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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: CATALYST PHARMACEUTICAL PARTNERS, INC. | Catalyst Pharmaceutical Partners, Inc | Northwestern University You are currently viewing:
This License Agreement involves

CATALYST PHARMACEUTICAL PARTNERS, INC. | Catalyst Pharmaceutical Partners, Inc | Northwestern University

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Title: LICENSE AGREEMENT
Governing Law: Illinois     Date: 9/2/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: catalyst pharmaceutical partners  inc. , catalyst pharmaceutical partners  inc , northwestern university
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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:

 

 

(a)

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.

 

 

(b)

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.

 

 

(c)

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.

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


 
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