Distribution and Supply Agreement
Exhibit 10.3
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
Distribution and Supply Agreement
Amendment 1
Xxxxxxx Europe Pty Limited
AND
Xxx Lilly and Company
This is Amendment number 1 to the agreement between Xxx Xxxxx and Company and Xxxxxxx Europe Pty Ltd. titled Distribution and Supply Agreement and dated February 9, 2011 (“Agreement”). By this amendment, entered into on this 2nd day of December, 2011, both parties agree as follows:
1. Recitals
WHEREAS, Elanco and Xxxxxxx are Parties to the Agreement in regard to the Zydax product;
WHEREAS, the Parties agree to pursue revised Targeted Claims for Zydax as indicated in the revised Schedule 1, attached;
WHEREAS, Elanco agrees to increase the amount of the EU Payment 1 and US Payment 1,
WHEREAS, Xxxxxxx agrees to ***; and
NOW THEREFORE, the Agreement is amended as follows:
2. Amended Provisions
a. Schedule 1 is replaced with the revised Schedule 1 included below.
b. In section 1.0, a new definition New Trial Study is added as follows: “New Trial Study means a study with a mutually agreed protocol that is reasonably designed to achieve and support a Zydax product in accordance with Schedule 1, as amended herein.”
c. In section 1.0, a new definition Zone is added as follows: “Zone means either the United States of America or the European Economic Community”
d. In section 1.0, the definition of Zydax is amended to add, after the words “Schedule 4”, the phrase: “and Schedule 1”
e. In section 2.3, the phrase “thirty (30) months” is replaced with “thirty eight (38) months.”
f. In Section 3.1(a)(i), the phrase “ and *** to be paid not later than January 10, 2012 after mutual execution of Amendment 1 to this Agreement.” is added at the end of the existing paragraph.
g. In Section 3.1(b)(i), the phrase “ and *** to be paid not later than January 10, 2012 after mutual execution of Amendment 1 to this Agreement.” is added at the end of the existing paragraph.
h. A new section is added as follows:
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
3.3 Xxxxxxx agrees to *** in accordance with the mutually agreed protocol. ***may include ***.
i. Section 13.1(a) is replaced in its entirety as follows:
(a) If registration of Zydax has not occurred in a zone by the end of the 38th month after Commencement Date, Xxxxxxx will pay monthly damages either in US dollars *** to Elanco beginning the first day of the first month after the 38th month post Commencement Date. Damages will be the cash amount *** for the “US Delay Damages” and *** for the “EU Delay Damages,” respectively.
j. Section 13.1(b) is replaced in its entirety as follows:
(b) Payment of the respective US Delay Damages or EU Delay Damages will continue until Zydax is registered in the Zone that was not registered as of the 38th month post Commencement date, or until, in each case, the EU Delay Damages are equal to $666,666 (Six Hundred and Sixty Six Thousand and Six Hundred and Sixty Six Hundred Dollars) and the US Delay Damages are equal to $1,333,334 (One Million Three Hundred and Thirty Three Thousand and Three Hundred and Thirty Four Hundred Dollars). For clarity delay damages are only payable in respect of the zone in which registration of the Product has not occurred as at the end of the 38th month post Commencement Date.
k. Section 13.1(d) is replaced in its entirety as follows:
(d) In the event that Registration for Zydax has still not been granted in either Zone, or Xxxxxxx is unable to supply the minimum supply quantities defined in Schedule 2 by the end of the ***month after the Commencement Date either party may terminate this Agreement by giving the other notice in writing, such termination to take effect immediately.
l. Section 13.2 is replaced in Its entirety as follows:
13.2 In the event that Registration for Zydax has still not been granted in any Zone by the end of ***month after the Commencement Date, either party may terminate this Agreement by giving the other notice in writing, such termination to take effect immediately.
m. Section 33.10 is replaced in its entirety as follows:
33.10 Clauses 13, 16, 18, 19, 22 to 30, 32 and 33 will survive the expiration or earlier termination of this Agreement.
3. Amendment Terms
a. The provisions of this Amendment, to the extent they conflict with the Agreement shall supersede such conflicting provisions
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
b. The parties agree that the Agreement remains in full force and effect as amended
c. The amended provisions shall survive the termination of this amended Agreement to the extent necessary to serve the purpose intended.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
IN WITNESS WHEREOF, the parties have executed this Agreement Amendment 1, effective upon the last date entered below.
XXX LILLY AND COMPANY | ||
By | /s/ Xxxx Xxxxxxx | |
Title | President | |
Date | 2 December 2011 | |
Xxxxxxx Europe Pty Ltd | ||
By | /s/ Xxxxxx Xxxxxx | |
Title | Chief Executive Officer | |
Date | 2 December 2011 | |
Attachment: Revised Schedule 1 |
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 1
Products
Product |
Trade Name | Presentation | Active ingredient | |||
Zydax 100 Injection | Zydax | 20mL preserved multiple dose vial | Glucuronoxylan Sulfate sodium *** |
***
Currently the targeted Label of Zydax will include, but not be limited to the following:
***
S-1 - 1 |