EXHIBIT 10.5
AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Amendment is made and entered into as of the date signed by the last
party to sign below (the "Effective Date"), by and between The Medicines
Company, a Delaware corporation having its principal office at One Cambridge
Center, Cambridge, MA 02142 ("Licensee"), and GyneLogix, Inc., having its
principal office at 280 South Taylor Ave., Suite 100, Louisville, CO
("Licensor").
INTRODUCTION
1. Licensor and Licensee entered into that certain Development and
Commercialization Agreement, dated effective as of August 16, 1999, (the
"Agreement"), relating to the licensing and development of a novel Lactobacillus
crispatus strain known as CTV-05.
2. Licensor and Licensee now wish to amend the Agreement to provide for a
reduced level of activity at Licensor's Boulder Facility and a corresponding
reduction in Licensee's funding of the Facility.
In consideration of the mutual covenants and promises contained in this
Amendment and the Agreement and other good and valuable consideration, the
receipt of which is hereby acknowledged, Licensor and Licensee hereby agree as
follows:
Article I. Capitalized terms used herein and not defined herein shall have
the respective meanings ascribed to such terms in the Agreement.
Article II. Effective April 1, 2002, Licensee's maximum financial
responsibility for the monthly operating expenses of the Boulder Facility shall
be reduced to an amount not to exceed $28,000. The details of the monthly
operating budget are set forth in Appendix A, attached hereto and made a part
hereof. Licensor agrees to continue to provide to Licensee the following
services at the Boulder Facility:
- Continuation of the current CTV-05 stability program
- Continuation of technology transfer for CTV-05
- As-needed support in connection with Licensee's CTV-05
process improvement activities
- As-needed support in connection with Licensee's CTV-05
regulatory filings and other regulatory activities
Unless Licensor and Licensee otherwise agree in writing, Licensee's obligation
to continue funding the operation of the Boulder Facility will terminate on
January 31, 2003.
Article III. This Amendment and the Agreement together constitute the
entire agreement and understanding between the parties relating to the subject
matter hereof and thereof.
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Article IV. This Amendment shall be governed in all respects by the laws
of the Commonwealth of Massachusetts, excluding its conflicts of laws
principles.
Article V. In all other respects, the Agreement shall remain in full force
and effect.
This Amendment may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed
by duly authorized representatives as of the day and year first above written.
GYNELOGIX, INC.
By: /s/ Gerald L. Chrisope
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Name: Gerald L. Chrisope
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Title: President
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Date: March 26, 2002
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THE MEDICINES COMPANY
By: /s/ John M. Nystrom
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Name: John M. Nystrom
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Title: Vice President and Chief Technology Officer
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Date: March 26, 2002
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APPENDIX A AMENDMENT TO COMMERCIALIZATION AGREEMENT
MONTHLY EXPENSE APRIL-02 MAY-02 JUNE-02 JULY-02 AUGUST-02 SEPTEMBER-02
- --------------- -------- ------ ------- ------- --------- ------------
BASE OVERHEAD
RENT $ 7,982.00 $ 7,982.00 $ 7,982.00 $ 7,982.00 $ 7,982.00 $ 7,982.00
UTILITIES $ 1,250.00 $ 1,250.00 $ 1,250.00 $ 1,250.00 $ 1,250.00 $ 1,250.00
DUES $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 250.00
EQUIPMENT RENTAL $ 290.00 $ 290.00 $ 290.00 $ 290.00 $ 290.00 $ 290.00
LIABILITY INSURANCE $ 160.00 $ 160.00 $ 160.00 $ 160.00 $ 160.00 $ 160.00
BUILDING MAINTENANCE/REPAIRS $ 400.00 $ 400.00 $ 400.00 $ 400.00 $ 400.00 $ 400.00
OFFICE SUPPLIES $ 230.00 $ 230.00 $ 230.00 $ 230.00 $ 230.00 $ 230.00
POSTAGE/DELIVERY $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 250.00
REFERENCE MATERIALS $ 255.00 $ 255.00 $ 255.00 $ 255.00 $ 255.00 $ 255.00
PROPERTY TAXES $ 195.00 $ 195.00 $ 195.00 $ 195.00 $ 195.00 $ 195.00
TELEPHONE $ 440.00 $ 440.00 $ 440.00 $ 440.00 $ 440.00 $ 440.00
OVERHEAD SUBTOTAL $ 11,702.00 $ 11,702.00 $ 11,702.00 $ 11,702.00 $ 11,702.00 $ 11,702.00
PAYROLL $ 14,250.00 $ 14,250.00 $ 14,250.00 $ 14,250.00 $ 14,250.00 $ 14,250.00
SALARY $ 1,425.00 $ 1,425.00 $ 1,425.00 $ 1,425.00 $ 1,425.00 $ 1,425.00
PAYROLL TAXES $ 522.00 $ 522.00 $ 522.00 $ 522.00 $ 522.00 $ 522.00
EMPLOYEE HEALTH
PAYROLL SUBTOTAL $ 16,197.00 $ 16,197.00 $ 16,197.00 $ 16,197.00 $ 16,197.00 $ 16,197.00
DIRECT COSTS AS AUTHORIZED BY TMC
LEGAL SERVICES (PATENT)
TRAVEL
CLINICAL TRIAL SUPPLIES
MANUFACTURING SUPPLIES
PRODUCT EQUIPMENT EXPENSE
DIRECT COSTS SUBTOTAL
MONTHLY TOTAL $ 27,899.00 $ 27,899.00 $ 27,899.00 $ 27,899.00 $ 27,899.00 $ 27,899.00
CONTRACT
MONTHLY EXPENSE OCTOBER-02 NOVEMBER-02 DECEMBER-02 JANUARY-03 TOTAL
- --------------- ---------- ----------- ----------- ---------- --------
BASE OVERHEAD
RENT $ 7,982.00 $ 7,982.00 $ 7,982.00 $ 7,982.00 $ 79,820.00
UTILITIES $ 1,250.00 $ 1,250.00 $ 1,250.00 $ 1,250.00 $ 12,500.00
DUES $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 2,500.00
EQUIPMENT RENTAL $ 290.00 $ 290.00 $ 290.00 $ 290.00 $ 2,900.00
LIABILITY INSURANCE $ 160.00 $ 160.00 $ 160.00 $ 160.00 $ 1,600.00
BUILDING MAINTENANCE/REPAIRS $ 400.00 $ 400.00 $ 400.00 $ 400.00 $ 4,000.00
OFFICE SUPPLIES $ 230.00 $ 230.00 $ 230.00 $ 230.00 $ 2,300.00
POSTAGE/DELIVERY $ 250.00 $ 250.00 $ 250.00 $ 250.00 $ 2,500.00
REFERENCE MATERIALS $ 255.00 $ 255.00 $ 255.00 $ 255.00 $ 2,550.00
PROPERTY TAXES $ 195.00 $ 195.00 $ 195.00 $ 195.00 $ 1,950.00
TELEPHONE $ 440.00 $ 440.00 $ 440.00 $ 440.00 $ 4,400.00
OVERHEAD SUBTOTAL $ 11,702.00 $ 11,702.00 $ 11,702.00 $ 11,702.00 $117,020.00
PAYROLL $ 14,250.00 $ 14,250.00 $ 14,250.00 $ 14,250.00 $142,500.00
SALARY $ 1,425.00 $ 1,425.00 $ 1,425.00 $ 1,425.00 $ 14,250.00
PAYROLL TAXES $ 522.00 $ 522.00 $ 522.00 $ 522.00 $ 5,220.00
EMPLOYEE HEALTH
PAYROLL SUBTOTAL $ 16,197.00 $ 16,197.00 $ 16,197.00 $ 16,197.00 $161,970.00
DIRECT COSTS AS AUTHORIZED BY TMC
LEGAL SERVICES (PATENT)
TRAVEL
CLINICAL TRIAL SUPPLIES
MANUFACTURING SUPPLIES
PRODUCT EQUIPMENT EXPENSE
DIRECT COSTS SUBTOTAL
MONTHLY TOTAL $ 27,899.00 $ 27,899.00 $ 27,899.00 $ 27,899.00 $278,990.00
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