EXCLUSIVE LICENSE AGREEMENT For Licensing Patent Rights
Exhibit 10.3
For Licensing Patent Rights
This Agreement is made and entered into by and between THE REGENTS OF THE UNIVERSITY OF COLORADO, a body corporate, having its principal office at 000 Xxxxxx Xxxx, Xxxxxx Xxxxx, Xxxxxxx, XX 00000 (hereinafter “University”) and ARCA Discovery, Inc., a Delaware corporation having its principal office at 0000 00xx Xxxxxx, Xxxxx 000, Xxxxxx, XX 00000 (hereinafter “Licensee”).
WITNESSETH
WHEREAS, University is the owner of certain Patent Rights (as later defined herein) relating to expression profiling in the intact human heart and a method of treating heart failure with bucindolol, identified as University Case nos. 2002.026H, CU1297H and CU1298H, developed by inventors Xxxxxxx Xxxxxxx et. al, and has the right to grant licenses under said Patent Rights; and
WHEREAS, University has granted certain rights to such Patents Rights to Myogen, Inc. (“Myogen”); and
WHEREAS, Myogen has relinquished some of its rights in the Patent Rights and has permitted University the right to grant certain licenses under said Patent Rights; and
WHEREAS, Licensee is interested in licensing and further developing the Patent Rights for commercial applications; and
WHEREAS, University desires to have the Patent Rights developed and commercialized to benefit the public and is willing to grant a license hereunder.
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto agree as follows:
ARTICLE 1. DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall have the following meanings:
| 1.01 | “Bucindolol” means the beta-adrenergic–receptor antagonist having the chemical formula:
2-{2-hydroxy- 3{{2-(3-indolyl)-1,1-dimethylethyl}amino}propoxy}-benzonitrile hydrochloride, and its racemates, isomers, prodrugs, active metabolites, analogs and any pharmaceutically acceptable salt or complex thereof, and diagnostics used in connection with its prescription. |
1 of 22
| 1.02 | “Bucindolol Invention” shall mean an Invention relating solely to the use of Bucindolol as a therapeutic or as a diagnostic used solely in connection with the development of Bucindolol. |
| 1.03 | “Effective Date” shall mean the date of the last signature on this Agreement. |
| 1.04 | “Fields of Use” shall mean the fields of use identified in Appendix B. |
| 1.05 | “Improvement” shall mean any invention in the field of human heart disease diagnosis, prevention and therapy, the practice of which would also require the practice of an invention claimed in or covered by the Patent Rights, and which is a modification of the inventions claimed in or covered by the Patent Rights and is created in whole or in part by Xxxxxxx Xxxxxxx. |
| 1.06 | “Invention” shall mean an invention in the field of human cardiovascular disease diagnosis, prevention and therapy conceived of or reduced to practice by University
employees Xx. Xxxxxxx Xxxxxxx, so long as he is voluntarily involved in Licensee as an employee, consultant or director, or by Xx. Xxxxxx Xxxxxxxx, and their University of Colorado collaborators (defined as those co-inventors indicated on invention disclosure forms or individuals named in research grants obtained by Drs. Xxxxxxx and Leinwand). |
| 1.07 | “IVEP Invention” shall mean an Invention of a biological entity identified as being potentially involved in one or more disease states including, without limitation, any human genes or gene products (including variants, post-translational modifications, isoforms and polymorphisms thereof) by Licensee by use of in vivo expression profiling techniques claimed by the Patent Rights. |
| 1.08 | “Know-How” shall mean, and be limited to, University’s proprietary information which has been created, developed, or fixed in any tangible medium of expression and which is directly related to the use of, or desirable for the practice of, the Patent Rights. All Know-How due under this Agreement shall be delivered to Licensee prior to or on the Effective Date in written, electronic, oral or other form of communication. |
| 1.09 | “Licensed Process(es)” shall mean any process, art, or method, that is covered in whole or in part by an issued, unexpired, valid and enforceable claim or a pending claim contained in the Patent Rights or that incorporates or makes use of Know-How. |
| 1.10 | “Licensed Product(s)” shall mean any: |
| (a) | product or part thereof that is covered in whole or in part by an issued, unexpired, valid and enforceable claim or a pending claim contained in the Patent Rights or that incorporates or makes use of Know-How; or |
| (b) | product, chemical composition, apparatus, or part thereof that is manufactured or discovered by using a Licensed Process(es) or is employed to practice a Licensed Process(es); or |
2 of 22
| (c) | product produced, discovered, manufactured or created through the use of any Licensed Product defined in §1.010(a) or §1.010(b). |
| 1.11 | “Net Sales” shall mean the [ * ], whether invoiced or not, less [ * ]. Net sales shall also include the [ * ] received by Licensee as determined by the [ * ]. |
| 1.12 | “Patent Rights” shall mean all of the following University intellectual property: |
| (a) | the United States and foreign patents and/or patent applications and/or provisional patent applications listed in Appendix A; and |
| (b) | United States and foreign patents issued from the applications listed in Appendix A and from divisionals and continuations of these applications; and |
| (c) | claims of United States and foreign continuation-in-part applications, and of the resulting patents, which are directed to subject matter specifically described in the United States and foreign applications listed in Appendix A; and |
| (d) | any reissues or reexaminations of United States and foreign patents described in (a), (b) or (c) above. |
| 1.13 | “Royalty” shall mean any consideration paid by Licensee pursuant to this Agreement. |
| 1.14 | “Territory” shall mean the geographical area identified in Appendix B. |
ARTICLE 2. GRANT OF RIGHTS AND ACCEPTANCE
| 2.01 | University hereby grants and Licensee accepts, during the term and subject to the terms and conditions of this Agreement, and further subject to University’s right to do so without incurring liability to third parties: |
| (a) | an exclusive license to make, have made, use, sell, offer to sell and import the Know-How in the Territory and within the Fields of Use; and |
| (b) | an exclusive license of University’s Patent Rights, except for Patent Rights in University Case No. 2002.026H, in the Territory to make, have made, use, sell, offer to sell, and import any Licensed Products in the Fields of Use and to practice any Licensed Processes in the Fields of Use; and |
| (c) | an exclusive license of University’s Patent Rights in University Case No. 2002.026H in the Territory to make, have made, use, sell, offer to sell and import any Licensed Products in the Fields of Use and to practice any Licensed Process in the Fields of Use (provided that such license may be converted into a co-exclusive license subject to Myogen’s right to obtain a co-exclusive license for such Patent Rights from University). |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
3 of 22
| 2.02 | This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of University other than Patent Rights regardless of whether such patents are dominant or subordinate to Patent Rights. |
| 2.03 | Improvements and New Inventions |
| (a) | Improvements. Subject to any preexisting contractual obligations, requirements of applicable law, and notwithstanding certain obligations to Myogen, Inc. (“Myogen”) under Section 5.2 of the Intellectual Property Agreement, as amended, between University License Equity Holdings, Inc. (“ULEHI”) and Myogen, University reference #IR360H-03, dated November 23, 2003 (the “Myogen-ULEHI Agreement”), Licensee shall have the option to include Improvements in the Patent Rights. Within thirty (30) days of notification by inventor(s) to University of an Improvement, University shall disclose such Improvement to Licensee. Licensee shall have six (6) months from such disclosure to exercise the option, and shall reimburse University for all patent costs incurred prior to and during the option period. Upon exercise of the option, the Improvement shall be deemed included in the Patent Rights licensed under this Agreement. If at the time of the invention of the Improvement a University researcher who is not a founder, employee or consultant of Licensee is named as an inventor on any such Improvement, Licensee shall pay an acquisition payment of ten thousand dollars ($10,000) to University; however, such acquisition payment shall not exceed ten thousand dollars ($10,000) in total per Improvement, and said Improvement shall be included in Patent Rights. Such acquisition payments shall be separate from Licensee’s obligations to pay patent costs and fees as described in Section 8 herein. |
| (b) | New Inventions. Subject to any preexisting contractual obligations or any amendments to the any of the Myogen agreements (if such amendment is agreed to by ARCA) and requirements of applicable law, University hereby grants Licensee: |
| (1) | [ * ] option to license on commercially reasonable terms an IVEP Invention or a Bucindolol Invention; and |
| (2) | [ * ] option to license on commercially reasonable terms any Invention declined to be licensed by Myogen under the Myogen-ULEHI Agreement, as provided therein. The fee for such options shall be [ * ] to University if a University researcher, who is also not a founder, employee or consultant of Licensee, is named as an inventor on any patent for each such Invention licensed by Licensee [ * ] and such Invention shall be included in the Patent Rights. Such acquisition payments shall be separate from Licensee’s obligations to pay patent costs and fees as described in Section 8 herein. |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
4 of 22
| 2.04 | This Agreement shall be subject to the mandatory public laws in any country where this Agreement will produce an effect. |
ARTICLE 3. SUBLICENSING
| 3.01 | Upon notification by Licensee to University, Licensee may sublicense to one or more third parties the rights granted in Article 2 subject to the following limitations: |
| (a) | Licensee agrees that any sublicenses granted by it shall impose restrictions and conditions upon sublicensees that are consistent with those imposed upon Licensee; and |
| (b) | University agrees that, in the event University terminates this Agreement for any reason, any sublicenses granted shall survive such termination and shall be enforceable by both University and sublicensee; and |
| (c) | Licensee agrees that any sublicenses granted shall adequately protect University’s security and property interest in University’s Know-How and Patent Rights. |
| 3.02 | Any sublicenses granted by Licensee shall provide only for cash consideration from sublicensees unless University has expressly consented otherwise in writing in advance. |
| 3.03 | Licensee agrees to forward to University a complete copy of each fully executed sublicense agreement postmarked within thirty (30) days of the execution of such agreement. |
ARTICLE 4. GOVERNMENT AND UNIVERSITY RIGHTS
| 4.01 | Notwithstanding any use of descriptive terms within this Agreement such as “exclusive”, this Agreement is subject to all of the terms and conditions of Title 35 USC §§ 200 et al (“Xxxx-Xxxx Act”) and 37 CFR Part 401, as such may be amended. Further, Licensee agrees to take all reasonable action necessary to enable University to satisfy its obligations hereunder. Such terms and conditions shall include Licensee’s obligation to assure that any Licensed Products used or sold in the United States shall be manufactured substantially in the United States. |
| 4.02 | University shall have the transferable right to practice the Patent Rights and Know-How for nonprofit research and education purposes. |
| 4.03 | University shall have the right to publish any information included in the Patent Rights and the Know-How provided that University takes reasonable steps to avoid the loss of any patent rights as a result of University exercising its rights under this §4.03. |
5 of 22
ARTICLE 5. ROYALTIES
| 5.01 | As consideration for the disclosure of University’s Know-How as well as the licenses and rights under University’s Patent Rights, Licensee agrees to pay to University: |
| (a) | nonrefundable Annual Minimum Royalties as set forth in Appendix C; and |
| (b) | Earned Royalties as set forth in Appendix C; and |
| (c) | Benchmark Royalties as set forth in Appendix C; and |
| (d) | Sublicensing Royalties as set forth in Appendix C. |
| 5.02 | No multiple Royalties shall be payable in the event that any Licensed Products or Licensed Processes are covered by more than one of the Patent Rights. |
| 5.03 | On sales of Licensed Products by Licensee to sublicensees or on sales made in other than arm’s-length transactions, the value of the Net Sales attributed under this Article 5 to such a transaction shall be that which would have been received in an arm’s-length transaction, based on a like transaction at that time. |
| 5.04 | Unless otherwise provided herein, all payments required under this Agreement shall be due within thirty (30) days of written notice from University. Payments past due shall bear interest at the rate of one and one-half percent (1 1/2%) per month compounded, or the maximum interest rate allowed by applicable law, whichever is less. |
ARTICLE 6. REPORTS, RECORDS AND AUDITS
| 6.01 |
On or before the thirtieth (30th) day following the end of each calendar quarter during the term of this Agreement, Licensee shall provide to University written accounts of the Net Sales of Licensed Products and/or Licensed Processes subject to Royalty hereunder made during the prior three (3) month period and shall simultaneously pay to University the Royalties due on such Net Sales, if any, in United States Dollars. Annual Minimum Royalties, if any, which are due University and prorated for each calendar quarter, shall be paid by Licensee along with the written report due under this Agreement. The written report shall discuss the progress and results, as well as ongoing plans, with respect to the Licensed Products and/or Licensed Processes. University shall have the right to request one meeting per year to discuss such information. Net Sales shall be reported in the format of Appendix D. |
| 6.02 | Licensee shall keep accurate records in sufficient detail to reflect its operations under this Agreement and to enable the Royalties accrued and payable under this Agreement to be determined. Such records shall be retained for at least three (3) years after the close of the period to which they pertain, or for such longer time as may be required to finally resolve any question or discrepancy raised by University. |
6 of 22
| 6.03 | Upon the request of University, with reasonable notice, but not more frequently than once a year, Licensee shall permit an independent public accountant selected and paid by University to have access during regular business hours to such records as may be necessary to verify the accuracy of Royalty payments made or payable hereunder. Said accountant shall disclose information acquired to University only to the extent that it should properly have been contained in the royalty reports required under this Agreement. If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Licensee shall reimburse University for the cost of the inspection and pay the amount of the underpayment including any interest as required by this Agreement. If an inspection shows an overpayment of Royalties, such sums shall be applied to and deducted from the following Royalty payments, or subsequent payments, until the overpayment has been extinguished. |
| 6.04 | Licensee acknowledges that University is subject to the Colorado Public Records Act (C.R.S. §§ 00-00-000 et seq.). All plans and reports marked “Confidential” shall be treated by University as confidential to the extent permitted under §§ 00-00-000. |
| 6.05 | Each party shall vigilantly protect the confidential information related to the Patent Rights and Know-How from disclosure to third parties; and no such disclosure shall be made except under sufficiently protective confidentiality agreements. All written documents containing confidential information and other material in tangible form, as well as oral communications containing confidential information received by either party under this Agreement shall be disclosed only pursuant to such confidentiality agreements and shall remain the property of the disclosing party, and such documents and materials, together with copies of excerpts thereof, shall promptly be returned to disclosing party upon request, except one copy may be retained for archival purposes. This section shall cover oral communications containing confidential information provided that such oral communications containing confidential information are summarized in writing by the disclosing party and provided to the recipient within thirty (30) days of such oral disclosure. |
ARTICLE 7. DUE DILIGENCE AND PERFORMANCE
| 7.01 | Licensee shall use commercially reasonable efforts to proceed with the development, manufacture, exploitation and sale or lease of Licensed Products and Licensed Processes and to diligently develop markets for the Licensed Products and Licensed Processes throughout the term of this Agreement. Licensee acknowledges and agrees to the performance milestones defined in Appendix E. |
| 7.02 | Licensee agrees to develop a vigorous sublicensing program to effect commercialization of Licensed Products and Licensed Processes in any Field of Use or Territory that Licensee decides not to exploit for itself, subject to commercial constraints and Licensee’s reasonable business judgment. |
| 7.03 | University may terminate this Agreement or convert this Agreement to a non-exclusive Agreement if Licensee fails to meet any of the due diligence or performance requirements of this Article 7, subject to provisions of section 10.03(c). |
7 of 22
ARTICLE 8. PATENTS, COSTS, AND ENFORCEMENT
| 8.01 | Licensee shall [ * ] University, within thirty (30) days of University’s invoice, an [ * ]. |
| 8.02 | Licensee shall control and diligently pursue the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Patent Rights on or after the Effective Date, using patent counsel of its choice. Licensee shall [ * ], except as otherwise provided in this Article 8. |
| 8.03 (a) | Licensee shall keep University advised as to the status of the Patent Rights by providing University, in a timely manner prior to their due date, with copies of all official documents and material correspondence relating to the prosecution, maintenance, and validity of any patent applications and patents included in the Patent Rights. University shall have reasonable opportunities to consult with Licensee on such patent applications and patents and shall provide such other reasonable assistance from time to time at the request of Licensee as necessary to file, prosecute and maintain such applications, at Licensee’s expense. Licensee shall diligently seek legally appropriate claims under the Patent Rights, and shall not abandon prosecution of any patent application without first notifying University a reasonable time in writing prior to any bar date, of Licensee’s intention and reason therefor, and providing University with reasonable opportunity to assume responsibility for prosecution, maintenance and associated costs of such patents and patent applications. If University pursues such patent protection, then from that time forward all such subject patent applications and any patents arising therefrom shall be excluded from the Patent Rights under this Agreement and Licensee shall forfeit all rights under this Agreement to such patent applications and any patents arising therefrom. |
| (b) | No claims of the filed patent applications or issued patent or foreign patent rights constituting Patent Rights hereunder shall be modified, deleted, or abandoned by Licensee or its patent counsel without reasonable, prior written notice to University and reasonable opportunity for University to consult with Licensee. Licensee’s obligations under this §8.03 shall include, without limitation, an obligation to inform University in a timely manner if Licensee will not pursue patents in any foreign countries where patent protection may be available, in order that University may prosecute patents in such countries if University so desires. If University pursues such foreign patent protection, or an issued patent which Licensee intends to abandon, then from that time forward such subject patent applications and any patents arising therefrom, or such issued patents, shall no longer be considered Patent Rights under this Agreement and Licensee shall forfeit all rights under this Agreement to such patent applications, any patents arising therefrom, or such issued patents. University shall be [ * ] with those patent applications and patents it decides to pursue and maintain. |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
8 of 22
| 8.04 | If Licensee fails to diligently prosecute the Patent Rights, University may provide Licensee with written notice that University wishes to resume control of the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Patent Rights. If University elects to resume such responsibilities, Licensee agrees to cooperate fully with University, its attorneys, and agents in preparation, filing, prosecution, and maintenance of any and all patent applications or patents and to provide University with complete copies of any and all documents or other materials that University deems necessary to undertake such responsibilities. |
| 8.05 | University and Licensee agree to inform the other party promptly in writing of any suspected infringement of the Patent Rights by a third party. Licensee shall have, for a period of [ * ] from the date of any notice of infringement of the Patent Rights, the first right to institute suit against such third party. If Licensee institutes such a suit, it shall bear all costs of the litigation and shall be entitled to retain the entire amount of any recovery or settlement less earned royalties due to University. Thereafter, University and Licensee shall each have the right to institute an action for infringement of the Patent Rights against such third party in accordance with the following: |
| (a) | If both University and Licensee agree to institute suit jointly, the suit shall be brought in both their names, the out-of-pocket costs thereof shall be borne equally, and any recovery or settlement shall be shared equally. University and Licensee shall agree to the manner in which they shall exercise control over such suit. Each party, at its option, may be represented by separate counsel of its own selection, the fees for which shall be paid for by the respective parties; |
| (b) | In the absence of an agreement to institute a suit jointly, University may, but is not obligated to, institute suit, and at its option, join Licensee as a plaintiff. If University decides to institute suit, it shall notify Licensee in writing. Licensee’s failure to notify University in writing within fifteen (15) days after the date of University’s notice, that it will join in enforcing the Patent Rights pursuant to the terms hereof, shall be deemed conclusively to be Licensee’s assignment to University of all rights, causes of action, and damages resulting from any such alleged infringement. University shall bear the entire cost of such litigation and shall be entitled to retain the entire amount of any recovery or settlement; |
| (c) | In the absence of an agreement to institute a suit jointly, and if University does not notify Licensee of its intent to pursue legal action within ninety (90) days of the end of the one hundred twenty (120) day period as provided above, Licensee may institute suit. Licensee shall bear the entire cost of such litigation and shall be entitled to retain the entire amount of any recovery or settlement less earned royalties due University; |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
9 of 22
| (d) | If Licensee undertakes to defend the Patent Rights by litigation, Licensee may defer from its royalty payments to University with respect to the Patent Rights subject to suit an amount not exceeding fifty percent (50%) of Licensee’s expenses and costs of such action, including reasonable attorney’s fees, provided however, that such deferral shall not exceed fifty percent (50%) of the total royalty due to University for each calendar year, and that such deferred payments shall be delivered to University upon settlement of the litigation. |
| 8.06 | In the event that a declaratory judgment action alleging invalidity or non-infringement of any of the Patent Rights shall be brought against Licensee or raised by way of counterclaim or affirmative defense in an infringement suit brought by Licensee under § 8.05, pursuant to this Agreement and the provisions of Chapter 29 of Title 35, U.S. Code or other statutes, or in the case of any action against Licensee alleging infringement by the Licensed Products or Licensed Processes, Licensee may: |
| (a) | defend the suit in its own name, at its own expense, and on its own behalf and collect for its use, damages, profits, and awards of whatever nature recoverable for such claims consistent with §8.05; and |
| (b) | settle any claim or suit for declaratory judgment involving the Patent Rights, except that Licensee shall have no right to deny the validity of any patent, patent claim, or patent application included in the Patent Rights in any compromise or settlement of any claim or suit for declaratory judgment without the express prior written consent of University; provided however, that |
University shall have a continuing right to intervene in such actions described in subparagraphs (a) and (b). Licensee shall take no action to compel University either to initiate or to join in any such declaratory judgment action. If Licensee elects not to defend against such declaratory judgment action, University, at its option, may do so at its own expense and shall be entitled to retain the entire amount of any recovery or settlement.
| 8.07 | In all cases, Licensee agrees to keep University reasonably apprised of the status and progress of any litigation. |
ARTICLE 9. NO WARRANTIES, INDEMNIFICATIONS AND INSURANCE
| 9.01 | UNIVERSITY MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO USE, SALE, OR OTHER DISPOSITION BY LICENSEE, SUBLICENSEE(S), OR THEIR VENDEES OR OTHER TRANSFEREES OF LICENSED PRODUCTS OR LICENSED PROCESSES INCORPORATING OR MADE BY USE OF THE PATENT RIGHTS. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OR SALE OF SUCH PRODUCTS OR PROCESSES WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, SERVICE XXXX, OR OTHER RIGHTS. |
10 of 22
| 9.02 | Notwithstanding anything in this Agreement to the contrary, nothing in this Agreement shall be construed as: |
| (a) | A warranty or representation by University as to rights in Know-How or the validity or scope of any of the Patent Rights; |
| (b) | A warranty or representation that the Patent Rights or anything made, used, sold or otherwise disposed of under the License will or will not infringe patents, copyrights or other rights of third parties; or |
| (c) | An obligation to furnish any know-how or technology not agreed to in this Agreement, to bring or prosecute actions or suits against third parties for infringement (except to the extent described in §8.05) or to provide any services other than those specified in this Agreement. |
| 9.03 | Licensee shall indemnify, defend, and hold harmless University, its regents, employees, students, officers, agents, affiliates, and representatives from and against all liability, demands, damages, losses, and expenses, for death, personal injury, illness, property damage, noncompliance with applicable laws and any other claim, proceeding, demand, expense and liability of any kind whatsoever in connection with or arising out of: |
| (a) | the use by or on behalf of Licensee, its sublicensees, affiliates, directors, officers, employees, or third parties of any Patent Rights; or |
| (b) | the design, manufacture, production, distribution, advertisement, consumption, sale, lease, sublicense or use of any Licensed Product(s), Licensed Process(es) or materials by Licensee, or other products or processes developed in connection with or arising out of the Patent Rights; or |
| (c) | any right or obligation of Licensee under this Agreement. |
| 9.04 | Licensee shall obtain general liability insurance, including product liability insurance, on such terms and in such amounts as are reasonable and customary within the industry. |
ARTICLE 10. DURATION AND TERMINATION
| 10.01 | The term of the License shall commence on the Effective Date and extend to the date of expiration of the last to expire of any patents embodying the Licensed Products or Licensed Processes, including any continuations, continuations-in-part, reissues, renewals or extensions thereof. The obligation to pay the Royalty set forth under Article 5 with respect to each Licensed Product or Licensed Process shall expire when the patent covering such Licensed Product or Licensed Process expires. |
11 of 22
| 10.02 | Licensee may terminate this Agreement at any time on sixty (60) days written notice to University if Licensee: |
| (a) | pays all amounts due, including the pro-rata Annual Minimum Royalties, as well as all non-cancelable costs, to University through the termination date; |
| (b) | submits a final report of the type described in Article 6; |
| (c) | returns any confidential materials provided to Licensee by University in connection with this Agreement; |
| (d) | suspends its use and sales of the Licensed Product(s) and Licensed Process(es); provided, however, that Licensee may for a period of one hundred and eighty (180) days after the effective date of such termination sell all Licensed Products that may be in inventory subject to Licensee’s obligations in Article 5 and Article 6; and |
| (e) | provides University the right to access any regulatory information filed with any U.S. or foreign government agency with respect to Licensed Products and Licensed Processes. |
| 10.03 | University may terminate this Agreement in the event that: |
| (a) | Licensee fails to pay University any amounts when due to University hereunder and Licensee fails to make such payment within sixty (60) days of written notice from University; or |
| (b) | Licensee becomes insolvent, files a Chapter 7 petition in bankruptcy, has such a petition filed against it, and such petition is not dismissed within ninety (90) days; or |
| (c) | Licensee is in material breach or default of this Agreement other than those occurrences listed in §10.03 (a) or (b), and Licensee fails to cure the breach or default within sixty (60) days of written notice of the breach or default. Licensee’s ability to cure such breach shall be limited to the first two material breaches properly noticed under the terms of this Agreement, regardless of the nature of those breaches. Any subsequent material breach shall entitle University to terminate this Agreement immediately. Events constituting a material breach or default shall include, but are not limited to, the following: |
| (i) | failure by Licensee to meet any performance milestone in Appendix E; |
| (ii) | operation, manufacture, use of or sale of the Licensed Products or Licensed Processes outside the Fields of Use or Territory; |
| (iii) | failure to keep adequate records or permit inspection or audit. |
12 of 22
ARTICLE 11. MISCELLANEOUS
| 11.01 | This Agreement shall be governed by and construed in accordance with the laws of the State of Colorado. |
| 11.02 | All notices, demands or consents required or permitted hereunder shall be deemed sufficient if given in writing and personally delivered, sent by registered mail, postage prepaid, or by a nationally recognized overnight courier service, and addressed to the party to receive such notice at the address given below, or such other address as may hereafter be designated by notice in writing. |
| University: | Licensee: | |
| Technology Transfer Office University of Colorado, 588 SYS Suite 390, 0000 Xxxxxxxxx Xxxxx Xxxxxxx, XX 00000-0000 <License Administrator, Case #s 2002.026H, CU1297H, CU1298H>
Electronic funds transfer can be made to:
Routing Transit Number (RTN): [ * ] Account Number: [ * ] Bank Name: [ * ] City, State: [ * ] Payee/beneficiary: [ * ] Attention: [ * ]
Please include sufficient information to identify payment. Licensee is responsible for electronic transfer expenses. |
ARCA Discovery, Inc. 0000 00xx Xxxxxx, Xxxxx 000 Xxxxxx, XX 00000 Attention: Xx. Xxxxxxx Xxxxxxx | |
| 11.03 | Licensee agrees not to identify University in any promotional advertising, press releases, sales literature or other promotional materials to be disseminated to the public or any portion thereof without University’s prior written consent in each case, except that Licensee may state that it has a license for the Patent Rights from University. Licensee further agrees not to use the name of University or any University faculty member, inventor, employee or student or any trademark, service xxxx, trade name, copyright or symbol of University, without the prior written consent of the University, entity or person whose name is sought to be used. |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
13 of 22
| 11.04 | Licensee agrees to: |
| (a) | cause Licensed Products or the product of Licensed Processes sold under this Agreement to be marked with the notice of the patent numbers or patent pending, as may be appropriate; |
| (b) | comply with all laws and regulations of the United States and any other country as appropriate concerning or controlling the import or export of the Licensed Products, data, software, laboratory prototypes or other commodities. University makes no representation that a license or consent for export will not be required by applicable governmental agencies, or if required, that it will be issued; and |
| (c) | comply with all applicable statutes, regulations, and guidelines, including applicable governmental regulations, policies and guidelines in its use of any University - supplied materials (“Materials”). Licensee agrees not to use the Materials for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46 (as those regulations may be amended from time to time). Licensee agrees not to use the Materials for research involving human subjects or clinical trials outside of the United States without notifying University in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to University of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of such research or trials. |
| 11.05 | In the event of any dispute arising out of or relating to this Agreement, the affected party shall promptly notify the other party in writing, and upon the other party’s receipt of such notice (“Notice Date”), the parties shall attempt in good faith to resolve the matter. Any disputes not so resolved shall be referred to senior executives of the parties, who shall meet at a mutually acceptable time and location within thirty (30) days of the Notice Date and shall attempt to mediate the dispute and negotiate a settlement. If the senior executives fail to meet within thirty (30) days of the Notice Date, or if the matter remains unresolved for a period of sixty (60) days after the Notice Date, the dispute may be submitted to a court of competent jurisdiction in the State of Colorado, and, by execution and delivery of this Agreement, each party (a) accepts, generally and unconditionally, the jurisdiction of such court and any related appellate court, and (b) irrevocably waives any objection it may now or hereafter have as to the venue of any such suit, action or proceeding brought in such court or that such court is an inconvenient forum. However, either party shall be free to seek appropriate injunctive relief without compliance with the mediation procedures set forth herein. |
| 11.06 | The terms and provisions contained in this Agreement constitute the entire Agreement between the parties and shall supersede all previous communications, representations, agreements or understandings, either oral or written, between the parties hereto with respect to the subject matter hereof, and no agreement or understanding varying or extending this Agreement will be binding upon either party hereto, unless in writing which specifically refers to this Agreement, signed by duly authorized officers or representatives of the respective parties, and the provisions of this Agreement not specifically amended thereby shall remain in full force and effect according to their terms. |
14 of 22
| 11.07 | The provisions and clauses of this Agreement are severable, and in the event that any provision or clause is determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability will not in any way affect the validity or enforceability of the remaining provisions and clauses hereof. |
| 11.08 | This Agreement does not establish a joint venture, agency or partnership between the parties, nor create an employer - employee relationship. This Agreement may be assigned to a party that acquires substantially all of the assets of Licensee upon thirty (30) days prior written notice to University. A change in control of Licensee shall not be considered an assignment of this Agreement. |
| 11.09 | The parties agree that nothing in this Agreement is intended or shall be construed as a waiver, either express or implied, of any of the immunities, rights, benefits, defenses or protections provided to University under governmental or sovereign immunity laws from time to time applicable to University, including, without limitation, the Colorado Governmental Immunity Act (C.R.S. §§00-00-000, et seq.) and the Eleventh Amendment to the United States Constitution. |
| 11.10 | The provisions of Articles 1, 8 and 11, and §§ 6.01, 6.02, 9.01-9.03, and any other provision of this Agreement that by its nature is intended to survive, shall survive any termination or expiration of this Agreement. |
15 of 22
IN WITNESS WHEREOF the parties hereto have caused this Agreement, which is effective on the date of the last to sign below, to be executed in duplicate by their respective duly authorized officers.
| University: | Licensee: | |||||||
| ARCA Discovery, Inc. | ||||||||
| By: | /s/ Xxxxx X Xxxxx | By: | /s/ Xxxxxxx X. Xxxxxxxx | |||||
| Title: | Associate VP | Title: | Chief Business & Financial Officer | |||||
| Date: | October 14, 2005 | Date: | October 14, 2005 | |||||
16 of 22
APPENDIX A
PATENT RIGHTS
| CU ID # |
Patent # | Title, Inventors | ||
| 2002.026H |
[ * ] | [ * ] | ||
| 2002.026H |
[ * ] | [ * ] | ||
| 2002.026H |
[ * ] | [ * ] | ||
| 2002.026H |
[ * ] | [ * ] | ||
| 2002.026H |
[ * ] | [ * ] | ||
| 2002.026H |
[ * ] | [ * ] | ||
| CU1297H |
[ * ] | [ * ] | ||
| CU1298H |
[ * ] | [ * ] | ||
| CU1297H/ CU1298H |
[ * ] | [ * ] | ||
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
17 of 22
APPENDIX B
FIELDS OF USE and TERRITORY
Territory = worldwide
Fields of Use = all fields
18 of 22
APPENDIX C
ROYALTIES
In accordance with Articles 5 and 6, Licensee shall pay the following Royalties to University:
Annual Minimum Royalty: [ * ] until first commercial sales of Licensed Product(s) and/or Licensed Process(es) occurs, payable quarterly in accordance with section 6.01; [ * ] of Licensed Product(s) and/or Licensed Process(es), payable quarterly in accordance with section 6.01. The Annual Minimum Royalty will be credited against any Earned Royalties that are payable for each reporting period.
Earned Royalty: A percentage of Net Sales as follows: [ * ] of Net Sales. If the Licensed Product or Licensed Process is sold as a combination product, or as a part of bundled products, in such a way that the price of the Licensed Product or Licensed Process included in the combination product is not separately stated on the invoice, for the purpose of determining [ * ] payments, Net Sales for the combination product, or bundled products, shall be determined by multiplying Net Sales of the combination product by the fraction [ * ]. If such [ * ] are not established, then the parties shall negotiate in good faith to determine the method of calculating Net Sales for combination products. No [ * ] shall be payable on Bucindolol.
Benchmark Royalties: Payable within thirty (30) days of each event, as follows:
(a) With respect to the [ * ] involving any Licensed Product(s) and/or Licensed Process(es) (excluding Bucindolol), [ * ].
(b) With respect to the [ * ] involving any Licensed Product(s) and/or Licensed Process(es) (excluding Bucindolol), [ * ].
(c) With respect to the [ * ] any Licensed Product(s) and/or Licensed Process(es) [ * ] (excluding Bucindolol), [ * ].
Sublicensing Royalties: Licensee shall pay University Sublicensing Royalties for all sublicense consideration received for the sublicense of the Patent Rights (excluding Bucindolol, and other than the sublicense of the Patent Rights to any Affiliates of Licensee) according to the following schedule: (a) [ * ], (b) [ * ] and (c) [ * ]. For purposes of this Agreement, an “Affiliate” shall mean every corporation, or entity, which, directly or indirectly, or through one or more intermediaries, controls, is controlled by, or is under common control with Licensee, as well as every officer, director, agent and representative of any such corporation or entity. For the purposes of the definition of Affiliate, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
19 of 22
indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.
Notwithstanding the foregoing, the exclusion of Royalties on Bucindolol shall apply to the Patent Rights but shall not apply to Improvements or other new Inventions involving Bucindolol that are created with the use of University facilities.
20 of 22
APPENDIX D
ROYALTY REPORT
| Licensee: | Case No.: | |||||||
| Inventor: | Patent No. | |||||||
| Period Covered: From: | / / | Through: | / / | |||||
| Prepared By: | Date: | |||||||
| Approved By: | Date: |
If license covers several major product lines, please prepare a separate report for each line. Then combine all product lines into a summary report. A discussion of the progress and results, as well as ongoing plans, with respect to the Licensed Products and/or Licensed Processes, see § 6.01, is attached.
| Report Type: |
____ Single Product Line Report: _____________________________________________ ____ Multiproduct Summary Report. Page 1 of _____ Pages ____ Product Line Detail. Line: ____________ Trademark: ___________ Pages: _____ |
| Gross Sales |
* Less: Allowances |
Net Sales |
Royalty Rate |
Period Royalty Amount | ||||||||
| Country |
This Year | Last Year | ||||||||||
| U.S.A. |
||||||||||||
| Canada |
||||||||||||
| Europe |
||||||||||||
| Japan |
||||||||||||
| Other: |
||||||||||||
| TOTAL: |
||||||||||||
Sublicense Fees this quarter: $________ (attach page showing names, addresses, and telephone numbers; and amount of fees received; territory; field of use)
Total Royalty: $________
The following royalty forecast is non-binding and for University internal planning purposes only:
Royalty Forecast Under This Agreement:
Next Quarter:_________ Q2:__________ Q3: ________ Q4: _________
21 of 00
XXXXXXXX X
PERFORMANCE MILESTONES
Licensee agrees to the following:
| a. | On or before [ * ], Licensee shall deliver to University a business plan that communicates the Licensee’s product development and marketing (strategic, tactical and financial) plans for Patent Rights. This document shall include forecasts showing the funds, personnel and time budgeted and planned for development of the Licensed Product(s) and Licensed Process(es) and Licensee shall provide similar reports or updates, as the case may be, to University on [ * ]. |
| b. | Licensee agrees that if any particular patent application or issued patent that is a part of the Patent Rights is not developed, sublicensed or being diligently used in research and development within [ * ] of the filing of the respective patent application, Licensee shall relinquish all rights to that portion of the Patent Rights to University without additional compensation, credit or refund of any amounts paid. |
| c. | Within [ * ] of the Effective Date, Licensee shall have raised a total of at least [ * ]. |
| [*] | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. |
22 of 22
