Guidelines for Use

Guidelines for Use can be immediately obtained, and the proprietary formulation can be used royalty free for a period of one year from date of submission.

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By submitting this form I agree to the terms of the Licensing Agreement set forth below and represent that I have the power and authority to bind Facility to the Licensing Agreement.

Following submission you will receive an email with Guidelines on Use and Protocols.

I agree to the terms of the Licensing Agreement.

Thank you! This is a proprietary patented formulation. Use is limited to the Licensee.

Guidelines for Administration Follow:

Guidelines for Intravenous TNS (The Norberg Solution) Administration

TNS is a larger Albumin molecule (17%) created by the compounding of Human Serum Albumin and Hydrolyzed Amino Acid Solution (Travasol®) in a normal saline solution by the hospital Pharmacy.

The solution is a 5% albumin and 2% amino acid mixture in NS.

Administration: TNS is an albumin product and should follow rates of administration comparable to patterns of 5% albumin and fresh frozen plasma although No Faster than 300mL/Hr. Adult dosing at 50 g increments (most cost-effective) resulting in 330 ml of 5% albumin, 2% amino acids (TNS). Standard flush protocols for blood produces post administration should be followed. Do not use unless solution is clear of particulate matter or if the solution is turbid.

Adult & Pediatric Dosing: 15ml/Kg (order in 1000mL increments). Infuse at clinically determined rate, rapidly for shock or over longer time (2 hours) if for volume expansion, respiratory distress or treatment of hypoalbuminemia. Re-dose immediately for shock or low albumin and after 6-12 hours for respiratory distress and volume overload, as clinically indicated. Do not exceed 2 g of albumin per kg of body weight for the daily dose.

Use in Specific Populations: Pregnancy & Lactation: No human or animal data are available to indicate the presence or absence of drug-associated risk.

Contraindications: TNS is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Precautions: TNS is an albumin based product and has extremely low adverse reactions but rare allergic reactions, including anaphylactic reactions have been reported for albumin. Standard treatments for allergic reactions should be available. Discontinue administration immediately if a hypersensitive reaction is suspected.

Storage: TNS solution should be stored at a temperature not exceeding 30°C (86°F). Protect from freezing. TNS It should not be used after 72 hours.

Additional Information: TNS is administered as a specialty product for treatment of a specific problem for this patient and is a specially prescribed treatment by the attending physician.

No special consent forms are needed as consent is included in the general consent for treatment and administration of blood products.

Special monitoring is not required during administration except as indicated by clinical status of the patient, or per the standard protocol of institution administering similar blood products.

Standard procedures for handling and infusion of blood products should be utilized.

Standard procedures for reporting complications or adverse reaction should be followed.

LICENSING AGREEMENT.

(Royalty Free – Non-Exclusive – 1 year – COVID-19)

This Agreement is entered into by SYSTEMEDICAL, LLC, a Colorado Limited Liability Company and FACILITY (identified above and defined below) on the date as set forth above.

1. INVENTION. The Norberg Solution™ (“TNS”) is a patented invention USPTO Number: 7,696,176 BI, which is a composition of Human Serum Albumin and an Amino Acid Solution. The Patent extends to the method of making and method of use of TNS.

2. LICENSED PRODUCT. SYSTEMEDICAL, LLC, a Colorado Limited Liability Company, (“SYSTEMEDICAL”) has the exclusive rights to manufacture, distribute, sell, market, and sub-license TNS within the United States and its territories.

3. SUBLICENSE / RIGHT TO USE. In an effort to aid in the therapeutic treatment of COVID-19, SYSTEMEDICAL hereby grants a royalty-free, limited, non-exclusive, sub-license for the manufacture / compounding and use of TNS by FACILITY for the medical treatment of patients for a period of one (1) year from the date of execution this Agreement. Other than the normal use in the treatment of FACILITY’s patients and billing for such treatment, FACILITY shall not attempt to make, nor make any commercial use of TNS. Rights of use under this Agreement are NOT limited to the treatment of COVID-19 patients.

4. CONSIDERATION. In exchange for the rights granted under this Agreement, FACILITY agrees to: (1) Promptly collect and share anonymous patient data with SYSTEMEDICAL; and (2) That any modifications or improvements shall be reported to SYSTEMEDICAL and any such modifications shall be and become the sole and separate property of SYSTEMEDICAL.

a. DATA POINTS: FACILITY agrees to collect the following patient data: Patient demographics, primary diagnosis, patient weights, days on ventilator, pre and post Albumin levels, and fluid input / output. FACILITY is requested, but not obligated to track Heparanse levels.

b. MODIFICATIONS: FACILITY agrees to provide information to SYSTEMEDICAL regarding any alterations or modifications to the TNS formula or any alternate use of a combination of Human Serum Albumin and Amino Acid formulation.

5. NO TRANSFER OR ASSIGNMENT. FACILITY shall not assign nor attempt to assign any rights or obligations hereunder. The rights granted hereunder are personal to FACILITY. Nothing in this AGREEMENT shall be construed to grant by implication, estoppel, waiver or otherwise any rights of use of any other intellectual property of SYSTEMEDICAL.

6. LIMITED PUBLICITY WITHOUT CONSENT. FACILITY may submit for publication any articles, case reports, studies, and may share with other practitioners the use of TNS. However, FACILITY shall not provide and shall not disclose in any publication, case reports, or to other practitioners the specific formulation for TNS. FACILITY shall not issue any press release or make any public announcement, comment or statement concerning TNS without the prior written consent of SYSTEMEDICAL. “Public announcements” as set forth in this paragraph shall not include the dissemination of information to peer-reviewed journals, AMA practice sections, or other peer-based forums. Under no circumstances may FACILITY disclose the formulation for TNS without the prior written consent of SYSTEMEDICAL. In any such publication, FACILITY shall state that TNS is a proprietary patented formulation of SYSTEMEDICAL.

7. OWNERSHIP RIGHTS. Any alterations, modifications, or improvements to TNS, or formulations based on the composition of the ingredients of TNS, or arising from or relating to the use of TNS shall become the sole and separate property of SYSTEMEDICAL and SYSTEMEDICAL shall have the right to commercialize and otherwise seek intellectual property protection of such alterations or improvements the same as if SYSTEMEDICAL had created and developed said improvements or alterations. FACILITY shall not assert any right or claim to any said improvements, inventions, alterations or modifications and expressly disclaims any right, title or interest is said modifications. All intellectual property rights are, and shall remain, the sole property of SYSTEMEDICAL.

8. TERMINATION AND INJUNCTION. This Agreement may be terminated by either party with, or without cause, and such termination shall be effective immediately upon delivery of the notice of termination by email or US Mail at the address(es) below. Following termination, FACILITY shall have no continued rights of use of TNS and FACILITY agrees to discontinue all use of TNS and to return any proprietary or confidential information obtained from SYSTEMEDICAL to SYSTEMEDICAL. FACILITY acknowledges that the formulation of TNS is a special, irreplaceable asset of great value to SYSTEMEDICAL and that a breach, in any way, of any of FACILITY’S obligations under this Agreement would cause serious and irreparable harm to SYSTEMEDICAL which may not be adequately compensated for in damages. FACILITY consents to an injunction being issued against it without notice immediately restraining and enjoining FACILITY from any further use of TNS without the necessity of SYSTEMEDICAL demonstrating reasonable likelihood of success on the merits and without demonstrating irreparable harm to SYSTEMDICAL and without the necessity of SYSTEMEDICAL posting a bond.

9. LIMITATION OF LIABILITY. SYSTEMEDICAL IS PROVIDING RIGHTS OF USE TO FACILITY AS A COVID-19 COUNTERMEASURE UNDER THE “COVID 19-DECLARATION” BY THE SECRETARY OF HEALTH AND HUMAN SERVICES PURSUANT TO THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT 42 USC 247D-6D. FACILITY IS PERMITTED TO MAKE USE UNDER THIS AGREEMENT FOR NON COVID-19 THERAPEUTIC TREATEMENT. HOWEVER, SYSTEMEDICAL SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, STRICT LIABILITY OR UNDER ANY OTHER LEGAL THEORY RELATED TO TNS, ITS USE OR ADMINISTRATION, INCLUDING, BUT NOT LIMITED TO, ANY DAMAGES ARISING OUT OF ITS USE, OR MISUSE, TO THE FULLEST EXTENT PERMITTED BY LAW. TNS IS MADE AVAILABLE TO FACILITY WITHOUT ANY WARRANTY, EXPRESS OR IMPLIED. IN NO EVENT SHALL FACILITY NAME, SEEK TO HOLD ANY OF THE OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS OF SYSTEMEDICAL PERSONALLY LIABLE FOR ANY ACTS OR OMISSIONS ARISING FROM OR RELATING TO THE USE OF TNS OR THIS AGREEMENT. FACILITY SHALL INDEMNIFY, DEFEND, AND HOLD HARMLESS SYSTEMEDICAL AND IS OFFICERS, DIRECTORS, AND EMPLOYEES AND AGENTS FROM ANY CLAIMS, DEMANDS, SUITS, OR ACTIONS ARISING FROM OR RELATING TO THE USE OF TNS.

10. CLINICAL OUTCOMES. FACILITY agrees to reasonably cooperate with SYSTEMEDICAL’s requests for information and reporting regarding use, with all protected healthcare information removed or redacted.

11. CHOICE OF LAW. This AGREEMENT shall be construed, interpreted and governed by and in accordance with the laws of the state of Colorado, without reference to conflicts of law principles, except where federal laws of the United States are applicable and have precedence. Venue for any proceeding shall be the state or federal courts of Colorado in Denver, Colorado.

12. FACILITY. “FACILITY” as defined herein shall mean, and the rights granted under this Agreement shall include and extend to all physicians, nurses, pharmacists, employees, agents and staff operating through FACILITY or with privileges under the practice group or hospital system of FACILITY. Such rights are granted on the express condition and based on the express agreement that FACILITY will reasonably police and will comply with the terms of this Agreement and ensure compliance by all employees, agents, contractors, affiliates, practice groups, and others operating with privileges under the practice group or hospital system of FACILITY. This Agreement shall be executed by the Medical Director, Pharmacist in Charge, or other administrator with the power and authority to bind FACILITY.

13. USE. FACILITY shall reasonably ensure that decisions regarding use and administration of TNS are made by physicians or other authorized medical personnel according to the laws of the applicable jurisdiction.

14. NOTICE. Any notice or other communication required by this Agreement shall be in writing and sent by first class U.S. Mail, postage prepaid, and shall be deemed delivered within five (5) days if sent to the following addresses or to such other address as such party shall designate by written notice to the other party, alternatively such notice may be sent by email read-receipt requested to SYSTEMEDICAL at contact information listed on www.sysmedco.com.