Exhibit 10.34
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
CONFIDENTIAL
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
and
REPROGENESIS, INC.
PATENT LICENSE AGREEMENT
(EXCLUSIVE)
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
Patent Exclusive IA/ra: [**].Reprogenesis
Date: October 30, 1996
TABLE OF CONTENTS
WITNESSETH...................................................................1
1 - DEFINITIONS..............................................................2
2 - GRANT....................................................................4
3 - DILIGENCE................................................................6
4 - ROYALTIES................................................................7
5 - REPORTS AND RECORDS......................................................9
6 - PATENT PROSECUTION......................................................11
7 - INFRINGEMENT............................................................11
8 - PRODUCT LIABILITY.......................................................13
9 - EXPORT CONTROLS.........................................................15
10 - NON-USE OF NAMES.......................................................15
11 - ASSIGNMENT.............................................................16
12 - DISPUTE RESOLUTION.....................................................16
13 - TERMINATION............................................................17
14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS.............................18
15 - MISCELLANEOUS PROVISIONS...............................................19
APPENDIX A..................................................................20
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
and
REPROGENESIS, INC.
PATENT LICENSE AGREEMENT
This Agreement is made and entered into this 7th day of November, 1996,
(the "EFFECTIVE DATE") by and between the MASSACHUSETTS INSTITUTE OF TECHNOLOGY,
a corporation duly organized and existing under the laws of the Commonwealth of
Massachusetts and having its principal office at 00 Xxxxxxxxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000, X.X.X. (hereinafter referred to as "M.I.T."),
and REPROGENESIS, INC., a corporation duly organized under the laws of Texas and
having its principal office at 00 Xxxxxx Xxxxx, Xxxxx 00, Xx. Xxxxxx Xxxxxx,
Xxxxxxx 00000, U.S.A. (hereinafter referred to as "LICENSEE").
WITNESSETH
WHEREAS, M.I.T. is the owner of certain PATENT RIGHTS (as later defined
herein) relating to M.I.T. Case No. 4521, "Controlled Release Systems Containing
Heparin and Growth Factors" by Xxxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxxx Xxxxxxxxx
and Xxxxx Xxxxxxxxxx, U.S. Patent No. 5,100,668, Issued March 31, 1992, and
M.I.T. Case No. [**], "[**]" by Xxxxxx Xxxxxxx, Aruna Natha and Xxxxxxx Xxxxxx
and has the right to grant licenses under said PATENT RIGHTS, subject only to a
royalty-free, nonexclusive license heretofore granted to the United States
Government;
WHEREAS, M.I.T. desires to have the PATENT RIGHTS developed and
commercialized to benefit the public and is willing to grant a license
thereunder;
WHEREAS, LICENSEE has represented to M.I.T., to induce M.I.T. to enter
into this Agreement, that LICENSEE is experienced in the development,
production, manufacture, marketing and sale of products similar to the LICENSED
PRODUCT(s) (as later defined herein)
and/or the use of the LICENSED PROCESS(es) (as later defined herein) and that it
shall commit itself to a thorough, vigorous and diligent program of exploiting
the PATENT RIGHTS so that public utilization shall result therefrom; and
WHEREAS, LICENSEE desires to obtain a license under the PATENT RIGHTS upon
the terms and conditions hereinafter set forth.
WHEREAS, LICENSEE and M.I.T. entered into a separate royalty bearing
License Agreement dated December 23, 1993.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties hereto agree as follows:
1 - DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall
have the following meanings:
1.1. "LICENSEE" shall include a related company of REPROGENESIS, INC., the
voting stock of which is directly or indirectly at least Fifty Percent (50%)
owned or controlled by REPROGENESIS, INC., an organization which directly or
indirectly controls more than Fifty Percent (50%) of the voting stock of
REPROGENESIS, INC. and an organization, the majority ownership of which is
directly or indirectly common to the ownership of REPROGENESIS, INC.
1.2. "PATENT RIGHTS" shall mean all of the following M.I.T. intellectual
property:
a. the United States patent applications listed in Appendix A, and
divisionals, continuations and claims of continuation-in-part
applications which shall be directed to subject matter supported
by such patent applications, and the resulting patents;
b. any patents resulting from reissues or reexaminations of the
United States patents described in a. above;
c. the Foreign patents listed in Appendix A;
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d. the Foreign patent applications listed in Appendix A, and
divisionals, continuations and claims of continuation-in-part
applications which shall be directed to subject matter supported
by such Foreign patent applications, and the resulting patents;
e. Foreign patent applications filed after the EFFECTIVE DATE and
divisionals, continuations and claims of continuation-in-part
applications which shall be directed to subject matter
specifically supported by such patent applications, and the
resulting patents; and
f. any Foreign patents, resulting from equivalent Foreign procedures
to United States reissues and reexaminations, of the Foreign
patents described in c. above.
1.3 A "LICENSED PRODUCT" shall mean any product or part thereof which:
a. is covered in whole or in part by a claim that has not expired or
been held invalid by a court of competent Jurisdiction or by a
pending claim contained in the PATENT RIGHTS in the country in
which any such product or part thereof is made, used or sold; or
b. is manufactured by using a process or is employed to practice a
process which is covered in whole or in part by a claim that has
not expired or been held invalid by a court of competent
jurisdiction or by a pending claim contained in the PATENT RIGHTS
in the country in which any LICENSED PROCESS is used or in which
such product or part thereof is used or sold.
1.4 A "LICENSED PROCESS" shall mean any process which is covered in whole
or in part by a claim that has not expired or been held invalid by a court of
competent jurisdiction or by a pending claim contained in the PATENT RIGHTS.
1.5 A "LICENSED SERVICE" shall mean any fee-bearing service performed by
LICENSEE or any sublicensee which uses a LICENSED PRODUCT or practices a
LICENSED PROCESS.
1.6 "NET SALES" shall mean LICENSEE's (and its sublicensees') xxxxxxxx to
a third party for LICENSED PRODUCTS, LICENSED PROCESSES and LICENSED SERVICES
produced hereunder less the sum of the following:
a. discounts allowed in amounts customary in the trade;
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b. sales, tariff duties and/or use taxes directly imposed and with
reference to particular sales;
c. outbound transportation prepaid or allowed;
d. insurance;
e. amounts allowed or credited on returns; and
f. bad debts.
Sales between LICENSEE and any of its affiliates or any of its
sublicensees, or between any of said affiliates or sublicensees, shall not be
included in such computation. No deductions shall be made for commissions paid
to individuals, whether they be with independent sales agencies or regularly
employed by LICENSEE and on its payroll, or for cost of collections. LICENSED
PRODUCTS shall be considered "sold" upon the earlier of receipt of payment or
six months after billed out or invoiced.
1.7 "TERRITORY" shall mean worldwide.
1.8 "FIELD OF USE" shall mean all.
2 - GRANT
2.1 M.I.T. hereby grants to LICENSEE the right and license in the
TERRITORY for the FIELD OF USE to practice under the PATENT RIGHTS and, to the
extent not prohibited by other patents, to make, have made, use, lease, offer
for sale, sell and import LICENSED PRODUCTS and LICENSED SERVICES, and to
practice the LICENSED PROCESSES, until the expiration of the last to expire of
the PATENT RIGHTS, unless this Agreement shall be sooner terminated according to
the terms hereof.
2.2 LICENSEE agrees that LICENSED PRODUCTS leased or sold in the United
States shall be manufactured substantially in the United States.
-4-
2.3 In order to establish a period of exclusivity for LICENSEE, M.I.T.
hereby agrees that it shall not grant any other license to make, have made, use,
lease, offer for sale, sell and import LICENSED PRODUCTS or LICENSED SERVICES;
or to utilize LICENSED PROCESSES subject to the royalty-free, nonexclusive
license rights of the United States Government per FAR 52.227-11, in the
TERRITORY for the FIELD OF USE during the period of time commencing with the
EFFECTIVE DATE and terminating with the last to expire of the PATENT RIGHTS.
2.4 M.I.T. reserves the right to practice under the PATENT RIGHTS for
noncommercial research purposes.
2.5 LICENSEE shall have the right to enter into sublicensing agreements
for the rights, privileges and licenses granted hereunder. Upon any termination
of this Agreement, sublicensees' rights shall also terminate, subject to
Paragraph 13.6 hereof.
2.6 LICENSEE agrees to incorporate terms and conditions substantively
similar to Articles 2, 5.1, 7.1, 7.2, 7.3, 7.5, 7.6, 8, 9, 10, 12 and 15 of this
Agreement into its sublicense agreements, that are sufficient to enable LICENSEE
to comply with this Agreement.
2.7 LICENSEE agrees to forward to M.I.T. a copy of any and all sublicense
agreements promptly upon execution by the parties.
2.8 LICENSEE shall not receive from sublicensees anything of value in lieu
of cash payments in consideration for any sublicense under this Agreement,
without the express prior written permission of M.I.T.
2.9 Nothing in this Agreement shall be construed to confer any rights upon
LICENSEE by implication, estoppel or otherwise as to any technology or patent
rights of M.I.T.
-5-
or any other entity other than the PATENT RIGHTS, regardless of whether such
patent rights shall be dominant or subordinate to any PATENT RIGHTS.
3 - DILIGENCE
3.1 LICENSEE shall use its reasonable best efforts to bring LICENSED
PRODUCTS and/or LICENSED SERVICES to market through a diligent development
program for exploitation of the PATENT RIGHTS.
3.2 In addition:
a. LICENSEE shall use its best efforts to introduce the first
LICENSED PRODUCT or LICENSED SERVICE to commercial sale by January
1, 2002.
b. LICENSEE shall use its best efforts to introduce to market
additional LICENSED PRODUCTS or LICENSED SERVICES within one year
of demonstration of the scientific and technical feasibility
of that particular LICENSED PRODUCT or LICENSED SERVICE, the
demonstration of its clinical effectiveness, and the receipt of
required approvals (if any are required) of regulatory
authorities, or, within six (6) months of the demonstration of
scientific, technical and clinical feasibility to complete a
sublicense agreement for the marketing of the LICENSED PRODUCT or
LICENSED SERVICE with a competent third party that shall commit
the third party to use its best efforts to bring the LICENSED
PRODUCT or LICENSED SERVICE to market within one year of the
sublicense agreement.
3.3 LICENSEE acknowledges that the primary objective of M.I.T. with
respect to the technology of this License Agreement is to promote development
and marketing of LICENSED PRODUCTS and LICENSED SERVICES for the public good.
Toward this end, M.I.T. shall have the right to terminate this Agreement
pursuant to Paragraph 13.3 hereof if LICENSEE fails to perform in accordance
with Paragraphs 3.1 or 3.2(a) above or if LICENSEE suspends its diligence in
performance of any of the development obligations of this Agreement for more
than three (3) months because of business circumstances such as lack of funds,
merger, acquisition, or the like. Failure to perform in accordance with
Paragraph 3.3(b) hereof shall only give M.I.T. the right to take back rights
granted hereunder as to the particular LICENSED PRODUCT or LICENSED
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SERVICE, and products or services which are directly competitive to, or
replacements of that LICENSED PRODUCT or LICENSED SERVICE, not introduced or
sublicensed, or at M.I.T.'s discretion the right to bring a willing sublicense
prospect to LICENSEE. However, if LICENSEE can demonstrate to the satisfaction
of M.I.T., at M.I.T.'s sole discretion, that circumstances beyond LICENSEE's
control precluded LICENSEE from fulfilling its diligence obligations, and that
it is unlikely that any third party could overcome these circumstances better
than LICENSEE, then M.I.T. shall not exercise its termination rights under this
Paragraph for one year from the date at which M.I.T. gives notice of termination
and if LICENSEE reestablishes diligence towards its objectives during this one
year period, any prior lack of diligence will be deemed cured.
4 - ROYALTIES
4.1 For the rights, privileges and license granted hereunder, LICENSEE
shall pay royalties to M.I.T. in the manner hereinafter provided to the end of
the term of the PATENT RIGHTS or until this Agreement shall be terminated:
a. License Issue Fee of Twenty Thousand Dollars ($20,000), which
said License Issue Fee shall be deemed earned and due immediately
upon the EFFECTIVE DATE.
b. Patent Issue Fee of Thirty Five Thousand Dollars ($35,000), which
shall be due upon issuance of the first patent claims of M.I.T.
Case No. 6584, "Inhibition of Vascular Occlusion Following
Vascular Intervention" by Xxxxxx Xxxxxxx, Aruna Natha and Xxxxxxx
Xxxxxx.
c. License Maintenance Fees of Fifteen Thousand Dollars ($15,000) per
year payable on January 1, 1999 and on January I of each year
thereafter until the issuance of the first patent claims, and
License Maintenance Fees of Twenty Five Thousand Dollars ($25,000)
per year payable on each January 1 after the issuance of the first
patent claims, provided, however, License Maintenance Fees may be
credited to Running Royalties subsequently due on NET SALES for
each said year, if any. License Maintenance Fees paid in excess of
Running Royalties shall not be creditable to Running Royalties for
future years.
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d. Running Royalties in an amount equal to Three Percent (3%) of NET
SALES of the LICENSED PRODUCTS, LICENSED PROCESSES and LICENSED
SERVICES used, leased or sold by and/or for LICENSEE and/or its
sublicensees; provided however, if LICENSEE is also obligated to
pay royalties under the License Agreement dated December 23, 1993
for the same LICENSED PRODUCT, LICENSED PROCESSES and LICENSED
SERVICES, the Running Royalties due under this paragraph shall be
reduced to One Half of One Percent (0.5%) of NET SALES of the
LICENSED PRODUCT, LICENSED PROCESSES and LICENSED SERVICES used,
Leased or sold by and/or for LICENSEE and/or its sublicensees.
e. Royalties representing a share of sublicensing revenue including,
but not limited to, sublicense issue fees, received by LICENSEE
for LICENSED PRODUCTS, LICENSED PROCESSES or LICENSED SERVICES
sold by the sublicensee equal to:
(i) Fifty Percent (50%) if only the PATENT RIGHTS are
sublicensed; or
(ii) Twenty Five Percent (25%) if the sublicense revenue
includes revenue received for the PATENT RIGHTS
sublicensed in conjunction with products developed by
LICENSEE and/or substantial technology developed by
LICENSEE; but in no event shall royalties be less than
half of the applicable running royalty rate specified in
4.1d.
4.2 All payments due hereunder shall be paid in full, without deduction of
taxes or other fees which may be imposed by any government, except as otherwise
provided in Paragraph 1.5(b).
4.3 No multiple royalties shall be payable because any LICENSED PRODUCT,
its manufacture, use, lease or sale are or shall be covered by more than one
PATENT RIGHTS patent application or PATENT RIGHTS patent licensed under this
Agreement.
4.4 Royalty payments shall be paid in United States dollars in Cambridge,
Massachusetts, or at such other place as M.I.T. may reasonably designate
consistent with the laws and regulations controlling in any foreign country. If
any currency conversion shall be required in connection with the payment of
royalties hereunder, such conversion shall be made
-8-
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
by using the exchange rate prevailing at the Chase Manhattan Bank (N.A.) on the
last business day of the calendar quarterly reporting period to which such
royalty payments relate.
4.5 In the event LICENSEE is required to make payments (including without
limitation royalties, option fees or license fees) to one or more third parties,
other than M.I.T., its affiliates, successors or assigns, to obtain a license or
similar right necessary to make, use or sell LICENSED PRODUCTS or to practice or
otherwise make use of the LICENSED PROCESSES and LICENSED SERVICES, LICENSEE may
deduct [**] Percent ([**]%) of such payments from royalties thereafter payable
to M.I.T., provided, however, that in no event shall the royalties due M.I.T. be
reduced by more than [**] Percent ([**]%) of NET SALES of the LICENSED PRODUCTS,
LICENSED PROCESSES or LICENSED SERVICES.
5 - REPORTS AND RECORDS
5.1 LICENSEE shall keep full, true and accurate books of account
containing all particulars that may be necessary for the purpose of showing the
amounts payable to M.I.T. hereunder. Said books of account shall be kept at
LICENSEE's principal place of business or the principal place of business of the
appropriate division of LICENSEE to which this Agreement relates. Said books and
the supporting data shall be open at all reasonable times for five (5) years
following the end of the calendar year to which they pertain, to the inspection
of M.I.T. or its agents for the purpose of verifying LICENSEE's royalty
statement or compliance in other respects with this Agreement. Should such
inspection lead to the discovery of a greater than Ten Percent (10%) discrepancy
in reporting to M.I.T.'s detriment, LICENSEE agrees to pay the full cost of such
inspection.
5.2 LICENSEE shall deliver to M.I.T. true and accurate reports, giving
such particulars of the business conducted by LICENSEE and its sublicensees
under this Agreement as shall be pertinent to diligence under Article 3 and
royalty accounting hereunder:
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Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
a. before the first commercial sale of a LICENSED PRODUCT, LICENSED
PROCESS or LICENSED SERVICES, annually, on January 31 of each
year; and
b. after the first commercial sale of a LICENSED PRODUCT, LICENSED
PROCESS or LICENSED SERVICES, quarterly, within sixty (60) days
after March 31, June 30, September 30 and December 31, of each
year.
These reports shall include at least the following:
a. number of LICENSED PRODUCTS manufactured, leased and sold by
and/or for LICENSEE and all sublicensees;
b. accounting for all LICENSED PROCESSES and/or LICENSED SERVICES
used or sold by and/or for LICENSEE and all sublicensees;
c. accounting for NET SALES, noting the deductions applicable as
provided in Paragraph 1.5;
d. Running Royalties due under Paragraph 4.1(c);
e. royalties due on other payments from sublicensees under paragraph
4.1(d);
f. total royalties due; and
g. names and addresses of all sublicensees of LICENSEE.
5.3 With each such report submitted, LICENSEE shall pay to M.I.T. the
royalties due and payable under this Agreement. If no royalties shall be due,
LICENSEE shall so report.
5.4 On or before the ninetieth (90th) day following the close of
LICENSEE's fiscal year, LICENSEE shall provide M.I.T. with LICENSEE's certified
financial statements for the preceding fiscal year including, at a minimum, a
balance sheet and an income statement.
5.5 The amounts due under Articles 4 and 6 shall, if overdue, bear
interest until payment at a per annum rate [**] Percent ([**]%) above the prime
rate in effect at the Chase Manhattan Bank (N.A.) on the due date. The payment
of such interest shall not foreclose M.I.T. from exercising any other rights it
may have as a consequence of the lateness of any payment.
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Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
6 - PATENT PROSECUTION
6.1 After the EFFECTIVE DATE, LICENSEE shall have the primary
responsibility for applying for, seeking prompt issuance of, and maintaining the
PATENT RIGHTS in M.I.T.'s name. LICENSEE shall seek strong, broad claims in
M.I.T.'s best interest. LICENSEE shall not abandon any major claim of the PATENT
RIGHTS without prior permission from M.I.T., such permission not to be
unreasonably withheld. Appendix B is a list of the foreign countries in which
patent applications corresponding to the United States patent applications
listed in Appendix A shall be filed. Appendix B may be amended by mutual
agreement of both parties. LICENSEE may abandon any PATENT RIGHTS if LICENSEE
notifies M.I.T. in writing in sufficient time for M.I.T. to maintain the PATENT
RIGHTS, and in such case, LICENSEE's rights under these PATENT RIGHTS shall
cease with such notification.
6.2 Payment of all fees and costs relating to the filing, prosecution and
maintenance of the PATENT RIGHTS shall be the responsibility of LICENSEE,
whether such fees and costs were incurred before or after the EFFECTIVE DATE.
(As of May 21, 1996, such fees and costs for which M.I.T. has been billed equal
approximately [**] Dollars ($[**])). LICENSEE shall pay such fees and costs to
M.I.T. within thirty (30) days of invoicing; late payments shall accrue interest
and shall be subject to Paragraph 5.5.
7 - INFRINGEMENT
7.1 LICENSEE shall inform M.I.T. promptly in writing of any alleged
infringement of the PATENT RIGHTS by a third party and of any available evidence
thereof.
7.2 M.I.T. shall have the right, but shall not be obligated, to prosecute
at its own expense all infringements of the PATENT RIGHTS and, in furtherance of
such right, LICENSEE hereby agrees that M.I.T. may include LICENSEE as a party
plaintiff in any such suit, without expense to LICENSEE. The total cost of any
such infringement action commenced
-11-
or defended solely by M.I..T. shall be borne by M.I.T., and M.I.T. shall keep
any recovery or damages for past infringement derived therefrom.
7.3 If within six months after having been notified of an alleged
infringement, M.I.T. shall have been unsuccessful in persuading the alleged
infringer to desist and shall not have brought and shall not be diligently
prosecuting an infringement action, or if M.I.T. shall notify LICENSEE at any
time prior thereto of its intention not to bring suit against any alleged
infringer in the TERRITORY for the FIELD OF USE, then, and in those events only,
LICENSEE shall have the right, but shall not be obligated, to prosecute at its
own expense any infringement of the PATENT RIGHTS in the TERRITORY for the FIELD
OF USE, and LICENSEE may, for such purposes, use the name of M.I.T. as party
plaintiff; provided, however, that such right to bring such an infringement
action shall remain in effect only during the EXCLUSIVE PERIOD. No settlement,
consent judgment or other voluntary final disposition of the suit may be entered
into without the consent of M.I.T., which consent shall not unreasonably be
withheld. LICENSEE shall indemnify M.I.T. against any order for costs that may
be made against M.I.T. in such proceedings.
7.4 In the event that LICENSEE shall undertake litigation for the
enforcement of the PATENT RIGHTS, or the defense of the PATENT RIGHTS under
Paragraph 7.5, LICENSEE may withhold up to Fifty Percent ([50]%) of the payments
otherwise thereafter due M.I.T. under Article 4 hereunder and apply the same
toward reimbursement of up to half of LICENSEE's expenses, including reasonable
attorneys' fees, in connection therewith. Any recovery of damages by LICENSEE
for each such suit shall be applied first in satisfaction of any unreimbursed
expenses and legal fees of LICENSEE relating to such suit, and next toward
reimbursement of M.I.T. for any payments under Article 4 past due or withheld
and applied
-12-
pursuant to this Article 7. The balance remaining from any such recovery shall
be divided equally between LICENSEE and M.I.T.
7.5 In the event that a declaratory judgment action alleging invalidity or
noninfringement of any of the PATENT RIGHTS shall be brought against M.I.T. or
LICENSEE, M.I.T., at its option, shall have the right, within thirty (30) days
after commencement of such action, to take over the sole defense of the action
at its own expense. If M.I.T. shall not exercise this right, LICENSEE may take
over the sole defense at LICENSEE's sole expense, subject to Paragraph 7.4.
7.6 In any infringement suit as either party may institute to enforce the
PATENT RIGHTS pursuant to this Agreement, the other party hereto shall, at the
request and expense of the party initiating such suit, cooperate in all respects
and, to the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens, and the
like.
7.7 LICENSEE, during the EXCLUSIVE PERIOD, shall have the sole right in
accordance with the terms and conditions herein to sublicense any alleged
infringer in the TERRITORY for the FIELD OF USE for future use of the PATENT
RIGHTS. Any upfront fees as part of such a sublicense shall be shared equally
between LICENSEE and M.I.T.; other revenues shall be treated per Article 4.
8 - PRODUCT LIABILITY
8.1 LICENSEE shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold M.I.T., its trustees, directors,
officers, employees and affiliates, harmless against all claims, proceedings,
demands and liabilities of any kind whatsoever, including legal expenses and
reasonable attorneys' fees, arising out of the death of or injury to any person
or persons or out of any damage to property, resulting from the production,
-13-
manufacture, sale, use, lease, consumption or advertisement of the LICENSED
PRODUCT(s) and/or LICENSED PROCESS(es) or arising from any obligation of
LICENSEE hereunder.
8.2 LICENSEE shall obtain and carry in full force and effect commercial,
general liability insurance, including product liability and errors and
omissions insurance, which shall protect LICENSEE and M.I.T. with respect to
events covered by Paragraph 8.1 above. Such insurance shall be written by a
reputable insurance company authorized to do business in the Commonwealth of
Massachusetts, shall list M.I.T. as an additional named insured thereunder,
shall be endorsed to include product liability coverage and shall require thirty
(30) days written notice to be given to M.I.T. prior to any cancellation or
material change thereof. The limits of such insurance shall not be less than
Three Million Dollars ($3,000,000) per occurrence with an aggregate of One
Million Dollars ($1,000,000) for personal 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. LICENSEE shall provide M.I.T. with Certificates of Insurance
evidencing the same.
8.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, M.I.T., ITS
TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS
AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT
NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT
OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL
BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY M.I.T. THAT THE
PRACTICE BY LICENSEE OF THE LICENSE
-14-
GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO
EVENT SHALL M.I.T., ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES
BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING
ECONOMIC DAMAGE 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.
9 - EXPORT CONTROLS
LICENSEE acknowledges that it is subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (including the Arms Export Control
Act, as amended and the United States Department of Commerce Export
Administration Regulations). The transfer of such items may require a license
from the cognizant agency of the United States Government and/or written
assurances by LICENSEE that LICENSEE shall not export data or commodities to
certain foreign countries without prior approval of such agency. M.I.T. neither
represents that a license shall not be required nor that, if required, it shall
be issued.
10 - NON-USE OF NAMES
LICENSEE shall not use the names or trademarks of the Massachusetts
Institute of Technology or Lincoln Laboratory, nor any adaptation thereof, nor
the names of any of their employees, in any advertising, promotional or sales
literature without prior written consent obtained from M.I.T., or said employee,
in each case, except that LICENSEE may state that it is licensed by M.I.T. under
one or more of the patents and/or applications comprising the PATENT RIGHTS.
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11 - ASSIGNMENT
This Agreement may be assigned only in connection with:
a. a change in name or legal status of LICENSEE that does not affect
the nature of its business activities, or
b. the sale of substantially all the assets of the business to which
the PATENT RIGHTS relates or a separable business unit related to
a particular LICENSED PRODUCT or LICENSED SERVICE with the written
permission of M.I.T., which shall not be unreasonably withheld, or
c. otherwise with the written permission of M.I.T., which shall not
be unreasonably withheld.
12 - DISPUTE RESOLUTION
12.1 Except for the right of either party to apply to a court of competent
jurisdiction for a temporary restraining order, a preliminary injunction, or
other equitable relief to preserve the status quo or prevent irreparable harm,
any and all claims, disputes or controversies arising under, out of, or in
connection with the Agreement, including any dispute relating to patent validity
or infringement, which the parties shall be unable to resolve within sixty (60)
days shall be mediated in good faith. The party raising such dispute shall
promptly advise the other party of such claim, dispute or controversy in a
writing which describes in reasonable detail the nature of such dispute. By not
later than five (5) business days after the recipient has received such notice
of dispute, each party shall have selected for itself a representative who shall
have the authority to bind such party, and shall additionally have advised the
other party in writing of the name and title of such representative. By not
later than ten (10) business days after the date of such notice of dispute, the
party against whom the dispute shall be raised shall select a mediation firm in
the Boston area and such representatives shall schedule a date with such firm
for a mediation hearing. The parties shall enter into good faith mediation and
shall share the costs equally. If the representatives of the parties have not
been able to resolve the dispute within
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fifteen (15) business days after such mediation hearing, then any and all
claims, disputes or controversies arising under, out of, or in connection with
this Agreement, including any dispute relating to patent validity or
infringement, shall be resolved by final and binding arbitration in Boston,
Massachusetts under the rules of the American Arbitration Association, or the
Patent Arbitration Rules if applicable, then obtaining. The arbitrators shall
have no power to add to, subtract from or modify any of the terms or conditions
of this Agreement, nor to award punitive damages. Any award rendered in such
arbitration may be enforced by either party in either the courts of the
Commonwealth of Massachusetts or in the United States District Court for the
District of Massachusetts, to whose jurisdiction for such purposes M.I.T. and
LICENSEE each hereby irrevocably consents and submits.
12.2 Notwithstanding the foregoing, nothing in this Article shall be
construed to waive any rights or timely performance of any obligations existing
under this Agreement.
13 - TERMINATION
13.1 If LICENSEE shall cease to carry on its business, this Agreement
shall terminate upon notice by M.I.T.
13.2 Should LICENSEE fail to make any payment whatsoever due and payable
to M.I.T. hereunder, M.I.T. shall have the right to terminate this Agreement
effective on thirty (30) days' notice, unless LICENSEE shall make all such
payments to M.I.T. within said thirty (30) day period. Upon the expiration of
the thirty (30) day period, if LICENSEE shall not have made all such payments to
M.I.T., the rights, privileges and license granted hereunder shall automatically
terminate.
13.3 Upon any material breach or default of this Agreement by LICENSEE
(including, but not limited to, breach or default under Paragraph 3.3), other
than those occurrences set out in Paragraphs 13.1 and 13.2 hereinabove, which
shall always take precedence in that order over any
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material breach or default referred to in this Paragraph 13.3, M.I.T. shall have
the right to terminate this Agreement and the rights, privileges and license
granted hereunder effective on ninety (90) days' notice to LICENSEE. Such
termination shall become automatically effective unless LICENSEE shall have
cured any such material breach or default prior to the expiration of the ninety
(90) day period.
13.4 LICENSEE shall have the right to terminate this Agreement at any time
on six (6) months' notice to M.I.T., and upon payment of all amounts due M.I.T.
through the effective date of the termination.
13.5 Upon termination of this Agreement for any reason, nothing herein
shall be construed to release either party from any obligation that matured
prior to the effective date of such termination; and Articles 1, 8, 9, 10, 12,
13.5, 13.6, and 15 shall survive any such termination. LICENSEE and any
sublicensee thereof may, however, after the effective date of such termination,
sell all LICENSED PRODUCTS, and complete LICENSED PRODUCTS in the process of
manufacture at the time of such termination and sell the same, provided that
LICENSEE shall make the payments to M.I.T. as required by Article 4 of this
Agreement and shall submit the reports required by Article 5 hereof.
13.6 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.
14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any payments, notice or other communication pursuant to this Agreement
shall be sufficiently made or given on the date of mailing if sent to such party
by certified first class mail, return receipt requested, postage prepaid,
addressed to it at its address below or as it shall designate by written notice
given to the other party:
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In the case of M.I.T.:
Director
Technology Licensing Office
Massachusetts Institute of Technology
00 Xxxxxxxxxxxxx Xxxxxx, Xxxx X00-000
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
In the case of LICENSEE:
President
REPROGENESIS, INC.
00 Xxxxxx Xxxxx
Xxxxx 00
Xx. Xxxxxx Xxxxxx, XX 00000
15 - MISCELLANEOUS PROVISIONS
15.1 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., 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.
15.2 The parties hereto acknowledge that this Agreement sets forth the
entire Agreement and understanding of the parties hereto as to the subject
matter hereof, and shall not be subject to any change or modification except by
the execution of a written instrument signed by the parties.
15.3 The provisions of this Agreement are severable, and in the event that
any provisions of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of the law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
15.4 LICENSEE agrees to xxxx the LICENSED PRODUCTS sold in the United
States with all applicable United States patent numbers. All LICENSED PRODUCTS
shipped to or
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sold in other countries shall be marked in such a manner as to conform with the
patent laws and practice of the country of manufacture or sale.
15.5 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
IN WITNESS WHEREOF, the parties have duly executed this Agreement the day
and year set forth below.
MASSACHUSETTS INSTITUTE OF
TECHNOLOGY REPROGENESIS, INC.
By /s/ Xxxx Xxxxxx By /s/ A. Xxxxx Xxxxxx
------------------------------------- ---------------------------------
Name Xxxx Xxxxxx Name A. Xxxxx Xxxxxx
------------------------------------ --------------------------------
Title Director Technology License Office Title President
----------------------------------- -------------------------------
Date 11-5-96 Date 11-7-96
------------------------------------ --------------------------------
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APPENDIX A
PATENT RIGHTS on the EFFECTIVE DATE
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
UNITED STATES PATENT RIGHTS
M.I.T. Case No. 4521
"Controlled Release Systems Containing Heparin and Growth Factors"
By Xxxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxxx Xxxxxxxxx and Xxxxx Xxxxxxxxxx
U.S. Patent No. 5,100,668
Issued March 31, 1992
M.I.T. Case No. [**]
Title: "[**]"
By Xxxxxx Xxxxxxx, Aruna Natha and Xxxxxxx Xxxxxx
U.S. Serial No. [**]
Filed on [**]
FOREIGN PATENT RIGHTS
M.I.T. Case No. [**]
PCT Serial No. [**] Filed on [**]
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