Exhibit 10.1
LICENSE
AGREEMENT
This Agreement made effective
as of this 27 th day of August, 2009 (the “Effective
Date”), by and between Northwestern University, an Illinois
corporation having a principal office at 633 Clark Street,
Evanston, Illinois 60208 (hereinafter referred to as
“Northwestern”) and Catalyst Pharmaceutical Partners,
Inc., a Delaware corporation having a principal office at 355
Alhambra Circle, Suite 1370, Coral Gables, FL, 33134 (hereinafter
referred to as “Licensee”) (each a “Party”
and collectively the “Parties”).
WITNESSETH
WHEREAS , Northwestern is the owner of certain patents
and patent application listed on Exhibit A and has
the right to grant licenses under such patents and patent
application, subject only to a royalty-free, nonexclusive license
heretofore granted to the United States Government;
WHEREAS , Northwestern desires to have such patent
rights, and know-how developed and commercialized to benefit the
public and is willing to grant a license hereunder;
WHEREAS , Licensee has represented to Northwestern that
Licensee has the expertise, experience, and resources necessary to
enable Licensee to commit itself to a diligent program to develop
and subsequently manufacture, market and sell products utilizing
such patent rights and know-how;
WHEREAS , Licensee desires to obtain a license under
such patent rights and know-how upon the terms and conditions
hereafter set forth;
NOW THEREFORE
, in consideration of the premises
and mutual covenants contained herein, the Parties hereto agree as
follows:
ARTICLE I -
DEFINITIONS
1.1 “ Affiliate ”
shall mean any corporation, firm, partnership or other entity which
controls, is controlled by or is under common control with a Party.
For the purposes of this definition, “control” shall
mean any right or collection of rights that together allow
direction on any vote with respect to any action by an entity or
the direction of management and operations of that entity. Such
right or collection of rights includes without limitation
(a) the authority to act as sole member or shareholder or
partner with a majority interest in an entity; (b) a majority
interest in an entity; and (c) the authority to appoint,
elect, or approve at least a majority of the governing board of
that entity.
1.2 “ FDA ” shall
mean the United States Food & Drug Administration and any
successor agency thereto.
1.3 “ Field ”
shall mean treatment of neurological conditions (including
addiction) in humans by means of altering biochemical pathways
associated with such conditions.
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1.4 “ IND ” shall
mean an Investigational New Drug Application as described in 21
C.F.R. § 312.20 et seq. (as the same may be amended from time
to time).
1.5 “ Know-How ”
shall mean technical information existing as of the Effective Date
which is owned by Northwestern and directly relates to practicing
inventions described in Patent Rights.
1.6 “ Licensed Products
” shall mean all products and services of Licensee, its
Affiliates and its sublicensees covered by or which incorporate or
are developed or made using the Patent Rights or
Know-How.
1.7 “ NDA ” shall
mean an application submitted to the FDA for approval to market a
new drug, as described in 21 C.F.R. § 314.50 et seq. (as the
same may be amended from time to time).
1.8 “ Net Sales ”
shall mean the gross amount invoiced by Licensee or its Affiliates
to unaffiliated third parties for the sale of Licensed Products,
less (a) trade credits, discounts, rebates and allowances
actually granted on account of price adjustments, rebate programs,
billing errors or the rejection or return of goods, (b) all
costs of shipping, freight, transportation and insurance for the
Licensed Product, but only to the extent that such costs are
included in Licensee’s or its Affiliate’s invoice price
to its customers for the Licensed Product, and (c) all sales,
use, excise and other taxes and compulsory payments to governmental
authorities (including tariffs and customs duties) that are
included in Licensee’s or its Affiliate’s invoice price
to its customers for the Product.
In the event that the Licensed
Product is sold in a fixed combination (“Combination
Product”) with one or more active therapeutic compounds not
subject to this Agreement (“Other Items”), the invoice
price of such Combination Product shall be set by Licensee in good
faith, applying a standard of fair and honest dealing with
Northwestern, and Net Sales in each country of the Licensed Product
included in the Combination Product shall be determined using the
following formulae:
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(a)
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If the Licensed
Product and Other Items contained in the combination are sold
separately in such country, the Net Sales for purposes of
calculating royalty payments will be the result obtained by
multiplying the Net Sales of the Combination Product in such
country by the fraction A/A+B, where A is the invoiced price in
such country of the Licensed Product in the Combination Product,
and B is the invoiced price in such country of all Other Items in
the Combination Product.
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(b)
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If the
Combination Product includes Other Items which are not sold
separately in such country (but the Licensed Product contained in
the Combination Product is sold separately in such country), the
Net Sales for purposes of calculating royalty payments will be the
result of multiplying the Net Sales of the Combination Product in
such country by the fraction A/C, where A is as defined above and C
is the invoiced price in such country of the Combination
Product.
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(c)
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If neither the Licensed Product
nor the Other Items contained in the Combination Product are sold
separately, or if only the Licensed Product is not sold separately,
Licensee shall in good faith, applying a standard of fair and
honest dealing with
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Northwestern, propose, after
discussion with Northwestern, the percentage of the revenue from
such Combination Product in such country that is attributable to
the Licensed Product and shall notify Northwestern in writing of
such proposal not less than 45 days prior to commencing sales of
such Combination Product. Unless Licensee receives written
objection from Northwestern to such proposal within 45 days
following Northwestern’s receipt of such proposal, then the
revenue so attributed to the Licensed Product shall be the Net
Sales for the purposes of this paragraph. In the event Northwestern
objects to Licensee’s proposal, Northwestern and Licensee
agree to negotiate in good faith to reach a mutually acceptable
determination, and Licensee shall not market such Combination
Product unless and until such a determination is
reached.
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1.9 “ Patent Rights
” shall mean the patents and patent application listed on
Exhibit A attached hereto and incorporated herein by
reference, and any patents which issue from such patent
application, and all divisions, continuations and
continuations-in-part, reissues, reexaminations or extensions of
any thereof, to the extent that such are supported by the
specification and entitled to the priority date of the patents or
pending patent application in Exhibit A . Patent
Rights shall also include any foreign counterparts of any of the
foregoing.
1.10 “ Regulatory
Approval ” shall mean the approval of either the FDA or
of a foreign counterpart thereto required to commence commercial
sale of a Licensed Product in such country in the Territory in
which such foreign counterpart has jurisdiction.
1.11 “ Territory
” shall mean the World.
1.12 “ Launch ”
shall mean, in each country of the Territory, the first commercial
sale of a Licensed Product by or on behalf of Licensee or its
Affiliates or its sublicensees in such country following the
Regulatory Approval of such Licensed Product in such
country.
ARTICLE II -
GRANT
2.1 In reliance upon the
representations made to Northwestern by Licensee that Licensee has
the experience, expertise and resources necessary to enable
Licensee to perform its obligations hereunder, Northwestern hereby
grants to Licensee and its Affiliates an exclusive license under
Patent Rights and Know-How to make, have made, use, import, offer
for sale and sell Licensed Products in the Territory in the
Field.
2.2 The grant under Paragraph 2.1
shall be subject to the obligations of Northwestern and of Licensee
to the United States Government under any and all applicable laws,
regulations, and executive orders including those set forth in 35
U.S.C. §200, et seq.
2.3 Northwestern and all inventors
of Patent Rights retain the right to utilize Patent Rights and
Know-How for noncommercial research and educational purposes.
Northwestern also retains the rights to distribute certain
materials upon request by the research community for academic
purposes through a Material Transfer Agreement (MTA), in compliance
with NIH guidelines.
2.4 The grant of this license does
not obligate Northwestern or any inventor of Patent Rights to make
available to Licensee, its sublicensees or Affiliates for their own
use and benefit, Northwestern space, facilities, students and
services, unless otherwise stated herein or in a separate
contractual agreement between Northwestern and Licensee.
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2.5 Northwestern hereby grants to
Licensee the right to grant sublicenses consistent with this
Agreement provided that Licensee shall be responsible for
the performance of its sublicensees, including the payment of
royalties, and shall provide Northwestern with executed copies of
such sublicense agreements within thirty (30) days of
execution of such agreements. Northwestern shall treat all such
sublicense agreements and the terms thereof as confidential
information of Licensee in accordance with
Section 3.1.
2.6 The grant of this license shall
not include research or discoveries that arise from collaborations
between inventors of Patent Rights and other faculty investigators
at Northwestern or outside Northwestern.
ARTICLE III - CONFIDENTIAL
INFORMATION
3.1 (a) Northwestern and Licensee
each agree that all information contained in documents marked
“Confidential” which are forwarded to one by the other
shall be received in strict confidence, used only for the purposes
of this Agreement, and not disclosed by the recipient (subject to
paragraph (e) of this Section 3.1), its agents or
employees to any third party without the prior written consent of
an authorized officer of the disclosing Party, unless such
information (i) was in the public domain at the time of
disclosure, (ii) later became part of the public domain
through no act or omission of the recipient, its employees, agents,
successors or assigns, (iii) was lawfully disclosed to the
recipient by a third party having the right to disclose it,
(iv) was already known by the recipient at the time of
disclosure (as evidenced by recipient’s written records),
(v) was independently developed by recipient (as evidenced by
recipient’s written records) or (vi) is required to be
submitted to a government agency to obtain and maintain the
approvals and clearances of Licensed Products.
(b) Disclosure may be made to
Affiliates, distributors, customers, and agents, to nonclinical and
clinical investigators, and to consultants, where necessary or
desirable with appropriate safeguards to protect the confidential
underlying disclosure. Either recipient may disclose confidential
information of the disclosing Party (to the extent such disclosure
is reasonably necessary) to such Party’s outside counsel,
accountants, or agents and to bankers and other third parties in
connection with due diligence or similar investigations;
provided in each case that any such consultant, banker,
lawyer, accountant, agent or third party is bound by obligations of
confidentiality and non-use at least as restrictive as those set
forth herein.
(c) Northwestern and Licensee also
agree that confidential information may be orally disclosed by one
Party to the other Party. Such information shall be confirmed in
writing and designated “Confidential” within thirty
(30) days of disclosure for the provisions of this Article III
to apply.
(d) The fact that a particular item
of know-how or information does not at the time of disclosure or
generation qualify as (or subsequently ceases to qualify as)
confidential information by virtue of one or more of the exclusions
specified in paragraph (a) (the “Excluded Item”)
will not relieve the recipient from its obligation of
confidentiality and non-use as to any other item of confidential
information of the disclosing party or as to the relationship of
the Excluded Item to any other item of confidential information of
the disclosing party.
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(e) If, based upon the advice of
legal counsel skilled in the subject matter, the recipient is
required to disclose confidential information of the disclosing
party to comply with an applicable law, regulation, legal process,
or order of a government authority or court of competent
jurisdiction, the recipient may disclose such confidential
information only to the person or entity required to receive such
disclosure; provided , however , that the recipient
required to disclose such confidential information shall
(i) to the extent reasonably practicable, give prior notice to
such disclosing Party to enable it to seek any available exemptions
from or limitations on such disclosure requirement and shall
reasonably cooperate in such efforts by the disclosing Party,
(ii) furnish only the portion of the confidential information
which is legally required to be disclosed, based upon the advice of
legal counsel skilled in the subject matter, (iii) use all
reasonable efforts to secure confidential protection of such
confidential information, and (iv) continue otherwise to
perform its obligations of confidentiality set out herein as to
such confidential information.
3.2 Each Party’s obligation of
confidence hereunder shall be fulfilled by using at least the same
degree of care with the other Party’s confidential
information as it uses to protect its own confidential information
but in any event not less than reasonable care. This obligation
shall exist while this Agreement is in force and for a period of
two (2) years thereafter except in the event of termination by
Northwestern for breach on the part of Licensee, in which event
Licensee’s obligation to maintain Northwestern’s
information confidential will exist for a period of ten
(10) years after the termination for breach. The provisions of
this Article III shall survive termination of this
Agreement.
3.3 This Agreement may be
distributed solely (a) to those employees, agents and
independent contractors of Northwestern and Licensee who have a
need to know its contents, (b) to those persons whose
knowledge of its contents will facilitate performance of the
obligations of the parties under this Agreement, (c) to those
persons, if any, whose knowledge of its contents is essential in
order to permit Licensee or Northwestern to maintain or secure the
benefits under policies of insurance, (d) subject to paragraph
(e) of Section 3.1, as may be required by law or
regulation or by court or administrative agency order, or
(e) such other persons as may be permitted by paragraph
(b) of Section 3.1. Notwithstanding, Licensor
acknowledges Licensee’s representations (i) that
Licensee is a company with a class of securities registered under
Section 12 of the Securities Exchange Act of 1934 and
(ii) that as a result Licensee will be obligated to disclose
this Agreement in its reports to the U.S. Securities and Exchange
Commission (“Commission”) and to file a copy of same as
an exhibit to its reports to the Commission.
ARTICLE IV - MILESTONES AND
DUE DILIGENCE
4.1 Licensee hereby represents that
Licensee has the experience, expertise and resources necessary to
enable Licensee to perform its obligations hereunder. Licensee
shall use commercially reasonable efforts to develop and
commercialize Licensed Products (assuming US clinical trial
protocols). Licensee shall, upon execution of this Agreement,
submit to Northwestern a preliminary development and business plan
that sets forth an outline of Licensee’s intended efforts to
develop and commercialize Licensed Products. Such plan shall
include a reasonably detailed description of the tasks generally
anticipated to be performed for the development of Licensed
Products in relation to the milestones set forth in
Section 4.2 and estimates of anticipated expenses.
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4.2 The parties agree that if all
milestones listed on Exhibit B are met, Licensee will
be deemed to be using commercially reasonable efforts to develop
and commercialize Licensed Products.
4.3 The parties agree that if any
milestone payment listed on Exhibit C, Section 2, is not met,
Licensee will be deemed to be in breach.
4.4 The parties acknowledge that the
process of drug development involves many variables and
uncertainties. Therefore, the failure to adhere to specific aspects
of the preliminary development and business plan shall not, without
more, give rise to any right to terminate this Agreement;
provided , however , that Northwestern shall not be
precluded from considering the preliminary development and business
plan as part of its evaluation of whether Licensee’s
development efforts are commercially reasonable so long as it also
considers any additional information provided by Licensee regarding
factors affecting such development efforts.
4.5 Licensee agrees to provide
annual progress reports with sufficient details to Northwestern
describing Licensee’s research and development efforts in the
development of Licensed Products during the preceding year. Such
progress reports shall be due each January, beginning January 2010,
until the date of first commercial sale of a Licensed
Product.
ARTICLE V -
PAYMENTS
In consideration of the license
granted by Northwestern to Licensee under this Agreement, Licensee
shall pay to Northwestern the amounts listed in Exhibit
C hereto.
ARTICLE VI - PAYMENT, REPORTS
AND RECORDS
6.1 Payment Dates and
Reports
Within sixty (60) days after
the end of each calendar quarter of each year during the term of
this Agreement (and within sixty (60) days after the end of
the first calendar quarter which ends following the expiration of
this Agreement), Licensee shall pay to Northwestern all amounts
which have become due and payable during such calendar quarter.
Such payments shall be accompanied by a statement showing the Net
Sales of each Licensed Product by Licensee and its Affiliates in
each country, the applicable royalty rate and the calculation of
the amount of royalty due, as well as all amounts of Sublicensing
Revenue received and a calculation of Northwestern’s share
thereof.
6.2 Accounting
a. Payments in U.S.
Dollars
All dollar sums referred to in this
Agreement are expressed in U.S. dollars and the Net Sales used for
calculating the royalties and other sums payable to Northwestern by
Licensee pursuant to Paragraph 6.1 shal