EXCLUSIVE LICENSE AGREEMENT
THIS LICENSE AGREEMENT is made and entered into as of this 28th day of
August, 2002 (the "Effective Date") by and between EMORY UNIVERSITY, a
non-profit Georgia corporation with offices located at 0000 Xxxxx Xxxxxx Xxxx,
X.X., Xxxxxxx, Xxxxxxx 00000 (hereinafter referred to as "EMORY"), and
CYBERKINETICS, INC., a for-profit Delaware corporation with offices located at
000 Xxxxxx Xxxxxx, Xxxxxxxxxx, XX 00000 (hereinafter referred to as
"CYBERKINETICS").
WITNESSETH
WHEREAS, EMORY is the assignee of all right, title, and interest in certain
inventions developed by an employee of EMORY and is responsible for the
protection and commercial development of such inventions; and
WHEREAS, Xxxxxx X. Xxxxxxxx, Ph.D., is an employee of EMORY and is named as
sole inventor (hereafter referred to as the "Inventor") in United States Patent
No. * * * for * * *, and
WHEREAS, CYBERKINETICS has the necessary expertise and will, as
appropriate, acquire the resources reasonably necessary to fully develop, obtain
approval for, and market products based upon the inventions claimed in the
above-referenced patent and the know-how not covered by the patent and licensed
hereunder; and
WHEREAS, EMORY wants to have such inventions developed, commercialized, and
made available for use by the public; and
WHEREAS, EMORY and CYBERKINETICS entered into that certain "Terms for
EMORY-CYBERKINETICS License Agreement" dated July 11, 2002 whereby EMORY and
CYBERKINETICS agreed to close the license between EMORY and CYBERKINETICS and a
stock purchase between EMORY and CYBERKINETICS for CYBERKINETICS to issue a
certain amount of its equity to EMORY based on the terms agreed upon therein;
and
WHEREAS, EMORY desires to grant, and CYBERKINETICS desires to receive, an
exclusive, worldwide license to make, have made, import, use, offer to sell and
sell products based on or incorporating the inventions;
NOW, THEREFORE, for and in consideration of the mutual covenants and the
premises herein contained, the parties, intending to be legally bound, hereby
agree as follows.
ARTICLE 1. DEFINITIONS
The following terms as used herein shall have the following meaning:
1.1 "Affiliate" shall mean any corporation or non-corporate business
entity, which controls, is controlled by, or is under common control with a
party to this Agreement. A corporation or non-corporate business entity shall be
regarded as in control of another corporation if it owns, or directly or
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
indirectly controls, at least fifty (50%) percent of the voting stock of the
other corporation, or (i) in the absence of the ownership of at least fifty
(50%) percent of the voting stock of a corporation or (ii) in the case of a
non-corporate business entity, or non-profit corporation, if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate business entity, as
applicable.
1.2. "Agreement" or "License Agreement" shall mean this Agreement,
including all APPENDICES attached to this Agreement.
1.3. "Dollars" shall mean United States dollars.
1.4 "EMORY" shall mean EMORY University.
1.5. "FDA" shall mean (a) the United States Food and Drug Administration or
successor entity thereto, and (b) any other foreign agency or commission
performing comparable functions where specifically specified in this Agreement.
1.6. "Field of Use" shall mean all fields.
1.7. "Indemnitees" shall mean EMORY, its directors, employees and students,
and their heirs, executors, administrators, successors and legal
representatives.
1.8. "Licensed Know-How" shall mean all technical information and data,
other than the Licensed Patents, whether or not presently known or learned,
invented, or developed by the Inventor or any employees of EMORY working under
the Inventor's direct supervision, prior to the date of this agreement and while
they were under a duty to assign intellectual property rights to EMORY, to the
extent that (a) such technical information and data are useful for the
manufacture, use, importation, offer for sale or sale of any Licensed Product;
(b) EMORY possesses the right to license the use of such information and data to
CYBERKINETICS for commercial purposes without incurring financial or other
non-contingent, material obligations to any third party and without breaching
any obligations of confidentiality with any such party; and (c) such information
and data is not presently owned by CYBERKINETICS and does not in the future
become publicly known other than through disclosure by CYBERKINETICS.
1.9. "Licensed Patents" shall mean U.S. Patent No. * * * for "* * *" Issued
* * *, together with any and all substitutions, extensions, divisionals,
continuations, continuations-in-part, which issue thereon anywhere in the world,
including reexamined and reissued patents and any extension of the term of any
such patent (including supplementary protection certificates) and all
corresponding foreign equivalents.
1.10. "Licensed Products" shall mean any products, the manufacture, use,
importation, offer for sale or sale of which incorporate Licensed Technology, or
which would, absent the licenses granted in this Agreement, infringe any Valid
Claim included in any Licensed Patent.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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1.11. "Licensed Technology" shall mean the Licensed Patents and the
Licensed Know-How
1.12. "Licensed Territory" shall mean the world.
1.13. "Net Sales" shall mean gross amounts invoiced for "End Sales" (as
defined below) of a Licensed Product less the sum of (i) trade, quantity and
cash discounts actually allowed or paid, (ii) refunds, rebates, chargebacks,
retroactive price adjustments (including Medicaid, managed care and similar
types of rebates) and service allowances, (iii) credits or allowances given or
made for rejections or returns of previously sold products or for wastage
replacement actually taken or allowed, (iv) taxes, duties or other governmental
charges levied on or measured by the billing amount, as adjusted for rebates and
refunds, and (v) charges for shipping, freight and insurance directly related to
the distribution of the Licensed Product (excluding amounts reimbursed by third
party customers). End Sales shall mean all sales of any Licensed Product by
CYBERKINETICS, its Affiliates, or its Sublicensees other than sales ("Excluded
Sales") to CYBERKINETICS, an Affiliate or a Sublicensee, provided, however, that
End Sales shall include the sale of any Licensed Product to CYBERKINETICS, an
Affiliate or a Sublicensee where the purchaser of such Licensed Product is the
ultimate end-user of such Licensed Product and such Licensed Product is used by
such purchaser for commercial purposes to generate revenue from one or more
third parties, as opposed to use for research, development, manufacturing,
quality control, testing or similar uses in connection with the development or
commercialization of any Licensed Product. Sales of a Licensed Product for use
in conducting clinical trials of such Licensed Product in a country of the
Licensed Territory in order to obtain regulatory approval of such Licensed
Product in such country shall be included in Net Sales calculations only to the
extent that the amount included in such Net Sales exceeds the fully loaded cost
incurred by the party supplying such Licensed Product to supply such Licensed
Product.
If a Licensed Product (a) consists of both (i) components causing such
product to be a Licensed Product and (ii) other components. or (b) is sold
together with one or more other products for a single invoiced price (e.g.,
where a product is a medical device comprised of one component that is Licensed
Product and other components that are not Licensed Products, or where a medical
device that is a Licensed Product is packaged for sale with a second medical
device that is not a Licensed Product) (each, a "Combination Sale"), the Net
Sales for such Licensed Product shall be the portion of such Combination Sale
properly allocable to such Licensed Product, determined as follows.
Except as provided below, the Net Sales for a Licensed Product sold in such
a Combination Sale shall equal the gross amount invoiced for sale of the
Licensed Product and any and all other products or components, as the case may
be, included in such Combination Sale, reduced by the adjustments specified
above in the definition of Net Sales (the "Net Combination Sale Amount"),
multiplied by the fraction A/(A+B), where:
* * *
In the event that CYBERKINETICS, its Affiliate or Sublicensee, as
applicable, separately sells the Licensed Product included in a Combination Sale
in a country, but does not separately sell all of the other products or
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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components, as the case may be, included in such Combination Sale in such
country, the calculation of "Net Sale" resulting from such Combination Sale
shall be determined by multiplying the Net Combination Sale Amount by the
fraction A/C where:
* * *
In the event that CYBERKINETICS, its Affiliate or Sublicensee, as
applicable, does not separately sell the Licensed Product contained in a
Combination Sale in the country where such Combination Sale occurs, but does
separately sell all of the other products or components, as the case may be,
included in the Combination Sale in such country, the calculation of Net Sales
resulting from such Combination Sale shall be determined by multiplying the Net
Combination Sale Amount by the fraction (C-D)/C, where:
* * *
Where the calculation of Net Sales resulting from a Combination Sale in a
country cannot be determined by any of the foregoing methods, the calculation of
Net Sales for such Combination Sale shall be * * *.
1.14. "Person" shall mean any natural person or legal entity.
1.15. "Regulatory Approval" or "Regulatory Registration" shall mean, in
relation to any Licensed Product, such approvals by the regulatory authorities
in a given country (including pricing approvals) as may be legally required
before such Licensed Products may be commercialized or Sold in such country.
1.16. "Sale" or "Sold" shall mean the sale, lease, transfer, exchange, or
other disposition of Licensed Products to a third party whether by gift or
otherwise by CYBERKINETICS, its Affiliates, Sublicensees, distributors or any
third party authorized by CYBERKINETICS to make such sale, transfer, exchange or
disposition. Sales of Licensed Products shall be deemed consummated upon the
first to occur of: (a) receipt of payment from the purchaser; (b) delivery of
Licensed Products to the purchaser or a common carrier; (c) release of Licensed
Products from consignment; (d) if deemed Sold by use, when first put to such
use; or (e) if otherwise transferred, exchanged, or disposed of, whether by gift
or otherwise, when such transfer, exchange, gift, or other disposition occurs.
Notwithstanding the foregoing definition of Sale, to the extent CYBERKINETICS
distributes any Licensed Product under a treatment trial or other expanded
access program at a sales price that exceeds its fully absorbed cost therefor,
such excess shall be deemed to be a Sale for which royalties are payable in
accordance with the other terms hereof.
1.17. "Sublicensee" shall mean any Person to whom CYBERKINETICS grants a
sublicense of some or all of the rights granted to CYBERKINETICS under this
Agreement.
1.18. "U.S. 510 (k)" shall mean Article 510 (k) of the Food, Drug and
Cosmetic Act also known as Premarket Notification (PMN), corresponding
application or its equivalent.
1.19. "U.S. IDE" shall mean Investigational Device Exemption, corresponding
applications or its equivalent.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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1.20. "U.S. Government Licenses" shall mean the non-exclusive license to
the U.S. Government directly, or acting through one of its recognized agencies.
1.21. "Valid Claim" shall mean an issued claim of any unexpired patent or
claim of any pending patent application included among the Licensed Patents,
which has not been held unenforceable, unpatentable or invalid by a decision of
a court or governmental body of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, which has not been rendered
unenforceable through disclaimer or otherwise, which has not been donated to the
public, and which has not been lost through an interference proceeding.
ARTICLE 2. GRANT OF LICENSE
2.1. LICENSE. Subject to the terms and conditions of this Agreement, EMORY
hereby grants CYBERKINETICS and its Affiliates an exclusive, sublicenseable,
royalty-bearing license under EMORY's interests and rights in the Licensed
Technology to make, have made, use, import, offer for sale, and sell Licensed
Products in the Licensed Territory and in the Licensed Field during the term of
this Agreement.
2.2. GOVERNMENT RIGHTS. The license granted in Article 2.1 above is subject
to the U.S. Government Licenses and other rights retained by the United States
in inventions developed by nonprofit institutions with the support of federal
funds. These rights are set forth in 35 USCA ss.201 et seq. and 37 CFR 401 et
seq., which may be amended from time to time by the Congress of the United
States or through administrative procedures.
2.3. RETAINED LICENSE. The license granted in Article 2.1 above is further
subject to a right and license retained by EMORY on behalf of itself and its
Affiliates to practice the Licensed Technology for EMORY's non-commercial
research and educational purposes only; provided, however, that nothing in this
Article 2.3 shall limit in any way the Inventor's rights under the "research
exception" under common law to practice the Licensed Technology solely for
non-commercial research and educational purposes.
2.4. SUBLICENSES. CYBERKINETICS shall have the right to grant sublicenses
consistent with its diligence obligations under Article 6 hereof. CYBERKINETICS
shall notify EMORY at least twenty (20) days prior to entering into any
sublicense agreement and will provide EMORY with copies of all sublicense
agreements within ninety (90) days of their execution date. CYBERKINETICS
understands that flipping the Licensed Technology in the form of a sublicense
without adding value (i.e. without itself having first undertaken further
development activity or requiring that its Sublicensee undertake further
development activities) to the Licensed Technology is prohibited and EMORY
retains the right to disapprove such sublicensing activities. CYBERKINETICS
shall remain responsible to EMORY for the payment of all fees and royalties due
under this Agreement, whether or not such payments are made to CYBERKINETICS,
its Affiliates or its Sublicensees. CYBERKINETICS shall include in any
sublicense granted pursuant to this Agreement a provision requiring the
Sublicensee to (i) abide by the confidentiality obligations herein, (ii)
indemnify EMORY and (iii) maintain liability insurance coverage to the same
extent that CYBERKINETICS is so required pursuant to Article 10.3 of this
Agreement. CYBERKINETICS shall not grant any rights to any Sublicensee, which
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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are inconsistent with the rights granted to and obligations of CYBERKINETICS
hereunder. Any act or omission of a Sublicensee, which would be a breach of this
Agreement if performed by CYBERKINETICS, shall be deemed to be a breach by such
Sublicensee of its sublicense agreement.
If this Agreement terminates for any reason, any Sublicensee shall, from
the effective date of such termination, automatically become a direct licensee
of EMORY with respect to the rights originally sublicensed to it by
CYBERKINETICS, provided such Sublicensee did not cause the termination of this
Agreement and such Sublicensee agrees to comply with all of the terms of this
Agreement and assumes the responsibilities of CYBERKINETICS hereunder to the
extent applicable from the rights originally sublicensed to it by CYBERKINETICS.
2.5. NO IMPLIED LICENSE. The license and rights granted in this Agreement
shall not be construed to confer any rights upon CYBERKINETICS by implication,
estoppel, or otherwise as to any technology not specifically identified in this
Agreement as Licensed Patents or Licensed Know-How.
ARTICLE 3. ROYALTIES AND OTHER PAYMENTS
3.1. SIGNING FEE. CYBERKINETICS shall, within thirty (30) days of execution
of the License Agreement, pay EMORY the sum of * * * as a signing fee.
3.2. RUNNING ROYALTIES FOR SALE OF LICENSED PRODUCTS BY CYBERKINETICS OR
ITS AFFILIATES OR SUBLICENSEES. CYBERKINETICS or its Affiliates or Sublicensees
shall pay EMORY royalty equal to the Applicable Percentage of Net Sales of
Licensed Products by CYBERKINETICS, its Affiliates or Sublicensees in the
Territory. The Applicable Percentage with respect to * * *of such Net Sales in
any fiscal year of CYBERKINETICS shall be * * * and with respect to all
additional such Net Sales in any such fiscal year shall be * * *, subject to
adjustment as provided below.
(a) The running royalties payable under this Article 3.2 on any Net
Sales of Licensed Products shall be reduced by * * * of any royalties payable to
third parties by CYBERKINETICS, its Affiliates or its Sublicensees on the same
Net Sales of Licensed Products. Absent the written consent of EMORY, the
reduction in royalty rates specified by this subparagraph (a) shall not operate
to reduce the running royalty rates payable by CYBERKINETICS, its Affiliates and
its Sublicensees to EMORY during any fiscal year of CYBERKINETICS to less than*
* * of Net Sales of Licensed Products during such fiscal year * * * in the case
of Know-How Only Net Sales (as defined below)).
(b) Licensee's obligation to pay a running royalty on a Licensed
Product shall terminate upon the later of (i) ) the expiration of the last Valid
Claim included within the Licensed Patents that but for the license in Article
2.1 would be infringed by the manufacture, sale, offer for sale or importation
of such Licensed Product and (ii) the tenth (10th) anniversary of the first
commercial sale of the first Licensed Product to achieve commercial sales.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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(c) All royalty payments due to EMORY hereunder shall be subject to
any tax withholding required under the laws of any country, and all payments to
EMORY hereunder shall be net of such taxes.
(d) The Applicable Percentage shall be reduced by * * * with respect
to any Net Sales with respect to any Licensed Product in a particular country
that is a Licensed Product in such country solely because such Licensed Product
incorporates Licensed Know-How and is not covered by a Valid Claim ("Know-How
Only Net Sales").
3.3. MILESTONE PAYMENTS. Upon the achievement of each event set forth
below, on a Licensed Product-by-Licensed Product basis, CYBERKINETICS shall pay
EMORY the amount indicated below, no later than thirty (30) days from the
occurrence of the indicated event:
Event Milestone Payment
----- -----------------
* * * * * *
* * * * * *
Once CYBERKINETICS has made a payment under this Article 3.3 upon the occurrence
of U.S. IDE Approval with respect to a particular Licensed Product,
CYBERKINETICS will not be obligated to make any payments under this Article 3.3
with respect to any other U.S. IDE Approval with respect to a Licensed Product
that is substantially similar to such Licensed Product or that represents only
an enhanced or improved version of such Licensed Product. CYBERKINETICS will be
obligated to make only one milestone payment under this Article 3.3 with respect
to each * * *, regardless of the number of Licensed Products that are sold * *
*.
3.4. MINIMUM ANNUAL ROYALTIES. Beginning on the * * * anniversary of the
Effective Date, on each anniversary of the Effective Date CYBERKINETICS shall
pay EMORY a minimum annual royalty of * * *. CYBERKINETICS may credit the
minimum annual royalty paid under this Article 3.4 against any royalties that
become payable to EMORY under Article 3.2 during the year to which such minimum
annual royalty relates.
3.5. REIMBURSEMENT FOR PATENT COSTS. CYBERKINETICS shall, within fifteen
(15) days of execution of this Agreement, pay EMORY the sum of * * * to
reimburse EMORY for costs incurred by EMORY as of the execution date of the
License Agreement in prosecuting and defending the Licensed Patents.
3.6. EQUITY. CYBERKINETICS shall issue to EMORY Forty Thousand (40,000)
shares of CYBERKINETICS common stock. The Equity transaction between
CYBERKINETICS and EMORY shall be fully specified in a separate Stock Purchase
Agreement made and entered into as of the Effective Date of this Agreement.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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ARTICLE 4. REPORTS AND ACCOUNTING
4.1. ROYALTY REPORTS AND RECORDS. During the term of this Agreement,
CYBERKINETICS shall furnish, or cause to be furnished to EMORY, written reports
relating to each of CYBERKINETICS, CYBERKINETICS 's Affiliates and Sublicensees
fiscal quarters showing:
(i) the gross selling price of all Licensed Products Sold by
CYBERKINETICS, its Affiliates and Sublicensees, in each country of the Licensed
Territory during the reporting period, together with the calculations of Net
Sales in accordance with Article 1.13;
(ii) the royalties payable in Dollars, which shall have accrued
hereunder with respect to such reporting period in respect to such Net Sales;
(iii) the exchange rates, if any, used in determining the royalties
payable;
(iv) a summary of all reports provided to CYBERKINETICS by
CYBERKINETICS' Sublicensees;
(v) the occurrence of any event triggering a Milestone Payment
obligation in accordance with Article 3.3.
Reports shall be made semiannually until the first Sale of a Licensed Product
and quarterly thereafter. Semiannual reports shall be due within thirty (30)
days of the close of every second and fourth CYBERKINETICS fiscal quarter.
Quarterly reports shall be due within thirty (30) days of the close of every
CYBERKINETICS fiscal quarter. CYBERKINETICS shall keep accurate records in
sufficient detail to enable royalties and other payments payable hereunder to
be determined. CYBERKINETICS shall be responsible for all royalties and late
payments that are due to EMORY that have not been paid by CYBERKINETICS'
Affiliates and Sublicensees. CYBERKINETICS' Sublicensees shall have, and shall
be notified by CYBERKINETICS that they have, the option of making any royalty
payment directly to EMORY.
4.2. RIGHT TO AUDIT. EMORY shall have the right, upon prior notice to
CYBERKINETICS, not more than once in each CYBERKINETICS fiscal year, through an
independent public accountant selected by EMORY and acceptable to CYBERKINETICS,
which acceptance shall not be unreasonably refused, to have access during
CYBERKINETICS' normal business hours as may be reasonably necessary to verify
the accuracy of the royalty reports required to be furnished by CYBERKINETICS
pursuant to Article 5.1 of the Agreement. CYBERKINETICS shall include in any
sublicenses granted pursuant to this Agreement a provision requiring the
Sublicensee to keep and maintain records of Sales made pursuant to such
sublicense and to grant access to such records by EMORY's independent public
accountant. If such independent public accountant's report shows any
underpayment of royalties by CYBERKINETICS, its Affiliates or Sublicensees,
within thirty (30) days after CYBERKINETICS' receipt of such report,
CYBERKINETICS shall remit or shall cause its Sublicensees to remit to EMORY:
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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(i) the amount of such underpayment; and
(ii) if such underpayment exceeds * * * of the total royalties
owed for the fiscal year then being reviewed, the reasonably necessary fees and
expenses of such independent public accountant performing the audit. Otherwise,
EMORY's accountant's fees and expenses shall be borne by EMORY. Any overpayment
of royalties shall be fully creditable against future royalties payable in any
subsequent royalty periods.
4.3. CONFIDENTIALITY OF RECORDS. All information subject to review under
this Article 4 shall be confidential. Except where otherwise provided by law,
EMORY and its accountant shall retain all such information in confidence.
ARTICLE 5. PAYMENTS
5.1. PAYMENT DUE DATES. Royalties, sublicense fees and other payments
payable to EMORY as a result of activities occurring during the period covered
by each royalty report provided for under Article 4 of this Agreement shall be
due and payable within fifteen (15) days of the date such royalty report is due.
Payments of royalties in whole or in part may be made in advance of such due
date. Any payment in excess of one hundred thousand dollars ($100,000.00) shall
be made by wire transfer to an account of EMORY designated by EMORY from time to
time; provided, however, that in the event that EMORY fails to designate such
account, CYBERKINETICS or its Affiliates and Sublicensees may remit payment to
EMORY at the address applicable for the receipt of notices hereunder; providing,
further, that any notice by EMORY of such account or change in such account,
shall not be effective until fifteen (15) days after receipt thereof by
CYBERKINETICS.
5.2. CURRENCY RESTRICTIONS. Except as hereinafter provided in this Article
5.2, all royalties shall be paid in Dollars. If, at any time, legal restrictions
prevent the prompt remittance of part of or all royalties with respect to any
country in the Licensed Territory where Licensed Products are Sold,
CYBERKINETICS, its Affiliates or Sublicensees shall have the right and option to
make such payments by depositing the amount thereof in local currency to EMORY's
account in a bank or depository in such country.
5.3. INTEREST. Royalties and other payments required to be paid by
CYBERKINETICS pursuant to this Agreement shall, if overdue, bear interest at the
lesser of (a) the maximum applicable legal rate of interest on overdue
commercial accounts or (b) a per annum rate equal of ten percent (10%) until
paid. The payment of such interest shall not foreclose EMORY from exercising any
other rights it may have because any payment is overdue.
ARTICLE 6. DEVELOPMENT AND MARKETING PROGRAM
6.1. DILIGENCE OBLIGATIONS. CYBERKINETICS shall directly, or in
collaboration with Affiliates, alliances and Sublicensees, use commercially
reasonable efforts to:
(i) conduct research and development programs relating to the use
of Licensed Patents and Licensed Know-How;
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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(ii) promptly register Licensed Products with regulatory
authorities in the Licensed Territory; and
(iii) market the Licensed Products in accordance with its
business plans and objectives. 6.2. Fulfillment; Conversion.
(a) For purposes of this Agreement, "commercially reasonable efforts"
shall mean the use of reasonable efforts including, to the extent appropriate,
pursuing sublicenses or corporate alliances, consistent with those used by
comparable biotechnology companies in the United States in research and
development projects for medical devices or kits deemed to have commercial value
comparable to the Licensed Products.
(b) CYBERKINETICS' obligations set forth in this Article 6 shall be
deemed to have been fully satisfied during the following time periods if
CYBERKINETICS accomplishes the following specified milestones:
(i) PRIOR TO * * * . CYBERKINETICS causes * * * with respect to *
* * to occur prior to * * * ;
(ii) PRIOR TO * * * . CYBERNETICS causes the * * * with respect
to a * * * to occur by * * *; and
(iii) AFTER * * * . CYBERNETICS * * * within * * * following the
* * * for a Licensed Product.
(c) For clarity, the diligence obligations set forth in this Article 6
are independent of the minimum annual royalties payable pursuant to Article 3.4
and the payment of such minimum annual royalties will not relieve CYBERKINETICS
of its obligations under this Article 6.
(d) CYBERKINETICS shall provide regular reports to EMORY after
submission of its U.S. 510 (k) filing(s) for Licensed Products concerning the
status of such filing(s) until final approval thereof, including any final
decision not to comply with any FDA request.
(e) CYBERKINETICS will notify EMORY promptly after any final decision
by CYBERKINETICS to permanently abandon development of Licensed Products based
upon any portion of the Licensed Technology.
(f) In the event CYBERKINETICS fails to meet any diligence requirement
set forth herein, EMORY shall have the option in its sole discretion to (i)
terminate the Agreement within the entire Licensed Territory or any portion of
the Licensed Territory for such application or indication, (ii) convert the
license granted in this License Agreement into a nonexclusive license within the
entire Licensed Territory or any portion of the Licensed Territory for such
indication, or (iii) terminate the Agreement within a portion of the Licensed
Territory and convert the license granted in this Agreement into a non-exclusive
license within a portion of the Licensed Territory. In order to allow EMORY to
determine to exercise any of the foregoing rights, in the event CYBERKINETICS
fails to meet any diligence requirement set forth herein, CYBERKINETICS shall,
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
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on EMORY'S request, subject to agreement between CYBERKINETICS and EMORY of
terms and conditions of confidentiality, permit EMORY to have access to all
CYBERKINETICS' data related to CYBERKINETICS' development efforts with respect
to the Licensed Technology for the purpose of allowing EMORY to assess the
commercial potential of the Licensed Technology.
(g) Prior to exercising any rights under this Article, EMORY shall
give CYBERKINETICS sixty (60) days' prior written notice and shall meet with
CYBERKINETICS, at CYBERKINETICS' request and expense, during such sixty (60) day
period, to discuss any disagreements about whether CYBERKINETICS has complied
with the requirements of this Article. CYBERKINETICS shall (i) within sixty (60)
days of CYBERKINETICS' receipt of written notice of such failure, provide to
EMORY a commercially reasonable plan to remedy such failure and (ii) cure such
failure in accordance with such plan within the time provided for under such
plan. If CYBERKINETICS fails to provide such a commercially reasonable plan
within sixty (60) days or does not cure such failure in accordance with such
plan within the time provided for under such plan, EMORY shall have the right in
its sole discretion to proceed with the exercise of all rights arid remedies
provided for herein.
6.3. PROGRESS REPORTS. CYBERKINETICS shall, no less frequently than once
every six (6) months until CYBERKINETICS has achieved Regulatory Approval for a
Licensed Product, provide EMORY with a written report detailing all activities
of CYBERKINETICS, its Affiliates and Sublicensees related to developing Licensed
Products and pursuing Regulatory Approval of Licensed Products to the extent
reasonably necessary for EMORY to review CYBERKINETICS' progress under Article
6.2. Such reports shall further, no less frequently than once per year,
incorporate sufficient and quantified detail on the resources allocated by
CYBERKINETICS to enable EMORY to determine that CYBERKINETICS is diligently
pursuing its research and development in accordance with its business plans and
this Agreement.
6.4. DEVELOPMENT OUTSIDE UNITED STATES. As soon as practicable and in
accordance with CYBERKINETICS' corporate goals and its obligations under this
Agreement, CYBERKINETICS shall directly, or in collaboration with Affiliates and
Sublicensees, commence its commercially reasonable efforts:
(i) to obtain Regulatory Approval for a Licensed Product in such
other countries of the Licensed Territory as CYBERKINETICS or CYBERKINETICS'
Affiliates and Sublicensees deem appropriate; and
(ii) upon Regulatory Approval of a Licensed Product in a
particular country diligently commence efforts to market such Licensed Product
in such country.
ARTICLE 7. PATENT PROSECUTION
7.1. CYBERKINETICS shall be responsible for preparing, filing, prosecuting,
maintaining and defending all Licensed Patents. CYBERKINETICS shall provide
EMORY with copies of all filings and relevant documentation and a reasonable
opportunity in advance to comment on such filings. CYBERKINETICS will not
abandon any patent application in the Licensed Patents, or make
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
11
prosecution-related decisions that would have a material impact on the nature or
scope of any claims in such patent applications, without giving EMORY a
reasonable opportunity to comment on such action or decision.
7.2. CYBERKINETICS shall bear all costs in connection with the preparation,
filing, prosecution, maintenance and defense of the Licensed Patents.
7.3. In the event that CYBERKINETICS determines to abandon prosecution of,
or to cease to maintain, any Licensed Patent in any country, CYBERKINETICS shall
so notify EMORY and shall permit EMORY, in its sole discretion, at EMORY's
expense, to continue to prosecute or maintain such Licensed Patent in such
jurisdiction, and CYBERKINETICS shall cooperate with EMORY in regard thereto. If
EMORY does so prosecute, the licenses granted to CYBERKINETICS under Article 2.1
shall terminate in such country with respect to any Licensed Patents issuing in
such country as a result of such prosecution.
7.4. Each party shall, and shall cause its Affiliates, employees, attorneys
and agents to, cooperate fully with the other party and provide all information
and data and execute any documents reasonably required or requested in order to
allow the other party to prepare, prosecute, file, and maintain patents and
patent applications pursuant to this Article 7 for no additional compensation.
ARTICLE 8. INFRINGEMENT
8.1. THIRD PARTY INFRINGEMENT. CYBERKINETICS and EMORY shall each promptly
notify the other in writing of any alleged or threatened infringement or claim
of invalidity (hereinafter "Infringement") of which they become aware of patents
included in the Licensed Patents, and the parties shall consult concerning the
action to be taken. CYBERKINETICS shall have the right, but not the obligation,
to prosecute or defend at its own expense any such Infringement. In such event,
CYBERKINETICS shall have the right, if EMORY is a legally indispensable party,
to bring such suit or action in the name of EMORY. CYBERKINETICS shall pay, on
behalf of and instead of EMORY, any order for costs that may be made against
EMORY by reason of it being joined as a party plaintiff in such proceedings by
CYBERKINETICS, provided that EMORY will not be obligated to reimburse
CYBERKINETICS for any costs so paid by CYBERKINETICS. CYBERKINETICS shall have
sole control of any such suit or action and all negotiations for its settlement
or compromise; provided, however, that CYBERKINETICS shall not settle or
compromise any such suit or action or enter into any consent order for the
settlement or compromise thereof that adversely affects any rights of EMORY
hereunder without the prior written consent of EMORY, not to be unreasonably
withheld.
If, within sixty (60) days after CYBERKINETICS first becomes aware of any
Infringement of the Licensed Patents, CYBERKINETICS fails to cause such
Infringement to terminate or to bring a suit or action to compel termination,
EMORY shall have the right, but not the obligation, to bring such suit or action
to compel termination at the sole expense of EMORY. In such event, EMORY shall
have the right, if CYBERKINETICS is a legally indispensable party, to bring such
suit or action in the name of CYBERKINETICS. EMORY shall hold pay, on behalf of
and instead of CYBERKINETICS, any order for costs that may be made against
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
12
CYBERKINETICS by reason of it being joined as a party plaintiff in such
proceedings by EMORY, provided that CYBERKINETICS will not be obligated to
reimburse EMORY for any costs so paid by EMORY. EMORY shall have sole control of
any such suit or action and all negotiations for its settlement or compromise;
provided, however, that EMORY shall not settle or compromise any such suit or
action or enter into any consent order for the settlement or compromise thereof
that adversely affects any rights of CYBERKINETICS hereunder without the prior
written consent of CYBERKINETICS, not to be unreasonably withheld.
8.2. ALLOCATION OF RECOVERY. Any recovery or damages derived from an action
under this Article 8 shall be used (i) first to reimburse the initiating party
for all legal expenses incurred by it relating to the suit and (ii) second to
reimburse the non-initiating party for all legal expenses incurred by it
relating to the suit, with any remaining recovery allocated between the parties
as follows:
(a) To the extent the remaining amount is attributed to sales of such
infringing products, CYBERKINETICS shall receive an amount equal to such amount
less the royalties that would have been payable on such sales pursuant to this
Agreement had such sales been made by CYBERKINETICS, which royalty amount shall
be paid to EMORY.
(b) To the extent the remaining amount is attributed to lost royalties
owed to EMORY under subparagraph (a) as a result of the infringement, EMORY
shall receive an amount equal to the royalties payable to EMORY under this
Agreement multiplied by any multiple of damages awarded in such action.
(c) Any remaining recovery amount not attributed to sales of such
infringing products shall be divided with sixty-seven percent (67%) of such
remaining amount allocated to the party initiating such proceedings and
thirty-three percent (33%) of such remaining amount allocated to the
non-initiating party.
8.3. OFFSET BY CYBERKINETICS. CYBERKINETICS. shall not offset its
out-of-pocket expenses incurred in regard to any such legal proceedings which
CYBERKINETICS initiates or carries on against any royalty payments or other
payments owed to EMORY except in the case of an action initiated independently
by a third party to invalidate any claims of the Licensed Patents, such as
through a reexamination. If such action occurs, CYBERKINETICS may suspend
royalty payments payable to EMORY until the action is concluded, at which time
CYBERKINETICS will make such suspended royalty payments to EMORY based upon the
Valid Claims then existing with respect to the Licensed Patents.
8.4. EMORY'S RIGHT TO PURSUE THIRD PARTY INFRINGERS. If CYBERKINETICS shall
fail, within sixty (60) days after receiving notice from EMORY of a potential
infringement, or providing EMORY with notice of such infringement, to either (a)
terminate such infringement or (b) institute an action to prevent continuation
thereof and, thereafter to prosecute such action diligently, or if CYBERKINETICS
notifies EMORY that it does not plan to terminate the infringement or institute
such action, then EMORY shall have the right to do so at its own expense.
CYBERKINETICS shall cooperate with EMORY in such effort including being joined
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
13
as a party to such action if necessary. EMORY shall be entitled to retain all
damages or costs awarded to EMORY in such action.
ARTICLE 9. EXCLUSION OF WARRANTIES AND INDEMNIFICATION
9.1. WARRANTIES OF EMORY.
(a) EMORY represents and warrants that, to the best of its knowledge:
(i) EMORY has disclosed to CYBERKINETICS all potential patent
rights in the control of third parties known to EMORY which may be needed to
commercialize the Licensed Patents, provided that for purposes of this
representation and warranty, "EMORY" shall mean the Inventor and any employees
of EMORY who work in the technology transfer area, and CYBERKINETICS
acknowledges that EMORY has not undertaken any investigation with respect to the
potential patent rights of any third party; and
(ii) Appendix A is a complete list of all patents and patent
applications included in the Licensed Patents as of the date hereof. EMORY will
from time to time during the term of this Agreement, promptly provide
CYBERKINETICS with, upon request, with an updated version of Appendix A.
(iii) EMORY is not aware of any patent infringement or notice of
any pending claim of infringement in respect of the Licensed Patents.
(b) EMORY further represents and warrants that it is the exclusive
owner of all rights, title and interests in the patents and patent applications
identified in Appendix A as of the date hereof, subject to the rights of the
U.S. Government.
9.2. WARRANTIES OF EACH PARTY. Each party hereto represents to the other
that it is free to enter into this Agreement and to carry out all of the
provisions hereof, including, in the case of EMORY, its grant to CYBERKINETICS
of the license described in Article 2.1.
9.3. MERCHANTABILITY AND EXCLUSION OF WARRANTIES. CYBERKINETICS possesses
the necessary expertise and skill in the technical areas pertaining to the
Licensed Patents, Licensed Products and Licensed Know-How to make, and has made,
its own evaluation of the capabilities, safety, utility and commercial
application of the Licensed Patents, Licensed Products and Licensed Know-How.
ACCORDINGLY, EXCEPT AS SET FORTH IN ARTICLE 9.1 AND 9.2, EMORY DOES NOT MAKE ANY
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE LICENSED PATENTS,
LICENSED KNOW-HOW OR LICENSED PRODUCTS AND EXPRESSLY DISCLAIMS ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER IMPLIED
WARRANTIES WITH RESPECT TO THE CAPABILITIES, SAFETY, UTILITY, OR COMMERCIAL
APPLICATION OF THE LICENSED PATENTS, LICENSED KNOW-HOW OR LICENSED PRODUCTS.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
14
9.4. INDEMNIFICATION BY CYBERKINETICS. CYBERKINETICS shall defend,
indemnify, and hold harmless the EMORY Indemnitees, from and against any and all
claims, demands, losses, liabilities, expense, or damage (including
investigative costs, court costs and reasonable attorneys' fees) the EMORY
Indemnitees may suffer, pay, or incur as a result of claims, demands or actions
against any of the EMORY Indemnitees arising or alleged to arise by reason of,
or in connection with, any and all personal injury (including death) and
property damage caused or contributed to, in whole or in part, by CYBERKINETICS'
or CYBERKINETICS' Affiliates, contractors, agents, or Sublicensees' manufacture,
testing, design, use, Sale, or labeling of any Licensed Products. CYBERKINETICS'
obligations under this Article shall survive the expiration or termination of
this Agreement for any reason.
9.5. INSURANCE. Without limiting CYBERKINETICS' indemnity obligations under
Article 9.4, CYBERKINETICS shall, prior to any clinical trial or Sale of any
Licensed Product, cause to be in force, an "occurrence based type" or "claims
made type" (with reasonable tail coverage) liability insurance policy which:
(a) insures Indemnitees for all claims, damages, and actions mentioned
in Article 9 of this Agreement; and
(b) includes a contractual endorsement providing coverage for all
liability which may be incurred by Indemnitees in connection with this
Agreement; and
(c) requires the insurance carrier to provide EMORY with no less than
thirty (30) days' written notice of any change in the terms or coverage of the
policy or its cancellation; and
(d) provides Indemnitees a comprehensive general/product liability
coverage in an amount no less than * * * per occurrence for bodily injury and *
* * per occurrence for property damage, subject to a reasonable aggregate
amount; and
(e) in the event that CYBERKINETICS, its Affiliates or Sublicensees
decide to go to market with a Licensed Product it shall, to the extent available
at commercially reasonable rates arrange (prior to the Sale of any Licensed
Product) and shall continue for the term of this Agreement and for a period of *
* * years thereafter an insurance policy or policies of product liability which
provide Licensee, its affiliates or Sublicensees with coverage for injury or
damage arising to users of Licensed Products in an amount no less than * * * per
claim, subject to annual aggregate of * * *; and
(f) CYBERKINETICS shall provide EMORY with a copy of any such
insurance policy prior to the commencement of clinical trials or the first Sale
of any Licensed Product and on each renewal and/or replacement of the policy
together with a copy of any schedule and evidence of payment of the premium.
Company will also advise EMORY with written notice within 30 days of any
material change in the terms or coverage of the policy or its cancellation.
(g) EMORY may periodically review the adequacy of the minimum limits
of liability insurance specified in this Article 9.5. EMORY reserves the right
to require CYBERKINETICS to adjust the liability insurance coverage above within
reason and without significantly increasing CYBERKINETICS' annual insurance
premiums.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
15
9.6. OCCURRENCE BASED COVERAGE NOT AVAILABLE. If CYBERKINETICS is unable to
obtain "occurrence based type" liability insurance, CYBERKINETICS shall procure
"claims made type" liability coverage to be effective prior to any clinical
trial or Sale of any Licensed Products, and throughout the term of this
Agreement and "tail coverage", extending at least ten (10) years after
termination of this Agreement. CYBERKINETICS shall notify EMORY prior to its
first clinical trial or commercial Sale of any Licensed Product, of all
insurance coverage and other assets available to CYBERKINETICS to meet
CYBERKINETICS' obligations under Article 9 of this Agreement. 9.7. Notice of
Claims: Indemnification Procedures.
(a) CYBERKINETICS shall promptly notify EMORY of any claims involving
any Indemnitees for which indemnification is or may be provided in Article 9.4
and shall advise EMORY of the policy amounts that might be needed to defend and
pay any such claims.
(b) An Indemnitee, which intends to claim indemnification under this
Article shall promptly notify the other party (the "Indemnitor") in writing of
any matter in respect of which the Indemnitee or any of its employees or agents
intend to claim such indemnification. The Indemnitee shall permit, and shall
cause its employees and agents to permit, the Indemnitor, at its discretion, to
settle any such matter and agrees to the complete control of such defense or
settlement by the Indemnitor; provided, however, that such settlement does not
adversely affect the Indemnitee's rights hereunder or impose any obligations on
the Indemnitee in addition to those set forth herein in order for it to exercise
such rights and that the Indemnitee makes no statement or undertakes any action
that may prejudice the ability of the Indemnitor to settle any such claim. No
such matter shall be settled without the prior written consent of the Indemnitor
and the Indemnitor shall not be responsible for any legal fees or other costs
incurred other than as provided herein. The Indemnitee, its employees and agents
shall cooperate fully with the Indemnitor and its legal representatives in the
investigation and defense of any matter covered by the applicable
indemnification. The Indemnitee shall have the right, but not the obligation, to
be represented by counsel of its own selection and at its expense.
ARTICLE 10. CONFIDENTIALITY
10.1. TREATMENT OF CONFIDENTIAL INFORMATION. Except as otherwise
provided hereunder, during the term of this Agreement and for a period of * * *
thereafter:
(i) CYBERKINETICS and its Affiliates and Sublicensees shall
retain in confidence and use only for purposes of this Agreement, any written
information and data supplied by EMORY to CYBERKINETICS under this Agreement and
marked as proprietary;
(ii) EMORY shall retain in confidence and use only for purposes
of this Agreement any written information and data supplied by CYBERKINETICS or
on behalf of CYBERKINETICS to EMORY under this Agreement and marked as
proprietary.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
16
For purposes of this Agreement, all such information and data which, a
party is obligated to retain in confidence shall be called "Information".
10.2 RIGHT TO DISCLOSE. To the extent that it is reasonably necessary to
fulfill its obligations or exercise its rights under this Agreement, or any
rights which survive termination or expiration hereof, each party may disclose
the other Party's Information to its Affiliates, Sublicensees, consultants,
outside contractors, governmental regulatory authorities and clinical.
investigators and in the case of CYBERKINETICS, its collaborators and potential
investors, on the condition that such entities or persons agree:
(i) to keep such Information confidential for at least the same
time periods and to the same extent as the disclaiming party is required to keep
the Information confidential;
(ii) to use such Information only for such purposes as the
disclosing party is authorized to use the Information under this Agreement;
(iii) not to use EMORY's name for any commercial purpose without
the prior written consent of EMORY.
Each party, its Affiliates and Sublicensees may disclose the other party's
Information to the government or other regulatory authorities to the extent that
such disclosure is necessary for the prosecution and enforcement of patents
included within the Licensed Patents, or authorizations to conduct clinical
trials or commercially market Licensed Products, provided that such party is
entitled to engage in such activities under this Agreement or is legally
required to make such disclosures.
10.3. RELEASE FROM RESTRICTIONS. The obligation not to disclose the other
party's Information shall not apply to any part of such Information that:
(i) is or becomes disclosed in a patent or patent application,
published or otherwise part of the public domain, other than by unauthorized
acts of the receiving party or its Affiliates or Sublicensees in contravention
of this Agreement;
(ii) is disclosed to the receiving party or its Affiliates or
Sublicensees by a third party provided that such third party was not obligated
to the other party to keep such information confidential; or
(iii) prior to disclosure under this Agreement, was already in
the possession of the receiving party, its Affiliates or Sublicensees, provided
that such Information was not obtained directly or indirectly from the other
party under this Agreement with an obligation to keep such information
confidential;
(iv) the receiving party is able to demonstrate results from
research and development by the receiving party or its Affiliates or
Sublicensees independent of disclosures from the other party, provided that the
persons developing such information have not had exposure to the Information
received from the disclosing party;
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
17
(v) is required by law to be disclosed by the receiving party,
provided that the receiving party shall notify the other party immediately upon
learning of such requirement in order to give the other party reasonable
opportunity to oppose such requirement; or
(vi) the disclosing party agrees in writing may be disclosed.
ARTICLE 11. TERM AND TERMINATION
11.1. TERM. Unless sooner terminated as otherwise provided in this
Agreement, the term of this Agreement shall commence on the Effective Date and
shall continue in full force and effect, until the expiration of CYBERKINETICS'
obligations to make royalty payments under Article 3.2.
11.2. TERMINATION. EMORY shall have the right to terminate this Agreement
upon the occurrence of any one or more of the following events and provided that
EMORY has given CYBERKINETICS the notice required in Article 11.3 and
CYBERKINETICS has failed to cure the breach described in such notice:
(a) failure of CYBERKINETICS to make any payment required pursuant to
this Agreement when due;
(b) failure of CYBERKINETICS to render reports to EMORY as required by
this Agreement;
(c) the institution of any proceeding by CYBERKINETICS under any
bankruptcy, insolvency, or moratorium law;
(d) any assignment by CYBERKINETICS of substantially all of its assets
for the benefit of its creditors;
(e) placement of CYBERKINETICS' assets in the hands of a trustee or a
receiver unless the receivership or trust is dissolved within thirty (30) days
thereafter and provided that in the case of in involuntary bankruptcy
proceeding, which is contested by CYBERKINETICS, such termination shall not
become effective until the bankruptcy court of jurisdiction has entered an order
upholding the petition;
(f) a formal decision reduced to writing and delivered to EMORY by
CYBERKINETICS or CYBERKINETICS' assignee of all of CYBERKINETICS' rights under
this Agreement to quit the business of commercializing the Licensed Patents and
Licensed Know-How or developing or selling Licensed Products; or
(g) the breach by CYBERKINETICS of any other material term of this
Agreement.
11.3. EXERCISE. Subject to Article 15.11, EMORY may exercise its right of
termination by giving CYBERKINETICS, its trustees, receivers or assigns, thirty
(30) days' (or such other extended period agreed in writing by the parties)
prior written notice of EMORY's election to terminate. Such notice shall include
the basis for such termination. Upon the expiration of such period, this
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
18
Agreement shall automatically terminate unless CYBERKINETICS has cured the
breach where such breach is capable of being remedied within such period or
extended period as applicable. Such notice and termination shall not prejudice
EMORY's right to receive royalties up to the point of termination or other sums
due to EMORY hereunder and shall not prejudice any cause of action or claim of
EMORY accrued or to accrue on account of any breach or default by CYBERKINETICS.
11.4. FAILURE TO ENFORCE. The failure of EMORY, at any time, or for any
period of time, to enforce any of the provisions of this Agreement, shall not be
construed as a waiver of such provisions or as a waiver of the right of EMORY
thereafter to enforce each and every such provision of this Agreement.
11.5. TERMINATION BY CYBERKINETICS. CYBERKINETICS shall have the right to
terminate this Agreement upon the occurrence of either of the following events:
(a) the breach of a material term of this Agreement by EMORY;
(b) if the Sale of Licensed Products requires approval by any
government agency, and after diligent pursuit of such approval, including but
not limited to: performing all reasonable tests or analyses as prescribed by
such agency regulations; submitting all relevant data to such agency; and
pursuing reasonable available administrative procedures and appeal processes
permitted by such agency and applicable law, CYBERKINETICS reasonably determines
it is unable to obtain approval for the Sale of Licensed Products or reasonably
determines such approval would, in CYBERKINETICS' sole judgment, be too
restrictive to justify continued development of a Licensed Product,
CYBERKINETICS may notify EMORY in writing of the final denial of approval to
Sell Licensed Products and CYBERKINETICS' desire to terminate this Agreement or
parts hereof related to specific Licensed Technology from which such Licensed
Products that are denied Regulatory Approval have been developed; or
(c) upon CYBERKINETICS' convenience, upon ninety (90) days' written
notice to EMORY, provided that no such termination shall relieve CYBERKINETICS
of its obligation under Articles 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6. with respect
to any milestone achieved and other payments made prior to the effective date of
such termination.
11.6. EXERCISE. CYBERKINETICS may exercise its right of termination
pursuant to Article 11.5(a), by giving EMORY thirty (30) days' prior written
notice of CYBERKINETICS' election to terminate. The notice shall include the
basis for such termination. Upon the expiration of such period, this Agreement
shall automatically terminate unless EMORY has cured the breach. Such notice of
termination shall not prejudice any cause of action or claim of CYBERKINETICS
accrued or to accrue on account of any breach or default by EMORY.
CYBERKINETICS may exercise its right of termination pursuant to Article
11.5 (b) as a result of the failure to obtain governmental approval to sell
Licensed Products by providing EMORY with a formal written request for such
termination enclosing evidence of the final denial of governmental approval.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
19
CYBERKINETICS may exercise its right of termination pursuant to Article
11.5 (c) by providing EMORY with written notice of such termination.
11.7. EFFECT. In the event this Agreement is terminated because of
CYBERKINETICS' default, CYBERKINETICS shall return, or at EMORY's direction
destroy, all data, writings and other documents and tangible materials,
containing EMORY's Information and supplied to CYBERKINETICS by EMORY.
Where the default for which this Agreement is terminated is set forth under
Articles 11.2(c) through (f) inclusive, subject to agreement between
CYBERKINETICS and EMORY of terms and conditions of confidentiality,
CYBERKINETICS shall provide EMORY access to CYBERKINETICS' product files
pertaining to the Licensed Products and design dossiers as well as data
generated by CYBERKINETICS' contractors and agents in the course of
CYBERKINETICS' efforts to develop Licensed Products or obtain governmental
approval for the Sale of Licensed Products to permit EMORY to assess the
commercial potential of the Licensed Technology. CYBERKINETICS agrees to
negotiate in good faith with EMORY and/or any potential licensee of the Licensed
Technology with respect to a license or sale of information, data and research
results then owned or controlled by CYBERKINETICS, including, but not limited
to, toxicity, efficacy and market research, to the extent such information, data
and research results are pertinent to the Licensed Technology. In such event,
CYBERKINETICS shall also xxxxx XXXXX and any replacement licensee of the
Licensed Technology the right to cross reference any regulatory filings (e.g.
510 (k), Registrations) made by CYBERKINETICS or its Affiliates with the FDA or
any corresponding foreign regulatory agency, in exchange for which EMORY or such
replacement licensee will reimburse CYBERKINETICS, on terms and at a rate to be
negotiated in advance in good faith by the parties involved, based on all
reasonable and documented direct and indirect, out-of-pocket costs incurred by
CYBERKINETICS in pursuing such regulatory approvals. CYBERKINETICS shall
cooperate (but shall not be required to incur any expense) with any such third
parties in pursuing governmental approval to sell any product covered by any
patent application or issued patent (which was formerly a Licensed Patent
licensed b1 EMORY to such third party.
ARTICLE 12. ASSIGNMENT
CYBERKINETICS may grant, transfer, convey, or otherwise assign any or all
of its rights and obligations under this Agreement in conjunction with the
transfer of all, or substantially all, of the business interests of
CYBERKINETICS to which this Agreement relates including for the purposes of
corporate re-organization. EMORY's written consent, which shall not be
unreasonably withheld, shall be required prior to any other assignment of
CYBERKINETICS' rights or obligations under this Agreement.
ARTICLE 13. BANKRUPTCY
In the event that CYBERKINETICS, for any reasons, plans the institution of
any proceeding under any bankruptcy, insolvency, or moratorium law of any
countries, CYBERKINETICS shall notify EMORY of its plan at least One Hundred and
Twenty (120) days prior to the official filing of such bankruptcy, insolvency,
or moratorium with government or legal authorities. In the event that this
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
20
Agreement or CYBERKINETICS' license to the Licensed Technology is transferred,
sold, novated or otherwise provided to a third party (the "Transferee") as part
of a bankruptcy or insolvency settlement under the ruling of a court of
competent jurisdiction, the obligations to pay royalties and other payments to
EMORY shall be borne by such Transferee.
ARTICLE 14. PUBLICITY
Neither party shall use the name of the other, nor of any employee of such
party, in any publicity, marketing efforts, news release or any other commercial
activities without the prior written approval of an authorized representative of
the other party. Notwithstanding the foregoing, either party may disclose the
terms of this Agreement and the parties' relationship as required by law.
ARTICLE 15. MISCELLANEOUS
15.1. ARBITRATION. Any disputes under this Agreement, shall be resolved
through arbitration conducted under the auspices of the American Arbitration
Association pursuant to that organization's rules for commercial arbitration and
shall have the right to enforce any such arbitral award. Any hearings shall be
held in Atlanta, Georgia. Both parties agree to be bound by any arbitral award
without prejudice to any other rights at law.
15.2. EXPORT CONTROLS. CYBERKINETICS acknowledges that EMORY is subject to
United States laws and regulations controlling the export of technical data,
biological materials, chemical compositions and other commodities and that
EMORY's obligations under this Agreement are contingent upon compliance with
applicable United States export laws and regulations. The transfer of technical
data, biological materials, chemical compositions and commodities may require a
license from the cognizant agency of the United States government or written
assurances by CYBERKINETICS that CYBERKINETICS shall not export data or
commodities to certain foreign countries without the prior approval of certain
United States agencies. EMORY neither represents that an export license shall
not be required nor that, if required, such export license shall be issued.
15.3. LEGAL COMPLIANCE. CYBERKINETICS shall use reasonable commercial
efforts to comply with all laws and regulations relating to its manufacture,
use, Sale, labeling or distribution of Licensed Products and shall not knowingly
take any action that would cause EMORY or CYBERKINETICS to violate any laws or
regulations.
15.4. INDEPENDENT CONTRACTOR. CYBERKINETICS' relationship to EMORY shall be
that of a licensee only. CYBERKINETICS shall not be the agent of EMORY and shall
have no authority to act for, or on behalf of, EMORY in any matter. Persons
retained by CYBERKINETICS as employees or agents shall not, by reason thereof,
be deemed to be employees or agents of EMORY.
15.5. PATENT MARKING. CYBERKINETICS shall xxxx Licensed Products Sold in
the United States with United States patent numbers in accordance with
applicable U.S. laws as in effect from time to time. Products manufactured or
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
21
Sold in other countries shall be marked in compliance with the intellectual
property laws in force in such foreign countries.
15.6. PLACE OF EXECUTION. This Agreement and any subsequent modifications
or amendments hereto shall be deemed to have been executed in the State of
Georgia. This Agreement shall not become effective or binding upon EMORY until
signed by its Assistant Vice President and Director of the Office of Technology
Transfer in the State of Georgia.
15.7. GOVERNING LAW. This Agreement and all amendments, modifications,
alterations, or supplements hereto, and the rights of the parties hereunder,
shall be construed under and governed by the laws of the State of Georgia and
the United States of America. Unless otherwise resolved under the provisions of
Article 15.1, only courts in the State of Georgia shall have jurisdiction to
hear and decide any controversy or claim between the parties arising under or
relating to this Agreement.
15.8. ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between EMORY and CYBERKINETICS with respect to the subject matter hereof and
shall not be modified, amended or terminated, except as herein provided or
except by another agreement in writing executed by the parties hereto.
15.9. SURVIVAL. Articles 9, 10, 11, 14, and 15 shall survive termination of
this Agreement for any reason. Article 11.7 shall survive termination pursuant
to Article 11.2.
15.10. SEVERABILITY. All rights and restrictions contained herein maybe
exercised and shall be applicable and binding only to the extent that they do
not violate any applicable laws and are intended to be limited to the extent
necessary so that they will not render this Agreement illegal, invalid or
unenforceable. If any provision or portion of any provision of this Agreement,
not essential to the commercial purpose of this Agreement, shall be held to be
illegal, invalid or unenforceable by a court of competent jurisdiction, it is
the intention of the parties that the remaining provisions or portions thereof
shall constitute their agreement with respect to the subject matter hereof, and
all such remaining provisions, or portions thereof, shall remain in full force
and effect. To the extent legally permissible, any illegal, invalid or
unenforceable provision of this Agreement shall be replaced by a valid
provision, which shall implement the commercial purpose of the illegal, invalid,
or unenforceable provision. In the event that any provision essential to the
commercial purpose of this Agreement is held to be illegal, invalid or
unenforceable and cannot be replaced by a valid provision which will implement
the commercial purpose of this Agreement, this Agreement and the rights granted
herein shall terminate provided, however, that it is replaced forthwith by a
legally enforceable substitute agreement that maintains the contractual
relationship between the parties as contemplated herein including specifically,
the rights and privileges granted to CYBERKINETICS in respect of the Licensed
Technology.
15.11. FORCE MAJEURE. Any delays in, or failure of performance of any party
to this Agreement, shall not constitute a default hereunder, or give rise to any
claim for damages, if and to the extent caused by occurrences beyond the control
of the party affected, including, but not limited to, acts of God, strikes or
other concerted acts of workmen, civil disturbances, fires, floods, explosions,
22
riots, war, rebellion, sabotage, acts of governmental authority or failure of
governmental authority to issue licenses or approvals which may be required.
ARTICLE 16. NOTICES
All notices, statements, and reports required to be given by one party to
the other shall be in writing and shall be deemed to have been given (i) upon
electronic confirmation of delivery, if sent by facsimile to the recipient below
followed by a copy which shall be sent by overnight delivery to the same
recipient, or (ii) upon delivery in person, or (iii) upon the expiration of five
(5) days after deposit in a lawful mail depository in the country of residence
of the party giving the notice, registered or certified postage prepaid, and
addressed as follows:
To EMORY: Director, Office of Technology Transfer
Emory University
0000 Xxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxx 00000
Notices related to EMORY's equity position in CYBERKINETICS, which include, but
are not limited to, stock, stock options, voting rights, etc. should be sent
to:
Emory University
Office of Vice President for Finance & Treasurer
000 Xxxxxxxxxxxxxx Xxxxxxxx
Xxxxxxx, XX 00000
To CYBERKINETICS: President
Cyberkinetics, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
With a copy to: Ropes & Xxxx
Xxx Xxxxxxxxxxxxx Xxxxx
Xxxxxx, XX 00000
Attn: Xxxxxxxx X. Xxxxx, Esq.
Either party hereto may change the address to which notices to such party are to
be sent by giving notice to the other party at the address and in the manner
provided above. Any notice may be given, in addition to the manner set forth
above, by courier, facsimile or email, provided that the party giving such
notice obtains acknowledgement by courier, facsimile or email that such notice
has been received by the party to be notified. Notice made in this manner shall
be deemed to have been given when such acknowledgement has been transmitted.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
23
IN WITNESS WHEREOF, EMORY and CYBERKINETICS have caused this Agreement to
be signed by their duly authorized representatives, as of the Effective Date.
EMORY UNIVERSITY: CYBERKINETICS, INC.:
By: By:
--------------------------------------------- ------------------------------------------------
Name: Xxxx X. Xxxxxxxx, Ph.D., X.X. Name:_______________________________________________
Title: Assistant Vice President & Director, Title:______________________________________________
Office of Technology Transfer
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
24
Appendix A
Licensed Patents
U.S. Patent No. * * * for "* * *" Issued * * *.
*** Information redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the
Commission.
25
