First Amendment To the License, Supply, Marketing, Distribution And Collaboration Agreement
First Amendment
To the
License, Supply, Marketing, Distribution And Collaboration Agreement
This First Amendment effective as of May 20, 2004 (the “First Amendment”), amends the License, Supply, Marketing, Distribution And Collaboration Agreement by and between Xxxxxx-Xxxxx Laboratories (“USL”) and Orion Corporation (“Orion”) effective as of November 24, 2003 (the “Agreement”).
Section 8.8 of the Agreement (entitled “Pharmacovigilance”) provides that “as soon as reasonably possible, the drug safety departments of both Parties shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product, which approach shall be documented in a Schedule 5 to this Agreement to be finalized and attached to, and incorporated in, this Agreement not later than one hundred eighty days (180) days after the Date of Agreement.” (All capitalized terms not defined in this First Amendment shall have the meaning given in the Agreement.) That one hundred eighty (180) day period will expire on May 22, 2004. The Parties are continuing to work in good faith on completing Schedule 5, but require additional time to do so. The parties now anticipate that Schedule 5 will be finalized and ready for execution on or before July 1, 2004, and wish to amend the Agreement to provide such additional time for the finalization and execution of Schedule 5.
Now therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Orion and USL agree to amend the Agreement as follows:
1. Section 8.8 is amended to delete the words in Section 8.8 “not later than one hundred eighty days (180) days after the Date of Agreement” and to insert in their place the words “not later than July 1, 2004.”
2. Except as expressly provided in this First Amendment, the Agreement shall remain unchanged and in full force and effect.
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IN WITNESS WHEREOF, the Parties’ duly authorized representatives hereto have executed this Amendment as of the day and year first above written.
SIGNATURES
Signed |
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Signed |
ORION CORPORATION |
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XXXXXX-XXXXX LABORATORIES, INC. |
By |
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By |
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/s/ Xxxx Xxxxxxxxxxx |
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/s/ Hannu Wennonen |
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/s/ Xxxxxx X. Xxxxx |
Signature |
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Signature |
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Signature |
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Timo Xxxxxxxxxxx |
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Xxxxx Wennonen |
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Xxxxxx X. Xxxxx |
Name |
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Name |
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Name |
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Senior Vice President |
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Director |
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Vice President, Corporate Development |
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Title |
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(Authorized Officer) |
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(Authorized Officer) |
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(Authorized Officer) |