Exhibit
10.1
AMENDMENT
This
Amendment is
made as of January 8, 2007 by and among DFB Biotech, Inc. a Delaware corporation
(“
Buyer
”),
and
BioSpecifics Technologies Corp., a Delaware corporation (“
BTC
”),
and its
wholly-owned subsidiary Advance Biofactures Corporation, a New York corporation
(“
ABC
”)
(BTC and ABC
each being hereinafter individually, and collectively where applicable, referred
to as “
Seller
”).
(Buyer and
Seller are at times referred to herein collectively as the “
Parties
.”)
RECITALS
Whereas
the Parties
entered into an Asset Purchase Agreement dated March 3, 2006 (the “
APA
”);
and
Whereas
the Parties
now desire to amend the APA as detailed herein to clarify certain provisions
of
the APA in light of subsequent events;
AGREEMENT
Now,
therefore, in
consideration of the premises and mutual covenants herein contained as well
as
other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties intending to be legally bound agree as
follows:
1.
|
Any
capitalized term in this Amendment not defined herein shall have
the same
meaning as set forth in the APA.
|
2.
|
The
following
definitions shall be added as defined terms to Section 1.1 of the
APA:
|
“
‘Auxilium’
- shall mean
Auxilium Pharmaceuticals, Inc., the Delaware corporation which is a party to
the
Auxilium License (as defined below).”
“
‘Retained
API’
- shall mean
collagenase, excluding collagenase for dermal formulations labeled for topical
administration,
OMITTED AND FILED SEPARATELY WITH THE SECURITIES &
EXCHANGE COMMISSION
.”
“Transferred
API’
- shall mean
collagenase, including but not limited to collagenase for dermal formulations
labeled for topical administration, which is the active pharmaceutical
ingredient of the Product,
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES & EXCHANGE COMMISSION
.”
“
‘Auxilium
License’
-
shall mean the
Development and License Agreement by and between BTC and its Affiliates (as
defined therein) and Auxilium, dated June 3, 2004, as amended May 10,
2005.”
“
‘Auxilium
Product’
- shall mean
pharmaceutical products, excluding all dermal formulations labeled for topical
administration, which contain Retained API as an active
ingredient.”
“
‘Competing
Product’
- shall mean a
product that contains Retained API as an active ingredient and is sold in a
country by a party (other than Auxilium its Affiliates or Sublicensees as
defined in the Auxilium License) for
an
indication when
Auxilium, its Afilliates or Sublicensees also markets an Auxilium Product
approved for such indication in such country.”
“
‘Retained
Cell Banks’
- shall mean the
cell banks of Seller as of the Closing Date, which are listed in Schedule
1.1(h).”
“
‘Transferred
Cell Banks’
- shall mean the
cell banks of Seller as of the Closing Date, which are listed in Schedule
1.1(d).”
3.
|
Each
definition below shall be deleted in its entirety from Section 1.1
of the
APA and replaced with the
following:
|
“
‘API’
- shall mean
collagenase, which is the active pharmaceutical ingredient for the Product,
obtained from fermentation of Clostridium.”
“
‘Overlap
Intangible Assets’
-
means the
intangible assets (including Records relating to the Transferred API and
Transferred Cell Banks) owned or licensed by ABC or BTC not solely related
to
topical uses and indications for collagenase, which are used in the research,
development, use, commercialization, manufacture, sale or distribution of the
Product, Retained and Transferred API, including those set forth in
Schedule
1.1(b)
.”
“
‘Product’
-
means the
collagenase ointment manufactured by Seller and marketed by Abbott Laboratories
under the trademark SANTYL as successor to Knoll Pharmaceutical Company pursuant
to the Knoll License Agreement, as well as all components of the SANTYL
collagenase ointment including but not limited to the Transferred API but
excluding the Retained API.”
“
‘Purchased
Assets’
-
means:
(a)
to
the extent
exclusively related to or used in connection with the API, the Product, or
Seller’s Topical Business, all items of inventory of the Seller and ABC-C,
wherever located, including all finished goods, work in process, raw materials,
spare parts, and all other related materials and supplies and listed on
Schedule
1.1(c)
(collectively
the
“Purchased
Inventories”
);
(b)
(i)
the ELA, the
Product, and the Transferred API; and (ii) all Records of Seller relating to
the
ELA, the Product, or related solely to the Transferred API;
(c)
the
Transferred
Cell Banks;
(d)
the
ABC-C Shares;
(e)
all
the equipment
and materials owned by BTC or ABC, located in the Lynbrook, New York or Curaçao
facilities, which are used exclusively in Seller’s Topical Business and listed
in
Schedule
1.1(e)
;
(f)
the
Knoll License
Agreement and the Tufts License Agreement and all Intellectual Property
thereunder;
(g)
all
Contracts
relating solely to Seller’s Topical Business to which Seller or ABC-C is a party
and listed in
Schedule
1.1(f)
(the
“Seller
Contracts”
);
(h)
to
the extent
related to the Transferred Employees, all personnel Records and other Records
that Seller is not required by law to retain in its possession;
(i)
except
as provided
in Section 7.14(a) , all Intellectual Property owned or controlled by Seller
or
ABC-C
relating
solely to
(i) Seller’s Topical Business, (ii) the Product, (iii) the Transferred API, (iv)
the ELA, or (v) topical uses and indications for collagenase, all as listed
on
Schedule
1.1(g)
,
(collectively the
“Intellectual
Property Assets”
);
(j)
all
clinical and
other data, reports and communications to the extent solely related to topical
indications and uses for collagenase or Seller’s Topical Business; and
(k)
all
governmental
authorizations and pending applications therefor, and registrations, to the
extent assignable, to the extent solely related to topical uses and indications
for collagenase or Seller’s Topical Business.”
“
‘Seller
Injectable Assets’
-
means any
tangible or intangible assets (including, patents, trademarks, copyrights,
or
other Intellectual Property asset, equipment, inventory, Contract or other
asset) owned, licensed or leased prior to the Closing Date by Seller, or any
Affiliate of Seller, relating to the research, development, use,
commercialization, manufacture, sale or distribution of the Auxilium Product,
and set forth in
Schedule
1.1(h)
.”
4.
|
Section
2.1(b) of the APA shall be deleted in its entirety and replaced with
the
following:
|
“(b)
Overlap
Intangible Assets
.
Upon the terms
and subject to the conditions set forth herein, at the Closing, but effective
as
of the Effective Time, Seller shall exclusively (even as to Seller),
perpetually, without royalty, and irrevocably license to Buyer the right to
use
the Overlap Intangible Assets for the research, development, use,
commercialization, manufacture, marketing, and sale of topical products, free
and clear of any Encumbrances, and Buyer shall accept such license from Seller
of, the Overlap Intangible Assets.”
5.
|
The
following
shall be added to the APA as Section
2.2(o):
|
“(o).
any
drug master
file owned by Seller, its Affiliates or sublicensees, including Auxilium. For
purposes of clarity, the Parties agree that the ELA is not, nor shall it be
construed to be, a drug master file.”
6.
|
Section
7.7(a) of the APA shall be deleted in its entirety and replaced with
the
following:
|
OMITTED
AND
FILED
SEPARATELY
WITH THE
SECURITIES
& EXCHANGE COMMISSION
7.
|
Section
7.15
of the APA shall be deleted in its entirety and replaced with the
following:
|
“
7.15
Maintenance
and Defense of Overlap Intangible Assets
Seller
agrees that
all patents and other Intellectual Property included within the definition
of
Overlap Intangible Assets shall be
maintained
and defended in
all relevant jurisdictions throughout the
OMITTED
AND
FILED SEPARATELY WITH THE SECURITIES & EXCHANGE
COMMISSION
.
Upon
OMITTED
AND
FILED SEPARATELY WITH THE SECURITIES & EXCHANGE
COMMISSION
,
if a decision is
made not to defend or maintain any such patent or other Intellectual Property,
then Seller agrees that Buyer may maintain or defend
such
patent or
other Intellectual Property and Seller shall provide, at Buyer’s expense, all
reasonable assistance requested by Buyer related to such maintenance or
defense.”
8.
|
The
following
shall be added to the APA as Section
7.18:
|
“
7.18
Buyer
Acknowledgment of Auxilium License
To
the extent
Records
included in
the Purchased Assets are subject to the Auxilium License, Buyer acknowledges
that Auxilium may have limited right
s
to such Records.
Therefore upon Auxilium’s reasonable written request
and provided that
such Records are in Buyer’s actual possession
,
Buyer will grant
Auxilium
a
limited
right to
access, cross-reference, and use (at Auxilium’s sole cost and expense) such
Records
to the extent (a)
they are subject to the Auxilium License and (b) they are
reasonably
required
in regulatory filings for the Auxilium Product.”
9.
|
The
following
shall be added to the APA as Section
7.19:
|
OMITTED
AND
FILED
SEPARATELY
WITH THE
SECURITIES
& EXCHANGE COMMISSION
10.
|
The
references to “API” in Schedule 1.1(b) and Schedule 1.1(g) shall be
amended to refer to “Transferred
API.”
|
11.
|
Except
as
expressly amended or modified hereby the APA shall remain in full
force
and effect in accordance with its original
terms.
|
[Remainder
of
page intentionally left blank]
IN
WITNESS
WHEREOF,
the
Parties have
caused this Amendment to be executed in triplicate originals as of the date
and
year first above written.
SELLER:
|
|
|
BioSpecifics
Technologies Corp.
|
|
Advance
Biofactures Corporation
|
By:
|
/s/
Thomas
Wegman
|
|
By:
|
/s/
Thomas
Wegman
|
|
Name:
Thomas
Wegman
|
|
|
Name:
Thomas
Wegman
|
|
Title:
President
|
|
|
Title:
President
|
|
|
|
|
|
BUYER:
|
|
|
|
DFB
Biotech, Inc.
|
|
|
|
By:
|
/s/
Paul
Dorman
|
|
|
|
|
Name:____________________________________
|
|
|
|
|
Title:______________________________________
|
|
|
|