SUPPLY AGREEMENT
This
AGREEMENT (the "Agreement") dated as of March 9, 2007(the "Effective Date")
between Surgical Technology Inc., a Minnesota corporation, having its principal
place of business at 000 Xxxx Xxxxxxxxx Xxxxxxxx Xxxx, Xxxxx Xxxx, Xxxxxxxxx
00000 (hereinafter referred to as "STI") and SyntheMed, Inc., a Delaware
corporation, with an address at 000 Xxxxxxxxx Xxxxx Xxxxxxxx, Xxxxxx XX 00000
(hereinafter referred to as "SyntheMed").
WHEREAS,
STI is a company engaged in, among other things, finishing and manufacturing
of
products for use in a wide variety of applications including medical
applications;
WHEREAS,
SyntheMed is engaged
in the development and commercialization of products designed to prevent or
reduce the formation of adhesions following a broad range of surgical
procedures, all of which are based on SyntheMed’s proprietary, bioresorbable
polymer technology.
WHEREAS,
SyntheMed’s lead product, REPEL-CV, is classified as a medical device by the US
Food and Drug Administration and is currently under review by the
FDA.
WHEREAS,
STI has demonstrated its ability and capacity to produce finished devices in
accordance with SyntheMed’s specifications;
WHEREAS,
SyntheMed desires STI to provide services to assemble, package, sterilize
(through a third party) and drop ship under SyntheMed’s label and direction
SyntheMed’s REPEL-CV finished product, to its customers, and STI desires to
provide services to assemble, package, sterilize (through a third party) and
drop ship under SyntheMed’s label and direction such finished product on behalf
of SyntheMed, all on the terms and conditions set forth herein.
NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants
and agreements provided herein, the parties hereto, intending to be legally
bound hereby, agree as follows:
1.
DEFINITIONS
1.1.
"Act" shall mean the Federal Food, Drug and Cosmetic Act.
1.2.
"Approval(s)" shall mean receipt from the FDA or other applicable Regulatory
Authority of final approval, including any applicable pricing, final labeling
or
reimbursement approvals, necessary to manufacture, market and sell a Commercial
Product in a country of the Territory.
1.3.
"SyntheMed Indemnified Party" shall have the meaning set forth in Section
15.1.
1.4.
"Claim(s)" shall mean all charges, complaints, actions, suits, proceedings,
hearings, investigations, claims and demands.
1.5.
"Commercial Product" shall mean SyntheMed’s finished product known as REPEL-CV.
1.6.
"Confidential Information" shall mean all oral or written information that
is
disclosed by either party (the "Disclosing Party") to the other party (the
"Receiving Party"), or that the Receiving Party becomes aware of as a result
of
its discussions and work with the Disclosing Party, and that is not generally
known to the public, including but not limited to, information of a technical
nature such as trade secrets; manufacturing processes or devices or know-how;
techniques, data, formulas, inventions, discoveries or innovations (whether
or
not patentable), specifications and characteristics of current products or
products under development; research projects, methods and results; matters
of a
business nature such as information about costs, margins, pricing policies,
markets, sales, suppliers and customers; product, marketing or strategic plans;
financial information; personnel records and other information of a similar
nature, provided, however, that Confidential Information shall not include
any
information that (i) is or becomes public knowledge without breach of the
Receiving Party's obligations hereunder; (ii) is rightfully acquired by the
Receiving Party from a third party that legally acquired the information and
is
not under a confidentiality restriction on disclosure or use; (iii) was already
known to the Receiving Party prior to receipt from the Disclosing Party as
evidenced by written and dated records; (iv) is independently developed by
the
Receiving Party;(v) is required to be disclosed by law or court order, provided
that notice of the requirement is promptly delivered to the Disclosing Party
in
order to provide the Disclosing Party with an opportunity to challenge or limit
the disclosure obligations; or (vi) is disclosed or used following the Receiving
Party's receipt of express written consent from an authorized representative
of
the Disclosing Party. The Receiving Party shall have the burden of proof
respecting any of the aforementioned events on which the Receiving Party relies
as relieving it of any confidentiality restrictions hereunder. Written
disclosures for which protection is sought must be obviously marked as
"Confidential" or "Proprietary" and oral disclosures for which protection is
sought must at the outset be clearly identified by the Disclosing Party as
Confidential Information and submitted by the Disclosing Party in summary form
to the Receiving Party, marked as above within thirty (30) days after
disclosure; provided, however, that protection under Article 9 shall also be
given to information that is not so marked if a reasonable person trained in
research, development, manufacturing and marketing within the Field would assume
that it is Confidential Information. For written information that would not
normally appear to constitute confidential information, for the restrictions
on
Confidential Information to apply, a party must xxxx such information
"CONFIDENTIAL."
1.7.
"Design History File" shall have the meaning set forth in Title 21 of the US
Code of Federal Regulations, Part 820.
1.8
“Designated Facility” means the distributor or customer designated from time to
time by SyntheMed for use or for sale of Commercial Product.
1.9.
"Disclosing Party" shall have the meaning set forth in Section 1.6.
1.10.
"FDA" shall have the meaning set forth in Section 3.1.
1.11.
"Governmental Authority" shall mean any court, tribunal, arbitrator, agency,
department, legislative body, commission or other instrumentality of (a) any
government of any country, (b) any foreign, federal, state, county, city or
other political subdivision thereof or (c) any supranational body.
1.12.
"Initial Term" shall have the meaning set forth in Section 2.1.
1.13.
"Intellectual Property" shall mean all inventions, discoveries and innovations
(whether patentable or unpatentable and whether or not reduced to practice),
all
improvements thereto, and all patents, patent rights, patent applications and
invention disclosures, together with all reissues, continuations,
continuations-in-part, revisions, extensions, and reexaminations thereof, all
registered or unregistered trademarks, trade names and service marks, including
all goodwill associated therewith, and copyrights, and all applications and
registrations for any of the foregoing owned or controlled by or issued to
SyntheMed or STI, and any trade secrets and know-how, in each case relating
to
the Commercial Products in the Field in the Territory.
1.14.
"STI Indemnified Party" shall have the meaning set forth in Section
15.2.
1.15.
"Losses" shall mean any and all damages, awards, deficiencies, settlement
amounts, defaults, assessments, fines, dues, penalties, costs, fees,
liabilities, obligations, taxes, liens, losses, and expenses (including without
limitation court costs, interest and reasonable fees of attorneys, accountants
and other experts) incurred by or awarded to third parties and required to
be
paid to third parties with respect to a Claim by reason of any judgment, order,
decree, stipulation or injunction, or any settlement subject to the
indemnification provisions of this Agreement, together with all documented
out-of-pocket costs and expenses incurred in complying with any judgments,
orders, decrees, stipulations and injunctions that arise from or relate to
a
Claim of a third party.
1.16.
"MDR" shall have the meaning set forth in Section 4.2(c).
1.17.
“Raw Material Film” means large dry component film roll provided to STI by or on
behalf of SyntheMed that meets specifications as described in Schedule 1.
1.18.
"Post Term Supply" shall have the meaning set forth in Section 2.1.
1.19.
"Product Specifications" shall mean the specifications detailing the Product,
as
shown in Schedule 2.
1.20.
"Product Warranties" shall have the meaning set forth in Section
11.1.
1.21.
"Product" shall mean the coated polymer film meeting the Product
Specifications.
1.22.
"Purchase Orders" shall have the meaning set forth in Section 5.3.
1.23.
"Purchase Commitment" shall have the meaning set forth in Section
4.2(b).
1.24.
"QSR" shall mean the Quality System Regulation promulgated by the FDA under
the
Act or other applicable regulatory agencies of countries in which the Commercial
Product will be sold as of the time of manufacture of the applicable Commercial
Products; including ISO 13485, the European Union Council Medical Device
Directives (the "EU Medical Device Directives"), and the Quality System
Regulations as described in 21 CFR Part 820.
1.25.
"Receiving Party" shall have the meaning set forth in Section 1.7.
1.26.
"Regulatory Authority" shall mean an authority or authorities designated or
otherwise recognized by a government for regulatory purposes in connection
with
protection and safety of the public health (e.g., FDA, Notified Bodies, Health
Canada, EMEA) in any country where Commercial Product is to be
sold.
1.27.
"Renewal Term" shall have the meaning set forth in Section 2.1.
1.28.
"Rolling Forecast" shall have the meaning set forth in Section
4.2(b).
1.29.
"Term" shall have the meaning set forth in Section 2.1.
1.30.
"Transfer Price" shall mean the price paid by SyntheMed to STI for the Product,
as set forth in Section 5.1 hereof.
1.31.
"USPTO" shall mean the United States Patent and Trademark Office.
2.
TERM
2.1
Term.
This Agreement shall commence on the Effective Date and, unless earlier
terminated as provided herein, continue for five (5) years thereafter (the
"Initial Term"). The Initial Term shall be automatically extended for successive
two (2) year terms (the "Renewal Terms"), unless written notice of any party's
intention not to extend is provided by either party at least six (6) months
prior to the expiration of the Initial Term or a Renewal Term (the Initial
Term
and the Renewal Terms are collectively referred to as the "Term"); however,
should any such notice of non-renewal be given by STI, STI shall, if so
requested by SyntheMed, supply Product(s) for up to an additional sixteen (16)
months following the expiration of the then
current
Term (the "Post Term Supply") with price and delivery terms to be negotiated
in
good faith by both parties.
3.
REGULATORY APPROVAL OF THE COMMERCIAL PRODUCTS
3.1
SyntheMed shall have responsibility for obtaining all necessary U.S. and foreign
Approvals for the Commercial Products for use, sale, marketing and distribution.
STI will cooperate with SyntheMed to the extent STI's participation is
reasonably necessary or appropriate in order for SyntheMed to procure such
Approval. Without limiting the generality of the foregoing, STI will make
available to SyntheMed, without charge, information in STI's possession and
control that is required to prepare submissions for Approval, as SyntheMed
may
reasonably request, and as is reasonably necessary to obtain Approvals. All
information provided by STI hereunder shall be presented in a form which
satisfies the requirements of applicable United States Food and Drug
Administration (“FDA”) and other Regulatory Authority guidelines and/or
regulations for such types of submissions seeking Approval. STI shall consult
with SyntheMed prior to engaging in any communication with the FDA or other
Regulatory Authority in connection with manufacture of Product or other
activities covered under this Agreement and shall provide SyntheMed a reasonable
opportunity to review and comment upon any such proposed communication, whether
written or oral. STI shall provide to SyntheMed copies of any and all
correspondence or other communications, whether written, oral or otherwise,
between it and the FDA or such other Regulatory Authorities relating to the
Product or Commercial Product or production of any part thereof. In the event
FDA or other Regulatory Authority requests additional information from STI,
STI
shall fully and promptly cooperate and advise SyntheMed of the estimated date
by
which it will respond to such request,.
4.
COMMERCIALIZATION AND SUPPLY
4.1
STI
agrees to:
a.
manufacture, package, label, store and deliver the Product in accordance with
the QSR.
b.
supply
SyntheMed with all of SyntheMed’s requirements of Product consistent with the
projected Rolling Forecasts (pursuant to Subsection 4.2(b));
c.
deliver Product hereunder to the Designated Facility or as otherwise directed
by
SyntheMed on the scheduled delivery dates as set forth in the relevant Purchase
Orders described in Section 5.3; (NOTE: Delivery
of 10 percent more or less than the quantity specified, shall constitute the
fulfillment of the order, and the difference shall be paid for or allowed at
the
current price.)
d.
permit
SyntheMed or its third party designee full opportunity to test the Product
to
ensure compliance with Product Specifications prior to delivery by STI, as
provided in Section 7.1;
e.
obtain
written approval from SyntheMed prior to implementing any changes to the Product
manufacturing process, raw materials, testing, systems, equipment, procedures,
software, or facilities if Section 4.4(j) herein is invoked, otherwise written
approval shall be requested for changes which may impact safety, quality, or
effectiveness of Commercial Product, which approval shall not be unreasonably
withheld or delayed; if an MDR reportable event, as described in CFR Part 803,
to a patient treated with the Commercial Product is found to be the result
of a
change in the processes used by STI for the manufacture of the Product and
the
change was not pre-approved by SyntheMed prior to implementation, then the
indemnification provided by SyntheMed as described in Section 15.2 (ii) to
STI
shall not apply to such event;
f.
obtain
written approval from SyntheMed prior to implementing changes to Product
Specifications;
g.
investigate diligently, at SyntheMed’s request, complaints or adverse events
which relate to Product or Commercial Product manufacture or production issues,
and report back to SyntheMed within seventy-two (72) hours of being notified
by
SyntheMed of any MDR reportable events, or within ten (10) days of being
notified of any other complaint;
h.
contact SyntheMed regarding any complaints STI receives relating to the Product
or Commercial Product, including notice of any adverse events within three
business days of their receipt;
i.
utilize in the manufacture of the Product only Raw Material Film supplied by
or
on behalf of SyntheMed; and
j.
follow
cGMP regulations as described in 21 CFR Part 211 as it relates to the
manufacture and supply of the Product.
4.2
SyntheMed agrees to:
a.
ensure
that STI is timely provided, at no charge, with sufficient amounts of Polymer
Film in order to enable STI to satisfy its manufacturing and delivery
obligations with respect to the Products;
b.
provide STI with rolling twelve (12) month forecasts of SyntheMed's requirements
of Product ("Rolling Forecast") (Schedule 5). Such forecasts shall be prepared
in good faith and provided on a quarterly basis. The first three months of
any
twelve month Rolling Forecast may be accompanied by firm Purchase Orders to
purchase Product, which Purchase Orders shall be considered a purchase
commitment ("Purchase Commitment"). SyntheMed may at any time cancel all or
any
portion of any Purchase Commitment, provided that SyntheMed shall, if such
cancellation occurs after actual commencement of Product manufacture for the
relevant Product Order, reimburse STI for any and all non-recoverable inventory
costs reasonably incurred by STI, which shall be STI's sole remedy for
SyntheMed's cancellation; provided further that (i) STI will attempt to minimize
any losses associated with such inventory and (ii) STI will reduce the Transfer
Price of any Product provided to SyntheMed that contains inventory for which
STI
has been reimbursed per
this
Section 4.2(b);
c.
investigate diligently all adverse events of which SyntheMed has knowledge
or
awareness, related to the Commercial Product, and promptly report such
occurrences to STI if in the good faith reasonable determination of SyntheMed,
the same could reasonably have been attributable to activities of STI. SyntheMed
shall be responsible for the cost and execution of all medical device reporting
("MDR") in accordance with 21 CFR Part 803 and all vigilance reporting required
in the markets where Commercial Products are sold; and
d.
except
as otherwise set forth herein, be solely responsible for all necessary Approvals
to market the Commercial Products including any re-approvals required due to,
among other things, specification changes.
5.
ORDERING, PRICE AND PAYMENTS
5.1
Initial Transfer Price. SyntheMed shall pay the Transfer Price listed in
Schedule 3 for the Product.
5.2
Transfer Price Adjustment. The Transfer Price may be adjusted from time to
time
throughout the Term of the Agreement beginning at any time after the ***
anniversary of the commencement of the Term for factors such as, but not limited
to, changes in raw material costs, labor costs, regulatory costs, or product
liability costs. However, such adjustment shall not exceed, unless otherwise
agreed, the consumer price index for the Midwest Urban MSA area, as published
by
the U.S. Department of Labor, Bureau of Labor Statistics and in effect on the
aforementioned date. If price adjustments are related to changes in the Product
Specifications requested by SyntheMed, STI will propose new pricing which will
be negotiated in good faith and, subject to the succeeding sentence, will be
effective immediately upon shipment of Products meeting the new Product
Specifications. Pricing adjustments will occur no more than *** and, unless
otherwise agreed, shall become effective no earlier than six months after
written notice thereof is provided to SyntheMed. STI shall include in its
notification a detailed justification for all adjustments. Such adjusted
Transfer Price shall be reflected in any STI invoices issued for Product shipped
after the effective date of adjustment.
5.3
Purchase Orders. SyntheMed shall provide STI with firm written purchase orders
("Purchase Orders") for Product in accordance with the lead-times set forth
in
Product Specifications and consistent with Purchase Commitments; provided,
that
SyntheMed shall have the right, prior to the date of manufacture, to issue
binding, written change orders to increase or decrease the quantity of such
Purchase Orders. STI shall use its commercially reasonable efforts to comply
with any reasonable revisions to Purchase Order requirements.
5.4
Acknowledgment. Within five (5) business days after receipt of a written
Purchase Order from SyntheMed, STI shall acknowledge such receipt in
writing.
5.5
Shipping. STI shall ship Product to the Designated Facility or other SyntheMed
designated location F.O.B. *** in accordance with the shipment packaging
materials and shipping method specified by SyntheMed. *** shall pay the actual
documented cost of shipping Product to the shipping destination. *** shall
be
responsible for all insurance, custom's charges and taxes related to shipping.
Title to and risk of loss for all Product supplied to SyntheMed hereunder shall
pass from
STI to
SyntheMed upon acceptance of the shipment by the carrier at the distributors
or
customers facility.
5.6
Invoices. STI shall invoice SyntheMed for the aggregate Product which it
manufactures, upon shipment to SyntheMed, and SyntheMed shall pay each invoice
within *** All payments shall be in United States currency.
5.7
Tax
Withholding. If SyntheMed in good faith concludes that tax withholdings under
the laws of any country are required with respect to payments to STI, it shall
withhold the required amount and pay it to the appropriate Governmental
Authority, and shall promptly provide STI with original receipts or other
evidence reasonably required and sufficient to allow STI to document such tax
withholdings adequately for purposes of claiming foreign tax credits and similar
benefits.
6.
QUALITY CONTROL AND REGULATORY COMPLIANCE
6.1
No
Product shall be released for shipment by STI unless and until SyntheMed shall
have been notified by STI of completion of Product manufacture and SyntheMed
has
reviewed and approved the testing results. SyntheMed will be afforded full
opportunity to test the Product to ensure compliance with the Product
Specifications and to confirm the results submitted to SyntheMed by STI. Such
testing may be accomplished either by SyntheMed directly or by a third party
designated by SyntheMed, which designee may be an independent testing
laboratory. Each
lot
of Product manufactured by STI shall have STI's Certificate of Conformance
and
Certificate of Analysis, the generic form of which is attached as Schedule
4.
6.2
SyntheMed or its designee shall be entitled to reject any shipment of Product
or
portion thereof that is not manufactured and/or delivered in accordance with
the
terms of this Agreement. SyntheMed shall notify STI of the existence and nature
of any non-compliance or defect
relating
to the assembly and packaging in writing, accompanied by representative samples,
***
after
receipt of the assembled or packaged product from STI and
STI
shall have a reasonable opportunity, not to exceed five (5) business days from
receipt of such notification or of receipt of the defective product if
applicable, to inspect such defective material and/or Product. SyntheMed shall
have no obligation to pay for any Product that is subject to such a claim of
non-compliance or defect. If STI fails to timely inspect or if such inspection
confirms such non-compliance or defect, STI shall promptly replace such
non-compliant or defective Product at its own cost and expense.
6.3
If,
after STI’s inspections of such Product, the parties disagree as to the
Product’s conformance to the Specifications or whether the Product has such a
defect, either party may deliver the Product to an independent third-party
laboratory, mutually and reasonably acceptable to both parties, for analytical
testing to confirm the Product’s conformance to the Product Specifications or
the presence or absence of defects. All costs associated with such third-party
testing shall be at STI’s expense unless the independent Party review concludes
the product conformed to specifications No inspection or testing of or payment
for Product by SyntheMed or any third-party agent of SyntheMed shall constitute
acceptance by SyntheMed thereof, nor shall any such inspection or testing be
in
lieu or substitution of any obligation of STI for testing, inspection and
quality control as provided in the Specifications or under applicable local,
state, or federal laws, rules, regulations, standards, codes or
statutes.
6.4
In
the event of an audit by a Regulatory Authority at SyntheMed which involves
any
Commercial Product, SyntheMed shall notify STI of such audit promptly after
receiving notice thereof. Pursuant to such notice of audit, STI shall supply
SyntheMed with quality control documents related to the Product portion of
the
Commercial Product, within one business day from a request by
SyntheMed.
6.5
STI
shall promptly notify SyntheMed whenever a request for a plant inspection is
received from the FDA or other Regulatory Authority that relates in any way
to
Product or Commercial Product, and shall promptly advise SyntheMed of any
scheduled or unscheduled Product or Commercial Product related FDA or other
Regulatory Authority inspection and the progress and results thereof. A copy
of
Form 483 observations or other applicable reports, which apply to Product or
Commercial Product, shall be supplied to SyntheMed within one business day
of
receipt. STI, at STI's sole expense, shall promptly take steps to remedy any
valid deficiencies found by the FDA or other Regulatory Authority inspectors
relating to the manufacture of Product, and to respond promptly in writing
to
the Form 483 observations. STI shall provide SyntheMed with a copy of its
responses to any Form 483 observations relating to the Products or Commercial
Products in advance of their submission to FDA. SyntheMed shall have the right
to review and approve any responses that directly relate to the manufacture
of
its product prior to their submission to FDA. STI shall notify SyntheMed of
the
date the mutually approved responses are filed with the FDA.
6.6
STI
shall not conduct a voluntary recall of Commercial Product without prior full
consultation with SyntheMed regarding the ramifications, costs and regulatory
strategies associated with such a recall.
6.7
SyntheMed and STI shall assist and cooperate with each other in giving effect
to
any "Recall," as that term is defined in 21 CFR 810.2. STI shall be responsible
for the manufacturing cost of Commercial Product and Product replacements as
per
this agreement of any Recall caused by STI's shipment of Products that did
not
meet Product Specifications and the costs associated with return and reshipment
including, without limitation, any direct costs associated with the shipment
and
reshipment and replacement of such Commercial Products and Products. STI shall
have no other obligations with respect to such Recalls, except as may be
provided for in Section 15.1. SyntheMed shall, however, bear all costs and
expenses of any recall caused by Commercial Product design, or other acts not
attributable to STI causing a Recall to occur, including, without limitation,
costs of notifying customers and costs associated with the shipment and
reshipment and replacement of such Commercial Products.
For
purposes of clarification, STI is not responsible for any costs associated
with
loss of sales.
6.8
STI
shall provide SyntheMed (or its third party designee) access to its sites and
quality system records for the purpose of auditing and reviewing the sites
for
compliance with STI’s obligations under this Agreement (the "Review"). Any
information obtained by SyntheMed as a result of such Review shall be subject
to
the provisions of Article 9 hereof. Such Review shall be made during regular
business hours, upon reasonable notice and at reasonable intervals. STI shall
respond to any findings under such Review in writing within thirty (30) days,
unless otherwise agreed; additionally, SyntheMed shall have the right to
re-Review any specific records to establish that any findings have been
corrected.
6.9
STI
shall cooperate with SyntheMed to provide any authorizations, documents,
information, testing protocols and procedures in STI's possession subject to
Section 3, or take such other actions, which SyntheMed may reasonably request
in
order to obtain or maintain any registration, approval, clearance, certification
or other authorization with or from any federal, state, local or foreign
government agency or any self-regulatory body.
6.10
Each
party shall keep and maintain complete and accurate records necessary for
regulatory compliance for a period of at least five years (5) years after the
product has been released for commercial distribution.
6.11
The
signed SyntheMed Quality Agreement (schedule 6) will be reviewed and updated
as
required per any applicable regulatory requirement changes.
6.12
All
documents specifically related to the manufacturing and distribution of
Synthemed product (i.e. batch records, manufacturing procedures, FDA/ISO
required documentation) will be the property of Synthemed and will be provided
if and when requested.
7.
INTELLECTUAL PROPERTY RIGHTS
7.1
STI
and SyntheMed acknowledge the exclusive right, title, interest and goodwill
in
and to each trademark, trade name or other Intellectual Property right owned
by
the other party. Neither STI nor SyntheMed will, at any time or in any way,
do
or cause to be done any act, or omission, or thing to challenge, contest or
in
any way impair the right, title, and interest of the other party. Except as
otherwise provided in this Agreement, STI and SyntheMed shall not in any manner
represent that either has any rights in or to any trademark, trade name or
other
Intellectual Property right of the other party and each acknowledges that the
permitted use of any trademark, trade name or other Intellectual Property right
of the other shall not create any ownership right, title, or interest in or
to
any trademark, trade name or other Intellectual Property right of the other
party.
8.
CONFIDENTIAL INFORMATION
8.1
The
parties agree:
a.
To
receive and hold all Confidential Information in strict confidence and to
disclose such Confidential Information only to its employees and representatives
who have a need to know the Confidential Information. Without affecting the
generality of the foregoing, the Receiving Party will exercise no less care
to
safeguard the Confidential Information than it exercises in safeguarding its
own
Confidential Information and will be responsible for any breach of the
provisions of Article 9 by its employees and representatives (including its
employees who, subsequent to the first disclosure of Confidential Information,
become former employees);
b.
That
the Receiving Party shall not, directly or indirectly, disclose or use the
Confidential Information, in whole or in part, for any purposes other than
those
contemplated herein. Without affecting the generality of the foregoing, the
Receiving Party shall not, directly or indirectly, disclose any such
Confidential Information to any third party or use the Confidential Information
for the benefit of any third party;
c.
That
neither party shall, without the prior written consent of the other party,
disclose to any third party Confidential Information and or any of the terms,
conditions or other facts with respect to the business relationship of the
parties. Any approved disclosure made shall be no more extensive than is
necessary to meet the minimum requirement imposed on the party making such
disclosure; it being understood that STI consents to such public disclosure
regarding the business relationship of the parties as SyntheMed or its counsel
deems necessary or appropriate to comply with applicable law;
d.
That
money damages may not be a sufficient remedy for a breach of this Article 8
and
that the non-breaching party may be entitled to equitable relief (including,
but
not limited to, a temporary restraining order or an injunction or specific
performance), without posting bond or establishing monetary damages, in the
event of any breach of the provisions of this Article 8;
e.
The
furnishing of Confidential Information hereunder shall not constitute or be
construed as a grant of any express or implied license or other right, or a
covenant not to xxx or forbearance from any other right of action by the
Disclosing Party to the Receiving Party under any of the Disclosing Party's
patents or other Intellectual Property rights;
f.
Upon
the Disclosing Party's request at any time, or upon termination or expiration
of
this Agreement, the Receiving Party shall immediately return or destroy all
written, graphic and other tangible forms of the Confidential Information (and
all copies thereof) in the Receiving Party's possession or control except for
one copy which may be retained by the party's legal counsel for legal archival
purposes only; and
g.
The
obligations of the Receiving Party regarding disclosure and use of Confidential
Information shall survive the termination of this Agreement and shall continue
for five (5) years after the date of termination of this Agreement.
9.
PUBLICITY
9.1
During the Term and thereafter, except as required by applicable law, neither
party shall, without securing the prior written consent of the other party,
release the terms of this Agreement to any third party or publicly announce
the
terms of this Agreement. Notwithstanding the foregoing, during the Term and
thereafter, SyntheMed may, in addition to the disclosure permitted under Section
8.1 above, disclose the existence and general nature of this Agreement in press
releases, shareholder reports, quarterly and annual corporate reports,
Securities and Exchange Commission filings and public or private equity
offerings. In addition, SyntheMed may provide a copy of this Agreement as part
of a due diligence review in connection with a merger, an acquisition, or a
public or private equity offering, so long as such review is under the auspices
of an appropriate confidentiality agreement.
10.
WARRANTIES AND REPRESENTATIONS
10.1
Subject to the provisions set forth in this Section 10.1 and Section 10.4,
STI
warrants: (i) that all Product delivered hereunder shall conform in all material
respects to Product Specifications at the time of shipment; (ii) that all
Product shall be manufactured substantially in accordance with (a) QSR, (b)
the
pertinent rules and regulations of the FDA and (c) the EU Medical Device
Directive; and (iii) that no Product delivered hereunder shall at time of
shipment be adulterated or misbranded within the meaning of the Act, or within
the meaning of any applicable state or municipal law in which the definitions
of
adulteration and misbranding are substantially the same as those contained
in
the Act, provided such laws are constituted and effective at the time of such
delivery (collectively, the "Product Warranties"). These Product Warranties
shall be null and void and shall not apply to any Product which is in any way
altered, modified, damaged or replaced by any person other than STI or its
agents or which is abused or misused, whether intentionally or
accidentally.
STI
services are generally limited to the assembly, packaging and sterilization
of
Repel CV. If other services are provided by Seller, the warranty, if any, for
such services will be as separately negotiated and agreed to in writing by
Seller and the Buyer.
Sterilization.
STI
warrants that its sterilization services shall be conducted by certified
facilities to meet or exceed industry sterilization standards and that
production load release testing will meet the specifications Any claim relating
to sterilization must be submitted to STI in writing, accompanied by
representative samples, within sixty (60) days after receipt of the sterilized
product from STI or promptly following rejection of a lot due to sterility
failure.
Upon
confirmation by STI of a warranty breach, STI will authorize the return of
the
defective products. Products claimed to be defective are not to be returned
without such prior STI written approval.
Exclusive
Remedy.
For
defective product, the exclusive remedy shall be for STI to, at its option,
repair the defective product, replace the defective product or issue credit
for
the defective product.
10.2
Each
party represents and warrants that it is and will remain in material compliance
with all applicable federal, state and local laws, regulations and orders as
they may apply to this Agreement.
10.3
STI
and SyntheMed each represent and warrant for itself that (i) it is duly
incorporated and validly existing and in good standing under the laws of the
state of its incorporation, (ii) it has the full right, power, and authority
to
execute and perform this Agreement, (iii) this Agreement does not conflict
with
or otherwise result in a breach of any agreement to which such party is a party
or to which it is bound, and (iv) this Agreement represents a valid, legally
binding obligation of it, enforceable against it in accordance with its
terms.
10.4
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED ELSEWHERE IN THIS AGREEMENT, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL
OR SPECIAL DAMAGES IN CONNECTION WITH OR ARISING OUT OF THIS
AGREEMENT.
11.
ASSIGNMENT
11.1
Neither party may assign or transfer this Agreement, in whole or in part, to
a
third party without the prior written consent of the other party, which consent
shall not be unreasonably withheld, conditioned or delayed.
Notwithstanding the foregoing, SyntheMed may assign this Agreement to any of
its
affiliates, or in connection with the sale of that part of its business relating
to the Commercial Products provided that in no event shall any such assignment
release SyntheMed from its responsibilities under this Agreement unless the
assignee has agreed in writing to assume all the obligations of SyntheMed
hereunder
11.2
This
Agreement will bind and inure to the benefit of the respective successors and
permitted assigns, whether so expressed or not.
12.
INSURANCE
12.1
STI
and SyntheMed shall each obtain and maintain at all times during the Term
following the first Purchase Order hereunder, product liability insurance in
the
amount of at *** per occurrence and *** and shall deliver to the other party
a
certificate evidencing such insurance.
13.
TERMINATION
13.1
In
addition to any other rights of termination granted to the parties in this
Agreement, each party shall have the right, but not the obligation, to terminate
this Agreement upon notice to the other party under the following
circumstances:
i. for
no
reason, upon six (6) months’ prior notice to the other party;
ii.
if
the other party declares bankruptcy, makes an assignment for the benefit of
its
creditors, if any proceedings take place for arrangement for the appointment
of
a receiver or trustee to take possession of such party's assets, or any other
proceeding under law for the entry of an order for the relief of creditors
of
such party shall be instituted the other party which shall not have been
vacated, discharged, stayed, satisfied or bonded pending appeal within
forty-five (45) days from the entry thereof or if such party shall become
insolvent; or
iii.
upon
a material breach of this Agreement by the other party, which breach is not
remedied or cured within sixty (60) days’ notice thereof by the terminating
party.
13.2
Upon
termination or expiration of this Agreement for any reason, including the end
of
the Term as defined in Section 2, nothing herein shall be construed to release
either party from any obligation, which matured prior to the effective date
of
termination, or which by their terms are intended to continue.
14.
INDEMNIFICATION
14.1
STI
agrees to indemnify, defend and hold SyntheMed and any of its officers,
directors, affiliates, employees, sales agents, successors and permitted assigns
(each, an "SyntheMed Indemnified Party") harmless from and against any and
all
Claims of third parties for any Losses arising out of or resulting from: (i)
the
failure of STI to ship Product that meets the Product Specifications or that
is
not manufactured in compliance with QSR or other applicable laws and
regulations; (ii) any STI breach of a representation, warranty, covenant or
obligation in this Agreement; or (iii) any negligence or willful misconduct
of
STI or its representatives, directors, officers, employees and agents, in
connection with the activities contemplated under this Agreement, in each case,
only to the extent such Claims listed in Section 14.1 (i - iv) are not (a)
due
to the negligence or willful misconduct of a SyntheMed Indemnified Party, or
(b)
otherwise subject to indemnification under Section 14.2.
14.2
SyntheMed agrees to indemnify, defend and hold STI and any of its officers,
directors, affiliates, employees, sales agents, successors and permitted assigns
(each, a "STI Indemnified Party") harmless from and against any and all Claims
of third parties for any Losses arising out of or resulting from: (i) any
SyntheMed breach of a representation, warranty, covenant or obligation in this
Agreement; (ii) any personal injury or death resulting from use of the
Commercial Product by end-users; or (iii) any negligence or willful misconduct
of SyntheMed or its representatives, directors, officers, employees and agents,
in connection with the activities contemplated under this Agreement.; in each
case, only to the extent such Claims listed in Section 14.2 (i - iii) are not
(a) due to the negligence or willful misconduct of a STI Indemnified Party,
or
(b) otherwise subject to indemnification under Section 14.1.
14.3
To
receive the indemnities contained in this Section 14, the party entitled to
indemnification hereunder (the "Indemnified Party") must provide the party
obligated to provide indemnification hereunder (the "Indemnifying Party") with
(i) reasonably prompt notice in writing of any such Claim or action, (ii)
information and reasonable assistance, at the Indemnifying Party's expense,
as
necessary or appropriate to defend or settle such Claim or action, and (iii)
full authority to defend or settle the Claim or suit. The Indemnified Party
shall have the right to employ separate counsel and participate in the defense
of any Claim or action, at its own expense. Except as provided in the last
sentence of this Section 14.3, the Indemnified Party may not settle any Claim
or
action under this Section 14 on behalf of the Indemnifying Party without first
obtaining the Indemnifying Party's written permission, and so long as the
Indemnifying Party is diligently conducting a defense as provided herein, it
shall not be liable for the attorneys' fees or expenses of the Indemnified
Party. If an Indemnified Party provides notice of a Claim that is subject to
indemnification in accordance herewith and is not notified within ten (10)
days
that the Indemnifying Party intends to defend such Claim, the Indemnified Party
shall be entitled to defend, settle and/or compromise such Claim, subject to
the
indemnification provided for herein. Nothing in this provision, however, shall
permit either party to enter into a settlement that imposes an obligation on
the
other party requiring them to take any affirmative action or refrain from any
act, unless such other party consents to such settlement.
15.
MISCELLANEOUS
15.1
Independent Contractor. Neither party shall have the right, power or authority
to assume or create any obligations or responsibility expressed or implied,
on
behalf of, or in the name of, the other party, or to bind the other party in
any
manner or to any extent whatsoever, without the prior written approval and
acceptance of the other party. Each of the parties hereto is an independent
contractor for the purposes of this Agreement and nothing contained herein
shall
be deemed or construed to create the relationship of agency, partnership or
joint venture or any other association except that of an independent contractor
relationship. Neither
Seller nor Buyer shall be liable for any delay or failure in the performance
of
this Proposal resulting from any cause beyond the reasonable control of the
respective parties, including labor strikes, fire, floods, riots, acts of
government and regulatory agencies or Acts of God.
15.2
Amendment and Waiver. This Agreement may be amended, and any provision of this
Agreement may be waived, provided that any such amendment or waiver will be
binding on each party only if such amendment or waiver is set forth in a writing
executed by such parties. Waiver of a breach of the Agreement shall not
constitute a waiver of any other subsequent breach of the Agreement. The waiver
of any provision of this Agreement shall not constitute a continuing waiver
of
that provision or a waiver of any other provision of this
Agreement.
15.3
Notices. All notices, demands and other communications to be given or delivered
under or by reason of the provisions of this Agreement shall be in writing
and
shall be deemed to have been given when sent by facsimile transmission with
acknowledged returned receipt, personally delivered or mailed by overnight
mail,
return receipt requested. Notices demands and communications shall, unless
another address or individual is specified in writing, be sent to the addresses
set forth as follows:
If to
SyntheMed: SyntheMed, Inc.
000
Xxxxxxxxx Xxxxx
Xxxxxxxx, Xxxxx 000
Xxxxxx
XX
00000
Attention:
President
If to
STI:
STI, Inc.
000
Xxxx Xxxxxxxxx
Xxxxxxxx Xxxx,
Xxxxx
Xxxx, Xxxxxxxxx
00000
Attention:
Vice
President, General Manager
15.4
Severability. Whenever possible, each provision of this Agreement will be
interpreted in such a manner as to be effective and valid under applicable
law,
but if any provision of this Agreement is held to be prohibited by or invalid
under applicable law, such provision will be ineffective only to the extent
of
such prohibition or invalidity, without invalidating the remainder of such
provision or the remaining provisions of this Agreement.
15.5
Complete Agreement. This Agreement and the documents referred to herein contain
the complete agreement between the parties and supersede all prior
understandings, agreements and representations by or between the parties,
written or oral, which may have related to the subject matter hereof in any
way.
15.6
Counterparts. This Agreement may be executed in one or more counterparts all
of
which taken together will constitute one and the same instrument.
15.7
Governing Law. The law of the State of New Jersey will govern, without regard
to
the conflicts of law provisions thereof, all questions concerning the
construction, validity and interpretation of this Agreement and the performance
of the obligations imposed by this Agreement.
15.8
Headings. Section headings used in this Agreement are for convenience only
and
form no part or in any way modify or define the text of meaning or any provision
of this Agreement.
15.9
Force Majeure. In
the
event that any 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,
injunction or any act, exercise, assertion or requirement of governmental
authority, epidemic, destruction of production facilities, any act of declared
or undeclared war or of a public enemy, or any riot or insurrection, any
nuclear, biological, chemical or similar attack, any act of terrorism,
or
any
similar occurrence cause outside the reasonable control of that party,
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 except as otherwise provided for in this Agreement, be
extended for the period of delay or inability to perform due to such
occurrence.
15.10
Equipment
STI
is
responsible for maintaining SyntheMed’s equipment and will, if requested by
SyntheMed, deliver such equipment to Synthemed at SyntheMed’s expense at the end
of the Term or permit Synthemed to remove the equipment. STI will provide
technical and other assistance necessary to effectively transfer packaging
operations to a third party, the reasonable cost of which will be borne by
SyntheMed. The scope of STI’s maintenance obligations will be discussed and
mutually agreed upon by SyntheMed; provided Synthemed shall bear the cost of
repair and replacement of broken parts and equipment, provided that the same
shall not have resulted from STI’s negligence or otherwise from STI’s breach of
its obligations herein. The Equipment covered in this section is defined in
Schedule 7.
15.11
Remedies. Unless otherwise expressly stated, any remedy expressly provided
for
herein shall not be deemed to be a limitation on any remedy for any such
situation or occurrence.
IN
WITNESS WHEREOF, the parties have executed this Agreement through
their
duly
authorized representatives as of the date first written above.
|
STI,
INC.
|
|
|
By:
/s/ Xxxxxx X. Xxxxxx
|
By:
[Illegible Signature]
|
|
Signature
|
Signature
|
|
Xxxxxx
X. Xxxxxx
|
/s/
Xxxxxxx X. Xxxxx
|
|
Name
|
Name
|
|
President
& CEO
|
Vice
President General Manager
|
|
Title
|
Title
|
|
3/9/07
|
March
23, 2007
|
|
Date
|
Date
|
List
of
Schedules
| 1. |
Large
Dry Component Film Roll
specification
|
| 2. |
REPEL-CV
Product Specifications
|
| 3. |
STI
Product Proposal to include
|
| a. |
STI
Finished Product Transfer Price
|
| b. |
Delivery
schedule/requirements
|
| c. |
Additional
Charges
|
| d. |
Definition
of Responsibilities
|
| 4. |
Finished
Product Certificate of Conformance/Analysis
(example)
|
| 5. |
SyntheMed
Product Forecast (SEE EXHIBIT B OF SCHEDULE
3)
|
| 6. |
SyntheMed
Quality Agreement
|
| 7. |
List
of Synthemed Owned Equipment
|
| 8. |
STI
Logistics Proposal
|
SCHEDULE
1
|
Material
Specification
|
1.
DESCRIPTION
Material:
***
2. MATERIAL
VENDORS
Chem
Development Inc. (CDI) -produces the material
Surgical
Technologies, Inc. (STI) - receives material for further processing
3. SPECIFICATION
The
following is the criteria used in order to demonstrate that each lot of the
large dry component film roll meets its design characteristics prior to being
released for further processing. Each criterion is tested on a lot by lot basis
at CDI. The results are reviewed and approved by Synthemed and if acceptable,
the material is released for further processing. At receiving inspection, the
product will be tested or accepted via a vendor certification. The method of
acceptance at receiving will be documented and agreed upon in advance by
SyntheMed, Inc.
| 3.1 |
***
|
| 3.2 |
***
|
| 3.3 |
***
|
| 3.4 |
***
|
| 3.5 |
***
|
4.
RESPONSIBILITIES
|
4.1
|
CDI
is responsible for the manufacturing of the material. CDI will be
responsible for assuring the material meets all the specified criteria
as
defined in section 3.
|
| 4.2 | STI is responsible for the receipt, inspection and release of material |
5. RECEIVING/STORAGE
|
5.1
|
STI
is responsible for the receipt and storage of material. These activities
will be performed in accordance with documented procedures which
are
compliant with all applicable regulatory requirements. SyntheMed
will
evaluate these procedures as part of its vendor qualification and
monitoring procedures.
|
6. INSPECTION
| 6.1 |
CDI
is responsible for the inspection of the material prior to release
for
further distribution. These activities will be performed in accordance
with documented procedures which are compliant with all applicable
regulatory requirements. SyntheMed will evaluate these procedures
as part
of its vendor qualification and monitoring
procedures.
|
| 6.2 |
STI
is responsible for the inspection of the incoming material. These
activities will be performed in accordance with documented procedures
which are compliant with all applicable regulatory requirements.
SyntheMed
will evaluate these procedures as part of its vendor qualification
and
monitoring procedures
|
SCHEDULE
2
|
Final
Product Specification
|
1. FINAL
PRODUCT RELEASE CRITERIA
The
following is the criteria used in order to demonstrate that each lot of REPEL-CV
meets its design characteristics prior to being released for commercial
distribution. Each criterion is either tested on a lot by lot basis or the
process has been validated to assure the criterion has been met.
***
These
tests are not performed on every lot produced. Their acceptability is based
on
successful process validation results and appropriate process testing and
controls.
***
2.0
PROCEDURE
2.1 The
approved facilities that will perform each test are listed in Section 3. Reports
from all the testing will be compiled by STI Quality Assurance..
2.2
The
results are entered on the REPEL -CV Lot Test Record and the reports are
attached. These are placed in or referenced in the DHR for the lot.
2.3
All
the final results are reviewed and approved by the Quality Assurance departments
of STI and SyntheMed
3.0 PRODUCT
TESTING
***
4.0
APPROVED CONTRACT TESTING VENDORS
***
SCHEDULE
3
Schedule
3
Proposal
No. 7020 Rev. 3
February
1, 2007
Surgical
Technologies, Inc. (“Seller”), is pleased to present to SyntheMed (“Buyer”) a
revised proposal for the procurement of components, packaging and EtO
sterilization of your Repel-CV. Upon execution by both parties, this Proposal
(as set forth in items 1 through 7 hereof, the “Proposal”), together with the
attached Standard Terms and Conditions, shall become a binding agreement
enforceable against the parties in accordance with its terms.
Your
proposal is broken down as follows:
1.0 FINANCIAL/DELIVERY
1.1
Long
Term Purchase Order
Based
on
issuance of a purchase order which specifies delivery dates and
quantities:
***
Subsequent
Deliveries:
as
scheduled
Note:
Buyer
and
Seller will develop a procedure under which Buyer will provide long-term
forecasts on a rolling periodic basis and for orders to become binding (see
Exhibit B). Seller commits to providing Buyer forecasted capacity needs on
a
timely basis. Buyer would have first priority use of the clean/dry room. Seller
will consult with and obtain Buyer’s approval (which approval shall not be
unreasonably withheld, conditioned or delayed) prior to conducting activities
using equipment owned by Buyer, which could interfere with the activities being
performed for Buyer.
***
2.0 MATERIALS
SUPPLIED BY BUYER
|
a.
|
All
materials must be clean, ready to be packaged, properly identified,
correctly counted and listed on a packing slip. (Note: Parts must
be
particulate free and suitable for clean room
processing.)
|
Materials
Provided: REPEL CV
***
3.0 MATERIALS
SUPPLIED AND MANAGED BY SELLER
***
4.0
ASSEMBLY
AND PACKAGING PROCESSES PERFORMED BY SELLER
***
5.0
EtO
STERILIZATION PREPARATION
***
6.0 EtO
STERILIZATION
***
7.0 POST
STERILIZATION QUARANTINE
***
8.0 STERILITY
TESTING COSTS
***
.1 Exhibit
A
SURGICAL
TECHNOLOGIES, INC. WARRANTY
|
1.
|
Scope
of Warranty. Seller
services are generally limited to the assembly, packaging and
sterilization of medical devices. If other services are provided
by
Seller, the warranty, if any, for such services will be as separately
negotiated and agreed to in writing by Seller and the
Buyer.
|
2. Limited
Warranty.
|
A.
|
Assembly
and Packaging.
Seller warrants that its assembly and packaging services shall be
free
from defects in material and workmanship to the level specified by
the
Buyer as set forth on Exhibit C. Any claim relating to this assembly
and
packaging warranty must be submitted to Seller in writing, accompanied
by
representative samples, within sixty (60) days after receipt of the
assembled or packaged product from
Seller.
|
|
B.
|
Sterilization.
Seller warrants that its sterilization services shall be conducted
by
certified facilities to meet or exceed industry sterilization standards
and that production load release testing will meet the specifications
set
forth on Exhibit C. Any claim relating to this sterilization warranty
must
be submitted to Seller in writing, accompanied by representative
samples,
within sixty (60) days after receipt of the sterilized product from
Seller
or promptly following rejection of a lot due to sterility
failure.
|
|
C.
|
Procedure.
The written claim, together with representative samples, shall be
sent to
the involved Seller facility:
|
|
Surgical
Technologies, Inc.
|
Xxxxxxx
Group B.V.
|
|
000
X. Xxxxxxxxx Xxxxxxxx Road
|
Postbus
00000
|
|
Xx.
Xxxx, XX 00000
|
0000
XX XxxxxxxxXxxxxxx
|
| Xxxx: Xxxxxx X. Xxxxxxx |
The
Netherlands
|
|
Attn:
Xxxxx Xxxxxx
|
Upon
confirmation by Seller of a warranty breach, Seller will authorize the return
of
the defective products. Products claimed to be defective are not to be returned
without such prior Seller written approval. The remedy for defective product
shall be as provided below.
|
3.
|
Exclusive
Remedy.
For defective product, the exclusive remedy shall be for Seller to,
at its
option, repair the defective product, replace the defective product
or
issue credit for the defective
product.
|
| 4. |
Disclaimer. Except
as expressly provided herein, Seller makes no warranty of any kind,
express or implied, including, but not limited to, the implied warranties
of merchantability and fitness for a particular purpose. The above
warranties are in lieu of all other warranties, and no person (including
any agent, dealer or representative of Seller) is authorized to make
any
representation or warranty concerning the Seller services except
to refer
Buyers to this warranty. Seller shall not be responsible for the
cost of
labor or other charges of any kind incurred outside its facilities
(except
for costs related to sterilization or other activities to be performed
under the Agreement on behalf of the Seller). Seller shall under
no
circumstances be liable with respect to defective product for special,
incidental, consequential or exemplary damages of any nature whatsoever,
however occasioned (whether by negligence or otherwise), including,
but
not limited to, commercial loss from any cause, business interruption
of
any nature, loss of profits or personal injury, even if Seller shall
have
been advised of the possibility of such
damages.
|
Exhibit
B
Long-Term
Forecasts
***
Exhibit
C
Release
Criteria
The
following is the criteria used to demonstrate that each lot of REPEL-CV meets
its design characteristics prior to being released for commercial
distribution. Each criterion is either tested on a lot by lot basis or the
process has been validated to assure the criterion has been met.
***
SCHEDULE
4
This
document certifies that Surgical Technologies, Inc. has properly completed
and
documented all the contracted manufacturing, packaging, testing, and
sterilization activities specified by the customer for the following product(s):
These activities were done in compliance to the applicable sections of: FDA
QSR;
ISO 13485:2003; EN 550, 552, & 556; and ANSI/AAMI/ISO 11135 & 11137. The
following release testing was performed on the specified product:
|
2 Mfg
Lot:
|
3 Sterile
Lot:
|
4 Release
Qty:
|
|||
|
Test
|
Pass/Fail
Criteria
|
Tested
by/ Method
|
5 Test
Result
|
||
|
***
|
***
|
***
|
***
|
||
|
|
|||||
|
STI
QA Approved by:
|
Date:
|
||
|
SyntheMed
QA Released
|
Date:
|
SCHEDULE
6
SYNTHEMED
QUALITY AGREEMENT
This
Quality Agreement (the "Agreement") is made as of November 10, 2006 between
SyntheMed, Inc. and STI with its principal office at 000 Xxxx Xxxxxxxxx Xxxxxxxx
Xxxx, Xxxxx Xxxx, Xxxxxxxxx 00000.
Purpose
The
purpose of this Agreement is to set forth the quality arrangements for ensuring
that the manufacture, packaging, quality control and release of REPEL-CV (the
"Agreement Product") shall take place in accordance with applicable sections
of
the Quality System Regulations (Good Manufacturing Practice) as detailed in
Title 21, Code of Federal Regulations, Part 820, US Food and Drug
Administration, or the requirements of the European Medical Device Directives
and ISO 13485.
Responsibilities
1.
Audits
STI
shall
give all reasonable access to its facilities to satisfy all applicable
regulatory audit requirements. Any such audits will determine if STI has
adequate premises, equipment, systems and a staff with sufficient knowledge
and
training to carry out satisfactorily the manufacture, assembly, packaging and
testing of the Agreement Product.
2.
Material
Specifications
STI
shall
manufacture the Agreement Product according to the methods agreed to by
SyntheMed. The information/specifications to be provided to STI may include
but
may not be limited to:
The
manufacturing formula
The
manufacturing method
The
environmental conditions required
The
master batch manufacturing record
The
finished product specification
All
analytical methods
3.
Change
control
STI
shall
not, except with the prior written consent of SyntheMed (which consent shall
not
be unreasonably withheld or delayed), change or cause to be changed any
materials, equipment, or method of production or testing related to the
Agreement Product provided however, that any such change for which SyntheMed
has
given its prior written consent shall also comply in all respects with all
applicable legal requirements, and provided further, that in the event any
change is required by any legal requirement and SyntheMed does not consent
to
such change within a reasonable period of time, STI shall be excused from all
performance hereunder.
4.
Documentation
STI
will
create the documentation to produce the Agreement Product to satisfy the
appropriate regulatory requirements. These documents will be reviewed and
approved by SyntheMed. They will be subject to Change Control as specified
in
section 3 above. STI will provide control of all documentation as required
under
all applicable regulations and as part of the STI quality system.
5.
Incoming
Material Testing
With
the
exception of customer supplied materials STI
shall
be responsible for the assessment of all incoming material to be used in the
manufacture of the Agreement Product in order to ensure compliance with the
agreed upon specifications. STI will be responsible for the approval of all
vendors of the materials other than the supplier of the Raw Material Film from
ChemDevelopment.
6.
In-Process
Controls
STI
shall
be responsible for any agreed upon quality control testing required during
the
manufacture of the Agreement Product. STI shall advise SyntheMed of any
significant changes prior to their implementation in the in-process controls
(ref section 3 above).
7.
Finished
Product Testing
STI
shall
be responsible for testing each batch of the Agreement Product (including any
testing requiring to be performed by a third party laboratory) to ensure its
compliance with the finished product specifications agreed to by SyntheMed.
STI
shall provide and/or make available a record of the test results for every
batch
manufactured and details of all out of specification investigations. SyntheMed
will review the documentation and approve the release of each batch of material
unless otherwise notified (see section 10).
8.
Stability
STI
shall
assist as needed in ensuring the generation of the stability data for the
Agreement Product.
9.
Storage.
Delivery and Transportation
STI
shall
be responsible for the quality of the Agreement Product on its premises and
be
responsible for any subsequent deterioration of the Agreement Product due to
its
storage or handling. STI shall utilize agreed upon means for transportation
for
delivery of the Agreement Product to SyntheMed or its designee.
10.
Release
Procedure
STI
shall
test (or have tested at a third party laboratory as agreed by SyntheMed) the
Agreement Product to the full finished product specification in accordance
with
the requirements specified. SyntheMed shall be responsible for the final release
of the Agreement Product according to agreed upon procedures. STI shall provide
or have available:
|
10.1
|
A
Certificate of Analysis listing all test results for each batch of
Agreement Product
|
|
10.2
|
A
copy of the manufacturing record for each batch of Agreement Product
delivered or Certification that all manufacturing was completed in
accordance with agreed upon
procedures
|
|
10.3
|
A
statement signed by a named senior QA person at STI stating that
the batch
has been manufactured in accordance with the specifications and in
accordance with all applicable regulatory requirements.
|
|
10.4
|
Any
other details or documents which may be agreed from time to time
between
the Quality Departments of STI and SyntheMed.
|
|
10.5
|
Information
and copies of investigation reports relating to any batch deviation,
out
of specification result or non-compliance with regulatory requirements
shall be communicated as soon as practicable to the Director, Quality
Systems at SyntheMed.
|
11. Retention
Samples
STI
may
be asked to keep adequate retention samples of the Agreement Product and raw
materials as agreed to with SyntheMed. STI
may
request reasonable fees for storage of materials.
12. Rejection
and Reworking
Prior
to
shipment of each batch supplied and where applicable, STI shall submit to
Synthemed all available information regarding major deviations, out of
specification results and investigations, or non-compliance with GMP. If a
batch
of the Agreement Product is rejected by for any reason, STI must advise
SyntheMed of the occurrence thereof and any other relevant details. Rework
of
the Agreement Product is not permitted without the consent of SyntheMed. (The
term 'rework' excludes any re-inspection activities that are specified in
Company's approved procedures).
13. Recalls
and Complaints
STI
shall
conduct any reasonable investigations requested by SyntheMed pursuant to
complaints received on the batches of the Agreement Product. A report of such
investigation shall be provided in timely fashion to the Quality Department
of
SyntheMed. In the event of a recall of the Agreement Product, STI’s
responsibility is limited to supplying appropriate information relevant to
any
alleged product defect prompting such recall action.
14. Batch
records
STI
shall
keep original copies of all records of manufacture for at least five(5) years
from the date of manufacture, and shall notify before disposing of such records.
STI
shall
also keep records relating to the receipt, testing and use of raw materials
and
packaging components for at least five (5) years from the date of approval
for
use in manufacturing.
15.
Sub-contracting
STI
may
sub-contract the manufacture, packaging or testing of the Agreement Product
to
another site, provided that (a) SyntheMed has been notified of the site and
(b)
SyntheMed has approved such site.
16.
Regulatory
Requirements
STI
shall
provide manufacturing information as reasonably requested by SyntheMed in
support of the preparation of any Regulatory submissions and/or requirements
for
the Agreement Product.
Approvals:
|
SyntheMed
|
STI
|
|
Date:
________________________
|
Date:
______________________
|
|
Name:
________________________
|
Name:
______________________
|
|
|
|
|
Title:
Director Quality Systems & RA
|
Title:
________________________
|
SCHEDULE
7
SCHEDULE
7
LIST
OF
SYNTHEMED OWNED EQUIPMENT
***
SCHEDULE
8
Schedule
8
Proposal
No. 7009 Rev. 1
Surgical
Technologies, Inc. (“Seller”) shall perform the activities to necessary to
process, pack and ship SyntheMed (“Buyer”) Repel-CV according to the following
price schedule effective as of the date of this agreement:
6
Per Shipment:
| § |
Labor
& Paperwork***
|
| § |
primary
boxes ***
|
| § |
Monitor
(if required)***
|
7
8
Monthly
Fee:
| § |
Temporary
Cooler Storage (off-site) ***
|
| § |
Storage:
******
|
9
10
Special
Occurrence:
Respond
to Alarm ***
