MATERIAL TRANSFER AGREEMENT

This Material Transfer Agreement (the “Agreement”) is made March 19, 2010 (the “Effective Date”) by and between Baxter Healthcare Corporation, a Delaware corporation with an office at One Baxter Way, Westlake Village, California 91362 and its Affiliates (“Baxter”), and Omni Bio Pharmaceutical, Inc., a corporation organized and existing under the laws of the State of Colorado, and having a business address at 5350 South Roslyn Street, Suite 430, Greenwood Village, Colorado 80111 (“OMNI”).

WHEREAS, Baxter makes and sells an alpha-1 antitrypsin product, Aralast NPTM; and

WHEREAS, OMNI desires to use Aralast NPTM in the Treatment of Patients with Type 1 Diabetes as set forth in Exhibit A and incorporated herein, (the “Evaluation”), to be conducted by Dr’s.Peter Gottlieb and Leland Shapiro at the Barbara Davis Center (“Investigators”),  OMNI is the sponsor of this Evaluation; and

WHEREAS, Baxter is willing to provide at no cost 1.25 kg of Aralast NPTM with a commercial value of Four Hundred Twenty Thousand Dollars ($420,000) to OMNI for the conduct of the Evaluation, in accordance with the terms and conditions contained herein; and

WHEREAS, if the Evaluation is successful, the Parties may desire to enter into further business discussions;

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby mutually acknowledged, the parties agree as follows:

1.

Definitions.

(a)           “Affiliate” shall mean any entity that controls or is controlled by such Party, or is under common control with such Party.  An entity shall be deemed to control another entity if (i) it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable ownership interest for an entity other than a corporation) or (ii) it possesses the power to direct or cause the direction of the management and policies of an entity.

 

(b)           “Background Intellectual Property” shall mean Intellectual Property in existence and owned or licensed by a Party as of the Effective Date.

 

(c)            “OMNI Technology” shall mean OMNI owned or licensed Intellectual Property relating to the treatment and/or prevention of human disease using alpha-1-antitrypsin, alpha-1 antitrypsin analogs, agents with alpha-1 antitrypsin activity, alpha-1 antitrypsin derived peptides and other alpha-1 antitrypsin derivatives, including, but not limited to, potentially sub licensable licensed Intellectual Property from the University of Colorado and/or Bio Holdings, Inc.

 

(e)           “Intellectual Property” shall mean any information, ideas, concepts, discoveries, inventions, developments, know-how, trade secrets, techniques, methodologies, modifications, innovations, improvements, writings, documentation, data, know-how, material, composition of matter, method, process, product, biological material or other tangible or intangible property, regardless of whether such property is patentable or not, or regardless of whether such property is protectable through trademark or copyright, including without limitation, any foreign or domestic (i) patent right together with any extension, registration, reissue, reexamination or renewal thereof, and any pending application, including any continuation, divisional, or continuation-in-part thereof for any of the foregoing; (ii) trademark; or (iii) copyright.

 

(f)           “Parties” shall mean OMNI and Baxter, and “Party” shall mean either of them, as the context dictates.

 

(g)           “Representatives” shall mean a Party’s employees, officers, directors, agents, Affiliates, consultants, contractors, professional advisors or other authorized representatives.

 

(h)           “Adverse Event” shall mean any expected or unexpected untoward experience associated with the use of a medical drug in an Evaluation subject (see also Section 5(b)-5(e)).

 

(j)           “Internal Use” shall mean analysis of Evaluation Data used by Baxter in accordance with the terms and conditions of this Agreement.

2.

Confidential Information.

(a)           Definitions and Obligations.  Both Parties will treat information marked or designated as ‘confidential’ as “Confidential Information” and shall not disclose such information to any third party, other than required government officials, the Investigators and employees of either Party who have a need to know such information and who are under similar obligations of confidentiality, for a period of five (5) years from the conclusion of the Study or termination date of this Agreement. Confidential Information shall expressly include all Intellectual Property related to this Agreement The obligations of this section do not apply to:

(i)           Information, which is in the public domain or comes into the public domain through no fault of either party;

(ii)           Information learned by OMNI or Baxter from a third party not subject to a duty to either party to not disclose such information;

(iii)           Information already known to the Party before receipt from the other Party, as shown by the Party’s prior written records; and

(iv)           Information, which either Party is required by law to disclose, provided that, in any such event, the other Party shall provide the Party having to make a disclosure with prior written notice and a reasonable opportunity to seek a protective order and OMNI shall furnish only that portion of the Confidential Information that its counsel advises is required to be disclosed by law.

3.

Scope of Work

(a)           The Evaluation will be conducted under either a waiver to an Investigational New Drug Application or an Investigational New Drug Application (“IND”) filed with the United States Food and Drug Administration (“FDA”) by the OMNI.  It will be the responsibility of OMNI to maintain the IND and comply with all reporting and other obligations associated with the IND.

(b)           OMNI represents and warrants that should it enter into any other agreements (i.e.  site agreements, contractors) pertaining to the performance of the Evaluation, the terms of those agreements shall not conflict with the terms of this Agreement.

4.

Quality and Transport of Materials.

(a)           Quality and Safety Information of Aralast NPTM.  Baxter shall provide the Investigators with information reasonably necessary, and known to Baxter for the Investigators to safely handle, store and use the Aralast NPTM in accordance with all applicable laws, rules and regulations, including any available Material Safety Data Sheets for the Aralast NPTM.

(b)           Shipping of Aralast NPTM.  Materials shall be shipped to the Barbara Davis Center attention to the Investigators, under appropriate standards and in compliance with applicable laws and regulations, upon receipt of written confirmation of execution of the Clinical Trial Agreement with the University of Colorado Denver Anschutz Medical Campus and the Barbara Davis Center for Childhood Diabetes.  Baxter shall obtain all necessary regulatory approvals required for the transportation and/or shipment of Materials.

5.

Materials.

(a)           Baxter agrees to provide the Investigators with 1.25 kg of Aralast NPTM and any reagents that may be required in order to conduct the Evaluation as well as such sufficient and comprehensive data concerning Materials storage and safety requirements.    At no time shall any Materials be used for any purpose other than as described in Exhibit A. The Investigators shall hold, store and transport the 1.25 kg of Aralast NPTM in compliance with all applicable federal, state, and local laws and regu lations Baxter will endeavor to supply the Materials as one lot or a few lots as is reasonably possible in order to maintain continuity in the product as administered to the Participants throughout the Evaluation period.

(a)           OMNI shall notify Baxter when OMNI intends to publish any information related to this Agreement or issue a press release relative thereto or regarding any aspect of this Agreement.  OMNI and Baxter agree to abide by all necessary laws regarding publication of material information, for example, laws governed by the SEC.

(a)           Any dispute, claim or controversy arising out of or relating to this Agreement or the breach, termination, enforcement, interpretation or validity thereof, including the determination of the scope or applicability for this agreement to arbitrate, shall be determined by arbitration in Illinois before three arbitrators, and in the English language.  The arbitration shall be administered by the International Institute for Conflict Prevention & Resolution (CPR) pursuant to its Arbitration Rules and Procedures.  Discovery shall be limited to that expressly authorized by the arbitrators upon a showing of substantial need, and the party requesting discovery shall bear the costs and/or fees relating to the discovery.  The award, reached as a result of the arbitration, shall not include punitive damages or damages in excess of compensatory damages and shall be final and binding.  Either party may seek to confirm and enforce any final award entered in arbitration in any court of competent jurisdiction.  This arbitration provision, and the arbitration itself, shall be governed by the Laws of Illinois and the Federal Arbitration Act, 9 U.S.C. §§ 1-16.

At the beginning of the screening visit, participants will be given a written consent form by qualified study personnel (the study coordinator and/or investigator or other designee). The personnel will understand the research study, will complete any necessary courses required by their Institutional Review Board prior to implementing the consent process. Personnel at the Barbara Davis center will complete COMIRB 101 as directed by institutional requirements. The consent process will occur in a quiet setting, and the participant will be given time to review the written consent form and ask questions prior to the initiation of study procedures. The Informed Consent Form for this clinical study will be reviewed with patients (and their guardian in the case of adolescent patients) prior to performing any study-related assessments. As king the participant to explain the study in his/her own words will assess the patient’s understanding and autonomy.  A translator will be utilized with non-English speaking patients.  If three or more patients are consented that speak a language other than English, then the consent form will be translated to their native language and submitted to the IRB for approval.  Following consent explanation, qualified personnel as listed above will obtain written consent prior to the initiation of study procedures. The consent form requests consent for each time the individual has blood drawn for these studies, and it notifies the participant that samples will be kept for future work.   The participant will be given a signed copy of the written consent form and assent form.

 

An assent form has also been developed for participants aged 6-17.  Those within that age range will be given the consent and assent forms and will have the opportunity to discuss the study apart from their parent(s) or guardian(s).  This will allow these individuals to ask questions they might not have felt comfortable asking previously.  In addition, the parent(s) or guardian(s) will be given the opportunity to discuss the study apart from the child or adolescent.  Individuals in this age group will be re-consented at the first visit they attend after their eighteenth birthday.  They can also choose to change their decision regarding stored samples, if desired.

 

 

 

 

PHI for this study, as stated in the HIPAA Authorization will be available to Dr. Leland Shapiro, MD, Dr. Peter Gottlieb, MD and study staff members of the University of Colorado Denver.  The Authorization will also allow the release of at least a portion of this information to the following groups for the listed purpose:

All subjects enrolled in this study will undergo intensive management of their diabetes.  The goal of management will be HbA1c levels within the currently recommended American Diabetes Association age specific target range in the absence of significant hypoglycemia or diabetic ketoacidosis.  Subjects will be expected to take a sufficient number of daily insulin shots to meet this goal.  Alternatively, subjects may use insulin pump therapy.  Subjects will also be expected to check blood sugar levels at least 4 times a day.  A Diabetes Management Team will be working with the subjects to achieve these goals.  A member of the diabetes management team may contact the subject’s primary diabetes treating physician about possible adjustments in insulin regimen, referral to a dietician, or other approaches that would improve glucose control if necessary.  Participants who fail to achieve glucose control within the ADA goals will not be excluded from the study, but additional measures will be instituted to improve glucose control.

A continuous glucose monitoring (CGM) device will be used to measure more accurately hyperglycemic and hypoglycemic episodes and to examine the effect of AAT on the variability of blood glucose levels. CGM will be performed for a target of seven days at each designated time point. The exact time will depend upon the time the subcutaneous sensor remains inserted. The study’s CGM monitoring outputs will be blinded to the subjects.

CGM outputs will be reviewed for adequacy of information capture; in the event of an inadequate tracing, the CGM session will be repeated.  The screening CGM measurement should be obtained prior to study drug dosing.

This procedure will be done during screening and at months 3, 6, 12, 18, and 24.  This test monitors how much insulin the beta cells are making.  Participants will be given specific instructions on insulin dosing and diet for 3 days prior to the MMTT.  On the morning of the test, participants may only drink water and will take no short acting insulin within 2 hours of the test.  An IV will be placed and blood will be drawn from it.  The participant will drink “Boost High Protein Nutritional Energy Drink” in 5 minutes.  Blood will be drawn from the IV 11 times over the next 4 hours.  The amount of blood taken for this test will be about 3 tablespoons (17 ml).  This is in addition to the volume of blood taken for the other tests at the visits.  Blood sugar will be adjusted as necessary after these samples are taken.