable Patent Licensing? Chucks drawn on A US. bank account and sent by Postal should he 1hr following Nallonzll Institutes of [with (NIH) Box 9"?071 SI. Louis, MO 63197?90?) Checks drawn on a US. bank account and sent by overnioI ht or courier should be sent to the following addrescr US Bank (on emment Lockbox IUUS (?om'entzon St. Louis. MO 03 10 Phone: 3H-4I8-4US7 (heck; draw-1 on a fon'ign bank account should be sent directly to the follmx'tng address: Naniunul lnslilLics uf Of?ce ?l Royalties Admmistmtic-n Um! um I L?Acvutm: Suite 325, .?vle 7660 Ruckxillg Maryland 20852 (5) Stu If. l?ulunl Amen-Iran? Mudul 00-10? (LdeL-d Pugc .?Orl?lo