Exhibit 10.19
DEVELOPMENT AND LICENSE AGREEMENT
between
METASYN, INC.
and
DAIICHI RADIOISOTOPE LABORATORIES, LTD.
dated as of March 29, 1996
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS................................................................................... 1
1.1. "Affiliate"................................................................................... 1
1.2. "Development Phase"........................................................................... 2
1.3. "Effective Date".............................................................................. 2
1.4. "FDA"......................................................................................... 2
1.5. "Field"....................................................................................... 2
1.6. "First Commercial Sale"....................................................................... 2
1.7. "IND"......................................................................................... 2
1.8. "Licensed Compound"........................................................................... 2
1.9. "Licensed Products"........................................................................... 2
1.10. "Master Agreement"............................................................................ 2
1.11. "MGH Patent Rights"........................................................................... 2
1.12. "Metasyn Patent Rights"....................................................................... 2
1.13. "Metasyn Technology".......................................................................... 3
1.14. "NDA"......................................................................................... 3
1.15. "Net Sales"................................................................................... 3
1.16. "Patent Rights"............................................................................... 3
1.17. "Program"..................................................................................... 4
1.18. "Stock Purchase Agreement".................................................................... 4
1.19. "Territory"................................................................................... 4
1.20. "Third Party"................................................................................. 4
1.21. "Valid Claim"................................................................................. 4
ARTICLE 2. LICENSE GRANTS; MANUFACTURING AND MARKETING RIGHTS................................................. 4
2.1. Grant of License Rights by Metasyn to DRL..................................................... 4
2.1.1. Grant for Licensed Compound............................................................ 4
2.1.2. Sublicenses............................................................................ 4
2.2. Manufacturing and Supply of Licensed Compounds and Licensed Products.......................... 5
2.2.1. Manufacture and Supply by Metasyn during the Development
Phase.................................................................................. 5
2.2.2. Manufacture and Supply by Metasyn After DRL's Launch of the
Licensed Products...................................................................... 5
2.2.3. Manufacture by DRL..................................................................... 6
2.2.4. Assistance by Metasyn to DRL for Manufacturing License................................. 7
2.3. Marketing and Distribution Rights and Obligations............................................. 7
2.4. No Other Technology Rights.................................................................... 7
ARTICLE 3. EFFORTS DURING DEVELOPMENT PHASE; MANAGEMENT....................................................... 7
3.1. Obligations of the Parties.................................................................... 7
3.1.1. Diligent Efforts of Metasyn............................................................ 7
3.1.2. Diligent Efforts of DRL................................................................ 8
3.1.3. Development Schedule................................................................... 8
3.1.4. Extensions............................................................................. 8
(i)
3.2. Attendance at Regulatory Meetings.............................................................. 8
3.3. Information Exchange, Reports.................................................................. 8
3.4. Representatives................................................................................ 9
3.5. Availability of Employees...................................................................... 9
3.6. Visit of Facilities............................................................................ 9
3.7. Training of DRL Scientists..................................................................... 9
ARTICLE 4. PAYMENTS............................................................................................ 9
4.1. Initial Payment................................................................................ 9
4.2. Milestone Payments............................................................................. 10
4.3. Royalties...................................................................................... 10
4.3.1. Royalties on Net Sales of the Licensed Products......................................... 10
4.3.2. Adjustments for Third Party Royalties................................................... 10
4.3.3. [ ]*.................................................................................... 11
4.3.4. Royalty Reports, Exchange Rates......................................................... 11
4.3.5. Audits.................................................................................. 11
4.3.6. Royalty Payment Terms................................................................... 12
4.4. [ ]*........................................................................................... 12
4.5. Interest on Late Payments...................................................................... 12
ARTICLE 5. INTELLECTUAL PROPERTY............................................................................... 12
5.1. Filing, Prosecution and Maintenance of MGH Patent Rights....................................... 12
5.1.1. Responsibility and Costs................................................................ 12
5.1.2. Abandonment............................................................................. 12
5.1.3. Notice of Infringement.................................................................. 13
5.1.4. Prosecution by MGH or Metasyn of MGH Patent Rights...................................... 13
5.1.5. Prosecution by DRL...................................................................... 13
5.1.6. [ ]*.................................................................................... 13
5.1.7. Declaratory Actions..................................................................... 14
5.2. Filing, Prosecution and Maintenance of Metasyn Patent Rights................................... 14
5.2.1. Prosecution and Maintenance............................................................. 14
5.2.2. Abandonment; Failure to Pay............................................................. 14
5.2.3. Cooperation............................................................................. 15
5.2.4. Infringement by Others; Prosecution by Metasyn.......................................... 15
5.2.5. Infringement by Others; Prosecution by DRL.............................................. 15
5.2.6. Cooperation in Infringement Actions..................................................... 16
5.2.7. Declaratory Actions..................................................................... 16
5.3. Infringement Action Against DRL................................................................ 16
5.4. Cooperation in Infringement Actions............................................................ 17
ARTICLE 6. CONFIDENTIALITY..................................................................................... 17
6.1. Nondisclosure Obligations...................................................................... 17
6.1.1. General................................................................................. 17
6.1.2. Limitations............................................................................. 17
6.2. Samples........................................................................................ 18
6.3. Terms of this Agreement........................................................................ 18
6.4. Publications................................................................................... 18
*Confidential information omitted and filed with the Commission
(ii)
6.4.1. Procedure............................................................................... 18
6.4.2. Delay................................................................................... 19
6.4.3. Resolution.............................................................................. 19
6.5. Injunctive Relief.............................................................................. 19
ARTICLE 7. REPRESENTATIONS AND WARRANTIES...................................................................... 19
7.1. Patent Validity................................................................................ 19
7.2. Accuracy of Exhibits A and B................................................................... 19
ARTICLE 8. INDEMNITY........................................................................................... 19
8.1. DRL Indemnity Obligations...................................................................... 19
8.2. Metasyn Indemnity Obligations.................................................................. 20
8.3. Procedure...................................................................................... 20
8.4. Insurance...................................................................................... 20
ARTICLE 9. EXPIRATION AND TERMINATION.......................................................................... 21
9.1. Expiration..................................................................................... 21
9.2. Termination.................................................................................... 21
9.2.1. Termination by Either Party............................................................ 21
9.2.2. Termination by Metasyn................................................................. 21
9.2.3. Termination by DRL..................................................................... 21
9.2.4. Automatic Termination.................................................................. 21
9.3. Effect of Expiration or Termination............................................................ 22
9.3.1. Manufacturing Approval and Technology.................................................. 22
9.3.2. Termination due to Termination of MGH License.......................................... 22
9.3.3. Termination Due to Section 9.2.4....................................................... 22
9.3.4. Survival............................................................................... 23
9.4. Remedy Other Than Termination.................................................................. 23
ARTICLE 10. MISCELLANEOUS...................................................................................... 23
10.1. Force Majeure.................................................................................. 23
10.2. Assignment..................................................................................... 24
10.3. Severability................................................................................... 24
10.4. Notices........................................................................................ 24
10.5. Applicable Law................................................................................. 25
10.6. Dispute Resolution............................................................................. 25
10.7. Public Announcements........................................................................... 26
10.8. Entire Agreement............................................................................... 26
10.9. Headings....................................................................................... 26
10.10. Independent Contractors........................................................................ 26
10.11. Agreement Not to Solicit Employees............................................................. 26
10.12. Exports........................................................................................ 27
10.13. Waiver......................................................................................... 27
10.14. Counterparts................................................................................... 27
(iii)
Exhibit A List of MGH Patent Rights (ss.1.12)
Exhibit B List of Metasyn Patent Rights (ss.1.13)
Exhibit C Development Schedule (ss.3.1.3)
Appendix I MGH License
(iv)
DEVELOPMENT AND LICENSE AGREEMENT
THIS DEVELOPMENT AND LICENSE AGREEMENT dated as of March 29, 1996 (the
"Agreement") is made between METASYN, INC., a Delaware corporation having its
principal place of business at 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000-0000 X.X.X. ("Metasyn"), and DAIICHI RADIOISOTOPE LABORATORIES, LTD., a
Japanese corporation having its principal place of business at 00-00, Xxxxxxxx
0-xxxxx Xxxx-xx, Xxxxx, 000 Xxxxx ("DRL").
R E C I T A L S
WHEREAS, Metasyn has obtained certain rights under certain patents and
patent applications owned by The General Hospital Corporation, doing business as
Massachusetts General Hospital, ("MGH") pursuant to an Amended and Restated
License Agreement dated July 10, 1995 between Metasyn and MGH (the "MGH
License") a copy of which is attached as Appendix I;
WHEREAS, Metasyn is developing a proprietary compound coded as MS-325
("Compound MS-325") which is intended for use as an enhancer for magnetic
resonance imaging, which compound is covered by said MGH patents and patent
applications as well as by Metasyn patent applications;
WHEREAS, DRL is interested in obtaining an exclusive license to develop
and sell Compound MS-325 in Japan; and
WHEREAS, Metasyn is willing to grant DRL such a license upon the terms
and conditions set forth below.
NOW THEREFORE, in consideration of the premises and of the covenants
herein contained, the parties hereto mutually agree as follows:
ARTICLE 1. DEFINITIONS
For purposes of this Agreement, the terms defined in this Article shall
have the meanings specified below:
1.1. "Affiliate" shall mean any corporation or other entity which
directly or indirectly controls, is controlled by or is under common control
with a party to this Agreement. A corporation or other entity shall be regarded
as in control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting stock or other
ownership interest of the other corporation or entity, or if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of the corporation or other entity or the power to elect
or appoint
fifty percent (50%) or more of the members of the governing body of the
corporation or other entity.
1.2. "Development Phase" shall mean the period commencing on the
Effective Date of the Agreement and continuing until final marketing approval
for the Licensed Products has been obtained in the Territory.
1.3. "Effective Date" shall mean the date first written above.
1.4. "FDA" shall mean the United States Food and Drug Administration.
1.5. "Field" shall mean the medical application of contrasting and/or
enhancement agents for magnetic resonance imaging in humans.
1.6. "First Commercial Sale" of the Licensed Products in Japan shall
mean the first sale for use or consumption by the general public of the Licensed
Products in such country based on the required marketing and pricing approval
granted by the governing health authority of Japan.
1.7. "IND" shall mean an investigational new drug application or its
equivalent filed with the FDA and necessary for beginning clinical trials in
humans, or any comparable application filed with the regulatory authorities of
Japan prior to beginning clinical trials in humans in Japan, with respect to the
Licensed Products.
1.8. "Licensed Compound" shall mean Compound MS-325 in bulk form.
1.9. "Licensed Products" shall mean pharmaceutically allowed products
comprising the Licensed Compound as a formulated final product which fulfill all
the governmentally approved specifications and quality control criteria for use
in the Field.
1.10. "Master Agreement" shall mean the Master Agreement between
Metasyn and DRL of even date herewith.
1.11. "MGH Patent Rights" shall mean the U.S. patents and patent
applications and the international patent applications identified in Exhibit A
and any division, continuation or continuation-in-part thereof, any foreign
patent applications corresponding to any such patent applications and any U.S.
or foreign patents or the equivalent thereof issuing thereon or any reissue or
extension thereof.
1.12. "Metasyn Patent Rights" shall mean the United States and foreign
patent applications set forth in Exhibit B hereto and any division, continuation
or continuation-in-part thereof, any foreign patent applications corresponding
to any such patent applications and any U.S. or foreign patents or the
equivalent thereof issuing thereon or any reissue or extension thereof.
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1.13. "Metasyn Technology" shall mean and include all present and
future inventions, trade secrets, copyrights, know-how, data, regulatory
submissions and other intellectual property of any kind owned or controlled by,
or licensed (with the right to sublicense) to, Metasyn necessary or useful for
the manufacture, use or sale of the Licensed Compound and the Licensed Products
in the Territory.
1.14. "NDA" shall mean a new drug application filed with the governing
health authority of Japan after completion of human clinical trials to obtain
marketing approval for a Licensed Product in Japan.
1.15. "Net Sales" shall mean DRL's gross invoice sales price for the
Licensed Products sold by DRL and/or its permitted sublicensees, less discounts,
reasonable and customary quantities of samples, returns, customs charges, sales,
taxes, transportation costs and packaging expenses. The transfer of the Licensed
Products by DRL or one of its permitted sublicensees to (i) an Affiliate of DRL
or (ii) another permitted sublicensee of DRL shall not be considered a sale; in
such cases, Net Sales shall be determined based on the invoiced sales price by
the Affiliate or permitted sublicensee to its customer, less the deductions
allowed under this Section 1.14. Every other commercial use or disposition of
Licensed Products by DRL or, to the extent permitted under Article 2, by
permitted sublicensees of DRL, other than reasonable quantities of promotional
samples or bona fide sale to a bona fide customer shall be considered a sale of
the Licensed Products at the weighted average Net Sales price then being
invoiced by the seller in arm's length transactions.
DRL or its permitted sublicensees shall be deemed to have sold a
"Bundled Product" if the Licensed Products are sold by DRL or its permitted
sublicensees pursuant to an agreement with an independent customer specifying,
for a combination of products or services, (i) a single price, (ii) other terms
of purchase not separately identifying either a price per product or the
effective deductions referred to above per product or (iii) a price for units of
the Licensed Products which is discounted below DRL's or its permitted
sublicensees' standard invoice price per unit of the Licensed Products by at
least five (5) percentage points more than the amount that any other product or
service in the Bundled Product is discounted below such other product's or
service's standard invoice price. In order to calculate the Net Sales of the
Licensed Products included in a Bundled Product (a) in the case of the foregoing
clauses (i) and (ii), the total Net Sales of the Bundled Product shall be
multiplied by a fraction, the numerator of which shall be the product of the
number of units of the Licensed Products sold multiplied by the standard invoice
price per unit of the Licensed Products, and the denominator of which shall be
the sum, for all products or services included in the Bundled Product, of the
products of the number of units sold for each product or service in the Bundled
Product multiplied by the standard invoice price per unit for each such product
or service and (b) in the case of the foregoing clause (iii), the parties will
determine whether an adjustment to Net Sales is appropriate and, if so, a
mutually agreeable method of calculation.
1.16. "Patent Rights" shall mean MGH Patent Rights and Metasyn Patent
Rights, collectively.
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1.17. "Program" shall mean the collaboration between Metasyn and DRL
during the Development Phase.
1.18. "Stock Purchase Agreement" shall mean the Stock Purchase
agreement to be entered into between Metasyn and DRL on or before May 31, 1996
pursuant to the terms of the Master Agreement.
1.19. "Territory" shall mean Japan.
1.20. "Third Party" shall mean any entity other than Metasyn or DRL
and their respective Affiliates.
1.21. "Valid Claim" shall mean either (a) a claim of an issued and
unexpired patent which has not been held permanently revoked, unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise or (b) a claim of a pending patent application which
claim was filed in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or refiling of said application.
ARTICLE 2. LICENSE GRANTS; MANUFACTURING AND MARKETING RIGHTS
2.1. Grant of License Rights by Metasyn to DRL.
2.1.1. Grant for Licensed Compound. Metasyn hereby grants to
DRL the exclusive right and license under the Patent Rights and Metasyn
Technology to (a) use the Licensed Compound in the Territory for use in the
Field, (b) use, manufacture, have manufactured, distribute for sale and sell the
Licensed Products in the Territory for use in the Field and (c) provide the
Licensed Compound to permitted sublicensees for the purpose of permitting such
sublicensees to manufacture or have manufactured Licensed Products in the
Territory for use in the Field. The foregoing notwithstanding, Metasyn reserves
the exclusive right to manufacture the Licensed Compound and its corresponding
Licensed Products subject to Section 2.2 below.
2.1.2. Sublicenses. DRL shall have the right to grant
sublicenses under the Patent Rights and the Metasyn Technology to Affiliates of
DRL and, with the prior written consent of Metasyn which shall not be
unreasonably withheld, to Third Parties.
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2.1.3. Reserved Rights of MGH and the U.S. Government. DRL
acknowledges that the license granted herein to the Patent Rights is dependent
upon the rights and licenses obtained by Metasyn under the MGH License and are
subject to certain rights reserved to MGH and the United States Government in
the MGH License. In the event that the MGH License is terminated due to
Metasyn's failure to comply with the due diligence obligations imposed on
Metasyn pursuant to Paragraph 3.1(b) of the MGH License, such failure shall
constitute a material breach by Metasyn and DRL may terminate this Agreement in
accordance with Section 9.2.1 hereof.
2.2. Manufacturing and Supply of Licensed Compounds and Licensed
Products.
2.2.1. Manufacture and Supply by Metasyn during the
Development Phase. Unless otherwise agreed between the parties pursuant to
Section 2.2.3, Metasyn shall manufacture and supply the Licensed Compound and
its corresponding Licensed Products to DRL in quantities sufficient to conduct
any preclinical and clinical development of the Licensed Compound and its
corresponding Licensed Products during the Development Phase. Metasyn shall be
responsible for (i) manufacturing the Licensed Compound and its corresponding
Licensed Product at the required quality and in quantities sufficient for
preclinical and clinical development of the Licensed Compound and its
corresponding Licensed Products during the Development Phase, (ii) providing
documentation to DRL regarding the manufacture of the Licensed Compound and its
corresponding Licensed Products which is needed to register the Licensed
Products in the Territory and (iii) arranging for pre-approval inspections which
may be required by the Japanese regulatory authorities. DRL shall pay Metasyn an
amount equal to Metasyn's Direct Cost (hereinafter defined) for any Licensed
Compound or Licensed Product supplied by Metasyn to DRL. For purposes of this
Section 2.2.1, "Direct Cost" shall mean (i) Metasyn's cost of materials,
including costs payable by Metasyn to third parties relating to production of
the Licensed Compound and/or Licensed Product, and (ii) Metasyn's direct labor
costs incurred in the manufacture of the Licensed Compound and/or Licensed
Product supplied by Metasyn. DRL shall periodically submit to Metasyn orders for
the quantities of the Licensed Compound and its corresponding Licensed Product
needed by DRL during the Development Phase. Each purchase order shall specify
the quantities of Licensed Compound and/or Licensed Product ordered and the date
by which delivery is reasonably requested. DRL shall pay fifty percent (50%) of
the estimated Direct Cost for the order upon submission of each purchase order
and shall pay the balance upon receipt of the vials of Licensed Compound and/or
Licensed Product. Upon DRL's request from time to time, Metasyn shall furnish to
DRL reasonable supporting data for Metasyn's calculation of the Direct Cost for
any Licensed Compound or Licensed Product.
2.2.2. Manufacture and Supply by Metasyn After DRL's Launch of
the Licensed Products. Unless otherwise agreed between the parties pursuant to
Section 2.2.3, Metasyn shall manufacture and supply the Licensed Compound and
its corresponding Licensed Products to DRL in quantities sufficient to meet the
demand for the Licensed Products in the Territory after the launch of the
commercial sale of the Licensed Products in the Territory. Metasyn shall be
responsible for (i) manufacturing the Licensed Compound and its corresponding
Licensed Product at the required quality and in quantities sufficient for
commercial sale in the Territory, (ii) providing documentation to DRL regarding
the
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manufacture of the Licensed Compound and its corresponding Licensed Products
which is needed for DRL to sell the Licensed Products under the relevant
governmental approval in the Territory and (iii) arranging for routine
establishment inspections. Metasyn shall supply the Licensed Compound and its
corresponding Licensed Products to DRL pursuant to the terms and conditions of a
supply agreement to be negotiated by the parties in good faith not later than
[ ]* from the date of DRL's filing of an IND with the government in the
Territory or such longer period as may be mutually agreed upon by the parties.
2.2.3. Manufacture by DRL. During the Development Phase and
thereafter, DRL may elect, as stated below, to manufacture Licensed Products in
the Territory by itself or by a designated third party manufacturer under the
Patent Rights and Metasyn Technology by formulating Licensed Compound purchased
from Metasyn into a final product. In the event that DRL designates any such
third party manufacturer, it shall enter into a reasonable confidentiality
agreement with such manufacturer approved by Metasyn in writing, such approval
not to be unreasonably withheld. If DRL determines that it or its designated
third party manufacturer wishes to elect to manufacture the Licensed Products in
the Territory, DRL shall deliver prior written notice to Metasyn at least one
hundred and eighty (180) days before DRL or such third party commences
manufacturing the Licensed Products or such shorter period as may be mutually
agreed by Metasyn and DRL. Such notice shall specify the date upon which DRL or
its third party manufacturer will commence manufacture of the Licensed Products
(the "DRL Commencement Date"). Prior to the DRL Commencement Date, the parties
shall discuss and agree upon in good faith appropriate amendments to the supply
agreement set forth in Section 2.2.1 and/or the supply agreement entered into
pursuant to Section 2.2.2 hereof or the negotiation of a new supply agreement to
replace the said existing agreements. If by the DRL Commencement Date the
parties are unable to reach agreement on such amendments or said new supply
agreement, the DRL Commencement Date shall be postponed and the matter will be
submitted to arbitration pursuant to Section 10.6 hereof. DRL may, in its
discretion, designate Metasyn as an alternative and/or parallel supplier of the
Licensed Products after the DRL Commencement Date, subject to Metasyn's consent.
In the event that Metasyn consents to serve as an alternate and/or parallel
supplier, the parties will negotiate in good faith a supply agreement for such
services.
Metasyn shall continue to be responsible for the manufacture of the
Licensed Compound and its Licensed Products pursuant to Sections 2.2.1 and 2.2.2
until the DRL Commencement Date and will continue to be responsible for the
manufacture of the Licensed Compound pursuant to said Sections thereafter. Upon
the DRL Commencement Date, DRL shall become responsible for (i) manufacturing
the Licensed Products at the required quality and in quantities, other than that
supplied by Metasyn, if any, sufficient for development and commercial sale of
the Licensed Products in the Territory, (ii) providing documentation, other than
that provided by Metasyn, regarding the manufacture of the Licensed Products
needed to register the Licensed Products in the Territory and to sell the
Licensed Products under the relevant governmental approval in the Territory and
(iii) arranging for pre-approval and/or routine establishment inspections with
respect to the Licensed Products made by DRL. After the DRL Commencement date,
the royalty rate set forth in Section 4.3.1 shall be increased pursuant to
Section 4.3.1 on Net Sales of the Licensed Compound and its corresponding
Licensed Products manufactured by DRL or its third party manufacturer.
*Confidential information omitted and filed with the Commission
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Notwithstanding the provisions of this Section 2.2.3, both parties shall
negotiate in good faith in case either party desires to have the other party
manufacture a part of its requirement of the corresponding Licensed Products.
2.2.4. Assistance by Metasyn to DRL for Manufacturing License.
After DRL delivers notice to Metasyn as provided in Section 2.2.3, upon request
by DRL, Metasyn shall disclose to DRL, free of charge, all information related
to the manufacture of the Licensed Products, and Metasyn will cooperate with DRL
to provide such technical assistance and characterization work as may be
necessary in connection with the manufacture and production of the Licensed
Products in the Territory. Such assistance shall be without charge, except that
DRL will reimburse any Metasyn personnel for their out-of-pocket costs if
required to travel away from Metasyn's premises. Metasyn will provide such
assistance to DRL as is consistent with the capacity and capabilities of
Metasyn.
2.3. Marketing and Distribution Rights and Obligations. DRL shall have
the exclusive right to market and distribute the Licensed Products in the
Territory. Upon receipt of approval for commercial sale of the Licensed Products
in the Territory, DRL agrees, at its own expense, to use diligent efforts to
market the Licensed Products in the Territory consistent with those used for
other DRL products with similar commercial potential.
2.4. No Other Technology Rights. Except as otherwise expressly provided
in this Agreement, under no circumstances shall a party hereto, as a result of
this Agreement, obtain any ownership interest in or other right to any
technology, know-how, patents, pending patent applications, products or
biological materials of the other party, including items owned, controlled or
developed by the other party, or transferred by the other party to said party,
at any time pursuant to this Agreement.
ARTICLE 3. EFFORTS DURING DEVELOPMENT PHASE; MANAGEMENT
3.1. Obligations of the Parties.
3.1.1. Diligent Efforts of Metasyn. During the Development
Phase and thereafter, Metasyn agrees, at its own expense, to use diligent
efforts to perform research, preclinical development and clinical development
with the Licensed Compound and its corresponding Licensed Products outside the
Territory and provide DRL with the plan and results of such activity in a timely
manner. Metasyn further agrees that, during the Development Phase, it will, at
its own expense, furnish current available information and make available
Metasyn's scientists and other employees and members of its scientific advisory
board, all in order to provide reasonable assistance to DRL with respect to such
modification of instruments for magnetic resonance imaging for cardiac
applications (arteriography and perfusion) as may be necessary or appropriate
for the completion of clinical trials of the Licensed Product in the Territory;
provided, however, that if Metasyn's employees or advisors are required to
travel to Japan, DRL shall be responsible for any and all travel and lodging
costs incurred by Metasyn and its employees or advisors in the course of
performing Metasyn's obligations hereunder; provided further that all out of
pocket costs for equipment, devices and materials shall be borne directly by
DRL.
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3.1.2. Diligent Efforts of DRL. During the Development Phase
and thereafter, DRL agrees, at its own expense, to use diligent efforts (with
the assistance of Metasyn as provided in Section 3.1.1 above) to perform
research, preclinical development and clinical development with the Licensed
Compound and its corresponding Licensed Products in the Territory. DRL shall
have sole responsibility for filing and obtaining health registrations for the
Licensed Products in the Territory.
3.1.3. Development Schedule. Each of the parties agree to use
its reasonable efforts to achieve its respective obligations as set forth in the
schedule for the development of the Licensed Compound and its Licensed Products
for the United States and Japan attached hereto as Exhibit C (the "Development
Schedule").
3.1.4. Extensions. If either party is unable to achieve an
objective set forth in this Section 3.1 or in the Development Schedule on time
due to circumstances beyond its control, the other party will not unreasonably
withhold consent to an extension of the time for achievement of the objective.
If either party's failure to achieve an objective on time is due to the other
party's failure to perform its obligations under this Article 3 or the
Development Schedule, the time for performance will be appropriately extended.
3.2. Attendance at Regulatory Meetings. DRL or Metasyn, as the case may
be, will provide the other party with reasonable prior notice of all meetings
between its representatives and regulatory authorities regarding marketing
approval of the Licensed Products. The recipient of such notice shall have the
right to have a representative present at all important meetings; provided,
however, that the party holding such meeting with a regulatory authority other
than the FDA may revoke this right with respect to any particular meeting if, in
its good faith reasonable judgment, the presence of any other party will be a
detriment to the success of the meeting. Each of DRL and Metasyn will furnish,
at the other's request, a representative to attend regulatory meetings of the
other regarding marketing approval of the Licensed Products.
3.3. Information Exchange, Reports. During the Development Phase and
thereafter, each party shall keep the other informed as to its progress related
to the Licensed Compound and its corresponding Licensed Products developed or
acquired by either party or its Affiliates, licensees or sublicensees, including
but not limited to any information on adverse reactions and copies of all
preclinical or clinical studies or tests performed by such party. In a timely
manner during the Development Phase and thereafter, each party shall provide the
other party with a reasonably detailed report which shall describe the reporting
party's progress with respect to its efforts under this Agreement. Each party
shall also provide the other party with reports on any competitiveness studies
that the reporting party may conduct concerning the Licensed Compound or its
corresponding Licensed Products and the results of such studies. In the event
that Metasyn grants to one or more third parties a license to develop and market
MS-325 outside the Territory, it agrees to retain the right to obtain from any
such licensees, and to provide to DRL, subject to appropriate confidentiality
undertakings from DRL, all information which Metasyn is obligated to provide DRL
under this Section 3.3. Similarly, DRL agrees to obtain from any sublicensees in
the Territory and permit Metasyn to share with any Metasyn licensees outside the
Territory all information
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which DRL is obligated to provide Metasyn under this Section 3.3 subject to
appropriate confidentiality undertakings from such licensees.
3.4. Representatives. Each party shall designate no more than three (3)
representatives to discuss and coordinate the conduct of the Program and to
facilitate the exchange of information between the parties pursuant to Section
3.3 above. A party may change one or more of its representatives at any time.
The representatives of the parties shall meet at times and places or in such
form (e.g. telephone or video conference) as the representatives shall agree.
Accurate minutes of the meetings of the representatives shall be kept which
record all proposed decisions and all actions recommended or taken, and such
minutes shall be available to both parties.
3.5. Availability of Employees. Each party agrees to make its employees
and non-employee consultants reasonably available at their respective places of
employment to consult with the other party on issues arising during the
Development Phase and in connection with any request from any regulatory agency,
including regulatory, scientific, technical and clinical testing issues.
3.6. Visit of Facilities. Representatives of Metasyn and DRL may, with
the other party's prior approval, which approval shall not be unreasonably
withheld, visit the sites of any clinical trials or other experiments being
conducted by such other party in connection with the Development Phase and,
subject to any necessary approvals of the relevant Third Party, manufacturing
sites used for the Licensed Compound and the Licensed Product. If requested by
the other party, Metasyn and DRL shall cause appropriate individuals working
thereon to be available for meetings at the location of the facilities where
such individuals are employed at times reasonably convenient to the party
responding to such request.
3.7. Training of DRL Scientists. During the Development Phase, Metasyn
will provide training of DRL scientific employees ("DRL Scientists") at
Metasyn's facility and at Metasyn's MRI or drug production sites. At appointed
times to be agreed upon by both parties, Metasyn will host the DRL Scientists
for seminars at Metasyn's facility. Upon Metasyn's request, the DRL Scientists
shall enter into appropriate confidentiality agreements with Metasyn having the
same or similar provisions as contained in such agreements between Metasyn and
its own scientific employees. At appointed times to be agreed upon by both
parties, Metasyn will request admission of DRL Scientists into hospitals,
universities or drug production sites to further train DRL Scientists. If
requested by the organization responsible for any such site, DRL Scientists
shall enter into confidentiality agreements with the organization responsible
for any such site prior to such admission in a form satisfactory to said
organization. All costs and expenses of the DRL Scientist shall be borne by DRL.
ARTICLE 4. PAYMENTS
4.1. Initial Payment. Metasyn acknowledges receipt from DRL of an
initial payment in United States dollars in the amount of $3.3 million (the
"Initial Payment") prior to the date hereof.
-9-
4.2. Milestone Payments. Upon the achievement of each of the milestones
set forth below, DRL shall make the corresponding payment stated below:
Milestone Payment
=============================================== ===============================
[ ]* [ ]* milestone payment
[ ]* [ ]* milestone payment
[ ]* [ ]* milestone payment
----------------------------------------------- -------------------------------
For purposes of this Section 4.2 and Exhibit C hereto, a clinical trial shall be
deemed to have commenced upon the enrollment of the first patient in such trial.
Within ten (10) days following the occurrence of each of the milestones
set forth above, DRL shall pay to Metasyn in United States dollars by certified
or bank check or wire transfer the corresponding milestone payment set forth
above, subject to Section 4.4. Payments made by DRL to Metasyn pursuant to this
Section 4.2 are not refundable under any circumstances and will not be credited
against royalty payments due to Metasyn pursuant to Section 4.3.
4.3. Royalties. Following the First Commercial Sale of the Licensed
Products in the Territory, DRL will pay, on a quarterly basis, a royalty in the
amounts set forth below on Net Sales of the Licensed Products during the
previous quarter.
4.3.1. Royalties on Net Sales of the Licensed Products. In
consideration of the licenses granted to DRL, DRL shall pay to Metasyn a royalty
in the amount of [ ]* of the Net Sales of the Licensed Products
sold by DRL, its Affiliates and/or sublicensees in the Territory. In the event
that DRL, its third party manufacturer or any permitted sublicensee of DRL
manufactures the Licensed Products pursuant to Section 2.2.3 hereof, the
[ ]* royalty rate shall be increased by a percentage to be agreed upon
by the parties in good faith during negotiations of the amendments to or
termination and replacement of the supply agreement pursuant to Section 2.2.3
above.
4.3.2. Adjustments for Third Party Royalties. If DRL is
required to pay royalties to Third Parties for rights under patents necessary to
sell the Licensed Products, it may deduct an amount equal to up to [ ]* of
such royalties from the royalties
* Confidential information omitted and filed with the Commission.
-10-
due Metasyn; provided that royalties due to Metasyn may not be reduced by more
than [ ]* in any given quarter.
4.3.3. [ ]* In the event that during any calendar year, [ ]*
for such year, then [ ]* provided that [ ]* in any given calendar quarter.
4.3.4. Royalty Reports, Exchange Rates. During the term of
this Agreement following the First Commercial Sale of the Licensed Products in
the Territory, DRL shall within thirty (30) days after each calendar quarter
furnish to Metasyn a written quarterly report showing: (i) the gross sales of
the Licensed Products sold by DRL, its Affiliates, and its sublicensees during
the reporting period and the calculation of Net Sales from such gross sales;
(ii) the royalty due thereon; (iii) withholding taxes, if any, required by law
to be deducted in respect of such royalties; and (iv) the exchange rates used in
determining the amount of United States dollars. All sales in currencies other
than United States dollars shall first be converted into United States dollars
calculated under the TT Spot Selling Rate employed by the head office of The
Sumitomo Bank Ltd. on the payment date. If no royalty is due for any royalty
period hereunder, DRL shall so report. DRL shall keep complete and accurate
records in sufficient detail to properly reflect all gross sales and Net Sales
and to enable the royalties payable hereunder to be determined.
4.3.5. Audits. Upon the written request of Metasyn, DRL shall
permit an internal auditor or independent public accountant selected by Metasyn
and acceptable to DRL, which acceptance shall not be unreasonably withheld or
delayed, to have access during normal business hours to such records of DRL as
may be reasonably necessary to verify the accuracy of the royalty reports
described herein, in respect of any fiscal year ending not more than [ ]* prior
to the date of such request. All such verifications shall be conducted at
Metasyn's expense and not more than once in each calendar year. In the event
such Metasyn representative concludes that additional royalties were owed to
Metasyn during such period, the additional royalty shall be paid by DRL within
thirty (30) days of the date Metasyn delivers to DRL such representative's
written report so concluding. The fees charged by such representative shall be
paid by Metasyn unless the audit discloses that the royalties payable by DRL for
the audited period are incorrect by more than [ ]*, in which case DRL shall pay
the reasonable fees and expenses charged by such representative. DRL shall
include in each Third Party sublicense granted by it pursuant to this Agreement
a provision requiring the sublicensee to make reports to DRL, to keep and
maintain records of sales made pursuant to such sublicense and to grant access
to such records by Metasyn's representatives to the same extent required of DRL
under this Agreement. Metasyn agrees that all information subject to review
under this Section 4.3.5
*Confidential information omitted and filed with the Commission.
-11-
or under any sublicense agreement is confidential and that Metasyn shall cause
its representatives to retain all such information in confidence.
4.3.6. Royalty Payment Terms. Royalties shown to have accrued
by each royalty report provided for under this Agreement shall be due thirty
(30) days after the end of each calendar quarter. Payment of royalties in whole
or in part may be made in advance of such due date. Royalties determined to be
owing with respect to any prior quarter shall be added, together with interest
thereon accruing under this Agreement from the date of the report for the
quarter for which such amounts are owing, to the next quarterly payment
hereunder.
4.4. [ ]*. A [ ]*. DRL shall [ ]*. DRL shall not [ ]* except as noted
above. DRL shall [ ]* to Metasyn. The parties will [ ]*
4.5. Interest on Late Payments. Any payments by DRL to Metasyn that are
not paid on or before the fifth day after date such payments are due under this
Agreement shall bear interest, to the extent permitted by applicable law, at two
(2) percentage points above the Prime Rate of interest declared from time to
time by The First National Bank of Boston in Boston, Massachusetts, calculated
on the number of days payment is delinquent.
ARTICLE 5. INTELLECTUAL PROPERTY
5.1. Filing, Prosecution and Maintenance of MGH Patent Rights.
5.1.1. Responsibility and Costs. Metasyn shall, in
coordination with MGH, be responsible for the preparation, filing, prosecution
and maintenance of all patent applications and patents included in MGH Patent
Rights in the Territory. All costs ("Costs") incurred by Metasyn for the
preparation, filing, prosecution and maintenance of all patents and patent
applications included in MGH Patent Rights in the Territory shall be the
responsibility of Metasyn.
5.1.2. Abandonment. If MGH notifies Metasyn of its intention
to abandon the prosecution of any patent applications under the MGH Patent
Rights or of its intention to refrain from making any payment or taking any
other action necessary to obtain or maintain a patent under the MGH Patent
Rights, Metasyn will thereafter at its expense take all action
*Confidential information omitted and filed with the Commission.
-12-
necessary or appropriate to prosecute and/or maintain such MGH Patent Rights in
the Territory.
5.1.3. Notice of Infringement. DRL shall inform Metasyn
promptly in writing of any alleged infringement of MGH Patent Rights licensed
hereunder to DRL in the Territory by a third party of which it shall have
knowledge and provide any available evidence of such infringement to Metasyn and
Metasyn, in turn shall promptly inform MGH of such alleged infringement of the
MGH Patent Rights.
5.1.4. Prosecution by MGH or Metasyn of MGH Patent Rights.
Under the MGH License, MGH has the first right to prosecute at its own expense
any infringements in the Territory of MGH Patent Rights. In the event that MGH
chooses not to prosecute such infringement of the MGH Patent Rights in the
Territory or, within six (6) months of receiving notice of such infringement, is
unsuccessful in causing the alleged infringer to desist and shall not have
brought or is not diligently enforcing an infringement action, Metasyn has the
right to bring such suit at Metasyn's expense.
5.1.5. Prosecution by DRL. In the event that Metasyn declines
to exercise its right to prosecute any infringement of the MGH Patent Rights in
the Territory pursuant to Section 5.1.4, DRL shall have the right to enforce
such MGH Patent Rights at its own cost and expense. In the case of enforcement
of the MGH Patent Rights, DRL shall have the rights granted to Metasyn under
Paragraphs 8.3 and 8.5 of the MGH License, except that DRL shall retain
Metasyn's share of any recoveries under the MGH License, subject to Section
5.1.6 below. In such event, DRL shall have the right, if Metasyn is a legally
indispensable party, to bring such suit or action in the name of Metasyn (in
addition to the right to bring the action in MGH's name). Metasyn shall have the
right to join any such suit or action brought by DRL and, in such event, shall
pay one-half of the cost of such suit or action.
5.1.6. [ ]*. In the event that DRL shall undertake the
enforcement of the MGH Patent Rights in the Territory by litigation, DRL
may [ ]*, provided that it applies the same toward reimbursement of any expenses
it has incurred in connection with such suit or action, including reasonable
attorneys fees, in accordance with the following procedures: (i) DRL may not
prospectively [ ]*, but must actually incur an expense before [ ]*; and (ii) any
expenses incurred by DRL may [ ]* in which the expenses were incurred.
Provided that Metasyn has joined in the action and shared the costs
thereof as stated in Section 5.1.5 above, no settlement, consent judgment or
other voluntary final disposition of the suit may be entered into without the
consent of Metasyn, which consent shall not unreasonably be withheld. Any
recovery or damages derived from such action shall first be used to reimburse
DRL for all legal expenses relating to the suit in excess of the amount of
withheld royalties and thereafter to be used to reimburse Metasyn for all of its
legal expenses relating to the suit if it has joined the suit or action. Any
recovery or damages still remaining shall thereafter be distributed (a) to pay
DRL its lost profits attributable to the
*Confidential information omitted and filed with the Commission.
-13-
infringement, or a reasonable royalty on the sales of the infringer, whichever
standard the court may have applied, and (b) to reimburse Metasyn for the amount
of royalties not received by Metasyn as a result of such infringement. Any
remaining recovery or damages shall be divided among the parties in proportion
to their contributions to the action.
5.1.7. Declaratory Actions. In the event that a declaratory
judgment action alleging invalidity or non-infringement of any of the MGH Patent
Rights in the Territory shall be brought against DRL, DRL shall notify Metasyn
and MGH in writing, and the parties shall consult concerning the action to be
taken. MGH, at its option, shall have the right within thirty (30) days after
commencement of such action to intervene and take over the sole defense of the
action at its expense. If MGH does not exercise the said option, Metasyn, at its
sole option, shall have the right, within sixty (60) days after commencement of
such action, to intervene, take over and duly prosecute the sole defense of the
action at its own expense. DRL shall have no obligation to defend any such
action, but DRL shall have the right to join in the defense of any such suit or
action by Metasyn, and in such event, shall pay [ ]* of the cost of such suit or
action. In such event, Metasyn will confer with DRL prior to making any decision
regarding settlement or other significant decisions regarding the suit or action
and no such decision will be made without DRL's consent, which consent will not
be unreasonably withheld or delayed.
If DRL has joined in the defense of such action, then DRL may [ ]*
provided that it applies the same toward reimbursement of any expenses it
has incurred in connection with such action, including reasonable attorneys
fees, in accordance with the following procedures: (i) DRL may not prospectively
[ ]*, but must actually incur an expense [ ]* and (ii) any expenses incurred by
DRL may [ ]* in which the expenses were incurred.
5.2. Filing, Prosecution and Maintenance of Metasyn Patent Rights.
5.2.1. Prosecution and Maintenance. Metasyn shall be
responsible for maintenance of the Metasyn Patent Rights in the Territory at its
expense in its own name, keeping DRL informed. If Metasyn elects not to continue
to seek or maintain patent protection on any patent or patent application
included in the Metasyn Patent Rights in the Territory, DRL shall have the
right, at its option and expense, but in the name of Metasyn to prepare, file,
prosecute (including oppositions) and maintain such patent applications and
patents; provided, however, that the rights of the parties with respect to any
such Metasyn Patent Rights in all other respects shall be as described in this
Agreement. Metasyn will advise DRL of all decisions taken with respect to any
such election in a timely manner in order to allow DRL to protect its rights
under this Section 5.2.1. DRL may offset all expenses incurred by DRL under this
Section 5.2.1 against royalty payments in accordance with the procedure set
forth in the second paragraph of Section 5.2.5 below.
5.2.2. Abandonment; Failure to Pay. Metasyn agrees that it
will not abandon the prosecution of any patent applications included within the
Metasyn Patent Rights nor shall it fail to make any payment or fail to take any
other action necessary to maintain a patent
*Confidential information omitted and filed with the Commission.
-14-
under the Metasyn Patent Rights unless it has notified DRL in sufficient time
for DRL to assume such prosecution or make such payment.
5.2.3. Cooperation. Each party shall make available to the
other party (or to the other party's authorized attorneys, agents or
representatives), its employees, agents or consultants to the extent reasonably
necessary or appropriate to enable the appropriate party to file, prosecute and
maintain patent applications and resulting patents as set forth in this Section
5.2 for periods of time reasonably sufficient for such party to obtain the
assistance it needs from such personnel. Where appropriate, each party shall
sign or cause to have signed all documents relating to said patent applications
or patents at no charge to the other party.
5.2.4. Infringement by Others; Prosecution by Metasyn. Metasyn
and DRL shall each promptly notify the other in writing of any alleged or
threatened infringement of patents or patent applications included in the
Metasyn Patent Rights licensed hereunder to DRL of which they become aware, and
the parties shall consult concerning the action to be taken. Metasyn shall have
the right, but not the obligation, to prosecute at its own expense any such
infringement. Any recovery or damages derived from such action shall be retained
by Metasyn.
5.2.5. Infringement by Others; Prosecution by DRL. If, within
six (6) months after Metasyn first becomes aware of any infringement of the
Metasyn Patent Rights, Metasyn declines to prosecute such infringement or fails
to cause such infringement to terminate or to bring diligently prosecute or a
suit or action to compel termination, DRL shall have the right, but not the
obligation, to bring such suit or action to compel termination at the sole
expense of DRL. In such event, DRL shall have the right, if Metasyn is a legally
indispensable party, to bring such suit or action in the name of Metasyn.
Metasyn shall have the right to join any such suit or action brought by DRL and,
in such event, shall pay [ ]* of the cost of such suit or action.
In the event DRL brings any such suit or action, DRL may [ ]* provided
that it applies the same toward reimbursement of any expenses it has incurred in
connection with such suit or action, including reasonable attorneys fees, in
accordance with the following procedures: (i) DRL may not prospectively [ ]* but
must actually incur an expense [ ]* and (ii) any expenses incurred by DRL may
[ ]* in which the expenses were incurred.
Provided that Metasyn has joined in the action and shared the costs
thereof as stated above, no settlement, consent judgment or other voluntary
final disposition of the suit may be entered into without the consent of
Metasyn, which consent shall not unreasonably be withheld. Any recovery or
damages derived from such action shall first be used to reimburse DRL for all
legal expenses relating to the suit in excess of the amount of withheld
royalties and thereafter to be used to reimburse Metasyn for all of its legal
expenses relating to the suit if it has joined the suit or action. Any recovery
or damages still remaining shall thereafter be distributed (a) to pay DRL its
lost profits attributable to the infringement, or a reasonable royalty on the
sales of the infringer, whichever standard the court may have
*Confidential information omitted and filed with the Commission.
-15-
applied, and (b) to reimburse Metasyn for the amount of royalties not received
by Metasyn as a result of such infringement. Any remaining recovery or damages
shall be divided among the parties in proportion to their contributions to the
action.
5.2.6. Cooperation in Infringement Actions. In any
infringement suit as either party may institute to enforce the Metasyn Patent
Rights pursuant to this Agreement, the other party hereto shall, at the request
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 and the like. DRL's cooperation in any
suit initiated by Metasyn shall be at Metasyn's expense. Metasyn's cooperation
in any suit initiated by DRL shall be at DRL's expense.
5.2.7. Declaratory Actions. In the event that a declaratory
judgment action alleging invalidity or non-infringement of any of the Metasyn
Patent Rights in the Territory shall be brought against DRL, DRL shall notify
Metasyn in writing, and the parties shall consult concerning the action to be
taken. Metasyn, at its sole option, shall have the right, within thirty (30)
days after commencement of such action, to intervene, take over and duly
prosecute the sole defense of the action at its own expense. DRL shall have no
obligation to defend any such action, but DRL shall have the right to join in
the defense of any such suit or action, and in such event, shall pay [ ]* of
the cost of such suit or action. In such event, Metasyn will confer with DRL
prior to making any decision regarding settlement or other significant decisions
regarding the suit or action and no such decision will be made without DRL's
consent, which consent will not be unreasonably withheld or delayed.
If DRL has joined in the defense of such action, then DRL may
[ ]* provided that it applies the same toward reimbursement of any expenses it
has incurred in connection with such action, including reasonable attorneys
fees, in accordance with the following procedures: (i) DRL may not prospectively
[ ]*, but must actually incur an expense [ ]* and (ii) any expenses incurred by
DRL may [ ]* in which the expenses were incurred.
5.3. Infringement Action Against DRL. In the event that a suit or
action is brought against DRL alleging infringement of any third-party patent
right as a result of the exercise of DRL's rights under Section 2.1, DRL shall
have the exclusive right to defend such suit or action at its sole expense.
Metasyn will confer with and assist DRL, at Metasyn's expense, in the conduct or
settlement of such defense. Metasyn shall have the right to be represented in
such suit or action by advisory counsel at its expense. DRL shall not have the
right to settle any such suit or action without the prior written consent of
Metasyn if as a result of such settlement Metasyn would be obligated to make any
payment, assume any obligation, part with any property or interest therein, be
subject to any injunction or order, grant any license or other right under the
Patent Rights, or acknowledge the invalidity of any of the Patent Rights.
If DRL undertakes the defense of or incurs expenses as a defendant in
such action, then DRL may [ ]*,
*Confidential information omitted and filed with the Commission.
-16-
provided that it applies the same toward reimbursement of any expenses it has
incurred in connection with such action, including the amount of any judgment or
settlement and reasonable attorneys fees, in accordance with the following
procedures: (i) DRL may not prospectively [ ]*, but must actually incur an
expense [ ]*; (ii) any expenses incurred by DRL, other than a judgment or
settlement, may [ ]* in which the expenses were incurred; and (iii) in the event
that DRL must pay any judgment or settlement, the amount of such judgment or
settlement [ ]* until DRL is fully reimbursed.
Any recovery or damages obtained by DRL in relation to any counterclaim
or the like filed by DRL in such suit shall be applied first in satisfaction of
any expenses and legal fees of DRL relating to the suit in excess of the amount
of any withheld royalties. Any recovery or damages remaining shall be applied
toward reimbursement of Metasyn for the amount of any royalties withheld. Any
recovery or damages still remaining shall be retained by DRL.
5.4. Cooperation in Infringement Actions. In any infringement suit
either party may institute to enforce or defend the Patent Rights or in which
either party defend claims of infringement of third-party patents pursuant to
this Agreement, the other party hereto shall, at the request of the party
initiating or defending such suit, cooperate at its expense in all respects and,
to the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples and the like.
ARTICLE 6. CONFIDENTIALITY
6.1. Nondisclosure Obligations.
6.1.1. General. Except as otherwise provided in this Article
6, during the term of this Agreement and for a period of ten (10) years
thereafter, both parties shall maintain in confidence and use only for purposes
specifically authorized under this Agreement (i) information and data received
from the other party resulting from or related to the development of the
Licensed Compound and the Licensed Products and (ii) all information and data
not described in clause (i) but supplied by the other party under this Agreement
marked "Confidential." For purposes of this Article 6, information and data
described in clause (i) or (ii) shall be referred to as "Information."
6.1.2. Limitations. To the extent it is reasonably necessary
or appropriate to fulfil its obligations or exercise its rights under this
Agreement, a party may disclose Information it is otherwise obligated under this
Section 6.1 not to disclose to its Affiliates, sublicensees, consultants,
outside contractors and clinical investigators, on a need-to-know basis on
condition that such entities or persons agree to keep the Information
confidential for the same time periods and to the same extent as such party is
required to keep the Information confidential; and a party or its sublicensees
may disclose such Information to government or other regulatory authorities to
the extent that such disclosure is reasonably necessary to obtain patents or
authorizations to conduct clinical trials of, and to commercially
*Confidential information omitted and filed with the Commission.
-17-
market, the Licensed Compound and its corresponding Licensed Products. The
obligation not to disclose Information shall not apply to any part of such
Information that: (i) is or becomes part of the public domain other than by
unauthorized acts of the party obligated not to disclose such Information or its
Affiliates or sublicensees; (ii) can be shown by written documents to have been
disclosed to the receiving party or its Affiliates or sublicensees by a Third
Party, provided such Information was not obtained by such Third Party directly
or indirectly from the other party under this Agreement pursuant to a
confidentiality agreement; (iii) prior to disclosure under this Agreement, was
already in the possession of the receiving party or its Affiliates or
sublicensees, provided such Information was not obtained directly or indirectly
from the other party under this Agreement pursuant to a confidentiality
agreement; (iv) can be shown by written documents to have been independently
developed by the receiving party or its Affiliates without breach of any of the
provisions of this Agreement; or (v) is disclosed by the receiving party
pursuant to interrogatories, requests for information or documents, subpoena,
civil investigative demand issued by a court or governmental agency or as
otherwise required by law, provided that the receiving party notifies the other
party immediately upon receipt thereof and provided further that the disclosing
party furnishes only that portion of the Information which it is advised by
counsel is legally required.
6.2. Samples. Samples of the Licensed Compound and/or the Licensed
Compound provided by Metasyn to DRL in the course of the Program shall not be
supplied or sent by DRL to any Third Party, other than to regulatory agencies,
except pursuant to a written materials transfer and/or confidentiality agreement
approved by Metasyn.
6.3. Terms of this Agreement. Except as provided in Section 10.7
hereof, Metasyn and DRL each agree not to disclose any terms or conditions of
this Agreement to any Third Party without the prior consent of the other party,
except as required by applicable law. If Metasyn determines that it is required
to file with the Securities and Exchange Commission or other governmental agency
this Agreement for any reason, Metasyn shall request confidential treatment of
such portions of this Agreement as it and DRL shall together determine.
Notwithstanding the foregoing, prior to execution of this Agreement, Metasyn and
DRL shall agree upon the substance of information that can be used as a routine
reference in the usual course of business to describe the terms of this
transaction, and Metasyn and DRL may disclose such information, as modified by
mutual agreement from time to time, without the other party's consent.
6.4. Publications.
6.4.1. Procedure. Each party recognizes the mutual interest in
obtaining patent protection for inventions which arise under this Agreement. In
the event that, either party, its employees or consultants or any other Third
Party under contract to such party wishes to make a publication (including any
oral disclosure made without obligation of confidentiality) relating to work
performed under this Agreement (the "Publishing Party"), such party shall
transmit to the other party (the "Reviewing Party") a copy of the proposed
written publication at least forty-five (45) days prior to submission for
publication, or an abstract of such oral disclosure at least thirty (30) days
prior to submission of the abstract or the oral disclosure, whichever is
earlier. The Reviewing Party shall have the right (a) to propose modifications
to the publication for patent reasons, (b) to request a delay in
-18-
publication or presentation in order to protect patentable information, or (c)
to request that the information be maintained as a trade secret and, in such
case, the Publishing Party shall not make such publication; provided, however,
that the Publishing Party need only provide the other party with a copy of a
proposed press release within ten (10) days prior to submission for publication
or such other period as the parties may mutually agree.
6.4.2. Delay. If the Reviewing Party requests a delay as
described in Section 6.4.1(b), the Publishing Party shall delay submission or
presentation of the publication for a period of ninety (90) days to enable
patent applications protecting each party's rights in such information to be
filed.
6.4.3. Resolution. Upon the receipt of written approval of the
Reviewing Party, the Publishing Party may proceed with the written publication
or the oral presentation.
6.5. Injunctive Relief. The parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any of the
provisions of this Article 6 by either party or their employees, agents,
officers or directors or any other person acting in concert with it or on its
behalf. Accordingly, each party shall be entitled to the granting of injunctive
relief by a court of competent jurisdiction against any action that constitutes
any such breach of this Article 6.
ARTICLE 7. REPRESENTATIONS AND WARRANTIES
7.1. Patent Validity. Nothing in this Agreement shall be construed as a
warranty or representation by Metasyn as to the validity or scope of any Metasyn
Technology or Patent Rights or that the exercise of the Patent Rights will not
infringe upon the rights of any Third Party.
7.2. Accuracy of Exhibits A and B. Metasyn represents and warrants that
Exhibits A and B list all Patent Rights which are relevant to the manufacture,
use and sale of the Licensed Compound and its corresponding Licensed Products in
the Territory as of the Effective Date.
ARTICLE 8. INDEMNITY
8.1. DRL Indemnity Obligations. Subject to the provisions of Section
8.2, DRL agrees to defend, indemnify and hold Metasyn, its Affiliates and their
respective directors, officers, employees and agents harmless from all costs,
judgments, liabilities and damages assessed by a court of competent jurisdiction
arising from claims asserted by a third party against Metasyn, its Affiliates or
their respective directors, employees or agents as a result of: (a) actual or
asserted violations of any applicable law or regulation by DRL, its Affiliates
or sublicensees by virtue of which the Licensed Products manufactured,
distributed or sold shall be alleged or determined to be adulterated,
misbranded, mislabeled or otherwise not in compliance with such applicable law
or regulation; (b) claims for bodily injury, death or property damage
attributable to the manufacture, distribution, sale or use of the Licensed
-19-
Products by DRL, its Affiliates or sublicensees; or (c) a recall ordered by a
governmental agency, or required by a confirmed failure, of Licensed Products
manufactured, distributed, or sold by DRL, its affiliates or sublicensees as
reasonably determined by the parties hereto.
8.2. Metasyn Indemnity Obligations. Metasyn, its Affiliates and their
respective directors, officers, employees and agents shall not be entitled to
the indemnities set forth in Section 8.1 where the claim, loss, damage or
expense for which indemnification is sought was either caused by (a) a defect in
manufacturing of Licensed Products manufactured by Metasyn or its Affiliates or
(b) a negligent or willful act or omission by Metasyn, its Affiliates, and their
respective directors, officers, employees or authorized agents and, in either
such case, Metasyn shall indemnify DRL, its Affiliates and their respective
directors, officers, employees and agents harmless from all costs, judgments,
liabilities and damages assessed by a court of competent jurisdiction arising
from claims asserted by a third party.
8.3. Procedure. A party or any of its Affiliates or their respective
employees or agents (the "Indemnitee") that intends to claim indemnification
under this Article 8 shall promptly notify the other party (the "Indemnitor") of
any loss, claim, damage, liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor shall assume the
defense thereof with counsel mutually satisfactory to the parties; provided,
however, that an Indemnitee shall have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate due
to actual or potential differing interests between such Indemnitee and any other
party represented by such counsel in such proceedings. The indemnity agreement
in this Article 8 shall not apply to amounts paid in settlement of any loss,
claim, damage, liability or action if such settlement is effected without the
consent of the Indemnitor, which consent shall not be withheld unreasonably. The
failure to deliver notice to the Indemnitor within a reasonable time after the
commencement of any such action, if prejudicial to its ability to defend such
action, shall relieve such Indemnitor of any liability to the Indemnitee under
this Article 8, but the omission so to deliver notice to the Indemnitor will not
relieve it of any liability that it may have to any Indemnitee otherwise than
under this Article 8. The Indemnitee under this Article 8, its employees and
agents, shall cooperate fully with the Indemnitor and its legal representatives
in the investigation of any action, claim or liability covered by this
indemnification. In the event that each party claims indemnity from the other
and one party is finally held liable to indemnify the other, the Indemnitor
shall additionally be liable to pay the reasonable legal costs and attorneys'
fees incurred by the Indemnitee in establishing its claim for indemnity.
8.4. Insurance. DRL and Metasyn shall each maintain appropriate product
liability insurance with respect to development, manufacture and sales of the
Licensed Products by DRL or Metasyn, respectively, in such amount as DRL or
Metasyn, respectively, customarily maintains with respect to sales of its other
products. DRL and Metasyn, as applicable, shall each maintain such insurance for
so long as it continues to manufacture or sell the Licensed Products, and
thereafter for so long as DRL or Metasyn, as applicable, maintains insurance for
itself covering such manufacture or sales.
-20-
ARTICLE 9. EXPIRATION AND TERMINATION
9.1. Expiration. Unless this Agreement is sooner terminated in
accordance with the provisions of this Article 9 hereof, the term of DRL's
obligation of royalty payments pursuant to Section 4.3 hereof shall cease upon
earlier of (i) fifteen (15) years after the First Commercial Sale of the
Licensed Products in the Territory or (ii) abandonment, invalidity or rejection
with no possibility of appeal or expiration of all claims of the Patent Rights
listed in Exhibits A and B.
DRL shall have an irrevocable paid-up license thereafter.
9.2. Termination.
9.2.1. Termination by Either Party. This Agreement may be
terminated by either party (i) by reason of a material breach (other than as
provided in clause (ii) hereof and Section 9.2.2 below) if the breaching party
fails to remedy such breach within ninety (90) days after written notice thereof
by the non-breaching party, (ii) if the other party fails to meet one of its
assigned product objectives listed in Exhibit C hereto within the specified
period of time for such objective (including any extensions granted pursuant to
Section 3.1.4 hereof) or (iii) upon bankruptcy, insolvency, dissolution or
winding up of the other party.
9.2.2. Termination by Metasyn. This Agreement may be
terminated by Metasyn if (i) DRL fails to make any expense or royalty payment
within ten (10) business days after such payment becomes payable and such
failure is not remedied within thirty (30) days after notice thereof from
Metasyn or (ii) if DRL fails to obtain final marketing approval for the Licensed
Products in the Territory by November 1, 2001 (provided that Metasyn will not
unreasonably withhold its consent to a reasonable extension of such date if DRL
can demonstrate that failure to meet such objective is the result of
circumstances beyond DRL's control or is the result of Metasyn's failure to
perform its obligations hereunder). The ability of DRL to cure a breach pursuant
to clause (i) hereof will apply only if the number of breaches properly noticed
under the terms of this Agreement does not exceed three (3) breaches by DRL
within any three (3) calendar year period. Any subsequent breach within that
three (3) calendar year period which commenced with the first of the three (3)
prior breaches by DRL will entitle Metasyn to terminate this Agreement upon
proper notice.
9.2.3. Termination by DRL. This Agreement may be terminated by
DRL upon thirty (30) days prior written notice to Metasyn if DRL determines in
its reasonable opinion that the Licensed Products lack clinical efficacy,
present injurious side effects or otherwise exhibit unacceptable properties.
9.2.4. Automatic Termination. In the event that the parties do
not enter into the Stock Purchase Agreement by May 31, 1996 or such later date
as the parties may mutually agree in writing (the "Expiration Date"), then this
Agreement shall automatically be terminated as of the end of the day on the
Expiration Date, unless:
(a) the reasons for not entering into the Stock Purchase Agreement are
due to Metasyn's failure to negotiate in good faith, in which case, in lieu of
termination of this Agreement and the remedies set forth in Section 9.3.3(b)
below, DRL may remit to Metasyn on or before the Expiration Date as an
additional license fee the amount of [ ]* in
*Confidential information omitted and filed with the Commission.
-21-
United States dollars by certified check or wire transfer (which fee will not be
refundable under any circumstances), which fee will be creditable against
royalty payments due to Metasyn pursuant to Section 4.3 hereof; provided that
royalties due to Metasyn may not be reduced by more than [ ]* in any given
quarter; or
(b) (i) the reasons for not entering into the Stock Purchase Agreement
are other than those described in clauses (a) or (b) of Section 9.3.3; and (ii)
on or before the Expiration Date, DRL remits to Metasyn as an additional license
fee the amount of [ ]* in United States dollars by certified check or wire
transfer (which fee will not be refundable under any circumstances and will not
be credited against any royalty payments due to Metasyn pursuant to Section 4.3
hereof), the net amount of which fee shall be creditable against the amounts due
under the Stock Purchase Agreement if, and only if, Metasyn and DRL enter into
the Stock Purchase Agreement on or before July 31, 1996; provided, however, that
if the sole reason for not entering into the Stock Purchase Agreement is due to
Metasyn's inability to issue shares to DRL pursuant to the Stock Purchase
Agreement as a result of either (x) a court of competent jurisdiction having
enjoined Metasyn from issuing such shares or (y) such issuance being prohibited
by any statute, rule or regulation applicable to the parties and the proposed
transaction or any order of any governmental agency or body having jurisdiction
over the parties, then the net amount of such additional license fee may be
creditable against amounts due under the Stock Purchase Agreement if, and only
if, Metasyn and DRL enter into the Stock Purchase Agreement on or before May 31,
1997.
9.3. Effect of Expiration or Termination.
9.3.1. Manufacturing Approval and Technology. In the event
this Agreement is terminated, except by DRL pursuant to Section 9.2.1 above, a)
if DRL has obtained manufacturing approval in the Territory, then DRL shall
promptly assign and transfer such manufacturing approval to Metasyn so as to
enable Metasyn to manufacture and sell the Licensed Products in the Territory,
and b) DRL will grant Metasyn licenses on reasonable and customary terms to be
negotiated in good faith by the parties for any technology or know-how developed
by DRL or its third party manufacturer relating to the manufacture of the
Licensed Products.
9.3.2. Termination due to Termination of MGH License. In the
event this Agreement is terminated by DRL in accordance with Section 9.2.1
hereof as a result of the termination of the MGH License, Metasyn shall grant a
royalty-free license to the rights stipulated in Section 2.1, excluding rights
involving MGH Patent Rights and DRL shall have the rights provided under
Paragraph 10.7 of the MGH License to cause the licenses to the MGH Patent Rights
granted to it hereunder to remain in full force and effect.
9.3.3. Termination Due to Section 9.2.4. In the event that
this Agreement is terminated pursuant to Section 9.2.4 above, then:
(a) In the event that the Stock Purchase Agreement is
not executed by the parties by the Expiration Date due to DRL's failure to
negotiate in good faith, then the entire Initial Payment shall be
non-refundable.
*Confidential information omitted and filed with the Commission.
-22-
(b) In the event that the Stock Purchase Agreement is not
executed by the parties by the Expiration Date due to Metasyn's failure to
negotiate in good faith, then Metasyn shall deliver to DRL a promissory note on
the Expiration Date for the principal amount of three million three hundred
thousand dollars ($3,300,000.00) (the "Refund Note"). The Refund Note shall bear
interest at a rate of ten percent (10%) per annum. The principal amount of the
Refund Note shall be repaid in two (2) payments of one million six hundred fifty
thousand dollars ($1,650,000.00) each, payable on the first and second
anniversaries of the Expiration Date. All unpaid principal together with all
accrued interest due under the Refund Note shall be due and payable in full on
the second anniversary of the Expiration Date. The Refund Note shall include
customary event of default provisions. In the event that Metasyn fails to pay
the Refund Note on any installment date or on maturity, DRL shall have available
to it all remedies at law or in equity.
(c) In the event that the Stock Purchase Agreement is not
executed by the parties by the Expiration Date for reasons other than those
described in clauses (a) and (b) above, then on the day after the Expiration
Date, Metasyn shall deliver to DRL a promissory note for the principal amount of
two million three hundred thousand dollars ($2,300,000.00) (the "Partial Refund
Note"). The Partial Refund Note shall bear interest at a rate of ten percent
(10%) per annum. The principal amount of the Partial Refund Note shall be repaid
in two (2) payments of one million one hundred fifty thousand dollars
($1,150,000.00) each, payable on the first and second anniversaries of the
Expiration Date. All unpaid principal together with all accrued interest due
under the Partial Refund Note shall be due and payable in full on the second
anniversary of the Expiration Date. The Partial Refund Note shall include
customary event of default provisions. In the event that Metasyn fails to pay
the Partial Refund Note on any installment date or on maturity, DRL shall have
available to it all remedies at law or in equity.
9.3.4. Survival. The provisions of Articles 4 (with respect
only to expense payments and royalties accrued at the time of expiration or
termination but not yet paid) 5, 6, 7 and 8, Section 10.11 and this Section 9.3
shall survive the expiration or termination of this Agreement.
9.4. Remedy Other Than Termination. In the event of breach by Metasyn
of any of its obligations hereunder that would entitle DRL to terminate this
Agreement pursuant to Section 9.2.1(i) hereof that Metasyn fails to remedy or
take reasonable action to initiate a remedy for within ninety (90) days after
notice thereof by DRL, in lieu of termination, DRL shall have the right and
option, upon obtaining final judgment or judicial or arbitral award of monetary
damages and/or costs against Metasyn, to offset the amount of such damages
and/or costs against any amounts otherwise due to Metasyn under Article 4
hereof.
ARTICLE 10. MISCELLANEOUS
10.1. Force Majeure. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not),
-23-
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party; provided, however, that the party so
affected shall use reasonable commercial efforts to avoid or remove such causes
of nonperformance, and shall continue performance hereunder with reasonable
dispatch whenever such causes are removed. Either party shall provide the other
party with prompt written notice of any delay or failure to perform that occurs
by reason of force majeure. The parties shall mutually seek a resolution of the
delay or the failure to perform as noted above.
10.2. Assignment. This Agreement may not be assigned or otherwise
transferred by either party without the prior written consent of the other
party; provided, however, that either Metasyn or DRL may, without such consent,
assign its rights and obligations under this Agreement (i) in connection with a
corporate reorganization, to any Affiliate, all or substantially all of the
equity interest of which is owned and controlled by such party or its direct or
indirect parent corporation, or (ii) in connection with a merger, consolidation
or sale of substantially all of such party's assets to an unrelated Third Party;
provided, however, that such party's rights and obligations under this Agreement
shall be assumed in writing by its successor in interest in any such transaction
and shall not be transferred separate from all or substantially all of its other
business assets, including those business assets that are the subject of this
Agreement. Any purported assignment in violation of the preceding sentence shall
be void. Any permitted assignee shall assume all obligations of its assignor
under this Agreement.
10.3. Severability. Each party hereby agrees that it does not intend to
violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or
community or association of countries. Should one or more provisions of this
Agreement be or become invalid, the parties hereto shall substitute, by mutual
consent, valid provisions for such invalid provisions which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that it
can be reasonably assumed that the parties would have entered into this
Agreement with such valid provisions. In case such valid provisions cannot be
agreed upon, the invalidity of one or several provisions of this Agreement shall
not affect the validity of this Agreement as a whole, unless the invalid
provisions are of such essential importance to this Agreement that it is to be
reasonably assumed that the parties would not have entered into this Agreement
without the invalid provisions.
10.4. Notices. Any consent, notice or report required or permitted to
be given or made under this Agreement by one of the parties hereto to the other
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by telephone, personal delivery or courier) or courier, postage
prepaid (where applicable), addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and shall be effective upon receipt by the
addressee.
If to Metasyn: Metasyn, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000
Attention: President
-24-
Telephone: 0-000-000-0000
Telecopy: 0-000-000-0000
with a copy to: Xxxxxx & Dodge
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxx Xxxxx, Esq.
Telephone: 0-000-000-0000
Telecopy: 1-617-227-4420
If to DRL: Daiichi Radioisotope Laboratories, Ltd.
00-00, Xxxxxxxx 0-xxxxx Xxxx-xx
Xxxxx, 000 Xxxxx
Attention: President
Telephone: 000 00 0 0000 0000
Telecopy: 011 81 3 5250 2609
with a copy to: Xxxxxx, XxXxxxxxx & Fish, LLP
Xxx Xxxxxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxx, Esq.
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
10.5. Applicable Law. This Agreement shall be governed by and construed
in accordance with the laws of the Commonwealth of Massachusetts, without giving
effect to the choice of laws provisions thereof.
10.6. Dispute Resolution.
10.6.1. The parties hereby agree that they will attempt in
good faith to resolve any controversy or claim arising out of or relating to
this Agreement promptly by negotiations. If a controversy or claim should arise
hereunder, the representatives of the parties will confer at least once and will
attempt to resolve the matter. If the matter has not been resolved within
fourteen (14) days of their first meeting, the representatives shall refer the
matter to the Chief Executive Officers of the parties. If the matter has not
been resolved within thirty (30) days of the first meeting of the Chief
Executive Officers of the parties (which period may be extended by mutual
agreement), subject to rights to injunctive relief and specific performance, and
unless otherwise specifically provided for herein, any controversy or claim
arising out of or relating to this Agreement, or the breach thereof, will be
settled as set forth in Section 10.6.2.
10.6.2. All disputes, controversies or differences which may
arise between the parties out of or in relation to this Agreement or any default
or breach thereof may be resolved by arbitration in accordance with the Rules of
Conciliation and Arbitration of the International Chamber of Commerce by one or
more arbitrators appointed in accordance with the sail Rules. If DRL is the
moving party, the arbitration shall take place in Boston,
-25-
Massachusetts, and if Metasyn is the moving party, the arbitration shall take
place in Tokyo, Japan. Any decision or award resulting from the arbitration
provided for herein shall be final and binding on the parties hereto.
Notwithstanding the above, either party has the right to bring suit in a court
of competent jurisdiction against the other party for (i) any breach of such
other party's duties of confidentiality pursuant to Article 6 of this Agreement
and (ii) any infringement of its own proprietary rights by the other party.
Judgment upon the arbitrator's award may be entered in any court of competent
jurisdiction. The award of the arbitrator may include compensatory damages
against either party, but under no circumstances will the arbitrator be
authorized to, nor shall he, award punitive damages or multiple damages against
either party. The parties agree not to institute any litigation or proceedings
against each other in connection with this Agreement except as provided in this
Section 10.6.2.
10.7. Public Announcements. The parties agree that press releases and
other announcements to be made by either of them in relation to this Agreement
shall be subject to the written consent of the other party, which consent shall
not be unreasonably withheld or delayed. The parties will agree to issue a joint
press release immediately following the execution of this Agreement, the form
and content of which shall be reasonably satisfactory to both parties.
Notwithstanding the foregoing, after the Effective Date, Metasyn shall be free
to issue any press releases regarding the preclinical, clinical and regulatory
development of the Licensed Compound or Licensed Product taking place in any
country other than Japan, and DRL shall be free to issue any press releases
regarding the preclinical, clinical and regulatory development of the Licensed
Compound or Licensed Product taking place in Japan.
10.8. Entire Agreement. This Agreement, together with the exhibits
hereto, the Development Schedule, any supply agreement that the parties may
execute pursuant to Section 2.2 hereof, the Master Agreement and the Stock
Purchase Agreement, contains the entire understanding of the parties with
respect to the subject matter hereof and supersedes the Letter of Intent dated
March 1, 1996 between Metasyn and DRL. All express or implied agreements and
understandings, either oral or written, heretofore made are expressly merged in
and made a part of this Agreement. This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both parties
hereto.
10.9. Headings. The captions to the several Articles and Sections
hereof are not a part of this Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
10.10. Independent Contractors. It is expressly agreed that Metasyn and
DRL shall be independent contractors and that the relationship between the two
parties shall not constitute a partnership, joint venture or agency. Neither
Metasyn nor DRL shall have the authority to make any statements, representations
or commitments of any kind, or to take any action, which shall be binding on the
other, without the prior consent of the other party to do so.
10.11. Agreement Not to Solicit Employees. During the term of this
Agreement and for a period of [ ]* following the expiration pursuant to
Section 9.1 or termination
*Confidential information omitted and filed with the Commission.
-26-
pursuant to Section 9.2 of this Agreement, Metasyn and DRL agree not to seek to
persuade or induce any employee of the other company to discontinue his or her
employment with that company in order to become employed by or associated with
any business, enterprise or effort that is associated with its own business.
10.12. Exports. The parties acknowledge that the export of technical
data, materials or products is subject to the exporting party receiving any
necessary export licenses and that the parties cannot be responsible for any
delays attributable to export controls which are beyond the reasonable control
of either party. Metasyn and DRL agree not to export or re-export, directly or
indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this Agreement in violation of
any applicable export control laws or governmental regulations. Metasyn and DRL
agree to obtain similar covenants from their licensees, sublicensees and
contractors with respect to the subject matter of this Section 10.12.
10.13. Waiver. The waiver by either party hereto of any right hereunder
or the failure to perform or of a breach by the other party shall not be deemed
a waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
10.14. Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
METASYN, INC.
By: /s/ Xxxxxxx X. Xxxx
-------------------------
Xxxxxxx X. Xxxx
Title: President and Chief Executive Officer
DAIICHI RADIOISOTOPE LABORATORIES, LTD.
By: /s/ Xxxxx Xxxxx
----------------------------
Title: Xxxxx Xxxxx
-------------------------------------
President and Chief Executive Officer
-------------------------------------
-27-
EXHIBIT A
MGH Patent Rights
1) U.S. Patent No. 4,899,755, "Hepatobiliary NMR Contrast Agents," Xxxxxxx
X. Xxxxxxx and Xxxxxx X. Xxxxx, Ser. No. 731,841, filed May 8, 1985,
issued February 13, 1990.
2) U.S. Patent No. 4,880,008, "In Vivo Enhancement of NMR Relaxivity,"
Xxxxxxx X. Xxxxxxx, Ser. No. 860,540, filed May 7, 1986, issued
November 14, 1989.
3) Canadian Patent No. 1,264,663, "Hepatobiliary NMR Contrast Agents,"
Xxxxxxx X. Xxxxxxx and Xxxxxx X. Xxxxx, Ser. No. 508,749, filed May 8,
1986, issued January 23, 1990.
4) European Patent Application, "Hepatobiliary NMR Contrast Agents,"
Xxxxxxx X. Xxxxxxx and Xxxxxx X. Xxxxx, Ser. No. 86903806.7
(Publication No. EP 0222886), filed May 8, 1986.
5) Japanese Patent Application, "Hepatobiliary NMR Contrast Agents,"
Xxxxxxx X. Xxxxxxx and Xxxxxx X. Xxxxx, Ser. No. 503050/86, filed
May 8, 1986.
6) European Patent Application, "Hepatobiliary NMR Contrast Agents,"
Xxxxxxx X. Xxxxxxx and Xxxxxx X. Xxxxx, Ser. No. 95120005.4, filed
December 18, 1995; a division of Ser. No. 86903806.7 (Publication No.
EP 0222886), filed May 8, 1986.
-28-
EXHIBIT B
Metasyn Patent Rights
1) U.S. Patent Application, "Diagnostic Imaging Contrast Agents With
Prolonged Blood Retention," Ser. No. 08/382,317, filed February 1
1995.
2) PCT Patent Application, "Diagnostic Imaging Contrast Agents With
Extended Blood Retention," Ser. No. PCT/US96/00164, filed January 16,
1996.
-29-
EXHIBIT C
Development Schedule
================================================================================
[ ]* [ ]*
[ ]* [ ]*
[ ]* [ ]*
[ ]* [ ]*
[ ]* [ ]*
[ ]* [ ]*
================================================================================
*Confidential information omitted and filed with the Commission.
-30-
APPENDIX I
MGH License
Filed herewith as Exhibit 10.14.
