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DURHAM JONES & PINEGAR, P.C. R. Stephen Marshall, smarshall@djplaw.com (2097) Bret F. Randall, brandall@djplaw.com (6634) Clinton E. Duke, cduke@djplaw.com (9784) Erin T. Middleton, emiddleton@djplaw.com (10666) Attorneys for Plaintiff 111 East Broadway, Suite 900 Salt Lake City, UT 84111 Telephone: (801) 415-3000 Facsimile: (801) 415-3500

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH, CENTRAL DIVISION

RIVERROCK BIOSCIENCE, LLC, a Delaware limited liability company, Plaintiff,

COMPLAINT

Civil No. ________________ v. N8 MEDICAL, LLC, a Nevada limited liability company, N8 MEDICAL, INC., a Nevada corporation, Defendants.

Plaintiff RiverRock Bioscience, LLC, for its complaint against defendant N8 Medical, LLC and N8 Medical, Inc., hereby states and alleges as follows: PARTIES, JURISDICTION, AND VENUE 1. Plaintiff RiverRock Bioscience, LLC (RiverRock) is a Delaware limited

liability company having its principal place of business in Orem, Utah. RiverRock is in the business of commercializing, manufacturing, selling, and distributing, in certain fields, various products relating to certain antimicrobial and antibiotic technology developed by Brigham

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Young University (BYU), pursuant to certain license agreements between BYU and RiverRock. 2. Defendant N8 Medical, LLC is a Nevada limited liability company with its

principal place of business located in Columbus, Ohio. N8 is in the business of commercializing, manufacturing, selling, and distributing, various products relating to certain antibiotic technology developed by BYU, in certain fields N8 purports to have subsequently acquired pursuant to a certain license agreement between N8 and BYU. 3. Defendant N8 Medical, Inc. is a Nevada corporation with its principal place of

business located in Columbus, Ohio. N8 Medical, Inc. has secured certain interests in the license agreement between BYU and N8 Medical, LLC. N8 Medical, Inc. and N8 Medical, LLC will be referred to collectively herein as N8. 4. The license agreement between N8 and BYU was entered subsequent to one of

the license agreements between BYU and RiverRock. Substantial disputes and controversies have arisen between RiverRock and N8 as to the scope of their respective license agreements and the priority of their respective rights in respect of a variety of fields, including, for example, drugs, medical devices, and food safety. 5. All of the license agreements at issue in this matter were negotiated and entered

into within the State of Utah and provide that Utah law shall govern their construction. 6. Because this action arises under the Patent Laws of the United States, including

35 U.S.C. 100 et. seq., this Court has subject matter jurisdiction pursuant to 28 U.S.C. 1331 and 1338(a). Further, because this action presents an actual controversy with respect to the infringement of the patents in suit, the Court may grant the declaratory relief sought pursuant to

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28 U.S.C. 2201 and 2202. This Court also has subject matter jurisdiction over the Claims asserted in this Complaint pursuant to 28 U.S.C. 1332(a). 7. The value of the matter in controversy exceeds $75,000 exclusive of interest and

costs and RiverRock and N8 are citizens of different States. 8. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391 and 1400.

In its license with BYU, N8 agreed to venue in Utah County, Utah for any legal disputes. 9. A substantial and actual controversy between the parties which is of sufficient

immediacy and reality to warrant declaratory relief. 10. This controversy concerns, inter alia, a dispute between the parties with respect to

the respective license agreements into which they each entered with BYU. 11. This Court has personal jurisdiction over N8. N8, directly and through their

agents, have availed themselves of the jurisdiction of the courts of the state of Utah through engaging in extensive business negotiations and operations in this jurisdiction, engaging and utilizing Utah-based legal counsel, and engaging and otherwise collaborating with faculty and staff at the University of Utah in connection with N8s business and commercialization efforts. Moreover, in its license with BYU, N8 agreed to venue in Utah County, Utah for any legal disputes. GENERAL ALLEGATIONS 12. On July 20, 2010, BYU and RiverRock entered into an Exclusive License

Agreement (RiverRock Exclusive License) relating to ceragenin compounds, also known as catatonic steroid antibiotics (CSA), a technology patented by BYU. The RiverRock Exclusive License grants exclusive rights to RiverRock in U.S. Patents No. 6,350,738 (the 738 patent attached hereto as Exhibit A), No. 6,486,148 (the 148 patent attached hereto as Exhibit B), 3
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No. 6,767,904 (the 904 patent attached hereto as Exhibit C), and No. 7,598,234 (the 234 patent attached hereto as Exhibit D) in defined fields of use, referred to in the contract as the Field of Application. The RiverRock Exclusive License is attached hereto as Exhibit E. 13. CSA compounds are synthetic compounds that mimic the polyfunctional and

broad spectrum activity of a key component of the human innate immune system. 14. The Field of Application in the RiverRock Exclusive License, Section 1.4, is

defined as follows: FIELD OF APPLICATION means cleaning products, soaps, and disinfectants and products containing them but excludes use in contact lenses and ophthalmology products of any kind; medical devices as defined by the FDA including dental, hospital and personal use devices; prescription pharmaceutical drugs and medications as well as those that were formerly prescription drugs and medications. 15. Section 5.6 of the RiverRock Exclusive License provides:

Within eighteen (18) months after the effective date of this Agreement LICENSEE will enter into at least one product development or distribution agreement in each of the three (3) following fields of application: (a.) cosmetics; (b.) paints; and (c.) personal sanitation products, defined as feminine protection, diapers, and adult incontinence protection. 16. by federal law. 17. All of the personal sanitation products listed in Section 5.6 of the RiverRock Any cosmetic product containing CSA technology qualifies as a drug as defined

Exclusive License containing the CSA antibiotic compound qualify as both a drug and as a medical device as defined by the U.S. Food and Drug Administration. 18. A large number of cleaning products, soaps, and disinfectant products containing

CSA compounds are regulated by the FDA, such as in the field of food safety, high level disinfectants, food additives, food contact substances, and hospital disinfectants and sanitizers.

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19.

In 2011, RiverRock agreed with N8 to refrain from claiming license rights in CSA

technology in the following specific product applications: toothpaste, mouthwash, floss, dentures, and similar oral consumer products; skin lotions, gels, antiseptics and creams; or antimicrobial band aids, gauze or wound dressings. 20. As used in this Complaint, the term RiverRock Field of Application shall mean

the following sub-fields: (1) cleaning products, soaps, and disinfectants and products containing them (excluding use in contact lenses and ophthalmology products of any kind); (2) medical devices as defined by the FDA including dental, hospital and personal use devices; and (3) prescription pharmaceutical drugs and medications as well as those that were formerly prescription drugs and medications; including, without limitation, antimicrobial fields that are regulated by the FDA, including food safety, food additives, food contact substances, and high level and general disinfectants; but excluding the following specific products: (a) toothpaste, mouthwash, floss, dentures, and similar oral consumer products; (b) skin lotions, gels, antiseptics and creams; or (c) antimicrobial band aids, gauze or wound dressings. 21. Immediately following execution of the License Agreement, RiverRock expended

considerable time, resources, and money attempting to commercialize the CSA technology within the RiverRock Field of Application, particularly in the fields of cosmetic-drugs, personal sanitation medical devices-drugs, paints, and food safety. RiverRocks direct expenses related to these commercialization efforts exceed $2 million. 22. On or about September 9, 2010, BYU entered into an Exclusive License

Agreement with N8 (the N8 License). The N8 License is attached hereto as Exhibit F. The N8 License purports to grant to N8 the following field of application for the CSA technology:

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FIELD OF APPLICATION means all products and processes subject to regulation by the U.S. Food & Drug Administration (FDA), including all medical devices, dental and pharmaceutical applications for humans, with the sole exclusions being those FDAregulated products, including medical device and pharmaceutical applications, in the fields of (i.) ophthalmology (including, but not limited to, eye drops, contact lens solutions and intraocular lenses). The following fields are also excluded: (ii.) any animal care product; (iii.) all disinfectants and sanitizers (as such terms are defined by FDA and EPA) for hospital use, general purpose use and/or consumer use as well as all soaps and similar cleaning products for external application for any consumer, hospital or industrial use but not including any product that would require approval as a new drug; and (iv.) indirect food additives that form part of food packaging, holding, or processing, but are not intended to be added directly to, become a component of, or have a technical effect in or on, food. 23. Since September of 2010, N8 has engaged in various business activities in fields

of application previously granted exclusively to RiverRock, including negotiations and partnerships with a global consumer products company and a variety of medical device manufacturing companies, N8s research efforts with a global research organization in support of certain medical applications for the CSA technology, in addition, upon information and belief, to N8s attempts to commercialize CSA technology applications in the food processing and safety fields. 24. To date, RiverRock has lost as much as $20 million in pending business

partnership and funding opportunities due to N8s claims to rights for CSA technology applications that BYU previously granted, on an exclusive basis, to RiverRock. 25. The irreducible distinguishing core of an exclusive license being meaningful

limitations on the licensors ability to engage in subsequent licensing of the same subject matter, BYU could not, as a matter of law, convey a valid second license to N8 covering the same subject matter and scope because it has previously granted and conveyed those property rights to RiverRock.

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26.

An actual case or controversy has arisen between the parties. N8 has asserted that

it is the exclusive licensee of the 738, 148, 904, and 234 patents in fields of use exclusively licensed to RiverRock and that RiverRocks intended making, using, or selling of the products and processes claimed in the patents in suit within those fields is unauthorized. FIRST CLAIM FOR RELIEF Declaratory Judgment - Non-infringement of U.S. Patent Nos. 6,350,738, 6,486,148, 6,767,904, and 7,598,234 27. RiverRock hereby incorporates into this Claim all of the allegations of the prior

paragraphs of this Complaint. 28. N8 purports to be the exclusive licensee of the 738, 148, 904, and 234 patents

within fields of use within the RiverRock Field of Application that were previously exclusively licensed to RiverRock. 29. RiverRock has been manufacturing a compound and developing partnerships to

experiment with and commercialize technology that N8 considers to be practicing the patents within fields purported to be exclusively licensed to N8. N8 has threatened to attempt to prevent RiverRock from engaging in this business or take legal action asserting N8s alleged exclusive rights against RiverRock. 30. RiverRocks desired actions do not and would not infringe, either directly or

indirectly, any claim of the patents in suit at least because these actions fall within the exclusive rights granted to RiverRock by BYU prior to the attempted grant of any similar rights to N8 from BYU.

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31.

Accordingly, there exists an actual controversy between RiverRock and N8

concerning whether the claims of the 738, 148, 904, and 234 patents are infringed by RiverRock. 32. Pursuant to 28 U.S.C. 2201, 2201, RiverRock is entitled to a declaratory

judgment that its making, using, offering to sell, selling, or sublicensing of products or processes within the RiverRock Field of Application, or contracting with third parties to do the same, does not infringe the 738, 148, 904, and 234 patents by virtue of the RiverRock Exclusive License with BYU. SECOND CLAIM FOR RELIEF Declaratory Judgment Scope of Field of Application 33. RiverRock hereby incorporates into this Claim all of the allegations of the prior

paragraphs of this Complaint. 34. Pursuant to 28 U.S.C. 2201, 2202, RiverRock is entitled to a declaratory

judgment from this Court that, under the RiverRock Exclusive License, RiverRock was granted the exclusive right to practice the CSA technology within the RiverRock Field of Application. THIRD CLAIM FOR RELIEF Declaratory Judgment Priority of Exclusive License 35. RiverRock incorporates into this Claim all of the allegations of the prior

paragraphs of this Complaint. 36. Pursuant to 28 U.S.C. 2201, 2202, RiverRock is entitled to a declaratory

judgment from this Court as follows: (a) That BYU, having conveyed to RiverRock the exclusive rights to

practice the CSA technology in the RiverRock Field of Application, lacked the 8
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legal capacity to grant or convey to N8 any right to practice the CSA technology within the scope of the RiverRock Field of Application and, therefore, the RiverRock Exclusive License has priority over the N8 License; and (b) That N8 does not have the legal right to practice the CSA

technology in the RiverRock Field of Application. PRAYER FOR RELIEF WHEREFORE, RiverRock prays for the following relief: 1. On the FIRST CLAIM FOR RELIEF for a declaratory judgment that RiverRocks

making, using, offering to sell, selling, or sublicensing of products or processes within the RiverRock Field of Application, or contracting with third parties to do the same, does not infringe the 738, 148, 904, and 234 patents. 2. On the SECOND CLAIM FOR RELIEF for a declaratory judgment that under the

RiverRock Exclusive License, RiverRock was granted the exclusive right to practice the CSA technology within the RiverRock Field of Application 3. On the THIRD CLAIM FOR RELIEF for a declaratory judgment as follows: (a) That BYU, having conveyed to RiverRock the exclusive rights to

practice the CSA technology in the RiverRock Field of Application, lacked the legal capacity to grant or convey to N8 any right to practice the CSA technology within the scope of the RiverRock Field of Application and, therefore, the RiverRock Exclusive License has priority over the N8 License; and (b) That N8 does not have the legal right to practice the CSA

technology in the RiverRock Field of Application.

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4.

That this case be declared an exceptional case and that RiverRock be awarded its

attorneys fees against N8 pursuant to 35 U.S.C. 285. 5. and proper. DATED this 14th day of December, 2011. DURHAM JONES & PINEGAR, P.C. For RiverRocks costs and such other and additional relief as the Court deems just

By /s/ R. Stephen Marshall R. Stephen Marshall Bret F. Randall Clinton E. Duke Erin T. Middleton Attorneys for plaintiff RiverRock Bioscience, LLC Plaintiffs Address: RiverRock Bioscience, LLC 1095 South 800 East Orem, UT 84097

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