EXHIBIT 10.20
WHENEVER CONFIDENTIAL INFORMATION IS OMITTED HEREIN (SUCH OMISSIONS ARE DENOTED
BY AN ASTERISK*), SUCH CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED SEPARATELY TO
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT.
LICENSE AGREEMENT
This Agreement is made and entered into this 9th day of September, 2003
(the "Effective Date") by and between Metabolix, Inc., a corporation duly
organized and existing under the laws of the State of Delaware and having its
principal office at 000 Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000
(hereinafter referred to as "Metabolix"), and Tepha, Inc., a corporation duly
organized and existing under the laws of the State of Delaware and having its
principal office at 000 Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000
(hereinafter referred to as "Tepha").
WHEREAS, Metabolix is the assignee from Monsanto Company ("Monsanto") of
all right, title and interest in the Patent Rights, Biological Materials and
Know-How (all as defined herein);
WHEREAS, Metabolix wishes to grant, and Tepha wishes to receive, license
rights to the Patent Rights, Biological Materials and Know-How; and
WHEREAS, the grant of such license rights is subject to the prior written
approval of Monsanto, which has been obtained, and a copy of which is attached
as Appendix D for reference only.
NOW THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties hereto agree as follows:
1. DEFINITIONS.
1.1. "Patent Rights" shall mean: (i) the U.S. and foreign patent
applications and patents set forth in Appendix A, and the
inventions described and/or claimed therein, and all other patent
rights assigned to Metabolix by Monsanto not relating to plant
crop production of PHAs shall be added to Appendix A by amendment;
(ii) any divisionals, continuations and continuation-in-part
applications which shall be directed to subject matter
specifically described in such patent applications; (iii) the
resulting U.S. and foreign patents; (iv) any reissues,
reexaminations or extensions of such patents; and (v) all foreign
counterparts of the above patent applications and patents. For the
avoidance of doubt, the Patent Rights do not include any of the
Zeneca Limited patent rights licensed to Metabolix by Monsanto in
the Patent Sub-License Agreement dated May 14, 2001.
1.2. "Biological Materials" shall mean the biological materials set
forth in Appendix B, and all Progeny and Unmodified Derivatives of
those materials, but excluding Modifications. "Progeny" shall mean
an unmodified descendant from the Biological Materials, such as
virus from virus, cell from cell, or organism from organism.
"Unmodified Derivatives" shall mean substances created by
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Tepha which constitute an unmodified functional subunit or product
expressed by the Biological Material(s), (some examples include:
subclones of unmodified cell lines, purified or fractionated
subsets of the Biological Material(s), proteins expressed by
DNA/RNA supplied by Metabolix, or monoclonal antibodies secreted
by a hybridoma cell line).
1.3. "Modifications" shall mean substances created by Tepha that
contain/incorporate Biological Material(s).
1.4. "Know-How" shall mean the know-how set forth in Appendix C.
1.5. "Field" shall mean IN VIVO human and veterinary medical use of
polymers falling within the Patent Rights, including, without
limitation, tissue engineering, cell therapy, implantables,
medical devices, wound sealants, prescription and non-prescription
drug delivery, and contrast agents, BUT EXCLUDING (i) medical
disposables, surgical drapes and trays, sanitary products, barrier
contraceptives, nutritional and all other diagnostic uses and (ii)
transgenic plant crop production of polymers. For the purpose of
clarity, it is agreed and understood that, notwithstanding
anything in the prior sentence to the contrary, diagnostic systems
and/or devices used to monitor the IN VIVO use of a Licensed
Product shall be included within the Field. For the purpose of
determining whether a use falls within the Field, the parties
shall apply the following guidelines: (x) regulation of a use by
the U.S. Food and Drug Administration or other regulatory body
shall be indicative but not presumptive that a use is an IN VIVO
use, and (y) uses marketed only to physicians shall primarily fall
within the Field, and (z) uses marketed directly only to consumers
shall primarily fall outside the Field.
1.6. "Net Sales shall mean Tepha's xxxxxxxx for the use, sale, lease or
other disposition of Licensed Products and Licensed Processes, and
the fair market value of noncash consideration, less:
1.6.1 discounts allowed in amounts customary in the trade;
1.6.2 sales, tariff duties and/or use taxes directly imposed and
with reference to particular sales;
1.6.3 outbound transportation prepaid or allowed; and
1.6.4 amounts allowed or credited on returns.
No deduction 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" when invoiced. "Net Sales" shall not include
Licensed Products sold for clinical testing, research or development. If
a Licensed Product or Licensed Process shall otherwise be distributed or
invoiced for a discounted price substantially lower than customary in the
trade or distributed at no cost to Tepha Affiliates or otherwise, Net
Sales shall be based on the customary amount billed for such Licensed
Products or Licensed Processes.
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2
Where the Licensed Product is a combination product consisting of
material whose composition or manufacture is covered by the Patent Rights
("Patented Material") plus other materials (such as a growth factor, but
not, for example, filler materials) that are not covered by the Patent
Rights, then "Net Sales" shall mean the Net Sales of the full product
multiplied by the fully loaded manufacturing cost of the Patented
Material divided by the total fully loaded manufacturing cost of the
total combination product. When the Licensed Product consists of a
combination product consisting of a component made from the Patented
Material plus other components, then "Net Sales" shall mean Net Sales of
the total product multiplied by the fully loaded manufacturing cost of
the Patented Material component divided by the fully loaded manufacturing
cost of the total product. By "fully loaded" is meant the cost of goods
sold plus overhead allocated to production and sale thereof.
1.7. "Tepha" and "Metabolix" shall include "Affiliates." "Affiliates"
shall mean a related company of Tepha or Metabolix, respectively,
the voting stock of which is directly or indirectly at least fifty
percent (50%) owned and controlled by Tepha or Metabolix, an
organization which directly or indirectly controls more than fifty
percent (50%) of the voting stock of Tepha or Metabolix, and an
organization the majority ownership of which is directly or
indirectly common to the ownership of Tepha or Metabolix.
1.8. "Licensed Process" means any process which is covered in whole or
in part by an issued, unexpired valid claim or a pending claim
contained in the Patent Rights in the country in which such
process is used or in which the Licensed Product made thereby is
used or sold.
1.9. "Licensed Product" means any product or part thereof which: (i) is
covered in whole or in part by an issued, unexpired valid claim or
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
(ii) is manufactured by using a process or is employed to practice
a process which is covered in whole or in part by an issued
unexpired valid claim or a pending claim contained in the Patent
Rights in the country in which a Licensed Process is used or in
which such product or part thereof is used or sold.
2. LICENSE GRANT AND OWNERSHIP
2.1. NONEXCLUSIVE LICENSE. Subject to the terms and conditions of this
Agreement, Metabolix hereby grants to Tepha the worldwide,
nonexclusive right and license, with the right to sublicense, in
the Field: (i) under the Patent Rights to make, have made, use,
lease, sell, offer for sale and import the Licensed Products 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; (ii) to make,
have made, use, lease, sell, offer for sale, import and create
Modifications of the Biological Materials; and (iii) to use
Know-How.
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3
2.2. EXCLUSIVE LICENSE. Subject to the terms and conditions of this
Agreement, Metabolix hereby grants to Tepha the worldwide,
royalty-free, exclusive right and license, with the right to
sublicense, in the Field to make, have made, use, lease, sell,
offer for sale and import Modifications.
2.3. DELIVERY. Tepha shall have thirty (30) days after the Effective
Date to review and make copies of the Know-How and Biological
Materials. Metabolix makes no representations regarding the
viability of any of the Biological Materials. After thirty (30)
days from the Effective Date, any request to review or make copies
of the Know-How or Biological Materials shall be at Metabolix's
discretion.
2.4. OWNERSHIP OF MODIFICATIONS. Tepha hereby assigns to Metabolix all
of its right, title and interest in and to the Modifications,
including any and all intellectual property rights therein. Tepha
also agrees to promptly execute all assignments and patent
applications, and similar documents as reasonably requested by
Metabolix. If Metabolix shall be unable to obtain Tepha's
execution of such documents for any reason, Tepha hereby
irrevocably appoints Metabolix and its agents as Tepha's agents
and attorneys-in-fact to execute such documents with the same
legal effect as if Tepha shall have executed them.
2.5. RIGHT TO SUBLICENSE. Tepha's right to sublicense in Paragraphs 2.1
and 2.2 is subject to Metabolix' prior written approval during the
period that Metabolix requires Monsanto's approval to sublicense.
Tepha agrees to insert a provision in each sublicense that
Metabolix is a third party beneficiary of the sublicense as to the
sublicensed Patent Rights, with the right to enforce the
applicable terms thereof in the event Tepha does not enforce its
rights.
2.6. NO OTHER RIGHTS. Nothing in this Agreement shall be construed to
confer any rights upon Tepha by implication, estoppel or otherwise
beyond the express licenses granted by Metabolix or as to any
technology or patent rights of Metabolix or any other entity other
than the Patent Rights, Biological Materials and Know-How.
2.7. MONSANTO RIGHTS. Monsanto retains certain rights to Patent Rights
as collateral in the event of default by Metabolix under a
Security Agreement between Monsanto and Metabolix dated May 12,
2001, and this Agreement is subject to Monsanto's rights therein.
Monsanto has granted its approval of this Agreement in the letter
attached as Appendix D; however, Monsanto retains all of its
rights during the remaining term of the Security Agreement,
including without limitation its rights to Patent Rights as
collateral, and in the event Tepha exercises its right to
sublicense third parties, such sublicenses shall also be subject
to such Monsanto's rights.
3. ROYALTIES
3.1. LICENSE ISSUE FEE. In partial consideration for the license rights
granted herein, Tepha shall pay Metabolix a License Issue Fee of *
which shall be deemed earned
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and due as follows: * on the Effective Date, and * on each of the
six-month, twelve-month and eighteenth-month anniversaries of the
Effective Date; provided, however, the balance of the full amount
of such License Issue Fee shall be due upon the raising by Tepha
of * (cumulatively) after the Effective Date in investment capital
and/or research and development funds in connection with the
Patent Rights, Biological Materials and Know-How, and payment
shall be made within thirty (30) days thereafter.
3.2 RUNNING ROYALTIES. In partial consideration for the license rights
granted herein, Tepha shall pay Metabolix running royalties of *
of Net Sales by Tepha ("Running Royalty"); provided, however, the
maximum cumulative Running Royalties due on particular Net Sales
of any Licensed Product or Licensed Process payable by Tepha to
Metabolix for any quarter under (i) this Agreement, and (ii) the
sublicense from Metabolix to Tepha to certain Massachusetts
Institute of Technology patent rights dated October 1, 1999, as
amended, shall be * of such Net Sales, subject to any deductions
permitted under Paragraph 3.7.
3.3 SUBLICENSE REVENUE. Tepha shall pay Metabolix a * share of gross
sublicensing revenue, including sublicense issue fees, milestone
payments, license maintenance fees, royalties on net sales, and
similar consideration, and including, for the avoidance of doubt,
the fair market value of any sublicense rights granted in a
multi-part transaction, but excluding research and development
funding received by Tepha; provided, however, the maximum
cumulative share of gross sublicensing revenue in regard to a
particular sublicense payable by Tepha to Metabolix for any
quarter under (i) this Agreement, and (ii) the sublicense from
Metabolix to Tepha to certain Massachusetts Institute of
Technology patent rights dated October 1, 1999, as amended, shall
be * of such gross sublicensing revenue. For purposes herein,
sublicensees' net sales shall have a parallel meaning to the
definition of Tepha's Net Sales in Paragraph 1.6.
3.4 PAYMENTS IN FULL. 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 1.6.2.
3.5 NO MULTIPLE ROYALTIES. No multiple Running Royalties shall be
payable because any Licensed Product or Licensed Process, its
manufacture, use, sale or importation are or shall be covered by
more than one patent application or patent licensed under this
Agreement.
3.6 PAYMENT. Royalty payments shall be paid in the United States
dollars in Cambridge, Massachusetts, or at such other place as
Metabolix 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 by using the
exchange rate published in the Wall Street Journal on the last
business day of the calendar quarterly reporting period to which
such royalty payments relate.
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3.7 THIRD PARTY LICENSES. To the extent that Tepha has executed or
shall obtain subsequent to the Effective Date licenses to third
party patents or other intellectual property that are necessary to
manufacture or sell Licensed Products or Licensed Processes in the
Field, Tepha may deduct from the Running Royalty due to Metabolix
under Paragraph 3.2, * of the running royalties due on such third
party patents or intellectual property up to an amount equal to *
of the Running Royalties due hereunder.
3.8 APPLICATION OF CREDITS. Any credits against Running Royalties
permitted under this Agreement may be applied by Tepha,
cumulatively, up to * the Running Royalties otherwise due in the
respective quarterly accounting period; provided, Tepha may carry
over unused credits to subsequent quarterly accounting periods.
Notwithstanding the applicability of credits under one or more
Paragraphs of this Agreement, the minimum Running Royalties due
from Tepha shall be * of the Running Royalties otherwise payable,
subject to the maximum set forth in Paragraph 3.2.
4. PATENT PROSECUTION
4.1. PATENT PROSECUTION. Throughout the term of this Agreement,
Metabolix, at its own expense, shall file, prosecute and maintain
the Patent Rights. If Metabolix shall elect not to file, prosecute
or maintain any Patent Right, Metabolix shall notify Tepha in
writing with at least thirty (30) days notice prior to any filing,
action, payment or the like being due, in which event Tepha shall
have the right to file, prosecute or maintain such Patent Right,
at Tepha's expense in Metabolix' name. Metabolix agrees to
execute, and agrees to use reasonable efforts to ensure that its
employees shall execute, all documents necessary to perfect
filing, advance prosecution and/or effect issue of any patents
upon any such applications. After notice of such election by
Metabolix, Tepha shall have no further royalty obligations under
Paragraphs 3.2 and 3.3 with respect to such patents or
applications.
5. RECORDS AND PAYMENTS
5.1. RECORDS AND AUDIT. Tepha shall keep true and accurate books of
account containing all particulars that may be necessary for the
purpose of showing the amounts payable to Metabolix hereunder.
Said books of account shall be kept at Tepha's principal place of
business and shall be open at all reasonable times for three (3)
years following the end of the calendar year to which they
pertain, to the inspection of Metabolix or its agents for the
purpose of verifying Tepha's royalty statements or compliance in
other respect with this Agreement. Should such inspection lead to
the discovery of a greater than * discrepancy in reporting to
Metabolix's detriment, Tepha agrees to pay the cost of such
inspection.
5.2. REPORTS AND PAYMENTS. Within thirty (30) days after the end of
each calendar quarter during the term of this Agreement, Tepha
shall send to Metabolix a report showing the Net Sales of the
Licensed Products and Licensed Processes,
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including calculation of deductions, and sublicensing gross
revenue for such quarter and shall pay the appropriate royalties
to Metabolix.
5.3. INTEREST. The amounts due under Articles 3 shall, if overdue, bear
interest until payment at a per annum rate * above * in effect at
Fleet Bank, or its successors, on the due date. The payment of
such interest shall not foreclose Metabolix from exercising any
other rights it may have as a consequence of the lateness of any
payment.
6. DUE DILIGENCE
6.1. DILIGENT EFFORTS. Tepha shall use diligent efforts to bring one or
more Licensed Products or Licensed Processes to market through a
thorough, vigorous and diligent program for exploitation of the
Patent Rights and shall continue active, diligent development and
marketing efforts for one or more Licensed Products or Licensed
Processes throughout the term of this Agreement
6.2. GOVERNMENTAL APPROVALS AND MARKETING OF LICENSED PRODUCTS. Tepha
or its designees shall be responsible for obtaining all necessary
governmental approvals for the development, production,
distribution, sale and use of any Licensed Product, at Tepha's, or
its designees', expense, including, without limitation, any safety
studies. Tepha or its designees shall have sole responsibility for
any warning labels, packaging and instructions as to the use of
Licensed Products and for the quality control for any Licensed
Product.
7. INFRINGEMENT
7.1. NOTICE. Tepha and Metabolix shall each inform the other promptly
in writing of any alleged or threatened infringement of the Patent
Rights by a third party and of any available evidence thereof.
7.2. PURSUIT OF INFRINGERS. During the term of this Agreement, Tepha
shall have the right, but shall not be obligated, to prosecute at
its own expense all infringements of the Patent Rights by a third
party in the Field by litigation or settlement discussions and, in
furtherance of such right, Metabolix agrees that Tepha may join
Metabolix as a party plaintiff in any such suit, without expense
to Metabolix. The total cost of any such infringement action
commenced solely by Tepha shall be borne by Tepha. In the event
that Tepha shall have exercised its right to bring an action,
Tepha shall be responsible for defending against any counterclaims
alleging invalidity or unenforceability of a Patent Right and for
prosecuting the action through to settlement or other final
disposition. In the event that Tepha shall undertake the
enforcement of the Patent Rights in the Field by litigation, Tepha
may *.
7.3. If within six (6) months after having been notified of any alleged
infringement, Tepha shall have been unsuccessful in persuading the
alleged infringer to desist and shall not have brought and shall
not be diligently prosecuting an infringement
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action, or if Tepha shall notify Metabolix at any time prior
thereto of its intention not to bring suit against any alleged
infringer, then, and in those events, only, Metabolix shall have
the right, but shall not be obligated, to prosecute at its own
expense any infringement of the Patent Rights in the Field. In
furtherance of such right, Tepha hereby agrees that Metabolix may
include Tepha as a party plaintiff in any such suit, without
expense to Tepha. The total cost of any such infringement action
commenced or defended solely by Metabolix shall be borne by
Metabolix, and Metabolix shall be responsible for defending
against any counterclaims alleging invalidity or unenforceability
of a Patent Right.
7.4. Any recovery of damages by the prosecuting party for any such suit
shall be applied first in satisfaction of any unreimbursed
expenses and legal fees of such party relating to the suit, and
next toward reimbursement of Metabolix for any royalties past due
or withheld and applied pursuant to Paragraph 7.2, if applicable.
The balance remaining from any such recovery shall be divided with
* to the non-prosecuting party and any remaining balance to the
prosecuting party.
7.5. In the event of the institution of any suit by a third party
against Metabolix, Tepha or its sublicensees for patent
infringement involving the Patent Rights in the Field, the party
sued shall promptly notify the other party in writing. Tepha shall
have the right, but not the obligation, to defend such suit at its
own expense. If Tepha shall elect not to defend, Tepha shall
promptly notify Metabolix. Metabolix shall have the right, but not
the obligation, to defend such suit at its expense.
7.6. If Tepha shall exercise its rights pursuant to Section 7.5 to
defend the Patent Rights, then * until a final decision shall be
rendered by a court or administrative tribunal of competent
jurisdiction from which no appeal can be or is taken provided
that:
7.6.1 If the enforceability of all material claims in such Patent
Right claiming the Licensed Product or Licensed Process is
upheld by a court of other legal or administrative tribunal
from which no appeal is or can be taken, *; or
7.6.2 If one or more claims in such Patent Right covering the
Licensed Product or Licensed Process shall be held to be
invalid or otherwise unenforceable by a court or other
legal or administrative tribunal in any country from which
no appeal is or can be taken or the scope thereof is
modified and, as a result such Patent Right no longer
offers substantial protection to a Licensed Product or
Licensed Process in such country, then *.
7.7. In any suit as either party may institute to enforce or defend 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. The
parties shall
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keep one another informed of the status of and of their respective
activities regarding any litigation or settlement thereof
concerning the Patent Rights in the Field or Licensed Products or
Licensed Processes; provided, however, that no settlement or
consent judgement or other voluntary final disposition of any suit
defended or action brought by a party pursuant to this Article 7
may be entered into without the consent of the other party, such
consent not to be unreasonably withheld or delayed.
7.8. Tepha, during the period of this Agreement, shall have the sole
right in accordance with the terms and conditions herein to
sublicense any alleged infringer for future use of the Patent
Rights in the Field.
8. PRODUCT LIABILITY
8.1. INDEMNIFICATION. Tepha shall at all times during the term of this
Agreement and thereafter, indemnify, defend and hold Metabolix and
Monsanto, their directors, officers, employees and Affiliates,
harmless against all claims and expenses, arising out of the death
of or injury to any person or persons or out of any damage to
property and against any other claim, proceeding, demand, expense
and liability of any kind whatsoever resulting from or relating to
the production, manufacture, sale, use, lease, consumption or
advertisement of the Licensed Products and/or Licensed Process(es)
*.
8.2. INSURANCE. Prior to the first use of a Licensed Product for
humans, Tepha shall obtain and carry in full force and effect
commercial, general liability insurance, including product
liability insurance, which shall protect Tepha, Metabolix and
Monsanto 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 Metabolix and Monsanto as additional named insured
thereunder, shall be endorsed to include product liability
coverage and shall require thirty (30) days written notice to be
given to Metabolix prior to any cancellation or material change
thereof. The limits of such insurance shall not be less than * per
occurrence with an aggregate of * for personal injury including
death; and * per occurrence with an aggregate of * for property
damage. Tepha shall provide Metabolix with Certificates of
Insurance evidencing the same. Tepha shall maintain such
commercial general liability insurance during the period that any
Licensed Product or Licensed Process is being used, distributed or
sold and for six (6) years thereafter.
9. WARRANTIES AND DISCLAIMER
9.1. *
9.2. DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT:
NEITHER PARTY, NOR THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES
AND AFFILIATES MAKE ANY REPRESENTATIONS OR EXTEND ANY WARRANTIES
OF ANY KIND,
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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 EITHER PARTY OR BY MONSANTO THAT THE PRACTICE OF THE
LICENSES GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OR
OTHER INTELLECTUAL OR PROPRIETARY RIGHTS OF ANY THIRD PARTY.
10. LIMITATION OF LIABILITY
10.1. NO CONSEQUENTIAL DAMAGES. * IN NO EVENT SHALL METABOLIX, TEPHA, OR
THEIR RESPECTIVE 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 SUCH PARTY SHALL BE ADVISED, SHALL HAVE
OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF
THE FOREGOING.
11. EXPORT CONTROLS
11.1. Tepha 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 Tepha that Tepha shall not export data or commodities to
certain foreign countries without prior approval of such agency.
Metabolix neither represents that a license shall not be required
nor that, if required, it shall be issued.
12. NON-USE OF NAMES
12.1. Except as required by law or in raising funding, neither party
shall use the names or trademarks of the other, nor any adaptation
thereof, nor the names of any of the other party's employees, in
any advertising, promotional or sales literature without prior
written consent obtained from such party, or said employee, in
each case, such consent not to be unreasonably withheld, except
that Tepha may state that it is licensed by Metabolix, under one
or more of the patents and/or applications comprising the Patent
Rights. Tepha may, however, use the name of any employee of
Metabolix who is a consultant or member of an advisory board of
Tepha, with their permission, and provided, also, that their
affiliation with Metabolix is identified.
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13. DISPUTE RESOLUTION
13.1. 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 to prevent irreparable harm, and except for any
dispute relating to patent validity or infringement, any and all
claims, disputes or controversies arising under, out of or in
connection with the Agreement, 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. If the
parties by their senior management representatives shall be unable
to resolve the dispute within thirty (30) days, then by no later
than forty (40) 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 no later than sixty
(60) business days after the date of such notice of dispute, such
representatives shall schedule a date for a mediation hearing with
the Cambridge Dispute Settlement Center or Endispute Inc. in
Cambridge, Massachusetts or another mutually agreeable mediator.
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 thirty (30) business days
after such mediation hearing, the parties shall have the right to
pursue any other remedies legally available to resolve such
dispute 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 Metabolix
and Tepha each hereby irrevocably consents and submits.
13.2. Notwithstanding the foregoing, nothing in this Article shall be
construed to waive any rights or timely performance of any
obligations under this Agreement.
14. CONFIDENTIALITY
14.1. CONFIDENTIAL INFORMATION. Both Metabolix and TEPHA agree that all
confidential information disclosed to the other party shall be
deemed "Confidential Information" of the disclosing party. In
particular, "Confidential Information" shall be deemed to include,
but not be limited to, Know-How, Biological Materials, trade
secrets, information, ideas, inventions, materials, samples,
processes, procedures, methods, formulations, protocols, packaging
designs and materials, test data, future development plans,
"Product" launch date, technological know-how and engineering,
manufacturing, regulatory, marketing, servicing, sales, or
financial matters relating to the disclosing party and its
business.
14.2. NONDISCLOSURE AND NONUSE. During the term and thereafter each
receiving party: (i) shall maintain all Confidential Information
in confidence; (ii) shall not disclose any Confidential
Information to any third party without prior written consent of
the disclosing party except that the receiving party may disclose
in connection
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with consultants, subcontractors or agents or raising funding and
technical development activities for purposes consistent with this
Agreement pursuant to a written non-disclosure agreement with said
parties, having terms of nondisclosure and nonuse at least as
restrictive as those set forth herein; and (iii) shall use such
Confidential Information only to the extent required to accomplish
the purposes of this Agreement. A receiving party may disclose
Confidential Information that is required to be disclosed pursuant
to the law, by request of the FDA or other government authority or
for medical or safety reasons, but only to the extent required to
be disclosed by the FDA or other government authority. Both
parties shall take precautions as each normally takes with its own
confidential and proprietary information to prevent disclosure to
third parties, but no less than reasonable precautions.
14.3. EXCEPTIONS. Both parties agree that, notwithstanding the above,
the obligations of confidentiality and nonuse shall not apply to:
14.3.1 Information that at the time of disclosure is, or
thereafter becomes, generally known to the public, through
no wrongful act or failure to act on the part of the
receiving party;
14.3.2 Information that was known by or in the possession of the
receiving party at the time of receiving such information
from the disclosing party, as evidenced by written
records;
14.3.3 Information obtained by the receiving party from a third
party who is not breaching a commitment of confidentiality
to the disclosing party by revealing such information to
the receiving party, as evidenced by written records; or
14.3.4 Information that is developed independently by the
receiving party without use of confidential information of
the other party, as evidenced by written records.
14.4. Both Parties shall make diligent efforts to ensure that all
employees, consultants, agents and subcontractors who may have
access to Confidential Information of the other party, and any
other third parties who might have access to Confidential
Information, shall sign nondisclosure agreements consistent with
the terms set forth in this Paragraph. No Confidential Information
shall be disclosed to any employees, subcontractors, agents,
consultants or third parties who do not have a need to receive
such information for the purposes of this Agreement.
15. TERMINATION
15.1. TERMINATION BY METABOLIX. If Tepha shall cease to carry on its
business, this Agreement shall terminate effective upon notice by
Metabolix.
15.2. TERMINATION FOR NONPAYMENT. Should Tepha fail to make any payment
whatsoever due and payable to Metabolix hereunder, Metabolix shall
have the right to terminate this Agreement effective on sixty (60)
days' notice, unless Tepha shall make all such payments to
Metabolix, within said sixty (60) day
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period. Upon the expiration of the sixty (60) day period, if Tepha
shall not have made all such payments to Metabolix, the rights,
privileges and license granted hereunder shall automatically
terminate.
15.3. TERMINATION FOR MATERIAL BREACH. Upon any material breach or
default of this Agreement by Tepha, other than those occurrences
set out in Paragraphs 15.1 and 15.2 hereinabove, which shall
always take precedence in that order over any material breach or
default referred to in this Paragraph 15.3, Metabolix shall have
the right to terminate this Agreement and the rights, privileges
and license granted hereunder effective on one hundred and twenty
(120) days' notice to Tepha. Such termination shall become
automatically effective unless Tepha shall have cured any such
material breach or default prior to the expiration of the one
hundred and twenty (120) day period. Upon any material breach or
default of this Agreement by Metabolix, Tepha shall have the right
to terminate this Agreement and the rights, privileges and license
granted hereunder effective on one hundred and twenty (120) days'
notice to Metabolix. Such termination shall become automatically
effective unless Metabolix shall have cured any such material
breach or default prior to the expiration of the one hundred and
twenty (120) day period.
15.4. TERMINATION BY TEPHA. Tepha shall have the right to terminate this
Agreement at any time on six (6) months' notice to Metabolix, and
upon payment of all amounts due Metabolix through the effective
date of termination.
15.5. DEFINITION OF EXPIRATION. For purposes of this Agreement, the term
"expiration" shall mean expiration of the last to expire of the
Patent Rights, and the co-terminus expiration of this Agreement,
subject to the surviving licenses and provisions. The term
"termination" shall mean termination of this Agreement prior to
expiration in accordance with this Article 15.
15.6. EFFECTS OF TERMINATION. Upon expiration or termination of this
Agreement for any reason: (i) nothing herein shall be construed to
release either party from any obligation that matured prior to
expiration or the effective date of termination; (ii) Articles 1,
2.4, 5.1 (for three (3) years), 7.1 (as to any infringement action
instituted prior to termination), 8, 10, 13, 14, 16.4, 16.5, 16.6
and 17 shall survive expiration or any termination; (iii) for a
period of six (6) months after the effective date of termination,
Tepha and its sublicensees may sell Licensed Products in
inventory, and complete Licensed Products in the process of
manufacture at the time of such termination and sell the same,
provided that Tepha shall pay the Running Royalties thereon as
required by Article 3 of this Agreement and shall submit the
reports required by Article 5 hereof on the sales of Licensed
Products; (iv) if requested, each party shall immediately return
all Confidential Information to the disclosing party and shall
cease and refrain from any further use of such Confidential
Information; (v) upon termination of this Agreement for any
reason, any sublicense not then in default shall continue in full
force and effect except that Metabolix shall be substituted in
place of the Tepha, and Metabolix shall have no obligations under
such sublicense beyond their
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obligations herein; (vi) upon termination (as defined in Paragraph
15.5), if requested by Metabolix, Tepha shall return all
Biological Materials and Know-How; and (vii) after expiration of
this Agreement (as defined in Paragraph15.5), Tepha shall retain a
perpetual, irrevocable, royalty-free, non-exclusive, transferable,
worldwide license in the Field, with the right to sublicense, to
use the Know-How.
15.7. LICENSE TO METABOLIX. Upon termination of this Agreement for any
reason (except expiration or termination by Tepha for breach by
Metabolix under Paragraph 15.3), Tepha shall, grant and hereby
grants Metabolix a nonexclusive license, with the right to
sublicense, to all information then in Tepha's possession relevant
to the commercialization of Licensed Products and/or Licensed
Processes, including, but not limited to, research results,
toxicology data, assays, preclinical data, prototypes,
manufacturing processes including cell lines and unused, unexpired
amounts of Licensed Products, clinical results, regulatory
submissions, suppliers and customer lists. In such event Tepha
shall receive a royalty equal to * of the gross amount of
consideration, if any, subsequently received by Metabolix with
respect to the Licensed Products and Licensed Processes.
16. GENERAL
16.1. INTEGRATED AGREEMENT. This Agreement (including its Appendices,
which are incorporated herein by reference) constitutes the
complete and exclusive statement of the agreement between the
parties, and supersedes all prior agreements, proposals,
negotiations and communications between the parties, both oral and
written, regarding the subject matter hereof.
16.2. WAIVER OR AMENDMENT. No waiver, alteration or amendment of any of
the provisions of this Agreement shall be binding unless made in
writing and signed by each of the parties hereto.
16.3. NOTICES. Any payment, 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,
postage prepaid, return receipt requested addressed to it at its
address below or as it shall designate by written notice given to
the other party.
If to Metabolix:
Metabolix, Inc.
000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: President
Fax: 000-000-0000
If to Tepha:
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Tepha, Inc.
000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: President
Fax: 000-000-0000
All such notices, if properly addressed, shall be effective when
received.
16.4. GOVERNING LAW. This Agreement shall be construed, governed,
interpreted and applied in accordance with the laws of the
Commonwealth of Massachusetts, without regard to conflict of laws
principles, and as necessary the laws of the United States of
America, except that questions affecting the construction and
effect of any patent shall be determined by the law of the country
in which the patent was granted. Each party agrees that venue for
any dispute arising under this Agreement shall be Boston,
Massachusetts, and waives any objection it has or may have in the
future with respect to such venue.
16.5. FAILURE TO EXERCISE REMEDY. If either party fails to enforce any
term of this Agreement or fails to exercise any remedy, such
failure to enforce or exercise on that occasion shall not prevent
enforcement or exercise on any other occasion.
16.6. NON-EXCLUSIVE RIGHTS. The rights and remedies of the parties
provided in this Agreement shall not be exclusive and are in
addition to any other rights and remedies available at law or in
equity.
16.7. ASSIGNMENT. Except as expressly provided in Article 2, neither
party shall directly or indirectly sell, transfer, assign or
delegate in whole or in part this Agreement, or any rights,
duties, obligations or liabilities under this Agreement
(collectively "assign"), by operation of law or otherwise, without
the prior written consent of the other party, such consent not to
be unreasonably withheld or delayed; provided, however, so long as
the assignee shall not be a competitor of the other party, either
party shall have the right to assign without consent all of its
rights, duties, obligations and liabilities under this Agreement
to any Affiliate or in connection with any sale, merger,
consolidation, recapitalization or reorganization involving in
each case the sale of all the capital stock of the party or all or
substantially all of the assets of such party to which this
Agreement relates. Subject to the foregoing, this Agreement shall
inure to the benefit of and be binding upon the permitted
successors and assigns of Metabolix and Tepha.
16.8. INDEPENDENT CONTRACTORS. The parties agree that in the performance
of this Agreement they are and shall be independent contractors.
Nothing herein shall be construed to constitute either party as
the agent of the other party for any purpose whatsoever, and
neither party shall bind or attempt to bind the other party to any
contract or the performance of any obligation or represent to any
third party that it has any right to enter into any binding
obligation on the other party's behalf.
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16.9. SEVERABILITY. 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.
16.10. COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which when executed shall be deemed to be an
original but all of which taken together shall constitute one and
the same agreement.
16.11. PATENT MARKING. Tepha shall apply the patent marking notices
required by the law of any country where Licensed Products are
made, used, sold or imported.
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IN WITNESS WHEREOF, the parties have duly executed this Agreement the day
and year set forth below.
Metabolix, Inc. Tepha, Inc.
By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxx X. Xxxxxxxx
--------------------------- -----------------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxxx X. Xxxxxxxx
------------------------- -----------------------------
Title: Vice President R & D Title: President
------------------------ ----------------------------
Date: September 9, 2003 Date: September 9, 2003
-------------------------- -----------------------------
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