SUPPLY AGREEMENT
[CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THESE PORTIONS
HAVE
BEEN REPLACED THROUGHOUT THIS AGREEMENT AND SCHEDULES BY THE FOLLOWING SYMBOL:
***]
This
AGREEMENT (the "Agreement") dated as of March 29, 2007 (the "Effective Date")
between Chem Development Inc, a Ohio corporation, having its principal place
of
business at 0000 Xxxxx Xxxxxxxxx, Xxxxxx, XX 00000 (hereinafter referred to
as
"CDI") and SyntheMed, Inc., a Delaware corporation, with an address at 000
Xxxxxxxxx Xxxxx Xxxxxxxx, Xxxxxx XX 00000 (hereinafter referred to as
"SyntheMed").
WHEREAS,
CDI is a company engaged in, among other things, 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,
CDI has demonstrated its ability and capacity to produce material in accordance
with SyntheMed’s specifications;
WHEREAS,
SyntheMed desires CDI to provide services to produce the large dry component
film roll and CDI desires to provide services to produce this material 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 Product
in
a country of the Territory.
1.3.
"SyntheMed Indemnified Party" shall have the meaning set forth in Section
14.1.
1.4.
"Claim(s)" shall mean all charges, complaints, actions, suits, proceedings,
hearings, investigations, claims and demands.
1.5.
"
Product" shall mean SyntheMed’s large dry component film roll used in REPEL-CV
that meets the Product Specification.
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 final manufacturer designated by SyntheMed
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 CDI, and any trade secrets and know-how, in each case relating
to
the Products in the Field in the Territory.
1.14.
"CDI Indemnified Party" shall have the meaning set forth in Section
14.2.
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 Polymer Material ” means *** provided to CDI 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
10.1.
1.21.
"Purchase Orders" shall have the meaning set forth in Section 5.3.
1.22.
"Purchase Commitment" shall have the meaning set forth in Section
4.2(b).
1.23.
"QSR" shall mean the Quality System Regulation promulgated by the FDA under
the
Act or other applicable regulatory agencies of countries in which the Product
will be sold as of the time of manufacture of the applicable 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.
1.24.
"Receiving Party" shall have the meaning set forth in Section 1.6.
1.25.
"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 Product is to be sold.
1.26.
"Renewal Term" shall have the meaning set forth in Section 2.1.
1.27.
"Rolling Forecast" shall have the meaning set forth in Section
4.2(b).
1.28.
"Term" shall have the meaning set forth in Section 2.1.
1.29.
"Transfer Price" shall mean the price paid by SyntheMed to CDI for the Product,
as set forth in Section 5.1 hereof.
1.30.
"USPTO" shall mean the United States Patent and Trademark Office.
2.
TERM
2.1
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 CDI, CDI 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 PRODUCTS
3.1
SyntheMed shall have responsibility for obtaining all necessary U.S. and foreign
Approvals for the Products for use. CDI will cooperate with SyntheMed to the
extent CDI's participation is reasonably necessary or appropriate in order
for
SyntheMed to procure such Approval. Without limiting the generality of the
foregoing, CDI will make available to SyntheMed, without charge, information
in
CDI'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 CDI 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. CDI 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. CDI 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 production of any part thereof. In the event FDA or other Regulatory
Authority requests additional information from CDI, CDI 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
CDI
agrees to:
a.
manufacture, package, label, store and deliver the Product in accordance with
the applicable sections of the QSR.
b.
supply
SyntheMed with all of SyntheMed’s requirements of Product(Schedule 2) consistent
with the projected Rolling Forecasts (Schedule 5)(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;
d.
permit
SyntheMed or its third party designee full opportunity to test the Product
to
ensure compliance with Product Specifications prior to delivery by CDI, as
provided in Section 6.1;
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 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 Product is found to be the result of a change in the processes
used by CDI 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 14.2 (ii) to CDI shall not apply
to such event;
f.
obtain
written approval from SyntheMed prior to implementing changes to Product or
process Specifications;
g.
investigate diligently, at SyntheMed’s request, complaints or adverse events
which relate to the Product’s 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 CDI receives relating to the Product,
including notice of any adverse events within three business days of their
receipt;
i.
utilize in the manufacture of the Product only Raw Polymer Material supplied
by
or on behalf of SyntheMed; and
j.
follow
GMP
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 CDI is timely provided, at no charge, with sufficient amounts of Raw
Polymer Material in order to enable CDI to satisfy its manufacturing and
delivery obligations with respect to the Product;
b.
provide CDI 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 CDI for *** which shall be CDI's sole remedy
for SyntheMed's cancellation; provided further that (i) CDI will attempt to
minimize any losses associated with such inventory and (ii) CDI will reduce
the
Transfer Price of any Product provided to SyntheMed that contains inventory
for
which CDI 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 Product, and promptly report such occurrences to
CDI
if in the good faith reasonable determination of SyntheMed, the same could
reasonably have been attributable to activities of CDI. 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 Products are sold; and
d.
except
as otherwise set forth herein, be solely responsible for all necessary Approvals
to market the 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 *** for factors
such as, but not limited to, changes in raw material costs (not including pass
through cost materials which will be adjusted when and if changes occur, both
higher or lower 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. Pricing adjustments will occur no more than *** and, unless
otherwise agreed, shall become effective no earlier than 30 days after written
notice thereof is provided to SyntheMed. CDI shall include in its notification
a
detailed justification for all adjustments. Such adjusted Transfer Price shall
be reflected in any CDI invoices issued for Product shipped after the effective
date of adjustment. If
price
adjustments are related to changes in the Product Specifications requested
by
SyntheMed, CDI will propose new pricing which will be negotiated in good faith
and, subject to the succeeding sentence, and will be effective immediately
upon
shipment of Products meeting the new Product Specifications.
5.3
Purchase Orders. SyntheMed shall provide CDI with firm written purchase orders
("Purchase Orders") for Production accordance with the established lead-times
set forth in Schedule 3, 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. CDI 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, CDI shall acknowledge such receipt in
writing.
5.5
Shipping. CDI shall ship Product to the Designated Facility or other SyntheMed
designated location *** 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
CDI to
SyntheMed upon acceptance of the shipment by the carrier at the distributors
or
customers facility.
5.6
Invoices. CDI shall invoice SyntheMed for the aggregate Product which it
manufactures, upon shipment to the Designated Facility, 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 CDI, it shall withhold the
required amount and pay it to the appropriate Governmental Authority, and shall
promptly provide CDI with original receipts or other evidence reasonably
required and sufficient to allow CDI 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 CDI unless and until SyntheMed shall
have been notified by CDI of completion of Product manufacture and afforded
full
opportunity to test the Product to ensure compliance with the Product
Specifications. 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 CDI shall have CDI's
Certificate of Conformance and Certificate of Analysis, the 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 CDI of the existence and nature
of any non-compliance or defect and CDI shall have a reasonable opportunity,
not
to exceed five (5) business days from receipt of such notification
and
receipt
of the defective product if applicable, to inspect such defective material
and/or Product.
All
defective Product must be returned to CDI for inspection. SyntheMed
shall have no obligation to pay for any Product that is subject to a
valid
claim of
non-compliance or defect
that is
not remedied.
If CDI
fails to timely inspect or if such inspection confirms such non-compliance
or
defect, CDI shall promptly replace such non-compliant or defective Product
at
its own cost and expense
provided
SyntheMed will provide replacement Raw Polymer Material to CDI. The aggregate
cost expense to CDI shall not exceed *** In
the
case of confirmed
non-compliant
Product
previously shipped by CDI, unless CDI provides SyntheMed with detailed written
instructions to return or dispose of such
Product
within 5 business days of a request by SyntheMed, SyntheMed may dispose of
such
Product as it sees fit and CDI shall promptly reimburse SyntheMed for all
direct, out-of-pocket costs incurred by SyntheMed in such
disposition.
6.3
If,
after CDI’s inspections of such Product, the parties disagree as to the
Product’s conformance to the Product 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 CDI’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 CDI for
testing, inspection and quality control as provided in the Product
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
Product, SyntheMed shall notify CDI of such audit promptly after receiving
notice thereof. Pursuant to such notice of audit, CDI shall supply SyntheMed
with quality control documents related to the Product, within one business
day
from a request by SyntheMed.
6.5
CDI
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
the Product, and shall promptly advise SyntheMed of any scheduled or unscheduled
Product or 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 shall be supplied to SyntheMed within
one business day of receipt. CDI, at CDI'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. CDI shall provide SyntheMed
with a copy of its responses to any Form 483 observations relating to the
Products in advance of their submission to FDA, and shall notify SyntheMed
of
the date such responses are filed with the FDA.
6.6
CDI
shall not conduct a voluntary recall of Product without prior full consultation
with SyntheMed regarding the ramifications, costs and regulatory strategies
associated with such a recall.
6.7
SyntheMed and CDI shall assist and cooperate with each other in giving effect
to
any "Recall," as that term is defined in 21 CFR 810.2. CDI shall be responsible
for the manufacturing cost (based
upon SyntheMed’s actual out-of-pocket cost) of
Product replacements as per this Agreement
of any
Recall,
but
only to the extent
caused
by CDI's shipment of Products that did not meet Product
Specifications
and
the
reasonable related
costs
associated with return and reshipment including, without limitation, any direct
costs associated with the shipment and reshipment and replacement of such
Products. CDI shall have no other obligations with respect to such Recalls,
except as may be provided for in Section 14.1. SyntheMed shall, however, bear
all costs and expenses of any recall caused by Product design, or other acts
not
attributable to CDI causing a Recall to occur, including, without limitation,
costs of notifying customers and costs associated with the shipment and
reshipment and replacement of such Products. For purposes of clarification,
CDI
is not responsible for any costs associated with loss of sales.
6.8
CDI
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 CDI’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. CDI 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
CDI
shall cooperate with SyntheMed to provide any authorizations, documents,
information, testing protocols and procedures in CDI'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 of 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
CDI
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 CDI 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, CDI 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 CDI 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,
CDI
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 conCDItuted 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 CDI or its
agents or which is abused or misused, whether intentionally or accidentally.
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
CDI
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 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
CDI
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 least *** per occurrence and *** umbrella coverage 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
CDI
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 but
only
to the extent arising
out of or resulting from: (i) the failure of CDI to perform
its obligations under this Agreement;
(ii)
any CDI breach of a representation, warranty, covenant or obligation in this
Agreement; or (iii) any negligence or willful misconduct of CDI 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 -
iii)
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 CDI and any of its officers,
directors, affiliates, employees, sales agents, successors and permitted assigns
(each, a "CDI 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 Product
by end-users
or other
product liability claim;
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 CDI 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.
Notwithstanding anything in this Agreement to the contrary, SyntheMed shall
not
be liable or responsible for indirect, speculative, punitive or consequential
damages of CDI, and CDI shall not be liable or responsible for indirect,
speculative, punitive or consequential damages of SyntheMed.
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.
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
CDI:
CDI,
Inc.
0000
Xxxxx
Xxxxxxxxx,
Xxxxxx,
XX
00000
Attention:
President
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
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.
CDI,
INC.
|
|
By:
/S/Xxxxxx X. Xxxxxx
|
By:
/S/Xxxxx X. Xxxxxx
|
Signature
|
Signature
|
Xxxxxx
X. Xxxxxx
|
Xxxxx
X. Xxxxxx
|
Name
|
Name
|
President
& CEO
|
President
|
Title
|
Title
|
3/30/07
|
3-29-07
|
Date
|
Date
|
List
of Schedules
1.
Raw Polymer Material specification
2.
Product Specifications (Raw Material Film)
3.
CDI Transfer Price, Lead Time requirements
4.
Finished Product Certificate of Conformance/Analysis (example)
5.
SyntheMed Product Forecast
6.
SyntheMed Quality Agreement
SCHEDULE
1
Material
Specification
|
1.
DESCRIPTION
Material:***
2. MATERIAL
VENDORS
BioVectra
- produces the material
Chem
Development Inc. (CDI) - receives material for further processing
3. SPECIFICATION
The
following is the criteria used in order to demonstrate that each lot of the
Dry
Raw Material Polymer Powder meets its design characteristics prior to being
released for further processing. Each criterion is tested on a lot by lot basis
at BioVectra. The results are reviewed and approved by Synthemed and if
acceptable, the material is released to CDI for further processing. At CDI
receiving inspection, the product will be tested or accepted via a vendor
certification. The methods and criteria of acceptance at receiving will be
documented and agreed upon in advance by SyntheMed.
***
4.
RESPONSIBILITIES
4.1
|
BioVectra
is responsible for the manufacturing of the material. BioVectra will
be
responsible for assuring the material meets all the specified criteria
as
defined in section 3.
|
4.2
|
CDI
is responsible for the incoming receipt, inspection and release of
material for further processing.
|
5. RECEIVING/STORAGE
5.1
|
CDI
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 |
BioVectra
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 |
CDI
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
Material
Specification
|
1.
DESCRIPTION
Material:
***
3. 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 to STI for further processing. At STI receiving
inspection, the product will be tested or accepted via a vendor certification.
The methods and criteria of acceptance at receiving will be documented and
agreed upon in advance by SyntheMed.
3.1 ***
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
6.3 |
CDI
is responsible for the in process and final 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.
|
6.4 |
STI
is responsible for the receiving 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
3
Xxxxxx,
XX 00000
|
||||||
phone
|
000-000-0000
|
|||||
fax
|
||||||
email
|
||||||
DATE
|
CHEMDEVELOPMENT
CONTACT
|
TERMS
|
||||
02/15/07
|
Xxx
Xxxxxx
|
***
|
||||
QUANTITY
|
DESCRIPTION
|
|
UNIT
PRICE
|
AMOUNT
|
||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
Repel
CV Film Casting Quotation
|
|
|
|||
|
|
|
|
|||
|
***
|
|
|
|||
|
|
|
||||
|
|
|
||||
|
***
|
|
|
|||
|
|
|
||||
|
Coating
cost per linear foot
|
***
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
***
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
All
materials and any additional equipment cost will be
charged
|
|
|
|||
|
additionally
with prior approval from Synthemed.
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
A
Purchase Order is required .
|
|
|
|||
|
|
|
|
|||
|
Thank
You
|
|
|
|
||
IF
WE ARE ENGAGED TO PERFORM WORK ON YOUR BEHALF, WHETHER BY PURCHASE
ORDER
OR OTHER MEANS, OUR WORK IS
|
||||||
PERFORMED
SUBJECT TO THE LIMITATIONS
OF LIABILITY
PROVISION WRITTEN ON THE REVERSE SIDE OF THIS DOCUMENT.
|
||||||
Part
of the
|
||||||
SCHEDULE
4
ChemDevelopment
|
||||||||||
Specialists
in Pilot Coating, Laminating & Formulating
|
||||||||||
0000
Xxxxx Xxxx. • Xxxxxx, XX 00000
|
||||||||||
000-000-0000
• fax 000-000-0000
|
||||||||||
xxx.xxxxxxxxxxxx.xxx
|
||||||||||
CERTIFICATE
OF COMPLIANCE
|
||||||||||
SPECIFICATION
#:
|
Synthemed001
|
|||||||||
COATING
LOT # :
|
112206
|
|||||||||
COATING
DATE # :
|
11/22/06
|
|||||||||
LINER
LOT # :
|
3026861
|
|||||||||
POLYMER
LOT # :
|
28004
|
|||||||||
A
side Results
|
B
side Results
|
|||||||||
Characteristic
|
Unit
|
USL
|
LSL
|
Avg.
|
s
|
Avg.
|
s
|
|||
***
|
***
|
***
|
***
|
***
|
***
|
***
|
***
|
|||
Q.A.
Reviewed and Approved:
|
Xxx
Xxxxxx
|
Date:
|
12/06/06
|
|||||||
It
is hereby certified all the products in this Coating Lot meets the
established
|
||||||||||
specifications
when tested in accordance with the referenced methods.
|
||||||||||
Records
substantiating the above statement are available upon
request.
|
||||||||||
SCHEDULE
5
SCHEDULE
5
Long-term
Forecast
***
SCHEDULE
6
SYNTHEMED
QUALITY AGREEMENT
This
Quality Agreement (the "Agreement") is made as of November 10, 2006 between
SyntheMed, Inc. and ChemDevelopment with its principal office at 00000 Xxxxxxxx
Xxxxx, Xxxxxx, XX 000000
Purpose
The
purpose of this Agreement is to set forth the quality arrangements for ensuring
that the manufacture, packaging, quality control and release of the Raw Material
Film Sheet (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
ChemDevelopment
shall give all reasonable access to its facilities to satisfy all applicable
regulatory audit requirements. Any such audits will determine if ChemDevelopment
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 destined to be further processed by
SyntheMed, Inc. or its designee.
2.
Material
Specifications
ChemDevelopment
shall manufacture the Agreement Product according to the methods agreed to
by
SyntheMed. The information/specifications to be provided to ChemDevelopment
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
ChemDevelopment
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, ChemDevelopment shall be excused
from all performance hereunder.
4.
Documentation
ChemDevelopment
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. ChemDevelopment will provide control of all documentation
as
required under all applicable regulations and as part of the ChemDevelopment
quality system.
5.
Raw
Material Purchasing/Testing
ChemDevelopment
shall be responsible for the assessment of all ingredients to be used in the
manufacture of the Agreement Product in order to ensure compliance with the
agreed upon specifications. ChemDevelopment will be responsible for qualifying
all vendors for the ingredients they use other than what is supplied by
SyntheMed (Dry Polymer Powder)
6.
In-Process
Controls
ChemDevelopment
shall be responsible for any agreed upon quality control testing required during
the manufacture of the Agreement Product. ChemDevelopment shall advise SyntheMed
of any significant changes prior to their implementation in the in-process
controls (ref section 3 above).
7.
Finished
Product Testing
ChemDevelopment
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.
ChemDevelopment 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
ChemDevelopment
shall assist as needed in ensuring the generation of the stability data for
the
Agreement Product.
9.
Storage.
Delivery and Transportation
ChemDevelopment
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. ChemDevelopment shall utilize agreed upon means
for
transportation for delivery of the Agreement Product to SyntheMed or its
designee.
10.
Release
Procedure
ChemDevelopment
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.
ChemDevelopment 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 ChemDevelopment 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 ChemDevelopment 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
ChemDevelopment
shall keep adequate retention samples of the Agreement Product and raw materials
as agreed to with SyntheMed.
12. Rejection
and Reworking
Prior
to
shipment of each batch supplied and where applicable, ChemDevelopment 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, ChemDevelopment
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
ChemDevelopment
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, ChemDevelopment’s
responsibility is limited to supplying appropriate information relevant to
any
alleged product defect prompting such recall action.
14. Batch
records
ChemDevelopment
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.
ChemDevelopment
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
ChemDevelopment
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
ChemDevelopment
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 ChemDevelopment
Date:
_________________________ Date:
_______________________
Name:
_________________________ Name:
______________________
Title:
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