CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.78
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE SECURITIES AND
EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED IS REQUESTED AND IS NOTED
WITH "[CONFIDENTIAL TREATMENT REQUESTED]." AN UNREDACTED VERSION OF THIS
DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDMENT TO EXCLUSIVITY AGREEMENT
THIS AMENDMENT ("Amendment 1") to the Exclusivity Agreement dated 22
December 2004 AGREEMENT ("Agreement") is made the 25th day of February
2005
BETWEEN:
(1) PFC Therapeutics, LLC, a limited liability company organized under the
laws of Delaware, USA and having its principal place of business at
0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, XX 00000 XXX
(hereinafter referred to as "PFC"), and
(2) XXX Pharma A/S, a company organized under the laws of Denmark and
having its principal place of business at Xxxxxxxxxxxxxx 00, XX-0000
Xxxxxxxx, Xxxxxxx (hereinafter referred to as "XXX").
RECITALS:
(A) Whereas the Parties wish to amend the Agreement to extend the period
for a satisfactory finalisation of due diligence to be performed by XXX
to allow PFC, at PFC's discretion and expense, to conduct clinical
"Proof of Concept Studies" as defined below.
(B) Whereas the Parties agree to work together as agreed between the
Parties from time to time during the extended period to define
potential objectives, criteria and protocols for Proof of Concept
Studies, and review data from such studies to the extent PFC conducts
such studies and has access to such data.
NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:
1. Definitions
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1.1. "Proof of Concept Studies" means studies in humans regarding Product in
[CONFIDENTIAL TREATMENT REQUESTED]. The clinical outcome of such
studies should - subject to the sole discretion of XXX - not raise
safety concerns such as imbalance in global or particular serious
adverse events in the Product treated group.
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1.2. Unless explicitly defined in this Amendment 1 all defined terms used in
Amendment 1 shall have the same meaning as in the Agreement.
2. Postponement of Date of Payment and Performance of the Parties Thereof
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and Amendment of the Dispute Resolution Clause
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2.1. The date of payment of the second installment in the amount of
[CONFIDENTIAL TREATMENT REQUESTED] of the Exclusivity Fee in accordance
with the Agreement shall be postponed from "no later than March 1,
2005" (as specified in Section 3.2 of the Agreement) to sixty (60) days
after PFC presents results from Proof of Concept Studies to XXX for due
diligence evaluation.
2.2. This Amendment 1 and the Agreement shall terminate with immediate
effect in case PFC notifies XXX in writing by registered mail that PFC
elects to not conduct such Proof of Concept Studies.
2.3. After signing of this Amendment 1 PFC, at its discretion and expense,
will conduct Proof of Concept Studies.
2.4. PFC shall have the sole discretion to determine when to present results
from the Proof of Concept Studies to XXX. At such time as PFC presents
results from Proof of Concept Studies to XXX, XXX will have sixty (60)
days to review such data and complete its due diligence, which may
include INTER ALIA further investigations of PFC and its affiliated
companies.
2.5. Upon a satisfactory finalisation of due diligence by XXX based on INTER
ALIA the Proof of Concept Studies mentioned in Section 2.4, XXX will
within the time limits mentioned above in Section 2.1 of this Amendment
1 make the Exclusivity Fee payment referred to in Section 3.2 of the
Agreement and the Parties will proceed to negotiate a License Agreement
and prepare a Briefing Package for submission to EMEA as contemplated
in the Agreement.
2.6. In addition to the milestone plan outlined in the Agreement, the
Parties agree to include an additional "proof of concept milestone" in
the License Agreement which should minimally reimburse PFC for expenses
related to conducting Proof of Concept Studies. Such milestone payment
is to be negotiated in good faith.
2.7. Should XXX, at any time prior to the date of payment now defined above
in Section 2.1 of this Amendment 1, at its sole discretion, decide not
to pursue its intent to enter into further agreements with PFC for the
Product, XXX shall in accordance with Section 4.3 of the Agreement give
notice hereof to PFC to the effect that XXX hereafter is released from
any further payment obligations towards PFC, including the obligation
to pay the second installment of the Exclusivity Fee mentioned above in
Section 2.1.
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2.8. Section 7.7 of the Agreement shall be deleted and replaced by the
following: "Any dispute arising out of or in connection with this
Amendment 1 and the Agreement, including any question regarding their
existence, validity or termination, shall be referred to and finally
resolved by arbitration under the Rules of the London Court of
International Arbitration, which Rules are deemed to be incorporated by
reference into this clause. The number of arbitrators shall be three.
The seat, or legal place, of arbitration shall be London, England. The
language to be used in the arbitration shall be English. The governing
law of this Amendment 1 and the Agreement shall be the substantive law
of England and Wales."
3. Miscellaneous
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3.1. Within four (4) business days of signing this Amendment 1, Alliance
Pharmaceutical Corp. will issue the press release attached hereto as
Exhibit I. During the term of Amendment 1, Alliance Pharmaceutical
Corp. will not issue any additional press releases referring to XXX
without the prior review and approval of XXX.
3.2. This Amendment 1 shall not give rise to any legally binding obligation
on the Parties to complete the License Agreement. Any legal commitment
with regard to the License Agreement shall only arise pursuant to a
definitive License Agreement and the related legal documents including,
but not limited to, a supply agreement as set out in the Agreement,
executed by both Parties and/or their Affiliates.
3.3. Any notice or communications required or permitted hereunder shall be
in writing and shall be deemed sufficiently given only if delivered in
person or sent by facsimile or by first class post or by a recognized
courier service, postage or other charges prepaid, addressed to the
recipient Party at the address set out at the top of this Amendment 1,
or to such other address as the addressee may have specified in a
notice duly given to sender as provided herein. Such notice or
communication will be deemed to have been given as of the date so
delivered, faxed, mailed or sent by courier.
3.4. This Amendment 1 shall inure to the benefit of and be binding upon the
Parties hereto and their respective successors and permitted assigns.
The rights and obligations of each Party hereto may not be assigned
without the written consent of the other.
3.5. This Amendment 1 shall not be amended, modified or supplemented except
by writing duly executed by an authorized officer of each Party.
3.6. With this Amendment 1, the Agreement, including the agreed Exclusivity
Period granted to XXX, shall remain in full force and effect as
stipulated.
IN WITNESS WHEREOF the Parties hereto have caused this Amendment 1 to
be duly executed by their authorized officers on the day and year
first above written.
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XXX Pharma A/S PFC Therapeutics, LLC
By: .......................... By: ..............................
Name: ........................ Name: ............................
Title: ....................... Title: ...........................
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