Exhibit
10.1
OMNIBUS AMENDMENT TO JOINT VENTURE AGREEMENT AND ADDITIONAL
AGREEMENTS
THIS
OMNIBUS AMENDMENT TO JOINT VENTURE AGREEMENT AND ADDITIONAL
AGREEMENTS (this “
Amendment ”)
is entered into as of June 9, 2008 by
and among Manhattan Pharmaceuticals, Inc., a Delaware corporation
(“
MHA ”),
Hedrin Pharmaceuticals K/S ,
a Danish limited liability partnership (“
Newco ”),
Hedrin
Pharmaceuticals General Partner ApS, a Danish private limited
company (“
Hedrin GP ”)
and
Nordic
Biotech Venture Fund II K/S, a Danish limited liability partnership
(“
Nordic ”).
WITNESSETH:
WHEREAS,
MHA and Nordic previously entered into that certain Joint
Venture Agreement dated as of January 31, 2008 (as previously
amended, the “
Joint Venture Agreement ”).
Capitalized terms not otherwise defined herein shall have the
meanings assigned to them in the Joint Venture
Agreement;
WHEREAS
, pursuant
to the Joint Venture Agreement, (i) MHA agreed to assign certain
assets to Newco in accordance with the terms of that certain
Assignment and Contribution Agreement dated as of February 21, 2008
(as amended from time to time, the “
Contribution Agreement ”),
(ii) MHA, Nordic and Hedrin GP entered into a Limited Partnership
Agreement dated as of February 21, 2008 (as amended from time to
time, the “
Partnership Agreement ”),
and (iii) MHA and Nordic entered into a Shareholders Agreement
dated as of February 21, 2008 (as amended from time to time, the
“
Shareholders Agreement ”)
with respect to Hedrin GP; and
MHA,
Newco, Hedrin GP and Nordic wish to recognize that substantial
progress has been made toward achieving the Payment Milestone
so as to justify a current partial Milestone Payment and that
more specificity is appropriate in the definition of the
Payment Milestone that will result in the payment of the
remaining Milestone Payment, all in accordance with the terms
hereof, and that the Joint Venture Agreement, Contribution
Agreement, Partnership Agreement and Shareholders Agreement
should be appropriately modified, in each case on the terms
and conditions set forth in this Amendment.
NOW,
THEREFORE, for good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the parties
hereto hereby agree as follows:
1.
Amendments to Joint Venture Agreement
.
(a)
Section
1 of the Joint Venture Agreement is hereby amended by deleting
the defined term “Milestone Payment” in its
entirety and adding the following two new defined terms in
alphabetical sequence in Section 1:
“Initial
Milestone Payment” means the payment by Nordic of an
additional $1,250,000 to Newco after the satisfaction of the
Initial Payment Milestone (as defined in the Contribution
Agreement).
“Second
Milestone Payment” means the payment by Nordic of an
additional $1,250,000 to Newco after the satisfaction of the
Second Payment Milestone (as defined in the Contribution
Agreement).
(b)
Section
1 of the Joint Venture Agreement is hereby amended by deleting
the defined term “Investment Amount” in its
entirety and replacing it with the following:
“
Investment Amount ”
means (i) $2,500,000 if neither the Initial Milestone Payment nor
the Second Milestone Payment has occurred, (ii) $3,750,000 if,
prior to June 30, 2009, the Initial Milestone Payment has occurred
but the Second Milestone Payment has not occurred, (iii) $3,500,000
if (A) on or after June 30, 2009, the Initial Milestone Payment has
occurred but the Second Milestone Payment has not occurred, or
(B) if
prior to June 30, 2009, the U.S.
Food and Drug Administration (“
FDA ”)
formally designates the Licensed Products (as defined in the
Contribution Agreement) as a drug and refers regulation thereof to
the FDA Center for Drug Evaluation and Research, and (iv)
$5,000,000 if both the Initial Milestone Payment and the Second
Milestone Payment have occurred.
2.
Amendments to Contribution Agreement
.
(a)
Section
5.3 of the Contribution Agreement is hereby deleted in its
entirety and replaced with the following:
“
5.3
Definition of Initial Payment Milestone and Second Payment
Milestone
For
purposes of this Agreement, (i) the term “
Initial Payment Milestone ”
shall mean a preliminary determination from the U.S. Food and Drug
Administration received prior to September 30, 2008 that the
Licensed Products will be regulated as a medical device, and (ii)
the term “
Second Payment Milestone ”
shall mean (A) a determination by the U.S. Food and Drug
Administration (“
FDA ”)
that a Licensed Product is substantially equivalent to a predicate
device in accordance with Section 513(f)(1) or 510(k) of the
Federal Food, Drug, and Cosmetic Act (as amended, the
“
FDC Act ”)
or any other marketing authorization of a Licensed Product by the
FDA as a medical device, (B) the issuance of a
“Classification Decision” as such term is used in
Attachment 1 of the FDA Guidance for Industry and CDRH Staff titled
“New Section 513(f)(2) - Evaluation of Automatic Class III
Designation” issued by the FDA on February 19, 1998, with
respect to a Licensed Product, or (C) the receipt of a formal
response to a “Request for Designation” from the Office
of Combination Products that designates a Licensed Product as a
device, in each of cases (A) through (C) prior to June 30,
2009.”
(b)
Section
5.1(a)(ii) of the Contribution Agreement is hereby deleted in
its entirety and replaced with two new subsections as
follows:
“(ii)
within
21 days after the achievement of the Initial Payment Milestone
(as defined below): (A) pay to MHA an additional
US$1,000,000.00 in cash (the “
Second Cash Payment ”)
and (B) if necessary to maintain MHA’s 50% ownership of
outstanding Partnership Shares, issue to MHA, and deliver a
certificate representing, a number of additional Partnership Shares
of Newco that will constitute, together with the Initial Equity
Issuance, 50% of all outstanding Partnership Shares (the
“
Second Equity Issuance ”).
(iii)
within
30 days after the achievement of the Second Payment Milestone
(as defined below): (A) pay to MHA an additional US$500,000.00
in cash (the “
Third Cash Payment ”
and together with the First Cash Payment and the Second Cash
Payment, the “
Cash Payments ”)
and (B) if necessary to maintain MHA’s 50% ownership of
outstanding Partnership Shares, issue to MHA, and deliver a
certificate representing, a number of additional Partnership Shares
of Newco that will constitute, together with the Initial Equity
Issuance and Second Equity Issuance, 50% of all outstanding
Partnership Shares (the “
Third Equity Issuance ”)
and, together with the Initial Equity Issuance and Second Equity
Issuance, the “
Equity Issuances ”).”
(c)
Section
5.1(c) of the Contribution Agreement is hereby deleted in its
entirety and replaced with the following:
“Upon
the Initial Equity Issuance, MHA shall own 50% of the
outstanding Partnership Shares of Newco. Upon the Second
Equity Issuance, MHA shall own 50% of the outstanding
Partnership Shares of Newco (after giving effect to the
issuance of additional Partnership Shares, if any, to Nordic
pursuant to the Partnership Agreement). Upon the Third Equity
Issuance, if any, MHA shall own 50% of the outstanding
Partnership Shares of Newco (after giving effect to the
issuance of additional Partnership Shares, if any, to Nordic
pursuant to the Partnership Agreement).”
(d)
Section
5.2(b) of the Contribution Agreement is hereby deleted in its
entirety and replaced with the following:
“(b)
(i)
The authorized capital of Newco, immediately after the Second
Equity Issuance, if any, consists of 2,000 Partnership Shares,
700 of which are owned, beneficially and of record, by Nordic,
and 700 of which are owned, beneficially and of record by MHA,
and (ii) the authorized capital of Newco, immediately after
the Third Equity Issuance, if any, consists of 2,000
Partnership Shares, 1,000 of which are owned, beneficially and
of record, by Nordic, and 1,000 of which are owned,
beneficially and of record by MHA.
