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EXHIBIT 10.8
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
AND
GMP TISSUE ENGINEERING, INC.
EXCLUSIVE PATENT LICENSE AGREEMENT
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TABLE OF CONTENTS
TABLE OF CONTENTS....................................................................................ii
R E C I T A L S...................................................................................... 1
1. Definitions...................................................................................... 2
2. Grant of Rights.................................................................................. 5
3. COMPANY Diligence Obligations.................................................................... 7
4. Royalties and Payment Terms...................................................................... 8
5. Reports and Records..............................................................................11
6. Confidentiality..................................................................................14
7. Patent Prosecution...............................................................................14
8. Infringement.....................................................................................15
9. Indemnification and Insurance....................................................................17
10. No Representations or Warranties.................................................................18
11. Assignment.......................................................................................19
12. General Compliance with Laws.....................................................................19
13. Termination......................................................................................20
14. Dispute Resolution...............................................................................22
15. Miscellaneous....................................................................................23
APPENDIX A...........................................................................................27
APPENDIX B...........................................................................................31
APPENDIX C...........................................................................................31
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MASSACHUSETTS INSTITUTE OF TECHNOLOGY
EXCLUSIVE PATENT LICENSE AGREEMENT
This Agreement, effective as of the date set forth above the
signatures of the parties below (the "EFFECTIVE DATE"), is between the
Massachusetts Institute of Technology ("M.I.T."), a Massachusetts corporation,
with a principal office at 00 Xxxxxxxxxxxxx Xxxxxx, Xxxxxxxxx, XX
Medical02139-4307,Children's Medical and GMP TISSUE ENGINEERING, INC.
("COMPANY"), a Delaware corporation, with a principal place of business at 0
Xxxx Xxxxxxx Xxxxxxxxx, Xxxxx 0000, Xxxx Xxxxxxxxxx, Xxxxxxx 00000.
RECITALS
WHEREAS, M.I.T. and CHILDREN'S MEDICAL CENTER CORPORATION
("CHILDREN'S"), with a principal office at 000 Xxxxxxxx Xxxxxx, Xxxxxx XX
00000, are the owners of certain PATENT RIGHTS (as later defined herein) and
have the right to grant licenses under said PATENT RIGHTS, subject only to a
royalty-free, nonexclusive non-transferable license to practice the PATENT
RIGHTS granted to the United States Government for government purposes;
WHEREAS CHILDREN'S has made M.I.T. its sole and exclusive agent for
licensing the PATENT RIGHTS;
WHEREAS, Xxxxxx Xxxxxx, an inventor of the PATENT RIGHTS, has or will
shortly acquire equity in Global Medical Products, Inc. ("GMP"), has executed
the Waiver of Participation in M.I.T.'s institutional equity share of Xxxxxx
Xxxxxx, which is attached as Appendix B hereto;
WHEREAS, M.I.T.'s Vice President for Research has approved that Xxxxxx
Xxxxxx, an inventor of the PATENT RIGHTS, now holds or shall shortly acquire
equity in GMP and that M.I.T. is accepting equity of the COMPANY as partial
consideration for the rights and licenses granted under this Agreement;
WHEREAS, M.I.T. and CHILDREN'S desire to have the PATENT RIGHTS
developed and commercialized to benefit the public and is willing to grant a
license thereunder;
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WHEREAS, COMPANY has represented to M.I.T., to induce M.I.T. to enter
into this Agreement, that COMPANY shall commit itself to a thorough, vigorous
and diligent program of exploiting the PATENT RIGHTS so that public utilization
shall result therefrom; and
WHEREAS, COMPANY desires to obtain a license under the PATENT RIGHTS
upon the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual promises and other good
and valuable consideration, M.I.T., on its own behalf and as agent for
CHILDREN'S, and COMPANY hereby agree as follows:
1. DEFINITIONS.
1.1 "AFFILIATE" shall mean any legal entity (such as a corporation,
partnership, or limited liability company) that is controlled by COMPANY. For
the purposes of this definition, the term "control" means (i) beneficial
ownership of at least fifty percent (50%) of the voting securities of a
corporation or other business organization with voting securities or (ii) a
fifty percent (50%) or greater interest in the net assets or profits of a
partnership or other business organization without voting securities.
1.2 "CONFIDENTIAL ITEMS" shall mean any proprietary information, which
are communicated to, learned by or otherwise acquired by the party receiving
such information or materials during or in the course of this Agreement,
further including information concerning the existence, scope or activities of
any research and/or development project of the disclosing party.
1.3 "EXCLUSIVE PERIOD" shall mean the period of time set forth in
Section 2.2.
1.4 "FIELD" shall mean central nervous system and peripheral nervous
system, including, but not limited to, treatment of spinal cord injury and
treatment of peripheral nerve injury.
1.5 "LICENSED PRODUCT" shall mean any product or part thereof that:
(i) absent the license granted hereunder, would infringe
one or more claims of the PATENT RIGHTS; or
(ii) is manufactured by using a LICENSED PROCESS or that,
when used, practices a LICENSED PROCESS.
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1.6 "LICENSED PROCESS" shall mean any process that, absent the license
granted hereunder, would infringe one or more claims of the PATENT RIGHTS or
which uses a LICENSED PRODUCT.
1.7 "NET SALES" shall mean the gross amount received by COMPANY and
its AFFILIATES from the sale of LICENSED PRODUCTS and LICENSED PROCESSES by
COMPANY or an AFFILIATE to non-AFFILIATE third parties, less the following:
(i) customary trade, quantity, or cash discounts to the
extent actually allowed and taken;
(ii) amounts repaid or credited by reason of rejection or
return;
(iii) to the extent separately stated on purchase orders,
invoices, or other documents of sale, any taxes or other governmental charges
levied on the production, sale, transportation, delivery, or use of a LICENSED
PRODUCT or LICENSED PROCESS which is paid by or on behalf of COMPANY; and
(iv) outbound transportation costs prepaid or allowed and
costs of insurance in transit.
No deductions shall be made for commissions paid to
individuals whether they be with independent sales agencies or regularly
employed by COMPANY and on its payroll, or for cost of collections. NET SALES
shall occur on the date of receipt of payment for a LICENSED PRODUCT or
LICENSED PROCESS. If a LICENSED PRODUCT or a LICENSED PROCESS is distributed at
a discounted price that is substantially lower than the customary price charged
by COMPANY, or distributed for non-cash consideration (whether or not at a
discount), NET SALES shall be calculated based on the non-discounted amount of
the LICENSED PRODUCT or LICENSED PROCESS charged to an independent third party
during the same REPORTING PERIOD or, in the absence of such sales, on the fair
market value of the LICENSED PRODUCT or LICENSED PROCESS.
1.8 "PATENT RIGHTS" shall mean:
(a) the United States, international and foreign patents
listed on Appendix A;
(b) the United States, international and foreign patent
applications and/or provisional applications listed on Appendix A and the
resulting patents;
(c) any patent applications resulting from the
provisional applications listed on Appendix A, and any divisionals,
continuations, continuation-in-part applications, and continued prosecution
applications (and their relevant international or foreign equivalents) of the
patent applications listed on Appendix A and of such patent applications that
result from the
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provisional applications listed on Appendix A, to the extent the claims are
directed to subject matter specifically described in the patent applications
listed on Appendix A, and the resulting patents;
(d) any patents resulting from reissues, reexaminations,
or extensions (and their relevant international equivalents) of the patents
described in (a), (b), and (c) above; and
(e) international (non-United States) patent
applications and provisional applications filed after the EFFECTIVE DATE and
the relevant international equivalents to divisionals, continuations,
continuation-in-part applications and continued prosecution applications of the
patent applications to the extent the claims are directed to subject matter
specifically described in the patents or patent applications referred to in
(a), (b), (c), and (d) above, and the resulting patents.
1.9 "REPORTING PERIOD" shall begin on the first day of each calendar
quarter and end on the last day of such calendar quarter.
1.10 "SUBLICENSE INCOME" shall mean any payments that COMPANY or an
AFFILIATE receives from a SUBLICENSEE in consideration of the sublicense of the
rights granted COMPANY and AFFILIATES under Section 2.1, including without
limitation license fees, milestone payments not allocated to research and
development but included as part of a sublicensing agreement (including
research and regulatory milestones), license maintenance fees, and other
payments including royalties received by COMPANY from SUBLICENSEES for LICENSED
PRODUCTS or LICENSED PROCESSES, but specifically excluding any payments
received for research and/or development or for performing pre-clinical or
clinical trials or obtaining appropriate regulatory approvals.
1.11 "SUBLICENSEE" shall mean any non-AFFILIATE sublicensee of the
rights granted COMPANY under Section 2.1.
1.12 "TERM" shall mean the term of this Agreement, which shall
commence on the EFFECTIVE DATE and shall remain in effect until the expiration
or abandonment of all issued patents and filed patent applications within the
PATENT RIGHTS, unless earlier terminated in accordance with the provisions of
this Agreement.
1.13 "TERRITORY" shall mean worldwide.
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2. GRANT OF RIGHTS.
2.1 License Grants. Subject to the terms of this Agreement, M.I.T.
hereby grants to COMPANY and its AFFILIATES for the TERM a royalty-bearing
license under the PATENT RIGHTS to develop, make, have made, use, sell,
distribute, lease, and import LICENSED PRODUCTS in the FIELD in the TERRITORY
and to develop and perform LICENSED PROCESSES in the FIELD in the TERRITORY.
2.2 Exclusivity. In order to establish an exclusive period for
COMPANY, M.I.T. agrees that it shall not grant any other license to make, have
made, use, sell, distribute, lease and import LICENSED PRODUCTS in the FIELD in
the TERRITORY or to perform LICENSED PROCESSES in the FIELD in the TERRITORY
during the period of time commencing on the EFFECTIVE DATE and terminating with
the last to expire of the PATENT RIGHTS. The grant of this license shall not
result in a breach of MIT's agreements with Advanced Tissue Sciences (ATS) or
Reprogenesis.
2.3 Sublicenses. COMPANY shall have the right to grant sublicenses of
its rights under Section 2.1. COMPANY shall incorporate terms and conditions
into its sublicense agreements sufficient to enable COMPANY to comply with this
Agreement. COMPANY shall promptly furnish M.I.T. with a fully signed photocopy
of any sublicense agreement. Upon termination of this Agreement for any reason,
any SUBLICENSEE not then in default shall have the right to seek a license from
M.I.T. M.I.T. agrees to negotiate such licenses in good faith under reasonable
terms and conditions.
Upon COMPANY'S request, MIT agrees to provide, on a timely basis, a
letter to an existing or potential SUBLICENSEE specifically named by COMPANY
stating that, in the event of termination of this Agreement, MIT will grant a
license to SUBLICENSEE under terms and conditions to be no less favorable as a
whole than those granted to SUBLICENSEE by COMPANY, provided that SUBLICENSEE
is not in default at the time such license is to be granted. COMPANY'S right to
request and SUBLICENSEE'S right to acquire such letter are specifically
conditioned on M.I.T.'s review of the final sublicense agreement and M.I.T.'s
conclusion, at its sole discretion, that such sublicense agreement is
reasonable and in the best interests of the commercialization of the PATENT
RIGHTS.
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2.4 U.S. Manufacturing. COMPANY agrees that any LICENSED PRODUCTS used
or sold in the United States will be manufactured substantially in the United
States.
2.5 Retained Rights.
(a) M.I.T. M.I.T. retains the right to practice under
the PATENT RIGHTS for research, teaching, and educational purposes.
(b) Federal Government. COMPANY acknowledges that the
U.S. federal government retains a royalty-free, non-exclusive, non-transferable
license to practice any government-funded invention claimed in any PATENT
RIGHTS as set forth in 35 U.S.C. xx.xx. 201-211, and the regulations promulgated
thereunder, as amended, or any successor statutes or regulations.
(c) The grant of Section 2.2, notwithstanding, COMPANY
acknowledges that Reprogenesis, Inc., an existing licensee of the PATENT
RIGHTS, has non-exclusive rights to practice under the PATENT RIGHTS to
regenerate nerve tissues contained in and necessary for the primary function of
regenerated tissues in the "breast and urological Fields" and that M.I.T. may
subsequently grant similar non-exclusive licenses for nerve tissue contained in
or necessary for the primary function of cardiac and cardiovascular tissue,
which such cardiac and cardiovascular tissues are regenerated using the
technology of the PATENT RIGHTS.
2.6 Option. M.I.T. hereby grants to COMPANY an exclusive six-month
first option to negotiate for an exclusive license to any invention(s) arising
from research in the MIT laboratory of Professor Xxxxxx Xxxxxx which are
invented within three (3) years of the EFFECTIVE DATE and which fall within the
claims of the PATENT RIGHTS as defined on the EFFECTIVE DATE, and which are in
the FIELD. Such option shall, however, be subject to any currently existing
third party rights, and the grant of this Paragraph 2.6 shall not restrict the
terms of any sponsored research agreement or material transfer agreements, past
or future. COMPANY's option to such inventions shall terminate six (6) months
from the date at which M.I.T. notifies COMPANY that a patent application has
been filed on the invention. COMPANY may exercise the option by agreeing to pay
a $25,000.00 license fee plus an additional $10,000.00 annual maintenance fee
plus the patent costs incurred by MIT for patent applications directed to the
invention, in which event such patent applications shall be added to Appendix A
of this Agreement.
2.7 No Additional Rights. Nothing in this Agreement shall be construed
to confer any rights upon COMPANY by implication, estoppel, or otherwise as to
any technology or patent
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
rights of M.I.T. or any other entity other than the PATENT RIGHTS, regardless
of whether such technology or patent rights shall be dominant or subordinate to
any PATENT RIGHTS.
3. COMPANY DILIGENCE OBLIGATIONS.
3.1 Diligence Requirements. COMPANY shall use diligent efforts, or
shall cause its AFFILIATES and SUBLICENSEES to use diligent efforts, to develop
LICENSED PRODUCTS or LICENSED PROCESSES and to introduce LICENSED PRODUCTS or
LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its
AFFILIATES or SUBLICENSEES shall make LICENSED PRODUCTS or LICENSED PROCESSES
reasonably available to the public. Specifically, COMPANY or AFFILIATE or
SUBLICENSEE shall fulfill the following obligations:
(a) Within 6 months after the EFFECTIVE DATE, COMPANY
shall furnish M.I.T. with a written research and development plan describing
the major tasks to be achieved in order to bring to market a LICENSED PRODUCT
or a LICENSED PROCESS, specifying the number of staff and other resources to be
devoted to such commercialization effort. M.I.T.'s approval of this research
and development plan is not required.
(b) Within sixty (60) days after the end of each
calendar year, COMPANY shall furnish M.I.T. with a written report (consistent
with Section 5.1(a)) on the progress of its efforts during the immediately
preceding calendar year to develop and commercialize LICENSED PRODUCTS or
LICENSED PROCESSES. The report shall also contain a discussion of intended
efforts and sales projections for the year in which the report is submitted.
(c) COMPANY shall obtain funding at a level of no less
than [***] within ninety (90) days of the EFFECTIVE DATE of this Agreement.
(d) COMPANY shall commit a minimum of [***] per year to
research and development specifically directed to developing products that fall
under the PATENT RIGHTS beginning in the year 2000 and continuing until the
completion of preclincal trials. This research money can be spent internally or
externally as sponsored research at a hospital or university.
(e) During the term of this Agreement, COMPANY shall
have a minimum of
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
[***] in cash, cash equivalents or short-term investments at all times. For the
purposes of this paragraph, COMPANY shall mean either the parent company GMP or
COMPANY.
(f) In addition to the diligence requirements listed
above, COMPANY and M.I.T. acknowledge that M.I.T. and CHILDRENS main objective
in entering into this Agreement is for the PATENT RIGHTS to be developed in the
FIELD. In furtherance of this goal, M.I.T. may, at any time during this
Agreement, request from COMPANY, in writing, a progress report, which includes
development plans, which COMPANY shall provide to M.I.T. within thirty (30)
days of receiving a written request. If M.I.T. is not satisfied that COMPANY is
diligently exploiting the PATENT RIGHTS in the FIELD within the budget
allocated in 3.1.(d), above, then M.I.T. and COMPANY shall meet, within a
reasonable period of time, to review COMPANY's progress and to agree to a
development plan. If COMPANY and M.I.T. are unable to come to agreement on such
a plan after good faith negotiations within ninety (90) days, then COMPANY
shall grant M.I.T. the nonexclusive right to develop the PATENT RIGHTS in the
FIELD, including the right to sublicense a third party.
In the event that M.I.T. determines that COMPANY (or an AFFILIATE or
SUBLICENSEE) has failed to fulfill any of its obligations under this Section
3.1, then M.I.T. may treat such failure as a material breach in accordance with
Section 12.3(b).
4. ROYALTIES AND PAYMENT TERMS.
4.1 Consideration for Grant of Rights. In consideration of the
exclusive rights granted COMPANY herein, COMPANY hereby agrees as follows:
(a) License Issue Fee and Patent Cost Reimbursement
COMPANY shall pay to M.I.T. on the EFFECTIVE DATE a license issue fee of [***].
This payment is nonrefundable.
(b) License Maintenance Fees. COMPANY shall pay to
M.I.T. the following license maintenance fees on the dates set forth below:
January 1, 2001, 2002, 2003 [***]
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
January 1, 2004
and each January 1 of
every year thereafter [***]
This annual license maintenance fee is nonrefundable;
however, the license maintenance fee may be credited against running royalties
subsequently due to M.I.T. from COMPANY on NET SALES earned during the same
calendar year, if any. License maintenance fees paid in excess of running
royalties due in such calendar year shall not be creditable to amounts due for
future years.
(c) Running Royalties. COMPANY shall pay to M.I.T. a
running royalty of [***] of NET SALES by COMPANY and AFFILIATES. Running
royalties shall be payable for each REPORTING PERIOD and shall be due to M.I.T.
within sixty (60) days of the end of each REPORTING PERIOD.
(d) Sharing of SUBLICENSE INCOME. COMPANY shall pay
M.I.T. [***] of SUBLICENSE INCOME received by COMPANY or AFFILIATES.
(e) No Multiple Royalties. If the manufacture, use,
lease, distribution or sale of any LICENSED PRODUCT or the performance of any
LICENSED PROCESS is covered by more than one of the PATENT RIGHTS, multiple
royalties shall not be due.
(f) Equity.
(i) Initial Grant. COMPANY shall issue a total
of [***] shares of Common Stock of COMPANY, $.001 par value per share, (the
"Shares") in the name of M.I.T. and of such persons as M.I.T. shall direct
("M.I.T. Holder"), and each M.I.T. Holder shall receive such number of shares as
M.I.T. shall direct.
COMPANY represents to M.I.T. that, as of the Effective Date,
the aggregate number of Shares equals [***] of the COMPANY's issued and
outstanding Common Stock calculated on a "Fully Diluted Basis." For purposes of
this Section 4.1(f), "Fully Diluted Basis" shall mean that the total number of
issued and outstanding shares of the COMPANY's Common Stock shall be calculated
to include conversion of all issued and outstanding securities then convertible
into common stock, the exercise of all then outstanding options and warrants to
purchase shares of common stock, whether or not then exercisable, and shall
assume the issuance or grant of all securities reserved for issuance pursuant to
any COMPANY stock or stock option plan in effect on the date of the calculation.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(ii) Anti-Dilution Protection. COMPANY shall
issue additional shares of Common Stock to M.I.T. and each M.I.T. Holder pro
rata, such that M.I.T.'s and each M.I.T. Holders' ownership of outstanding
Common Stock (representing [***] on the effective date) shall not fall below
[***] on a Fully Diluted Basis, as calculated after giving effect to the
anti-dilutive issuance. Such anti-dilution protection shall continue until the
earlier of (i) the date upon which COMPANY achieves liquidity (by non-limiting
example, through acquisition or an Initial Public Offering) or (ii) the date
upon which COMPANY has received funding through equity or other sources in the
aggregate of [***]. Thereafter, no additional shares shall be due to M.I.T. or
any M.I.T. Holder pursuant to this section.
(f) Third-Party Royalties. In the event that COMPANY is
legally required to make royalty payments to one or more third parties in order
to make, use, or sell LICENSED PRODUCTS or to perform LICENSED SERVICES,
COMPANY may offset a total of fifty percent (50%) of such third-party payments
against any royalty payments that are due to MIT in the same REPORTING PERIOD,
provided that in no event shall the royalty payments under Section 4.1(c),
when aggregated with any other offsets and credits allowed under this
Agreement, fall below one and one-half percent (1.5%) of NET SALES.
4.2 Payments.
(a) Method of Payment. All payments under this Agreement
should be made payable to "Massachusetts Institute of Technology" and sent to
the address identified in Section 14.1. Each payment should reference this
Agreement and identify the obligation under this Agreement that the payment
satisfies.
(b) Payments in U.S. Dollars. All payments due under
this Agreement shall be payable in United States dollars. Conversion of foreign
currency to U.S. dollars shall be made at the conversion rate existing in the
United States (as reported in the Wall Street Journal) on the last working day
of the calendar quarter of the applicable REPORTING PERIOD. Such payments shall
be without deduction of exchange, collection, or other charges, and,
specifically, without deduction of withholding or similar taxes or other
government imposed fees or taxes, except as permitted in the definition of NET
SALES.
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(c) Late Payments. Any payments by COMPANY that are not
paid on or before the date such payments are due under this Agreement shall
bear interest, to the extent permitted by law, at two percentage points above
the Prime Rate of interest as reported in the Wall Street Journal on the date
payment is due.
5. REPORTS AND RECORDS.
5.1 Frequency of Reports.
(a) Before First Commercial Sale. Prior to the first
commercial sale of any LICENSED PRODUCT or first commercial performance of any
LICENSED PROCESS, COMPANY shall deliver reports to M.I.T. annually, within
sixty (60) days of the end of each calendar year, containing information
concerning the immediately preceding calendar year, as further described in
Section 5.2.
(b) Upon First Commercial Sale of a LICENSED PRODUCT or
Commercial Performance of a LICENSED PROCESS. COMPANY shall report to M.I.T.
the date of first commercial sale of a LICENSED PRODUCT and the date of first
commercial performance of a LICENSED PROCESS within sixty (60) days of
occurrence in each country.
(c) After First Commercial Sale. After the first
commercial sale of a LICENSED PRODUCT or first commercial performance of a
LICENSED PROCESS, COMPANY shall deliver reports to M.I.T. within sixty (60)
days of the end of each REPORTING PERIOD, containing information concerning the
immediately preceding REPORTING PERIOD, as further described in Section 5.2.
5.2 Content of Reports and Payments. Each report delivered by COMPANY
to M.I.T. shall contain at least the following information for the immediately
preceding REPORTING PERIOD:
(i) the number of LICENSED PRODUCTS sold, leased or
distributed by COMPANY, its AFFILIATES and SUBLICENSEES to independent third
parties in each country, and, if applicable, the number of LICENSED PRODUCTS
used by COMPANY, its AFFILIATES and SUBLICENSEES in the provision of services
in each country;
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(ii) a description of LICENSED PROCESSES performed by
COMPANY, its AFFILIATES and SUBLICENSEES in each country as may be pertinent to
a royalty accounting hereunder;
(iii) the gross price charged by COMPANY, its AFFILIATES
and SUBLICENSEES for each LICENSED PRODUCT and, if applicable, the gross price
charged for each LICENSED PRODUCT used to provide services in each country; and
the gross price charged for each LICENSED PROCESS performed by COMPANY, its
AFFILIATES and SUBLICENSEES in each country;
(iv) calculation of NET SALES for the applicable
REPORTING PERIOD in each country, including a listing of applicable deductions;
(v) total royalty payable on NET SALES in U.S. dollars,
together with the exchange rates used for conversion;
(vi) the amount of SUBLICENSE INCOME received by COMPANY
from each SUBLICENSEE and the amount due to M.I.T. from such SUBLICENSE INCOME,
including an itemized breakdown of the sources of income comprising the
SUBLICENSE INCOME; and
(vii) the number of sublicenses entered into for the
PATENT RIGHTS, LICENSED PRODUCTS and/or LICENSED PROCESSES.
If no amounts are due to M.I.T. for any REPORTING PERIOD, the report
shall so state.
5.3 Financial Statements. On or before the ninetieth (90th) day
following the close of COMPANY's fiscal year, COMPANY shall provide M.I.T. with
COMPANY's financial statements for the preceding fiscal year including, at a
minimum, a balance sheet and an income statement, certified by COMPANY's
treasurer or chief financial officer or by an independent auditor.
5.4 Records. COMPANY shall maintain, and shall cause its AFFILIATES
and SUBLICENSEES to maintain, complete and accurate records relating to the
rights and obligations under this Agreement and any amounts payable to M.I.T.
in relation to this Agreement, which records shall contain sufficient
information to permit M.I.T. to confirm the accuracy of any reports delivered
to M.I.T. and compliance in other respects with this Agreement. The relevant
party shall retain such records for at least three (3) years following the
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end of the calendar year to which they pertain, during which time M.I.T., or
M.I.T.'s appointed agents, shall have the right, at M.I.T.'s expense, to
inspect such records during normal business hours to verify any reports and
payments made or compliance in other respects under this Agreement. In the
event that any audit performed under this Section reveals an underpayment in
excess of ten percent (10%), COMPANY shall bear the full cost of such audit and
shall remit any amounts due to M.I.T. within thirty (30) days of receiving
notice thereof from M.I.T.
6. CONFIDENTIALITY.
6.1 Each party shall hold in confidence, and shall not disclose to any
person except on a need-to-know and only to those who are bound to protect the
confidentiality of such Confidential Items, for a period ending five (5) years
after the Term of this Agreement any Confidential Items disclosed to it by the
other party to this Agreement. The party receiving such Confidential Items shall
use such Confidential Items only for purposes of this Agreement and shall not
exploit such Confidential Items for its own benefit or the benefit of another
without the specific prior written consent of the disclosing party.
6.2 The confidentiality and non-use obligations of the receiving party
shall not apply to the extent that (a) the receiving party is
required (i) to disclose information by law, order or regulation of
a governmental agency or a court of competent jurisdiction, or (ii)
to disclose information to any governmental agency for purposes of
obtaining approval to test or market a product, provided in either
case that the receiving party shall provide to the disclosing party
written notice and sufficient opportunity to object to such
disclosure or to request confidential treatment thereof; or (b) the
receiving party can demonstrate that the Confidential Item:
(i) is disclosed in one or more printed publications
available to the public, is described in an issued
patent anywhere in the world, is otherwise in the
public domain at the time of disclosure to the
receiving party, or subsequent to its disclosure to
the receiving party becomes publicly know through no
breach of this Agreement by the receiving party;
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(ii) becomes known to the receiving party through
disclosure from sources other than the disclosing
party having the lawful right to disclose such
Confidential Items without obligation of
confidentiality to any person;
(iii) is generally disclosed to third parties by the
disclosing party without similar confidentiality
restrictions on such third parties;
(iv) is approved for release by written authorization of
an officer of the disclosing party; or
(v) is already known by the receiving party as evidenced
by its prior written records;
provided, however, that a breach of the foregoing obligations shall
not be absolved by the subsequent occurrence of any of the above
exceptions. With respect to MIT, this obligation of confidentiality
alone applies only to the MIT Technology Licensing Office.
7. PATENT PROSECUTION.
7.1 Responsibility for PATENT RIGHTS. M.I.T. shall prepare, file,
prosecute, and maintain all of the PATENT RIGHTS. COMPANY shall have reasonable
opportunities to advise M.I.T. and shall cooperate with M.I.T. in such filing,
prosecution and maintenance.
7.2 International (non-United States) Filings. Appendix A, Section 2
is a list of countries in which patent applications corresponding to the United
States patent applications listed in Appendix A, Section 1 have been or shall
be filed, prosecuted, and maintained. COMPANY may direct M.I.T. to file and
prosecute in any foreign country any patent applications and patents for any
PATENT RIGHTS, provided that COMPANY agrees to reimburse M.I.T. for all costs
and fees associated with such filing, prosecution and maintenance. Pursuant to
Section 7.3 below, such payments shall be due within thirty (30) days of
invoicing and late payments shall accrue interest pursuant to Section 4.2(c).
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7.3 Payment of Expenses. During any period of time during which third
party reimbursement of patent costs falls below one hundred percent (100%) of
costs, COMPANY shall be responsible for unreimbursed fees and cost, including
attorneys fees, relating to the filing, prosecution and maintenance of the
PATENT RIGHTS. This shall consist of unreimbursed costs incurred after the
EFFECTIVE DATE. Should M.I.T. enter into another license agreement for the
PATENT RIGHTS in a separate field of use (excluding the license agreements in
existence at the time of entering into this License Agreement) M.I.T. will
consider a fair and equitable way to share the reimbursement of patent costs
among COMPANY and the new licensees. COMPANY shall reimburse all amounts due
pursuant to this Section within thirty (30) days of invoicing; late payments
shall accrue interest pursuant to Section 4.2(c). As of the effective date, no
amounts are due from the Company under this Section 7.3. Company's obligation
under this Section 7.3 shall be to contribute a fair and equitable portion of
such costs as measured against other licensees in other license fields.
8. INFRINGEMENT.
8.1 Notification of Infringement. Each party agrees to provide written
notice to the other party promptly after becoming aware of any infringement of
the PATENT RIGHTS.
8.2 Right to Prosecute Infringements.
(a) COMPANY Right to Prosecute. So long as COMPANY
remains the exclusive licensee of the PATENT RIGHTS in the FIELD in the
TERRITORY, COMPANY, to the extent permitted by law, shall have the right, under
its own control and at its own expense, to prosecute any third party
infringement of the PATENT RIGHTS in the FIELD in the TERRITORY, subject to
Sections 8.4 and 8.5. If required by law, M.I.T. shall permit any action under
this Section to be brought in its name, including being joined as a
party-plaintiff, provided that COMPANY shall hold M.I.T. harmless from, and
indemnify M.I.T. against, any costs, expenses, or liability that M.I.T. incurs
in connection with such action.
Prior to commencing any such action, COMPANY shall consult with M.I.T.
and shall consider the views of M.I.T. regarding the advisability of the
proposed action and its effect on the public interest. COMPANY shall not enter
into any settlement, consent judgment, or other voluntary final disposition of
any infringement action under this Section without the prior written consent of
M.I.T.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(b) M.I.T. Right to Prosecute. In the event that COMPANY
is unsuccessful in persuading the alleged infringer to desist or fails to have
initiated an infringement action within a reasonable time after COMPANY first
becomes aware of the basis for such action, M.I.T. shall have the right, at its
sole discretion, to prosecute such infringement under its sole control and at
its sole expense, and any recovery obtained shall belong to M.I.T, provided,
however, that MIT shall hold COMPANY harmless from, and indemnify COMPANY
against, any costs, expenses, or liability that COMPANY incurs in connection
with such action.
8.3 Declaratory Judgment Actions. In the event that a declaratory
judgment action is brought against M.I.T. or COMPANY by a third party alleging
invalidity, unenforceability, or non-infringement of the PATENT RIGHTS, M.I.T.,
at its option, shall have the right within twenty (20) days after commencement
of such action to take over the sole defense of the action at its own expense.
If M.I.T. does not exercise this right, COMPANY may take over the sole defense
of the action at COMPANY's sole expense, subject to Sections 8.4 and 8.5.
8.4 Offsets. COMPANY may offset a total of fifty percent (50%) of any
expenses incurred under Sections 8.2 and 8.3 against any payments due to M.I.T.
under Article 4, provided that in no event shall such payments under Article 4,
when aggregated with any other offsets and credits allowed under this
Agreement, be reduced by more than fifty percent (50%) in any REPORTING PERIOD.
8.5 Recovery. Any recovery obtained in an action brought by COMPANY
under Sections 8.2 or 8.3 shall be distributed as follows: (i) each party shall
be reimbursed for any expenses incurred in the action for which it has not
otherwise been reimbursed (including the amount of any royalty or other
payments withheld from M.I.T. as described in Section 8.4), (ii) as to ordinary
damages, COMPANY shall receive an amount equal to its lost profits or a
reasonable royalty on the infringing sales, or whichever measure of damages the
court shall have applied, and COMPANY shall pay to M.I.T. based upon such
amount [***] of the royalties and other amounts that COMPANY would have paid to
M.I.T. if COMPANY had sold the infringing products, processes and services
rather than the infringer, and (iii) as to special or punitive damages, the
parties shall share equally in any award.
8.6 Cooperation. Each party agrees to cooperate in any action under
this Article which is controlled by the other party, provided that the
controlling party reimburses the cooperating party promptly for any third party
costs and expenses incurred by the cooperating party in connection with
providing such assistance.
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8.7 Right to Sublicense. So long as COMPANY remains the exclusive
licensee of the PATENT RIGHTS in the FIELD in the TERRITORY, COMPANY shall have
the sole right to sublicense any alleged infringer in the FIELD in the
TERRITORY for future use of the PATENT RIGHTS in accordance with the terms and
conditions of this Agreement relating to sublicenses. Any upfront fees as part
of such sublicense shall be treated as set forth in Article 4.
9. INDEMNIFICATION AND INSURANCE
9.1 Indemnification.
(a) Indemnity. COMPANY shall indemnify, defend, and hold
harmless M.I.T., CHILDREN'S and their trustees, officers, faculty, students,
employees, and agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss, or expense (including
reasonable attorneys fees and expenses) incurred by or imposed upon any of the
Indemnitees in connection with any claims, suits, actions, demands or judgments
arising out of any theory of liability (including without limitation actions in
the form of tort, warranty, or strict liability and regardless of whether such
action has any factual basis) concerning any product, process, or service that
is made, used, sold, imported, or performed pursuant to any right or license
granted under this Agreement.
(b) Procedures. The Indemnitees agree to provide COMPANY
with prompt written notice of any claim, suit, action, demand, or judgment for
which indemnification is sought under this Agreement. COMPANY agrees, at its
own expense, to provide attorneys reasonably acceptable to M.I.T. and
CHILDREN'S to defend against any such claim. The Indemnitees shall cooperate
fully with COMPANY in such defense and will permit COMPANY to conduct and
control such defense and the disposition of such claim, suit, or action
(including all decisions relative to litigation, appeal, and settlement);
provided, however, that any Indemnitee shall have the right to retain its own
counsel, at the expense of COMPANY, if representation of such Indemnitee by the
counsel retained by COMPANY would be inappropriate because of actual or
potential differences in the interests of such Indemnitee and any other party
represented by such counsel. COMPANY agrees to keep M.I.T. and CHILDREN'S
informed of the progress in the defense and disposition of such claim and to
consult with M.I.T. and CHILDREN'S with regard to any proposed settlement.
9.2 Insurance. COMPANY shall obtain and carry in full force and effect
commercial general liability insurance, including product liability and errors
and omissions insurance which
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shall protect COMPANY and Indemnitees with respect to events covered by Section
9.1(a) above subject to the standard policy exclusions. Such insurance (i)
shall be issued by an insurer licensed to practice in the Commonwealth of
Massachusetts or an insurer pre-approved by M.I.T., such approval not to be
unreasonably withheld, (ii) shall list M.I.T. and CHILDREN'S as an additional
named insured thereunder, (iii) shall be endorsed to include product liability
coverage, and (iv) shall require thirty (30) days written notice to be given to
M.I.T. and CHILDREN'S prior to any cancellation or material change thereof. The
limits of such insurance shall not be less than One Million Dollars
($1,000,000) per occurrence with an aggregate of Three Million Dollars
($3,000,000) for bodily injury including death; One Million Dollars
($1,000,000) per occurrence with an aggregate of Three Million Dollars
($3,000,000) for property damage; and One Million Dollars ($1,000,000) per
occurrence with an aggregate of Three Million Dollars ($3,000,000) for errors
and omissions. In the alternative, COMPANY may self-insure subject to prior
approval of M.I.T. COMPANY shall provide M.I.T. with Certificates of Insurance
evidencing compliance with this Section. COMPANY shall continue to maintain
such insurance or self-insurance after the expiration or termination of this
Agreement during any period in which COMPANY or any AFFILIATE or SUBLICENSEE
continues (i) to make, use, or sell a product that was a LICENSED PRODUCT under
this Agreement or (ii) to perform a service that was a LICENSED PROCESS under
this Agreement, and thereafter for a period of five (5) years.
10. NO REPRESENTATIONS OR WARRANTIES
10.1 No Representations
EXCEPT AS MAY OTHERWISE BE EXPRESSLY SET FORTH IN THIS AGREEMENT,
M.I.T. AND CHILDREN'S MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND
CONCERNING THE PATENT RIGHTS, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING,
AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.
Specifically, and not to limit the foregoing, M.I.T. and CHILDREN'S make no
warranty or representation (i) regarding the validity or scope of the PATENT
RIGHTS, and (ii) that the exploitation of the PATENT RIGHTS or any LICENSED
PRODUCT or LICENSED PROCESS will not infringe any patents other than PATENT
RIGHTS or other intellectual property rights of M.I.T. or of a third party.
EXCEPT AS PROVIDED IN SECTION 10.2 BELOW, IN NO EVENT SHALL M.I.T.,
CHILDREN'S, THEIR TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND
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AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND,
INCLUDING ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS
OF WHETHER M.I.T. SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT
SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
10.2 Limited Warranty. M.I.T. represents and warrants on its own
behalf , and not as agent for CHILDREN's, that it has the right to license the
PATENT RIGHTS in the FIELD, and that the FIELD is part of the EXCLUDED FIELD OF
USE of the Advanced Tissue Sciences License Agreement, dated July 24, 1992 and
any amendments thereto (the "ATS License Agreement"), and is not part of the
FIELD OF USE of the Reprogenesis License Agreement, as amended and restated on
July 1, 1996; provided, however, that any liability under this warranty is
limited to the fees paid or to be paid under this License Agreement.
11. ASSIGNMENT.
This Agreement is personal to COMPANY and no rights or obligations may
be assigned by COMPANY without the prior written consent of M.I.T., which shall
not be unreasonably withheld. M.I.T. shall respond within ten (10) business
days to any requests from COMPANY to approve assignments. M.I.T. shall have the
right to terminate this Agreement immediately upon written notice to COMPANY
upon a purchase of a majority of COMPANY's outstanding voting securities in a
single transaction by a third party without M.I.T.'s prior written consent,
which shall not be unreasonably withheld. M.I.T.s consent shall not be required
for any sales to the public.
12. GENERAL COMPLIANCE WITH LAWS.
12.1 Compliance with Laws. COMPANY shall use reasonable commercial
efforts to comply with all commercially material local, state, federal, and
international laws and regulations relating to the development, manufacture,
use, and sale of LICENSED PRODUCTS and LICENSED PROCESSES.
12.2 Export Control. COMPANY and its AFFILIATES and SUBLICENSEES shall
comply with all United States laws and regulations controlling the export of
certain commodities and technical data, including without limitation all Export
Administration Regulations of the United States Department of Commerce. Among
other things, these laws and regulations prohibit or require a license for the
export of certain types of commodities and technical data to
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specified countries. COMPANY hereby gives written assurance that it will comply
with, and will cause its AFFILIATES and SUBLICENSEES to comply with, all United
States export control laws and regulations, that it bears sole responsibility
for any violation of such laws and regulations by itself or its AFFILIATES or
SUBLICENSEES, and that it will indemnify, defend, and hold M.I.T. harmless (in
accordance with Section 9.1) for the consequences of any such violation.
12.3 Non-Use of M.I.T. and CHILDRENS Names. COMPANY and its AFFILIATES
and SUBLICENSEES shall not use the name of "Massachusetts Institute of
Technology," "Lincoln Laboratory", "Children's Medical Center Corporation" or
any variation, adaptation, or abbreviation thereof, or of any of its trustees,
officers, faculty, students, employees, or agents, or any trademark owned by
M.I.T. or CHILDREN'S or any terms of this Agreement in any promotional material
or other public announcement or disclosure without the prior written consent of
M.I.T.or CHILDREN'S, as appropriate. Upon any such request, MIT agrees to
respond within five (5) business days. The foregoing notwithstanding, without
the consent of M.I.T. or CHILDREN'S, COMPANY may state that it is licensed by
M.I.T. and CHILDREN'S under one or more of the patents and/or patent
applications comprising the PATENT RIGHTS.
In any event, the COMPANY, its AFFILIATES and sublicensees shall have
the right to make such disclosures, public announcements, publications and
dissemination of information otherwise restricted or prohibited under this
Agreement, without the prior consent of MIT, to the extent such actions are
deemed necessary pursuant to applicable governmental orders or governing laws
and regulations.
12.4 Marking of LICENSED PRODUCTS. To the extent commercially feasible
and consistent with prevailing business practices, COMPANY shall xxxx, and
shall cause its AFFILIATES and SUBLICENSEES to xxxx, all LICENSED PRODUCTS that
are manufactured or sold under this Agreement with the number of each issued
patent under the PATENT RIGHTS that applies to such LICENSED PRODUCT.
13. TERMINATION.
13.1 Voluntary Termination by COMPANY. COMPANY shall have the right to
terminate this Agreement, for any reason, (i) upon at least six (6) months
prior written notice to M.I.T., such notice to state the date at least six (6)
months in the future upon which termination is to be effective, and (ii) upon
payment of all amounts due to M.I.T. through such termination
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effective date. Upon the effective date of such termination, COMPANY shall be
released from all obligations under this Agreement, except for those specified
in 13.4, below.
13.2 Cessation of Business. If, prior to a permitted assignment,
COMPANY ceases to carry on its business related to this Agreement, M.I.T. shall
have the right to terminate this Agreement immediately upon written notice to
COMPANY.
13.3 Termination for Default.
(a) Nonpayment. In the event COMPANY fails to pay any
amounts due and payable to M.I.T. hereunder, and fails to make such payments
within thirty (30) days after receiving written notice of such failure, M.I.T.
may terminate this Agreement immediately upon written notice to COMPANY.
(b) Material Breach. In the event COMPANY commits a
material breach of its obligations under this Agreement, except for breach as
described in Section 13.3(a), and fails to cure that breach within ninety (90)
days after receiving written notice thereof, M.I.T. may terminate this
Agreement immediately upon written notice to COMPANY.
13.4 Effect of Termination.
(a) Survival. The following provisions shall survive the
expiration or termination of this Agreement: Articles 1, 8, 10, 14 and 15, and
Sections 4.1(f), 5.2 (obligation to provide final report and payment), 5.4,
12.1, 12.2 and 13.4.
(b) Inventory. Upon the early termination of this
Agreement, COMPANY and its AFFILIATES and SUBLICENSEES may complete and sell
any work-in-progress and inventory of LICENSED PRODUCTS that exist as of the
effective date of termination, provided that (i) COMPANY pays M.I.T. the
applicable running royalty or other amounts due on such sales of LICENSED
PRODUCTS in accordance with the terms and conditions of this Agreement, and
(ii) COMPANY and its AFFILIATES and SUBLICENSEES shall complete and sell all
work-in-progress and inventory of LICENSED PRODUCTS within six (6) months after
the effective date of termination.
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(c) Pre-termination Obligations. In no event shall
termination of this Agreement release COMPANY, AFFILIATES, or SUBLICENSEES from
the obligation to pay any amounts that became due on or before the effective
date of termination.
14. Dispute Resolution.
14.1 Mandatory Procedures. The parties agree that any dispute arising
out of or relating to this Agreement shall be resolved solely by means of the
procedures set forth in this Article, and that such procedures constitute
legally binding obligations that are an essential provision of this Agreement.
If either party fails to observe the procedures of this Article, as may be
modified by their written agreement, the other party may bring an action for
specific performance of these procedures in any court of competent
jurisdiction.
14.2 Equitable Remedies. Although the procedures specified in this
Article are the sole and exclusive procedures for the resolution of disputes
arising out of or relating to this Agreement, either party may seek a
preliminary injunction or other provisional equitable relief if, in its
reasonable judgment, such action is necessary to avoid irreparable harm to
itself or to preserve its rights under this Agreement.
14.3 Dispute Resolution Procedures.
(a) Mediation. In the event any dispute arising out of
or relating to this Agreement remains unresolved within sixty (60) days from
the date the affected party informed the other party of such dispute, either
party may initiate mediation upon written notice to the other party ("Notice
Date"), whereupon both parties shall be obligated to engage in a mediation
proceeding under the then current Center for Public Resources ("CPR") Model
Procedure for Mediation of Business Disputes (xxxx://xxx.xxxxxx.xxx), except
that specific provisions of this Article shall override inconsistent provisions
of the CPR Model Procedure. The mediator will be selected from the CPR Panels
of Neutrals. If the parties cannot agree upon the selection of a mediator
within fifteen (15) business days after the Notice Date, then upon the request
of either party, the CPR shall appoint the mediator. The parties shall attempt
to resolve the dispute through mediation until the first of the following
occurs: (i) the parties reach a written settlement; (ii) the mediator notifies
the parties in writing that they have reached an impasse; (iii) the parties
agree in writing that they have reached an impasse; or (iv) the parties have
not reached a settlement within sixty (60) days after the Notice Date.
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(b) Trial Without Jury. If the parties fail to resolve
the dispute through mediation, or if neither party elects to initiate
mediation, each party shall have the right to pursue any other remedies legally
available to resolve the dispute, provided, however, that the parties expressly
waive any right to a jury trial in any legal proceeding under this Article.
14.4 Performance to Continue. Each party shall continue to perform its
undisputed obligations under this Agreement pending final resolution of any
dispute arising out of or relating to this Agreement; provided, however, that a
party may suspend performance of its undisputed obligations during any period
in which the other party fails or refuses to perform its undisputed
obligations. Nothing in this Article is intended to relieve COMPANY from its
obligation to make undisputed payments pursuant to Articles 4 and 6 of this
Agreement.
14.5 Statute of Limitations. The parties agree that all applicable
statutes of limitation and time-based defenses (such as estoppel and laches)
shall be tolled while the procedures set forth in Sections 13.3(a) are pending.
The parties shall cooperate in taking any actions necessary to achieve this
result.
14.6 Estoppel Certificate. In the event that COMPANY represents and
warrants to MIT that it is in full compliance with this Agreement, M.I.T.
agrees that in reliance upon such representation and warranty, M.I.T. shall
provide a statement to COMPANY that to the best knowledge of M.I.T., COMPANY is
in compliance with this Agreement. For the purposes of this section,
"knowledge" shall mean that M.I.T. is relying solely upon COMPANY's
representation and warranty and M.I.T. shall not undertake an independent
investigation for the purposes of such certificate.
15. MISCELLANEOUS.
15.1 Notice. Any notices required or permitted under this Agreement
shall be in writing, shall specifically refer to this Agreement, and shall be
sent by hand, recognized national overnight courier, confirmed facsimile
transmission, confirmed electronic mail, or registered or certified mail,
postage prepaid, return receipt requested, to the following addresses or
facsimile numbers of the parties:
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If to M.I.T.: Technology Licensing Office, Room NE25-230
Massachusetts Institute of Technology
00 Xxxxxxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attention: Director
Tel: 000-000-0000
Fax: 000-000-0000
If to CHILDREN'S Children's Medical Center Corporation
000 Xxxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Director of Technology Transfer Office
Tel: 000-000-0000
Fax: 000-000-0000
If to COMPANY: Global Tissue Engineering, Inc.
0 Xxxx Xxxxxxx Xxxxxxxxx Xxxxx 0000
Xxxx Xxxxxxxxxx, Xxxxxxx 00000
Attention: President
Tel: 000-000-0000
Fax: 000-000-0000
All notices under this Agreement shall be deemed effective upon
receipt. A party may change its contact information immediately upon written
notice to the other party in the manner provided in this Section.
15.2 Governing Law. This Agreement and all disputes arising out of or
related to this Agreement, or the performance, enforcement, breach or
termination hereof, and any remedies relating thereto, shall be construed,
governed, interpreted and applied in accordance with the laws of the
Commonwealth of Massachusetts, U.S.A., without regard to conflict of laws
principles, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent shall
have been granted.
15.3 Force Majeure. Neither party will be responsible for delays
resulting from causes beyond the reasonable control of such party, including
without limitation fire, explosion, flood, war, strike, or riot, provided that
the nonperforming party uses commercially reasonable efforts to avoid or remove
such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.
15.4 Amendment and Waiver. This Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument
signed by both parties. Any waiver of
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any rights or failure to act in a specific instance shall relate only to such
instance and shall not be construed as an agreement to waive any rights or fail
to act in any other instance, whether or not similar.
15.5 Severability. In the event that any provision of this Agreement
shall be held invalid or unenforceable for any reason, such invalidity or
unenforceability shall not affect any other provision of this Agreement, and
the parties shall negotiate in good faith to modify the Agreement to preserve
(to the extent possible) their original intent. If the parties fail to reach a
modified agreement within thirty (30) days after the relevant provision is held
invalid or unenforceable, then the dispute shall be resolved in accordance with
the procedures set forth in Article 14. While the dispute is pending
resolution, this Agreement shall be construed as if such provision were deleted
by agreement of the parties.
15.6 Binding Effect. This Agreement shall be binding upon and inure to
the benefit of the parties and their respective permitted successors and
assigns.
15.7 Headings. All headings are for convenience only and shall not
affect the meaning of any provision of this Agreement.
15.8 Entire Agreement. This Agreement constitutes the entire agreement
between the parties with respect to its subject matter and supersedes all prior
agreements or understandings between the parties relating to its subject
matter.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
THE EFFECTIVE DATE OF THIS AGREEMENT IS February 22, 2000 .
-----------------------------------
MASSACHUSETTS INSTITUTE OF GMP TISSUE ENGINEERING, INC.
TECHNOLOGY, for itself and as agent
For CHILDREN'S MEDICAL CENTER
CORPORATION
By: By:
------------------------------------------ ------------------------
Name: Xxxx Xxxxxxx, President
----------------------------------------
Title:
---------------------------------------
MASSACHUSETTS INSTITUTE OF
TECHNOLOGY
By:
------------------------------------------
Name: J. Xxxxx Xxxxxxx, Ph.D.
Title: Vice President for Research
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APPENDIX A
List of Patent Applications and Patents
I. United States Patents and Applications
M.I.T. CASE NO. 3946
Novel Non-Peptide Bioerodible Polymers Based on
Naturally Occurring x-Amino Acids
by Xxxxxxx Xxxx and Xxxxxx Xxxxxx
Serial No.703153, Filed 02/19/85, Patent No. 4638045, Issued 01/20/87
M.I.T. CASE NO. 4051
The Use of Biodegradable Poly (Iminocarbonates) as
Biomaterials for Medical Applications
by Xxxxxxx Xxxx and Xxxxxx Xxxxxx
Serial No. 820351, Filed 01/21/86, Patent No. 4806621, Issued 02/21/89
M.I.T. CASE NO. 4279
Controlled Cellular Implantation Using Artificial Matrices
by Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx
Serial No. 203522, Filed 02/28/94, Patent No. 5759830, Issued 06/02/98
Serial No. 203705, Filed 02/28/94, Patent No. 5770417, Issued 06/23/98
Serial No. 203521, Filed 02/28/94, Patent No. 5770193, Issued 06/23/98
M.I.T. CASE NO. 4332
Biodegradable Materials for the Regeneration of Tissues
by Xxxxx Xxxxxxx, Xxxxxx Xxx and Xxxxxxx Xxxxxx
Serial No. 087772, Filed 08/21/87, Patent No. 4947840, Issued 08/14/90
M.I.T. CASE NO. 4371
Hydroxamic Acid Polymers From Primary Amide Polymers
by Xxxxxx Xxxxxxxx, Xxxxxxx Xxxx, Xxxxxxx Xxxxxx, Xxxxxx Xxxxxx,
Xxxx Laurencin and Xxxxx Xxxxxxxxxx
Serial No. 283594, Filed 12/13/88, Patent No. 5128420, Issued 07/07/92
M.I.T. CASE NO. 4973
Method of Implanting Large Cell Volume on a Polymeric Matrix
by Xxxx Xxxxxxx, Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx
Serial No. 08/203509, Filed 02/28/94, Patent No. 5804178, Issued 09/08/98
M.I.T. CASE NO. 5573
Preparation of Highly-Porous Biodegradable Polymer Membranes
by a Particulate-Leaching Technique
by Xxxxx Xxxxxxxx-Cima, Xxxxxx Xxxxxx, Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxxxxx,
and Xxxxxx Xxxxxxx
Serial No. 08/012270, Filed 02/01/93, Patent No. 5514378, Issued 05/07/96
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M.I.T. CASE NO. 5729
Prevascularized Polymeric Implants for Organ Transplantation
by Xxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxxx Xxxxx and Xxxxxx Xxxxxxx
Serial No. 345217, Filed 11/28/94, Pending
M.I.T. CASE NO. 6560
Porous Biodegradable Polymeric Materials for Cell Transplantation
by Xxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxxxxxx Xxxxx and Xxxxxx Xxxxxxx
Serial No. 052387, Filed 04/23/93, Pending
M.I.T. CASE NO. 6798
Localized Delivery of Growth Factors to Transplanted Cells
by Xxxxx-Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxxxx, Xxxxx Xxxxxx and Xxxxxx Xxxxxxx
Serial No. 08/358235, Filed 12/16/94, Pending
M.I.T. CASE NO. 6984
Functional, Degradable Poly(Lactic Acid-co-Amino Acid) Graft Copolymers
by Xxxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxx Xxxxx, and J. Ou
Serial No. 08/491490, Filed 06/16/95, Patent No. 5654381, Issued 08/05/97
M.I.T. CASE NO. 7138
Neuronal Stimulation Using an Electrically Conductive Polymer Polypyrrole
by Xxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxx, Xxxxxxxxx Xxxxxxx and Xxxxxx Xxxxxxx
Serial No. 08/552761, Filed 11/03/95, Pending
II. International (non-U.S.) Patents and Applications
M.I.T. CASE NO. 4279
Controlled Cellular Implantation Using Artificial Matrices
by Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx
Austria Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Belgium Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Switz., Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
France, Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued\ 06/19/96
Germany, Serial No. 88900726.6, Filed 11/20/87,
Patent No. P3751843.7, Issued 06/19/96
Italy, Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Lux, Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Neth., Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Sweden, Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
UK, Serial No. 88900726.6, Filed 11/20/87,
Patent No. 0299010, Issued 06/19/96
Japan, Serial No. 63-500950, Filed 11/20/87,
Patent No. 2067741, Issued 07/10/96
Canada, Serial No. 552171, Filed 11/18/87,
Patent No. 1340581, Issued 06/08/99
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M.I.T. CASE NO. 4371
Hydroxamic Acid Polymers From Primary Amide Polymers
by Xxxxxx Xxxxxxxx, Xxxxxxx Xxxx, Xxxxxxx Xxxxxx, Xxxxxx Xxxxxx,
Xxxx Laurencin and Xxxxx Xxxxxxxxxx
Japan, Serial No. 502717/88, Filed 02/25/88, Patent No. 2634657, Issued 04/25/97
Austria, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Belgium, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Germany, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
France, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
UK, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Italy, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Neth., Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Lux., Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Sweden, Serial No. 88903023.5, Filed 02/25/88, Patent No. 0347424
Switz., Serial No. 88903023.5, Filed 02/25/88, Patent Xx. 0000000
Xxxxxx, Xxxxxx Xx. 000000, Filed 02/26/88, Pending
M.I.T. CASE NO. 4973
Method of Implanting Large Cell Volume on a Polymeric Matrix
by Xxxx Xxxxxxx, Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx
Austria, Serial No. 90907948, Filed 04/25/90,
Patent No. E119787, Issued 10/25/95
Belgium, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
Switz., Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
Germany, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 69017820, Issued 10/05/95
Spain, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
France, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
UK, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
Italy, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
Neth., Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 10/05/95
Sweden, Serial No. 90907948.5, Filed 04/25/90,
Patent No. 0422209, Issued 03/15/95
Australia, Serial No. 55691/90, Filed 04/25/90,
Patent No. 636346, Issued 08/23/93
Japan, Serial No. 10-69123, Filed 04/25/90, Pending
Canada, Serial No. 2031532, Filed 04/25/90, Pending
Japan, Serial No. 2-507248, Filed 04/25/90, Pending
Korea, Filed 04/25/90, Pending
Norway, Filed 04/25/90, Pending
Finland, Filed 04/25/90, Pending
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M.I.T. CASE NO. 5729
Prevascularized Polymeric Implants for Organ Transplantation
by Xxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxxx Xxxxx and Xxxxxx Xxxxxxx
Austria, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
Belgium, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
France, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
Germany, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
Italy, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
Lux., Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued 05/07/97
Neth., Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
Sweden, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued
05/07/97
UK, Serial No. 92924131.3, Filed 10/28/92, Patent No. 0610423, Issued 05/07/97
Canada, Serial No. 2121040, Filed 10/28/92, Pending
Japan, Serial No. 5-508521, Filed 10/28/92, Pending
M.I.T. CASE NO. 6798
Localized Delivery of Growth Factors to Transplanted Cells
by Xxxxx-Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxxxx, Xxxxx Xxxxxx and Xxxxxx Xxxxxxx
Europe, Serial No. 95943823.5, Filed 12/14/95, Pending
Japan, Serial No. 8-519275, Filed 12/14/95, Pending
Canada, Serial No. 2207286, Filed 12/14/95, Pending
M.I.T. CASE NO. 7138
Neuronal Stimulation Using an Electrically Conductive Polymer Polypyrrole
by Xxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxx, Xxxxxxxxx Xxxxxxx and Xxxxxx Xxxxxxx
Europe, Serial No. 96937894.2, Filed 10/31/96, Pending
Canada, Serial No. 2236749, Filed 10/31/96, Pending
Japan, Serial No. 9-517608, Filed 10/31/96, Pending
Korea, Serial No. 98-703320, Filed 10/31/96, Pending
Australia, Serial No. 75532/96, Filed 10/31/96, Pending
New Zeal., Serial No. 321886, Filed 10/31/96, Pending
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APPENDIX B
WAIVER of PARTICIPATION
As a recipient of founder's stock in a company based on technology
(listed below) licensed by M.I.T. to GMP Neuro-Growth, Inc. through the
granting of a license (the "License Agreement"), and in accordance with
M.I.T.'s licensing policies, the undersigned hereby releases all rights, title
and interest he/she, his/her heirs and assigns may have as an inventor/author
under M.I.T.'s Guide to the Ownership, Distribution and Commercial Development
of M.I.T. Technology, as that policy may be amended from time to time, to
receive any portion of the shares of stock received by M.I.T. in partial
consideration for the License.
Technology Licensed:
M.I.T. Case No. 3946 "Novel Non-Peptide Bioerodible Polymers Based on
Naturally Occurring x-Amino Acids" by Xxxxxxx Xxxx and Xxxxxx Xxxxxx;
M.I.T. Case No. 4051 "The Use of Biodegradable Poly (Iminocarbonates)
as Biomaterials for Medical Applications" by Xxxxxxx Xxxx and Xxxxxx
Xxxxxx; M.I.T. Case No. 4279 "Controlled Cellular Implantation Using
Artificial Matrices" by Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx;
M.I.T. Case No. 4332 " Biodegradable Materials for the Regeneration of
Tissues" by Xxxxx Xxxxxxx, Xxxxxx Xxx and Xxxxxxx Xxxxxx;
M.I.T. Case No. 4371 "Hydroxamic Acid Polymers From Primary
Amide Polymers" by Xxxxxx Xxxxxxxx, Xxxxxxx Xxxx, Xxxxxxx Xxxxxx, Xxxxxx
Xxxxxx, Xxxx Laurencin and Xxxxx Xxxxxxxxxx;
M.I.T. Case No. 4973 "Method of Implanting Large Cell Volume on a
Polymeric Matrix" by Xxxx Xxxxxxx, Xxxxxx Xxxxxx and Xxxxxx Xxxxxxx;
M.I.T. Case No. 5573 "Preparation of Highly-Porous Biodegradable
Polymer Membranes by a Particulate-Leaching Technique" by Xxxxx
Xxxxxxxx-Cima, Xxxxxx Xxxxxx, Xxxxxxxx Xxxxx, Xxxxxxxx Sarkinos and
Xxxxxx Xxxxxxx;
M.I.T. Case No. 5729 "Prevascularized Polymeric Implants for
Organ Transplantation" by Xxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxx Xxxxxx,
Xxxxx Xxxxx and Xxxxxx Xxxxxxx;
M.I.T. Case No. 6560 "Porous Biodegradable Polymeric Materials for
Cell Transplantation" by Xxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxxxxxx Xxxxx
and Xxxxxx Xxxxxxx;
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34
M.I.T. Case No. 6798 "Localized Delivery of Growth Factors to
Transplanted Cells" by Xxxxx-Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxxxx, Xxxxx Xxxxxx
and Xxxxxx Xxxxxxx;
M.I.T. Case No. 6984 "Functional, Degradable Poly(Lactic Acid-co-Amino
Acid) Graft Copolymers" by Xxxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxxx Xxxxx and
J. Ou;
M.I.T. Case No. 7138 "Neuronal Stimulation using an Electrically
Conductive Polymer Polypyrrole" by Xxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxx,
Xxxxxxxxx Xxxxxxx and Xxxxxx Xxxxxxx
and any future cases added to APPENDIX A of the License Agreement.
Witness: Signed:
------------------------------- -------------------------
Name: Xx. Xxxxxx X. Xxxxxx
--------------------------
Date:
--------------------------
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