CONFIDENTIAL LICENSEAMENDMENT

EX-10.114 5 dex10114.htm AMENDMENT TO NON-EXCLUSIVE PATENT & LICENSE AGMT. Prepared by R.R. Donnelley Financial -- Amendment to Non-Exclusive Patent & License Agmt.

Exhibit 10.114

[LETTERHEAD OF DEPARTMENT OF HEALTH & HUMAN SERVICES]

 

 

April 5, 2002

 

Dr. Nancy Katz
Calpyte Biomedical Corporation, Inc.
1265 Harbor Bay Parkway
Alameda, CA  94502

 

SUBJECT: OTT Reference Number: L-108-99/1
  USPA SN: 06/602,945  06/602,946
  Effective Date: 03/15/02
  Institute: NCI

Dear Dr. Katz:

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, 6011 Executive Boulevard, Suite 325, Rockville, Maryland  20852, Attention: Royalties Section.

Also, please be sure to write the OTT 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 ###-###-#### or by facsimile at ###-###-####.

Sincerely,

/s/ Barbara Ward

Barbara Ward
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:

  •   OTT 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

Catalog Number Product Name Country Units Sold Unit Price Gross Sales
(US$)
1 A US 250 250.00 62,500
1 A UK 32 515.62 16,500
1 A France 25 625.00 15,625
2 B US 0 440.00 0
3 C US 57 1,002.19 57,125
4 D US 12 125.00 1,500
      Total Gross Sales
153,250                
         Less Deductions:    
      Freight
3,000                
      Returns
7,000                
                       Total Net Sales  
143,250                
                       Royalty Rate  
8%                  
                       Royalty Due  
11,460                
   

 

 Less MAR payment  
10,000                
                       Net Royalty Due  
1,460                

 

Mail royalty reports to: Mail payment to:
Ms. Linda Harris   National Institutes of Health
Office of Technology Transfer   P.O. Box 380120
National Institutes of Health   Pittsburgh, PA ###-###-####
6011 Executive Blvd., Suite 325   Make out check to “NIH Patent Licensing”
Rockville, MD 20852-3804   OTT 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/ Jack Spiegel 3/15/2002  
 
Jack Spiegel, 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
6011 Executive Boulevard, Suite 325
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/ Nancy E. Katz 3/20/02  
 
Nancy Katz Date  
CEO

Mailing Address for Notices:

Nancy Katz
CEO
Calypte Biomedical Corp.
1265 Harbor Bay Pkwy.
Alameda, CA 94502
Phone:   ###-###-####
Fax:        ###-###-####

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).