EXHIBIT
99.2
License
Agreement
PARTIES
This License Agreement (the
“Agreement”), entered into as of this 7th day of
October, 2005, (the “Effective Date”), is between
Cytomedix, Inc., a Delaware corporation having a principal place of
business at 416 Hungerford Drive, Suite 330, Rockville, Maryland
20850, and COBE Cardiovascular, Inc., a Colorado corporation having
a principal place of business at 14401 West 65th Way, Arvada,
Colorado 80004. Capitalized terms used herein and not otherwise
defined shall have the meaning set forth in Article 1
hereof.
RECITALS
WHEREAS, Cytomedix and Cobe have been engaged in
discussions relating to a license of U.S. Patent No. 5,165,938
(“the ‘938 Patent; and
WHEREAS, the parties hereto desire, on the terms
and conditions contained herein, to settle whatever claims one may
have against the other in connection with the '938 Patent, and to
enter into a mutually agreeable licensing arrangement;
NOW, THEREFORE, in consideration of the
following terms, covenants and conditions, Cytomedix and Cobe
hereby agree as follows:
TERMS OF
AGREEMENT
(a) any
individual who or Entity that, in whatever country organized or
resident, directly or indirectly through one or more
intermediaries, is controlled by, or is under common control with,
or controls a Party; or
(b) any Entity
in which any individual or Entity recited in the preceding
sub-paragraph (a) directly or indirectly through one or more
intermediaries has at least a forty percent (40%) ownership or
voting rights interest (whether through stock ownership, stock
power, voting proxy, or otherwise), or has the maximum ownership
interest it is permitted to have in the country where such Entity
exists.
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1.2.
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“Cobe” means COBE
Cardiovascular, Inc., its parent companies, subsidiaries, companies
under common control with Cobe Cardiovascular, Inc. (whether
foreign or domestic), or any entity in which any of the preceding
entities (a) directly or indirectly owns 50% or more of the
capital, assets, voting securities, partnership or other ownership
interest (or has the maximum ownership interest it is permitted to
have in the country where such entity exists), or (b) has the power
to direct or cause the direction of, either directly or indirectly,
the management and policies of such entity, whether through
ownership of voting securities, interlocking management, contract, or
otherwise.
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“Cytomedix” means
Cytomedix, Inc., its parent companies, subsidiaries, companies
under common control with Cytomedix, Inc. (whether foreign or
domestic), or any entity in which any of the preceding entities (a)
directly or indirectly owns 50% or more of the capital, assets,
voting securities, partnership or other ownership interest (or has
the maximum ownership interest it is permitted to have in the
country where such entity exists), or (b) has the power to direct
or cause the direction of, either directly or indirectly, the
management and policies of such entity, whether through ownership
of voting securities, interlocking management, contract, or otherwise
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1.4.
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“PARTY” shall mean, as applicable,
either: (a) Cytomedix, Inc.; or (b) Cobe Cardiovascular,
Inc.
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1.5.
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"Distributor" means an entity which contracts with Cobe to
either a) provide promotion, sales and distribution services of
Royalty-Bearing Products, or b) buy Royalty-Bearing Products from
Cobe for resale.
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1.6.
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“Disposable Product(s)” shall mean
products that are intended or expected to be used only one time
that are either Cobe branded disposable equipment or disposable
equipment purchased from Cobe for resale under any trademark,
tradename or brand name approved by Cobe and that have instructions
for use primarily intended for producing (in conjunction with
Hardware Products) or applying compositions consisting of platelets
or platelet releasate (which includes, but is not limited to,
platelet concentrate or platelet rich plasma (“PRP”))
to facilitate the healing of wounds or other damaged tissue.
Disposable Products do not include, for example, items such as
syringes, needles, cell washing bowls, catheters, gauze or other
forms of dressing, gloves, etc. that are not sold within a platelet
or PRP-related kit. Any Licensee product which is marketed by
Licensee without direct or indirect reference to platelets or
platelet releasate, and which is not otherwise covered by the
Licensed Patents, shall not be considered a Disposable Product. For
the term of this Agreement, the items listed in Exhibit B will be
considered Disposable Products irrespective of the Licensee’s
marketing activities thereon. Cobe reserves the right to supplement
the items listed in Exhibit B.
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1.7.
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“Earned
Royalty” shall mean royalties payable under this Agreement on
Royalty-Bearing Products actually sold or leased (in countries
where Licensee has a license identified in Exhibit A) by Licensee
to third parties and paid for by those third parties, and as to
which sale(s) Licensee recognizes as revenue pursuant to
Licensee’s standard finance and accounting policies. Earned
Royalty does not apply to items which have been returned to
Licensee and a refund has been made, nor to items which are not
sold but are provided on loan, as free or at no cost, as no-cost
replacement items for warranty or other purposes, for demonstration
purposes, for training, education or clinical trial purposes, or to
an academic institution in connection with not-for-profit research
or teaching.
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1.8.
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“Entity” shall mean any corporation,
firm, partnership, proprietorship, or other form of business
organization.
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1.9.
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"Gross Price"
shall mean, with respect to a Royalty-Bearing Product, the unit
price, without deduction, actually received from the third-party
end user customer by the Licensee that sells directly to such
third-party end user customer for the sale of such Royalty-Bearing
Product (eliminating transactions among intermediaries), without
inclusion of (i) sales tax, (ii) value added or other excise taxes
paid or payable, or (iii) freight charges.
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1.10.
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“Hardware
Product(s)” shall mean products that are intended to be used
multiple times and are either Cobe branded equipment or equipment
purchased from Cobe for resale under any trademark, tradename or
brand name approved by Cobe having instructions for use primarily
for producing compositions consisting of platelets or platelet
releasate (which includes, but is not limited to, platelet
concentrate or platelet rich plasma (“PRP”)) to
facilitate the healing of wounds or other damaged tissue. Any
Licensee product which is marketed by Licensee without direct or
indirect reference to platelets or platelet releasate, and which is
not otherwise covered by the Licensed Patents, shall not be
considered a Hardware Product. For the term of this Agreement, the
items listed in Exhibit C will be considered Hardware Products
irrespective of the Licensee’s marketing or promotional
activities associated therewith. Cobe reserves the right to revise
the items listed in Exhibit C.
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1.11.
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“ Licensee” shall mean Cobe and its
Distributors and customers and any direct or indirect authorized
sub-licensee of Cobe under the rights herein provided, as
applicable.
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1.12.
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“Licensed Fields” means
any and all fields of use.
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1.13.
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" Licensed Patents” means the patents and
patent applications listed in Exhibit A and any related patent
application (including any continuation, continued prosecution,
continuation-in-part, divisional, foreign counterpart or
substitution thereof) and any patent (including any reissue or
reexamination thereof), in any country granted from, or claiming
priority to, or for the benefit of any of the aforementioned patent
applications or patents, as well as rights in any third-party
patent acquired as a result of an interference action involving any
of the foregoing.
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1.14.
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“Net
Sales Price” shall mean the Gross Price for sales of
Royalty-Bearing Products, less the following "Invoice Adjustments":
(i) discounts and sales commissions, (ii)credits or repayments due
to rejections, defects, returns, (iii) net of amounts previously
included in the Net Sales Price of a product that were written-off
by Cobe or such sublicensee of Cobe during such period as
uncollectible, and (iv) charitable donations of Royalty-Bearing
Products. Net Sales which are denominated in currencies other than
U.S. Dollars shall be converted into U.S. Dollars according to
Cobe's standard accounting policy for conversion of foreign
currencies. All deductions for discounts and sales commissions in
subclause (i) above shall be deemed to be an amount equal to twelve
and one-half percent (12.5%) of the Gross Price.
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1.15.
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“Royalty-Bearing Products” shall
mean Hardware Product(s) and Disposable Product(s) only.
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1.16.
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“Quarter” shall mean the respective
three-month accounting periods ending in March, June, September and
December of any year.
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1.17.
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“Royalty
Year” shall mean the year beginning with the first full
Quarter following the Effective Date, and each year thereafter
until November 24, 2009.
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2.
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License
Grant/Covenant Not to Sue/Releases .
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2.1.
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License
Grant. Cytomedix
hereby grants to Cobe a non-exclusive license under the Licensed
Patents to make, have made, use, import, sell, promote, market,
offer for sale or otherwise transfer Royalty-Bearing Products in
the Licensed Fields throughout the world. This grant includes the
right for Cobe to grant sublicenses of the rights conveyed in the
preceding sentence to Distributors and customers, either directly
or through one or more intermediaries and, with the prior written
consent of Cytomedix (which shall not be unreasonably withheld) to
other sublicensees. This grant also includes the right for any
customers (ultimate or in privity or other) of any Licensee to use
and/or sell (for further use or resale) Royalty-Bearing Products
subject to this Agreement without payment of any additional royalty
to Cytomedix, including, but not limited to, the products listed in
Exhibits B and C. In other words, the license grant “runs
with the Royalty-Bearing Product.”Cytomedix will only receive
one royalty payment per licensed Royalty-Bearing
Product.
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2.2.
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Distributor
and Customer Immunity .
The license set forth in Paragraph 2.1 shall constitute a
grant of immunity against any action for or claim of infringement
(whether based on a direct or contributory infringement, inducement
to infringe, or other theory) against the Licensee’s
Distributors and authorized resellers, agents, employees, customers
and users relating to Royalty-Bearing Products sold or otherwise
disposed of by any Licensee prior to or after this
Agreement.
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2.3.
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Cytomedix, on
behalf of itself, its predecessors and successors, and each of
their respective affiliates, officers, directors, employees and
agents, hereby irrevocably and unconditionally releases and forever
discharges Cobe and its officers, directors, employees, agents,
shareholders, representatives, parent companies, subsidiaries,
affiliated companies, partners, predecessors, and all other persons
acting by or on their behalf (collectively, the “Cobe
Releasees”), of and from any claims that Cytomedix has ever
had or may now have against the Cobe Releasees related to the
claims, counterclaims and affirmative defenses that were or could
have been asserted in connection with matters relating to the '938
Patent. Cytomedix also releases customers of Cobe as to any claims
that Cytomedix has ever had against them based on their use of a
product sold to them by Cobe.
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2.4.
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Cobe, on behalf
of itself, its predecessors and successors, and each of their
respective shareholders, affiliates, members, officers, directors,
employees and agents, hereby irrevocably and unconditionally
releases and forever discharges Cytomedix, its officers, directors,
employees, agents, shareholders, representatives, parent companies,
subsidiaries, affiliated companies, predecessors, and all other
persons acting by or on behalf of Cytomedix (collectively, the
"Cytomedix Releasees"), of and from any claims that Cobe has ever
had or may now have against Cytomedix or any of the other Cytomedix
Releasees related to the claims, counterclaims, and affirmative
defenses that were or could have been asserted in connection with
matters relating to the '938 Patent. Except as it may otherwise be
compelled by a court of competent jurisdiction, domestic or foreign
governmental authority agency or tribunal, or in connection with a
valid subpoena, Cobe and Cobe Releasees further agree not to
challenge, cause to be challenged, or assist others to challenge,
directly or indirectly, the validity and/or enforceability of the
Licensed Patents in any court or other tribunal, including the
United States Patent and Trademark Office and foreign patent
offices. In the event Cobe is served with a subpoena, agency
directive, or court order compelling it to testify or provide
documents or other information related to the Licensed Patents or
this Agreement, Cobe shall promptly notify Cytomedix of any such
request pursuant to the notice provisions set forth in Paragraph
10.1 of this Agreement so as to allow Cytomedix to, at its cost and
expense, seek a protective order, file a motion to quash, or seek
other appropriate relief on behalf of Cobe or Cobe Affiliate or
Cobe Distributor or Cobe customer.
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2.5.
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Covenant Not
to Sue. Cytomedix,
for itself and its Affiliates, covenants not to file or to continue
to prosecute any suit against Cobe or Cobe Distributor or any
customers of Cobe or Cobe’s Affiliates or Distributors,
claiming that Cobe’s (or Cobe Affiliates, Distributors or
customers) making, having made, using, selling, or offering for
sale any Royalty-Bearing Product infringes any Licensed
Patent.
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2.6.
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No Implied
Licenses . No other
rights or licenses not expressly granted herein with respect to the
Licensed Patents or any other intellectual property owned or
controlled by Cytomedix are granted or shall be deemed granted to
Licensee or any other person.
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2.7.
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Taxes and
Authorizations . Cobe
shall be solely responsible for the payment and discharge of any
taxes, duties, or withholdings relating to any transaction in
connection with the manufacture, use, sale, or other
commercialization of any Royalty-Bearing Product. Cobe shall, at
its own expense, be responsible for applying for and obtaining any
approvals, authorizations, or validations relative to this
Agreement under the appropriate federal, state, or local
laws.
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3.1.
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License
Payment . Within two
months after the Effective Date, Cobe shall pay Cytomedix a license
payment of forty-five thousand, three hundred ninety U.S. Dollars
($45,390.00).
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3.2.
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Earned
Royalties . Cobe shall
pay a royalty on sales of Royalty-Bearing Products by any Licensee
to third parties, and paid for by those third parties, that take
place after the Effective Date and prior to November 24, 2009 under
the following conditions:
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3.2.1.
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The Earned
Royalty rate shall be one and one-half percent (1.5%) of the Net
Sales Price of Hardware Products sold in countries where the sale
of such Hardware Product is covered by a granted, valid, unexpired
patent within the Licensed Patents.
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3.2.2.
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The Earned
Royalty rate shall be seven and one-half percent (7.5%) of the Net
Sales Price of Disposable Products sold in countries where the sale
of such Disposable Products is covered by a granted, valid,
unexpired patent within the Licensed Patents.
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3.2.3.
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No payments
shall be due with respect to the sale of any Licensed Products
after November 24, 2009 in the United States and, in each other
country of the Licensed Territories, on a country-by-country basis,
after the expiration of the last to expire of the Licensed Patents
in such country, at which time in each such country the licenses
granted in this Agreement shall become fully paid-up and royalty
free.
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3.3.
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No Royalty
Stacking . Only one
royalty shall be payable in respect to any Royalty-Bearing
Product.
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3.4.
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Reports,
Payments and Currency Conversions . Within two months after the end of each
Quarter, Cobe shall furnish Cytomedix with a written report setting
forth the sales of Royalty-Bearing Products upon which a royalty is
payable under this Article 3 during such Quarter and the
computation of the royalties payable with respect thereto. Each
report shall be accompanied by the amount due in U.S. Dollars, less
any taxes required to be withheld by governmental agencies in
respect to royalties payable to Cytomedix for that Quarter. Each
report and any accompanying payment shall be se
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