Document:

exv10w2

EXHIBIT 10.2

     Portions of this exhibit have been omitted pursuant to a request for confidential treatment.
The omitted portions, marked by [***], have been separately filed with the Securities
and Exchange Commission.

LICENSE AGREEMENT

BETWEEN

PROTALIX BIOTHERAPEUTICS LTD.

AND

VIRGINIA TECH INTELLECTUAL PROPERTIES, INC.

FOR

CASE NO. VTIP 97 012

 

Execution Copy

LICENSE AGREEMENT

 This agreement (“Agreement”) is made by and between Protalix Biotherapeutics LTD., a
corporation having an address at 2 Snunit Street, Science Park, POB 455, Karmiel 20100,
Israel (“LICENSEE”) and Virginia Tech Intellectual Properties, Inc., a non-profit
organization having an address at 1872 Pratt Drive, Suite 1625, Blacksburg, Virginia
24060 (“VTIP”).

 This Agreement is effective on the date of the last signature (“Effective Date”).

RECITALS

WHEREAS, the inventions disclosed in VTIP Disclosure No. 97.012 and titled “[***]” (“Invention”),
were made in the course of research at Virginia Tech by Dr. Carol Cramer (hereinafter the
“Inventors”) and are covered by Patent Rights as defined below;

WHEREAS, the Inventors were employees of Virginia Tech, and they were obligated to assign all of
their right, title and interest in the Invention to Virginia Tech;

WHEREAS, Virginia Tech has assigned all of their right, title and interest in the Invention to
VTIP;

WHEREAS, VTIP is desirous that the Invention be developed and utilized to the fullest possible
extent so that its benefits can be enjoyed by the general public;

WHEREAS, LICENSEE is desirous of obtaining certain rights from VTIP for commercial development,
use, and sale of the Invention, and VTIP is willing to grant such rights; and

WHEREAS, LICENSEE understands that VTIP may publish or otherwise disseminate information concerning
the Invention (as defined below) at any time and that LICENSEE is paying consideration thereunder
for its access to the Invention not continued secrecy therein.

NOW, THEREFORE, the parties agree:

ARTICLE 1. DEFINITIONS

The terms, as defined herein, shall have the same meanings in both their singular and plural
forms.

1.1 “Affiliate” means any corporation or other business entity: (i) in which
LICENSEE owns or controls, directly or indirectly, at least fifty percent (50%) of
the outstanding stock or other voting rights entitled to elect directors, or (ii)
which owns or controls directly or indirectly by at least fifty percent (50%) of
the outstanding stock or other voting rights entitled to elect directors of
LICENSEE; but in any country where the local law does not permit foreign equity
participation of at least fifty percent (50%), then an “Affiliate” includes any
company in which LICENSEE owns or controls or is owned or controlled by, directly
or indirectly, the maximum percentage of outstanding stock or voting rights
permitted by local law.

1.2 “Combination Product” means any product which is a Licensed Product and
contains other product(s) or product component(s): (i) the sale, use or import of
which by itself does not constitute an infringement of a Valid Claim within Patent
Rights; (ii) can be sold separately by LICENSEE, its Sublicensee or an Affiliate;
and (iii) enhances the market price of the final product(s) sold, used or imported
by LICENSEE, its Sublicensee, or an Affiliate.

1.3 “Field” means all uses.

 

			
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1.4 “Licensed Method” means any method that is covered by Patent Rights the
use of which would constitute, but for the license granted to LICENSEE under this
Agreement, an infringement of any Valid Claim within Patent Rights.

1.5 “Licensed Product” means any composition or product that is covered by a Valid
Claim within Patent Rights, or that is produced by a Licensed Method, the
manufacture, use, sale, offer for sale, or importation of which would constitute,
but for the license granted to LICENSEE by VTIP herein, an infringement of any
Valid Claim within the Patent Rights: Whether a product is a “Licensed Product”
shall be determined on a country-by-country and product-by-product basis.

1.6 “NDA” means an application for FDA approval to market a new drug.

1.7 “Net Sales” means the total of the gross invoice prices of Licensed Products
sold by LICENSEE, its Sublicensees, or Affiliates, or any combination thereof,
less the sum of the following actual and customary deductions where applicable
and separately listed: (a) cash, trade, or quantity discounts; (b) chargebacks and
rebates, including without limitation, chargebacks payable to wholesalers for
goods sold under customer contracts and rebates payable in connection with
government programs or other third party payors; (c ) sales, use, tariff,
import/export duties or other excise taxes imposed on particular sales (except for
value-added and income taxes imposed on the sales of Product in foreign
countries); (d) wholesale service and transportation charges; and (e) credits to
customers because of rejections or returns. For purposes of calculating Net
Sales, transfers by LICENSEE to a Sublicensee or an Affiliate of Licensed Product
under this Agreement for (i) end use (but not resale) by the Sublicensee or
Affiliate shall be treated as sales by LICENSEE at list price of LICENSEE, or (ii)
resale by a Sublicensee or an Affiliate shall generate a royalty based upon the
Sublicensee’s or Affiliate’s Net Sales price as calculated above. For Licensed
Products which are Combination Products, the Net Sales for such Combination
Products shall be adjusted by multiplying the actual Net Sales by the fraction
A/(A+B) where A is the invoice price of the Licensed Product, if sold separately,
and B is the invoiced price of the other product or product component if sold
separately. If the other product or product component is not sold separately,
then the actual Net Sales shall be adjusted by multiplying the actual Net Sales by
the fraction A/C where A is the price of the Licensed Product if sold separately
and C is the invoice price of the Combination Product. If neither of the
foregoing apply, then the Net Sales of the Combination Product shall be determined
by the Parties in good faith.

1.8 “Patent Costs” means all out-of-pocket expenses for the preparation, filing,
prosecution, and maintenance of all United States and foreign patents included in
Patent Rights. Patent Costs shall also include reasonable out-of-pocket expenses
for patentability opinions, inventorship determination, preparation and
prosecution of patent application, re-examination, re-issue, interference, and
opposition activities related to patents or applications in Patent Rights.

1.9 “Patent Rights” means any of the following: the US patent number [***]
disclosing and claiming the Invention, filed by Inventors and assigned to VTIP;
and continuing applications thereof including divisions, substitutions, and
continuations-in-part (but only to extent the claims thereof are enabled by
disclosure of the parent application); any patents issuing on said applications
including reissues, reexaminations and extensions; and any corresponding foreign
applications or patents.

 

			
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1.10 “Sublicense Income” means upfront payments and milestone payments paid
by a Sublicensee to LICENSEE in consideration of the grant of a sublicense. For
avoidance of doubt, “Sublicense Income” shall not include amounts paid as earned
royalties (that is, royalties based on product sales), funded research payments,
payments for the purchase by the Sublicensee of equity of LICENSEE or amounts
paid in reimbursement of expenses incurred by LICENSEE in the research or
development of a Licensed product.

1.11 “Sublicensee” means a third party to whom LICENSEE has granted a sublicense
of the right to practice the Patent Rights.

1.12 “Territory” means world-wide.

1.13 “Term” means the period of time beginning on the Effective Date and ending on
the earlier of (i) the expiration date of the longest-lived Patent Rights; or (ii)
the twenty-first (21st) anniversary of the first commercial sale of
Licensed Product.

1.14 “Valid Claim” means a claim within the Patent Rights that has not been
pending for in excess of seven (7) years, has not expired, been abandoned or
finally determined to be unenforceable or invalid by a court or other
administrative agency with competent jurisdiction.

ARTICLE 2. GRANTS

2.1 License. Subject to the limitations set forth in this Agreement, VTIP hereby grants to
LICENSEE, and LICENSEE hereby accepts, a license under Patent Rights to make, have made, use, sell,
offer for sale, and import Licensed Products and to practice Licensed Methods, in the Field within
the Territory and during the Term.

The license granted herein is non-exclusive and VTIP may grant to third parties further licenses
under Patent Rights in the Field, within the Territory and during the Term.

2.2 Right to Sublicense. (a) LICENSEE may grant a sublicense to a Sublicensee only as part of an
agreement pursuant to which LICENSEE grants rights to such Sublicensee to other intellectual
property rights owned or controlled by LICENSEE.

(b) With respect to each sublicense granted pursuant to Paragraph 2.2 (a), LICENSEE shall:

(1) not receive, or agree to receive, real or personal property in lieu of cash as consideration
from the Sublicensee without the express written consent of VTIP;

(2) to the extent applicable, include all of the rights of and obligations due to VTIP and
contained in this Agreement;

(3) promptly provide VTIP with a copy of each sublicense issued; and

(4) provide a report of all amounts received from the Sublicensee and a report of all Net Sales by
the Sublicensee during the Term.

2.3 Reservation of Rights. VTIP reserves the right to:

(a) use the Invention, and Patent Rights for humanitarian, educational and research purposes;

(b) publish or otherwise disseminate any information about the Invention at any time, except for
Confidential Information of LICENSEE, any Sublicensee or their Affiliates conveyed to VTIP or its
Affiliates hereunder; and

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(c) allow other non-profit institutions to use Invention and Patent Rights for humanitarian,
educational and non-commercial research purposes in their facilities.

ARTICLE 3. CONSIDERATIONS

3.1 Fees and Royalties. The parties hereto understand that individually, the fees and royalties
payable by LICENSEE to VTIP under this Agreement are partial considerations for the license granted
herein to LICENSEE Patent Rights. LICENSEE shall pay VTIP:

(a) a license issue fee of [***] within ten (10) days after the Effective Date;

(b) milestone payments in the amounts payable according to the following schedule or events:

Amount Date or Event

[***]

(c) an earned royalty equal to [***] on Net Sales of Licensed Products by LICENSEE, its
Sublicensees and/or their Affiliate(s); and

(d) [***] of all Sublicense Income received by LICENSEE from its Sublicensees;

(e) beginning with the calendar year during which the first commercial sale of the first
License Product by LICENSEE, its Sublicensee, or an Affiliate occurs, if the total earned
royalties paid by LICENSEE under Paragraphs 3.1(c ) and (d) to VTIP in any such year
cumulatively amounts to less than [***] (“minimum annual royalty”), then LICENSEE shall
pay to VTIP, on or before February 28 of the year following such year, an amount equal to
[***] minus the total amounts paid by LICENSEE for such preceding year under Paragraphs
3.1(c) and 3.1 (d); provided, however, that for the year during which the first
commercial sale of the first Licensed Product occurs, the amount of minimum annual royalty
payable shall be prorated for the number of months remaining in that calendar year.

For those Licensed Products that are subject to royalties payable to a Third Party, the
royalties due hereunder shall be reduced by [***] for every one percent (1%) of royalty due to
a Third Party, but in no event shall royalties due hereunder be reduced by more than [***] of
the applicable royalty rate payable hereunder for such Licensed Products.

All fees and royalty payments specified in Section 3.1 above shall be paid by LICENSEE pursuant
to Paragraph 4.3 and shall be delivered by LICENSEE to VTIP as noted in Paragraph 10.1.

3.2 Due Diligence.

LICENSEE shall use commercially reasonable efforts, alone or through its Sublicensees or their
Affiliates, to development, manufacture and sell Licensed Products.

 

			
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ARTICLE 4. REPORTS, RECORDS AND PAYMENTS

4.1 Reports.

(a) Progress Reports.

(1) Beginning March 1, 2005 and ending on the date of first commercial sale of a Licensed
Product in the United States, LICENSEE shall submit to VTIP an annual progress report providing
an overview of LICENSEE’s (and its Affiliate’s and Sublicensee’s) efforts to develop a Licensed
Product.

(2) LICENSEE shall also report to VTIP, in its immediately subsequent progress report, the date
of first commercial sale of a Licensed Product in each country.

(b) Royalty Reports. After the first commercial sale of a Licensed Product anywhere in the
world, LICENSEE shall submit to VTIP [***] royalty reports on or before each [***] of each
year. Each royalty report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s)
most recently completed [***] and shall show:

(1) the total invoiced sales and the Net Sales during the most recently completed [***] and the
royalties, in US dollars, payable with respect thereto;

(2) the number of each type of Licensed Product sold;

(3) Sublicense Income received during the most recently completed [***] in US dollars, and the
amount payable hereunder with respect thereto;

(4) the method used to calculate the royalties; and

(5) the exchange rates used (if applicable).

If no sale of Licensed Products has been made and no Sublicense Income has been received by
LICENSEE during any reporting period, LICENSEE shall so report.

4.2 Records & Audits.

(a) LICENSEE shall keep, and shall require its Affiliates and Sublicensees to keep, accurate
and correct records of all Licensed Products manufactured, used, and sold, and Sublicense
Income received under this Agreement. Such records shall be retained by LICENSEE for at least
five (5) years following a given reporting period.

(b) All records maintained under Section 4.2(a) shall be available during normal business
hours for inspection at the expense of VTIP by VTIP’s Internal Audit Department or by a
Certified Public Accountant selected by VTIP and in compliance with the other terms of this
Agreement for the sole purpose of verifying reports and payments. Such inspector shall not
disclose to VTIP any information other than information relating to the accuracy of reports and
payments made under this Agreement or other compliance issues. In the event that such
inspection shows an under reporting and underpayment in excess of [***] for any twelve (12)
month period, then LICENSEE shall pay the cost of the audit as well as any additional sum that
would have been payable to VTIP had the LICENSEE reported correctly. For underpayment not in
excess of [***] for any twelve (12) month period, LICENSEE shall pay the difference within
[***] days without inspection cost.

 

			
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4.3 Payments.

(a) All fees and royalties due VTIP shall be paid in United States dollars and all checks
shall be made payable to VTIP. When Licensed Products are sold in currencies other than United
States dollars, LICENSEE shall first determine the earned royalty in the currency of the
country in which Licensed Products were sold and then convert the amount into equivalent United
States funds, using the exchange rate quoted in the Wall Street Journal on the last business
day of the applicable reporting period.

(b) Royalty Payments.

(1) Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when
delivered to a third party or Affiliate.

(2) LICENSEE shall pay earned royalties [***] on or before [***] of each [***]. Each such
payment shall be for earned royalties accrued within the most recently completed calendar
quarter.

(3) Royalties earned on sales occurring or under sublicense granted pursuant to this Agreement
In any country outside the United States shall not be reduced by LICENSEE for any taxes, fees,
or other charges imposed by the government of such country on the payment of royalty income,
except that all payments made by LICENSEE in fulfillment of VTIP tax liability in any
particular country may be credited against earned royalties or fees due VTIP for that country.
LICENSEE shall pay all bank charges resulting from the transfer of such royalty payments.

(4) If at any time legal restrictions prevent the prompt remittance of part or all royalties
by LICENSEE with respect to any country where a Licensed Product is sold or a sublicense is
granted pursuant to this Agreement, LICENSEE shall convert the amount owed to VTIP into US
currency and shall pay VTIP directly from its US sources of fund for as long as the legal
restrictions apply.

(c) Late Payments. In the event royalty, reimbursement and/or fee payments are not received
by VTIP when due, LICENSEE shall pay to VTIP interest charges at a rate of [***] per year.
Such interest shall be calculated from the date payment was due until actually received by
VTIP.

ARTICLE 5. PATENT MATTERS

5.1 Patent Infringement.

(a) If LICENSEE learns of any substantial infringement of Patent Rights, LICENSEE shall so
inform VTIP and provide VTIP with reasonable evidence of the infringement. Neither party shall
notify a third party of the infringement of Patent Rights without the consent of the other
party. Both parties shall use reasonable efforts and cooperation to terminate infringement
without litigation.

(b) LICENSEE may request VTIP to take legal action against such third party for the
infringement of Patent Rights. Such request shall be made in writing and shall include
reasonable evidence of such infringement and damages to LICENSEE. If the infringing activity
has not abated [***] following LICENSEE’s request, VTIP shall elect to or not to commence suit
on its own account .VTIP shall give notice of its election in writing to LICENSEE by the end of
the [***] after receiving notice of such request from LICENSEE. LICENSEE may thereafter bring
suit for patent infringement [***], if and only if VTIP elects not to commence suit and the
infringement occurred in a jurisdiction where LICENSEE has an exclusive license under this
Agreement. If LICENSEE elects to bring suit, VTIP may join that suit [***].

(c) [***].

 

			
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(d) [***].

5.2 Patent Marking. LICENSEE shall mark all Licensed Products, or their containers, in
accordance with the applicable patent marking laws.

ARTICLE 6. GOVERNMENTAL MATTERS

6.1 Governmental Approval or Registration. If this Agreement or any associated transaction is
required by the law of any nation to be either approved or registered with any governmental agency,
LICENSEE shall assume all legal obligations to do so. LICENSEE shall notify VTIP if it becomes
aware that this Agreement is subject to a United States or foreign government reporting or approval
requirement. [***]

6.2 Export Control Laws. LICENSEE shall observe all applicable United States and foreign laws with
respect to the transfer of Licensed Products and related technical data to foreign countries,
including, without limitation, the International Traffic in Arms Regulations and the Export
Administration Regulations.

6.3 Preference for United States Industry. If LICENSEE sells a Licensed Product or Combination
Product in the US, LICENSEE shall manufacture said product substantially in the US to the extent
required by law.

ARTICLE 7. TERMINATION OF THE AGREEMENT

7.1 Termination by VTIP. If LICENSEE fails to perform or violates any material term of this
Agreement, then VTIP may give written notice of default (“Notice of Default”) to LICENSEE. If
LICENSEE fails to cure the fault within [***] of the Notice of Default (or up to [***] if the
breach is not cured within [***], LICENSEE is making good faith efforts to achieve a cure and
such extension will not increase damages suffered by VTIP), VTIP may terminate this Agreement
and the license granted herein by a second written notice (“Notice of Termination”) to
LICENSEE. If a Notice of Termination is sent to LICENSEE, this Agreement shall automatically
terminate on the effective date of that notice. Termination shall not relieve LICENSEE of its
obligation to pay any fees owed at the time of termination and shall not impair any accrued
right of VTIP.

7.2 Termination by Licensee.

(a) LICENSEE shall have the right at any time and for any reason to terminate this Agreement
upon a [***] written notice to VTIP. Said notice shall state LICENSEE’s reason for terminating
this Agreement.

(b) Any termination under Paragraph 7.2(a) shall not relieve LICENSEE of any obligation or
liability accrued under this Agreement prior to termination or rescind any payment made to VTIP
or action by LICENSEE prior to the time termination becomes effective. Termination shall not
effect in any manner any rights of VTIP arising under this Agreement prior to termination.

7.3 Survival on Termination. The following Paragraphs and Articles shall survive the
termination of this Agreement:

(a) Article 4 (REPORTS, RECORDS AND PAYMENTS);

(b) Paragraph 7.4 (Disposition of Licensed Products on Hand);

(c) Paragraph 8.2 (Indemnification);

(d) Article 9 (USE OF NAMES AND TRADEMARKS);

 

			
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(e) Paragraph 10.2 hereof (Secrecy); and

(f) Paragraph 10.5 (Failure to Perform).

7.4 Disposition of Licensed Products on Hand. Upon termination of this Agreement, LICENSEE
may dispose of all previously made or partially made Licensed Product within a period of one
hundred and twenty (120) days of the effective date of such termination provided that the sale
of such Licensed Product by LICENSEE, its Sublicensees, or Affiliates shall be subject to the
terms of this Agreement, including but not limited to the rendering of reports and payment of
royalties required under this Agreement.

ARTICLE 8. LIMITED WARRANTY AND INDEMNIFICATION

8.1 Limited Warranty.

(a) VTIP warrants that it has the lawful right to grant this license, that the Patent Rights
have been prepared, filed and prosecuted in good faith and that no third party has asserted a
claim against VTIP that the Patent Rights are invalid or unenforceable.

(b) The license granted herein is provided “AS IS” and without WARRANTY OF MERCHANTABILITY or
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE or any other warranty, express or implied. VTIP
makes no representation or warranty that the Licensed Product, Licensed Method or the use of
Patent Rights will not infringe any other patent or other proprietary rights.

(c) In no event shall either Party be liable for any incidental, special or consequential
damages hereunder.

(d) Nothing in this Agreement shall be construed as:

(1) a warranty or representation by VTIP as to the validity or scope of any Patent Rights;

(2) a warranty or representation that anything made, used, sold or otherwise disposed of under
any license granted in this Agreement is or shall be free from infringement of patents of third
parties;

(3) an obligation to bring or prosecute actions or suits against third parties for patent
infringement except as provided in Paragraph 5.1 hereof;

(4) conferring by implication, estoppel or otherwise any license or rights under any patents
of VTIP other than Patent Rights as defined in this Agreement, regardless of whether those
patents are dominant or subordinate to Patent Rights; (VTIP is not aware of any other Patent
Rights that are necessary to the exercise of Patent Rights as defined in this Agreement, which
Patent Rights have not been offered as of the execution of this Agreement); or

(5) an obligation to furnish any know-how not provided in Patent Rights.

8.2 Indemnification.

(a) LICENSEE shall indemnify, hold harmless and defend VTIP, its officers, employees, and
agents; the sponsors of the research that led to the Invention; and the Inventors of the
patents and patent applications in Patent Rights and their employers against any and all
claims, suits, losses, damage, costs, fees, and expenses resulting from or arising out of
exercise of this license or any sublicense. This indemnification shall include, but not be
limited to, any product liability. The foregoing indemnity obligation shall not apply to the
extent a claim, suit, loss, damage, cost, fee, or expense arises out of the negligence of an
indemnitee, or a breach of this Agreement by VTIP or one if its Affiliates.

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(b) LICENSEE, at its sole cost and expense, shall insure its activities in connection with the
work under this Agreement and obtain, keep in force and maintain insurance or an equivalent
program of self insurance as follows:

(1) comprehensive or commercial general liability insurance (contractual liability included)
with limits of at least: (i) each occurrence, $1,000,000; (ii) products/completed operations
aggregate, $1,000,000; (iii) personal and advertising injury, $1,000,000; and (iv) general
aggregate (commercial form only), $1,000,000; and

(2) as between the parties, the coverage and limits referred to above shall not in any way
limit the liability of LICENSEE.

(c) LICENSEE shall furnish VTIP with certificates of insurance showing compliance with all
requirements. Such certificates shall: (i) provide for thirty (30) day advance written notice
to VTIP of any modification; (ii) indicate that VTIP has been endorsed as an additional insured
under the coverage referred to above; and (iii) include a provision that the coverage shall be
primary and shall not participate with nor shall be excess over any valid and collectable
insurance or program of self-insurance carried or maintained by VTIP.

(d ) VTIP shall notify LICENSEE in writing of any claim or suit brought against VTIP in
respect of which VTIP intends to invoke the provisions of this Article. LICENSEE shall
control the defense of any claims for which it is providing indemnification hereunder and shall
keep VTIP informed on a current basis of its defense of any such claims.

ARTICLE 9. USE OF NAMES AND TRADEMARKS

9.1 Nothing contained in this Agreement confers any right to use in advertising, publicity,
or other promotional activities any name, trade name, trademark, or other designation of
either party hereto (including contraction, abbreviation or simulation of any of the
foregoing). Unless required by law, the use by LICENSEE of the name, Virginia Tech
Intellectual Properties, Inc. is prohibited, without the express written consent of VTIP.

9.2 VTIP may disclose to the Inventors the terms and conditions of this Agreement upon their
request. If such disclosure is made, VTIP shall request the Inventors not disclose such terms
and conditions to others.

9.3 VTIP may acknowledge the existence of this Agreement and the extent of the grant in
Article 2 to third parties, but VTIP shall not disclose the financial terms of this Agreement
to third parties, except where VTIP is required by law to do so.

ARTICLE 10. MISCELLANEOUS PROVISIONS

10.1 Correspondence. Any notice or payment required to be given to either party under this
Agreement shall be deemed to have been properly given and effective:

(a) on the date of delivery if delivered in person, or

(b) five (5) days after mailing if mailed by first-class or certified mail, postage paid, to
the respective addresses given below, or to such other address as is designated by written
notice given to the other party.

If sent to LICENSEE:

Protalix Biotherapeutics LTD.

2 Snunit Street

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Science Park

POB 455

Karmiel 20100, Israel

Attention: President

If sent to VTIP:

Virginia Tech Intellectual Properties, Inc.

1872 Pratt Drive, Suite 1625

Blacksburg, VA 24060

Attention: Keith Jones

Director of Commercialization  —  Life Sciences

10.2 Secrecy.

(a) “Confidential Information” shall mean confidential information disclosed by one Party (the
“Disclosing Party”) to the other Party (the “Recipient”) during the term of this Agreement,
which if disclosed in writing shall be marked “Confidential”, or if first disclosed otherwise,
shall within thirty (30) days of such disclosure be reduced to writing by the Disclosing Party
and sent to the Recipient:

(b) Recipient shall:

(1) use the Confidential Information for the sole purpose of performing under the terms of this
Agreement;

(2) safeguard Confidential Information against disclosure to others with the same degree of
care as it exercises with its own data of a similar nature;

(3) not disclose Confidential Information to others (except to its employees, agents or
consultants who are bound by a like obligation of confidentiality) without the express written
permission of the Disclosing Party, except that Recipient shall not be prevented from using or
disclosing any of the Confidential Information that:

(i) Recipient can demonstrate by written records was previously know to it;

(ii) is now, or becomes in the future, public knowledge other than through acts or omissions
of Recipient; or

(iii) is lawfully obtained by Recipient from sources independent of Disclosing Party; and

(c) The secrecy obligations of Recipient with respect to Confidential Information shall
continue for a period ending five (5) years from the termination date of this Agreement.

10.3 Assignability. This Agreement may be assigned by VTIP. This Agreement may not be
assigned by LICENSEE except in connection with the sale or other transfer of LICENSEE’s entire
business or that part of LICENSEE’s business to which the license granted hereby relates.
LICENSEE shall give VTIP thirty (30) days’ prior notice of such assignment or transfer. Any
other assignment of this License Agreement without the prior written consent of VTIP shall be
void. Such written consent shall not be unreasonably withheld or delayed.

10.4 No Waiver. No waiver by either party of any breach or default of any covenant or
agreement set forth in this Agreement shall be deemed a waiver as to any subsequent and/or
similar breach or default.

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10.5 Failure to Perform. In the event of a failure of performance due under this Agreement
and if it becomes necessary for either party to undertake legal action against the other on
account thereof, then the prevailing party shall be entitled to reasonable attorney’s fees in
addition to costs and necessary disbursements.

10.6 Governing Laws. The scope and validity of any patent or patent application subject to
this Agreement shall be governed by the applicable laws of the country of the patent or patent
application.

10.7 Force Majeure. A party to this Agreement may be excused from any performance required
herein if such performance is rendered impossible or unfeasible due to any catastrophe or other
major event beyond its reasonable control, including, without limitation, war, riot, and
insurrection; laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or
other serious labor disputes; and floods, fires, explosions, or other natural disasters. When
such events have abated, the non-performing party’s obligations herein shall resume.

10.8 Headings. The headings of the several sections are inserted for convenience of reference
only and are not intended to be a part of or to affect the meaning or interpretation of this
Agreement.

10.9 Entire Agreement. The Agreement embodies the entire understanding of the parties and
supersedes all previous communications, representations or understandings, either oral or
written, between the parties relating to the subject matter hereof.

10.10 Amendments. No amendment or modification of this Agreement shall be valid or binding on
the parties unless made in writing and signed on behalf of each party.

10.11 Severability. In the event that any of the provisions contained in this Agreement is
held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality or
un-enforceability shall not affect any other provisions of this Agreement, and this Agreement
shall be construed as if the invalid, illegal, or unenforceable provisions had never been
contained in it.

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IN WITNESS WHEREOF, both VTIP and LICENSEE have executed this Agreement, in duplicate
originals, by their respective and duly authorized officers on the day and year written.

					
	 	
Protalix Biotherapeutics LTD.:

 	 
	 	By:  	/s/ David Aviezer
 	 
	 	 	Name:  	David Aviezer 	 
	 	 	Title:  	
CEO 	 
	 	 	

Date: 25/1/05 	 
	 
	 	ATTEST:

 	 
	 	By:  	/s/ Ophir Shahaf
 	 
	 	 	Name:  	Ophir Shahaf 	 
	 	 	
Date: 25/1/05 	 
	 
	 	VTIP:

 	 
	 	By:  	/s/ Brad Fenwick
 	 
	 	 	Name:  	Brad Fenwick 	 
	 	 	Title:  	President
 	 
	 	 	

Date: 1/27/05 	 
	 
	 	ATTEST:

 	 
	 	By:  	/s/ Debra S. Lucas
 	 
	 	 	Name:  	Debra S. Lucas 	 
	 	 	
Date: 1/27/05 	 
	 

13Exhibit 10.1

EXHIBIT 10.1

EXECUTION COPY

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE REDACTED PORTIONS OF THIS EXHIBIT, AND SUCH
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

LICENSE AND TECHNICAL ASSISTANCE AGREEMENT

This License and Technical Assistance Agreement (“Agreement”), effective as of the 10th day of
September, 2010, is by and between ABT Holding, Inc., a Delaware corporation and subsidiary of
Athersys, Inc. having its principal place of business at 3201 Carnegie Avenue, Cleveland, Ohio
44115-2634 (“Athersys”), and RTI Biologics, Inc., a Delaware corporation having its principal place
of business at 11621 Research Circle, Alachua, Florida 32615 (“RTI”). As used herein, RTI and
Athersys may be referred to collectively as “the Parties” or individually as a “Party

WHEREAS, RTI is a processor of orthopedic and other biologic matrix surgical implants, and has
experience in, and certain proprietary technology related to, the generation and characterization
of efficacious and safe in-vivo applications of biomaterials for the repair and natural healing of
human bone and other human tissues (“RTI Capabilities”);

WHEREAS, Athersys possesses expertise, know-how, trade secrets, and other valuable
intellectual property related to, among other things, the isolation, culture, expansion and use of
Multipotent Adult Progenitor Cells (“Athersys Capabilities”);

WHEREAS, RTI and Athersys anticipate that this Agreement will enable them to jointly develop a
commercially viable product combining RTI Technology with Athersys Technology, as defined herein
below, and utilizing RTI Capabilities and Athersys Capabilities as further described in this
Agreement;

WHEREAS, it is the intent of RTI and Athersys that the work performed as a result of this
Agreement, and any intellectual property derived therefrom, shall be afforded the benefits provided
for by the CREATE Act of 2004, as codified by 35 USC 103(c), if requested by the appropriate Party.

			
	 	 	 
	Confidential
	 	 

 

 

 

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NOW, THEREFORE, in view of the foregoing premises, and in consideration of the mutual
covenants, terms and conditions hereinafter set forth, the Parties hereto agree as follows:

Definitions

For purposes of this Agreement, capitalized terms used in this Agreement shall have the meaning
ascribed to them in the preamble and Recitals above, in the listing immediately below, or in the
various Articles that follow.

“Affiliate(s)” shall mean, in relation to a Party, any person, corporation or other business entity
presently or in the future controlled by, controlling, or under common control with that Party, but
only for so long as such control shall continue. For purposes hereof, a person, corporation or
other business entity who beneficially owns or controls, directly or indirectly, at least 50% of
the voting, interests, including securities, of another business entity shall be presumed to
“control” such other business entity. As of the Effective Date of this Agreement, the Parties
respective Affiliates include those listed in Exhibit C.

“Athersys Technology” shall mean the MAPC Licensed Patents, the MAPC Technology, the Collaboration
Technology, and Collaboration Patents. Athersys Technology excludes RTI Technology.

“Collaboration” shall mean any research, experimentation and evaluation performed by RTI and/or
Athersys pursuant to Section 3.1 of this Agreement and the Collaboration Plan attached hereto as
Exhibit B, as it may be amended from time to time, or pursuant to the MTA.

“Collaboration Data” shall mean all data produced in the course of undertaking and performing the
Collaboration, including data generated by either RTI and/or Athersys, or any of their respective
employees, agents or contractors in the course of undertaking and performing the Collaboration, but
in each case to only to the extent that such data does not otherwise constitute Collaboration
Technology.

“Collaboration Patent” shall mean any patent application or patent that claims any Collaboration
Invention.

“Collaboration Technology” shall mean, whether tangible or intangible, every technology,
biological, chemical or other material, formula, process, routine, subroutine, technique,
specification, instruction, concept, method, algorithm, know-how, use, device, article of
manufacture, work of authorship, invention, discovery and Athersys’ Confidential Information that
(a) is or was newly discovered, developed, perfected, improved, designed, engineered, devised,
conceived, or first reduced to practice by Athersys and/or RTI or any of their employees, agents or
contractors in the course of undertaking and performing the Collaboration, including all
Collaboration Inventions, regardless of whether any of the foregoing constitutes a
trade secret or copyrightable or patentable subject matter in any foreign or domestic jurisdiction
and (b) is not RTI Technology.

			
	 	 	 
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“Cumulative Net Revenue” (also referred to as “CNR”) shall mean gross revenues (i) received by RTI
and its Affiliates from End Users to whom or to which RTI or RTI Affiliates directly transferred or
sold MAPC Technology Products, or (ii) received by Third Parties from End Users to whom or to which
were transferred or sold MAPC Technology Products, in each case, less the following: (a) amounts
refunded, rebated or credited to End Users after their receipt by RTI, the Affiliate or the Third
Party, as applicable, in the ordinary course of RTI’s, the Affiliate’s or the Third Party’s
business, as applicable; (b) customary charges for taxes, transportation, shipping and shipping
insurance to the extent separately identified on the invoice to the End User; (c) commissions on
transfers or sales actually paid by RTI, the Affiliate or the Third Party, as applicable, to
distribution or sales agents (whether an employee or independent contractor of RTI, the Affiliate
or the Third Party, as applicable) not to exceed (i) [*%] of the gross revenues
(excluding anything that would be permitted to be deducted therefrom under the foregoing clauses
(a) and (b)) of the associated MAPC Technology Products until the cumulative CNR under this
Agreement from the Effective Date reaches [$*] and (ii) [*%] of such gross
revenues thereafter.

“End User” shall mean the health care facility or other health care provider to whom the MAPC
Technology Product is provided for implantation or administration to a patient(s) for treatment in
the Field.

“Field” shall mean the repair and/or (re)generation of osseous tissue for use in general
orthopedic, sports medicine, spine, trauma, reconstructive, and maxillo-facial repair applications.

“MAPC Licensed Patents” shall mean those patents and patent applications that are, as of the
Effective Date or during the Term, (a) either owned by or licensed to Athersys or any of its
Affiliates with the right to license/sublicense to RTI upon the terms hereof, and (b) necessary for
RTI to make, have made, use, sell, offer for sale or import MAPC Technology Products in accordance
with the terms of this Agreement. MAPC Licensed Patents include those patents and applications
listed on Exhibit A, as such exhibit may be updated from time to time by Athersys.

“MAPC Technology” shall mean any trade secrets, technology, biological, chemical or other
materials, formulas, processes, routines, subroutines, techniques, specifications, instructions,
concepts, methods, algorithms, know-how, uses, devices, article of manufactures, inventions, or
discoveries that are (a) not patented or subject to a published patent application, (b) either
owned by or licensed to Athersys or any of its Affiliates with the right to license/sublicense to
RTI upon
the terms hereof as of the Effective Date or during the Term, (c) necessary for RTI to research,
develop, make, have made, use, sell or transfer, offer for sale or transfer, distribute, import, or
export in accordance with the terms of this Agreement or are otherwise disclosed to RTI or its
Affiliate by Athersys or its Affiliate in the course of undertaking and performing the
Collaboration, and (d) relate to the use, extraction, isolation, expansion, maintenance, or culture
of MAPCs.

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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“MAPC Technology Product” shall mean any product resulting in whole or in part from the undertaking
and performance of the Collaboration that (a) contains [ *  ]. Culture expanded cell
products, including MultiStem® products and related products, are excluded from this definition and
the Collaboration.

“MTA” shall mean that Amended Material Transfer Agreement, effective as of 3 April, 2007, between
Athersys, Inc. (predecessor to Athersys) and Regeneration Technologies, Inc. (predecessor to RTI),
as amended thereafter from time to time, including Amendment No. 1 effective as of 17 July, 2008,
Supplement to Exhibit C of such Amendment No. 1, and Amendment No. 2 effective as of 2 April, 2010.

“Multipotent Adult Progenitor Cell” (also referred to as a “MAPC”) shall mean any multipotent adult
progenitor cell that (a) is extracted and isolated from human bone marrow, (b) has the potential to
develop into cells of the mesenchymal, endothelial and endodermal lineages, (c) has the potential
to be expanded in culture more than twenty doublings, and (d) is described in any of the patents
and patent applications owned by or licensed to Athersys or any of its Affiliates as of the
Effective Date, including those listed on Exhibit A.

“Pre-market Approval” means, in the United States, a Premarket Approval Application (PMA),
Investigational New Drug Application (IND), New Drug Application (NDA) or Biologic License
Application (BLA) under the United States Federal Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, all as amended, and in any jurisdiction outside the United States, a
substantial equivalent to any of the foregoing applicable to such jurisdiction. For further
clarification, the definition of Pre-Market Approval shall not include a 510(k) application in the
United States or its foreign equivalent.

“Regulatory Authority” means, with respect to a jurisdiction, any governmental authority or agency
or department thereof charged with the responsibility of regulating drugs and/or medical devices,
including, in the United States the United States Food and Drug Administration and in any other
jurisdiction, any foreign equivalent(s) thereto.

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
	Confidential
	 	4

 

 

 

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“RTI Technology” shall mean the patents, patent applications, technology, biological, chemical
or other materials, formulas, processes, routines, subroutines, techniques, specifications,
instructions, concepts, methods, algorithms, know-how, uses, devices, articles of manufacture,
inventions, discoveries, works of authorship and RTI’s Confidential Information that are, as of the
Effective Date or during the Term, either owned by or licensed to RTI or any of its Affiliates with
the right to license/sublicense to Athersys upon the terms hereof. RTI Technology excludes
Athersys Technology, MAPC Technology and Collaboration Technology, but includes all RTI Technology
Inventions and all patent rights claiming RTI Technology Inventions.

“Territory” shall mean worldwide.

“Third Party” shall mean any person or entity other than a Party to this Agreement and its
respective Affiliates.

Article I: Grants of Rights

1.1 Athersys Technology. Subject to the terms and conditions of this Agreement, Athersys,
on behalf of itself and its Affiliates, hereby grants to RTI an Exclusive license or sublicense (as
the case may be) to the Athersys Technology solely to research, develop, make, have made, use, sell
or transfer, offer for sale or transfer, distribute, import, and export MAPC Technology Products in
the Field in the Territory. This license includes the right to sublicense solely to Affiliates of
RTI. As used in this Section 1.1, the term “Exclusive” shall mean exclusive of all others,
including Athersys, subject to (a) the rights reserved for Athersys, its Affiliates and their
respective contractors, to develop, make, have made, and use MAPC Technology Products in the Field
in the Territory in connection with the Collaboration and (b) rights granted to Third Parties
before the Effective Date for research purposes, and (c) the right reserved for Athersys and its
Affiliates to grant rights to the Athersys Technology for research purposes.

1.2 Stand-by Licenses. To ensure continuity of the rights granted herein, upon reasonable
request by RTI, RTI and Athersys will work cooperatively to enter into stand-by license agreements
with Third Parties from whom Athersys has been licensed intellectual property rights within the
Athersys Technology.

1.3 No Use of MultiStem Trademark. RTI will not, and will cause its Affiliates and its and
their respective direct and indirect distributors not to, use “MultiStem®” or any other word
confusingly similar thereto as or as part of a trademark or service mark in any form, including in
marketing or promotional literature, packaging, labels, presentations, or other tangible materials,
regardless of the media upon which such materials are created, stored, presented or distributed.

			
	 	 	 
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1.4 Limited Use of MAPC and Multipotent Adult Progenitor Cell. To the extent that RTI, any
of its Affiliates or its sublicensees, or any of their respective direct and indirect distributors
desires to use or uses either or both of the terms “MAPC” or “Multipotent Adult Progenitor Cell,”
such uses shall be limited to the following forms: “MAPC-based,” “MAPC Technology Product,” “MAPC
Technology Implant,” “MAPC Technology-based,” Multipotent Adult Progenitor Cell-based,” or other
variations of the terms upon consent of Athersys, such consent not to be unreasonably withheld.
For the sake of clarity, this limitation is intended to reinforce and support the distinctiveness
of the MAPC Technology Product relative to Athersys’s culture expanded cell products, including
MultiStem products and related products, and to limit any confusion in the marketplace and with
clinicians and regulators, among others. As reasonably requested by Athersys from time to time,
RTI shall, at its own expense, submit copies, photographs or representative samples of any
materials used by RTI or its sublicensees to promote MAPC Technology Products.

1.5 Other Opportunities. Athersys, on behalf of itself and its Affiliates, hereby grants
to RTI a right of first negotiation with respect to the use of MAPC Technology and MAPC Licensed
Patents in other product development and marketing opportunities for HCT/Ps not in the Field but
involving cartilage, tendons and ligaments applications (“Other Opportunities”). Should the
Parties fail to reach an agreement within a prescribed reasonable time frame for negotiation to be
established by the Parties at the beginning of negotiations with respect to the Other
Opportunities, Athersys and its Affiliates may negotiate with Third Parties. In the event the
foregoing negotiations between the Parties are unsuccessful, Athersys will nevertheless agree to
further discussions in good faith related to such Other Opportunities for so long as it is not
prohibited by any contractual or other legal obligation. Furthermore, Athersys agrees to notify
RTI within fifteen (15) business days of the receipt of a written proposal with defined terms from
a Third Party to research, develop, or commercialize a cell-based product constituting Other
Opportunities.

1.6 RTI Technology. Subject to the terms and conditions of this Agreement, RTI, on behalf
of itself and its Affiliates, hereby grants to Athersys and its Affiliates a non- exclusive license
and or sublicense (as the case may be) to the RTI Technology solely to research, develop, make,
have made, and use MAPC Technology Products in connection with the Collaboration. This license
includes the right to sublicense solely to Affiliates of Athersys.

1.7 Reservation of Rights. Except as expressly stated in this Article I, no rights or
licenses are granted under this Agreement by either Party or its Affiliates under any intellectual
property of such Party or its Affiliates to the other Party or its Affiliates, whether by
implication, estoppel or otherwise, and all such rights not expressly stated are hereby reserved by
each Party and its Affiliates.

			
	 	 	 
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Article II: Consideration, Reports and Records

2.1 License Fee. In consideration of the rights and benefits granted to RTI herein, RTI
shall pay to Athersys a one-time license fee of Five Million Dollars ($5,000,000) (hereinafter the
“License Fee”) payable in installments upon the dates indicated below (there being no penalty for
pre-payment in RTI’s sole discretion) or upon satisfaction of the following conditions precedent:

2.1.1 One Million Dollars ($1,000,000) concurrently with the execution of this Agreement;

2.1.2
One Million Dollars ($1,000,000) on or before December 31, 2010;

2.1.3
One Million Dollars ($1,000,000) on or before March 31, 2011;

2.1.4
One Million Dollars ($1,000,000) [ * ];

2.1.5
One Million Dollars ($1,000,000) [ * ].

2.2 Royalties.

2.2.1 Subject to Section 2.2.2, RTI shall pay royalties to Athersys as follows based on CNR,
as CNR is accumulated during the Term:

2.2.1.1 For CNR in the range of [$*], RTI shall pay Athersys [*%] of said CNR.

2.2.1.2 For CNR in the range of [$*], RTI will pay Athersys [*%] of said CNR.

2.2.1.3 For CNR in excess of [$*], RTI will pay Athersys [*%] of said CNR.

2.2.2 In the event of a change in market conditions beyond RTI’s control, such as that arising
from, for example purposes only, a force majeure event or disruptive technology, that results in a
[ * ], then RTI’s royalty rate will be [ * ].

2.2.3 Payments to be made in accordance with Section 2.2 shall be calculated quarterly by RTI
and made to Athersys within sixty (60) days following the end of the given calendar quarter for
which said payments were calculated. The Parties will work in good faith to resolve any questions
or disputes related to the payments.

2.3 Milestone Payments. Upon first achieving specific CNR milestones, as defined herein
below, RTI shall make milestone payments to Athersys as follows:

2.3.1 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].

2.3.2 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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2.3.3 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].

2.3.4 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].

2.3.5 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].

2.3.6 Nothing in this Agreement shall be interpreted so as to create any obligation for RTI to
pay more than a cumulative total of $35,500,000.00 in milestone payments under this Section 2.3.

2.3.7 For the purposes of this Section 2.3, the total amount of CNR shall be measured as [
* ].

2.3.8 Payments to be made in accordance with Section 2.3 shall be made to Athersys within
sixty (60) days following achievement of the milestone.

2.4 [ * ].

2.5 Inter-Company Sales or Transfers. Sales or transfers between or among RTI and its
Affiliates and their respective direct and indirect distributors shall not by subject to, nor used
for calculating, CNR or payments due under Section 2.2 or 2.3 unless RTI, the Affiliate or the
distributor is an End User. Instead, only the first sale or transfer for fee to an End User or
Third Party shall be used to calculate CNR and said payments.

2.6 Payment Instructions. Payments pursuant to this Article II shall be made via bank wire
transfer to:

	 	 	 
	Bank:

	 	PNC
	 

	 	Cleveland, Ohio
	 

	 	[ * ]
	 
	 	 
	Account Name:

	 	Athersys, Inc.
	Account Number:

	 	[ * ]

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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With respect to any payments to be made pursuant to this Agreement, and where said payment would
otherwise become due and owing on a weekend, an RTI recognized holiday, or a holiday recognized by
the United States government, said payment shall become due and owing on the next following
business day.

2.7 Reports. Within thirty (30) business days following the end of each calendar quarter,
RTI will provide Athersys with a written report listing, on a country by country basis, the number
of MAPC Technology Products transferred or sold by RTI and its Affiliates in the quarter, the
gross revenues of transfers or sales of MAPC Technology Products to End Users in the quarter, the
CNR achieved for the quarter, the amount of royalties due for such transfers or sales pursuant to
Section 2.2, any milestones that were achieved in such quarter under Section 2.3, and any offsets
or reductions in royalties being applied pursuant to Section 2.2.2 or 2.4 and the basis therefor.

2.8 Records and Inspection Rights. During the Term and for at least three (3) years
thereafter, RTI shall keep complete and accurate business records with respect to the MAPC
Technology, MAPC Technology Products, all gross revenues derived from sales or transfers to End
Users thereof, the calculation of CNR and all payments due to Athersys hereunder; such records
shall include all documentation required to adequately demonstrate the accuracy of RTI’s
calculations of the amounts due to Athersys hereunder. With no greater frequency than twice per
calendar year, and with at least thirty (30) days advance written notice by Athersys to RTI, RTI
shall allow Athersys or its representatives to inspect such business records to ensure compliance
with this Agreement. Said records will be made available for inspection Monday through Friday
(excluding holidays observed by RTI) during the hours of 9:00 a.m. to 5:00 p.m. Eastern Standard
Time. If such inspection reveals that RTI has underpaid any amount due hereunder for any reporting
period by more than [ * ], then, in addition to prompt payment of the amount due, RTI
shall reimburse Athersys for its actual, reasonable out of pocket costs and expenses for such
inspection.

2.9 Currency. All payments due under this Agreement are stated in, and shall be computed
and paid in, United States Dollars. For the purposes of determining the amount of any CNR received
in any foreign currency, such CNR shall be converted into United States Dollars in a manner
consistent with the selling entity’s normal practices used to prepare its audited financial
statements; provided that such practices use a widely accepted source of published exchange rates.

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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2.10 Taxes. If any payments made by RTI pursuant to this Agreement become subject to
withholding taxes under the laws or regulation of any jurisdiction, RTI shall deduct and withhold
the amount of such taxes for the account of Athersys to the extent required by applicable Law or
regulations; such amounts payable to Athersys shall be reduced by the amount of taxes deducted and
withheld; and RTI shall pay the amounts of such taxes to the proper governmental authority in a
timely manner and promptly transmit to Athersys an official tax certificate or other evidence of
such tax obligations together with proof of payment from the relevant governmental authority of all
amounts deducted and withheld sufficient to enable Athersys to claim such payment of taxes. RTI
will provide Athersys with reasonable assistance to enable Athersys to recover such taxes as
permitted by applicable Law or regulations.

2.11 Interest. Any payment received after the date due hereunder shall bear interest at
the [ * ], compounded monthly, from the date due until the full amount including any
interest thereon is paid.

Article III – Collaboration and Technical Assistance

3.1 Collaboration Plan. With technical assistance from Athersys (as described in Section
3.4), RTI shall use commercially reasonable efforts to develop for commercialization in the Field a
MAPC Technology Product utilizing RTI Technology and Athersys Technology. To the extent not
otherwise provided in this Agreement, details of the Collaboration between the Parties shall be as
set forth in the Collaboration Plan attached to this Agreement as Exhibit B.
(“Collaboration Plan”).

3.2 Costs. Except as may be otherwise expressly provided for in this Agreement, including
the Collaboration Plan, both Parties shall bear their own expenses related to the performance of
this Agreement. If after [ * ] Athersys and its Affiliates incur costs greater than
[$*] related to tasks performed under the Collaboration Plan, RTI will reimburse
Athersys for said costs provided (1) Athersys notifies RTI in advance of incurring such excess
costs and RTI approves the expenditures, and (2) such excess costs are not attributable to
negligence on the part of Athersys.

3.3 Technical Assistance. In addition to the responsibilities and obligations of the
Parties as set forth in the Collaboration Plan, Athersys agrees to make its employees reasonably
available to consult with RTI regarding issues related to the extraction, isolation, maintenance
and preparation of cells using the MAPC Technology, including requests from any regulatory agency
with respect to regulatory, scientific, technical and clinical testing issues, and shall permit its
contractors knowledgeable in the extraction, isolation, maintenance and preparation of cells using
the MAPC Technology to consult with RTI in the presence of (but not without any) such
Athersys employees. In addition to the foregoing, representatives of RTI and Athersys may, upon
reasonable notice and at times reasonably acceptable to the other Party (i) visit the facilities
where the Collaboration is being conducted, and (ii) consult informally with personnel of the other
Party performing work on the Collaboration during such visits, by telephone, by facsimile or
electronic transmission, or in any other such manner as the Parties may agree. If so requested by
one Party, the other Party shall cause appropriate individuals working on the Collaboration to be
available for meetings at the location of the facilities where such individuals are employed at
times reasonably convenient to the Party responding to such request.

 

	 	 	 
	*	 	Confidential treatment has been requested for the
redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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3.4 Collaboration Data. Collaboration Data shall be shared and disclosed between the
Parties on a regular basis through the Term of the Collaboration. Collaboration Data that relate
specifically and exclusively to RTI Technology shall be considered the Confidential Information of
RTI owned by RTI, notwithstanding which Party first disclosed such data to the other Party.
Collaboration Data that relate to Athersys Technology, including data regarding cell media, cell
potency, cell differentiation and cell performance characteristics, shall be considered the
Confidential Information of Athersys owned by Athersys, notwithstanding which Party first disclosed
such data to the other Party. Collaboration Data that would be used ordinarily for regulatory,
business development, or commercialization purposes, including the MAPC Technology Product’s
identity, application and performance, or any other Collaboration Data that are not specified as
the Confidential Information of RTI or Confidential Information of Athersys shall be considered the
Confidential Information of both Parties and owned jointly by both Parties (“Jointly Owned
Collaboration Data”), notwithstanding which Party first disclosed such data or information to the
other Party.

3.5 Use of Contractors. RTI shall not use contractors to perform any activities under the
Collaboration Plan related to the use, extraction, isolation, expansion, maintenance, or culture of
MAPCs without the prior written consent of Athersys, which consent shall not be unreasonably
withheld. If RTI seeks to use a contractor for any such activities, it shall provide to Athersys a
copy of the proposed contract between RTI and the contractor before entering into any such
agreement so that Athersys can ensure it contains provisions consistent with the requirements of
this Agreement.

Article IV: Confidentiality

4.1 Athersys Confidential Information. With respect to Athersys, the term “Confidential
Information” refers to the Collaboration Data solely or jointly owned by Athersys pursuant to
Section 3.4, Athersys’ and its Affiliates’ specialized and proprietary trade secrets, formulas,
processes, methods, technology, know-how, customer and vendor information and lists, financial
data, undisclosed and unreleased products, and other items or information related to or that
constitutes the Athersys Technology and any manufacturing, laboratory and clinical testing and
research methodologies or models; in each case that when furnished, shown, or disclosed to RTI or
its Affiliate is designated, whether in writing or orally (followed by a written confirmation and
summary), as “Confidential,” or which is of such nature and character that a reasonable person in
the trade would understand it to be confidential without the necessity of it being so designated.

			
	 	 	 
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4.2 RTI Confidential Information. With respect to RTI, the term “Confidential Information”
refers to the Collaboration Data solely or jointly owned by RTI pursuant to Section 3.4, RTI’s and
its Affiliates’ specialized and proprietary trade secrets, formulas, processes, methods,
technology, know-how, customer and vendor information and lists, financial data, undisclosed and
unreleased tissue lines or products, and other items or information related to its allograft
tissue, xenograft tissue, surgical implants, devices, associated processing and sterilization
technologies for each, instrumentation, and any manufacturing, laboratory and clinical testing and
research methodologies or models; in each case that when furnished, shown, or disclosed to Athersys
is designated, whether in writing or orally (followed by a written confirmation and summary), as
“Confidential,” or which is of such nature and character that a reasonable person in the trade
would understand it to be confidential without the necessity of it being so designated.

4.3 Confidential ad infinitum. The Parties recognize and agree that each Party may possess
certain trade secrets that will likely continue to have commercial and competitive value for an
indeterminate period of time, and perhaps in perpetuity. Therefore, a Party may in its sole
discretion designate as “Confidential ad infinitum” those certain trade secrets it reasonably
believes fit such criteria. Any provision of this Agreement to the contrary not withstanding,
trade secrets must be designated in writing as “Confidential ad infinitum” within one (1) month of
disclosure to the receiving Party, unless a later designation is otherwise consented to by the
receiving Party, such consent not to be unreasonably withheld. Trade secrets that are Confidential
ad infinitum shall at a minimum be given all the same protections as Confidential Information, with
certain added or heightened requirements as further described below. Election not to designate a
trade secret as Confidential ad infinitum, or failure to so designate, shall not be deemed to erode
or abrogate a trade secret’s underlying status as Confidential Information.

4.4 Joint Confidential Information. The Jointly Owned Collaboration Data and content of
the negotiations between the Parties concerning this Agreement shall be the Confidential
Information of both Parties. A Party wishing to disclose any part of this joint Confidential
Information must first obtain written permission from the other Party by contacting the designated
corporate representative for such purpose as set forth in Section 4.7. Such written permission
will not be unreasonably denied or delayed. The foregoing notwithstanding, either Party may
disclose the Jointly Owned Collaboration Data in connection with any of its activities permitted
under Article V or as otherwise specified in this Article IV.

4.5 Survival. The obligations and rights of the Parties under this Article 4 shall survive
any expiration or termination of this Agreement for any reason whatsoever (including, without
limitation, termination by either party for a material breach by the other Party of its obligations
hereunder) for, in the case of Confidential Information, a period of seven (7) years, or, in the
case of trade secrets that are Confidential ad infinitum, for an initial period of ten (10) years
with options to renew the Confidential ad infinitum designation for additional terms of five (5)
years for as long as the disclosing Party reasonably and in good faith believes such continuing
status is competitively advantageous. The disclosing Party must submit thirty (30) days advance
written notice of its intent to renew the Confidential ad infinitum designation. Because of the
unique and proprietary nature of the information that is Confidential and/or Confidential ad
infinitum, it is understood and agreed that either Party’s remedies at law for a breach by the
other Party of its obligations under Article 4 will be inadequate and that the non-breaching Party
shall, in the event of any such breach, be entitled to seek equitable relief (including, without
limitation, injunctive relief and specific performance), in addition to all other remedies provided
under this Agreement or available at law. A Party seeking relief pursuant this Section 4.5 shall
not be required to post a bond as a condition for obtaining and/or exercising such relief.

			
	 	 	 
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4.6 Restrictions on Use and Disclosure. Each Party agrees not to use the Confidential
Information of the other Party, excluding Jointly Owned Collaboration Data, for any purpose except
for the purposes of the Collaboration and as necessary to carry out the terms of any business
relationship between the Parties hereto. Each Party further agrees that it will not disclose the
Confidential Information of the other Party, including the Jointly Owned Collaboration Data, to any
Third Party other than such Party’s employees, agents or contractors who are directly involved in
the business relationship between the Parties hereto, and then only on a need-to-know basis and
under an obligation of confidentiality that restricts further disclosure consistent with the
obligations of non-use and non-disclosure provided herein. Each Party agrees that it will take
reasonable security measures and use reasonable care to preserve and protect the secrecy of the
other Party’s Confidential Information, including the Jointly Owned Collaboration Data.

4.7 Return of Information. Upon request after termination of this Agreement by a Party for
return of the Confidential Information of such Party, excluding Jointly Owned Collaboration Data,
the other Party shall, within fifteen (15) business days of the request, either return or destroy
all written or tangible material containing or reflecting Confidential Information of the
requesting Party (whether prepared by the requesting Party or otherwise), without retaining any
copies, summaries, analyses, or abstracts thereof except that each Party’s independent outside
counsel may retain one copy for attorney’s eyes only. An authorized officer of the recipient shall
confirm in writing recipient’s compliance with this Section 4.7 with twenty (20) business days
after the disclosing Party’s request for the return of Confidential Information.

4.8 Permitted Disclosures. When Confidential Information of the other Party or Jointly
Owned Collaboration Data is required to be disclosed by a Party to comply with (i) applicable
laws and regulations, (ii) the rules of a national securities exchange on which the shares of such
Party are listed, or (iii) the order of a court or administrative law judge or tribunal of
competent jurisdiction, such Party shall (a) provide to the other Party, to the extent reasonably
practicable, prior written notice of such required disclosure and, (b) upon request by the other
Party, provide such Party assistance with taking all reasonable and lawful actions to obtain
confidential treatment for the Confidential Information, and (c) take all reasonable and
practicable steps to minimize the extent of such disclosure. A Party may disclose the Confidential
Information of the other Party and the Jointly Owned Collaboration Data to any actual or bona fide
potential lender, private investor, licensee/sublicensee, acquiror or successor under an obligation
of confidentiality that restricts further disclosure consistent with the obligations of non-use and
non-disclosure provided herein. A Party may disclose the Jointly Owned Collaboration Data to an
regulatory authority as reasonably required in connection with seeking or obtaining any approvals
for any of its products.

			
	 	 	 
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4.9 Exceptions. The obligations of a Party under this Article 4 will not apply to
information which such Party can affirmatively show:

(a) was independently developed or discovered by such Party without use or benefit of
the other Party’s Confidential Information, as demonstrated by written records;

(b) is already available to the public;

(c) becomes available to the public through no fault of such Party; or

(d) was independently developed by an employee or consultant of such Party who had no
previous direct or indirect knowledge or benefit of the disclosures made under this
Agreement.

4.10 Press Releases. Except as may be deemed to be required by applicable laws or
regulations by counsel to a Party, neither Party shall issue any press releases about the
relationship of the Parties under this Agreement other than in a form or with content as mutually
agreed. Each Party may issue the press release attached hereto at Exhibit D upon or
promptly after this Agreement becomes effective.

Article V: Ownership and Use of Inventions

5.1 Inventions and Inventorship. Inventorship of inventions or discoveries that are
conceived during the performance of the Collaboration (“Inventions”), whether or not patentable,
shall be determined in accordance with U.S. patent laws. To facilitate proper
determination of inventorship and ownership of Inventions in accordance with this Article V,
the Parties shall fully and promptly disclose, in confidence, any and all Inventions conceived by
such Party, its Affiliate or its or their respective employees and contractors in writing to the
other Party. A subsequent invention or discovery shall be deemed an “improvement” of an earlier
invention or discovery if the practice of the subsequent invention would infringe upon or
constitute misappropriation of any intellectual property rights in the earlier invention or
discovery (in the absence of a license to such intellectual property rights).

			
	 	 	 
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5.2 RTI Technology Inventions. [ * ].

5.3 Other Inventions. [ * ].

5.4 Patent Prosecution for Inventions. [ * ]. Each Party agrees to cooperate
in timely completion and execution of all documents or other items necessary to further the
domestic and/or international intellectual property protection available to the Inventions.

5.5 Prior Inventions. Nothing contained in this Agreement shall be deemed to grant either
Party, directly or by implication, estoppel, or otherwise, any right, title, interest or license to
any patents, patent applications, copyrights, trademarks, trade dress, trade secrets or other
intellectual property owned or developed by the other Party before the Effective Date.

Article VI: Term

6.1 Term. Unless terminated sooner pursuant to Sections 6.1.1 – 6.1.4, the term of this
Agreement shall be for the longer of (i) five (5) years from the Effective Date of this Agreement,
(ii) two (2) years after the last sale or distribution of a MAPC Technology Product by RTI or any
of its Affiliates, (iii) the active life of any past, present, or future issued patents within the
Athersys Technology, wherein said claims would be infringed by the MAPC Technology Products but for
the licenses granted pursuant to this Agreement, or (iv) the life of trade secrets within the
Athersys Technology applicable to RTI’s manufacture of MAPC Technology Products. The period from
the Effective Date until expiration or termination of this Agreement is the “Term.”

6.1.1 Bankruptcy. Athersys may, in its sole discretion, choose to terminate this
Agreement in the event RTI is subject to a bankruptcy event. RTI may, in its sole discretion,
choose to terminate this Agreement in the event Athersys is subject to a bankruptcy event. For
purposes hereof, a “bankruptcy event” means, with respect to a Party, if the Party shall have
become insolvent or bankrupt, or shall have an assignment for the benefit of its creditors, or
there
shall have been appointed a trustee or receiver of the Party or for all or a substantial part of
its property or any case or proceeding shall have been commenced or other action taken by or
against the Party in bankruptcy or seeking reorganization, liquidation, dissolution, winding up,
arrangement or readjustment of its debts or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there
shall have been issued a warrant of attachment, execution, restraint or similar process against any
substantial part of the property of the Party, and any such event shall have continued for sixty
(60) days undismissed, unbonded and undischarged.

 

	 	 	 
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omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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6.1.2 Abrogation of Rights. In the event any of Athersys’ or, where applicable, its
Affiliates’ rights to the Athersys Technology expire or are otherwise terminated, diminished,
revoked, rescinded, repealed, or invalidated such that there is a material effect on the
development and commercialization of the MAPC Technology Products, RTI may, in its sole discretion,
choose to terminate this Agreement.

6.1.3 Diligence. Athersys may, in its sole discretion, choose to terminate this
Agreement, upon notice to RTI, if (i) RTI and its Affiliates have not made their first commercial
sale or distribution of a MAPC Technology Product after the passage of [ * ] from the
Effective Date and no longer continue to make commercially reasonable efforts to develop a MAPC
Technology Product, (ii) RTI and its Affiliates have not had more than [$*] of CNR after
the passage of [ * ] from the Effective Date, or (iii) after the passage of [
* ] from the Effective Date, RTI and its Affiliates have not had more than
[$*] of CNR during any calendar year.

6.1.4 Breach. If either Party materially breaches any of its respective obligations
under this Agreement, and such breach is not cured within sixty (60) days after the giving of
written notice by the other Party specifying such breach, then such other Party shall have the
right to terminate this Agreement by providing the breaching Party written notice within ten (10)
days following the expiration of such sixty (60)-day period (such termination to be effective upon
receipt of such termination notice). For the purpose of this Section, a material breach shall
include a material inaccuracy in any warranty or representation contained herein.

6.2 Survival of Obligations. The termination or expiration of this Agreement shall not
relieve the Parties of any obligations accruing prior to such expiration or termination, and any
such expiration or termination shall be without prejudice to the rights of any Party against
another Party. Upon termination of this Agreement for any reason other than by RTI pursuant to
Section 6.1.4, any unpaid portion of the License Fee due under Sections 2.1.1, 2.1.2, and 2.1.3
shall become due and payable within thirty (30) days after termination, whether or not the time or
other condition for any portion of such payment has been satisfied. In addition, the following
provisions shall survive any expiration or termination of this Agreement for any reason:
“Definitions” section; section 1.7; sections 2.5 —  2.11 (with respect to any payments accrued
prior to or upon termination); section 3.4; article IV (for the period specified in section 4.5);
article V; this section 6.2; article VII; and sections 8.2, 8.3, 8.5- 8.11.

 

	 	 	 
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redacted portions of this exhibit, and such confidential portions have been
omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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Article VII: Insurance and Indemnification

7.1 Insurance. Each Party hereby represents and warrants that it now maintains, and will
continue to maintain, primary commercial general liability insurance, including products liability
coverage, in a minimum amount of [$*] per occurrence and [$*] in the
aggregate. At a minimum, each Party shall maintain the policy(ies) required hereunder for the
entire term of this Agreement and, if any such policy(ies) shall provide coverage on a claims made
basis, the Party holding such policy will be required to maintain a claims made policy(ies)
providing such coverage for an additional period of not less than [ * ] following the
end of the term of this Agreement.

7.2 Indemnification by Athersys. Athersys shall indemnify, defend, and hold RTI and, as
applicable, its Affiliates, and its and their respective employees, officers and directors (“RTI
Indemnitees”) harmless from and against any and all claims, suits, and demands of Third Parties and
any and all associated losses, damages or costs (including attorneys’ fees) arising out of or
incurred in connection with (i) Athersys Indemnitees’ gross negligence or willful misconduct in the
performance of Athersys’ obligations under the Agreement, (ii) a breach by any Athersys Indemnitee
of the covenants, warranties and/or representations made by Athersys in this Agreement or an act or
failure to act by a sublicensee of Athersys that if done or not done by Athersys would constitute a
breach of any of the covenants, warranties and/or representations made by Athersys in this
Agreement, or (iii) the use of Athersys Technology, RTI Technology, Collaboration Technology by any
of the Athersys Indemnitees; provided, however, all of the foregoing is only to the extent that
such claims, suits, or demands (a) do not result from a breach of any of the provisions of the
Agreement by any of the RTI Indemnitees, or (b) do not result from the gross negligence or willful
misconduct of any of the RTI Indemnitees.

7.3 Indemnification by RTI. RTI shall indemnify, defend, and hold Athersys and, as
applicable, its Affiliates, and its and their respective employees, officers and directors
(“Athersys Indemnitees”) harmless from and against any and all claims, suits, and demands of Third
Parties and any and all associated losses, damages or costs (including attorneys’ fees) arising out
of or incurred in connection with (i) RTI Indemnitees’ gross negligence or willful misconduct in
the performance of RTI’s obligations under the Agreement, (ii) a breach by any RTI Indemnitee of
the covenants, warranties and/or representations made by RTI in this Agreement or an act or failure
to act by a sublicensee of RTI that if done or not done by RTI would constitute a breach of any of
the covenants, warranties and/or representations made by RTI in this Agreement, or (iii) the use of
Athersys Technology, RTI Technology, or
Collaboration Technology by any of the RTI Indemnitees and/or the development, manufacture, use,
storage, handling, distribution or sale of a MAPC Technology Product on, by or on behalf of any RTI
Indemnitee or sublicensee; provided, however, all of the foregoing is only to the extent that such
claims, suits, or demands (a) do not result from a breach of any of the provisions of the
Agreement by any of the Athersys Indemnitees, (b) do not result from the gross negligence or
willful misconduct of any of the Athersys Indemnitees, or (c) [ * ].

 

	 	 	 
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omitted and filed separately with the Securities and Exchange Commission.

			
	 	 	 
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7.4 Notice and Cooperation. To receive the benefit of the foregoing indemnities, the Party
seeking indemnification must promptly notify the other Party in writing of a claim, suit or demand,
and provide reasonable cooperation (at the indemnifying Party’s expense) and full authority to
defend or settle that portion of a claim, demand or suit indemnified by the indemnifying Party;
provided, however, the indemnifying Party shall not be entitled to defend or settle any claim,
demand or suit on behalf of the indemnified Party in any manner that admits liability, requires any
action, or involves and restriction from action of the indemnified Party, without first obtaining
written permission from the indemnified Party. Failure of the Party seeking indemnification to
provide prompt notice shall not relieve the indemnifying Party of any of its obligations under this
Article VII, except to the extent the indemnifying Party is prejudiced by such failure. The
indemnifying Party shall have no obligation to indemnify the indemnified Party with respect to any
settlement made without the indemnifying Party’s written consent, or with respect to any portion of
a claim, demand or suit that is not covered by the indemnification provision of Section 7.2 or 7.3,
whichever is applicable. In the event a claim, demand or suit contains both indemnified and
non-indemnified elements, each Party shall be responsible for its own costs and expenses related to
the portion of the claim, demand or suit for which it is responsible. Costs and expenses that are
attributable to both indemnified and non-indemnified elements of a claim (i.e. the costs and
expenses cannot reasonably be disaggregated and assigned to distinct elements), demand or suit
shall be borne equally by the Parties.

Article VIII: Miscellaneous Provisions

8.1 Representations, Covenants and Warranties. In addition to any other covenant,
representation and/or warranty provided for elsewhere in this Agreement, the Parties represent,
covenant and warrant as follows.

8.1.1 Athersys represents, covenants and warrants that: (i) Athersys has the right (both in
law and equity) to grant the licenses, covenants and warranties set forth in this Agreement; (ii)
neither Athersys nor its Affiliates have any outstanding encumbrances or agreements, including any
agreements with any Third Parties, which would be inconsistent with the licenses, covenants and
warranties set forth in this Agreement; (iii) as of the Effective Date, neither Athersys nor its
Affiliates are aware of any pending or threatened claims of infringement related to the
Athersys Technology; (iv) as of the Effective Date, to Athersys’ knowledge, no issued or granted
patent rights licensed to RTI pursuant to this Agreement are presently invalid or unenforceable;
(v) Athersys and its Affiliates have

 

	 	 	 
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taken,
and will continue to take, commercially reasonable measures that Athersys deems appropriate under the circumstances to attempt to maintain the
confidentiality and trade secret status of all trade secrets within the Athersys Technology
material to the success of the MAPC Technology Products; (vi) as of the Effective Date, to
Athersys’ knowledge, the research, development, manufacture, use, sale, or distribution of a MAPC
Technology Product as contemplated hereby will not infringe any United States patents owned by a
Third Party and issued or granted as of the Effective Date and, to Athersys’ knowledge, there are
no material facts that are in the possession of Athersys as of the Effective Date, that Athersys
has not disclosed to RTI, and that would lead a reasonable person to conclude that the research,
development, manufacture, use, sale, or distribution of a MAPC Technology Product as contemplated
hereby will infringe any United States patents owned by a Third Party and issued or granted as of
the Effective Date; (vi) no employee or agent of Athersys or any of its Affiliates will make an
untrue statement of a material fact to any governmental authority with respect to the MAPC
Technology Products, Athersys Technology, or RTI Technology; and (vii) Athersys and its Affiliates
will comply materially with all applicable laws, rules, regulations, permits, governmental
licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions
and decrees, including the Federal Food, Drug and Cosmetic Act, in the research, development,
manufacture, and use of the MAPC Technology Products, and will promptly inform RTI in writing if
either Athersys or any of its Affiliates receive any written notice from any regulatory authority
claiming that any such activities as conducted by them are not in such compliance.

8.1.2 RTI represents, covenants and warrants that: (i) RTI has the right (both in law and
equity) to grant the licenses, covenants and warranties set forth in this Agreement and to use the
RTI Technology to develop and commercialize any MAPC Technology Product contemplated by this
Agreement; (ii) neither RTI nor its Affiliates have any outstanding encumbrances or agreements,
including any agreements with any Third Parties, which would be inconsistent with the licenses,
representations, covenants and warrants set forth in this Agreement; (iii) as of the Effective
Date, neither RTI nor its Affiliates are aware of any pending or anticipated claims of infringement
related to the RTI Technology or its anticipated use in the development and commercialization of a
MAPC Technology Product; (iv) RTI and its Affiliates have taken, and will continue to take,
commercially reasonable measures that RTI deems appropriate under the circumstances to attempt to
maintain the confidentiality and trade secret status of all trade secrets within the RTI Technology
material to the commercial success of the MAPC Technology Products; (v) as of the Effective Date,
to RTI’s knowledge, the research, development, manufacture, use, sale, or distribution of a MAPC
Technology Product as contemplated by this Agreement will not infringe any United States patents
owned by a Third Party and issued or
granted as of the Effective Date; (vi) no employee or agent of RTI or any of its Affiliates
will make an untrue statement of a material fact to any governmental authority with respect to the
MAPC Technology Products, Athersys Technology, or RTI Technology; and (vii) RTI and its Affiliates
will comply materially with all applicable laws, rules, regulations, permits, governmental
licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions
and decrees, including the Federal Food, Drug and Cosmetic Act, in the research, development,
manufacture, use, offer for sale or transfer, sale or transfer, distribution, marketing and other
activities in connection with the MAPC Technology Products and Athersys Technology, and will
promptly inform Athersys in writing if either RTI or any of its Affiliates receive any written
notice from any regulatory authority claiming that any such activities as conducted by them are not
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8.2 Remedies Cumulative. Except as specifically provided herein, no remedy made available
to either Party hereunder is intended to be exclusive of any other remedy, and each and every
remedy shall be cumulative and shall be in addition to every other remedy provided hereunder or
available at law or in equity.

8.3 Notices. Any notice, report, or consent required or permitted by this Agreement to be
given or delivered, shall be in writing and shall be deemed given or delivered if delivered in
person, sent by courier, expedited delivery service, registered or certified mail(postage prepaid,
return receipt requested), or by telecopy (if confirmed), as follows:

	 	 	 	 	 	 	 
	RTI:	 	ATHERSYS:
	 
	 	 	 	 	 	 
	 

	 	Robert P. Jordheim
	 	 	 	William Lehmann
	 

	 	Executive VP and CFO
	 	 	 	President and COO
	 

	 	RTI Biologics, Inc.
	 	 	 	ABT Holding, Inc.
	 

	 	11621 Research Circle
	 	 	 	3201 Carnegie Avenue
	 

	 	Alachua, Florida 32615
	 	 	 	Cleveland, OH 44115-2634
	 

	 	Fax: (386) 462-3821
	 	 	 	Fax: (216) 361-9495
	 
	 	 	 	 	 	 
	With a copy to:	 	With a copy to:
	 
	 	 	 	 	 	 
	 

	 	Legal Department
	 	 	 	Thomas A. Briggs
	 

	 	RTI Biologics, Inc.
	 	 	 	Jones Day
	 

	 	11621 Research Circle
	 	 	 	12265 El Camino Real, Ste 200
	 

	 	Alachua, Florida 32615
	 	 	 	San Diego, CA 92130
	 

	 	Fax: (386) 462-3821
	 	 	 	Fax: (858) 314-1150

8.4 Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
agreement.

			
	 	 	 
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8.5 Waivers. Performance of any obligations required of a Party hereunder may be waived
only by a written waiver signed by the other Party, which waiver shall be effective only with
respect to the specific obligations described therein. Anything contained herein to the contrary
notwithstanding, the Parties shall be excused from performing their obligations under this
Agreement if performance is delayed or prevented by any event beyond such Party’s reasonable
control and without the fault or negligence of the Party seeking to excuse performance, including,
but not limited to, acts of God, fire, terrorism, explosion, weather, plague, war, insurrection,
civil strife or riots, provided, however, such performance shall be excused only to the extent of
and during such disability and such Party makes commercially reasonable efforts to remove the
disability. Any Party seeking to excuse or delay performance under this section shall provide
detailed written notice to the other Party of the nature and anticipated duration of the delay.

8.6 Assignment. Neither Party may assign this Agreement or any of its rights or
obligations hereunder (including, without limitation, its rights and duties of performance) to any
Third Party without the prior written consent of the other Party hereto. Notwithstanding the
foregoing, this Agreement and the rights, interests and obligations hereunder may be assigned by
RTI or Athersys to (i) any entity that is an Affiliate as of the Effective Date of this Agreement
and remains an Affiliate as of the proposed date of Assignment, or (ii) any entity that is not a
competitor of the non-assigning Party (or its Affiliates) and that either becomes an Affiliate or
successor in interest after the Effective Date by operation of a merger, acquisition,
change-in-control, or reorganization or that purchases all or substantially all of the assets of
the assigning Party to which this Agreement relates. Assignees to whom this Agreement is assigned
pursuant to the foregoing Sections 8.6(i) and (ii) shall receive all of the Assignor’s rights,
benefits, interest, and obligations provided for in this Agreement. In the event of assignment,
the assigning Party shall remain bound to all provisions of this Agreement under Article IV.

8.7 Entire Agreement; Amendments. This Agreement constitutes the entire agreement between
the Parties with respect to the subject matter hereof, and supersedes and cancels all prior
agreements, communications and understandings, whether written or oral. This Agreement may not be
modified or amended except by an instrument in writing signed by both of the Parties hereto.

8.8 Severability. Should any part or provision of this Agreement be found invalid or held
unenforceable, the remainder shall remain valid and in full force. The Parties agree to negotiate
in good faith an amendment of such part or provision in a manner consistent with the intention of
the Parties as expressed in this Agreement.

			
	 	 	 
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8.9 Independent Contractors. Nothing contained in this Agreement shall be construed as
creating a joint venture, partnership or employment relationship between the Parties hereto. Except
as specified herein, neither Party shall have the right, power or implied authority to create any
obligation or duty, express or implied, on behalf of the other Party hereto.

8.10 Governing Law. This Agreement shall be construed and enforced in accordance with the
laws of the State of New York, without application of its conflicts of laws principles.

8.11 Drafting and Interpretation of Agreement. This Agreement shall be treated as having
been drafted through the equal participation of both Parties, and no provision shall be interpreted
against any Party on the basis that the Party is deemed to be the sole or primary drafter of the
provision. The following rules of interpretation apply to this Agreement: (i) “include”, “includes”
and “including” are not limiting and mean include, includes and including, without limitation; (ii)
definitions contained in this Agreement are applicable to the singular as well as the plural forms
of such terms; (iii) references to an agreement, statute or instrument mean such agreement, statute
or instrument as from time to time amended, modified or supplemented; (iv) references to a person
or entity are also to its permitted successors and assigns; (v) references to an “Article”,
“Section”, “Exhibit” or “Schedule” refer to an Article or Section of, or any Exhibit or Schedule
to, this Agreement unless otherwise indicated; (vi) the word “will” shall be construed to have the
same meaning and effect as the word “shall”; and (vii) the word “any” shall mean “any and all”
unless otherwise indicated by context. All money in this Agreement is stated in and shall be
reported and paid in United States Dollars.

<signatures follow on next page>

			
	 	 	 
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IN WITNESS WHEREOF, this Agreement has been executed by the Parties hereto as of the last date
written below.

	 	 	 	 	 	 	 	 	 
	RTI Biologics, Inc.	 	ABT Holding, Inc.	 	 
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert P. Jordheim
	 	By:
	 	/s/ William Lehmann	 	 
	 

	 	 

	 	 	 	 

	 	 
	 

	 	Robert P. Jordheim
	 	 	 	William Lehmann	 	 
	 

	 	Executive VP and CFO.
	 	 	 	President and COO.	 	 
	 
	 	 	 	 	 	 	 	 
	Date: September 10, 2010	 	Date: September 10, 2010	 	 

			
	 	 	 
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EXHIBIT A

[ * ]

 

	 	 	 
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EXHIBIT B

[ * ]

 

	 	 	 
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EXHIBIT C

Affiliates

RTI Affiliates:

Tutogen Medical, Inc.

Tutogen Medical (US), Inc.

Tutogen Medical, GmbH

Tutogen Medical, SARL

RTI Donor Services, Inc.

RTI Services, Inc.

Athersys Affiliates:

Athersys, Inc.

ABT Holding Company

ReGenesys BVBA

Advanced Biotherapeutics, Inc.

Athersys Limited

ReGenesys LLC

			
	 	 	 
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EXHIBIT D

Initial Press Release

	 	 	 
	FOR RELEASE AT 7:00 AM ET

	 	For more information, contact:
	 
	 	 
	SEPT. 13, 2010

	 	RTI BIOLOGICS:
	 
	 	 
	 

	 	Robert Jordheim
	 
	 	 
	 

	 	Chief Financial Officer
	 
	 	 
	 

	 	rjordheim@rtix.com
	 
	 	 
	 

	 	Wendy Crites Wacker, APR
	 
	 	 
	 

	 	Corporate Communications
	 
	 	 
	 

	 	wwacker@rtix.com 
	 
	 	 
	 

	 	Phone (386) 418-8888
	 
	 	 
	 

	 	ATHERSYS:
	 
	 	 
	 

	 	William (B.J.) Lehmann, J.D.
	 
	 	 
	 

	 	President and Chief Operating Officer
	 
	 	 
	 

	 	bjlehmann@athersys.com
	 
	 	 
	 

	 	(216) 431-9900
	 
	 	 
	 

	 	Investor Relations:
	 
	 	 
	 

	 	Lisa M. Wilson
	 
	 	 
	 

	 	In-Site Communications
	 
	 	 
	 

	 	lwilson@insitecony.com
	 
	 	 
	 

	 	(917) 543-9932
	 
	 	 
	 

	 	Media Relations:
	 
	 	 
	 

	 	Dan Budwick
	 
	 	 
	 

	 	Pure Communications, Inc.
	 
	 	 
	 

	 	dan@purecommunicationsinc.com
	 
	 	 
	 

	 	(973) 271-6085

			
	 	 	 
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RTI BIOLOGICS AND ATHERSYS ANNOUNCE COLLABORATION IN THE ORTHOPEDIC MARKET

Applying Complementary Stem Cell and Regenerative Medicine Technologies

ALACHUA, Fla. and CLEVELAND (Sept. 13, 2010) – RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a
leading provider of orthopedic and other biologic implants, and Athersys Inc. (Athersys) (Nasdaq:
ATHX), a leader in regenerative medicine and cell therapy research and development, announced today
an agreement under which Athersys will provide RTI access to its Multipotent Adult Progenitor Cell
(MAPC) technologies.

Under the agreement, RTI has licensed Athersys’ technology to isolate and preserve cells from organ
and tissue donors. This will enable RTI to develop and commercialize MAPC technology-based biologic
implants exclusively for certain orthopedic applications. With this license, RTI expands its
capabilities for accessing the fastest growing segment of the bone graft substitutes market, while
Athersys extends the application of its robust stem cell technology platform to an important
segment of the orthopedic market.

“We are very excited about our collaboration with Athersys and the potential to apply its MAPC and
related technologies in the orthobiologics market,” said Brian K. Hutchison, RTI’s chairman and
CEO. “After significant research into stem cells and the evaluation of multiple technologies, we
have determined that the MAPC technology offers the greatest potential to create high quality,
innovative implants for our surgeons and their patients. Licensing this technology is an important
step in enhancing and further differentiating RTI’s orthobiologics offering, an area of strategic
focus for the company.”

			
	 	 	 
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“We are enthusiastic about our relationship with RTI and this application of our proprietary stem
cell technologies to the orthopedic market,” said William Lehmann, Jr., president and COO of
Athersys. “Our primary focus is the development and commercialization of expanded, “off-the-shelf”
cell products, such as MultiStem®, for the treatment of certain cardiovascular, central
nervous system-related, inflammatory and immune system disorders, diseases and conditions. This
collaboration allows for the utilization of our already developed stem cell technologies in an
additional area. Further, it provides potential near term revenues from the orthopedic market.”

Under the agreement, Athersys will receive a $3 million license fee and is also eligible to receive
payments up to a cumulative total of $37.5M as follows: $2 million contingent upon successful
achievement of certain development and commercialization milestones, and an additional maximum
total of $35.5 million contingent upon achievement of certain cumulative revenue milestones, which
will reflect the ultimate commercial success of the product in this fast growing market. In
addition, Athersys will receive tiered royalties from the distribution of implants using Athersys’
technologies.

RTI plans to make MAPC technology-based biologic implants available to its customers for use in
orthopedic surgeries in the first half of 2012.

About RTI Biologics Inc.

RTI Biologics Inc. is a leading provider of sterile biological implants for surgeries
around the world with a commitment to advancing science, safety and innovation. RTI prepares human
donated tissue and bovine tissue for transplantation through extensive testing and
screening, precision shaping and using proprietary, validated processes. These allograft and
xenograft implants are used in orthopedic, dental, hernia and other specialty surgeries.

RTI’s innovations continuously raise the bar of science and safety for biologics – from being the
first company to offer precision-tooled bone implants and assembled technology to maximize each
gift of donation, to inventing validated sterilization processes that include viral inactivation
steps. Two such processes – the BioCleanse® Tissue Sterilization Process and the
Tutoplast® Tissue Sterilization Process – have a combined record of more than two million
implants distributed with zero incidence of allograft-associated infection. These processes have
been
validated by tissue type to inactivate or remove viruses, bacteria, fungi and spores from the
tissue while maintaining biocompatibility and functionality.

			
	 	 	 
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RTI’s worldwide corporate headquarters are located in Alachua, Fla., with international locations
in Germany and France. The company is accredited by the American Association of Tissue Banks in the
United States.

RTI Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are based on management’s current
expectations, estimates and projections about our industry, our management’s beliefs and certain
assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to
identify such forward-looking statements. In addition, except for historical information, any
statements made in this communication about anticipated financial results, growth rates, new
product introductions, future operational improvements and results or regulatory approvals or
changes to agreements with distributors also are forward-looking statements. These statements are
not guarantees of future performance and are subject to risks and uncertainties, including the
risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our
actual results may differ materially from the anticipated results reflected in these
forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the
company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at
www.sec.gov.

			
	 	 	 
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About Athersys Inc.

Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of
therapeutic product candidates designed to extend and enhance the quality of human life. The
company is developing MultiStem®, a patented, adult-derived “off-the-shelf” stem cell
product platform for multiple disease indications, including damage caused by myocardial
infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and
inflammatory bowel disease. The company is also developing a portfolio of other
therapeutic programs, including orally active pharmaceutical product candidates for the treatment
of metabolic and central nervous system disorders, utilizing proprietary technologies, including
Radom Activation of Gene Expression (RAGE®). Athersys has forged strategic alliances and
collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned
research institutions in the United States and Europe to further develop its platform and products.
More information is available at www.athersys.com.

Athersys Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties. We have attempted to identify
forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” or other
similar expressions. These forward-looking statements are only predictions and are largely based on
our current expectations. A number of known and unknown risks, uncertainties, and other factors
could affect the accuracy of these statements. Some of the more significant known risks that we
face are the risks and uncertainties inherent in the process of discovering, developing, and
commercializing products that are safe and effective for use as human therapeutics, the uncertainty
regarding market acceptance of any MAPC technology-based biologic implants in orthopedic
applications under the agreement with RTI and our ability to reach milestones and realize any
additional payments under such agreement. These risks may cause our actual results, levels of
activity, performance, or achievements to differ materially from any future results, levels of
activity, performance, or achievements expressed or implied by these forward-looking statements.
You should not place undue reliance on forward-looking statements contained in this press release,
and we undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise.

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