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EXHIBIT
10.30
JOINT DEVELOPMENT
AGREEMENT
This JOINT
DEVELOPMENT AGREEMENT (the “ Agreement ”) is
entered into by MiMedx, Inc. , a Florida corporation, having
a principal place of business located at 1234 Airport Road, Suite
105, Destin, FL 32541 (“ MiMedx ”) and Offray
Specialty Narrow Fabrics, Inc. , a New York corporation having
a principal place of business located at 360 Route 24, P.O. Box
421, Chester, NJ 07930-0421 (“ Offray ”) (with
MiMedx and Offray hereinafter collectively referred
to as the “ Parties ,” each a “
Party ”).
RECITALS
WHEREAS,
MiMedx has technical expertise in producing NDGA-treated
collagen fibers suitable for medical implants, such as braided or
woven collagen implants, and owns or has exclusive rights to
patents and patent applications covering NDGA-treated collagen and
implants;
WHEREAS,
Offray has technical expertise in woven textile production
and manufacturing; and
WHEREAS, the
Parties desire to collaborate to jointly develop commercial
production processes for fabricating woven and/or braided
NDGA-treated collagen fiber bioprostheses.
NOW, THEREFORE, in
consideration of the foregoing and such other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties , intending to be legally bound,
agree and covenant as follows:
AGREEMENT
| 1. |
DEVELOPMENT ACTIVITIES
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1.1 Development
Activities; Defined.
The Parties
shall cooperate and use all reasonable diligence to:
(i) jointly research and develop, for a period of one
(1) year from the date of the last signature to this
Agreement (the “Effective Date”), commercial
production processes and equipment for fabricating woven and/or
braided NDGA-treated collagen fibers into bioprostheses (the
“First Phase”); and (ii), upon successful completion of
the First Phase, the Parties shall cooperate to develop, for
a period of eighteen (18) months after completion of the First
Phase, a manufacturing process that reliably
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produces at least one
(1) woven NDGA-treated collagen fiber bioprosthesis and which,
as determined and mutually agreed upon by the Parties in
writing, is suitable for commercial medical product production
(collectively, the “Second Phase”) (with (i) and
(ii) collectively referred to as the “Development
Activities”).
1.2 First
Phase.
Offray shall
perform feasibility testing by weaving MiMedx collagen
fibers at Offray’s Watsontown, Pennsylvania facility
(the “Watsontown Facility”). The Parties
recognize that successful testing conducted during the First Phase
may require multiple fabrication and/or test iterations.
MiMedx shall evaluate whether the feasibility testing
conducted during the First Phase is successful using its own
material testing and validation of a woven collagen fiber product
made by Offray , and may, upon prior written notice to, and
the prior written consent of, Offray , which consent shall
not be unreasonably withheld, conduct an audit of
Offray’s Watsontown Facility and the work conducted by
Offray during the First Phase, including all laboratory
notebooks, equipment and prototypes made to arrive at any tested
specimens developed as part thereof.
1.3 Offray
Employees.
Offray
agrees that each employee and consultant who performs any services
in any way relating to the First Phase or Second Phase (as defined
below) shall be appropriately informed of the terms of this
Agreement , and that each such employee and consultant shall
be under legal obligation to Offray by contract or otherwise
sufficient to impose on such employee or consultant a legal
obligation to comply with the terms and conditions of this
Agreement , including, without limitation, the
confidentiality obligations of Section 8 of this
Agreement , and, for each employee, consultant or
consultant’s entity for individuals that may be an inventor,
a legal obligation to assign to Offray all rights to and in
all intellectual property, including, without limitation, all
inventions, copyrights, patents and trademarks, created by such
employee or consultant during their employment by or with
Offray .
1.4 Second
Phase.
Upon successful
completion of the First Phase, as determined by MiMedx in
its sole discretion, the Parties shall cooperate and use all
reasonable diligence to conduct the Second Phase. During the Second
Phase, MiMedx scientists shall travel to
Offray’s Watsontown Facility at MiMedx’s
expense and assist as needed for the design and development of
the
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manufacturing process to be
developed during the Second Phase. During the Second Phase, and
upon Offray’s request, MiMedx shall assist
Offray in analyzing any prototype bioprosthesis products.
Notwithstanding the foregoing, MiMedx may, at its sole
discretion, request a sample woven bioprosthesis product produced
by Offray in order to conduct its own material testing and
validation of any such woven bioprosthesis product produced by
Offray during the Second Phase, MiMedx will use all
reasonable efforts to promptly return any test analysis of
prototypes of woven bioprosthesis products within two
(2) weeks of receipt of any such materials and/or products to
be tested, unless agreed otherwise by the Parties . During
the Second Phase, MiMedx may, upon prior written notice to,
and the prior written consent of, Offray , which consent
shall not be unreasonably withheld, perform an onsite quality
control, manufacturing and regulatory audit of the Watsontown
Facility to assess compliance with the United States Food and Drug
Administration guidelines or other similar foreign regulatory
authority.
1.5 Monthly
Evaluation and Reporting.
During the First
and Second Phase, the Parties shall communicate with each
other at least monthly to evaluate ongoing Development Activities.
Offray shall also provide bi-monthly progress reports
regarding the status and progress of the First Phase and, if
initiated, the Second Phase. The progress reports shall include a
brief written review of the work performed during the previous two
(2) weeks containing the following: (i) a summary of the
work performed on the Development Activities; (ii) an overview
of any progress made towards completion of the First or Second
Phase, as the case may be; and (iii) recommendations for any
proposed alterations in or to the Development Activities.
MiMedx shall review each progress report and provide any
response to Offray in writing within one (1) week of
MiMedx’s receipt thereof. Notwithstanding the
foregoing, the Parties , may, if mutually agreed upon, also
routinely confer with regard to the Development Activities
in-person or by telephone.
1.6 Salaries of
Employees.
All salaries,
benefits, and insurance in any way relating to this
Agreement , including, without limitation, any work
performed on the Development Activities, shall be paid by each
Party for its own employees. Any overtime hours expended, or
additional staff hired, by a Party for the purposes of this
Agreement , including, without limitation, any work
performed on the Development Activities, shall be paid by each
Party with no cost, obligation, or liability to the other
Party .
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1.7 Manufacturing
and Supply Agreement.
If the First and
Second Phase of the Development Activities are successful, as
mutually agreed upon by the Parties , MiMedx agrees
to consider Offray as a potential commercial supplier if
Offray is able to demonstrate that it can meet or exceed
reasonable and customary United States medical supplier standards
for delivery, manufacturing capacity, competitive cost and ability
to meet all quality and manufacturing regulatory
requirements.
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MIMEDX
SUPPORT AND PAYMENTS
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2.1
Equipment.
In support of the
First Phase, MiMedx shall purchase a handloom of
Offray’s choosing with a cost not to exceed $4,000
(US). This and any other equipment purchased by MiMedx for
use in the Development Activities shall be owned by MiMedx
and, upon request, returned to MiMedx , regardless of the
outcome of the Development Activities, unless each Party
agrees otherwise in writing. MiMedx shall not be obligated
to pay for any other equipment used in the Development Activities
unless approved by MiMedx in advance in writing.
2.2 Payment for
Development Activities.
In addition to the
royalty payments set forth in Section 3.4, MiMedx shall
pay Offray for the First Phase in accordance with the Fee
Schedule dated June 18, 2007 (not to exceed $15,200 US,
without prior written consent of MiMedx ) between the
Parties , attached hereto as Exhibit A. If the first Phase
is successful and MiMedx decides to pursue the Second Phase,
the Parties shall mutually agree upon reimbursement of
and/or payment for reasonable expenses to be paid to Offray
for the Second Phase, such Agreement to be in wring and
signed by the Party to be charged.
2.3 Supply of
Collagen Fibers/Assistance.
MiMedx shall
supply Offray with NDGA-treated collagen fibers or NDGA to
treat collagen fibers to be used in the Development Activities in
reasonable amounts and meeting appropriate product specifications
as necessary to properly conduct the Development Activities, and
shall provide technical assistance to Offray with regard to
the Development Activities as reasonably requested by Offray
.
2.4 Travel and
travel costs.
MiMedx
shall, upon proper documentation provide by Offray , refund
or reimburse Offray for all reasonable travel costs,
including, without limitation, coach class airfare and
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reasonable living (i.e. room
and board) expenses, for Offray employees and consultants
who, at the request of MiMedx , travel to
MiMedx’s Destin, Florida location or other specified
location for meetings relating in any way to the Development
Activities.
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OWNERSHIP OF INTELLECTUAL PROPERTY
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3.1
Definitions.
For purposes of
this Agreement :
(a)
“Intellectual Property” means any and all intellectual
property, including, but not limited to, inventions, copyrights,
copyright applications or registrations, original works of
authorship, developments, improvements, patents, patent
applications, Patent Rights (as defined in Section 3.1(e))
trademarks, trademark applications, trade names, trade secrets,
designs, technical information, formulations, processes, know-how,
data, specifications, test results, drawings, manufacturing
equipment and other information, whether or not patented or
patentable, or otherwise subject to protection under any applicable
laws, rules and regulations, which in any way relate to, or arise
from, this Agreement , including, without limitation, the
Development Activities.
(b)
“Joint Intellectual Property” means Intellectual
Property having at least one (1) co-creator who is an
employee, agent, servant, representative or consultant of
Offray and one co-creator who is an employee, agent,
servant, representative or consultant of MiMedx .
(c) “
MiMedx Intellectual Property” means Intellectual
Property having as creators only employees, agents, servants,
representatives or consultants of MiMedx .
(d) “
Offray Intellectual Property” means Intellectual
Property having as creators only employees, agents, servants,
representatives or consultants of Offray .
(e)
“Patent Rights” means all rights under any patent or
patent application in any country, including any substitution,
extension or supplementary protection certificate, reissue,
reexamination, renewal, division, continuation or
continuations-in-part thereof which in any way relate to, or arise
from, this Agreement , including, without limitation, the
Development Activities. “Joint
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Patent” means
any patent from the Patent Rights that is jointly owned such that
the patent has at least one inventor who is an employee, agent,
servant, representative or consultant of Offray and at least
one inventor who is an employee, agent, servant, representative or
consultant of MiMedx . “ Offray Patent”
means any patent from the Patent Rights with all inventors being
only employees, agents, servants, representatives or consultants of
Offray . “ MiMedx Patent’ means any
patent from the Patent Rights with all inventors being only
employees, agents, servants, representatives or consultants of
MiMedx .
3.2 Ownership of
Joint Intellectual Property/Royalty.
MiMedx and
Offray shall jointly own all Joint Intellectual
Property.
3.3 Ownership of
MiMedx Intellectual Property.
MiMedx shall
own all MiMedx Intellectual Property.
3.4 Ownership of
Offray Intellectual Property/Royalty/License.
Offray shall
own all Offray Intellectual Property.
Offray
hereby grants to MiMedx an exclusive, irrevocable, right and
license, with the right to sublicense the Offray
Intellectual Property and the Joint Intellectual Property,
including the right to use or have used, make or have made, market,
have marketed, offer for sale, import for sale, and sell and have
sold any product of process covered by Offray Patent(s)
and/or any Joint Patent(s) in the field of medical collagen
bioprosthesis (the Field).
MiMedx
hereby covenants and agrees to pay Offray a two percent
(2%) royalty on gross sales revenues of any products covered
by or products produced by processes covered by an Offray
Patent. MiMedx hereby covenants and agrees to pay a 1
percent (1%) royalty on gross sales revenues of any products
covered by or products produced by processes covered by a Joint
Patent. However, to be clear, no multiple royalties shall be due or
payable because any product and/or method to produce such product
is covered by or more than one Offray Patent and/or Joint
Patent. For example, in the situation where a product and/or method
to produce such product is covered by both at least one
Offray Patent(s) and at least one Joint Patent(s) or two or
more Offray Patents, the royalty due shall still remain at
2% and in the situation where a product and/or method to produce
such product is covered by one or more Jointly Owned Patents, the
royalty due shall be 1%. Terms for payment of and accountability
for sales will be defined by a later drafted Agreement
should a Joint Patent(s) or Offray Patent issue and the
Parties agree to
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act in good faith to
establish such implementing details and definitions as reasonable
and customary.
3.5 Patent
Prosecution and Maintenance.
MiMedx
shall, at its sole discretion, have the right, but not the
obligation, to prepare, file prosecute and maintain at its own
expense any patent applications and/or patents relating to the
Joint Intellectual Property. If, after ninety (90) days
written notice from either Party to the other Party
that there exists Joint Intellectual Property that a Party
reasonably believes should be protected, MiMedx declines to
fund or prepare and file a patent application relating thereto,
then Offray shall have the right, at Offray s
expense, to prepare, file, prosecute and maintain any patent
application(s) relating to such Joint Intellectual Property. If
MiMedx declines to fund and Offray decides to do so
for a particular Joint Patent, then the exclusive license under
Section 3.4 converts to a non-exclusive license for that Joint
Patent.
Each Party
shall be responsible for protecting any Intellectual Property
solely owned by that Party , unless agreed otherwise in
writing.
3.6 Laboratory
Notebooks.
Each Party
agrees to use its reasonable efforts to have its employees and/or
consultants timely and promptly record, date and witness any and
all Intellectual Property in bound laboratory notebooks.
Intellectual Property shall be disclosed and reported to the other
Party within thirty (30) days of the date indicated for
the same in the laboratory notebook.
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INFRINGEMENT OF INTELLECTUAL PROPERTY
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4.1 Notice of
Infringement.
Upon becoming aware
of any alleged infringement of Intellectual Property, each
Party shall promptly notify the other Party of any
and all available evidence of infringement, and the Parties
shall cooperate to diligently investigate and determine, in the
exercise of reasonable judgment and good practice, whether the
activities in question in fact constitute an infringement of
In
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