LETTERHEAD OF DEPARTMENT OF HEALTH & HUMAN SERVICES] April 5, 2002 Dr. Nancy Katz Calpyte Biomedical Corporation, Inc. 1265 Harbor Bay Parkway Alameda, CA 94502
Exhibit 10.114
[LETTERHEAD OF DEPARTMENT OF HEALTH & HUMAN SERVICES]
April 5, 2002
Dr. Xxxxx Xxxx
Calpyte
Biomedical Corporation, Inc.
0000 Xxxxxx Xxx Xxxxxxx
Xxxxxxx, XX 00000
SUBJECT: | XXX Reference Number: L-108-99/1 |
USPA SN: 06/602,945 06/602,946 | |
Effective Date: 03/15/02 | |
Institute: NCI |
Dear Xx. Xxxx:
On behalf of the National Institutes of Health, I am please to enclose a copy of the above referenced License Agreement. When the agreement was executed, your Company retained your original.
If applicable, enclosed are the invoices for the license issue and the first minimum annual royalty payment which is due under the terms of this agreement.
Please mail correspondence, reports and official notices directly to the Office of Technology Transfer, 0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxx 00000, Attention: Royalties Section.
Also, please be sure to write the XXX Reference Number L-109-99/1 on all checks, correspondence, and official notices relating to this license agreement. This will ensure prompt and accurate credit to your agreement.
If you have any questions or concerns, please don't hesitate to telephone me at (000) 000-0000 extension 214 or by facsimile at (000) 000-0000.
Sincerely,
/s/ Xxxxxxx Xxxx
Xxxxxxx
Xxxx
Royalties Coordinator
via: Overnight Mail
CONFIDENTIAL
LICENSE AMENDMENT
Whereas, the Public Health Service (PHS), Department of Health and Human Services (DHHS) and Calypte Biomedical Corporation, Inc. (Licensee) entered into a license agreement (L-108-99/0) effective August 6, 1996 relating to U.S. Patents 4,520,113, 4,647,773, 4,652,599, 4,708,818 and 5,135,864 and corresponding international patents disclosing antibody tests for HIV-1 ("Agreement"); and
Whereas PHS and Licensee wish to amend the Licensed Fields of Use of the Agreement by including all currently existing products of Licensee that detect HIV-1 antibodies in human body fluids, except for the Calypte HIV-1 urine EIA that uses a recombinant gp160 antigen as Licensed Products in order to permit Licensee to commercialize such products under the Licensed Patent Rights and protect the interests of PHS; and
Whereas Licensee has accumulated significant unpaid earned royalties, due under the Agreement; and
Whereas PHS has negotiated a payment plan with Licensee to cure the unpaid royalties and maintain the Agreement in compliance with its terms;
Now Therefore, in consideration of the foregoing, PHS and Licensee hereby agree to amend the subject Agreement as follows:
Replace Paragraph 9.04 with the following:
9.04 |
Licensee shall submit to PHS within thirty (30) days after each calendar quarter-year ending March 31, June 30, September 30 and December 31 a royalty report setting forth for the preceding quarter-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due, and additional information, as specified in and according to the format in, Appendix G. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of Licensee and shall include a detailed listing of all deductions made under Paragraph 2.10 to determine Net Sales made under Article 6 to determine royalties due. If, by January 30, 2003, all back royalties specified in the Payment Plan and all 2002 royalties have been paid, then Licensee shall submit to PHS within sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding quarter-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due, and additional information, as specified in and according to the format in, Appendix G. |
Appendix B
Replace the Licensed Fields of Use with the following:
Production and sale of HIV-1 lysate and immunodiagnostic products for detection of HIV-1 antibodies in human body fluids.
Add an Appendix G:
Appendix G--Royalty Report
SAMPLE LICENSE ROYALTY REPORT |
Report information includes:
- XXX license reference number (L-108-99/1)
- Reporting period
- Catalog number, unit price and units sold of each Licensed Product (domestic, foreign and sublicensee sales)
- Gross Sales per catalog number per country, converted to US dollars (include foreign currency conversion rate)
- Total Gross Sales
- Itemized deductions from Gross Sales
- Total Net Sales
- Earned Royalty Rate and associated calculations
- Gross Earned Royalty
- Adjustments for Minimum Annual Royalty (MAR) paid
- Net Earned Royalty due
Example
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Catalog Number | Product Name | Country | Units Sold | Unit Price | Gross Sales (US$) |
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1 | A | US | 250 | 250.00 | 62,500 |
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1 | A | UK | 32 | 515.62 | 16,500 |
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1 | A | France | 25 | 625.00 | 15,625 |
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2 | B | US | 0 | 440.00 | 0 |
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3 | C | US | 57 | 1,002.19 | 57,125 |
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4 | D | US | 12 | 125.00 | 1,500 |
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Total Gross Sales | 153,250 | ||||
Less Deductions: | |||||
Freight | 3,000 | ||||
Returns | 7,000 | ||||
Total Net Sales | 143,250 | ||||
Royalty Rate | 8% |
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Royalty Due | 11,460 | ||||
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Less MAR payment | 10,000 | |||
Net Royalty Due | 1,460 |
Mail royalty reports to: | Mail payment to: | |
Ms. Xxxxx Xxxxxx | National Institutes of Health | |
Office of Technology Transfer | P.O. Box 380120 | |
National Institutes of Health | Pittsburgh, PA 15251-6120 | |
0000 Xxxxxxxxx Xxxx., Xxxxx 000 | Make out check to “NIH Patent Licensing” | |
Rockville, MD 20852-3804 | XXX license reference number must appear on check |
Payment Plan
Licensee agrees to the following payment plan:
Due Date | Unpaid Amount Due |
Additional Payments Due | ||
4/30/2002 | Q1 2002 royalties | |||
6/30/2002 | 100,000 | |||
7/31/2002 | Q2 2002 royalties | |||
9/30/2002 | 100,000 | |||
10/31/2002 | Q3 2002 royalties | |||
12/31/2002 | 105,259 | |||
1/30/2003 | Q4 2002 royalties | |||
8/31/2003 | First half 2003 royalties | |||
Total | 305,259 |
Following the last year 2002 payment in the table above, Licensee will continue to pay earned royalties due within sixty (60) days of the end of each calendar year.
In all other respects, the Agreement effective August 6, 1996, remains in full force and effect.
SIGNATURE PAGE
In Witness Whereof, the parties have executed this amendment on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.
For PHS:
/s/ Xxxx Xxxxxxx | 3/15/2002 | ||
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Xxxx Xxxxxxx, Ph.D. | Date | ||
Director Division of Technology Development and Transfer | |||
Office of Technology Transfer | |||
National Institutes of Health |
Mailing Address for Notices: | Office of Technology Transfer | |
National Institutes of Health | ||
0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000 | ||
Rockville, Maryland 20852-3804 |
For Licensee (The undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.)
/s/ Xxxxx X. Xxxx | 3/20/02 | ||
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Xxxxx Xxxx | Date | ||
CEO |
Mailing Address for Notices:
Xxxxx Xxxx
CEO
Calypte Biomedical Corp.
0000 Xxxxxx Xxx Xxxx.
Alameda, CA 94502
Phone: 000-000-0000
Fax:
000-000-0000
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. "3801-3812 (civil liability) and 18 U.S.C. '1001 (criminal liability including fine(s) and/or imprisonment).