Exhibit 10.1
LICENSE AGREEMENT
This Agreement is effective as of the 28th day
of September, 2009 (the “Effective Date”) by and
between Bio Holding, Inc., a corporation organized and existing
under the laws of the State of North Carolina and having a business
address at 1302 Nash Street N, Wilson, North Carolina 27893-2364
(“BIO HOLDING”) 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 400, Greenwood Village, Colorado 80111
(“OMNI”).
Whereas BIO HOLDING owns various proprietary and
intellectual property rights including those pertaining to
treatment of various clinical conditions such as, but not limited
to, diabetes in respect to which it is prepared to grant the
licenses provided for herein to OMNI; and
Whereas OMNI wishes to acquire licenses under
and to obtain access to BIO HOLDING’s proprietary and
intellectual property rights for treatment of diabetes;
Now therefore, in consideration of the mutual
covenants contained herein and for other good and valuable
consideration, the adequacy and receipt of which is hereby
acknowledged, the parties agree to the following terms and
conditions.
ARTICLE I
GENERAL DEFINITIONS AND
RELATIONSHIPS AMONG DEFINITIONS
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“AGREEMENT” means this document, its
attachments, all addenda, schedules, exhibits, appendices, and any
amendments to the foregoing.
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“CONFIDENTIAL INFORMATION” means any
and all information which is disclosed by either party to the other
verbally, electronically, visually, or in a written or other
tangible form which is either identified or should be reasonably
understood to be confidential or proprietary. CONFIDENTIAL
INFORMATION includes, but is not limited to, the specific terms
and/or conditions of this AGREEMENT, trade secrets, ideas,
processes, formulas, programs, software, source of supply,
technology, discoveries, developments, inventions, techniques,
marketing plans, strategies, forecasts, unpublished financial
statements, prices, costs, and customer lists.
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“TERRITORY” means
worldwide.
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“EXCLUDED
FIELD OF USE” means any purposes other than treatment that is
related directly to treatment of diabetes. EXCLUDED
FIELD OF USE includes treatments of any clinical conditions that is
not directly related to diabetes such as, but not limited to,
treatment of any complications or secondary clinical conditions
associated with diabetes, other than those uses which may be
complications or secondary clinical conditions that were previously
licensed to Omni by agreements between the Regents of University of
Colorado and APRO Pharmaceutical or MaxCure (now
“OMNI”) relating to Executed License Agreements
(attached as Exhibit A) hereinafter referred to as
“OMNI’s Secondary Clinical
Conditions.”
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“FIELD OF
USE” means solely for treatment of diabetes. FIELD
OF USE does not include treatment of any complications or secondary
clinical conditions related to diabetes, other than
OMNI’s Secondary Clinical Conditions.
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“GROSS
REVENUE” means the total gross revenue derived by OMNI
related to selling or use of LICENSED PRODUCTS in the FIELD OF USE
and the total gross revenue derived by OMNI by sub-licensing the
LICENSED TECHNOLOGY in the FIELD OF USE within the TERRITORY in an
arm’s length transaction. A LICENSED PRODUCTS
and/or LICENSED TECHNOLOGY shall be considered sold hereunder when
invoiced or, if not invoiced, when performed, when paid for, or
when a sub-license is executed. Where LICENSED PRODUCTS
and/or LICENSED TECHNOLOGY are not sold, but are otherwise disposed
of, the GROSS REVENUE of such LICENSED PRODUCTS and/or LICENSED
TECHNOLOGY for the purposes of computing royalties shall be the
selling price at which products of similar kind and quality, sold
in similar quantities, are currently being offered for sale by OMNI
or the sub-licensing price at which technologies of similar nature
and scope are currently being offered for sub-licensing by OMNI or
those within the pharmaceutical industry. Where such
LICENSED PRODUCTS are not currently offered for sale by OMNI, the
GROSS REVENUE of such LICENSED PRODUCTS for the purposes of
computing royalties shall be the average selling price at which
products of similar kind and quality, sold in similar quantities,
are currently being sold or offered for sale by
others. Where such LICENSED TECHNOLOGY is not currently
offered for sub-licensing by OMNI, the GROSS REVENUE of such
LICENSED TECHNOLOGY for the purposes of computing royalties shall
be the average sub-licensing price at which technology of similar
kind are currently being licensed or offered for license by
others.
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“TERM” means the last expiration
date of the LICENSED PATENTS, except as otherwise provided in
Article VI.
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BIO HOLDING and
OMNI are hereunder commonly referred to as “Parties”
(in singular and plural usage, as required by the
context).
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“LICENSED
PATENT(S)” means valid U.S. and any corresponding foreign
patents and patent applications listed in Exhibit “B”
attached to this AGREEMENT as well as all future valid patents and
patent applications which are developed or generated by BIO HOLDING
that are directed to FIELD OF USE. As used herein, the
term “valid patent” refers to issued patents which have
not been subject to a decision by a court of competent jurisdiction
declaring such patent invalid and from which no appeal has been
taken.
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“BIO
HOLDING Technology” shall mean all Technology now or
hereafter owned by, legally in the possession of, or developed by
BIO HOLDING, which BIO HOLDING has the right to license, including,
but not necessarily limited to, the LICENSED PATENTS, all know-how;
trade secrets; inventions (conceived of or reduced to practice,
whether patented or not); developments; all foreign and domestic
patents and patent applications; and improvements and
modifications; including, without limitations, methods, processes;
compositions; formulations; characterization information;
engineering, design and production information; and product
compositions.
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“LICENSED
TECHNOLOGY” shall mean BIO HOLDING Technology that relate
directly to FIELD OF USE.
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“LICENSED
PRODUCTS” shall mean a treatment of a patient with AAT or AAT
derivative or any material, compositions, or other matter which is
the subject of the LICENSED PATENT.
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“LICENSE” shall mean the exclusive
license granted by BIO HOLDING to OMNI, as described in Article
II.
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ARTICLE II
GRANT TO OMNI
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Grant . Subject to the terms and conditions
of this AGREEMENT, BIO HOLDING hereby grants and agrees to grant to
OMNI, during the TERM of this AGREEMENT, an exclusive,
non-assignable, LICENSE under the LICENSED PATENTS (i) to practice,
perform, make, have made, use, sell, import, and offer to sell
LICENSED PRODUCTS solely for the FIELD OF USE within the TERRITORY;
and (ii) to sub-license the LICENSED TECHNOLOGY to a third party
(with prior written approval by BIO HOLDING, which will not be
unreasonably withheld) solely for the FIELD OF USE within the
TERRITORY.
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No Rights to
Transfer License . The rights and licenses granted by
BIO HOLDING in this AGREEMENT are personal to OMNI. OMNI
shall not assign or otherwise transfer any license or right granted
hereunder or any interest therein, without the prior written
consent of BIO HOLDING (which may be withheld in BIO
HOLDING’s sole and absolute discretion). Any
attempted assignment or transfer without such prior written consent
shall be void and shall automatically terminate all rights of OMNI
under this AGREEMENT.
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Sublicensing . Upon prior written approval by BIO
HOLDING, such approval not to be unreasonably withheld, OMNI may
sublicense to one or more third parties, the rights granted in
Section 2.1 subject to the following limitations:
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OMNI agrees
that any sublicenses granted by it shall impose restrictions and
conditions upon sublicensees equivalent in scope to those imposed
upon OMNI;
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OMNI agrees
that, in the event BIO HOLDING terminates this Agreement pursuant
to section 6.2 or 6.3, any sublicenses granted, in BIO HOLDING's
sole discretion, shall be directly enforceable by BIO
HOLDING;
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OMNI agrees
that any sublicenses granted shall adequately protect BIO HOLDING's
security and property interest in BIO HOLDING's Intellectual
Property Rights; and
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Any sublicenses
granted by OMNI shall provide only for cash consideration from
sublicensees unless BIO HOLDING has expressly consented otherwise
in writing in advance. Any sublicenses made in
other than arm’s-length transactions, the value of the
transaction attributed under this Section 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.
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For purposes of
this Agreement, the term “sublicense” shall mean the
license by OMNI to a third party of all or a portion of the
LICENSED TECHNOLOGY licensed to it by BIO HOLDING hereunder in
consideration of payments from such sublicensee to OMNI, and shall
not include OMNI’s engagement of or joint venture with
subcontractors to perform various services for OMNI in connection
with its development of the LICENSED PRODUCTS and LICENSED
TECHNOLOGY, including, but not limited to, laboratory work,
pre-clinical and clinical testing, assistance with the regulatory
approval process, manufacturing, marketing and other similar
product development services provided that such services are for
the sole benefit of OMNI and such third party does not have any
independent rights to use LICENSED TECHNOLOGY. OMNI
agrees to assume all obligations for protecting the BIO
HOLDING’s Intellectual Property rights in any such joint
venture work consistent with the terms of this
Agreement.
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Copy of
Sublicense . OMNI agrees to forward to BIO
HOLDING a copy of each fully executed sublicense agreement
postmarked within thirty (30) days of the execution of such
agreement.
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ARTICLE III
REPORTS AND
CONSIDERATION
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License
Fees . As
partial consideration for the licenses granted by this AGREEMENT,
OMNI shall pay BIO HOLDING twenty-five thou
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