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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, arms length transactions, less customary deductions, determined in accordance with
MiddleBrooks 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. MiddleBrooks
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
MiddleBrooks 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 MiddleBrooks 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
Lexs 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 Lexs ownership and rights in or to any of the Rights
or assist others in challenging Lexs 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 Lexs 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 MiddleBrooks 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 Lexs behalf for all actions before and communications with Regulatory Authorities, the
United States Patent and Trademark Office, other Governmental Authorities and with any designated
registrars of domain names, as shall be necessary and appropriate to enable MiddleBrook to perform
the Regulatory Obligations. Furthermore, as Lexs agent for such Regulatory Obligations,
MiddleBrook shall have complete and sole discretion to take or not take such actions as it deems
reasonable and appropriate, provided that MiddleBrook shall comply with all Legal Requirements and
shall not cause, and shall use commercially reasonable efforts to prevent, the termination of any
of the Rights.
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6.3 Exchange of Information. The Parties shall establish procedures to ensure that
the Parties exchange on a timely basis all necessary information to enable MiddleBrook to comply
with all Regulatory Obligations, including, without limitation, filing updates, pharmacovigilance
filings and investigator notifications. To the extent either Party receives any information
regarding Adverse Drug Experiences related to the use of Licensed Products, such Party shall (i)
provide the other Party with such information within five (5) days of its receipt, (ii) promptly
provide all follow-up information that may reasonably be requested and (iii) otherwise act in
accordance with such Adverse Event Reporting Procedures to be agreed upon in writing by the Parties
from time to time. Without limiting the foregoing requirement, MiddleBrook shall provide Lex with
copies of all communications between MiddleBrook and any Governmental Authorities relating to any
of the Licensed Patents, Rights and Licensed Products, in every case within five (5) Business Days
of the sending or receipt of such communication by MiddleBrook.
6.4 Costs and Expenses. MiddleBrook shall bear all costs and expen






