FIRST AMENDMENT LICENSE AGREEMENT (Clotalyst)
Exhibit 10
This First Amendment to the Agreement (“First Amendment”), made and entered into as of March
30, 2007 by and between CELL FACTOR TECHNOLOGIES, INC., now BIOMET BIOLOGICS, INC. (“Biomet”), an
Indiana corporation having its principal office at 00 Xxxx Xxxx Xxxxx, Xxxxxx, Xxxxxxx 00000, and
THERMOGENESIS CORP. (“TGC”) a Delaware corporation having its principal offices at 0000 Xxxxxx
Xxxx, Xxxxxx Xxxxxxx, Xxxxxxxxxx 00000.
TGC and Biomet entered into a certain supply agreement effective on March 29, 2005
(“Agreement”).
TGC and Biomet desire to amend this Agreement to change its structure from a supply agreement
to a license agreement and make other modifications.
The parties therefore agree as follows:
1. Title. The title of the Agreement is hereby amended by replacing “Supply Agreement” with
“License Agreement.”
2. Recitals. In the recitals, the third WHEREAS clause is hereby amended by replacing it as
follows:
WHEREAS, CFT desires to license TGC’s Clotalyst Rights and Clotalyst Reagent Rights
(as defined below);
3. Article I. Definitions. Article I of the Agreement is hereby amended as follows:
(a) by replacing Section 1.5 as follows:
| 1.5 | “Product(s)” means TGC’s Thrombin disposable and Reagent that meets the performance specifications in Appendix A and will be sold under the CFT trademark Clotalyst. After CFT purchases all required Products under Section 2.1, the definition of Products will be replaced by the following definition. “Product(s)” means Clotalyst Reagent. |
(b) by adding Section 1.9 as follows:
1.9 “Clotalyst Reagent” means TGC’s current TPD reagent for incorporation into CFT’s
Clotalyst that is covered by a valid claim of a patent within Clotalyst Reagent Rights.
(c) by adding Section 1.1 0 as follows:
| ThermoGenesis & Biomet | First Amendment |
| 1.10 | “Clotalyst Rights” means TGC’s Intellectual Property required for CFT to make, use, sell, offer to sell, sell, and import the Clotalyst, including, but not limited to U.S. Patent No. 6,274,090 and U.S. Patent No. 6,472,162. |
(d) by adding Section 1.11 as follows:
| 1.11 | “Clotalyst Reagent Rights” mean TGC’s Intellectual Property required for CFT to make, use, offer to sell, sell, and import Clotalyst Reagent. |
(e) by adding Section 1.12 as follows:
| 1.12 | “Net Sales” mean sales less commissions received by CFT and/or its licensees from the sale of CFT’s Clotalyst disposable that uses the Clotalyst Reagent and meets the performance specifications in Appendix A. |
4. Article II. Terms and Conditions of Sale. Article II of the Agreement is hereby amended
as follows:
(a) by replacing Section 2.1 with the following:
| 2.1 | Purchase. TGC shall supply Product and CFT shall purchase Product at the transfer price according to the terms and conditions of sale set forth below. CFT shall purchase five hundred (500) Products as of the date in the introductory paragraph, and CFT shall purchase at least five hundred (500) Products each subsequent calendar quarter to reach a total purchase quantity of at least two thousand five hundred (2,500 Products after the date in the introductory paragraph of this First Amendment. |
(b) by replacing Section 2.2 with the following:
| 2.2 | Forecast. CFT shall provide TGC with a mutually agreed upon reasonable forecast for the purchase of Products. |
(c) by deleting in its entirety Section 2.5.
(d) by adding new Section 2.16 as follows:
2.16 Purchase of Clotalyst Reagent. TGC shall supply Clotalyst Reagent and CFT
shall purchase Clotalyst Reagent at a transfer price that shall not exceed ten dollar
($10.00) for each Product, F.O.B. TGC Point of Shipment according to the terms and
conditions of sale. The Clotalyst Reagent transfer price will be adjusted according to the
PPI index change at the second and forth anniversary of this First Amendment, with each adjustment not being more than a ten
percent (10%) change.
| ThermoGenesis & Biomet | First Amendment |
5. Article III. Manufacturing and Regulatory Responsibilities. Article III of the Agreement
is hereby amended as follows:
(a) by replacing Section 3.1 with the following:
3.1 Manufacturing. TGC shall assist CFT to assume manufacturing responsibility
for the Clotalyst (excluding Clotalyst Reagent) by transferring to CFT all manufacturing
information and know-how related to the Clotalyst.
(b) by replacing Section 3.3(a) with the following:
(a) Approvals. TGC shall be responsible for obtaining and maintaining any and
all reasonably necessary regulatory approvals and clearances required for marketing and
selling Clotalyst Reagent in the Territory including TGC’s tasks identified in Appendix B
to this Agreement.
(c) by replacing Section 3.3(b) with the following:
(b) FDA Accession Number. TGC shall provide CFT with the name under which the
Clotalyst Reagent was cleared by the FDA (under the CryoSeal I PMA approval) and the FDA
PMA approval application number, as appropriate, so CFT can access TGC’s Clotalyst Reagent
FDA file. TGC shall reasonably assist CFT to obtain CFT’s own NDA, ANDA, or biological
license application in the event that CFT decides to manufacture Clotalyst Reagent under
CFT’ license in Section 9.3.
(d) by replacing Section 3.3(c) with the following:
(c) Labeling. TGC shall label Clotalyst Reagent with TGC’s primary closure
labeling.
6. Term. Section 4.1 of the Agreement is hereby amended by replacing it as follow:
4.1 Term. This Agreement shall commence on the date hereof and shall
continue for the life of last to expire of the patents within Clotalyst Reagent Rights.
7. Article IX. License. The Agreement is hereby amended adding a new Artic e IX as follows:
ARTICLE IX
License
License
9.1 License Conversion Fee. CFT shall pay to TGC a fee for license conversion
and completion of minimum payments of thirty thousand dollars ($30,000) upon signing this
First Amendment.
9.2 Clotalyst License. TGC hereby grants to CFT, under Clotalyst Rights, a
non-exclusive, royalty-bearing license to make, use, offer to sell, sell and import the
Clotalyst, excluding Clotalyst Reagent, throughout the Territory.
| ThermoGenesis & Biomet | First Amendment |
9.3 Royalties. CFT shall pay to TGC a royalty of six percent (6.0%) on Net
Sales throughout the Territory of CFT’s Clotalyst disposable that uses the Clotalyst
Reagent.
9.4 Accounting
(a) Payment of Royalties. Royalties are due for payment each calendar
quarter that ends in March, June, September and December. CFT shall pay TGC
royalties due for payment within forty-five (45) days after the end of each
calendar quarter, and each payment will include a written report indicating the Net
Sales of Products.
(b) Royalty Records. CFT shall maintain records in sufficient details
to determine the royalties payable under this Agreement, and CFT shall retain these
records for at least three (3) years after the royalties are due for payment.
(c) Records Inspection. TGC may request to inspect CFT’s record
directly related to Net Sales that occurred during the immediately preceding three
(3) years or less by providing CFT with an inspection notice. Upon CFT’s receipt of
such notice, CFT will have sixty (60) days to perform a self-inspection of its
records to verify, and adjust if necessary, CFT’s royalty payment made under this
Agreement and inform TGC of results from this self-inspection. If TGC does not
agree with CFT’s self-inspection results, TGC may at its own expense request CFT to
permit a mutually agreed upon independent entity to inspect CFT’s records directly
related to Net Sales that occurred during the immediately preceding three (3) years
or less. Within a reasonable time after TGC’s request for an independent
inspection, CFT shall make available CFT’s records directly related to Net Sales to
the independent entity for the sole purpose of verifying the royalties payable
under this Agreement. Prior to gaining access to CFT’s records, the independent
entity shall be required to enter into a written non-disclosure agreement that
prohibits disclosure of CFT’ records to any third party. If the independent entity
determines with CFT’s agreement that CFT has underpaid royalties by more than five
thousand dollar: ($5,000) or five percent (5%), whichever is less, CFT shall
reimburse TGC for the reasonable records inspection expenses.
(d) Royalty Adjustment. If after the date of this Agreement in the
introductory clause, CFT is required to pay a non-affiliated third party or parties
a royalty to commercialize Products, CFT shall reduce the corresponding royalties
payable to TGC by fifty percent (50%) of the amount actually paid t the
non-affiliated third party or parties; provided, however, the effective royal rate CFT pays TGC, regardless of the amount of
third party or parties royalties paid by CFT, will not be reduced by more than
fifty percent (50%) of the amount otherwise payable.
[SIGNATURE PAGE FOLLOWS]
| ThermoGenesis & Biomet | First Amendment |
The parties are signing this First Amendment as of the date in the introductory paragraph
| Biomet Biologics, Inc. | ||||||
/s/ Xxxxx X. Xxxxxxx
|
/s/ Xxxx X. Xxxxxxx | |||||
By
|
By | |||||
Xxxxx X. Xxxxxxx
|
Xxxx X. Xxxxxxx | |||||
President, General Manager of Surgical
|
Vice President — Operations | |||||
Wound Care |
[First Amendment to ThermoGenesis Corp. and Biomet Biologics, Inc. License Agreement dated as
of March 30, 2007 (BMT6511)]
