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Title: |
License and Supply Agreement |
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Entities: |
CollaGenex Pharmaceuticals Inc.; Silicon Valley Bank; Wachovia Bank, NA; Hale and Dorr LLP; Quinn Emanuel Urquhart Oliver & Hedges; Mutual Pharmaceutical Company, Inc.; United Research Laboratories |
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Date: |
2004 |
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Size: |
Preview shows 11KB of 151KB total |
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Price: |
$71 |
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ID: |
#284040 |
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LICENSE AND SUPPLY AGREEMENT
among
COLLAGENEX PHARMACEUTICALS, INC.,
and
MUTUAL PHARMACEUTICAL COMPANY, INC.
and
UNITED RESEARCH LABORATORIES
APRIL 8, 2004
{PAGE}
COLLAGENEX-MUTUAL License & Supply Agmt
i
LICENSE AND SUPPLY AGREEMENT
Table of Contents
ARTICLE I - DEFINITIONS................................................ 2
ARTICLE II - INTELLECTUAL PROPERTY GRANTS.............................. 11
ARTICLE III - PAYMENTS AND INVENTORY COMPETITIVE PRICING
ADJUSTMENTS............................................................ 14
ARTICLE IV - SUPPLY.................................................... 24
ARTICLE V - REPRESENTATIONS, WARRANTIES AND COVENANTS.................. 36
ARTICLE VI - INTELLECTUAL PROPERTY AND CONFIDENTIAL INFORMATION........ 43
ARTICLE VII - TERM AND TERMINATION..................................... 47
ARTICLE VIII - INDEMNIFICATION, INSURANCE AND DISPUTE
RESOLUTION............................................................. 53
ARTICLE IX - MISCELLANEOUS............................................. 61
{PAGE}
LICENSE AND SUPPLY AGREEMENT
PREAMBLE
This LICENSE AND SUPPLY AGREEMENT dated as of the 8th day of April, 2004
(the "Execution Date") is by and among CollaGenex Pharmaceuticals, Inc., a
Delaware corporation having its principal place of business in Newtown,
Pennsylvania ("COLLAGENEX"), on the one hand; and Mutual Pharmaceutical Company,
Inc., a Pennsylvania corporation having its principal place of business in
Philadelphia, Pennsylvania ("Mutual") and United Research Laboratories, Inc., a
Pennsylvania corporation having its principal place of business in Philadelphia,
Pennsylvania ("URL") (Mutual and URL are, collectively, "URL/MUTUAL"), on the
other hand (CollaGenex and URL/Mutual are, collectively, the "Parties").
WHEREAS, the Parties wish to amicably settle certain litigation currently
ongoing between them; and WHEREAS, URL/MUTUAL desires to exclusively purchase
certain products from COLLAGENEX for resale to its distributors and other
customers for ultimate sale to consumers in the Territory, and COLLAGENEX
desires to supply such products to URL/MUTUAL in the Territory, subject to the
terms and conditions set forth in this Agreement; and
WHEREAS, COLLAGENEX is willing to grant, and URL/MUTUAL is willing to
receive, a sublicense under certain patents owned by The Research Foundation of
State University of New York, a non-profit educational corporation organized
under the laws of New York state ("FOUNDATION") to enable URL/MUTUAL to sell
such products in the Territory to its distributors and other customers for
ultimate sale to consumers in such Territory, subject to the terms and
conditions set forth in this Agreement.
1
{PAGE}
NOW, THEREFORE, in consideration of the mutual covenants, agreements and
stipulations set forth herein, and in the Consent Agreement (as defined
hereinafter), Settlement Agreement (as defined hereinafter), and the Stipulated
Orders (as defined hereinafter), the receipt and legal sufficiency of which are
hereby mutually acknowledged, COLLAGENEX and URL/MUTUAL hereby agree as follows:
ARTICLE I - DEFINITIONS
Section 1.1 Definitions. As used in this Agreement, the following terms, whether
used in the singular or plural, shall have the following meanings:
"A/B Rated" shall mean "therapeutically equivalent" as evaluated by FDA,
applying the definition of "therapeutically equivalent" set forth in the Preface
to the current edition of the FDA publication "Approved Drug Products With
Therapeutic Equivalence Evaluations" (the "Orange Book").
"Adverse Event Reports" shall have the meaning set forth in Section 4.3.
"Affiliate" shall mean any corporation, firm, partnership or other entity,
whether de jure or de facto, which controls, is controlled by, or is under
common control with a Party. For purposes of this definition, "control" shall
mean: (a) in the case of corporate entities, direct or indirect ownership of at
least 50% of the stock or shares (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular jurisdiction)
entitled to vote for the election of directors or otherwise having the power to
vote on or direct the affairs of such Party; and (b) in the case of
non-corporate entities, direct or indirect ownership of at least 50% of the
equity interest or the power to direct the management and policies of such
noncorporate entities.
"Agreement" shall mean this License and Supply Agreement.
2
{PAGE}
"AMP" shall mean Average Manufacturer's Price for Periostat(R)as reported
quarterly by CollaGenex to The Secretary of the United States Department of
Heath and Human Services and/or the Heath Care Financing Administration pursuant
to Section 1927 of the Social Security Act, 42 U.S.C.ss.1396s, and/or Section
4401 of the Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101-508.
"ANDA" shall mean an Abbreviated New Drug Application as defined in the
U.S. Federal Food, Drug and Cosmetic Act and all applicable regulations
promulgated thereunder.
"Applicable Law" shall mean all applicable provisions of all U.S. federal
or state statutes, laws, regulations, ordinances, decrees, orders, decisions,
injunctions, judgments, and permits and licenses of or from U.S. federal or
state governmental authorities relating to the use or regulation of the subject
item.
"Bottle" shall mean a bottle containing one hundred (100) tablets of
COLLAGENEX Supplied Product. "Box" shall mean a box of twelve (12) Bottles.
"Business Day" shall mean any day other than a day which is a Saturday, a Sunday
or federal bank holiday in the USA. "cGMP" shall mean current good manufacturing
practices of the FDA, as set forth in 21 C.F.R. Parts 210 and 211 and all
Applicable Law.
"Calendar Quarter" shall mean each of the three (3) month periods during a
calendar year starting on the first of January, April, July and October.
"Change of Control" shall mean, with respect to the applicable Party, an
event where:
(a) any Third Party (alone or together with such Third Party's
Affiliates) or "group" (as such term is defined under Section 13(d) of the
Securities Exchange Act of 1934, as
3
{PAGE}
amended) (i) acquires beneficial ownership of capital stock of such Party
entitling the holder(s) thereof to greater than fifty percent (50%) of the
voting power of the then outstanding capital stock of such Party with
respect to the election of directors of such Party, or (ii) otherwise
actually controls or is in a controlling position with respect to the
voting power of the then outstanding capital stock of such Party; or
(b) such Party consummates a merger, consolidation, reorganization or
similar transaction or series of related transactions, whether direct or
indirect, with another Third Party, alone or together with such Third
Party's Affiliates (the "Acquiring Corporation"), in which: (i) such Party
is not the surviving corporation in such transaction, (ii) the members of
the Board of Directors of such Party prior to such transaction constitute
less than one half of the members of the Board of Directors of the
Acquiring Corporation following such transaction, (iii) greater than fifty
percent (50%) of the voting power of the outstanding capital stock of the
Acquiring Corporation with respect to the election of directors following
such transaction is held by Third Parties who were shareholders of the
Acquiring Corporation prior to such transaction, or (iv) such Party is
otherwise effectively controlled by the Acquiring Corporation, or
(c) such Party sells to any Third Party(s) (alone or together with
such Third Party's Affiliates) in one or more related transactions
properties or assets representing greater than fifty percent (50%) of: (i)
such Party's consolidated total assets as reflected on its most recent
annual audited financial statements, provided that, all or substantially
all of the properties and assets used in connection with such Party's
pharmaceutical business are included in such transaction(s), (ii) such
Party's pharmaceutical business, or (iii) such Party's consolidated
operating income for the most recent fiscal year as reflected on its most
recent annual audited financial statements.
4
{PAGE}
Notwithstanding anything to the contrary in this definition, a Change of
Control shall not be deemed to have occurred with respect to a Party where any
acquisition, merger, consolidation, reorganization, sale or similar transaction
occurs solely between such Party and any one or more of its Affiliates.
"COLLAGENEX" shall have the meaning set forth in the Preamble.
"COLLAGENEX NDA" shall mean NDA No. 50,783 for Periostat(R) 20 mg tablets
as approved by the FDA.
"COLLAGENEX Party" shall have the meaning set forth in Section 8.2.
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