Exhibit 10.7
Amendment No. 1 to
DEVELOPMENT AND LICENSE AGREEMENT
THIS AMENDMENT NO. 1 TO THE DEVELOPMENT AND LICENSE AGREEMENT
(“Amendment No. 1”) is
entered into by and between Auxilium Pharmaceuticals, Inc., a
company incorporated under the laws of Delaware with offices at 160
W. Germantown Pike, Norristown, PA 19401 and its Affiliate
(collectively, “Auxilium”) and BioSpecifics
Technologies Corp. a company organized and existing under the laws
of the State of Delaware with offices located at 35 Wilbur Street,
Lynbrook, New York 11563 and its Affiliates (collectively,
“BTC”).
Whereas ,
Auxilium and BTC (the “
Parties ”)
have entered into that certain Development and License Agreement
dated June 3, 2004 (the “License Agreement”);
and
Whereas ,
the Parties desire to amend the License Agreement in various
respects.
NOW, THEREFORE ,
for good and valuable consideration,
AND INTENDING TO BE LEGALLY BOUND ,
BTC and Auxilium hereby agree as follows:
1.1
SECTION 1.4. The following sentence shall be added to Section 1.4
of the License Agreement:
“For
purposes of clarity, Auxilium Holdings Inc. is an Affiliate of
Auxilium Pharmaceuticals, Inc. and Advance BioFactures of
Curacao, NV and Advance BioFactures Corporation are Affiliates
of BioSpecifics Technologies, Inc. and such Affiliates are
parties to this Agreement.”
1.2
Section 6.1. Section 6.1(a) of the License Agreement is hereby
deleted in its entirety and replaced with the following
language:
“6.1
Joint Manufacturing Committee .
(a)
BTC
and Auxilium will establish a Joint Manufacturing Committee
(the “JMC”) made up of two (2) representatives
designated by each Party hereto which shall oversee the
scale-up and manufacturing of Product on a worldwide basis,
including the planning, manufacturing and supply (including
supply chain management). Each of BTC and Auxilium shall have
one vote on the JMC. The objective of the JMC shall be to
reach agreement by consensus on all matters falling within its
authority hereunder. In the event of a deadlock with respect
to any action involving or related to the manufacture of
clinical supplies of Product, the vote of Auxilium, after
reasonable opportunity for open discussion among the members
of the JMC, shall control. In the event of a deadlock with
respect to any action involving or related to the manufacture
of commercial supplies of Product, the vote of Auxilium after
reasonable opportunity for open discussion among
the
members
of the JMC shall control until such time as BTC is providing
Auxilium with fifty percent (50%) of its commercial supplies
pursuant to the terms of this Agreement. At that point, in the
event of a deadlock with respect to any action involving or
related to the manufacture of commercial supplies of Product,
the vote of BTC after reasonable opportunity for open
discussion among the members of the JMC shall
control.
1.3
SECTION 6.2. Section 6.2 of the License Agreement is hereby deleted
in its entirety and replaced with the following
language:
“6.2
Development and Scale Up.
Auxilium shall, at its own cost and expense, utilizing the Back-Up
Supplier (defined below ),
develop the formulation and the finished dosage form and scale up
the Manufacture for clinical supply of the Enzyme and the Product
for each Indication for use in the Field, including the lyophilized
injection formulation, to be registered with Regulatory Authorities
in accordance with Law and in sufficient time prior to anticipated
commercial launch of a Product to provide for sufficient Supply of
Product for use in the Field. Auxilium will have the sole right and
responsibility for selecting the finished dosage form and
presentation for the Product in the Field. The costs paid to third
parties to develop the lyophilization of the injection formulation
shall be shared equally by the Parties.
1.4
SECTION 6.3. Section 6.3 (a) through (c) of the License Agreement
are hereby deleted in their entirety and replaced with the
following language:
“6.3
Clinical Supply .
(a)
Back-Up Suppliers .
Auxilium shall qualify one or more back-up suppliers for the
Manufacture of clinical and commercial supplies of Product in the
Field promptly after the Effective Date (the “Back-Up
Suppliers”.) For purposes of clarity, the term Back-Up
Suppliers shall include one or more entities in the supply chain,
as may be necessary to Manufacture Product for clinical and/or, if
applicable, commercial use. Auxilium’s agreement(s) with the
proposed Back-Up Suppliers shall be consistent with the respective
rights and obligations of Auxilium and BTC hereunder and a copy of
which, redacted with respect to financial terms, shall be provided
to BTC upon the execution of this Agreement and promptly after the
execution thereof, as to any such agreements executed after the
date hereof. BTC will use Commercially Reasonable Efforts to
provide such Back-Up Suppliers with sufficient know-how to
Manufacture Product, including (i) providing all protocols,
registration applications and other substantive regulatory
documents, including, but not limited to, all data, scientific
dossiers and governmental authorizations; (ii) providing access and
reference to all regulatory dossiers and filings produced by BTC,
its Affiliates and sublicensees relating to the Product; (iii)
providing access to BTC Know-How in reasonably satisfactory form,
and (iv) providing all technical assistance reasonably requested by
the Back-Up Suppliers related to the Manufacture of the Product.
Auxilium will require that the Back-Up Suppliers execute a written
confidentiality agreement with Auxilium and a written materials
transfer agreement with BTC, in a form reasonably acceptable to BTC
and consistent with industry standards, which includes, among other
things, an undertaking by the Back-Up Suppliers to keep
confidential the Manufacturing and Product information and know-how
disclosed to the Back-Up Suppliers by BTC. In
addition,
Auxilium
will require and the Back-Up Suppliers shall be obligated
promptly to provide BTC and Auxilium with such information and
know-how whether patentable or not concerning the Manufacture
of the Product that Back-Up Suppliers may develop or acquire
from time to time in connection with such Manufacture and the
Product, except for information and know-how unrelated to the
Manufacture of the Product that is proprietary to the Back-Up
Suppliers (“Back-Up Suppliers’ Proprietary
Information”). Such information may be utilized by BTC
and Auxilium, without cost or other obligation to the Back-Up
Supplier, consistent with the terms of this
Agreement.
(b)
Supply Obligations .
During the Term Auxilium is entitled to and shall be responsible
for arranging, through the Back-Up Suppliers, for the supply of all
Product for use by Auxilium in Clinical Trials. After the Effective
Date, Auxilium shall purchase, at its own cost and expense,
sufficient quantities of the Product to conduct all of its
requisite Clinical Trials from the Back-Up Suppliers.
(c)
BTC
shall have the right to purchase and Auxilium shall sell to
BTC, at Auxilium’s cost therefore, such supplies of
Product as BTC may require for pre-clinical and clinical
trials approved by JDC and such other non-preclinical and
non-clinical purposes (i.e. process development, manufacturing
and related activities) as are consistent with BTC’s
rights under this Agreement. Auxilium will invoice BTC for the
costs associated with such supplies which will be payable by
BTC within sixty (60) days of receipt.
1.5
SECTION 6.4. Section 6.4 (a) is hereby deleted in its entirety and
replaced with the following language:
“6.4
Commercial Supply; Supply Agreement .
BTC shall have the option (the “Supply Option”)
exercisable no later than six (6) months after FDA approval of the
first NDA or BLA with respect to a Product. (the “Approval
Date”) to assume the right and obligation to supply or
arrange for the supply, from a third party other than the Back-Up
Suppliers, of that portion of commercial quantities of the Product
in the Territory described below (the “BTC Supply
Portion”). Auxilium and BTC shall each keep the other
reasonably informed of their respective progress in securing FDA
approval of the appropriate BLA or NDA and the timing thereof and
other relevant matters affecting the contemplated supply by BTC of
commercial quantities of the Product. Upon the Approval Date,
Auxilium shall withhold $
<OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION> of
Milestone No 4 (the “the Retention Amount”) until BTC
notifies Auxilium of its decision regarding the exercise of the
Supply Option. If BTC exercises the Supply Option, Auxilium will
retain the Retention Amount until the sooner of (1) date on which
an agreement between BTC and a third party contractor is executed
for the commercial manufacture of the Product for the benefit of
Auxilium which contains milestones requiring such contractor to
successfully complete validation batches for the Product on or
before the Supply Date, a copy of which, with financial information
redacted, will be provided to Auxilium; or (2) the date on which
BTC commences construction by breaking ground for a cGMP facility
for the commercial manufacture of Product for the benefit of
Auxilium, provided, however that construction plans and timelines
for such facility shall be promptly provided to Auxilium prior to
commencement of such construction. If BTC does not exercise the
Supply Option, the Retained Amount will be
released
to BTC within thirty (30) days after BTC notifies Auxilium in
writing of its decision not to exercise the Supply Option. If
BTC exercises the Supply Option, commencing on the date 3.75
years from the Approval Date (the “Supply Date”)
BTC shall be responsible for supplying Auxilium either itself
or through a third party other than the Back-up Supplier and
Auxilium shall purchase from BTC the BTC Supply Portion of
Auxilium’s requirements of commercial supplies of
Product during the Term. If BTC does not exercise the Supply
Option, Auxilium shall be responsible for arranging for all
commercial supplies of Product during the Term. Except as
specifically provided otherwise in the Agreement, in no event
shall BTC Manufacture or supply the Enzyme or Product to any
third party. In the event BTC exercises the Supply Option, the
Parties shall use Comm
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