LICENSE AGREEMENT between UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION and ELAN PHARMACEUTICALS INC.
Exhibit 10.14
between
UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION
and
ELAN PHARMACEUTICALS INC.
This License Agreement (“Agreement”) is made and entered into this 31st day of December, 2008 (“Effective Date”) by and between the UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION, having an office at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“UTRF”), and Elan Pharmaceuticals Inc., a corporation organized and existing under the laws of the State of Delaware having an address of ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Licensee”).
RECITALS:
WHEREAS, UT (defined below) has assigned its rights in the Licensed Technology (defined below) to UTRF for administration;
WHEREAS, Licensee desires to utilize and commercialize the Licensed Technology in the Field of Use (defined below) and is willing to expend commercially reasonable efforts and resources to do so upon the grant of a license to use the Licensed Technology under the terms and conditions set forth herein; and
WHEREAS, UTRF desires to transfer the Licensed Technology in the Field of Use for the ultimate benefit of the public and believes that such transfer will be facilitated by the grant of a license to Licensee under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the recitals, covenants, conditions, and undertakings contained herein, the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
When used in this Agreement, the following terms shall have the meanings set out below. The singular shall be interpreted as including the plural and vice versa, unless the context clearly indicates otherwise.
Section 1.1 “Action” shall have the meaning set forth in Article 8.1(a) hereof.
Section 1.2 “Affiliate” means any corporation, partnership, or other entity that at any time during the Term of this Agreement, directly or indirectly Controls or is Controlled by or is under common Control with a party to this Agreement, but only for so long as the relationship exists. A corporation or other entity shall no longer be an Affiliate when through loss, divestment, dilution or other reduction of ownership, the requisite Control no longer exists.
Section 1.3 “Annual Maintenance Fee” shall have the meaning set forth in Article 5.1(b) hereof.
Section 1.4 “Control” or “Controls” or “Controlled” means: in the case of a corporation, ownership or control, directly or indirectly, of at least fifty-one percent (51%) of the shares of stock entitled to vote for the election of directors: or (ii) in the case of an entity other than a corporation, ownership or control, directly or indirectly, of at least fifty-one percent (51%) of the assets of such entity.
Section 1.5 “Federal Policy” shall have the meaning set forth in Article 2.2 hereof.
Section 1.6 “Field of Use” means any and all diagnostic or therapeutic applications directed toward identification or treatment of disease.
Section 1.7 “Indemnified Party” shall have the meaning set forth in Article 9.1 hereof.
Section 1.8 “Instituting Party” shall have the meaning set forth in Article 8.2 hereof.
Section 1.9 “License” shall have the meaning set forth in Article 2.1 hereof.
Section 1.10 “License Issue Fee” shall have the meaning set forth in Article 5.1(a) hereof.
Section 1.11 “Licensed Know-How” means, except to the extent published or otherwise generally known to the public, any technical data, information, knowledge, methods, or processes: (i) developed by a UT Contributor in the course of employment by UT; (ii) owned or controlled during the Term by UTRF; (iii) disclosed to Licensee by a UT Contributor or UTRF; and (iv) necessary or reasonably useful for the practice of any of the Licensed Patents.
Section 1.12 “Licensed Patents” means:
(a) Any United States and foreign patents and/or patent applications listed in Appendix A;
(b) Any divisionals, continuations, continuations-in-part, or other patent applications throughout the Territory arising from or claiming priority to or the benefit of any applications described in (a) above;
(c) Any United States and foreign patents issued from any applications described in (a) or (b) above;
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(d) Any claims of United States and foreign patent applications (including, without limitation, continuations-in-part of patent applications or patents described in (a) or (b) above), and of the resulting patents (i) that are directed to subject matter claimed in the patents or patent applications described in (a), (b), or (c) above, and (ii) that UTRF has the right to license hereunder; and
(e) Any reissues, extensions, substitutions, renewals, patents-of-addition, re-examinations, restorations, supplemental protection certificates of any United States patent or any patent resulting from equivalent foreign procedures with respect to any foreign patent described in (a), (b), (c), or (d) above.
Section 1.13 “Licensed Product” means any product, method, procedure, service, or process whose manufacture, use, sale, lease, or import:
(a) Is covered by a Valid Claim of the Licensed Patents in the country in which such product, method, procedure, service, process, or part thereof is manufactured, used, sold, leased, or imported; or
(b) Is derived from, made with, uses, or incorporates, in whole or in part Licensed Know-How.
Section 1.14 “Licensed Technology” means Licensed Products, Licensed Patents, and Licensed Know-How.
Section 1.15 “Net Sales” means:
(a) The gross receipts received by Licensee, Licensee’s Affiliates, or Sublicensees from the use, sale, lease, or other transfer or disposition (including, without limitation, the performance of services utilizing the Licensed Technology) to an independent third party who is not a sublicensee or an Affiliate of a Party or Sublicensee (hereinafter “Sale”) of a Licensed Product, less the following deductions; provided they actually pertain to the Sale of Licensed Products and are separately invoiced:
(i) refunds actually given in connection with the Sale in amounts customary in the trade for quantity purchases, cash payments, and prompt payments;
(ii) refunds actually given for Licensed Products that are rejected, returned, or destroyed by customers;
(iii) sales, tariff duties and/or use taxes directly imposed and with reference to a particular Sale (but not including income taxes), to the extent included in gross receipts;
(iv) outbound transportation expenses (including insurance relating thereto) directly related to the Sale, to the extent included in gross receipts;
(v) charge back payments and rebates granted to (i) managed health care organizations, (ii) federal, state and/or local governments or their agencies, (iii) purchasers and reimbursers, or (iv) trade customers, including without limitation, wholesalers and chain and pharmacy buying groups; and
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(vi) the cost of export licenses, import duties, value added tax, and prepaid freight directly related to the Sale, to the extent included in gross receipts.
(b) For purposes of the calculation of Net Sales:
(i) no deductions shall be made for any other costs or expenses, including commissions paid to individuals whether they are with independent sales agencies or regularly employed by Licensee or a Sublicensee;
(ii) “Net Sales” shall not include the gross amounts from the Sale of any Licensed Products to any Sublicensee unless such Sublicensee is an end-user of such Licensed Products (i.e., Sublicensee’s purchase of Licensed Products is not for the purpose of resale). If such Sublicensee is an end-user, such consideration shall be included in Net Sales at the greater of the actual selling price or the average selling price charged to a third party.
Section 1.16 “Patent Expenses” means all fees, costs and expenses (including, without limitation, the professional fees of US and foreign patent counsel) relating to the filing, prosecution and maintenance of the Licensed Patents. For purposes of clarification, included Patent Expenses are any and all fees, costs, and expenses incurred before or after issuance of the Licensed Patents, including, without limitation, fees, costs, and expenses incurred in association with any reissue or reexamination of a Licensed Patent, any interference or opposition proceeding involving one or more Licensed Patents, or any extension or request for extension of the term of one or more Licensed Patents.
Section 1.17 “Publication” shall have the meaning set forth in Article 17 hereof.
Section 1.18 “Royalty Percentage” shall have the meaning set forth in Article 5.1(d) hereof.
Section 1.19 “Running Royalties” shall have the meaning set forth in Article 5.1(d) hereof.
Section 1.20 “Sponsored Research Agreement” or “SRA” shall mean that certain sponsored research agreement effective as of September 20, 2006 by and between UT, UTRF and Licensee, as amended September 20, 2007.
Section 1.21 “Sublicense” means a direct grant of right, license, or option to the Licensed Technology from Licensee to a third party and any further sublicense at any tier.
Section 1.22 “Sublicensee” means any recipient of a Sublicense.
Section 1.23 “Sublicense Revenue” means all payments received by Licensee and its Affiliates pursuant to each Sublicense, including, without limitation, up-front fees, milestone payments, and license maintenance fees. Notwithstanding the foregoing, running royalties received by Licensee or its Affiliates that are calculated as a percentage of Sublicensee’s Net Sales are not included in Sublicense Revenue.
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Section 1.24 “Sublicense Royalties” shall have the meaning set forth in Article 5.1(e) hereof.
Section 1.25 “Term” shall have the meaning set forth in Article 14.1 hereof.
Section 1.26 “Territory” means the world, subject to the provisions of Article 7.3.
Section 1.27 “UT” means The University of Tennessee, an educational agency of the State of Tennessee.
Section 1.28 “UT Contributor” means Dr. ▇▇▇▇▇▇▇▇ ▇▇▇▇ (“▇▇. ▇▇▇▇”) or Dr. ▇▇▇▇ ▇▇▇▇▇▇▇ (“▇▇. ▇▇▇▇▇▇▇”) or any employee of UT under the supervision of Dr. Wall and/or ▇▇. ▇▇▇▇▇▇▇.
Section 1.29 “Valid Claim” means (a) a claim of an issued patent which (i) has not expired and which has not been held revoked, invalid or unenforceable by decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed with the time allowed for appeal having expired, and (ii) which has not been admitted to be invalid through reissue or disclaimer or otherwise; or (b) a claim of a pending patent application which (i) was filed in good faith; and (ii) has not been pending for more than eight (8) years.
ARTICLE 2
GRANT
Section 2.1 Grant of License. During the Term hereof, and subject to the terms and conditions of this Agreement, UTRF hereby grants to Licensee:
(a) an exclusive (even as to UT and UTRF, subject to any rights expressly reserved in this Agreement), research and commercial right and license in the Field of Use, with the right to grant Sublicenses, under UTRF’s rights in Licensed Patents to practice under the Licensed Patents; and
(b) an exclusive (even as to UT and UTRF, subject to any rights expressly reserved in this Agreement), commercial right and license in the Field of Use, with the right to grant Sublicenses, to utilize the Licensed Know-How for the purpose of practicing under the Licensed Patents (collectively, the “License”).
Section 2.2 Limitations on the Rights Granted. (a) Federal Government Rights. To the extent that any invention included within the Licensed Technology has been or is in the future funded in whole or in part by the United States government, the United States government retains certain rights in such inventions as set forth in 35 U.S.C. §§200-212 and all regulations promulgated thereunder, as amended, and any successor statutes and regulations
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(“Federal Policy”). As a condition of the License granted hereby, Licensee acknowledges and shall comply with all aspects of Federal Policy applicable to the Licensed Technology, including the obligation that Licensed Products used or sold in the United States be manufactured substantially in the United States. Nothing contained in this Agreement obligates UTRF to take any action that would conflict in any respect with its or UT’s past, current or future obligations to the United States government under Federal Policy. To the best of its actual knowledge as of the Effective Date, no invention included within the Licensed Technology has been or will be in the future funded in whole or in part by the United States Government. In the event that UTRF becomes aware of any such funding of the Licensed Technology by the United States Government, UTRF shall provide prompt notice thereof to Licensee.
(b) Reserved Rights. The License is expressly made subject to UTRF’s and UT’s reserved right to practice under the Licensed Patents in the Field of Use for its own non-commercial academic research and teaching purposes.
(c) Licensed Know-How Limitation. UTRF shall have no obligation to provide Licensee with Licensed Know-How or Licensed Materials, or to provide technical assistance in the exercise of the License. In the event Licensee requires technical assistance with respect to the activities conducted by Licensee pursuant to this Agreement, obtaining such technical assistance (whether from the UT Contributor or otherwise) shall be Licensee’s responsibility and at Licensee’s expense.
Section 2.3 Applicability. Nothing in this Agreement shall be construed to confer any rights upon Licensee by implication, estoppel, or otherwise as to any patent rights other than the Licensed Patents and Licensed Know-How, regardless of whether such other rights shall be dominant or subordinate to any Licensed Patents.
ARTICLE 3
SUBLICENSES
Section 3.1 Rights and Requirements. Licensee shall have the right to sublicense the rights granted to Licensee under this Agreement; provided that:
(a) Licensee shall remain liable to UTRF for the full and timely performance of this Agreement, including for any activities by any Sublicensee, including without limitation any Running Royalties due for Net Sales of a Licensed Product by any Sublicensee. No Sublicense shall relieve Licensee of any of its obligations under this Agreement.
(b) This Agreement is in effect and Licensee is not in breach of its obligations under this Agreement;
(c) All Sublicenses granted by Licensee under this Agreement shall conform to this Agreement in the following respects:
(i) Licensee shall not grant any rights to a third party that are inconsistent with Licensee’s rights and obligations under this Agreement;
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(ii) Any Sublicense granted by Licensee shall, in addition to such provisions as Licensee deems appropriate for its own benefit, include definitions and provisions on royalties, diligence, confidentiality and publicity, reporting and audit requirements, indemnification, insurance and warranties, patent notices, and use of names consistent with Licensee’s rights and obligations under this Agreement;
(iii) Any act or omission of a Sublicensee which would constitute a breach of this Agreement if it were the act or omission of Licensee shall be defined as an Event of Default in the Sublicense, subject to the same cure provisions in favor of Sublicensee as are otherwise provided herein for breach by Licensee.
(iv) Sublicenses shall include such other provisions as are needed to enable Licensee to comply with this Agreement.
(d) Licensee shall provide UTRF with a copy of each executed Sublicense Agreement within thirty (30) days of its execution.
Section 3.2 Special Termination Rules. Upon termination of this Agreement, each Sublicense shall be governed by Article 14 of this Agreement.
Section 3.3 Failure to Conform to this Article. Licensee’s failure to conform any Sublicense to this Article will have the following effects:
(a) The non-conforming Sublicense will be voidable at UTRF’s sole discretion; provided that UTRF has provided written notice to Licensee and within 60 days of such notice from UTRF, Licensee fails to cure such non-conformance of the Sublicense; and
(b) Said failure will constitute a material breach of this Agreement subject to the termination provisions of Article 14 of this Agreement.
ARTICLE 4
DILIGENCE
Section 4.1 Diligence. Licensee shall use its commercially reasonable efforts to proceed diligently to research, develop and commercialize the Licensed Technology in the Field of Use.
ARTICLE 5
ROYALTIES AND OTHER PAYMENTS
Section 5.1 Fees and Royalties. For the rights, privileges and License granted hereunder, Licensee shall pay to UTRF the following fees and royalties in the manner hereinafter provided until this Agreement expires or is terminated.
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(a) License Issue Fee. Within 30 days of the Effective Date, Licensee shall pay to UTRF the non-refundable sum of $10,000 (“License Issue Fee”).
(b) Annual Maintenance Fee. Licensee shall pay UTRF, in addition to all other amounts payable hereunder, a non-refundable license maintenance fee in the amount of $10,000 on the first anniversary of the Effective Date, $10,000 on the second anniversary of the Effective Date, $25,000 on the third anniversary of the Effective Date, and $25,000 on the anniversary of the Effective Date each year thereafter during the Term (“Annual Maintenance Fee”).
(c) Reserved.
(d) Running Royalties. In addition to all other amounts payable hereunder, Licensee shall pay to UTRF an amount equal to one percent (1%) (the “Royalty Percentage”) of Net Sales of any Licensed Product covered by a Valid Claim of a Licensed Patent (“Running Royalties”). Payment of Running Royalties shall be made on a semi-annual basis by the last day of July, and January each year on Net Sales occurring during the immediately preceding calendar quarter. For example, payment of Running Royalties will be due by the last day of January on Net Sales occurring during the last half (July through December) of the immediately preceding calendar year. Notwithstanding the foregoing, Licensee shall owe no Running Royalties on any Sale that does not take place during the Term of this Agreement. For purposes of determining whether a Sale takes place during the Term of this Agreement, a Sale shall be deemed to occur upon the earlier of the shipment of a Licensed Product or invoicing.
(e) Sublicense Royalties. In addition to all other amounts payable hereunder, Licensee shall pay to UTRF Sublicense Royalties equal to the Royalty Percentage of Sublicense Revenue (“Sublicense Royalties”) attributable to Patent Rights (the “Attributable Amount”). The Attributable Amount shall be the total amount of Sublicense Revenue divided by the number of total patents licensed in the Sublicense multiplied by the number of patents in Licensed Patents; provided, however, that in no event shall the Attributable Amount be less than one third (1/3) of the Royalty Percentage. Payment of Sublicense Royalties shall be made on a semi-annual basis by the last day of July and January each year on Sublicense Revenue generated during the immediately preceding calendar half year. For example, payment of Sublicense Royalties will be due by the last day of July on Sublicense Revenue occurring during the first half (January through June) of the same calendar year.
Section 5.2 Maximum Royalties. In the event that any royalties payable under this Agreement are higher than the maximum royalties permitted by the law or regulations of a particular country:
(a) The Running Royalties payable for Licensee’s Net Sales in such country shall be equal to the maximum permitted royalty under such law or regulations;
(b) Notice documenting that Running Royalties payable under this Agreement are higher than a country’s maximum royalties shall be provided to UTRF;
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(c) An authorized representative of Licensee shall notify UTRF, in writing, within 30 days of discovering that such Running Royalties are approaching or have reached the maximum amount; and
(d) Licensee shall provide UTRF with written documentation regarding the laws or regulations establishing any such maximum.
Section 5.3 Effect of Taxes on Royalties. In the event that any taxes are levied by any foreign taxing authority on Running Royalties payable by Licensee under this Agreement, and Licensee determines in good faith that it must pay such taxes:
(a) Licensee shall have the right to pay such taxes levied on Running Royalties to the local tax authorities on behalf of UTRF;
(b) Licensee shall pay the net amount of Running Royalties due after reduction by the amount of such taxes that are actually owed and paid;
(c) Licensee shall provide UTRF with appropriate documentation and receipts supporting such payment; and
(d) Licensee shall inform UTRF in writing within thirty (30) days of being notified that taxes will or have been levied by a taxing authority on Running Royalties.
Section 5.4 Late Payments. In the event any payments are not received by UTRF when due, Licensee shall pay to UTRF interest on the overdue balance at the lesser of 1% per month or the maximum rate of interest allowed by law. Licensee shall also pay all reasonable collection costs at any time incurred by UTRF in obtaining payment of amounts past due, including reasonable attorneys fees. The payment of such interest shall not foreclose UTRF from exercising any other rights it may have as a consequence of the lateness of any payment.
Section 5.5 Payment Shortage. If an examination of records provided under Article 6 of this Agreement reveals a payment shortage of greater than 5% of the total amount due under any one royalty payment, Licensee shall promptly reimburse UTRF for the reasonable cost of examination, the shortage in payment, and the interest accrued on the shortage under Article 5.4 of this Agreement.
Section 5.6 Manner of Payments. All payments shall be paid in United States dollars and sent to the notice address under Article 16.1, or at such other place as UTRF may reasonably designate consistent with the laws and regulations controlling in the United States or any foreign country. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate listed in the Wall Street Journal for major New York banks on the last business day of the calendar quarter to which such royalty payments relate. If the transfer of moneys owed to UTRF or the conversion into United States Dollar equivalents in any such instance is not lawful or possible, the payment of such part of the royalties as is necessary shall be made by the deposit thereof, in the currency of the country where the sales were made on which the royalty was based, to the credit and account of UTRF or its nominee in any commercial bank or trust company of its choice located in that country, prompt notice of which shall be given by Licensee to UTRF.
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Section 5.7 Event of Default. Licensee’s failure to make any payment will constitute a material breach of this Agreement subject to the termination provisions of Article 14 of this Agreement.
Section 5.8 Effect of Receipt or Acceptance. Receipt or acceptance by UTRF of any payment or report under this Agreement shall not prevent UTRF from subsequently challenging the validity or accuracy of such payment or report.
ARTICLE 6
REPORTS AND RECORDS
Section 6.1 Books of Account. Licensee shall keep, and shall require each Sublicensee to keep, full, true and accurate books of account containing all particulars necessary to determine and show the amounts payable to UTRF hereunder. Licensee shall keep all books of account at its principal place of business or, upon written notice to UTRF, the principal place of business of its appropriate division to which this Agreement relates and shall require the same of each Sublicensee. Licensee shall ensure that its books are open at all reasonable times for five (5) years following the end of the calendar year to which they pertain, to the inspection by UTRF or its agents, upon reasonable notice and no more than once in any calendar year, for the purpose of verifying compliance with this Agreement, and Licensee shall require the same of each Sublicensee.
Section 6.2 Delivery of Reports. Licensee shall deliver to UTRF true and accurate reports, relating to the business conducted by Licensee and its Sublicensees under this Agreement as set forth in Article 6.3:
(a) Before the first commercial use or sale of a Licensed Product or the granting of the first Sublicense under this Agreement (whichever occurs first), annually, on January 31 of each year; and
(b) After the first commercial use or sale of a Licensed Product or the granting of the first Sublicense under this Agreement, on a semi-annual basis by the last day of July and January each year on relevant business conducted by Licensee during the immediately preceding calendar half year.
Section 6.3 Content of Reports. Reports shall include at least the following on a Licensed Product-by-Licensed Product, country-by-country, and Sublicense-by-Sublicense basis:
(a) The number/amount of Licensed Products, used, leased, sold, and imported by and/or for Licensee and each Sublicensee; and
(b) Total amounts invoiced and total amounts received for Licensed Products used, leased, and sold by and/or for Licensee and all Sublicensees; and
(c) Accounting for Net Sales of Licensee and each Sublicensee; and
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(d) A copy of each statement or report submitted to Licensee by a Sublicensee; provided that such statement or report has not previously been provided by Licensee to UTRF; and
(e) Total amount due under this Agreement (including, without limitation, the manner in which all royalties were calculated and a breakdown for each type of royalties listed in Article 5 and their respective amounts payable); and
(f) The current status of any regulatory activities pertaining to Licensed Products; and
(g) The name, address, and phone number of each Sublicensee and the Licensed Patents licensed to each Sublicensee (including the named inventors of each of the Licensed Patents being sublicensed) as of the last date of the reporting period; and
(h) Upon reasonable request by UTRF, a summary report describing the compliance by Licensee with the diligence provisions of Article 4.1; and
(i) If no payment shall be due, Licensee shall so report.
Section 6.4 Responsibility for Accuracy. Licensee shall be responsible for completeness and accuracy of its own records and reports as well as those of each Sublicensee. Each report submitted to UTRF by Licensee shall be signed by a duly authorized officer of Licensee or of the respective Sublicensee as appropriate.
ARTICLE 7
PATENT PROSECUTION
Section 7.1 Rights and Duties. (a) During the Term and subject to consultation with UTRF, Licensee will be responsible for preparing, applying for, seeking issuance of, and maintaining patent applications and issued patents included in Licensed Patents in such countries as it deems appropriate for its business objectives and for prosecuting or defending interferences, oppositions, and reexaminations declared with regard to patent applications and issued patents included in such Licensed Patents. Licensee will notify UTRF before taking any substantive actions.
(b) UTRF shall make, execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain and maintain Licensed Patents in any and all countries. All costs and expenses of application and prosecution of such Licensed Patents shall be paid by Licensee.
(c) In the event that Licensee elects not to file, prosecute, or maintain any Licensed Patent in the Territory, Licensee shall so notify UTRF of such decision no later than thirty (30) days before any applicable statutory bar date or response date, as the case may be, to permit UTRF (at its own expense) to prosecute and/or maintain the patent application(s) and/or patent(s) that were the subject of such notice.
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Section 7.2 Patent Numbering. Licensee and all its Sublicensees shall ▇▇▇▇ all products covered by Licensed Patents with patent numbers in accordance with the statutory requirements in the country(ies) of manufacture, use, and sale.
Section 7.3 Exclusion of Certain Foreign Patents. In order that Licensee will not incur expenses for foreign Licensed Patents that it considers unnecessary to its business objectives, Licensee may notify UTRF in writing of particular countries that it wishes to exclude from the License. From and after the date of such notice:
(a) Licensee shall have no rights, privileges, or license under this Agreement in the specified country(ies);
(b) Licensee shall have no responsibility for expenses incurred in the filing, prosecution, or maintenance of Licensed Patents in the specified country(ies);
(c) Licensee agrees that it will not thereafter manufacture, use, sell, lease, or import Licensed Products in the specified country(ies).
(d) The specified country(ies) will be automatically deleted from the definition of Territory; and
(e) All patents and patent applications in the specified country(ies) will be automatically deleted from the Licensed Patents.
ARTICLE 8
INFRINGEMENT
Section 8.1 Enforcement. If either Licensee or UTRF becomes aware of any infringement of the Licensed Patents by a third party, the party having the knowledge will give the other party prompt written notice.
(a) Licensee. Licensee shall have the first right during the Term, at its sole cost and expense, to commence any action that Licensee deems appropriate, including notifying the infringer to cease and desist all such infringing activity, filing a complaint and/or instituting an action or a lawsuit for any known or suspected third party activity that may infringe the Licensed Patents (each, an “Action”), and, in furtherance of such right, UTRF hereby agrees that Licensee may include UTRF as a party plaintiff in any such Action, without expense to UTRF. In the event Licensee commences an Action, UTRF shall retain the right, at its own expense, to join such Action as a co-litigant.
(b) UTRF. Should Licensee fail to commence and pursue any particular Action, then UTRF may commence, at its sole cost and expense, such Action as UTRF deems appropriate; provided that:
(i) UTRF gives Licensee a written 60-day notice of its intention to initiate such Action; and
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(ii) Licensee fails to initiate said suggested Action within said 60 day notice period; and
(iii) Licensee shall retain the right to join such Action as a co-litigant.
Section 8.2 Cooperation. Upon the request of the party that institutes an Action (the “Instituting Party”), the other party (the “Co-Party”) shall:
(a) Join any such Action as a necessary party; and
(b) Use its commercially reasonable efforts to assist and cooperate with the Instituting Party in such Action.
The Instituting Party shall reimburse the Co-Party for any reasonable and pre-approved costs related to such assistance and cooperation.
Section 8.3 Recovery of Damages. After reimbursement of the parties’ previously unreimbursed out-of-pocket expenses of such Action or any previous Action, any remaining recovery of damages resulting from any Action shall be retained by the Instituting Party.
Section 8.4 Declaratory Judgment Action. In the event that a declaratory judgment action alleging invalidity or noninfringement of any of the Licensed Patents shall be brought against UTRF, it shall immediately notify Licensee thereof, and Licensee may, within thirty (30) days of Licensee’s receipt of UTRF’s notice regarding such action and with the written consent of UTRF which shall not be unreasonably withheld, intervene and take over the sole defense of the action against UTRF at Licensee’s own expense; provided that Licensee may not enter into a consent judgment acknowledging the invalidity or noninfringement of any of the Licensed Patents or an admission of fault or of wrongdoing or that materially affects the rights of UTRF hereunder without the prior written approval of UTRF, which approval shall not be unreasonably withheld.
Section 8.5 Notice and Settlement. The Instituting Party shall reasonably notify the Co-Party of the course of any Action and shall not settle any Action without prior approval of the Co-Party (i) during the Term if such settlement contains an admission of the invalidity of any Licensed Patents or (ii) either during or after the Term if such settlement contains an admission of fault or wrongdoing or materially affects the rights of the Co-Party hereunder. Such approval shall not be unreasonably withheld.
ARTICLE 9
INDEMNIFICATION; INSURANCE;
REPRESENTATIONS; DISCLAIMER OF WARRANTIES
Section 9.1 Indemnification. In the event that UTRF, UT, any of their trustees, directors, officers, or employees (each an “Indemnified Party”) is, as a result of the manufacture, marketing, use, sale, lease, or import of Licensed Products under this Agreement, made a party in
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a lawsuit for infringement of a patent by a third party or is made a party in any lawsuit arising out of the manufacture, marketing, use, sale, lease, or import of Licensed Products under this Agreement or any Sublicense, including, without limitation, actions founded on product liability (a “Claim”), the following provisions shall apply:
(a) Licensee shall defend or settle, at Licensee’s expense, any such Claim; provided that Licensee shall not enter into any such settlement (i) without the prior approval of UTRF, which approval shall not be unreasonably withheld, if such settlement contains an admission of the invalidity of any Licensed Patent or materially affects the rights of UTRF hereunder; or (ii) without the prior approval of the Indemnified Party(ies), which approval shall not be unreasonably withheld, if such settlement contains an admission of fault or wrongdoing on the part of such Indemnified Party(ies);
(b) Licensee shall indemnify and hold the Indemnified Party(ies) harmless for any and all damages, losses, liability, and costs resulting from such Claim except for damages, losses, liability, or costs resulting from the breach of this Agreement, willful misconduct or misrepresentation by UTRF, UT, or their respective trustees, directors, officers, or employees, as adjudicated by decision of a court of competent jurisdiction, unappealable or unappealed within the time provided by law, subject to the conditions for this indemnity set forth in Section 9.1(c).
(c) The indemnity set forth above in Sections 9.1(a) and 9.1(b) shall apply only if the following conditions are met:
(i) UTRF must promptly (within no more than thirty (30) days) notify Licensee upon receipt of oral or written notice of any actual or threatened Claim upon which indemnification hereunder could be based. If UTRF does not promptly notify Licensee of an actual or alleged Claim and Licensee is materially prejudiced thereby, this indemnity shall not apply to a Claim against UTRF.
(ii) Within thirty (30) days after a Claim is made, the Indemnified Party shall provide written consent for Licensee to undertake and control the defense of such Claim.
(iii) If a Claim is made, the Indemnified Party shall assist Licensee and cooperate in defending against and gathering information with respect thereto.
(iv) The Indemnified Party shall not, except at its own cost, voluntarily make or agree to make any payment in connection with any Claim without the prior written consent of an authorized representative of Licensee.
Section 9.2 Insurance. During the Term Licensee shall obtain and carry in full force and effect commercial, general liability insurance which shall cover Licensee and the Indemnified Parties with respect to events covered by Article 9.1 above. Licensee shall provide UTRF and University with Certificates of Insurance. Such insurance shall:
(a) Be written by a reputable insurance company authorized to do business in the State of Tennessee;
(b) Be endorsed to include product liability coverage;
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(c) Have a limit of not less than $3,000,000.00 per occurrence with an aggregate of $10,000,000.00 for personal injury or death, and $3,000,000.00 per occurrence with an aggregate of $10,000,000.00 for property damage.
Section 9.3 Representations and Warranties. (a) Each party represents and warrants that:
(i) It is authorized to enter into this Agreement;
(ii) Entering into this Agreement does not and will not create a conflict with or breach of the terms of any other agreement to which it is a party; and
(iii) All rights exercised and obligations undertaken in connection with this Agreement will comply with all applicable foreign, federal, state, and local laws and regulations.
(b) UTRF represents and warrants that to the best of its actual knowledge as of the Effective Date, it has fully complied and will fully comply with the requirements, to the extent applicable, of 35 U.S.C. § 200 et seq. and all implementing regulations, to the extent applicable, that are necessary to perfect title to the Licensed Patents.
Section 9.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, UTRF, ITS DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. IN NO EVENT SHALL UTRF OR ITS RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES OR AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER UTRF SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS:
(a) A REPRESENTATION MADE OR WARRANTY GIVEN BY UTRF THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY;
(b) A REPRESENTATION MADE OR WARRANTY GIVEN BY UTRF AS TO THE VALIDITY OR SCOPE OF THE LICENSED PATENTS;
(c) A REPRESENTATION MADE OR WARRANTY GIVEN BY UTRF THAT ANY PATENT APPLICATION INCLUDED IN THE LICENSED PATENTS WILL ULTIMATELY ISSUE AS A PATENT;
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(d) A REQUIREMENT THAT UTRF SHALL BE RESPONSIBLE FOR THE EXPENSES OF FILING OR PROSECUTING ANY PATENT APPLICATION OR MAINTAINING ANY ISSUED PATENT IN FORCE;
(e) AN OBLIGATION ON THE PART OF UTRF TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR INFRINGEMENT OF THE LICENSED PATENTS OR FOR UNAUTHORIZED USE OF THE KNOW-HOW;
(f) AN OBLIGATION ON THE PART OF UTRF TO DEFEND ANY ACTION OR SUIT BROUGHT BY ANY THIRD PARTY;
(g) A REPRESENTATION MADE OR WARRANTY GIVEN BY UTRF AS TO THE SAFETY, RELIABILITY OR EFFICACY OF THE LICENSED PRODUCTS;
ARTICLE 10
EXPORT CONTROLS
Section 10.1 Limitations. Licensee hereby agrees that it will not sell, transfer, export or re-export any Licensed Products or Licensed Technology:
(a) In any form, or any direct products thereof, except in compliance with all applicable laws, including the export laws of any U.S. Government agency and any regulations thereunder; and
(b) To any persons or any entities with regard to which there exist grounds to suspect or believe that they are violating applicable laws, including export laws of any U.S. Government agency.
Section 10.2 Responsibilities. Licensee shall be solely responsible for obtaining all licenses, permits or authorizations required from the U.S. and any other government for any such export or re-export.
ARTICLE 11
NON-USE OF NAMES
Section 11.1 Licensee shall not use the names or trademarks of UTRF, of UT, nor any adaptation thereof, nor the names of any of their employees, directors, trustees, or any UT Contributor in any advertising, promotional or sales literature without prior written consent obtained from UTRF, UT, or said employee, director, trustee, or UT Contributor, as applicable, in each case, except that Licensee may state that it is licensed by UTRF under one or more of the patents and/or patent applications comprising the Licensed Patents.
Section 11.2 UTRF shall not use the names or trademarks of Licensee, nor any adaptation thereof, nor the names of any employee of Licensee, in any advertising, promotional, sales or other literature without prior written consent obtained from Licensee, or said employee, as applicable, in each case, except that UTRF may state that it has licensed one or more of the patents and/or applications comprising the Licensed Patents to Licensee.
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ARTICLE 12
CONFIDENTIALITY
Section 12.1 Disclosure of Agreement. Nothing herein shall preclude a Party from disclosing the existence of this Agreement and the general scope of the License granted hereunder. However, neither Party shall disclose the economic terms of this Agreement except as may be required by applicable law or be a court of competent jurisdiction or in order to defend or prosecute litigation, and except that UTRF may disclose such economic terms to the UT Contributor, UT, and the State of Tennessee and as required by Federal Policy.
Section 12.2 Confidential Information. Subject to the exceptions set forth herein, all information or material disclosed pursuant to this Agreement and/or related to the Licensed Technology shall be confidential (“Confidential Information”). The recipient of Confidential Information (“Receiving Party”) agrees to hold in confidence, and not to distribute or disseminate to any person or entity, for any reason for a period of ten (10) years after receipt, any Confidential Information received under or relating to this Agreement from the other Party (“Providing Party”), except for Confidential Information which:
(a) was known or used by the Receiving Party prior to the date of disclosure to the Receiving Party as evidenced by written records; or
(b) either before or after the date of disclosure is lawfully disclosed to the Receiving Party by sources other than the Providing Party which are rightfully in possession of the Confidential Information and not subject to any obligation of confidentiality, as evidenced by written records; or
(c) either before or after the date of disclosure to the Receiving Party becomes generally known to the public, through no fault or omission on the part of the Receiving Party; or
(d) is independently developed by or for the Receiving Party without reference to, knowledge of, or reliance upon the Confidential Information as evidenced by written records; or
(e) is required to be disclosed by the Receiving Party to comply with applicable laws, to defend or prosecute litigation or to comply with governmental regulations; provided that the Receiving Party provides prior written notice of such disclosure to the Providing Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure; provided that specific information shall not be deemed to be within any of these exclusions merely because it is embraced by more general information falling with these exclusions.
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Disclosures of Confidential Information to Licensee, including, without limitation, disclosures that are made to Licensee by UT Contributors, shall be deemed, for purposes of this Article, to be disclosures made by UTRF.
Section 12.3 Disclosure to Counsel. The Parties agree that counsel of the parties may receive Confidential Information.
ARTICLE 13
ASSIGNMENT
Section 13.1 This Agreement shall be binding upon and shall inure to the benefit of UTRF and its assigns and successors, and shall be binding upon and shall inure to the benefit of Licensee and its assigns; provided that Licensee obtains prior written approval from UTRF for any assignment of this Agreement to a third party, which approval shall not be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, no prior written approval from UTRF shall be required for any assignment of this Agreement by Licensee to an Affiliate of Licensee or in connection with the transfer or sale of all or the majority of its business related to the subject matter of this Agreement, or in the event of a change in control of Licensee. Licensee’s right to assign the rights granted to Licensee under this Agreement shall be further conditioned upon the following:
(a) This Agreement is in effect and Licensee is not in breach of its obligations under this Agreement; and
(b) Licensee shall forward any such assignment document(s) to UTRF within thirty (30) days after the effective date thereof.
Section 13.2 Failure to Conform to this Article. Any attempt to assign the rights granted to Licensee under this Agreement that fails to fulfill any of the terms of this Article in any way shall make said attempt voidable at UTRF’s sole discretion.
ARTICLE 14
TERM AND TERMINATION
Section 14.1 Term. This Agreement shall take effect upon the Effective Date, and unless earlier terminated pursuant to the provisions of this Article 14, shall continue in full force and effect on a country-by-country basis for the longer of (i) a period of twenty (20) years from the Effective Date, or (ii) in each country in which a Valid Claim for any Licensed Patent shall continue to exist, until the last Valid Claim for any Licensed Patent shall expire in such country, at which time this Agreement shall expire as to such country (“Term”). After expiration of the Term in a country, Licensee shall have a perpetual, fully paid, royalty-free license to the Licensed Technology in such country, such license being of no greater scope than that granted hereunder. Licensee shall continue to be obligated to pay (i) Running Royalties on account of Licensed Products sold in any country for which the Term shall not have expired; and (ii) Sublicense Royalties on Sublicense Revenue attributable to any country for which the Term shall not have expired; and (iii) the Annual Maintenance Fee for as long as there is at least one country for which the Term shall not have expired.
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Section 14.2 Failure to Carry on Licensee’s Business. If Licensee shall be adjudicated by a court of competent jurisdiction to be insolvent or is dissolved or declared bankrupt or is placed in receivership pursuant to proceedings directed against Licensee or if Licensee declares bankruptcy or insolvency, this Agreement shall terminate immediately, unless UTRF, after being informed of the same, elects to the contrary.
Section 14.3 Licensee’s Failure to Make Payment. Should Licensee fail to pay UTRF any payment due and payable under this Agreement, UTRF shall have the right to terminate this Agreement on one hundred and twenty (120) days’ notice, unless Licensee pays UTRF, within one hundred and twenty (120) days after Licensee’s receipt of such notice, all such overdue payments along with interest due and payable. Upon the expiration of the 120-day period, if Licensee shall not have paid all such payments along with interest due and payable, the rights, privileges and License granted hereunder shall terminate.
Section 14.4 Licensee’s Material Breach. UTRF shall notify Licensee in writing of any material breach or default of this Agreement by Licensee. Licensee shall have sixty (60) days after receipt of such written notice from UTRF to correct such default. If such default is not corrected within the sixty (60) day period, UTRF shall have the right, at its option, to terminate this Agreement. The failure of UTRF to exercise such right of termination for non-payment of royalties or otherwise shall not be deemed to be a waiver of any right UTRF might have, nor shall such failure preclude UTRF from exercising or enforcing said right upon any subsequent breach or default by Licensee.
Section 14.5 Licensee’s Right to Terminate. Licensee shall have the right to terminate this Agreement:
(a) On sixty (60) days’ written notice in the event that UTRF is in material breach or default of this Agreement and fails to cure such breach or default within sixty (60) days after UTRF’s receipt of such notice; or
(b) At any time on three (3) month’s written notice to UTRF provided that Licensee has paid all amounts due UTRF through the effective date of the termination.
Section 14.6 Surviving Obligations. Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. In addition, if the Agreement has been terminated for a reason other than breach on the part of Licensee, then Licensee (and any Sublicensee not then in default) may, after the effective date of such termination, sell all Licensed Products and complete Licensed Products in the process of manufacture at the time of such termination and sell the same; provided that Licensee shall pay to UTRF the royalties thereon as required by Article 5 of this Agreement and shall submit the reports required by Article 6 on the sales of Licensed Products.
Section 14.7 Effect on Sublicensees. Upon termination of this Agreement for any reason, any Sublicensee not then in default shall have the right to seek a license from UTRF.
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ARTICLE 15
RESERVED
ARTICLE 16
RESERVED PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
Section 16.1 Any payment, notice or other communication required or permitted hereunder (hereinafter “notice”) shall be in writing and shall be hand-delivered, sent by overnight courier, mailed by certified United States mail, return receipt requested, or sent by facsimile, to the address(es) given below or to such other address(es) as the parties may hereafter specify in writing. Notice shall be deemed given and received five (5) days after being deposited with the U.S. Postal Service certified mail postage prepaid, or if notice is hand-delivered or sent by overnight courier, upon the date of actual delivery, or if sent by facsimile, upon the date the receiving party acknowledges receipt in writing, by email or otherwise. An email notice shall be given concurrently to all the email addresses provided by the recipient party and the first acknowledgment of receipt from the recipient party shall establish the date on which such notice is given.
UTRF:
University of Tennessee Research Foundation
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Attn: President
With copy to:
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University of Tennessee Research Foundation
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Licensee:
Elan Pharmaceuticals, Inc.
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Attn: Chief Intellectual Property Counsel
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ARTICLE 17
PUBLICATIONS
Section 17.1 UT Rights to Publish Licensed Technology. Licensee recognizes that under UTRF and UT policy, the results of a UT research project must be publishable and agrees that researchers engaged in such research shall have the right, with regard to the Licensed Technology, to present at symposia, professional meetings and to publish in journals, theses or dissertations, or otherwise of their own choosing (“Publication”); provided that (a) UTRF shall provide such Publication regarding the Licensed Technology to Licensee promptly upon receipt; and (b) UTRF shall not be deemed in breach or default of this Agreement merely due to a Publication that UTRF does not receive prior to publication. Notwithstanding the foregoing, the publication provisions contained in the Sponsored Research Agreement among the parties hereto, effective as of September 20, 2006, shall remain in full force and effect in accordance with the terms thereof.
ARTICLE 18
MISCELLANEOUS PROVISIONS
Section 18.1 The parties hereto acknowledge that the SRA remains in full force and effect according to its terms and this Agreement does not supersede the SRA in any respect. For the avoidance of doubt, the terms of the SRA shall govern, and no representation or warranty thereto is made by UTRF in this Agreement, with respect to the following:
(a) the secret or confidential nature of any know-how;
(b) any obligation on the part of UTRF to take any action to prevent the disclosure of the licensed technology by UT, UT’s employees or any third party; and
(c) whether any of the inventors will agree to provide technical assistance or consultation to licensee, or that such technical assistance or consultation, if provided, would be sufficient to enable Licensee to successfully exploit the Licensed Technology.
Section 18.2 Subject to Section 18.1, the parties hereto acknowledge that this Agreement sets forth the entire Agreement and understanding of the parties hereto as to the subject matter hereof, and shall not be subject to any change or modification except by the execution of a written instrument subscribed to by the parties hereto.
Section 18.3 The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
Section 18.4 The failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party.
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Section 18.5 Neither party will be liable for any failure to perform as required by this Agreement, if and to the extent that the failure to perform is caused by circumstances reasonably beyond such party’s control, including without limitation labor disturbances or disputes, accidents, failure to obtain any required governmental approval, civil disorders, acts of aggression, acts of God, energy or other conservation measures, explosions, failure of utilities, mechanical breakdowns, disease, thefts, or other such occurrences.
Section 18.6 This Agreement may be executed by facsimile and in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same document. The parties agree that facsimile copies of signatures have the same effect as original signatures.
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IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized officers the day and year set forth below.
| ELAN PHARMACEUTICALS INC. (“Licensee”) | ||
| By: | /s/ ▇▇▇▇ ▇▇▇▇▇▇ | |
| Name: | ▇▇▇▇ ▇▇▇▇▇▇ | |
| Title: | Vice President, IP | |
| Date: | (12-31-08) 1-13-09 | |
| UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION (“UTRF”) | ||
| By: | /s/ ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇ | |
| Name: | ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇ | |
| Title: | President | |
| Date: | 12-31-08 | |
APPENDIX A
to
between
UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION
and
ELAN PHARMACEUTICALS INC.
LICENSED PATENTS
U.S. Patent Application # 11/966,988, titled “Treatment and Prophylaxis of Amyloidosis”
PCT International Application No. PCT/US07/089169, titled “Treatment and Prophylaxis of Amyloidosis”
A-1