Document:

exv10w8

 

Exhibit 10.8

SUPPLY & INVENTORY AGREEMENT

     THIS AGREEMENT is entered into by and between St. Francis Medical Technologies, Inc., a
California Corporation with offices at 960 Atlantic Avenue, Suite 102, Alameda, California 94501
(“SFMT”) and RMS Company, a Minnesota Corporation, with offices at 8600 Evergreen Blvd.,
Minneapolis, MN 55433 (“RMS”).

     WHEREAS, RMS is a provider of precision machined components (“Products”); and

     WHEREAS, SFMT is the manufacturer of medical devices (“Devices”) and wishes to purchase from
RMS, Products for use in its Devices:

     NOW THEREFORE, in consideration of the terms and provisions of this Agreement, and for other
good and valuable consideration, the receipt and sufficiency of which is acknowledged by the
execution and delivery of this Agreement, SFMT and RMS agree as follows:

     1. DEFINITIONS

     Product. Shall mean any of the Products supplied by RMS as listed in Appendix A.

     2. PURCHASE OF PRODUCT

          A. Prices. During the term of this Agreement, RMS shall manufacture and sell the Products
only to SFMT at the prices listed in Appendix A. Products may be added to or removed from Appendix
A by mutual agreement of the parties in writing. Prices shown in Appendix A are for specified
production quantities. Purchase Orders for less than a specified quantity will be priced at the
next lower quantity. Any reduction in cost of materials shall be passed onto SFMT. If the
Purchase Order is filled in partial quantities, or if pre-production samples are requested, an
additional charge may apply.

          B. Blanket Purchase Orders. At the beginning of each contract year, SFMT shall place a
Blanket Purchase Order by part number to cover the Estimated Annual Usage (EAU) plus the SFMT
desired inventory levels to be held at RMS. SFMT shall authorize Production Releases against the
Blanket Purchase Order to RMS at the first and sixth month of the contract year. For certain part
numbers, and by mutual agreement, SFMT may authorize the entire contract year quantity in the first
month Production Release.

          C. Quantities. Unless specifically agreed to the contrary, the quantity specified on a
Production Release is deemed to be approximate and RMS is permitted to produce over or under to the
extent of 10%. Where closer control is required, special arrangements must be made before the
Production Release is accepted.

          D. Cancellations. SFMT may terminate all or any part of a Purchase Order without cause.
SFMT’s liability shall be for completed Product at the unit price of the order; for all partially
completed work (computed by multiplying the percentage of completion, by the unit price

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

of the Product); for raw materials and engineering work computed on the basis of the actual
cost to RMS plus reasonable handling and overhead charges.

          E. Taxes. Prices do not include any taxes. All applicable taxes, including, but not limited
to, duty, excise, use or sales taxes, or any other taxes or assessments now or hereafter imposed,
levied, or increased by or under the authority of any federal, state or local law, rule or
regulation concerning the parts or fabrication or sale thereof shall be assumed and paid by SFMT.

     3. FINISHED PRODUCT INVENTORY

          A. Minimums. RMS shall maintain minimum inventory levels for each part number as defined by
SFMT in Appendix A.

          B. Releases. At the beginning of each week, or at other intervals selected by SFMT, SFMT
shall issue Inventory Releases to RMS for shipment during that week. There are no minimum
inventory release quantities for a given part number.

          C. Aged Inventory. SFMT agrees to receive and accept any inventory held by RMS for longer
than six months. RMS shall notify SFMT prior to the shipment of any such inventory.

     4. DELIVERY

          A. Freight. All shipments shall be “F.O.B. RMS plant”. SFMT shall pay the: 1) cost of freight
to SFMT facilities, 2) cost of any premium transport if requested by SFMT and 3) contract carrier
insurance costs if requested by SFMT.

          B. Passing of Title. Title and risk of loss or damage to the goods shall pass from RMS to
SFMT upon RMS’ delivery to the common carrier.

          C. Early Deliver. SFMT shall not be obliged to accept any deliveries tendered before the
agreed date and may return the Product to RMS at RMS’s sole risk and expense if delivered more than
five (5) days early. Alternatively SFMT may elect to retain such Products and pay the price
thereof in accordance with this Agreement.

          D. Failure to Deliver. RMS shall attempt to meet SFMT’s delivery dates. However, if
conditions arise which prevent compliance with delivery schedules, RMS shall not be liable for any
damage or penalty for delay or for failure to give notice of delay. Without limiting the
generality of the foregoing, RMS shall not be liable for delay by reason of inability to obtain the
necessary labor, materials, or manufacturing facilities, shortages, delays in transportation, or
any other causes beyond the control of RMS. SFMT’s sole remedy for delay shall be that SFMT may
terminate the Purchase Order for delays in delivery or other delays thirty (30) days after written
notice of such intention to RMS.

          E. Errors. Claims for errors in quantity, weight, number, or shipping damage must be made
within thirty (30) working days after receipt of the parts. RMS will not be responsible for claims
not reported within that period.

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     5. REJECTION

          SFMT is entitled to inspect the Goods and/or Services (including the performance of tests)
before or after receipt (but prior to disposition) and reject them for failure to conform to the
Purchase Order within thirty (30) days of receipt of such goods, regardless of whether any payment
has been made by SFMT, whether the nonconformity substantially impairs the value of the Goods
and/or Services, or whether the nonconformity may be cured by RMS.

     6. PAYMENT

          A. Payment Terms. Payment on properly rendered invoices shall be made by SFMT within thirty
(30) days from the date SFMT receives the invoice. If SFMT pays on the invoice within 10 days of
the date of the invoice, SFMT shall be entitled to a 1/2 % discount on such payment.

          B. Financial Condition. If the financial condition of SFMT at any time does not justify the
continuance of production or shipment on the terms or payment specified, RMS may require full or
partial payment in advance, or at its option shall be entitled to cancel any order then outstanding
and shall receive reimbursement for its reasonable and proper cancellation charges including
shipments (if any) previously made.

     7. SPECIFICATIONS

     All goods covered by an order will conform to the specifications (including all technical
data, designs and/or drawings) provided by SFMT. SFMT acknowledges and agrees that RMS is
manufacturing goods to SFMT’s specifications, and warrants their sufficiency. In the event that
orders are for goods previously manufactured by RMS for SFMT and SFMT has never provided
specifications, RMS will manufacture the goods to conform to the same goods previously delivered.
RMS is not providing any design and/or consulting services to SFMT, including, but not limited to,
services relating to the use of the goods or design of any system incorporating such goods.

     8. WARRANTY

     RMS warrants that all goods will conform to the specifications provided by SFMT and will be
free from defects in workmanship under normal use and maintenance conditions.

     RMS warrants that the title conveyed to all goods under this Agreement will be good, and
transfer of title of such goods will be rightful. RMS further warrants that the goods under this
Agreement shall be delivered free from any security interest or other lien or encumbrance.

     THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTIES REGARDING MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, RELATING TO THE USE OR
PERFORMANCE OF THE PARTS. RMS shall not be liable for its failure to conform with any requirements
not adequately identified by SFMT in the specifications, after RMS has requested clarification.
RMS’s express and implied warranties extend to any person who may reasonably be expected to use,
consume or to be affected by the goods and who is injured by breach of the

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warranty(ies). RMS may not exclude or limit the operation of this section with respect to
injury to the person of an individual to whom the warranty extends.

     9. PRODUCTS LIABILITY INSURANCE

     RMS shall, as a condition to this Agreement, secure and keep in full force and effect product
liability insurance providing coverage for and naming SFMT, in an amount of not less than
$2,000,000 per incident, and in an amount of $2,000,000 in the aggregate, with respect to any
claims that might be made by any third parties in the nature of product liability claims, whether
in the nature of personal or property injury or disability. RMS shall provide to SFMT, within not
more than ten (10) days from the signature of this Agreement, certificates evidencing the existence
of such insurance, together with appropriate riders or other amendments to that insurance,
providing for SFMT’s interest in compliance with this section 9. RMS shall issue irrevocable
instructions to its insurance agent and to the issuing company to notify SFMT of any discontinuance
or lapse of said insurance not less than thirty (30) days prior to the discontinuance becoming
effective.

     10. SUBCONTRACTING

     RMS must obtain prior written approval from SFMT to subcontract a machining portion of a
Purchase Order. In connection with any such subcontract, RMS may disclose confidential
specifications or other information to the subcontractor, but only if the subcontractor agrees in
writing to maintain such specifications as confidential in accordance with its usual business
practices.

     11. CONFIDENTIALITY

     Each party agrees to accept the disclosures of the other party made in the course of their
business relationship on a confidential basis, to exercise the same degree of care with respect to
the other party’s confidential information as is exercised in preserving and safeguarding its own
confidential information but no less than a reasonable degree of care, and not to disclose such
confidential information to other parties. This Article shall survive termination of this
Agreement.

     12. OWNERSHIP AND USE

     All ideas, inventions, copyrightable subject matter (including computer or electronic data
files, drawings, and other materials), and other items prepared by RMS or arising specifically in
connection with Purchase Orders (including only machine processes, fixturing and tooling) shall
remain the property of RMS. All items furnished by SFMT, shall be the property of SFMT and no
reproductions or property interest shall be retained by RMS. To the extent allowed by law,
copyrightable subject matter created by RMS shall be deemed “work made for hire”. Such items shall
only be used for the benefit of SFMT and shall not be disclosed to any other party. Such property
while in RMS’s custody shall be at RMS’s risk and shall be returned to SFMT in the same condition
as received, ordinary wear and tear accepted.

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     13. ASSIGNMENT

     Neither party may delegate or assign it’s rights, obligations, or duties under this Agreement
without the prior express written consent of the other part, except that SFMT may delegate or
assign this Agreement, in whole or in part, to any entity in which SFMT holds a direct or indirect
interest of at least fifty (50) percent, or to any successor of the business relating to the
Devices and/or Products. All terms and conditions of this Agreement shall apply to any successor
of SMFT.

     14. TERM

     Unless otherwise specified, this Agreement shall continue in force for each Product specified
in Appendix A for five (5) years from the date of this Agreement. This Agreement may be extended
by mutual agreement of the parties in writing.

     15. TERMINATION

     Either party shall have the right to terminate this Agreement:

          A. Breach of Agreement. For material breach of any provision of this Agreement, provided that
written notice has been given to the party of the alleged breach and the other party has not cured
the breach within thirty (30) days after delivery of such notice.

          B. Ceases to function. Automatically, by one party if the other party ceases to function as a
going concern, becomes insolvent, makes an assignment for the benefit of creditors, files a
petition in bankruptcy, permits a petition in bankruptcy to be filed against it, or admits in
writing its inability to pay its debts as they become due or if a receiver is appointed from a
substantial part of its assets.

     16. GOVERNING LAW

     This Agreement shall be governed by the laws of the State of Minnesota and, in particular, the
Minnesota Statutes Uniform Commercial Code (“UCC”), Chapter 336. SFMT and RMS each hereby consents
to the jurisdiction and venue of any local state or federal court located within the State of
Minnesota upon service of process made in accordance with the statutes of Minnesota and the United
States, and further agree that any and all causes of action whether or not arising under this
Agreement by and between the parties hereto shall only be brought in a local, state or federal
court situated within the State of Minnesota.

     17. ENTIRE AGREEMENT

     This Agreement is intended to be, and shall be construed as a binding Agreement summarizing
and evidencing the discussions between SFMT and RMS. This Agreement constitutes the entire
agreement between the parties, superseding all previous proposals, oral or written. No
representation or statement not contained on the original copy of this Agreement shall be binding
on the parties as a warrant or otherwise, nor shall this Agreement be modified or amended unless in
writing and signed by an authorized representative of the parties.

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     The obligations herein shall be binding once this Agreement is executed and delivered. The
individuals signing this letter represent that they are duly authorized signatories of the party
for which they are signing.

	 	 	 
	SFMT

/s/
Burney Winslow

	 	RMS

/s/ Lee M. Zachman

	 

	 	 
	By

/s/
Burney Winslow

	 	By

/s/ Lee M. Zachman
	 

	 	 
	Name

/s/
VP Engineering

	 	Name

/s/
President
	 

	 	 
	Title

/s/
7/16/04

	 	Title

/s/ 7/12/04
	 

	 	 
	Date

	 	Date

 

 

APPENDIX A

Rev 0
July 1, 2004

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Non-	 	 
	 	 	 	 	 	 	Sterilized	 	Sterilized
	P/N	 	Rev	 	Description	 	Price	 	Price
	100156
	 	B	 	6mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 
	100157
	 	B	 	8mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 
	100158
	 	B	 	10mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 
	100159
	 	B	 	12mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 
	100160
	 	B	 	14mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 
	100161
	 	B	 	16mm X STOP Assy, Packaged	 	$	[***Redacted]	 	 	$	[***Redacted]	 

 

			
	* *	 	Prices based on combined order quantities totaling [***Redacted] units

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.exv10w9

 

Exhibit 10.9

INVIBIO, INC.

AND

ST. FRANCIS MEDICAL TECHNOLOGIES, INC.

 

AGREEMENT FOR THE SUPPLY OF

POLYARYLETHERETHERKETONE

 

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

     THIS AGREEMENT is entered into as of 21st October 2002 (the “Effective Date”), by and between
Invibio, Inc., a Delaware corporation with offices at 3A Caledon Court, Greenville, South Carolina
29615 (“Supplier”), and St. Francis Medical Technologies, Inc., a Delaware corporation with offices
at 1900 Bates Avenue, Suite L, Concord, California 94520 (“Buyer”).

     WHEREAS, Supplier is engaged in the sale of polyaryletheretherketone resin–based raw materials
(“Biomaterials”) and Stock Shape.

     WHEREAS, Buyer wishes to purchase Biomaterials and/or Stock Shape from Supplier solely for use
in Products (as defined below), and Supplier is willing to supply Buyer with such Biomaterials
and/or Stock Shape solely for use with such Products on the terms and subject to the conditions
provided in this Agreement.

     NOW THEREFORE, in consideration of the foregoing and the mutual promises set forth below and
other good and valid consideration, the sufficiency of which is acknowledged by the parties,
Supplier and Buyer agree as follows:

     1. DEFINITIONS

     “Affiliates:” A Party on the one hand, and business concerns, organizations, or individuals or
other entities on the other hand are affiliates of each other if, directly or indirectly, (a)
either one has the power to control the other, or (b) a third party controls or has the power to
control both. Reference in this Agreement to “Buyer” is intended to encompass all Affiliates of
Buyer.

     “Agreement” shall mean this Supply Agreement, as it may be amended from time to time as
permitted herein.

     “Biomaterials” shall mean Supplier’s polyaryletheretherketone resin–based raw material.

     “Products” shall mean those devices described in Exhibit A which incorporate the Stock Shape
and/or Biomaterials.

     “Specifications” means the specifications for the Biomaterials set forth in Exhibit B attached
hereto.

     “Stock Shape” shall mean extruded rod stock composed of Biomaterials that have been melt
processed so as to conform with the Supply Manufacturing Definition.

     “Supply Manufacturing Definition” shall mean the dimensional, mechanical and physical
properties of the Stock Shape, as set forth in Exhibit C. Such Supply Manufacturing Definition may
be changed, modified, amended or supplemented from time to time by Supplier upon giving not less
than three months written notice to the Buyer. The Buyer shall be entitled, during that notice
period, to place one final order for delivery at the earliest reasonably practicable date for a
quantity of the Stock Shape manufactured to the Supply Manufacturing Definition then in force which
shall be no greater than the total quantity of Stock Shape ordered by Buyer in the twelve (12)
month period immediately prior to the notification date.

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

2. SALE AND PURCHASE OF BIOMATERIALS AND STOCK SHAPE

          2.1 Sale and Purchase.

               (a) During the term of this Agreement and upon the terms and conditions of this Agreement,
Buyer may purchase from time to time exclusively from Supplier and Supplier shall, provided that
Buyer is in compliance with this Agreement, sell to Buyer Biomaterials and Stock Shape for use
solely in connection with the worldwide use, manufacture, manufacture by others for Buyer,
distribution, import, export, offer for sale, and sale by Buyer of Products to third parties.
Buyer shall place orders for Biomaterials or Stock Shape in bulk with a lead time of at least
ninety (90) days and Buyer shall place no more than two (2) orders within any twelve (12) month
period (the “Bi–annual Order”); it being understood that Supplier shall have no obligation of any
kind to supply Biomaterials or Stock Shape under this Agreement in amounts in excess of the
Bi–annual Order. The Buyer shall with its first Order and then on each anniversary of the date of
this Agreement provide a non–binding, written forecast setting out Buyer’s anticipated requirements
for the Biomaterials and Stock Shape for the twelve month period.

               (b) Notwithstanding anything to the contrary contained in Section 2.1 (a), Supplier shall have
no liability or obligation to Buyer to sell any Biomaterials or Stock Shape to Buyer in the event:
(1) of any termination of this Agreement by Supplier pursuant to Section 3; or (2) Buyer fails to
make any payment required by this Agreement within thirty (30) days after such payment is due
pursuant to the terms of this Agreement (a “Payment Default”). Buyer shall pay interest at a rate
of 10% per annum on any payments that are past due under this Agreement.

               (c) Provided Seller is in compliance with this Agreement, Buyer shall pay to Supplier [***Redacted] United States dollars (US$ [***Redacted]) per kilogram for samples of Biomaterials
and Biomaterials delivered to Buyer. Buyer shall pay to Supplier [***Redacted] United
States dollars (US$[***Redacted]) per meter of Twelve (12) mm diameter Stock Shape delivered to Buyer
and [***Redacted] United States dollars (US$[***Redacted]) per meter of Twenty (20) mm
diameter Stock Shape delivered to Buyer. All payments due under this section shall be made
immediately available in cleared funds within (30) days of the date of invoice and receipt of
Biomaterials or Stock Shape by Buyer. Prices are subject to change at Supplier’s sole discretion,
provided that Buyer is given at least ([***Redacted]) ([***Redacted]) days notice of such change and provided further
that such price increases are no more frequent than annually and in no event no greater in amount
than [***Redacted] percent ([***Redacted]%) per annum. There shall be no price increase for a period of at least one
year from the effective date of this Agreement.

     2.2 Guaranteed Annual Payment. Provided Seller is in compliance with this Agreement,
in addition to other payments required to be paid to Supplier by Buyer under this Agreement, Buyer
shall pay to Supplier guaranteed annual payments (the “Guaranteed Annual Payment”) as follows:

	 	 	 	 	 
	 

	 	US$[***Redacted]
	 	No later than thirty (30) days after execution of this Agreement
	 
	 	 	 	 
	 

	 	US$[***Redacted]
	 	Each year thereafter on the anniversary of the effective date of this Agreement.

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

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     In the event that this Agreement is terminated for any reason other than for material
breach by Supplier, Buyer shall immediately pay to Supplier all the Guaranteed Annual Payments that
would have been due to Supplier under the full term of this Agreement as set forth in Section 3.1.
Each Guaranteed Annual Payment shall be paid to Supplier in United States dollars to an account
designated by Supplier.

          2.3 Delivery. All Biomaterials and Stock Shape delivered to Buyer shall be F.O.B.
Supplier’s shipping point, Philadelphia, Pennsylvania, U.S.A. and upon delivery to the proper
carrier as agreed to by Buyer, title and risk of loss and delay shall pass to Buyer.

          2.4 Rejection of Biomaterial or Stock Shape for Nonconformity. Buyer shall provide,
within thirty (30) calendar days, a written confirmation that the Biomaterials of each shipment
conform with the Specifications, or if applicable, that the Stock Shape of each shipment conforms
with the Supply Manufacturing Definition. Buyer may reject all or any portion of any shipment of
Biomaterials and/or Stock Shape if, and only if: (a) the Buyer reasonably believes such shipment is
non–conforming in any material respect with (i) in the case of the Biomaterials, the Specification
or (ii) in the case of the Stock Shape, the Supply Manufacturing Definition, and (b) the provisions
of this Section 2.4 are satisfied. In order to reject a shipment, Buyer must give written notice
to Supplier of the rejection of the Biomaterials or Stock Shape within thirty (30) calendar days of
receipt of the shipment, including a written indication of Buyer’s reasons for the rejection.
Buyer shall cooperate with Supplier in determining the extent, if any, of non–conforming
Biomaterials or Stock Shape. If no such notice of rejection is given within thirty (30) calendar
days of receipt of the shipment, Buyer shall be deemed to have accepted such delivery of
Biomaterials or Stock Shape and acknowledged such Biomaterial’s conformance with the Specification
or such Stock Shape’s conformance with the Supply Manufacturing Definition. In any event, Buyer
shall pay the purchase price, insurance and freight charges for each shipment (whether or not
rejected as otherwise provided herein) and may not elect to withhold the purchase price (or
applicable insurance and freight charges) of properly rejected Stock Shape, provided that if
Supplier disputes the rejection, a refund of payment therefor by Supplier shall be made for such
Biomaterials and/or Stock Shape determined to be materially non–conforming at the time the dispute
is resolved. Supplier shall notify Buyer as promptly as reasonably possible whether it accepts
Buyer’s basis for any rejection. Buyer shall not withhold any payment due under Section 2.2 of
this Agreement on the basis of rejected Biomaterials or Stock Shape.

          2.5 Certain Additional Covenants.

               (a) Limited Use. Absent prior written permission from Supplier, Buyer shall use the
Biomaterials and/or Stock Shape only in the Products. Buyer shall not sell or otherwise transfer
any Biomaterials or Stock Shape to any third party, except as incorporated in Products in the
ordinary course of business and except as otherwise provided in this Agreement. Buyer shall not
grant any sublicense for any right, express or implied, arising under this Agreement; provided
however, Buyer can have a third party shape, form, mold, machine and/or manufacture Products from
the Biomaterials and/or the Stock Shape for Buyer. Buyer shall not use any other
polyaryletheretherketone, other than the Biomaterials or the Stock Shape, in the Products. Nothing
in this Agreement shall preclude Supplier from providing Biomaterials or Stock Shape to any third
parties. Notwithstanding anything to the contrary contained herein, Supplier shall be entitled to

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discontinue any further shipments and/or sales hereunder (and shall have no liability
therefor) upon 10 days prior written notice to Buyer if Supplier reasonably believes that Buyer has
breached this Section.

               (b) Alterations. Buyer shall not make any alterations to the chemical structure of
the Biomaterials and/or Stock Shape, including, but not limited to the following: alteration of the
bulk particle size; alteration by addition of extenders, colorants, or plasticizers; alteration by
addition of additives that have a biological function; alteration by addition of any other
additives not specifically mentioned herein; alteration to the molecular weight or chain branching;
alteration to the solution or melt viscosity; or, alteration to the thermal stability or other
thermal properties; or plasma coatings; or surface modifications. Notwithstanding the above, as
previously indicated, it is understood that Buyer and/or a third party for Buyer may shape, form,
mold, machine and manufacture Products from the Biomaterials and Stock Shape and such activities
shall not be considered alterations.

               (c) Safety/Efficacy Issues. Supplier and Buyer shall give each other prompt written
notice after such party or its Affiliates becomes aware of any adverse facts or issues relating to
the safety or efficacy of any Biomaterials, Stock Shape or Products sold hereunder. Buyer shall
notify Supplier on at least an annual basis in a brief summary form (with Supplier able to receive
reasonable additional information upon request) concerning reports to the United States Food and
Drug Administration (“FDA”) and/or customer complaints arising in the normal course of Buyer’s
business relating to the Biomaterials, Stock Shape or Products. To the extent that this
information is confidential, Supplier shall maintain such information as confidential in accordance
with this Agreement. It shall be Buyer’s ultimate responsibility to determine the efficacy and
safety of use of the Biomaterials and/or the Stock Shape for the Products. With the exception of
Products that are FDA Class 3 devices, in the event that Supplier reasonably believes that any such
adverse facts or issues relating to the safety of the Biomaterials, Stock Shape or Products may
result in liability to Supplier, Supplier may, at its sole discretion, immediately terminate this
Agreement. For Products that are FDA Class 3 devices, Supplier may not terminate this Agreement
based on safety or efficacy issues relating solely to the Products, unless such the sale and
marketing of such Products is prohibited by FDA.

               (d) Regulatory Responsibilities. Supplier and Supplier’s Affiliates shall manufacture
the Biomaterials and Stock Shape under this Agreement in compliance with ISO9001 in accordance with
Supplier’s quality system protocols. Upon terms of confidentiality acceptable to Supplier,
Supplier agrees to provide reasonable assistance to Buyer in obtaining governmental approvals;
including providing a letter of entitlement, at Buyer’s request, (in accordance with the pro–forma
set out in Appendix E) to the United States Food and Drug Administration (“FDA”) and to Buyer to
enable FDA to reference Supplier’s master file on Buyer’s behalf and providing biocompatibility
data, and updates on such data, in relation to the Biomaterials.

               (e) Intellectual Property. Supplier or its Affiliates is the sole owner of any and
all proprietary rights in and to the Biomaterials and Stock Shape that have been or are developed
by Supplier or its Affiliates. This Agreement shall not be construed as to create any ownership by
Buyer in any proprietary rights of Supplier or its Affiliates. Each party shall continue to own
all proprietary rights in any inventions, ideas, discoveries, patents, copyrights, trademarks,
trade secrets

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and other intellectual property rights (collectively, the “Proprietary Assets”) that it owns
as of the date of this Agreement. All inventions, including improvements, and all ideas or
discoveries conceived by or made in the course of this Agreement and relating to the Biomaterials
or Stock Shape, whether patentable or not, shall be the sole property of the party that develops
the same. Except for the worldwide license Buyer shall have to use the Biomaterials and/or the
Stock Shape obtained pursuant to this Agreement, nothing in this Agreement shall be deemed to
waive, impair, assign or license any patent, copyright, trademark, trade secret or other
proprietary rights of Supplier or its Affiliates, and no payments hereunder shall be deemed
consideration with respect to any such proprietary rights. Supplier or its Affiliates is the sole
owner of any and all proprietary rights in and to the trademarks INVIBIO, PEEK–OPTIMA and OPTIMA,
(the “Trademarks”). Buyer shall have no obligation to use said Trademark, however if Buyer, in
Buyer’s sole discretion, chooses to use said Trademarks, Buyer shall use the Trademarks only in
connection with the sale and marketing of Products and in accordance with the Invibio Trademark
Usage Agreement by and between Supplier or Supplier’s Affiliates and Buyer and attached hereto as
Exhibit D. Buyer shall not assert any rights in the goodwill of the Trademarks and shall not
challenge the validity of Supplier’s or its Affiliates’ rights in and to, or the validity of any
registrations for, the Trademarks.

          2.6 Confidentiality Obligations.

               (a) The confidential information of the parties that is disclosed during the course of this
Agreement shall be maintained in confidence and shall not be disclosed to any other person, firm or
agency, governmental or private, (other than employees or agents of the receiving party who have a
need to know such information and who are under written obligations of confidentiality) without the
prior written consent of the providing party, except to the extent that such information:

                    i. is known at the time of its receipt by the receiving party; or

                    ii. is in the public domain other than through the fault of the receiving party, or

                    iii. is subsequently disclosed to the receiving party by a third party who may lawfully do so
and who is not under an obligation of confidentiality to the providing party, or

                    iv. is required to be disclosed in a judicial or administrative proceeding after reasonable
legal remedies for maintaining the subject matter in confidence have been exhausted by the
disclosing party.

                    v. is developed independently by the receiving party without reference to the confidential
information of the disclosing party.

               (b) Duration of Confidentiality Obligations. Obligations of confidentiality shall
extend until such time as the information in question falls within one of the exceptions set forth
in Section 2.6(a).

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               (c) Financial Terms of this Agreement. The parties shall not disclose the financial
terms of this Agreement to any third party (other than employees of the party or that party’s
Affiliates who have a need to know such information and who are under written obligations of
confidentiality) without the prior written consent of the other party, unless such disclosure is
otherwise required by law or other applicable regulation.

               (d) Return of Confidential Information. Upon termination of this Agreement, each
party shall immediately return to the disclosing party all confidential information disclosed
during the course of this Agreement, and all extracts, abstracts, charts or copies made therefrom.
The receiving party may retain one copy of the confidential information for archival purposes.

     3. TERMINATION

          3.1 Term. Unless terminated by either party pursuant to the other provisions of this
Agreement, this Agreement shall continue in effect up to and including the fifth anniversary of the
Effective Date of this Agreement.

          3.2 Termination by Mutual Agreement. This Agreement may be terminated upon mutual
written agreement between the parties. Termination of this Agreement under this Section shall
result in a complete forfeiture by Buyer of any payments made or then owing under Sections 2.2 of
this Agreement.

          3.3 Termination for Default. If either party materially defaults in the performance
of this Agreement and such default or noncompliance shall not have been remedied within thirty (30)
calendar days after the receipt by the defaulting party of a written notice thereof from the other
party, the party not in default may terminate this Agreement. It will not be a material default
under this Agreement, if the defaulting party shall begin promptly to remedy such default and shall
continue diligent efforts to cure such default as soon as reasonably practicable, as long as such
default is cured within ninety (90) calendar days of receipt of such written notice. Termination
of this Agreement for a material default of the Buyer shall result in a complete forfeiture by
Buyer of any payments made or then owing under Sections 2.2 of this Agreement.

          3.4 Termination By Buyer. Notwithstanding any other sections, as Buyer has agreed to
make purchases exclusively from Suppler pursuant to Section 2.1 Sale and Purchase, Buyer may
terminate this Agreement at anytime. Any rights that Buyer has in the Biomaterials or the Stock
Shape shall survive such termination. Upon termination by Buyer no further unaccrued payments
shall be due to Supplier per Section 2.l(c) Sale and Purchase.

          3.5 Surviving Obligations on Termination. Except as provided elsewhere in this
Agreement, in the event of termination of this Agreement as provided herein, this Agreement shall
immediately terminate and be of no further force and effect, and there shall be no liability on the
part of either party, provided that (a) this Section and Sections 2.5, 2.6, 4.1, 4.2, 4.3 5.8, and
5.9 shall survive the termination of this Agreement, and (b) any rights of Supplier to payments
accrued under section 2.1(c) as of the date of termination of this Agreement hereunder shall
survive termination of this Agreement. In the event of termination, at Buyer’s sole option, Buyer
may return to Supplier all

-6-

 

Biomaterials and/or Stock Shape in its possession which have not been integrated into the
Products as of the date of termination, and Supplier shall refund the purchase price paid by Buyer.
In the event of termination, at Buyer’s sole option, Buyer may sell through to third parties any
Products and do all acts with respect to any remaining Biomaterials and/or Stock Shape which acts
are not a material breach of this Agreement.

          3.6 Bankruptcy. A Party shall inform the other Party of the commencement of any
bankruptcy proceedings by or against that Party, at least thirty (30) calendar days prior to the
date of the commencement of such proceedings. A Party’s failure to timely provide such notice
shall be deemed a material, pre–petition incurable breach and shall result in immediate termination
of this Agreement, notwithstanding any provision to the contrary contained within this Agreement.
Either Party, at its sole discretion, may terminate this Agreement upon timely notice under this
Section of the commencement of any bankruptcy proceedings by or against the other Party.

     4. WARRANTY AND INDEMNIFICATION

          4.1 Supplier Warranties.

               (a) Supplier warrants to Buyer that the Biomaterials when shipped to Buyer by Supplier shall
conform in all material respect to the Specifications as then in effect and that the Stock Shape
when shipped to Buyer by Supplier shall conform in all material respect to the Supply Manufacturing
Definition as then in effect. Supplier warrants, to its current knowledge and belief that the
Biomaterials and Stock Shape do not infringe any patent rights of any third party. Notwithstanding
any other provision of this Agreement, Buyer shall not make any warranties or representations
regarding the Biomaterials and Stock Shape other than those warranties and representations
expressly made by Supplier herein.

               (b) EXCEPT FOR THE FOREGOING WARRANTIES, SUPPLIER MAKES NO WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, A WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR OF INTELLECTUAL
PROPERTY NON–INFRINGEMENT, INCLUDING BUT NOT LIMITED TO PATENT NON–INFRINGEMENT, WHICH ARE
EXPRESSLY DISCLAIMED, WHETHER EXPRESS OR IMPLIED, IN FACT OR BY LAW, AND SUPPLIER SHALL HAVE NO
FURTHER OBLIGATION OR LIABILITY WITH RESPECT TO THE BIOMATERIALS AND STOCK SHAPE. SUPPLIER DOES
NOT MAKE ANY WARRANTY TO BUYER’S CUSTOMERS OR AGENTS. SUPPLIER HAS NOT AUTHORIZED ANYONE TO MAKE
ANY REPRESENTATION OR WARRANTY OTHER THAN AS PROVIDED ABOVE. SUPPLIER SHALL IN NO EVENT BE LIABLE
FOR ANY GENERAL, INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, INCIDENTAL OR SIMILAR DAMAGES,
INCLUDING WITHOUT LIMITATION, DAMAGES FOR HARM TO BUSINESS, LOST PROFITS OR LOST SAVINGS, EVEN IF
SUPPLIER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES REGARDLESS OF THE FORM OF ACTION.

               (c) Notwithstanding anything to the contrary contained herein, if Buyer receives any
Biomaterials which do not generally conform to the Specifications or if Buyer receives any Stock
Shape which does not generally conform to the Supply Manufacturing Definition and

-7-

 

Buyer notifies Supplier in writing of such failure within the time period provided in Section
2.4 of this Agreement, then Buyer’s exclusive remedy shall be, and is limited to, the repayment of
any applicable purchase price paid to Supplier for such Biomaterials or Stock Shape or at the
option of the Buyer, the provision of replacement Biomaterials or Stock Shape in like quantity as
soon as reasonably practicable but in no event later than ninety (90) days after receipt of written
notice of such failure. Buyer’s exclusive remedy and Supplier’s sole liability under this warranty
shall, in any event, be expressly limited to the repayment of any applicable amounts paid under
Section 2.1 EXCEPT AS PROVIDED ABOVE, SUPPLIER SHALL NOT BE LIABLE TO BUYER FOR ANY DAMAGES UNDER
THIS WARRANTY OR THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, DAMAGES COVERED IN SECTION 4.1(b)
ABOVE, FOR ANY CLAM INVOLVING THE BIOMATERIALS AND/OR STOCK SHAPE.

          4.2 Buyer Indemnification.

               (a) Buyer agrees to indemnify, defend and hold harmless Supplier and its Affiliates (including
without limitation is directors, officers, employees, agent, representatives and shareholders) from
and against any and all claims by any third party, including any claims, actions, suits,
proceedings, liabilities, obligations, losses, damages (including any fines, penalties or punitive
damages), settlement, interests, costs and expenses (including attorneys’ fees, court costs and
other reasonable out–of–pocket expenses incurred in investigating, preparing or defending any of
the foregoing or in enforcing rights hereunder) resulting therefrom by reason of or in connection
with or arising out of or relating to any sale, transfer, or use by any person of any Products or
services sold or otherwise made available by Buyer or any related persons or entities (including
without limitation any current or former direct or indirect parent or subsidiary or any Affiliate
or associate thereof) in which Biomaterials and/or Stock Shape are incorporated or otherwise
involved, except to the extent arising or resulting from (i) the failure of the Biomaterials to
conform with the Specifications and such failure is proved to be the actual and proximate cause of
the claimed personal injury and/or property damage or (ii) the failure of the Stock Shape to
conform with the Supply Manufacturing Definition and such failure is proved to be the actual and
proximate cause of the claimed personal injury and/or property damage.

               (b) Should Supplier or any person or entity seek indemnification hereunder, Supplier must
promptly notify Buyer within sixty (60) calendar days of the date of actual notice of any claim for
which it seeks indemnification, provided that any such failure shall not relieve Buyer of its
obligations hereunder except to the extent that Buyer is actually prejudiced by such failure to
notify. Supplier shall promptly provide Buyer, on an ongoing basis, with all information and
materials relating to the claim. In the event that Buyer shall be called upon to provide the
indemnification set forth herein, Buyer shall control the defense, litigation and/or settlement of
such claim (except to the extent that any settlement involves some commitments, responsibilities
and/or obligations on the part of Supplier, in which case such settlement shall require the prior
written consent of the Supplier which will not be unreasonably withheld), action or proceeding with
attorneys of its choosing, and the Supplier and all other indemnified persons or entities shall
cooperate as may reasonably be required by Buyer (but at Buyer’s reasonable expense in such
defense, litigation and/or settlement). Supplier reserves the right to participate at its own cost
in any proceedings with counsel of its own choosing provided that if Buyer fails to appoint
suitably and reasonably qualified counsel, Buyer shall be responsible for all attorney’s fees and
costs incurred

-8-

 

by or charged to Supplier; provided however that Supplier shall have ten (10) days from the
time Supplier is notified of counsel selected by Buyer to object to such counsel selected by Buyer,
and thereafter Supplier cannot object to such counsel and in no event shall Buyer thereafter be
responsible for any attorney’s fees and costs incurred by or charged to Supplier. Supplier, Buyer
and their respective counsel will cooperate fully and make available all books, records,
information and witnesses under their control and reasonably necessary or useful in connection with
the defense of any such claim. Buyer shall not, in the defense of any such claim or proceeding,
except with the prior written consent of Supplier which shall not be unreasonably withheld, consent
to the entry of any judgment or enter into any settlement which would be to the financial or other
detriment of Supplier. Buyer shall confer with Supplier concerning the terms of any proposed
settlement or judgment arising in the course of such defense prior to consenting to the entry of
any judgment or entering in any settlement. Buyer shall use reasonable efforts to prevent Supplier
from being added as a defendant to any lawsuit involving or relating to Products, and shall use
reasonable efforts to seek immediate dismissal, or summary judgment of non–liability of Supplier
for any lawsuit involving or relating to Products in which Supplier is a named defendant, by
employing defense mechanisms including, but not limited to, those set forth in the Biomaterials
Access Assurance Act of 1998, as codified in 21 U.S.C. § 1601 et. seq., and the bulk supplier
and/or learned intermediary doctrines.

          4.3 Buyer Insurance. Buyer shall maintain, during the entire term of its
indemnification obligations hereunder, comprehensive liability insurance, including medical implant
product liability coverage, in the minimum amounts of U.S. $3,000,000 prior to commencement of
clinical trials and US $5,000,000 upon commencement of and during all US clinical trials of a
Product and US $7,000,000 upon the first receipt of FDA clearance to market a Product in the US and
thereafter per occurrence for damage, injury and/or death to persons (the “Insurance Policy”). The
Insurance Policy shall: (a) be provided by an insurance company or underwriter reasonably
acceptable to Supplier and (b) name Supplier as an additional insured. Buyer shall provide
Supplier with a certificate of insurance indicating the existence and coverage of the Insurance
Policy, that all outstanding periodical premiums have been paid, and indicating that the coverage
shall not be canceled nor modified unless at least thirty (30) calendar days prior written notice
thereof has been provide to Supplier. Such certificate of insurance shall be provided on the
Effective Date and on each anniversary thereof during the entire term of Buyer’s indemnification
obligations hereunder. In the event that the Insurance Policy is canceled, or modified such that
it does not include all requirements of this Section, such cancellation or modification shall
constitute a material default and Supplier shall have the right to immediately terminate this
Agreement without prior written notice as otherwise required under Section 3.3. Termination of
this Agreement under this Section shall result in a complete forfeiture by Buyer of any payments
made or then owing under Section 2.2 of this Agreement.

     5. GENERAL PRO VISIONS

          5.1 Entire Agreement. This Agreement contains the entire agreement of the parties
regarding the subject matter hereof and supersedes all prior agreements, understandings and
negotiations regarding the same. This Agreement may not be changed, modified, amended or
supplemented except by a written instrument signed by both parties. Furthermore, it is the
intention of the parties that this Agreement be controlling over additional or different terms of
any order,

-9-

 

confirmation, invoice or similar document, even if accepted in writing by both parties, and
that waivers and amendments shall be effective only if made by non–preprinted agreements clearly
understood by both parties to be an amendment or waiver hereof.

          5.2 Assignment. This Agreement may be assigned by Buyer to any entity that agrees to
and can perform all the duties and obligations of Buyer and said entity shall receive all the
benefits of the Buyer.

          5.3 Severability. If any provisions of this Agreement shall be held illegal or
unenforceable, in any country or territory, that provision shall be limited or eliminated to the
minimum extent necessary so that this Agreement shall otherwise remain in full force and effect and
enforceable.

          5.4 Further Assurances. Each party hereto agree to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary or appropriate in
order to carry out the purposes and intent of this Agreement.

          5.5 Notice and Reports. All notices, consents or approvals required by this Agreement
shall be in writing sent by certified or registered air mail, postage prepaid or by facsimile or
email (confirmed by such certified or registered mail) to the respective party at the address
specified in the first paragraph hereof or such other addresses as may be designated in writing by
the respective party. Notices shall be deemed effective on the date of mailing.

          5.6 Relationships of the Parties. Both parties are independent contractors under this
Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to
constitute Supplier and Buyer as partners, agents or joint venturers with respect to this
Agreement. Neither party hereto shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other party or to bind the other party to
any contract, agreement or undertaking with any third party. There is not now, nor has there ever
existed, any common ownership, common management or other affiliation between Supplier and Buyer.
Supplier and its Affiliates have not and will not participate in the design, manufacture, sale or
distribution of any Products.

          5.7 Waiver. The waiver by either party of a breach of any provisions contained herein
shall be in writing and shall in no way be construed as a waiver of any succeeding breach of such
provision or the waiver of the provision itself.

          5.8 Applicable Law. This agreement shall be governed by and construed in accordance
with the laws of the state of Illinois without regard to the conflict of law provisions thereof.

          5.9 Dispute Resolution. Any dispute between the parties arising out of or related to
this Agreement shall, in the first instance, be the subject of a meeting between the parties to
negotiate a resolution of such dispute. The meeting shall be conducted by at least one individual
from each party who has full decision making authority with respect to the dispute at issue.
Should the negotiations not lead to a settlement of the dispute within thirty (30) calendar days of
the date of

-10-

 

the meeting, either party may then initiate binding arbitration in accordance with the then
Commercial Arbitration Rules (the “Rules”) of the American Arbitration Association (“AAA”). In the
event that a party refuses to participate in the meeting, then the other party may immediately
initiate binding arbitration as otherwise provided in this Section. A single neutral arbitrator
shall be appointed in accordance with the Rules. The arbitrator shall be experienced in the area
of supply and licensing of biomaterials and/or medical implant components or devices, and in the
area of intellectual property relating to biomaterials and/or medical implants, components or
devices. The arbitration shall take place in Chicago, Illinois and be based upon Illinois law
pursuant to Section 5.8. The arbitrators, shall render a written opinion and an award. The only
discovery that shall be permitted is the production of documents by a party to this Agreement. The
parties shall share equally in the cost, paid to the AAA for the arbitrator and for AAA
administration, of any arbitration. No party has a right to appeal the arbitrator’s ruling, to any
court or otherwise. Judgment upon the arbitrator’s ruling may be entered in any Court of competent
jurisdiction.

          5.10 Captions. Paragraph captions are inserted for convenience only, and in no way
are to be construed to define, limit or affect the construction or interpretation hereof.

          5.11 Force Majeure. A party shall not be liable for nonperformance or delay in
performance caused by any event reasonably beyond the control of such party including, but not
limited to, wars, hostilities, revolutions, riots, civil commotion, national emergency, strikes,
lockouts, unavailability of supplies, epidemics, fire, flood, earthquake, force of nature,
explosion, embargo, or any other Act of God, or any law, proclamation, regulation, ordinance, or
other act or order of any court, government or governmental agency, provided that the party seeking
such relief from nonperformance makes reasonable efforts to overcome any such occurrences and
promptly notifies the other party in writing of such circumstances.

-11-

 

     IN WITNESS WHEREOF, and by their signatures below, the undersigned persons represent that they
have the requisite authority to bind their respective companies to the terms and conditions set
forth herein.

	 	 	 	 	 	 	 	 	 	 	 	 	 
	SUPPLIER:	 	 	 	BUYER:
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	INVIBIO, INC.	 	 	 	ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	By:

	 	 	 	/s/ Michael J. Callahan 	 	 	 	By:	 	 	 	/s/ Burney Winslow          
            10/21/02
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Print Name:	 	 	Michael J. Callahan 	 	 	 	Print Name:	 	 	Burney Winslow 
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Title:

	 	 	 	President 	 	 	 	Title:	 	 	 	VP Engineering 
	 	 	 	 	 	 	 

-12-

 

EXHIBIT A

Products

     Product details including catalog or
article number or name or other identifying
descriptions shall be provided by Buyer as
soon as they become
available.

 

 

	 	 	 
	PEEK–OPTIMA®

	 	PEEK–OPTIMA® LT1
	SPECIFICATIONS

	 	Page 1 of 1
	MANUAL

	 	Rev: 0
	ISSUE 1

	 	Date: 23rd Oct 2001

EXHIBIT B

The Specification

			
	GRADE PEEK–OPTIMA® LT 1
	 	SPECIFICATION Ref. INV 01

	 	 	 	 	 	 	 
	          PROPERTY	 	TEST METHOD	 	UNITS	 	SPECIFICATION
	 
	Melt Viscosity
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Melt Stability
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Colour
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Black Speck (sized film)
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Black Speck (Granule)–
Average
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	MF1
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Tensile Strength (at yield)
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Tensile Elongation (at break)
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Impact Strength
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Notched Izod
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Flexural Modulus
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Flexural Strength
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Specific Gravity
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Moisture Content1
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Extraneous Contam
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Granule Cut2
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Glass Transition Temperature
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Melting Point
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Re–crystallisation Temperature
	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]

Notes:

	1.	 	[***Redacted]
	 
	 	 	[***Redacted]
	 
	2.	 	[***Redacted]

	 	 	 	[***Redacted]
	 
	 	 	 	[***Redacted]

	3.	 	[***Redacted]

Granules are dusted with Calcium Stearate as a processing lubricant in the range 0.001 – 0.05 %

SPECIFICATION APPROVAL

	 	 	 	 	 
	Quality Assurance & Laboratory Manager:

	 	 	 	.([***Redacted])
	 

	 	 

	 	 
	23rd October 2001
	 	 	 	 

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

	 	 	 
	PEEK–OPTIMA®
SPECIFICATIONS

	 	GRADE: PEEK–OPTIMA LT1 R20
	MANUAL

	 	Page 1 of 1
	ISSUE 1

	 	REVISION: 3
	 

	 	DATE: 17th SEPTEMBER 2001

EXHIBIT C

Supply Manufacturing Definition

PEEK–OPTIMA LT1 Extruded Rod.

Grade LT1R20

Diameter 20 mm +0.2mm/ +1.1mm

Sampling and testing:

The tests shown below shall be performed by supplier on material taken from the start and end of
each production batch. The batch shall meet the requirements of this Supply Manufacturing
Definition when the results of these tests agree with the values shown below.

	 	 	 	 	 	 	 	 	 
	          PROPERTY	 	TEST METHOD	 	UNITS	 	VALUE
	 
	Tensile strength (at Yield)

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	 
	 	 	 	 	 	 	 	 
	Tensile Elongation

	 	[***Redacted]	 	[***Redacted]		[***Redacted]
	 
	 	 	 	 	 	 	 	 
	Flexural strength

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	 
	 	 	 	 	 	 	 	 
	Flexural modulus

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	 
	 	 	 	 	 	 	 	 
	Notched impact strength

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	 
	 	 	 	 	 	 	 	 
	Density

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	 
	 	 	 	 	 	 	 	 
	DSC
	 	 	 	 	 	 	 	 
	Tg (Onset)

	 	[***Redacted]	 	[***Redacted]	 	[***Redacted]
	Tc (Recrystallistion)

	 	 	 	 	 	 	 	[***Redacted]
	Tm (Melt)

	 	 	 	 	 	 	 	[***Redacted]

Notes:

	1.	 	[***Redacted]
	 
	2.	 	[***Redacted]
	 
	3.	 	[***Redacted]
	 
	 	 	 
	 
	4.	 	[***Redacted]
	 
	 	 	 

	 	 	 	 	 
	[***Redacted]
	 	 

	 	Date: 17th September 2001 
	 

	 	 

Quality Assurance and Laboratory Manager.
	 	 

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

	 	 	 
	PEEK–OPTIMA®

	 	GRADE: PEEK–OPTIMA LT1 R 12
	SPECIFICATIONS

	 	Page 1 of 1
	MANUAL

	 	REVISION:
	ISSUE 1

	 	DATE:

EXHIBIT C

Supply Manufacturing Definition

PEEK–OPTIMA
LT1 Extruded Rod.

Grade LT1R12

The Supply Manufacturing Definition for PEEK–OPTIMA LT1R12 shall be provided by Supplier as
soon as it becomes available.

-2-

 

EXHIBIT D

Invibio Trademark Usage Agreement

INVIBIO LIMITED

AND ST FRANCIS MEDICAL TECHNOLOGIES, INC.

 

TRADE MARK SUB–LICENSE

 

 

 

     THIS
AGREEMENT is made on 21st October 2002.

     BETWEEN

     INVIBIO LIMITED, a company incorporated in England and Wales (registered no. 04088050), whose
registered office is at Technology Centre, Hillhouse International, Thornton Cleveleys, Lancashire,
FY5 4QD (“Sub–Licensor”); and ST. FRANCIS MEDICAL TECHNOLOGIES, INC., a Delaware corporation with
offices at 1900 Bates Avenue, Suite L, Concord, California 94520 (“Sub–Licensee”).

     WHEREAS:

     (A) Sub–Licensor is the exclusive licensee under a trade mark licence of Trade Mark Rights in
relation to goods. Under the trade mark licence, Sub–Licensor is granted the right to grant
sub–licences of the rights granted to it.

     (B) Pursuant to an Agreement For the Supply of Polyaryletheretherketone between Sub–Licensor
or one of its Affiliates and the Sub–Licensee (the “Supply Agreement”), Sub–Licensor has agreed to
sub–licence the use of the Trade Mark Rights to the Sub–Licensee on a worldwide basis.

Sub–Licensor hereby grants, and Sub–Licensee hereby accepts the grant of, a sub–licence to use the
Trade Mark Rights as set out in this Agreement.

     IT IS AGREED as follows:

     1. INTERPRETATION

          1.1 Unless specifically defined herein, all capitalised terms shall have the same meaning as
are given to them in the Supply Agreement.

          1.2 In this Agreement capitalised words and phrases have the following meaning:

     “Guidelines” means the guidelines, included as an attachment, relating to the use of the Trade
Mark and Logo (if any) provided to Sub–Licensee as amended from time to time;

     “Logo” means the Logo form of a Trade Mark from time to time as set out in the Guidelines;

     “Trade Mark” means Sub–Licensor’s and Sub–Licensor’s Affiliates’ INVIBIO, PEEK–OPTIMA and
OPTIMA trademarks thereof used in relation to the Biomaterials and Stock Shape;

     “Trade Mark Rights” means the trade mark applications and registrations, from time to time,
for the Trade Mark in various jurisdictions as set out in Schedule 1 and Appendix 1 and a reference
in this Agreement to a “Trade Mark Right” is a reference to any and each of the Trade Marks Rights.

 

 

     2. GRANT

          2.1 Subject to the provisions of this Agreement, Sub–Licensor hereby grants to Sub–Licensee a
non–exclusive worldwide licence to use the Trade Mark Rights in relation to the use manufacture,
manufacture by another for Sub–Licensee, marketing, distribution, offer for sale, sale, and import,
and export of Buyer Products.

          2.2 Sub–Licensor hereby grants the Sub–Licensee a right to copy and reproduce the Logos in
relation to use on or in relation to Buyer Products and advertising and promotional material in
relation to the Buyer Products.

     3. SUB–LICENSEE’S UNDERTAKINGS

          3.1 Except as otherwise provided for in this Agreement, Sub–Licensee acknowledges and agrees
that by its use of the Trade Mark pursuant to this Agreement, Sub–Licensee has not, does not, and
shall not, nor shall it be deemed to, acquire at any time now or hereafter, whether by way of this
Agreement and/or the use of the Trade Mark, any right, title or interest of any nature whatsoever,
in or with respect to the Trade Mark. Use of the Trade Mark by Sub–Licensee and all rights derived
therefrom in the Trade Mark shall enure to the exclusive benefit of the owner of the Trade Mark
Rights. Without prejudice to the foregoing and at Sub–Licensor’s expense, Sub–Licensee shall do
any act or execute any document to ensure that any rights in the Trade Mark that Sub–Licensee may
have acquired shall vest in the owner of the Trade Mark Rights.

          3.2 Sub–licensee shall ensure that the quality of Buyer Products produced and provided under
the Trade Mark and/or Logo by Sub–Licensee complies with all relevant applicable laws, regulations
and standards prevailing in the relevant industry.

          3.3 Sub–Licensee shall use the Trade Mark and logo in the form, manner and way indicated in
the Guidelines and no other way. For the avoidance of doubt, in the event of inconsistency between
the Guidelines and this Agreement, this Agreement shall prevail.

          3.4 At Sub–Licensor’s expense, Sub–Licensee shall provide Sub–Licensor, at its reasonable
request, with all relevant documents in Sub–Licensee’s possession or control (for example,
documents providing evidence of use) that may be required for the protection, renewal and the
maintenance in force of the Trade Mark Rights.

          3.5 All advertising and promotional uses of the Trade Mark shall be submitted and approved by
Sub–Licensor before use or launch. Where Sub–licensor does not approve such use within 15 days of
receipt of the advertising and promotional material it shall be deemed to have approved such use,
provided that such use is otherwise in accordance with this Agreement. Sub-Licensor reserves the
right not to approve such advertising and promotional material, such refusal not to be unreasonable
or without a cogent reason.

          3.6 Sub–Licensee shall not use, either during this Agreement or hereafter, any trade mark that
is similar to INVIBIO, or OPTIMA in relation to the Buyer Products.

-2-

 

     4. INFRINGEMENT

          4.1 Sub–licensee shall promptly give notice in writing to Sub–Licensor in the event that it
becomes aware of:

               4.1.1 any infringement or suspected infringement of the Trade Mark in the field of Buyer
Products or Logo, generally; and

               4.1.2 any claim that the use of the Trade Mark in relation to the Buyer Products, or the use
of the Logo, generally, infringes the rights of any third person.

     5. TERMINATION

          5.1 Sub–Licensor may terminate this Agreement by notice to Sub–Licensee on or at any time
after the occurrence of an event specified in clause 5.2.

          5.2 The events are:

               5.2.1 termination of the Supply Agreement, except that Sub–Licensee shall be allowed to sell
through any Products and do all acts for all Biomaterials and Stock Shape in its possession and/or
it owns as contemplated by the Supply Agreement;

               5.2.2 Sub–Licensee being in material breach of material obligation under this Agreement
except that Sub–Licensee shall have 90 (ninety) days to cure;

               5.2.3 Sub–Licensee challenging the ownership and registration, continuing ownership or
registration of the Trade Mark Rights in the name of owner of the Trade Mark Rights.

     6. ASSIGNMENT

          6.1 Sub–Licensee may, assign this Agreement only with the Supply Agreement.

     7. GENERAL

          7.1 No variation of this Agreement (including this clause) is valid unless it is in writing
and signed by or on behalf of each party.

          7.2 This Agreement contains the entire agreement between the parties concerning the subject
matter hereof and supersedes any pre–existing agreement and any oral or written communications
between the parties.

          7.3 Any notice or other communication in connection with this Agreement must be in writing in
the English language and must be delivered personally, sent by certified or registered air–mail,
postage prepaid or by facsimile or email (confirmed by such certified or registered mail) to the
respective party at the address specified in the first paragraph hereof, or such other addresses as
may be designated in writing by the respective party. Notices shall be deemed effective on the
date of mailing.

-3-

 

     8. GOVERNING LAW AND LANGUAGE

          8.1 This Agreement is governed by the law of the England and Wales.

EXECUTED by the Parties

	 	 	 	 	 
	Michael
Callahan

	 	 	 	Burney Winslow
	Signed by

	 	 	 	Signed by
	/s/
Michael Callahan 
	 	 	 	/s/ Burney
Winslow                    
      10/21/02
	 	 	 
	 	 
	for and on behalf of

	 	 	 	for and on behalf of
	INVIBIO LIMITED

	 	 	 	ST. FRANCIS MEDICAL TECHNOLOGIES INC.

-4-

 

SCHEDULE 1

TRADE MARK RIGHTS

	 	 	 	 	 	 	 	 	 	 	 
	 	 	APPLICATION/	 	 	 	 	 	 	 	 
	 	 	REGISTRATION	 	FILING	 	 	 	 	 	 
	   COUNTRY	 	NO.	 	DATE	 	MARK	 	CLASSES	 	STATUS
	 
	JAPAN
	 	4377047	 	18.03.99	 	PEEK–OPTIMA	 	10	 	GRANTED
	SINGAPORE
	 	T99/04883H	 	12.05.99	 	PEEK–OPTIMA	 	10	 	PENDING
	CTM
	 	1087592	 	22.02.99	 	PEEK–OPTIMA	 	1, 10, 17	 	GRANTED
	HONG KONG
	 	B11451	 	10.03.99	 	PEEK–OPTIMA	 	17	 	GRANTED
	HONG KONG
	 	B07270	 	10.03.99	 	PEEK–OPTIMA	 	10	 	GRANTED
	HONG KONG
	 	B11450	 	10.03.99	 	PEEK–OPTIMA	 	1	 	GRANTED
	JAPAN
	 	11–24513	 	18.03.99	 	PEEK–OPTIMA	 	1	 	PENDING
	JAPAN
	 	4249593	 	18.03.99	 	PEEK–OPTIMA	 	17	 	GRANTED
	SINGAPORE
	 	T99/04882Z	 	12.05.99	 	PEEK–OPTIMA	 	1	 	PENDING
	SINGAPORE
	 	T99/04884F	 	12.05.99	 	PEEK–OPTIMA	 	17	 	PENDING
	SWITZERLAND
	 	Awaited	 	Awaited	 	PEEK–OPTIMA	 	1, 10, 17	 	PENDING
	U.K.
	 	2190848	 	04.03.99	 	PEEK–OPTIMA	 	1, 10, 17	 	PENDING
	USA
	 	75 / 653,689	 	04.03.99	 	PEEK–OPTIMA	 	1	 	GRANTED
	USA
	 	75 / 658,497	 	11.03.99	 	OPTIMA	 	1	 	PENDING

 

 

APPENDIX 1

ATTACHMENT – Using the InvibioTM and PEEK–OPTIMA® Logo’s

 

 

 

 

	Using the InvibioTM and PEEK-OPTIMA* Logo’s

	Invibio”, Biomaterial SolutionsTMand the lnvibioTM logo are trademarks of Invibio Ltd.
It is important to maintain the integrity of the trademarks when using the logo’s in any publication and authorised
format Please takecare in following these guidelines.
Logo Usage
I            Invibio
biomaterial solutions ^
InvibioTM
a. Correct corporate logo
Minimum size
Minimum size Colours:
Colours:
• PMS 541
• PMS 542

	b. Correct product logo

	Four Colour Separations

	• PMS 541 (C:100% M:51% K:30%) • PMS 542 (C:76% M:24% K:9%)

	Logo Usage In Text

	When referring to PEEK-OPTIMA* polymer from InvibioTM in text, always produce in uppercase and where possible add the TM
or ® symbol as appropriate. Where it is not possible to add the TM symbol, refer to PEEK-OPTIMA* polymer as PEEK-OPTIMA
polymer from Invibio”.

	Mono Logo. Usage

 

 

	Reversed Logo Usage

	Logo only to be reversed out of a solid colour background which provides suitable contrast, and within the same tonal
range.

	Spacing

	Allow white space around all logo applications to a minimum of size of the letter “0” contained within each logo.

	Incorrect Logo Usage

	When using the PEEK-OPTIMA* polymer and InvibioTM logos the following common errors must be avoided:

	Incorrect colours            Reversed logo on a            Logo used at an angle            Incorrect spacing
patterned background

 

 

	Brand Icon Usage

	1. When PEEK-OPTIMA* polymer from InvibioTM is used as a component part or as an ingredient within a compound or finished
product, the following icon should be used on each page where a photo of the component is used and in which PEEK-OPTIMA*
polymer is mentioned.

	a) Colour version-minimum size

	a) Mono version -minimum size

	e.g. The brand icon should preferably be placed on the base left of each page

	2. The brand icon should be used in its full format to accredit trademark ownership at least once in all literature in
which PEEK-OPTIMA* polymerfrom Invibio” is mentioned.

	e.g. Back cover of a brochure
Colour version — actual size

	3. The brand icon should be used in its full format to accredit trademark ownership at least once on all packaging
containing PEEK-OPTIMA* polymer from InvibioTM.

	e.g. Brand icon on the front of product box

	For approval/queries on the use on the logo or brand icon or to receive artwork or future copies of this guide please
contact: Marketing Department. Invibio Inc. 3A Caledon Court, Greenville. SC 29615 USA Tel: 866-imibio fax: (864) 672-732
or Invibio ltd. Technology Centre, Hillhouse International, Thornton develeys. Lancashire FY5 4QD UK Tel:+44 (0)1253
866812 Fax:+44 (0) 1253 851458 email: info@invibk.com www.invibio.com

 

 

APPENDIX E

PRO–FORMA FDA Access Letter

PMA Document Mail Center (HFZ–401)

Center for Devices and Radiological Health

Food and Drug Administration

9200 Corporate Boulevard

Rockville, MD 20850

Subject:      [      ]

PEEK–OPTIMA Polyaryletheretherketone

     This letter will authorize the Food and Drug Administration to use the material contained in
Device Master File No [      ] of Invibio Inc. in support of submissions to the FDA by St Francis
Medical Technologies Inc. for the following applications:

     This authorization will expire [      ]

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00110-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00110-of-00352.parquet"}]]