Exhibit 10.34

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

 

 

 

EXECUTION COPY

SUPPLY AGREEMENT

by and between

Organogenesis Inc.

and

NMT Medical, Inc.

Dated: March 30, 2005

 

 

 

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SUPPLY AGREEMENT

TABLE OF CONTENTS

 

     Page

ARTICLE I - DEFINITIONS

   1

ARTICLE II - SUPPLY OF MATERIAL

   3

ARTICLE III - ORDERS; FORECASTS; DELIVERY

   5

ARTICLE IV - TESTING; ACCEPTANCE; MANUFACTURING CHANGES

   7

ARTICLE V - PRICES; PAYMENT TERMS

   8

ARTICLE VI - WARRANTY; DISCLAIMERS

   9

ARTICLE VII - INDEMNIFICATION

   10

ARTICLE VIII - CONFIDENTIALITY

   12

ARTICLE IX - GOVERNING LAW; DISPUTES

   13

ARTICLE X - ASSIGNMENT; CONTRACTING

   13

ARTICLE XI - TERM; TERMINATION

   14

ARTICLE XII - NOTICES

   15

ARTICLE XIII - GENERAL

   16

APPENDIX A – PRODUCT DESCRIPTION AND SPECIFICATIONS

APPENDIX B – PRICING

 

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SUPPLY AGREEMENT

THIS SUPPLY AGREEMENT (this “Agreement”) made and entered into as of the 30th
day of March, 2005 (the “Effective Date”) by and between Organogenesis Inc., a
Delaware corporation, located in Canton, Massachusetts (hereinafter, “OI”), and
NMT Medical, Inc., a Delaware corporation located in Boston, Massachusetts
(hereinafter, “NMT”).

WHEREAS, NMT and OI have entered into a License and Development Agreement of
even date herewith (“License and Development Agreement”) for the development of
the Material (as defined below) for incorporation into one or more NMT products;

WHEREAS, pursuant to the terms of the License and Development Agreement, OI
granted to NMT, and NMT obtained from OI, a license under certain patents and
know-how to make, have made, manufacture, have manufactured, use, lease, sell,
offer for sale, and import the Material for incorporation into NMT products;

WHEREAS, NMT has covenanted with OI not to exercise the licenses (or grant
sublicenses) to make, have made, or and import the Material as long as OI
complies with certain supply and other obligations;

WHEREAS, the parties desire that OI manufacture and supply the Material to NMT,
its Affiliates and Manufacturers (each as defined below) on the terms set forth
herein;

NOW, THEREFORE, in consideration of the promises and mutual covenants contained
herein, NMT and OI agree as follows:

ARTICLE I - DEFINITIONS

1.1 “Affiliate” shall have the meaning set forth in the License and Development
Agreement.

1.2 “Approved Production Facilities” shall mean a production facility that meets
the quality standards for manufacturing the Material as set forth in
Section 2.4(b).

1.3 “Combined Product” shall have the meaning set forth in the License and
Development Agreement.

1.4 “Confidential Information” shall have the meaning set forth in the License
and Development Agreement.

1.5 “Delivery Date” shall have the meaning set forth in Section 3.1(a).

1.6 “Excluded Patent” shall have the meaning set forth in the License and
Development Agreement.

 

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1.7 “Field” shall have the meaning set forth in the License and Development
Agreement.

1.8 “Forecast” shall have the meaning set forth in Section 3.2(a).

1.9 “Manufacturer” shall mean a manufacturer of products for NMT or its
Affiliates that incorporate the Material, as designated by NMT in writing to OI
from time to time during the Term.

1.10 “Material” shall mean the material described in Appendix A to this
Agreement, and any successors and improvements thereto requested or ordered by
NMT. It is acknowledged that the Material is a “Licensed Product” as defined in
the License and Development Agreement.

1.11 “Orders” shall have the meaning set forth in Section 3.1(a).

1.12 “PPI” shall mean the United States Producer Price Index for pharmaceutical
preparation manufacturing, as published by the Bureau of Labor Statistics on its
Web site (www.bls.gov/ppi), or if not available from such Web site, then as
published by the Bureau of Labor Statistics in its monthly periodical “Producer
Price Indexes.” If no PPI data has been published for the periods relevant to an
adjustment under Section 5.2 hereof, then the parties shall agree in good faith
on a substitute Producer Price Index by the relevant Price Review Date (as
defined in Section 5.2).

1.13 “Price” shall have the meaning set forth in Section 5.1.

1.14 “QSR” shall mean Quality Systems Regulation applicable to the
manufacturing, processing, packaging or holding of medical devices in the United
States, as regulated by the U.S. Food and Drug Administration.

1.15 “Shelf Life” shall mean the shelf life specified for the Material (or a
particular type of Material) in the applicable Specifications.

1.16 “Specifications” shall mean the specifications for the Material, as set
forth in Appendix A hereto, as it may be amended from time to time pursuant to
Section 4.2 hereof.

1.17 “Supply Threatening Event” shall have the meaning set forth in the License
and Development Agreement.

1.18 “Unit” shall mean a single product that combines the Material with NMT’s
superstructure which is designed to frame the Material.

1.19 “Term” shall have the meaning set forth in Section 11.1.

 

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ARTICLE II - SUPPLY OF MATERIAL

2.1 Supply. On and subject to the terms and conditions of this Agreement,
including, without limitation, lead times, ordering procedures, forecasts and
scheduling procedures set forth herein, OI agrees to sell the Material to NMT
and its Affiliates in such quantities as they may order from time to time solely
for incorporation in Combined Products.

2.2 NMT Exclusivity. For as long as the licenses granted to NMT pursuant to the
License and Development Agreement remain exclusive, OI shall not knowingly, and
shall require that its Affiliates do not knowingly sell, offer, solicit or
accept orders for, agree to supply or otherwise market the Material to any
person or entity for use in the Field other than NMT, its designated Affiliates
or Manufacturers.

2.3 OI Exclusivity. Until the occurrence of a Supply Threatening Event, if any,
NMT shall purchase 100% of its requirements of Material from OI.

2.4 Manufacturing Facilities; Approvals.

 

  (a) OI represents and warrants that it has, and that its Contractors will have
at any time they are providing Material hereunder, all governmental and other
approvals required for the operation of its Approved Production Facilities
necessary for the manufacture and supply of Material under this Agreement. OI
shall, and shall ensure that its Contractors shall, conduct all operations in
connection with the supply of Material under this Agreement (including without
limitation, to the extent applicable, the design, sourcing, manufacture, quality
control, supply and tracking of the Material) in accordance with QSR.

 

  (b)

No manufacturing or production facility shall be considered an “Approved
Production Facility” unless and until such facility is so approved by NMT in
writing. NMT shall issue such approval provided that the manufacturing or
production facility substantially complies with QSR. At NMT’s request and
expense, a mutually agreed upon designee shall be appointed to inspect all
production equipment, materials, inventory and facilities at any facility that
OI submits for approval, and NMT or such designee shall be entitled to interview
employees of OI or its Contractor, as the case may be, review safety, accident,
environmental and other reports and records, perform limited testing and
diagnosis of production processes and otherwise ascertain whether the proposed
Approved Production Facility substantially complies with QSR. OI shall cooperate
and provide reasonable assistance and access in connection with such inspections
as NMT or the designee may require. If NMT or the designee determines that a
facility proposed by OI to be an Approved Production Facility does not
substantially comply with QSR, NMT or the designee shall specify in writing the
alleged deficiency and OI shall have [**] days

 

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to correct such deficiency. If the deficiency is corrected, the facility shall
be approved; if the deficiency is not corrected, approval of such facility may
be declined. The parties acknowledge that, as of the Effective Date, OI
maintains only one manufacturing facility in Canton, Massachusetts, that NMT has
inspected that facility, and that such facility is hereby deemed to be an
Approved Production Facility. One time per year, at NMT’s request and expense,
each previously Approved Production Facility shall be subject to the inspection
and qualification process described immediately above. Pending the designee’s
conclusion, the facility shall continue to be an Approved Production Facility.
If the designee concludes that the Approved Production Facility no longer
substantially complies with QSR, OI shall have [**] days to bring the facility
into substantial compliance, provided, however, that such period shall be
extended for a reasonable period of time necessary to bring the facility into
substantial compliance, provided that OI is making diligent efforts to do so.

 

  (c) Without limiting the generality of the foregoing, subject to protection of
OI’s Confidential Information in accordance with this Agreement (including
restrictions on use of such information in accordance with the restrictions set
forth in the License and Development Agreement), OI shall permit employees or
representatives of NMT, during normal business hours and upon at least five
business days’ prior notice, to visit OI’s and its Contractors’ Approved
Production Facilities to observe and examine the manufacture of the Material.
All such NMT employees or representatives, while at the facilities of OI and its
Contractors, shall comply with all reasonable written safety and security rules
and regulations established by OI and its Contractors. OI and its Contractors
shall permit reasonable inspection of its Approved Production Facilities by
representatives of governmental regulatory agencies, if and to the extent NMT
submits to OI in writing a reasonable basis as to why such inspection is
necessary or desirable in order to comply with any statute or regulation or to
obtain or maintain any necessary governmental approvals for products marketed by
NMT.

 

  (d) OI represents that it has provided a true and complete copy of its
disaster recovery plan to NMT for its review prior to the Effective Date and
that such disaster recovery plan is reasonable and sufficient to ensure the
rapid recovery of manufacturing capacity for the Material should OI’s primary
Approved Production Facility suffer an event that makes it difficult or
impossible to manufacture Material in the quantities ordered and forecasted by
NMT. OI shall notify NMT of any material amendment to its disaster recovery
plan.

 

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2.5 Compliance with MDR Regulations. Each party shall comply with all relevant
laws and regulations applicable to such party in connection with the performance
of such party’s obligations hereunder, including without limitation the Medical
Device Reporting (“MDR”) regulations of the U.S. Food and Drug Administration.
OI shall provide to NMT all data and other information, immediately after OI
first becomes aware of or comes into possession of such data or information,
that suggests that the Material may (a) have caused or contributed to a death or
serious injury, (b) have malfunctioned and, if the malfunction were to recur,
likely would cause or contribute to a death or serious injury, or (c) be subject
to any condition, reaction, attribute or shortcoming that is likely to cause
injury, loss, damage or liability to any third party. NMT shall provide to OI
all data and other information, immediately after NMT first becomes aware of or
comes into possession of such data or information, that indicates that the
Material may have (a) caused or contributed to a death or serious injury, or
(b) malfunctioned and, if the malfunction were to recur, likely would cause or
contribute to a death or serious injury. In addition, OI shall take other
actions reasonably requested by NMT to support NMT’s compliance with the MDR
regulations.

ARTICLE III - ORDERS; FORECASTS; DELIVERY

3.1 Orders.

 

  (a) Orders; Lead Times. NMT, its Affiliates and/or its Manufacturers may place
written orders (“Orders”) for Material under this Agreement from time to time.
Orders shall specify (i) the quantity of Material to be delivered, (ii) one or
more Material delivery dates, none of which may be earlier than [**] weeks after
the date of the Order (“Delivery Date(s)”), and (iii) one or more Material
delivery destinations. All Orders are subject to conformance with the Forecasts
described in Section 3.2(a). As noted therein, NMT shall be obligated to Order
an amount of Material equal to or greater than the Fixed Quarter (as defined
below) of the [**] rolling Forecast.

 

  (b) Fulfillment of Orders. OI shall accept and fill all Orders placed under
this Agreement which conform to the terms of this Agreement, subject to Sections
3.1(c) and 3.2. OI shall deliver the requested quantity of Material by the
requested Delivery Date(s). During a Fixed Quarter, OI shall be required to fill
all Orders equal to the [**] of (a) [**]% of the amount forecast for such Fixed
Quarter Order or (b) [**]% of the amount of Material actually purchased by NMT
in the immediately preceding Fixed Quarter, and will use its commercially
reasonable efforts to fill orders in excess of such amounts. During a Fixed
Quarter, NMT may vary monthly Orders within such Fixed Quarter so long as the
amount Ordered during such Fixed Quarter equals at least [**]% of the amount
forecast for such Fixed Quarter. OI shall acknowledge all Orders in writing not
more than five business days after receipt thereof.

 

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  (c) Manufacturers. Notwithstanding anything in the foregoing to the contrary,
OI shall accept Orders from a Manufacturer only if NMT has notified OI in
writing that OI may accept such Orders from such Manufacturer. NMT shall provide
such written notification to OI on a Manufacturer-by-Manufacturer basis. Such
written notification to OI shall not be construed as notification to OI that OI
may accept any Orders from any other Manufacturer. NMT shall be responsible to
OI for payment for Materials shipped to Manufacturers in accordance with this
Section.

3.2 Forecasts; Scheduling.

 

  (a) Forecasts. NMT shall furnish to OI, at least [**] weeks prior to the
beginning of each calendar quarter during the Term, a [**]-quarter rolling
forecast (the “Forecast”), including the quantity of Material that NMT, its
Affiliates and its Manufacturers will Order in such calendar quarter (the “Fixed
Quarter”) and an estimate of the quantity of Material for which NMT, its
Affiliates and its Manufacturers will submit Orders during each of the three
calendar quarters following the Fixed Quarter. Each such Forecast after the
first shall update and replace prior Forecasts as to the calendar quarters
covered by such prior Forecasts. If NMT fails to furnish a revised Forecast at
least [**] weeks prior to a calendar quarter, the next quarter of the existing
Forecast shall become the next Fixed Quarter. The Forecasts shall constitute
binding commitments for each Fixed Quarter but, with respect to the other
quarters of the Forecast, shall be merely estimates of the quantity of Material
needed and are not to be considered Orders or binding in any way.
Notwithstanding the foregoing, the Forecast for the first calendar quarter
following the Effective Date shall not be binding on NMT and OI will, with [**]
weeks lead time per Order, sell to NMT during such quarter sufficient quantities
of Material for use in testing and evaluation.

 

  (b) Rescheduling. NMT, its Affiliates and Manufacturers may defer any and all
shipments of Material ordered hereunder for up to [**] days, once per Delivery
Date specified in NMT’s original Order, provided that OI receives written notice
(or oral notice, so long as such notice is confirmed in writing within [**]
business days) thereof at least [**] business days before the initial Delivery
Date specified in the Order. Additional rescheduling may be requested by NMT,
its Affiliates or Manufacturers, and OI shall not unreasonably withhold its
consent to such rescheduling.

3.3 Shipment and Delivery.

 

  (a) Delivery Location. OI shall ship Material to NMT, its Affiliates or
Manufacturer, and invoice NMT, at the respective addresses indicated on the
applicable Order.

 

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  (b) Title; Risk of Loss. Title to and risk of loss for Material shall pass to
NMT, its Affiliates or Manufacturers, as the case may be, upon receipt by the
carrier. OI will invoice NMT and NMT shall pay for the cost of shipping and
insurance. OI shall cooperate with NMT in the documentation and proof of loss
claims promptly presented by NMT, its Affiliates or Manufacturers to the
appropriate carrier and/or insurer.

 

  (c) Shipping Instructions. OI will, or will instruct its Contractor to, pack
and ship Material in a manner consistent with reasonable industry practices for
perishable biological materials.

ARTICLE IV - TESTING; ACCEPTANCE; MANUFACTURING CHANGES

4.1 Testing and Acceptance.

 

  (a) In-Process Testing. OI shall perform the in-process Material inspection
and testing procedures described on Appendix A to this Agreement. Before
shipping any Material, OI shall supply NMT with a Certificate of Compliance with
respect to such testing and the results thereof in the format specified on
Appendix A. OI shall retain two (2) sample units of each manufacturing lot of
Material shipped hereunder, for one (1) year after the Material expiration date
listed Appendix A and, upon reasonable request of NMT, shall make such samples
available for inspection and testing by NMT.

 

  (b) Incoming Testing and Acceptance. NMT shall receive all Material shipped
hereunder subject to inspection and performance testing. NMT shall have a
maximum of [**] days from the receipt of Material to complete such testing and
notify OI in writing of acceptance or rejection of Material. If NMT does not
deliver such written notice to OI within such [**]-day period, NMT shall be
deemed to have accepted the Material. If NMT notifies OI that NMT has rejected
any Material, OI shall replace and/or rework such Material and return such
Material to NMT, transportation and insurance prepaid. OI shall use commercially
reasonable efforts to perform such replacement and/or rework within [**] days.
Acceptance of Material hereunder shall not be deemed to constitute an
acknowledgement by NMT, any Affiliate or Manufacturer as to the quality of such
Material or their compliance with the warranty extended by OI under Section 6.1.

4.2 Manufacturing Changes.

 

  (a)

Modifications by OI. OI shall keep NMT apprised of the development and evolution
plan for the Material, including by inviting, where practicable, NMT to OI and
Affiliate meetings, if any, that address issues

 

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directly applicable to use of the Material in the Field and shall consider in
good faith NMT’s requests and suggestions for improvements to the Material. OI
shall provide NMT with [**] months prior written notice of any changes in the
components, raw materials, or suppliers thereof, or manufacturing process,
location or capacity, or changes, improvements or enhancements that affect
compliance with the Specifications or Acceptance Criteria (collectively,
“changes”), which OI may propose to make to the Material (any such notice, a
“Product Change Notice”), in order to permit NMT to evaluate such proposals and
to verify that regulatory and customer performance criteria will be satisfied.
NMT shall have the right to approve or disapprove all proposed changes before
the incorporation of such changes into the Material. NMT shall notify OI in
writing of its approval or disapproval, including an explanation of NMT’s
reasons for such disapproval, not more than one (1) month after receipt of a
Product Change Notice. For clarity, if NMT disapproves a proposed change, OI
shall not incorporate such change into the Material unless such change is
required by FDA regulations or in OI’s reasonable judgment is required for
product safety reasons. Upon written approval by NMT of changes in the
Specifications described in a Product Change Notice, the approved changes shall
be deemed to be incorporated into Appendix A. Each of NMT and OI shall negotiate
in good faith with respect to any Price changes resulting from modifications
requested by OI. Provided that OI diligently seeks to obtain FDA approval of any
changes that require such approval, OI shall have such time as is reasonably
necessary to do so.

 

  (b) Modifications by NMT. NMT reserves the right to request modification of
the Specifications for Material, and OI shall use reasonable efforts to
implement such modification. If, in the opinion of OI, any such modification is
technically difficult or infeasible or shall cause a change in OI’s cost of
manufacturing the Material or in any other terms upon which the Material may be
offered hereunder, OI shall notify NMT before implementing such modification
(and in any event, no later than [**] months after NMT requests any
modification), and shall provide NMT with such information as NMT shall
reasonably require in order to evaluate such change. Each of NMT and OI shall
negotiate in good faith with respect to any Price changes resulting from
modifications requested by NMT and agreed to by OI. Such modifications shall
thereafter be deemed to be incorporated into Appendix A.

ARTICLE V - PRICES; PAYMENT TERMS

5.1 Prices. The price for Material ordered hereunder shall be as set forth on
Appendix B to this Agreement (“Price”), as it may be adjusted in accordance with
Sections 4.2 and 5.2 hereof.

 

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5.2 Price Adjustment. The Price for Material then in effect shall be adjusted
[**] (the “Price Review Date”), to equal the then-current price multiplied by
the [**]. For purposes of this Section 5.2, [**] shall be calculated by [**].

5.3 Taxes. All amounts paid under this Agreement are exclusive of all foreign
and domestic taxes, including, without limitation, federal, state and local
taxes, levies and assessments. NMT shall be responsible for the payment of all
such taxes, levies and assessments imposed on Material supplied to NMT hereunder
or otherwise resulting from this Agreement, excluding taxes based upon OI’s net
income from the transaction. Where applicable, the parties shall cooperate in
obtaining in a timely manner all documentation, including without limitation
exemption certificates, necessary to allow OI to refrain from collections, such
as sales tax, which it would otherwise be obligated to make.

5.4 Payment Terms.

 

  (a) Invoices. NMT shall pay to OI the Price of all Material delivered
hereunder within [**] days after receipt of OI’s invoice therefor.

 

  (b) Date of Invoices. OI will issue invoices at the time of delivery.

 

  (c) Security Interest. OI shall retain a purchase money security interest in
all Materials sold hereunder.

ARTICLE VI - WARRANTY; DISCLAIMERS

6.1 OI Warranties. During the applicable Shelf Life of the Material, OI warrants
to NMT that all Material delivered hereunder:

 

  (a) shall be free from defects in materials and workmanship;

 

  (b) shall be manufactured in compliance with QSR;

 

  (c) shall conform to the Specifications; and

 

  (d) shall conform with all requirements of the U.S. Food, Drug and Cosmetic
Act, as amended, and regulations promulgated thereunder, and all applicable U.S.
state and local laws in effect as of the date of delivery.

6.2 Title. OI warrants to NMT that it shall pass good and clear title to all
Material to NMT upon OI’s delivery of the Material to NMT, its Affiliates or
Manufacturers, and that all such Material shall be free from all third party
liens, encumbrances and security interests.

 

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6.3 Disclaimer of Warranties. THE WARRANTIES CONTAINED IN THIS AGREEMENT ARE IN
LIEU OF ANY OTHER WARRANTY, WHETHER EXPRESSED OR IMPLIED, WRITTEN OR ORAL
(INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE),
AS TO THE MATERIAL.

6.4 No Consequential Damages. OTHER THAN AS PROVIDED UNDER SECTION 7.1, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, INDIRECT, SPECIAL,
PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES ARISING HEREUNDER, INCLUDING,
WITHOUT LIMITATION, LOSS OF USE, LOSS OF REVENUE OR LOST PROFITS, EVEN IF SUCH
PARTY HAS BEEN ADVISED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE VII - INDEMNIFICATION

7.1 Indemnification by OI.

 

  (a) Except as set forth in Section 7.2, OI shall, at its sole cost and expense
defend, indemnify and hold harmless NMT, its Affiliates, Manufacturers,
subcontractors, agents and customers (the “NMT Indemnitees”) against any third
party claims, demands, actions or causes of action asserting (i) that any
Material infringes or misappropriates any Intellectual Property right of any
third party (including, without limitation, any patent claim that may have been
asserted in the past, is presently being asserted or may be asserted in the
future by Cook, Inc. or any other third party, but excluding any claim brought
with respect to the Excluded Patent) or (ii) that any third party injuries,
losses, damages or liability of any kind whatsoever resulted from or arose out
of the use, promotion, distribution or sale of Material which did not meet the
Specifications as part of a Combined Product, whether asserting negligence,
defective design, defective manufacture or any other theory.

 

  (b) OI shall not be obligated to indemnify under this Section 7.1 in respect
of any damage to the extent caused by any alteration or modification to the
Material that is not made by or with the approval of OI or its Affiliates or is
made at the specific direction of NMT.

 

  (c)

Should any NMT Indemnitee be enjoined or subject to a claim for injunctive
relief by a third party in respect of any Material, OI will use its reasonable
best efforts to either procure for the NMT Indemnitees the right to continue
exercising all rights granted hereunder with respect to such Material, or modify
such Material so that it becomes non-infringing but performs in accordance with
all applicable specifications. If OI is unable to effect either of the remedies
set forth in the preceding sentence within [**] days following the making of
such a claim, NMT shall have the right

 

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to return any Material that is the subject of such a claim and OI shall refund
to the relevant NMT Indemnitee the full Price paid for such Material.

7.2 Indemnification by NMT.

 

  (a) NMT shall, at its sole cost and expense, defend, indemnify and hold
harmless OI, its Affiliates, Contractors and agents (the “OI Indemnitees”)
against any third party claims, demands, actions or causes of action asserting
(i) that the Combined Product (including the Material, but excluding claims
based primarily on the Material) infringes or misappropriates any Intellectual
Property right of any third party, (ii) that any third party injuries, losses,
damages or liability of any kind whatsoever resulted from or arose out of the
use, promotion, distribution or sale of any portions of the Combined Product
(other than Material which did not meet the Specifications), whether asserting
negligence, defective design, defective manufacture or any other theory.

 

  (b) If OI becomes aware that any condition, reaction, attribute or shortcoming
of the Material is likely to cause any injuries, losses, damages or liability (a
“Deficiency”) and delays informing NMT in writing of such Deficiency and if
there would have been sufficient time for NMT to avoid such injuries, losses,
damages or liability had OI not engaged in such delay, then NMT shall not be
obligated to indemnify any OI Indemnitee under this Section 7.2 in respect of
any injuries, losses, damages or liability to the extent caused directly or
indirectly by such Deficiency.

7.3 Indemnification Procedure. A Party seeking indemnity hereunder (the
“Indemnitee”) shall promptly notify the indemnifying Party (the “Indemnitor”) in
writing of any claim giving rise to an obligation of indemnity hereunder and
give the Indemnitor full authority, information and assistance (at the
Indemnitor’s expense) for the defense of such claim. Failure of the Indemnitee
to notify the Indemnitor promptly of the claim shall not be a ground for
refusing to provide the indemnity, unless the Indemnitor has been materially
prejudiced by such delay. In addition to the Indemnitor’s obligation to defend,
the Indemnitor shall pay all damages, settlements, claims, fees, expenses and
costs (including, without limitation, legal fees and expenses) (“Damages”)
awarded therein against or otherwise incurred by the Indemnitee in connection
with any claim. The Indemnitee shall not settle any such claim without the
written consent of the Indemnitor, not to be unreasonably delayed or denied. The
Indemnitor shall not agree to any settlement of any such claim that does not
include a complete release of the Indemnitee from all liability with respect
thereto or that imposes any liability, obligation or restriction on the
Indemnitee without the prior written consent of the Indemnitee. The Indemnitee
may participate in the defense of any claim through its own counsel, and at its
own expense. In the event the Indemnitor fails to perform pursuant to this
Section 7.3, the Indemnitee shall have the right to assume the control and
defense of such matter, and the

 

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Indemnitor shall be fully responsible for all reasonable costs, expenses
(including but not limited to reasonable attorneys’ and expert fees), judgment
and damages of the Indemnitee incurred in connection therewith and shall
indemnify and hold harmless the Indemnitee therefrom. If the Indemnitor does not
defend as required hereunder, the Indemnitee may also withhold any payments that
would otherwise be due hereunder to cover its out-of-pocket expenses to defend
any such suit.

7.4 Exclusive Remedy. The remedies and obligations of the parties under this
Section 7 and under Section 11 are the sole remedies and obligations of the
parties in respect of infringement of third party intellectual property rights.

ARTICLE VIII - CONFIDENTIALITY

8.1 Confidential Information. Each party shall hold the Confidential Information
of the other party secret, and shall protect and preserve the confidential
nature and secrecy of such Confidential Information. All Confidential
Information shall be held in confidence by the party receiving such Confidential
Information (the “Receiving Party”) following the date of disclosure and shall
be used only as necessary in connection with the performance of its obligations
or the exercise of its rights under this Agreement. Employees of the Receiving
Party shall be bound in writing to maintain the confidentiality of such
Confidential Information to at least the extent provided in this Section 8.1.
All Confidential Information shall be maintained in secure premises by the
Receiving Party, and the Receiving Party shall take all appropriate measures to
prevent the unauthorized disclosure thereof. Neither party shall at any time
during or after the Term, without the other party’s prior written consent:

(i) disclose or communicate to any third party all or any of the other party’s
Confidential Information except as permitted by this Agreement;

(ii) permit unauthorized persons to have access to the places where the other
party’s Confidential Information is reproduced or stored; or

(iii) make, or assist any person to make, any use of the other party’s
Confidential Information not authorized by this Agreement, and shall use its
best efforts to ensure that any employee or other person who acquires the other
party’s Confidential Information shall not make any unauthorized use thereof.

8.2 Release from Restrictions. The provisions of Section 8.1 shall not apply to
any Confidential Information disclosed hereunder which:

 

  (a) either before or after the date of the disclosure to the Receiving Party
becomes published or generally known to the public, through no fault or omission
on the part of the Receiving Party or an Affiliate of the Receiving Party; or

 

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  (b) is required to be disclosed by the Receiving Party to comply with
applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the Receiving Party provides prior
written notice of such disclosure to the other party and cooperates with the
other party in the other party’s efforts to avoid and/or minimize the degree of
such disclosure.

ARTICLE IX - GOVERNING LAW; DISPUTES

9.1 Governing Law. This Agreement will be construed and enforced according to
the laws of the Commonwealth of Massachusetts without regard to its choice of
laws or conflict of laws provision.

9.2 Disputes. If any controversy or claim arises out of the provisions of this
Agreement or the breach thereof, the parties will try to settle those conflicts
amicably between themselves through good faith negotiations. If the parties
cannot satisfactorily settle any such claim, dispute or controversy, the parties
hereby submit to the exclusive jurisdiction of the state and federal courts in
Suffolk County, Massachusetts for the resolution of all disputes arising
hereunder.

ARTICLE X - ASSIGNMENT; CONTRACTING

10.1 Assignment. Except as expressly permitted hereby, neither party shall
directly or indirectly sell, transfer, assign, or delegate in whole or in part
this Agreement, or any rights, duties, obligations or liabilities under this
Agreement (collectively “assign”), by operation of law or otherwise without the
prior written consent of the other party, such consent not to be unreasonably
withheld or delayed; provided, however, so long as the assignee is not a
competitor of the other party, either party shall have the right to assign all
of its rights, duties, obligations and liabilities under this Agreement to any
Affiliate or in connection with any sale, merger, consolidation,
recapitalization or reorganization involving in each case the sale of all or
substantially all of the capital stock of the party or the assets of such party
to which this Agreement relates. This Agreement shall inure to the benefit of
and be binding upon the permitted successors and assigns of OI and NMT.

10.2 Contracting. OI shall not engage the services of third party contractors,
subcontractors or consultants other than providers of standardized goods and
services that are widely available on a commercial basis (such as raw materials,
packaging, shipping and logistics) (“Contractors”) in the performance of its
obligations under this Agreement without the prior written consent of NMT,
specifying both the specific Contractor and the scope of work which it is
permitted to undertake, which consent shall not be unreasonably withheld. OI
will give NMT all information regarding such Contractor which NMT reasonably
requests, including a summary of OI’s past experience with such Contractor. In
the event that NMT permits OI to use the services of one or more Contractor,
each such Contractor shall sign a written agreement imposing all of the
provisions and restrictions of this Agreement relating to intellectual property,
confidentiality, quality assurance and any other provisions that are material to
OI’s performance

 

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hereunder upon such Contractor to the same extent as OI and employees of OI. OI
shall be fully responsible for each such Contractor’s performance as though the
services were performed by OI. NMT shall have no responsibility or obligation to
any such Contractor, and OI shall pay all such Contractors in accordance with
the agreement between them and ensure that all Contractors deliver all
deliverables for which they are responsible without lien or encumbrance.

10.3 No Other Assignment or Contracting. Any attempted assignment or contracting
of rights under this Agreement that is not in compliance with this Article X
shall be void and of no force or effect and the assignee shall acquire no rights
whatsoever and the non-assigning party shall not be required to recognize the
assignment. This provision limits both the right and the power to assign this
Agreement and all rights hereunder.

ARTICLE XI - TERM; TERMINATION

11.1 Term. This Agreement shall remain in force from the Effective Date until
terminated as provided in this Article XI.

11.2 Termination.

 

  (a) If any party is in default of any material obligation hereunder, and fails
to remedy such default within [**] days after written notice thereof by the
other party, this Agreement may be terminated, at the option of the party giving
the default notice, by written notice delivered to the alleged defaulting party.

 

  (b) Each party has the right to terminate this Agreement immediately by giving
written notice to the other party in the event of a filing of a petition in
bankruptcy, insolvency or reorganization against or by the other party, or if
the other party becomes subject to a composition for creditors, whether by law
or agreement, or the other party goes into receivership or becomes insolvent.

 

  (c) This Agreement shall terminate automatically upon any termination of the
License and Development Agreement.

11.3 Effects of Termination. Upon termination of this Agreement by either party:

 

  (a) OI may refuse to take further Orders or make further deliveries of
Material under this Agreement; provided, however, that OI shall deliver to NMT,
its Affiliates or Manufacturers, as the case may be, all Material that has
already been paid for by NMT hereunder, or is intended to be the reworked,
repaired or replacement Material for defective or non-conforming Material
hereunder;

 

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  (b) except for Orders required to be made during a Fixed Quarter, NMT may
cancel any or all Orders issued hereunder, without liability (except for costs
incurred by OI in connection with the Order prior to the date of cancellation),
and may refuse to make further Orders; provided, however, that termination of
this Agreement shall not affect NMT’s obligation to pay OI all amounts owing or
to become owing as a result of Material delivered to and accepted by NMT on or
prior to the date of such termination; and

 

  (c) each party shall return to the other party all Confidential Information of
the other party then in such party’s possession.

11.4 Survival of Obligations. The provisions of this Section 11.4, Sections 2.5,
5.4 (with respect to any due but unpaid amounts) and 11.3, and Articles VI, VII,
VIII, IX and XII of this Agreement shall survive any termination of this
Agreement and continue to be enforceable in accordance with their terms.

ARTICLE XII - NOTICES

Service of all notices provided for in this Agreement will be deemed duly given
if sent by registered or certified mail, postage prepaid, or shipped prepaid by
a nationally-recognized overnight courier service providing evidence of receipt
to the addresses below, or other such individuals or addresses furnished by
written notice given as provided herein to the other party. The date of mailing
or shipment will be the date of such notice. Notices shall be addressed as
follows, unless either party provides a new address to the other party:

 

To NMT:   NMT Medical, Inc.   27 Wormwood Street   Boston, MA 02115   Fax No.:
(617) 737-0924   Attn: With a Copy to:   Michael Lacascia, Esq.  
Wilmer Cutler Pickering Hale and Dorr, LLP   60 State Street   Boston, MA 02109
  Fax No.: (617) 526-5000 To OI:   Organogenesis Inc.   150 Dan Road   Canton,
Massachusetts 02021   Fax No.:   Attn: With a Copy to:   Andrew Z. Schwartz

 

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  Foley Hoag LLP   155 Seaport Boulevard   Boston, MA 02210   Fax No.:
(617) 832-7000

ARTICLE XIII - GENERAL

13.1 Force Majeure. If either party is prevented from performing, or is unable
to perform, any of its obligations under this Agreement due to any act of God,
fire, casualty, flood, war, strike, lock out, failure of public utilities,
epidemic, destruction of production facilities, insurrection, shortage of
materials, labor, equipment, transportation or energy, or any other cause beyond
the reasonable control of the party invoking this provision, and if such party
shall have used its best efforts to avoid such occurrence and minimize its
duration and has given prompt written notice to the other party, then the
affected party’s performance shall be excused and the time for performance shall
be extended for the period of delay or inability to perform due to such
occurrence.

13.2 Publicity. Neither party shall, without the prior written consent of the
other, disclose the specific terms and conditions of this Agreement, except as
may be required by applicable securities or other laws, rules, regulations or
the order of a court having jurisdiction.

13.3 Relationship of Parties. Nothing contained in this Agreement shall be
deemed to constitute either party as the agent or representative of the other
party, or both parties as joint venturers or partners for any purpose. Neither
party shall be responsible for the acts or omissions of the other party, and
neither party will have the authority to speak for, represent or obligate the
other party in any way without prior written authority from the other party.

13.4 Severability. If any provision of this Agreement is held by a court of
competent jurisdiction to be unenforceable because it is invalid or in conflict
with any law of any relevant jurisdiction, the validity of the remaining
provisions shall not be affected and the rights and obligations of the parties
shall be construed and enforced as if the Agreement did not contain the
particular provisions held to be unenforceable.

13.5 Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument, and facsimile signatures shall be deemed
originals.

13.6 Headings. The headings contained in this Agreement are for convenience of
reference only and shall not be considered in interpreting or construing this
Agreement.

13.7 Waivers. The waiver by either party of a breach or a default of any
provision of this Agreement by the other party shall not be construed as a
waiver of any succeeding breach or default of the same or any other provision,
nor shall any delay or omission on the part of either

 

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party to exercise or avail itself of any right, power or privilege that it has
or may have hereunder operated as a waiver of any right, power or privilege by
such party.

13.8 Fees. Each party will bear the cost of their own legal and accounting fees
except as specifically provided otherwise in this Agreement.

13.9 Entire Agreement. This Agreement (which includes the Appendices hereto)
constitutes the entire agreement between the parties with reference to the
subject matter hereof. No waiver, consent, modification or change of the terms
of this Agreement shall bind either party unless in a writing signed by both
parties by their duly authorized representatives. There are no understandings,
agreements, representations or warranties, express or implied, with respect to
the subject matter hereof except as expressly set forth in this Agreement. Only
the terms and conditions of this Agreement shall govern the transactions
contemplated hereunder, notwithstanding any additional, different or conflicting
terms that may be contained in any Order, acceptance, invoice or other document
provided by one party to the other.

[Signature Page to Follow]

 

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IN WITNESS WHEREOF, the parties hereto have caused this instrument to be duly
executed as of the Effective Date.

 

NMT MEDICAL, INC.     ORGANOGENESIS INC. By:   

/s/ John E. Ahern

    By:  

/s/ Geoff Mackay

Name:    John E. Ahern     Name:   Geoff Mackay Title:    President and CEO    
Title:   President and CEO

 

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APPENDIX A

Product Description and Specifications

 

Characteristics

  

Specification

Shelf Life    [**] Material Composition    [**] Processing Requirements    [**]
Differential Scanning Calorimetry (DSC) Temperature Onset    [**] Min. Tensile
Specification    [**] Min. Suture Pull Specification    [**] Labeling   

[**]

Packaging    [**] Workmanship    [**] Dimensions   

[**]

Embedded Particulate    [**]

ACCEPTANCE

There shall be no change in OI’s process without prior notification to and
approval of NMT.

Any non-conformance to the specified properties shall be cause for rejection.

CERTIFICATION

OI shall supply a Certificate of Compliance for each lot indicating conformance
to Specification above. Certificate of Compliance shall accompany the shipment.

Certificate of Compliance shall confirm that the Material is to specification as
per the most recent revision of the above specification and shall contain at a
minimum:

 

  •  

NMT part number including revision number

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  •  

Purchase order number;

 

  •  

OI lot number;

 

  •  

Material composition;

 

  •  

DSC value;

 

  •  

Minimum Tensile value;

 

  •  

Minimum Suture Pull value;

 

  •  

Quantity;

 

  •  

Quality control signature and date;

 

  •  

OI expiration date.

INSPECTION

Inspect per NMT IP-0120

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APPENDIX B

Pricing

The Price for Material shall be $[**] per Unit of Material, subject to the terms
and conditions of this Agreement.