|
EXHIBIT
10.32
TECHNOLOGY LICENSE
AGREEMENT
BETWEEN
SHRINERS HOSPITALS FOR
CHILDREN
and
UNIVERSITY OF SOUTH
FLORIDA RESEARCH FOUNDATION
As
Licensors
AND
MIMEDX,
INC.
As Licensee
This Technology
License Agreement (this “License Agreement”) is made
effective as of the 29th day of January, 2007 (the “Effective
Date”), by and between SHRINERS HOSPITALS FOR CHILDREN, a
Florida corporation and UNIVERSITY OF SOUTH FLORIDA RESEARCH
FOUNDATION, INC., a corporation not for profit under Chapter 607
Florida Statutes, and a direct support organization of the
University of South Florida (“University”) pursuant to
section 1004.28 Florida Statutes (hereinafter referred to as
“RESEARCH FOUNDATION”) (jointly and severally,
“Licensor”), and MIMEDX, INC, a Florida corporation
(the “Licensee”).
RECITALS:
A. Licensor owns or
has rights in and to certain technology, including the
nordihydroguaratic acid and/or polymer-enhanced collagen processes,
compositions and products and/or other biocompatible materials and
devices arising from research and work performed or directed by, or
with help from, Dr. Thomas Koob (“Dr. Koob”) or
his laboratory while he was affiliated with Licensor, as will be
further defined below in the definition of “Licensed.
Technology.”
B. Licensor desires
to grant Licensee, and Licensee desires to receive from Licensor,
an. exclusive perpetual worldwide license to the Licensed
Technology to manufacture, have manufactured, market, use, offer to
sell and sell, Licensed Products pursuant to the terms and
conditions herein set forth.
Section 1.
Definitions .
1.1
“Affiliate” means, with respect to any Person, a Person
who controls, is controlled by, or is under common control with,
such Person. For purposes of the definition of
“Affiliate,” control means the ability to vote or
control the vote of more than 50% of the voting securities of such
Person.
1.2
“Background Technology” means all inventions,
innovations, trade secrets, patents, patent applications. Know How,
materials and other Intellectual Property that is now as of the
Effective Date of this Agreement, owned or co-owned by Licensor or
that Licensor licensed or otherwise has any rights directly related
to the Patents or development of products or processes utilizing or
related to the Licensed Technology. A list of Background Technology
is attached as Schedule 5.2.
1.3
“Confidential Information” means all confidential
information comprised in relating to or arising out of, the
Background Technology, Know-How, Improvements, or other
intellectual Property, that is proprietary to Licensor or licensed
to Licensor by any Person and that is not generally known to the
public.
1.4 “Cure
Period” has the meaning set forth in
Section 4.2.
1.5
“Effective Date” means the effective date of this
License Agreement, as set out above.
1.6
“FDA” means the United States Food and Drug
Administration.
1.7
“Improvements” means any enhancements, additions,
modifications, supplements or improvements to processes or products
including all or any of the Licensed Technology, which are:
(1) presently in development or hereafter developed by either
Licensor; (2) which are not subject to any contrary funding
restriction; and (3) which are made by any person employed by
Licensor who is identified as an inventor or reporting to an
inventor or subordinate to an inventor under patents existing or
arising from Sections 1.12 b, e, d, and e of the Licensed
Technology which invention is dominated by any claim under patents
existing or arising from Sections 1.12 b, e, d, and e of the
Licensed Technology such that it cannot be practiced without
infringing on a valid claim in the Licensed Technology.
1.8
“Intellectual Property” means any and all of the
following: inventions, innovations, discoveries, patents and
utility models and applications therefore existing now and all
reissues, divisions, re-examinations, renewals, extensions;
provisionals, continuations and continuations-in-part thereof and
equivalent or similar rights anywhere in the world in the existing
inventions and discoveries. Intellectual Property shall also
include all Background Technology, Know-How, Improvements,
Confidential Information, all copyrights, copyright registrations
and applications therefore and all other rights corresponding
thereto throughout the world, and all other intellectual property
and proprietary rights whatsoever, pertaining to any of them,
whether patentable or nonpatentable. Intellectual Property includes
all documentation, engineering, scientific and practical
information and formulas, Models, prototypes, research data,
design, and manufacturing procedures, techniques, raw material
data, specifications and expertise, in any such use, now or
hereafter existing and related directly to, the foregoing made by
any person employed by Licensor who is identified as an inventor or
reporting to an inventor or subordinate to an inventor under the
patents existing or arising from Sections:1.12 h, c, d, and c of
the Licensed Technology which is dominated by any claim under
patents existing or arising from Sections 1.12 b, c, d, and e of
the Licensed Technology such that it cannot be practiced without
infringing on a valid claim in the Licensed Technology Any required
technology transfer of Intellectual Property including Patents,
Background, Know How, Improvements and
- 2 -
Confidential Information
shall be at the additional expense of the Licensee. Notwithstanding
the foregoing, Intellectual Property expressly excludes new
patentable or copyrightable inventions arising after the Effective
Date of the License Agreement not included within the definition of
Improvements.
1.9
“Know-How” means technical and other information or
knowledge made by any person employed by Licensor who is identified
as an inventor or reporting to an inventor or subordinate to an
inventor under the patents existing or arising from Sections 1.12
b, c, d, and a of the Licensed Technology, which Know-How is
dominated by any claim under the patents existing or arising from
Sections 1.12 b, c, d, and e of the Licensed Technology such that
it cannot be practiced without infringing on a valid claim in the
Licensed Technology, and which Know-How is created prior to or
after the Effective Date of this Agreement which is not in the
public domain including all trade secrets, information and
knowledge comprising or relating to concepts, non patentable
discoveries, data, designs, formulae, methods, models, assays,
research plans, procedures, designs for experiments and tests and
results of experimentation and testing (including results of
research or development) processes (including manufacturing
processes, specifications and techniques), laboratory records,
chemical, clinical, analytical and quality data, trial data, case
report forms, data analyses, reports, manufacturing data, or
summaries and information contained in submissions to and
information from regulatory authorities, and includes any rights
including copyright, database or design rights protecting any of
the foregoing. The fact that an item is known to the public shall
not be taken to exclude the possibility that a compilation
including the item, or a development relating to the item, is or
remains not known to the public. Notwithstanding the foregoing,
Know-How expressly excludes new patentable or copyrightable
inventions arising after the Effective Date of the License
Agreement not included within the definition of
Improvements.
1.10 “License
Agreement” means this Technology License Agreement, as may be
amended from time to time.
1.11
“Licensed Product” means any medical device or product
that is covered by or made by a process covered by a valid claim in
an unexpired enforceable Patent in the Intellectual Property. If a
Licensed Product is covered by at least one claim in a pending
published patent application at a time of commercial sale, and that
claim subsequently issues in a Patent substantially as published
such that it is subject to provisional royalties under 35 U.S.C.
154(d), then, except that no double royalty shall be due if the
Licensed Product is covered by more than one Patent, royalties that
would have been due had the pending application been an issued
Patent, shall be due retroactively at issuance.
1.12
“Licensed Technology” means, individually and
collectively, the Intellectual Property, as defined above, relating
to any of the items listed below:
(a) all
existing patent applications and patents associated with technology
related to nordihydroguaratic acid (“NDGA”) coatings,
devices, scaffolds, substrates, or other materials and/or polymer
treated collagen material for medical devices, implants, prosthesis
and/or constructs and methods for making same;
- 3 -
(b) U.S.
Patent Nos. 6,565,960 and 6,821,530, including any
reexaminations, reissues and extensions thereof;
(c) U.S.
Provisional Application Serial No 60/805,494, filed 6/22/06,
entitled NDGA-REINFORCED COLLAGEN SCAFFOLD, co-owned with the
University of South Florida;
(d) The
following existing Records of Medical Inventions submitted to
Licensor naming Dr. Koob as an inventor or a PI (Principle
Investigator):
(1)
Bioprosthesis for Replacement or Augmentation of Tendons and
Ligaments;
(2)
Biocompatible Drug Delivery Vehicle Composed of NIXIA Polymerized
Collagen Fibers, related to the provisional identified under
(c) above;
(3)
Manufacturing Method for high strength NDGA polymerized collagen
fibers as also described in Provisional Application Serial No
60/883A08, tiled 1/4/07;
(4) Extension
of “Manufacturing method for high strength NDGA polymerized
collagen fillers” (Shriners Ref No MR 0616, MR - 0479)) as
also described in U.S. Provisional Application Serial
No. 60/883,408, filed 1/4/07;
(5) Braided
NDGA-collagen ribbons for ligament repair (Shriners Ref
No. MR-0674) as also described in U.S. Provisional Application
Serial No. 60/882,065, filed 12/27/06; and
(6) BioRivets
of NDGA-collagen fibers (Shriners Ref No. MR-0675);
(e) Corneal
replacement technology, which is the subject of a grant application
under review by the National Institute of Health
(“NW”), which lists Dr. Koob as a Co-Principal
Investigator for which the University of South Florida
(“USF”) has filed a U.S. Provisional. Application
Serial No. 60/767,234 on 3/13/06, with Thomas 3. Koob, Ph.D,
(“Dr. Koob”) as a co-inventor;
(f) all other
Intellectual Property, including without limitation, Background
Technology, Know-How, and Improvements relating to any of the
foregoing; and
(g) all
future U.S. and foreign patent applications filed for and/or
patents issuing for any of the above.
1.13
“Licensee Indemnitees” has the meaning set forth in
Section 6.1.
1.14
“Licensor Indemnitees” has the meaning set forth in
Section 6.2.
1.15
“Losses” has the meaning set forth in
Section 6.1.
- 4 -
1.16 “Net
Sales” means the gross revenue actually received for the sale
of licensed Products by Licensee and its sublicensees during a
relevant period of time; excluding (i) sales, use occupation
or excise tax directly imposed and with reference to particular
sales, (ii) duties or other governmental charges directly
imposed and with reference to particular sales, (iii) prepaid
or allowed freight (to the extent included in the amount billed the
third party customer), postage, duty or insurance included therein,
(iv) returns, discounts, rebates, and discounts actually
allowed, refunds, credits or repayments due to rejections, defects
or returns, and net of amounts previously included in Net Sales
that were written-off during such period as collectible. Licensor
is due one royalty as defined in this License Agreement on the
sales of the same Licensed Products whether paid directly by the
Licensee or by a sublicensee. No deductions shall be made for
commissions paid to individuals whether they are with independent
sales agencies or regularly employed by LICENSEE and on its
payroll, or for cost of collections. If the Licensed Product., is
commercially used by, sold or leased to any Person for a
consideration other than money, Net Sales shall be the gross
selling price of comparable Licensed Products sold in arm’s
length transactions by Licensee or, if no sales or leases of
comparable Licensed Products have been made, then the fair market
value thereof except that this latter provision shall apply only to
commercial use and shall not apply to Licensed Products
transferred, conveyed or otherwise used by third parties for
research, development and/or clinical trials performed on behalf of
or for Licensee. Licenses or assignments hereof to an Affiliate of
Licensee who is not an end user shall not be included in Net
Sales.
1.17 “New
Patent(s)” means any patent(s) issuing from patent
applications filed after the Effective date of this License
Agreement for any of the record of invention disclosures and/or
provisional applications enumerated in the definition of
“Licensed Technology” or any Improvements developed by
or for Licensor whether wholly or partially owned by Licensor or
co-owned with Licensee. The Parties shall fully cooperate with each
other with regard to such application and prosecution of the New
Patents. The term “Co-owned Patent” means a patent(s)
owned by and/or assigned to either or both of the University of
South Florida and the Licensor and Licensee (or a successor in
interest of any of them) based on the laws of inventorship and
ownership.
1.18
“Parties” means Licensor and Licensee, and
“Party” means either one of them.
1.19
“Patent” or “Patents” means, individually,
in combination, or collectively, as the ease may be: (a) U.S.
Patent Nos. 6,565,960 and 6,821, 530; (b) any future
patent claiming priority to one or more of the pending applications
listed at 1,12, including:
(a) Method of
Manufacturing High-Strength NDGA Collagen Fibers, 60/883,408, filed
1/4/07;
(b) Braided
NDGA-Collagen Fibers, 60/882,065, filed 12/27/06;
(c) NDGA
Reinforced Collagen Scaffold, 601805,495 filed 6/22/06;
and
(d) Corneal
Replacement, 60/767,234 files 3/13106;
(c) any future patent
issuing claiming subject matter described in any record of
invention listed at 1.12; and (d) any other New
Patent.
- 5 -
1.20
“Person” means an individual, partnership, corporation,
business trust, limited liability company, limited liability
partnership, joint stock company, trust, unincorporated
association, joint venture or other entity or a government
agency,
1.21
“Rules” has the meaning set forth in
Section 8.6.
1.22 “Third
Party” means any Person, firm or entity other than the
Parties.
Section 2.
Licenses .
2.1 Licensor hereby
grants to Licensee an exclusive, perpetual as to Know How except as
terminable under Section 4.2 below and terminable as to
Patents as stated in Section 4.1 below, and fully-paid, except
with respect to sublicenses and royalties and any other conditions
of this License Agreement, license, with unlimited right to
sublicense, in and to the Licensed Technology: (i) to practice
and use the Licensed. Technology anywhere in the world;
(ii) to use manufacture, have manufactured, market, offer for
sale and sell Licensed Products anywhere in the world; and
(iii) to export from and import into the United States,
Licensed Products (the “License”), The License hereby
granted covers all applications, uses, activities, products,
devices and processes whatsoever without limitation. This License
shall automatically apply to any future patent applications,
patents, divisions, reissues, provisionals, continuations,
continuations-in-part, renewals and extensions thereof by Licensor
in the United States and elsewhere that are included in the
Licensed Technology. Licensor reserves for itself, The University
of South Florida, and the inventors the right to practice under the
Licensed Technology for noncommercial research and education
purposes, including research for non-profit or governmental
sponsors. Except as provided in the preceding sentence, Licensor
shall not itself, nor shall it directly or indirectly assist or
consent to any Third Party, to manufacture, have manufactured,
market, offer for sale or sell Licensed Products or otherwise
practice and use the Licensed. Technology in any commercial manner
anywhere in the world, and Licensor shall (to the extent known to
Licensor and within Licensor’s control) expressly prohibit
any Third Party from so doing, unless and only to the extent that
such Third Party purchases such Licensed Products from Licensee for
the express purposes of so doing.
2.2 Licensor shall
disclose to Licensee on a continuing and regular basis (but no less
frequently than semiannually), all Know-How and Improvements in the
Licensed Technology developed or acquired by or for Licensor after
the Effective Date.
Section 3.
Consideration . In consideration of the License and other
rights granted hereby, Licensee shall pay or provide Licensor the
following:
3.1 License
Fee . Licensee has prior to the Effective Date paid to Licensor
an upfront, one-time license fee of $100,000, receipt of all of
which is hereby acknowledged by licensor.
3.2 Milestone
Payment . Within thirty (30) days after the receipt by
Licensee of the approval of the FDA allowing the sale of the first
Licensed Product, Licensee will pay to Licensor a one-time
milestone payment of $200,000, by check or wire transfer of
immediately available funds to an account designated by Licensor in
writing.
- 6 -
3.3 Equity
Interest . Upon the execution and delivery of this: License
Agreement, Licensee shall issue to Licensor such number of shares
of common stock of Licensee constituting eight percent (8%) of
the issued and outstanding equity interest in Licensee, pursuant to
a subscription agreement to be executed and delivered by Licensor
to Licensee. The subscription agreement shall provide, among other
things, that Licensor’s percentage interest in Licensee shall
not be diluted prior to such time as Licensee has raised $5,000,000
in equity capital. Thereafter, Licensor’s equity interest
shall be subject to proportional dilution.
3.4 Royalty
. Licensee shall pay to Licensor a. quarterly royalty payment equal
to three percent (3%) of the Net Sales for the preceding
quarter after the first commercial sale of the Licensed Products.
Licensee shall pay a reduced royalty of one and one half percent
(1.5%) for Licensed Products covered by a Co-owned Patent
which is invented a) more than one year after the Effective Date of
this License Agreement and b) where the invention claimed was
invented. at Licensee’s physical facilities or at the
physical facilities of a third party under contract with Licensee,
where such third party is not the Licensors, the University, or
utilizing Licensor’s or University employees, students, or
support. in the event a Licensed Product is covered by more than
one Patent, the highest royalty rate under this Section 3.4
shall apply. Within thirty (30) days after the end of each
calendar quarter, Licensee shall provide Licensor with a written
report indicating the amount of the Net Sales for the preceding
cal
|
