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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: INSPIRE PHARMACEUTICALS INC., | nonprofit Wisconsin corporation, | Development Co. Ltd. You are currently viewing:
This License Agreement involves

INSPIRE PHARMACEUTICALS INC., | nonprofit Wisconsin corporation, | Development Co. Ltd.

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Wisconsin     Date: 3/11/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

EXCLUSIVE LICENSE AGREEMENT, Parties: inspire pharmaceuticals inc.  , nonprofit wisconsin corporation  , development co. ltd.
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EXHIBIT 10.44

 

[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]

 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement (hereinafter called the “Agreement”) is made effective the 2nd day of November, 2004, by and between Wisconsin Alumni Research Foundation (hereinafter called “WARF”), a nonstock, nonprofit Wisconsin corporation, and Inspire Pharmaceuticals, Inc. (hereinafter called “Licensee”), a corporation organized and existing under the laws of Delaware.

 

WHEREAS, WARF and Yeda Research and Development Co. Ltd. (hereinafter called “Yeda”) own certain inventions described in the “Licensed Patents” defined below and have entered into an agreement under which Yeda has granted to WARF the exclusive right to grant, negotiate, execute, administer and enforce licenses under the Licensed Patents for the benefit of WARF and Yeda (collectively referred to hereinafter as the “Licensors”); and

 

WHEREAS , WARF is willing to grant a license to Licensee under any one or all of the Licensed Patents and Licensee desires a license under all of them;

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties covenant and agree as follows:

 

Section 1. Definitions .

 

For the purpose of this Agreement, the Appendix A definitions shall apply.

 

Section 2. Grant .

 

A. License .

 

WARF hereby grants to Licensee on behalf of the Licensors, and Licensee hereby accepts, subject to the terms and conditions hereof, an exclusive license under the Licensed Patents, with the right to grant sublicenses in accordance with Section 2B below, to develop, make, have made, use, market, distribute, import, offer for sale and sell Products in the Licensed Field and Licensed Territory.

 

B. Sublicenses .

 

(i) Licensee may grant written sublicenses to third parties with respect to the rights licensed hereunder. Any agreement granting a sublicense shall state that the sublicense is subject to the termination of this Agreement, but that such Sublicensee shall have the right simultaneously with such termination to obtain a license directly from WARF, and WARF shall simultaneously grant such a license, under the terms and conditions set forth in this Agreement. During the term of this Agreement, Licensee shall have the same responsibility for the activities of any Sublicensee as if the activities were directly those of Licensee. Licensee shall provide WARF with the name, contact information and address of each Sublicensee, as well as information regarding the number of full-time employees of any such Sublicensee to allow WARF to determine whether it can maintain its small entity filing status for patent prosecution and maintenance purposes.

 

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(ii) With respect to sublicenses granted by Licensee under this Section 2B, Licensee shall pay to WARF what Licensee would have been required to pay to WARF had Licensee sold the amount of Products sold by such Sublicensee. In addition, if Licensee receives fees or milestone payments in consideration for the grant of rights under any sublicense, and such amounts are not royalty payments based directly upon the amount or value of Products sold by the Sublicensee, then Licensee shall pay to WARF a percentage of such fee or milestone payments as follows:

 

(a) [CONFIDENTIAL] of such fee or milestone payments received under each sublicense agreement entered into within [CONFIDENTIAL] of the date hereof;

 

(b) [CONFIDENTIAL] of such fee or milestone payments received under each sublicense agreement entered into prior to the date that is [CONFIDENTIAL] from the date hereof but subsequent to the date that is [CONFIDENTIAL] from the date hereof; and

 

(c) [CONFIDENTIAL] of such fee or milestone payments received under each sublicense agreement entered into subsequent to the date that is [CONFIDENTIAL] from the date hereof.

 

The parties agree that payments received by Licensee as payment to or reimbursement for actual costs and expenses, including direct, indirect and overhead allocations, calculated in accordance with Licensee’s accounting practices applied on a consistent basis in accordance with generally accepted accounting principles, incurred in conducting research or other activities on behalf of a Sublicensee as part of a research or collaboration or other agreement, or payments received by Licensee as consideration for services or goods provided to a Sublicensee, shall not be considered as payments subject to the percentage distribution set forth above. If goods provided by Licensee to its Sublicensees are Products as defined under this Agreement, then any payments received by Licensee for such goods shall be subject to Section 4C. Licensee shall not receive from its Sublicensees anything of value in lieu of cash payments in consideration for any sublicense granted under this Agreement, without the express prior written consent of WARF, such consent not to be unreasonably withheld, conditioned or delayed.

 

C. Reservation of Rights .

 

Licensors hereby reserve the right to practice and use the inventions of the Licensed Patents solely for Non-Commercial Research Purposes, and to grant non-profit research institutions and governmental agencies non-exclusive licenses under the Licensed Patents for Non-Commercial Research Purposes, provided that such use shall specifically prohibit any human use or clinical administration.

 

D. License to WARF .

 

Licensee hereby grants WARF a nonexclusive, royalty-free, irrevocable, paid-up license, with the right to grant sublicenses solely to non-profit research institutions and governmental agencies, to practice and use “Improvements” for Non-Commercial Research Purposes, provided that such use shall specifically prohibit any human use or clinical administration. “Improvements” shall mean any patented modification by Licensee during the term of this Agreement of an invention described in the Licensed Patents that (1) would be infringed by the practice of an invention claimed in the Licensed Patents; or (2) if not for the license granted under this Agreement, would infringe one or more Valid Claims of the Licensed Patents. Licensee shall provide WARF with a written, enabling disclosure of each such invention, unambiguously identifying it as an invention governed by this paragraph, within six (6) months of the issuance of a patent thereon.

 

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Section 3. Development .

 

Licensee agrees to and warrants that it has, or will obtain, the expertise reasonably necessary to independently evaluate the inventions of the Licensed Patents and to undertake the development of Products for sale in the commercial market, and that it so intends to develop Products for the commercial market. Further, the parties agree that Licensee has, as of the date hereof, provided WARF with a development plan encompassing at least the information set forth in Appendix E describing the steps Licensee reasonably anticipates, consistent with industry practice, as necessary to allow the inventions of the Licensed Patents to be utilized to provide Products for sale in the commercial market. The parties acknowledge that such plan may be subject to change, as determined by Licensee in its sole and reasonable discretion. In addition, within one (1) month following the end of each annual period ending on December 31 until the Date of First Commercial Sale of Products, Licensee will provide WARF with a written Development Report summarizing Licensee’s product development activities since the last Development Report and any necessary adjustments to the development plan. If Licensee fails to provide a written Development Report to WARF within forty-five (45) days of receipt of written request from WARF as a result of Licensee’s failure to provide the Development Report to WARF within the required time period set forth above (i.e., by January 31 for the prior calendar year), such failure shall be deemed a material breach of a material covenant under this Agreement. All development activities and strategies and all aspects of product design and decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise and/or the expertise of Licensee’s contractors and collaborators with respect thereto. WARF’s review of Licensee’s development plan is solely to verify the existence of Licensee’s commitment to the development activity described in Appendix E hereto and to assure compliance with Licensee’s obligations to utilize the inventions of the Licensed Patents to commercialize Products for the marketplace. WARF reserves the right to audit Licensee’s records relating to development of Products as required hereunder. Such record keeping and audit procedures shall be subject to the procedures and restrictions set forth in Section 6 for auditing the financial records of Licensee.

 

Section 4. Consideration .

 

A. License Fee .

 

Licensee agrees to pay to WARF a license fee of $150,000 within thirty (30) days of execution of this Agreement.

 

B. Milestone Fees .

 

Licensee agrees to pay to WARF the amounts detailed below within thirty (30) days of the achievement of the corresponding milestones.

 

 

 

 

Milestone


 

 

Milestone Fee


 

[CONFIDENTIAL]

 

$[CONFIDENTIAL]

 

 

[CONFIDENTIAL]

 

$[CONFIDENTIAL]

 

 

[CONFIDENTIAL]

 

$[CONFIDENTIAL]

 

 

[CONFIDENTIAL]

 

$[CONFIDENTIAL]

 

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Each milestone payment above shall only be made once under this Agreement upon the initial accomplishment of the relevant milestone in connection with the first Product for which such milestone event occurs. Thus, a maximum of $1,800,000 in potential milestones is payable during the term of this Agreement.

 

C. Royalty; Combination Products; Third Party Royalties .

 

(i) In addition to the Section 4A license fee and Section 4B milestone fees, Licensee agrees to pay to WARF a royalty calculated as [CONFIDENTIAL] of the Selling Price of Products sold by or on behalf of Licensee in jurisdictions in the Licensed Territory where the use or sale of such Products would, but for the licenses granted hereunder, infringe a Valid Claim of the Licensed Patents in that jurisdiction. The royalty shall be deemed earned as of the earlier of the date the Product is actually sold or otherwise transferred for consideration, or the date an invoice is sent by Licensee. No multiple royalty shall be payable because the manufacture, use, sale or distribution of a Product is covered by more than one Valid Claim. In addition, with respect to transfers of Products by, between or among Licensee and Licensee’s affiliates or Sublicensees, no royalty shall be due and payable where the affiliate or Sublicensee will resell the Products and such resale will be subject to the earned royalty calculation.

 

(ii) Notwithstanding the foregoing or anything to the contrary in this Agreement, in the event that Products are sold by Licensee as part of a combination or bundled product, the Selling Price of such combination/bundled product, for the purposes of determining royalty payments due under this Agreement, shall be determined by multiplying the Selling Price (as defined on Appendix A) of the combination/bundled product by the fraction A/(A+B), where A is the average sale price of the Product when sold separately in finished form and B is the average sale price of the other product(s) or system sold separately in finished form, so that A+B is the average sale price of the product(s). In the event that such average sale price cannot be determined for both the Product and such other product(s) or system(s) in combination, the Selling Price for the purposes of determining royalty payments with respect to such combination or bundled product shall be commercially reasonable and determined by good faith negotiation between WARF and Licensee.

 

(iii) Notwithstanding the foregoing, in addition to and without limitation of any reduction in royalties pursuant to Section 4C(ii) above, if Licensee makes payments to one or more independent third parties during any calendar year to obtain or maintain a license or similar right under intellectual property owned by such independent third party as determined in good faith by Licensee, after consultation with WARF, to be reasonably necessary to avoid infringement thereof by the manufacture, use, or sale of Products, or to reasonably avoid infringement-related litigation with respect to such patent(s), then Licensee may deduct [CONFIDENTIAL] of such third party payments from royalties payable to WARF with respect to that calendar year, provided that such deduction does not exceed [CONFIDENTIAL] of the royalties payable to WARF under this Agreement during any such calendar year.

 

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D. Minimum Royalty .

 

Licensee further agrees to pay to WARF a minimum royalty of $10,000 per calendar year, or pro rated portion thereof for each partial calendar year, during which this Agreement is in effect starting in calendar year 2008, against which any earned royalty paid for the same calendar year will be credited. The minimum royalty for a given year shall be due at the time payments are due for the calendar quarter ending on December 31. It is understood that the minimum royalties will apply on a calendar year basis, and that sales of Products requiring the payment of earned royalties made during a prior or subsequent calendar year shall have no effect on the annual minimum royalty due WARF for any given calendar year.

 

E. Patent Fees and Costs .

 

(i) Licensee also agrees to reimburse the Licensors for all reasonable, documented costs associated with the filing, prosecution and maintenance of the Licensed Patents. Licensee shall pay to WARF $67,353.32 within thirty (30) days of execution of this Agreement to reimburse the Licensors for the previously-incurred expenses incurred with respect to the Licensed Patents. Licensee shall pay to WARF all reasonable, documented future expenses associated with the filing, prosecution and maintenance of the Licensed Patents within thirty (30) days of receiving an invoice from WARF with respect thereto.

 

(ii) WARF shall keep Licensee advised as to the maintenance of all Licensed Patents by promptly forwarding to Licensee copies of all official correspondence received or provided to the corresponding patent office relating thereto (including, but not limited to, patent applications, Office Actions, responses, etc.). Licensee shall have the right to advise WARF as to such maintenance; and further, Licensee shall have the right to make reasonable requests to WARF as to the conduct of such maintenance; provided, however, that Licensee understands and agrees that WARF has the sole and final authority to make final decisions.

 

(iii) WARF will maintain the Licensed Patents until WARF makes a good faith determination, in consultation with Licensee, that continued maintenance is unnecessary. If WARF makes such a good faith determination to abandon a Licensed Patent, WARF shall provide Licensee written notice of WARF’s intent to abandon such patent at least ninety (90) days in advance of any applicable statutory deadline. In such event, Licensee shall have the right to continue maintenance of said patent, at its own expense, on behalf of WARF, Yeda and Licensee, to the extent allowed under applicable law, by providing written notice thereof to WARF within such ninety (90) day period.

 

F. Accounting; Payments; Taxes .

 

(i) Amounts owing to WARF under Sections 2B and 4C shall be paid on a quarterly basis, with such amounts due and received by WARF on or before the sixtieth (60 th ) day following the end of the calendar quarter ending on March 31, June 30, September 30 or December 31 in which such amounts were earned. The balance of any amounts which remain unpaid more than thirty (30) days after they are due to WARF shall accrue interest until paid at the rate of the lesser of one percent (1%) per month or the maximum amount allowed under applicable law. However, in no event shall this interest provision be construed as a grant of permission for any payment delays.

 

(ii) Except as otherwise directed, all amounts owing to Licensors under this Agreement shall be paid in U.S. dollars to WARF at the address provided in Section 16(a). For converting any royalty payments on Selling Prices made in a currency other than U.S. dollars, Selling Prices shall first be determined in the currency of the country in which they are earned and shall be converted each calendar quarter into an account in U.S. dollars at the average of the bid and ask prices reported in the Wall Street Journal as of the close of the last business day of such calendar quarter in which such royalty is due. If the last day of such calendar quarter is not a business day, then the closest preceding business day shall be used for such calculation. All such converted Selling Prices

 

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for each country shall be consolidated for each calendar quarter and the applicable royalty payable determined therefrom. WARF is exempt from paying income taxes under U.S. law. Therefore, all payments due under this Agreement shall be made without deduction for income taxes, assessments, or other charges of any kind which may be imposed on WARF by any government outside of the United States or any political subdivision of such government with respect to any amounts payable to WARF pursuant to this Agreement, where WARF has registered as a tax exempt entity and any such jurisdiction has approved such claim; otherwise, Licensee shall be entitled to deduct from any payments due to WARF all applicable taxes.

 

(iii) A full accounting showing how any amounts owing to WARF under Sections 2B and 4C have been calculated shall be submitted to WARF on the date of each such payment. Such accounting shall be on a per-country and product line, model or trade name basis and shall be summarized on a form similar to that shown in Appendix C of this Agreement. In the event no payment is owed to WARF, a statement setting forth that fact shall be supplied.

 

Section 5. Certain Warranties .

 

A. WARF represents and warrants that, except as otherwise provided under Section 14 of this Agreement with respect to U.S. Government interests:

 

(i) WARF and Yeda are the sole owners of the Licensed Patents or otherwise have the sole and exclusive right to grant the licenses granted to Licensee in this Agreement, and to the best of the WARF’s knowledge, free and clear of any liens, claims, and encumbrances of any non-governmental third party;

 

(ii) WARF and Yeda have entered into a definitive agreement granting to WARF the exclusive right to grant, negotiate, execute, administer and enforce exclusive licenses under the Licensed Patents with Licensee and such definitive agreement does not conflict with any provision or right or obligation granted or received hereunder;

 

(iii) subject to Section 2C above and to any research rights previously granted by Licensors to the inventors of the Licensed Patents or research rights reserved by the inventors of the Licensed Patents, WARF and Yeda have not granted to any third party any rights to or under the Licensed Patents that currently conflict or in the future will conflict with, contradict, or overlap with those granted hereunder; and

 

(iv) WARF and Yeda have not received any notification that the Licensed Patents are invalid or that the exercise of any rights granted hereunder will infringe on any patent or other proprietary right of any third party.

 

Nothing in this Agreement shall be construed as:

 

(i) a warranty or representation by the Licensors as to the validity or scope of any of the Licensed Patents;

 

(ii) a warranty or representation that anything made, used, sold or otherwise disposed of under the license granted in this Agreement will or will not infringe patents of third parties; or

 

(iii) an obligation to furnish any intellectual property not provided in the Licensed Patents or any services other than those specified in this Agreement.

 

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B. THE LICENSORS MAKE NO REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND ASSUME NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO THE USE, SALE, OR OTHER DISPOSITION BY LICENSEE, ITS SUBLICENSEE(S), OR THEIR VENDEES OR OTHER TRANSFEREES, OF PRODUCTS INCORPORATING OR MADE BY USE OF INVENTIONS LICENSED UNDER THIS AGREEMENT.

 

C. Licensee represents and warrants that Products produced under the license granted herein for sale in the United States shall be manufactured substantially in the United States as required by 35 U.S.C § 204 and applicable regulations of Chapter 37 of the Code of Federal Regulations.

 

Section 6. Recordkeeping .

 

A. Licensee shall keep books and records sufficient to verify the accuracy and completeness of Licensee’s accounting referred to above, including, without limitation, inventory, purchase and invoice records relating to all Products and their manufacture. In addition, Licensee shall maintain documentation evidencing that Licensee is in fact pursuing the development of Products as required herein. Such documentation may include, but is not limited to, invoices for studies advancing development of Products, laboratory notebooks, internal job cost records, and filings made to the Internal Revenue Department to obtain tax credit, if applicable, for research and development activities. Such books and records shall be preserved for a period of not less than four (4) years after they are created during the term of this Agreement. Licensee shall use commercially reasonable efforts to include similar recordkeeping provisions in any sublicense granted under this Agreement.

 

B. Licensee shall take all steps necessary so that WARF may, within thirty (30) days of its request and at WARF’s cost and expense (except as provided under Section 6D below), but not more than once in any consecutive four (4) calendar quarters, review all the relevant books and records relating to Licensee’s activities under this Agreement to allow WARF to verify the accuracy of Licensee’s royalty reports


 
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