EXHIBIT 10.4
REGISTRATION AND TRADEMARK LICENSE AGREEMENT
This REGISTRATION AND TRADEMARK
LICENSE AGREEMENT (this “ Agreement ”) is made
as of November 7, 2007 between Lex Pharmaceuticals,
Inc. (“ Lex ”), a Delaware corporation, and
MiddleBrook Pharmaceuticals, Inc. , a Delaware corporation
(“ MiddleBrook ”). Lex and MiddleBrook are each
referred to individually as a “ Party ,” and
collectively as the “ Parties .”
Background Statement
MiddleBrook and Lex are Parties to an
Asset Purchase Agreement, dated as of the date hereof (the “
Purchase Agreement ”), and the Related Agreements (as
defined in the Purchase Agreement). Pursuant to the Purchase
Agreement, MiddleBrook has conveyed certain assets to Lex,
including the trademarks, trademark applications and domain name
set forth on Schedule A (the “ Marks
”), the approved new drug application numbers 50-405 and
50-406 (including all supplements and amendments thereto, the
“ Approved Registrations ”) and Technical Data
and Technical Data Embodiments (as set forth in
Section 2. 1(a)(i) of the Purchase Agreement).
Pursuant to the Purchase Agreement, and subject to conditions set
forth therein, Lex may purchase from MiddleBrook investigational
new drug application number 73,767 (including any approval thereof
and all supplements and amendments thereto, the “ IND
”) and Technical Data and Technical Data Embodiments (as set
forth in Section 2. 1(a)(ii) of the Purchase
Agreement and, together with the Marks, Approved Registrations and
IND, the “ Rights ”). The Parties desire that
MiddleBrook shall have a license to use the Rights and the Parties
are entering into this Agreement to set forth the terms and
conditions of such license.
Statement of Agreement
1. Definitions .
1.1 Terms Defined in Purchase
Agreement . Terms defined in the Purchase Agreement and not
otherwise defined by this Agreement shall have the meaning given to
such terms in the Purchase Agreement.
1.2 “ Adverse Drug
Experience ” means the definition in the current 21
C.F.R. Section 314.80, as in effect from time to time.
1.3 “ Agreement ”
has the meaning set forth in the introductory paragraph.
1.4 “ Approved
Registrations ” has the meaning set forth in the
Background Statement.
1.5 “ Consignment
Agreement ” means the Inventory Consignment Agreement,
dated as of the date hereof, between Kef and MiddleBrook.
1.6 “ Governmental
Authority ” means any nation or government, any state or
other political subdivision thereof, any municipal, local, city or
county government, any entity exercising executive, legislative,
judicial, regulatory or administrative functions of or pertaining
to government.
1.7 “ IND ” has
the meaning set forth in the Background Statement.
1.8 “ Indemnitee ”
has the meaning set forth in Section 9.3 .
1.9 “ Indemnitor ”
has the meaning set forth in Section 9.3 .
1.10 “ Kef ” means
Kef Pharmaceuticals, Inc., a Delaware corporation.
1.11 “ Kef Stock Purchase
Agreement ” means that certain Stock Purchase Agreement,
dated as of November ___, 2007, between MiddleBrook, the
stockholders of Kef and Deerfield Management, L.P., pursuant to
which MiddleBrook has a right to purchase all of the capital stock
of Kef upon the terms and conditions set forth in such Stock
Purchase Agreement.
1.12 “ Kef Stock Purchase
Right ” means Stock Purchase Right as defined in the Kef
Stock Purchase Agreement.
1.13 “ Lex ” has
the meaning set forth in the introductory paragraph.
1.14 “ Lex Stock Purchase
Agreement ” means that certain Stock Purchase Agreement,
dated as of the date hereof, between MiddleBrook, the stockholders
of Lex and Deerfield Management, L.P., pursuant to which
MiddleBrook has a right to purchase all of the capital stock of Lex
upon the terms and conditions set forth in such Stock Purchase
Agreement.
1.15 “ Lex Stock Purchase
Right ” means Stock Purchase Right as defined in the Lex
Stock Purchase Agreement.
1.16 “ License ”
has the meaning set forth in Section 2.1 .
1.17 “ Licensed Patents
” has the meaning given to it the Patent Sublicense.
1.18 “ Licensed
Product(s) ” means all dosage forms, formulations,
strengths and package sizes and types of any Cephalexin antibiotic
products that may be marketed now or in the future under the
Rights.
1.19 “ Marks ” has
the meaning set forth in the Background Statement.
1.20 “ MiddleBrook
” has the meaning set forth in the introductory
paragraph.
1.21 “ Minimum Royalty
” has the meaning set forth in Section 3.2
.
1.22 “ Net Sales ”
shall mean, with respect to a Licensed Product, the gross amount
invoiced by or on behalf of MiddleBrook for that Licensed Product
sold to third parties in bona fide , arm’s length
transactions, less customary deductions, determined in accordance
with MiddleBrook’s standard accounting methods as generally
and consistently applied by MiddleBrook, to the extent included in
the gross invoiced sales price of any Licensed Product and
otherwise directly paid or incurred by MiddleBrook or distributors
with respect to the sale of such a Licensed Product, including:
(i) applicable sales credits (as described below),
(ii) payments or rebates incurred pursuant to federal, state
and local government (or agency thereof)
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programs, including Medicare and Medicaid rebates, (iii) costs
for transit insurance, freight, handling or other transportation
billed to customers to the extent included in the invoiced price
and (iv) sales, use or excise taxes included in the invoiced
price. Applicable sales credits include credits or discounts
deducted from the sales price for: (A) customer returns,
returned goods allowances, rejected goods and damaged goods not
covered by insurance, (B) cash or terms discounts,
(C) direct to customer discount or customer rebate programs,
including coupons, (D) third party rebates and chargebacks,
(E) trade show discounts and stocking allowances,
(F) price adjustments on customer inventories following price
changes, (G) product recalls, (H) deductions due for
discount card programs, (I) amounts credited for uncollectible
amounts on previously sold products and (J) agreed by Lex and
MiddleBrook in writing, other specifically identifiable amounts
included in gross sales of Licensed Products that were or
ultimately will be credited and that are substantially similar to
those listed above.
1.23 “ Party ”
means either MiddleBrook or Lex and “ Parties ”
shall mean both MiddleBrook and Lex.
1.24 “ Patent Sublicense
” means the Patent Sublicense that may be entered into
between Kef and MiddleBrook pursuant to that certain Asset Purchase
Agreement, dated as of the date hereof, between MiddleBrook and
Kef.
1.25 “ Person ”
means any corporation, administrator, association, joint venture,
partnership, limited liability company, organization, business,
individual, trust, government or agency or political subdivision
thereof or other legal entity.
1.26 “ Purchase
Agreement ” has the meaning set forth in the Background
Statement.
1.27 “ Regulatory
Authority ” shall mean any federal, national,
multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity with authority over
the marketing, pricing and/or sale of a pharmaceutical product in a
country, including without limitation FDA in the United
States.
1.28 “ Regulatory
Obligations ” has the meaning set forth in
Section 6.1 .
1.29 “ Regulatory
Responsibilities Agreement ” means the Agreement
Regarding Regulatory Responsibilities, dated as of the date of this
Agreement, between Lex and MiddleBrook.
1.30 “ Related
Agreements ” has the meaning set forth in the Background
Statement.
1.31 “ Rights ”
has the meaning set forth in the Background Statement.
1.32 “ Royalty ”
has the meaning set forth in Section 3 .
1.33 “ Term ”
means the period beginning on the date hereof and continuing until
the License is terminated pursuant to the terms of this
Agreement.
1.34 “ Territory ”
means the United States of America and Puerto Rico.
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2. Grant of License
.
2.1 Grant . Lex hereby grants
to MiddleBrook, upon and subject to the terms and conditions of
this Agreement, an exclusive license under the Rights to develop,
manufacture, market, distribute and sell, and have manufactured,
marketed, distributed and sold, the Licensed Products in the
Territory (the “ License ”).
2.2 Exclusivity . The License
is exclusive as to all Persons, including Lex.
2.3 No Transfer . MiddleBrook
shall not assign the License or grant any sublicense under the
License, other than (i) a sublicense to manufacture the
Licensed Products solely for sale by or on behalf of MiddleBrook or
(ii) such sublicenses as may be necessary to continue the
development of, and to obtain marketing approval for, Licensed
Products under the Approved Registrations or the IND.
2.4 Obligation to Develop and
Market . MiddleBrook shall at all times during the Term use its
commercially reasonable efforts, consistent with usual
pharmaceutical industry practice, to develop and commercialize the
Licensed Products during the term of this Agreement.
MiddleBrook’s obligations under this Section 2.4
may be suspended for so long as there exists any material safety
(including toxicity), efficacy, regulatory, medical or intellectual
property issue relating to the Licensed Products.
3. Royalty . In
consideration of the grant of the License, MiddleBrook shall pay
Lex a royalty (the “ Royalty ”) as
follows:
3.1 Percent of Net Sales . The
Royalty shall be equal to nine percent (9%) of MiddleBrook’s
Net Sales of Licensed Products plus such additional amount as may
be necessary for MiddleBrook to pay the Minimum Royalty.
3.2 Minimum Royalty .
Regardless of the amount of Net Sales, the minimum Royalty during
any calendar quarter shall be Four Hundred Thousand Dollars
($400,000) (the “ Minimum Royalty ”);
provided , that any payments made by MiddleBrook to Kef
during any calendar quarter pursuant to the Consignment Agreement
shall be included for purposes of determining whether MiddleBrook
has paid the Minimum Royalty for such calendar quarter. The Minimum
Royalty shall be pro-rated during the first and last calendar
quarters of the Term to reflect the portion of such calendar
quarters during which the License is in effect.
3.3 Quarterly Payment . Within
forty-five (45) days after the end of each calendar quarter
any part of which is during the Term, MiddleBrook shall deliver to
Lex (i) a written statement showing all Net Sales during such
calendar quarter and (ii) the greater of (A) the Royalty
due upon such Net Sales and (B) the Minimum Royalty. All
payments shall be made by wire transfer of immediately available
funds to an account designated by Lex.
3.4 Audit . Upon not less than
seven (7) days written notice, Lex shall have the right to
audit the books and records of MiddleBrook relating to sales of
Licensed Products for the purpose of determining the correctness of
MiddleBrook’s computation and payment of the Royalty. Such
audit may not be conducted more than once in any six-month period
and shall be conducted during normal business hours. Lex may engage
an accounting firm at its cost to
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perform
or assist in such audit. MiddleBrook shall provide Lex, its
officers, agents and accountants with access to all pertinent books
and records and shall reasonably cooperate with Lex’s efforts
to conduct such audits.
4. Ownership of Rights .
MiddleBrook acknowledges that, as between the Parties, Lex is the
sole and exclusive owner of the Rights, and MiddleBrook shall do
nothing inconsistent with such ownership. MiddleBrook shall not
challenge Lex’s ownership and rights in or to any of the
Rights or assist others in challenging Lex’s ownership
thereof. MiddleBrook agrees that nothing in this Agreement shall
give MiddleBrook any right, title or interest in the Rights other
than the License granted herein. Upon Lex’s request,
MiddleBrook shall provide such information and assistance, and
execute and deliver such documents, as Lex may reasonably request
for purposes of registering, maintaining or enforcing any of the
Rights.
5. No Warranty . The
Parties acknowledge that (i) Lex has acquired the Rights from
MiddleBrook as of the date hereof on the basis of representations
and warranties regarding the Rights made by MiddleBrook for the
benefit of Lex and (ii) pursuant to the Regulatory
Responsibilities Agreement, MiddleBrook shall be responsible for
maintaining and performing all Legal Requirements relating to the
Rights. LEX MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER
REGARDING THE RIGHTS OR THE LICENSED PRODUCTS, AND MIDDLEBROOK
ACKNOWLEDGES THAT IT IS ACCEPTING THE RIGHTS “AS IS”
UNDER THE LICENSE.
6. Regulatory
Obligations .
6.1 Performance by MiddleBrook
. During the Term, MiddleBrook shall take all reasonable and
appropriate actions, at MiddleBrook’s sole cost and expense,
to maintain the Rights and shall oversee, monitor, coordinate and
perform all regulatory actions, communications and filings with and
submissions, including filings and submissions of supplements and
amendments thereto, to each applicable Regulatory Authority or
Governmental Authority with respect to each Licensed Product (the
“ Regulatory Obligations ”). Notwithstanding the
foregoing, nothing herein shall operate to prevent Lex from taking
such actions as Lex, in its sole discretion, deems appropriate to
ensure that all Regulatory Obligations are properly and timely
performed, subject to prior notice to and consultation with
MiddleBrook.
6.2 Regulatory Meetings and
Correspondence . MiddleBrook shall be responsible for
interfacing, corresponding and meeting with the applicable
Regulatory Authorities with respect to each Licensed Product. Lex
shall execute such notices, powers of attorney, acknowledgments,
consents and other instruments as MiddleBrook may reasonably
request to authorize MiddleBrook to act on Lex’s behalf for
all actions before and communications with Regulatory Authorities,
the United States Patent and Trad
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