Exhibit 10.19
*** Text omitted and filed
separately
Confidential Treatment
Requested
Under 17 C.F.R. §§
200.80(b)(4)
and 240.24b - 2
FIRST AMENDMENT TO LICENSE
AGREEMENT
This First Amendment to License
Agreement (this “Amendment”) is dated as of the 22nd
day of October, 2003, by and between Abbott Laboratories, an
Illinois corporation (“Abbott”) and Empire
Pharmaceuticals, Inc., a Delaware corporation
(“Empire”).
RECITALS
WHEREAS, Abbott and Empire
previously entered into a License Agreement dated as of March 29,
2002, wherein Abbott licensed to Empire certain worldwide rights
related to the pharmaceutical compound known as ANCROD (the
“Agreement”); and
WHEREAS, Abbott and Empire desire to
revise certain obligations contained in the Agreement, including an
extension of the time periods for delivery by Abbott of information
relating to the Compound and inventory of the Compound, an
extension of the time periods for the payment by Empire of amounts
due with respect to delivery of the Compound and a modification of
the royalty and milestone provisions of the Agreement.
NOW THEREFORE, for good and valuable
consideration, Abbott and Empire, intending to be legally bound,
hereby agree to amend the Agreement effective as of the date set
forth above as follows:
AGREEMENT
1. Unless otherwise defined herein,
capitalized terms in this Amendment shall be as defined in the
Agreement.
2. Exhibit D to the Agreement
shall be deleted and the attached Exhibit D-2 shall be
substituted in its place.
3. All references in the Agreement
to “ Exhibit D ” shall be deemed to refer to the
attached Exhibit D-2 .
4. On or before November 1, 2003,
Empire shall pay to Abbott Three Hundred Fifty Thousand Dollars
($350,000.00). Of such amount, One Hundred and Fifty Thousand
Dollars ($150,000.00) shall constitute the second installment of
the total amount payable for Shipment B under Exhibit D-2
and Two Hundred Thousand Dollars ($200,000.00) shall constitute the
payment for Shipment C under Exhibit D-2 . Empire hereby
acknowledges receipt of Shipment B referenced in Exhibit D-2
.
5. Section 3.1(a) of the
Agreement shall be amended by adding the following sentences at the
end of the existing paragraph:
“Abbott shall complete
delivery of the information required hereunder by November 15,
2003. Except for the items listed below, completion shall be
evidenced by a certification from the Divisional Vice President,
Licensing and New Business Development
Japan/PAA of Abbott certifying that,
to the best of such Divisional Vice President’s knowledge,
Abbott has delivered to Empire all information and materials
required under this Section 3.1(a) .”
“Notwithstanding the delivery
of the above certificate, Abbott shall, by November 15, 2003,
deliver the following items: (i) the final signed ESTAT report
which has been reviewed by appropriate Abbott quality assurance
personnel; (ii) SAS data sets and integrated safety data sets for
the stroke studies known as A-2, A-20 and A-120; (iii) data sets
for the ESTAT Study (AN005); and (iv) 17 boxes of materials used to
create the safety database.”
6. Section 3.1(c) of the
Agreement shall be deleted and the following paragraph substituted
in its place:
“(c) At least thirty (30) days
prior to the delivery date for Shipment C, Empire shall provide
Abbott with all logistical information necessary for delivery of
the material. Upon delivery of raw venom, Empire shall have
forty-five (45) days following receipt of the raw venom to
determine the compliance of Shipment C with the Testing
Specifications. Within such forty-five (45) day testing period,
Empire shall provide Abbott with written notice via facsimile of
its determination whether or not the raw venom of Shipment C
complies with the Testing Specifications. Failure to provide such
notice shall be deemed an admission by Empire that all of such raw
venom complies with the Testing Specifications. If Empire provides
Abbott with timely notice that the raw venom of Shipment C does not
comply with the Testing Specifications, then Empire shall promptly
return the non-compliant raw venom to Abbott and, upon
Abbott’s receipt of such r
