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YALE EXCLUSIVE LICENSE AGREEMENT

License Agreement

YALE EXCLUSIVE LICENSE AGREEMENT | Document Parties: ARIES VENTURES INC | YALE UNIVERSITY You are currently viewing:
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ARIES VENTURES INC | YALE UNIVERSITY

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Title: YALE EXCLUSIVE LICENSE AGREEMENT
Governing Law: Connecticut     Date: 12/22/2005
Industry: Metal Mining     Sector: Basic Materials

YALE EXCLUSIVE LICENSE AGREEMENT, Parties: aries ventures inc , yale university
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Exhibit 10.13

 

YALE EXCLUSIVE LICENSE AGREEMENT

 

THIS AGREEMENT by and between YALE UNIVERSITY, a corporation organized and existing under and by virtue of a charter granted by the general assembly of the Colony and State of Connecticut and located in New Haven, Connecticut (“YALE”), and SCHERING AKTIENGESELLSCHAFT with Offices in Müllerstrasse 178, D-13353, Berlin, Germany (“LICENSEE”) shall be effective the date of final execution below (“Effective Date”). Each of LICENSEE on one hand and YALE on the other hand, is referred to a “Party” and collectively as the “Parties.”

 

In the course of research conducted under YALE auspices, Dr. William Sessa, in the Department of Pharmacology at YALE (the “INVENTOR”), produced an Invention entitled “eNOS Mutations Useful For Gene Therapy and Therapeutic Screening” (the “INVENTION”); and

 

Pursuant to an assignment by the INVENTOR to YALE of all his right, title and interest in and to the INVENTION and any resulting patents, YALE is the owner of the INVENTION, subject to rights reserved by the U.S. government; and

 

LICENSEE wishes to obtain a license to the INVENTION and any resulting patents, and YALE is willing to grant such a license to LICENSEE subject to the terms and conditions of this Agreement;

 

Therefore, in consideration of these statements, the parties agree as follows:

 

ARTICLE  1            DEFINITIONS

 

The following terms used in this Agreement shall be defined as set forth below:

 

1.1            “AFFILIATE” means any entity or person that directly or indirectly controls, is controlled by or is under common control with LICENSEE. For purposes of this definition, “control” means possession of the power to direct the management of such entity or person, whether through ownership of more than 50% of voting securities, by contract or otherwise.

 

1.2            “CONFIDENTIAL INFORMATION” means any and all information, KNOW-HOW, and data, technical or non-technical, which relates to LICENSED INTELLECTUAL PROPERTY or to the Agreement itself and which is disclosed to one Party by the other Party during the negotiation of or under this Agreement.

 

1.3            “DILIGENCE REPORTS” has the meaning set forth in Section 6.2.

 

1.4            “FIELD” means all cardiovascular-related therapeutic uses of LICENSED INTELLECTUAL PROPERTY that does not involve small molecule drug delivery.

 

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1.5            “FIRST COMMERCIAL SALE” means the date LICENSEE or an AFFILIATE or sublicensee of LICENSEE first sells commercially, pursuant to a REGULATORY APPROVAL, a LICENSED PRODUCT in United States, Japan or any country of the European Union; provided however, that where such first commercial sale has occurred in any country for which pricing, or reimbursement approval is necessary for widespread sale, then such sale shall not be deemed a FIRST COMMERCIAL SALE until such pricing or reimbursement approval has been obtained.

 

1.6            “IND” means an investigational new drug application required to be filed with the Federal Food, Drug and Cosmetic Administration pursuant to 21 C.F.R. §312, as such regulations may be amended from time to time, to test drug products in humans or foreign equivalent.

 

1.7            “KNOW-HOW means information that relates to the LICENSED INTELLECTUAL PROPERTY and is contained in manuscripts, the Office of Cooperative Research at Yale invention disclosure form, or other documents or information which is disclosed by the INVENTORS of the LICENSED INTELLECTUAL PROPERTY and which is useful, but not patentable.

 

1.8            “LICENSED INTELLECTUAL PROPERTY” means the INVENTION as covered by the United States or foreign patent application(s) and patents(s) arising out of the provisional patent application attached as Appendix “A” and owned by YALE during the term of this Agreement and includes LICENSED INTELLECTUAL PROPERTY referred to in the The Research Agreement between LICENSEE and YALE as of the Effective Date (see Appendix B), together with any continuations, continuations-in-part, and any divisional, or substitute patents, any reissues or re-examinations of any such applications or patents, and any extension of the term of any such patent.

 

1.9            “LICENSED METHODS” means any method, procedure, process or other subject matter, the manufacture, use or sale of which without a license from YALE, would infringe any ISSUED CLAIM of the LICENSED INTELLECTUAL PROPERTY.

 

1.10          “LICENSED PRODUCTS” means any products, apparatus, kit, or component part thereof in the FIELD, the manufacture, use or sale of which without a license from YALE, would infringe any ISSUED CLAIM of the LICENSED INTELLECTUAL PROPERTY,

 

1.11          “LICENSED TERRITORY” shall mean the whole world.

 

1.12          “ISSUED CLAIM” means a claim of an issued patent or patent application claiming the LICENSED INTELLECTUAL PROPERTY that has not been held unenforceable, unpatentable or invalid by a decision of a court or government agency of competent jurisdiction, unappealable or unappealed within the time allowed to appeal, and which has not been admitted to be invalid or unenforceable through re-issue, re-examination, disclaimer or otherwise.

 

1.13          “NDA” means a new drug application filed with the FDA pursuant to 21 C.F.R. 200, as such regulations may be amended for approval by such agency for the sale of LICENSED PRODUCT in the United States. Reference to NDA includes, to the extent applicable, an biologies license application.

 

1.14          “NET SALES: means the amount invoiced by LICENSEE, an Affiliate or permitted sublicensee for sales of LICENSED PRODUCTS, as the case may be, to a third party, less deductions for (i) shipping or freight charges prepaid or allowed, and other charges such as insurance, relating thereto as is customary in LICENSEE’S normal business practices; (ii) sales and excise taxes or customs duties paid by the

 

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selling party and any other governmental charge imposed upon the sales of such LICENSED PRODUCTS, as the case may be; (iii) distributors fees, rebates, or allowances actually granted, allowed or incurred; (iv) quantity cash discounts or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of such LICENSED PRODUCT, as the case may be; (v) allowances or credits to customers, not in excess of the selling price of such LICENSED PRODUCTS, as the case may be, on account of governmental requirements, rejection, outdating recalls or for value of returned trade goods of such LICENSED PRODUCTS, as the case may be; and (vi) an estimate for bad debts determined in accordance with such Party’s normal accounting procedures consistently applied within and across its pharmaceutical operating units, whether or not invoiced to the customer. For the purpose of calculating LICENSEE’S NET SALES, the Parties recognize that (a) LICENSEE’S customers may include persons in the chain of commerce who enter into agreements with LICENSEE as to price even though title to the LICENSED PRODUCT, as the case may be, does not pass directly from LICENSEE to such customers, and even thought payment for such LICENSED PRODUCT, as the case may be, is not made by such customers directly to LICENSEE and (b) in such cases chargebacks paid by LICENSEE to or thorough a third party (such as a wholesaler) can be deducted by LICENSEE from gross revenue in order to calculate a Party’s NET SALES. Any deductions listed above which involve payment by LICENSEE shall be taken as a deduction against aggregate sales for the period in which the payment is made. Sales of LICENSED PRODUCTS, as the case may be, between a Party and its Affiliates solely for research or clinical testing purposes shall be excluded from the computation of NET SALES.

 

1.15          “PHASE I CLINICAL TRlAL(S)” means a Phase I clinical trial for a LICENSED PRODUCT as described in 21 C.F.R. §312 (a).

 

1.16          “REGULATORY APPROVAL”, means any approvals, product and/or establishment licenses, registrations, or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, storage, importation, export, transport or sale of LICENSED PRODUCT in a regulatory jurisdiction.

 

ARTICLE   2   LICENSE GRANT AND TERM

 

2.1            Subject to all the terms and conditions of this Agreement, YALE hereby grants to LICENSEE an exclusive, worldwide license, under the LICENSED INTELLECTUAL PROPERTY within the FIELD, with the right to grant sublicenses, to make, have made, use, sell, offer to sell, import and export LICENSED PRODUCTS and to practice any LICENSED METHOD (the “LICENSE”).

 

2.2            The LICENSE is expressly made subject to Yale’s reservation of the right to make, use and practice the LICENSED INTELLECTUAL PROPERTY for its own non-commercial purposes. Nothing in this Agreement shall be construed to grant by implication, estoppel or otherwise any licenses under patents of YALE other than the LICENSED INTELLECTUAL PROPERTY.

 

2.3            Unless terminated earlier as provided in Article 12, the LICENSE shall commence on the date of full execution of this Agreement and the LICENSE, shall automatically end on the date of the last to expire of the patents described in the LICENSED INTELLECTUAL PROPERTY.

 

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2.4            If LICENSED INTELLECTUAL PROPERTY exists in countries outside the U.S., the LICENSE granted in Article 2.1 shall automatically convert to a paid-up, non-exclusive license, on a country-by-country basis when the last to expire of the patents as described in the LICENSED INTELLECTUAL PROPERTY in that country expires,

 

2.5            Appendix B is incorporated and a part of this Agreement.

 

ARTICLE   3   SUBLICENSES

 

3.1            YALE hereby grants to LICENSEE the right to sublicense the right to make, use, sell, offer to sell, import or export any LICENSED PRODUCT and to practice any LICENSED METHOD, provided this Agreement is in effect and LICENSEE is not in breach.

 

3.2            Any sublicense granted by LICENSEE shall include substantially the same Definitions, and provisions on Due Diligence, Confidentiality and Publicity, Reporting Requirements, Indemnification, Insurance and Warranties, Patent Notices and Use of Yale’s Name: provided further , such sublicenses do not relieve LICENSEE from the royalty rate obligations of Article 5 of this Agreement.

 

3.3            If, prior to LICENSEE reaching the “B3” decision, that is, to file an IND and initiate Phase I CLINICAL TRIALS in the United States with respect to a LICENSED PRODUCT, LICENSEE enters into a sublicense with a third party with respect to such LICENSED PRODUCT for such third party to Solely develop and commercialize such LICENSED PRODUCT, then LICENSEE shall pay to YALE Thirty (30%) Percent of any lump sum fee, milestone payment, or advance payment received by LICENSEE from any sublicensee. “Solely” means that Schering does not retain any rights to develop and commercialize such LICENSED PRODUCT, that is, for the avoidance of doubt, Schering acts in the nature of a broker and grant all its rights and responsibilities to a third party.

 

3.4            LICENSEE shall promptly:

 

a)    provide YALE with a copy of each sublicense granted by LICENSEE under this Agreement and any amendments to such sublicense or termination of it;

 

b)    guarantee to pay all payments due YALE from sublicenses; and

 

c)    summarize and deliver copies of all reports due to LICENSEE from sublicensees.

 

ARTICLE   4   LICENSE ISSUE FEE

 

4.1            LICENSEE shall pay to YALE, upon execution of this Agreement, a non-refundable license issue fee of Fifty Thousand ($50,000.00) Dollars. Said fee is not an advance upon Earned Royalties.

 

4.2            LICENSEE shall pay the following milestone payments. Milestone payments are paid once only on the first LICENSED PRODUCT that meets such milestone regardless of the number of LICENSED PRODUCTS, the number of times a milestone is reached or number of indications for such LICENSED PRODUCT (S).

 

4.2.1      One Hundred-Fifty Thousand ($150,000.00) Dollars:

 

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upon entering LICENSEE’S “B2” phase of drug development (preclinical development dossier and regulatory toxicity).

 

4.2.2      Eight Hundred-Twenty-Five Thousand ($825,000.00) Dollars:

 

upon filing the first 1ND for the first LICENSED PRODUCT in any one of the United States, or Japan or a country in the European Union.

 

4.2.3      Nine Hundred Thousand ($900,000.00) Dollars:

 

upon filing first BLA or NDA in the United States.

 

4.2.4      One Million Five Hundred Thousand ($1,500,000.00) Dollars:

 

upon the FIRST COMMERCIAL SALE of the first LICENSED PRODUCT.

 

4.2.5      Three Million ($3,000,000.00) Dollars:

 

upon first Ten Million ($10,000,000.00) Dollars in NET SALES.

 

4.3            Neither the license issue fee of Article 4.1 nor the milestone payments of Article 4.2 shall be credited against royalties payable under Article 5.  If there is no ISSUED CLAIM in the LICENSED INTELLECTUAL PROPERTY claiming the LICENSED PRODUCT in whole or in part, then LICENSEE shall not pay the Milestones stated in Sections 4.2.4 and 4.2.5.

 

ARTICLE   5   ROYALTIES

 

5.1            Provided there is a ISSUED CLAIM in such country, as consideration for the license granted under this Agreement LICENSEE on a country-by-country basis shall pay to YALE an earned royalty of NET SALES in each calendar year as follows:

 

4% on NET SALES up to $250 million

 

5% on NET SALES greater than $250 million and less than $500 million

 

6% on NET SALES greater than $500 million

 

5.2            LICENSEE shall pay all royalties accruing to YALE within thirty (30) days after the end of each calendar quarter (March 31, June 30, September 30 and December 31) in which NET SALES occur.

 

5.3            During the term of this Agreement, LICENSEE agrees to pay an annual License Maintenance Fee (“LMF”) commencing on the January 1 after the date of final execution and every January 1 thereafter until the January 1 that LICENSEE starts to pay Minimum Royalty Payments under Article 5.4. The LMF shall be Fifteen Thousand ($15,000.00) Dollars.

 

5.3.1 The LMF shall not be owed YALE in those years in which LICENSEE is funding Professor Sessa’s laboratory with a minimum of Seventy Five Thousand ($75,000.00) Dollars in direct costs.

 

5.4            Provided royalties are due pursuant to Section 5.1 of this Agreement, during the term of this Agreement, LICENSEE agrees to pay YALE annual Minimum Royalty Payments (“MRP”), commencing on the first January 1 to occur Six (6) months after the date of the FIRST COMMERCIAL SALE in the United States. The MRP shall be in the

 

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amount of Fifty Thousand Dollars ($50,000.00). LICENSEE shall continue to pay the MRP until the end of the term of the last to expire ISSUED CLAIM in the LICENSED INTELLECTUAL PROPERTY that claims the LICENSED PRODUCT. YALE shall fully credit each MRP made against any Earned Royalties payable by LICENSEE in the same year.

 

5.5            If it is established that any ISSUED CLAIM is dominated by another patent and LICENSEE is required to obtain a license from a third party in order to practice the LICENSED INTELLECTUAL PROPERTY, then royalty payment due YALE may be reduced by the royalty and payments made to such third party, but in no event may LICENSEE reduce the earned royalty on NET SALES by more than Forty Percent (40%). LICENSEE shall justify any such deduction to YALE.

 

YALE shall pay any and all taxes levied on account of royalties or other payments that it receives from LICENSEE under this Agreement. If laws or regulations require that taxes be withheld, LICENSEE will (i) deduct those taxes from the remittable royalty, (ii) timely pay the taxes to the proper taxing authority, and (iii) send proof of payment to YALE within thirty (30) days of receipt of confirmation of payment from the relevant taxing authority. LICENSEE agrees to make all lawful and reasonable efforts to minimize such taxes to YALE.

 

5.6            Payments by LICENSEE under this Agreement shall be paid to YALE in U.S. dollars by wire transfer of immediately available funds to an account at a commercial bank designated by YALE. Where payments are based on NET SALES in countries other than the United States, the amount of such NET SALES expressed in the currency of each country shall be converted first into Deutsche Marks, or if the Deutsche Mark shall have been replaced by the Euro, into Euros, and then into U.S. dollars at the average exchange rate (calculated at the average of the “bid” and “asked” exchange rate) for the applicable quarter, provided, however, that the conversion of the currency in question into Deutsche Marks or Euros prior to conversion into U.S. dollars shall be for calculation purposes only, and no additional fee or commission will be incurred as a consequence of the multiple currency conversions. In determining the average exchange rate for an


 
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