SUPPLY AGREEMENT
This
AGREEMENT (the "Agreement") dated as of JUNE 12, 2007 (the "Effective Date")
between Diagnostic Chemicals Limited, doing business as, BioVectra, a Xxxxxx
Xxxxxx Island, Canada corporation, having its principal place of business at
00
XxXxxxxxxx Xxxxxx, Xxxxxxxxxxxxx, XX X0X 0X0, Xxxxxx (hereinafter referred
to as
"BioVectra") and SyntheMed, Inc., a Delaware corporation, with an address at
000
Xxxxxxxxx Xxxxx Xxxxxxxx, Xxxxx 000, Xxxxxx, XX 00000 (hereinafter referred
to
as "SyntheMed").
WHEREAS,
BIOVECTRA is a company engaged in, among other things, synthesis of polymers
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,
BIOVECTRA has demonstrated its ability and capacity to produce polymer raw
material in accordance with SyntheMed’s specifications for use in REPEL-CV;
WHEREAS,
SyntheMed desires BIOVECTRA to manufacture, supply and sell to SyntheMed polymer
raw material for further processing and incorporation into SyntheMed’s REPEL-CV
finished product, for sale by SyntheMed to its customers, and BIOVECTRA desires
to manufacture, supply and sell to SyntheMed such polymer raw material, 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 Product.
1.3.
"BIOVECTRA Indemnified Party" shall have the meaning set forth in Section
14.2.
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
“Designated Facility” means the facility designated from time to time by
SyntheMed for further processing of Product.
1.8.
"Device Master File" shall mean materials that may be used to provide detailed
information to the FDA or other Regulatory Body about facilities, processes,
or
articles used in the manufacturing, processing, packaging, and storing of the
Products.
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 exerting
authority or jurisdiction over BioVectra’s manufacture of Product.
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,
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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 BIOVECTRA, and any trade secrets and know-how, in each case
relating to the Products or Commercial Products.
1.14.
"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.
1.15.
"Post Term Supply" shall have the meaning set forth in Section 2.1.
1.16.
"Product" shall mean the polymer
raw material
meeting
the Product Specifications.
1.17.
"Product Specifications" shall mean the specifications detailing the Product,
as
shown in Schedule 1.
1.18.
"Product Warranties" shall have the meaning set forth in Section
11.1.
1.19.
"Purchase Orders" shall have the meaning set forth in Section 5.3.
1.20.
"Purchase Commitment" shall have the meaning set forth in Section
4.2(b).
1.21
“Quality Agreement” shall mean the Quality Agreement executed between the
parties on December 11, 2006.
1.22.
"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.
1.23.
"Receiving Party" shall have the meaning set forth in Section 1.6.
1.24.
"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) exerting authority or jurisdiction over BIOVECTRA’s manufacture of
Product.
1.25.
"Renewal Term" shall have the meaning set forth in Section 2.1.
1.26.
"Rolling Forecast" shall have the meaning set forth in Section 4.2(b).Schedule
2.
1.27.
"SyntheMed Indemnified Party" shall have the meaning set forth in Section
14.1.
1.28.
"Term" shall have the meaning set forth in Section 2.1.
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1.29.
"Transfer Price" shall mean the price paid by SyntheMed to BIOVECTRA 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
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
one (1) 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 BIOVECTRA, BIOVECTRA shall,
if
so requested by SyntheMed, supply Product(s) for up to an additional twelve
(12)
months following the expiration of the then
current
Term (the "Post Term Supply") at a price to be agreed upon between the parties
at that time. This extended term period may be extended if required in order
to
get all regulatory approvals.
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.
BIOVECTRA will cooperate with SyntheMed to the extent BIOVECTRA's participation
is reasonably necessary or appropriate in order for SyntheMed to procure such
Approval, any required work which falls outside the scope of the work reasonably
contemplated by the parties under this Agreement, shall be performed at a price
to be negotiated between the parties.. Without limiting the generality of the
foregoing, BIOVECTRA will make available to SyntheMed, without charge,
information in BIOVECTRA'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 BIOVECTRA
hereunder shall be presented in a form which satisfies the Quality Agreement
and
QSR. BIOVECTRA 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. BIOVECTRA 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 manufacture of the Product. In the event FDA or
other Regulatory Authority requests additional information from BIOVECTRA,
BIOVECTRA 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
BIOVECTRA agrees to:
a.
manufacture, package, label, store and deliver the Product in accordance with
the Product Specifications, Quality Agreement and QSR.
b.
supply
SyntheMed with all of SyntheMed’s requirements of Product consistent with the
accepted Purchase Order (pursuant to Subsection 5.3);
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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 BIOVECTRA,
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,
or software, which may impact safety, quality, or effectiveness of Product,
which approval shall not be unreasonably withheld or delayed.;
f.
obtain
written approval from SyntheMed prior to implementing changes to Product
Specifications;
g.
investigate diligently, at SyntheMed’s request, complaints which relate to
Product or to the manufacture of Product, and report back to SyntheMed within
four (4) days of being notified by SyntheMed such complaint;
h.
provide to SyntheMed any complaints BIOVECTRA receives relating to the Product
or the manufacture of Product within three business days of their receipt by
BIOVECTRA;
i.
utilize in the manufacture of the Product only approved raw materials as agreed
to by SyntheMed; and
j.
follow
the Quality Agreement and QSR.
k.
if an
MDR reportable event, as described in CFR Part 803, to a patient treated with
the Commercial Product is found to be a direct result of a change in the
processes used by BIOVECTRA 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
BIOVECTRA shall not apply to such event
4.2
SyntheMed agrees to:
a.
ensure that BIOVECTRA is timely provided, at no charge, a production schedule
in
order to enable BIOVECTRA to satisfy its manufacturing and delivery obligations
with respect to the Products; and
b.
provide BIOVECTRA with rolling twelve (12) month forecasts of SyntheMed's
requirements of Product ("Rolling Forecast"). 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 BIOVECTRA for ***, which shall be BIOVECTRA's
sole remedy for SyntheMed's cancellation; provided further that (i) BIOVECTRA
will attempt to minimize any losses associated with *** and (ii) BIOVECTRA
will
***.
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c.
investigate diligently all adverse events of which SyntheMed has knowledge
or
awareness, related to the Commercial Product, and promptly report such
occurrences to BIOVECTRA if in the good faith reasonable determination of
SyntheMed, the same could reasonably have been attributable to activities of
BIOVECTRA. 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 *** 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 Chemical Solvents
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, BIOVECTRA 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
three (3) months after written notice thereof is provided to SyntheMed.
BIOVECTRA shall include in its notification a detailed justification for all
adjustments. Such adjusted Transfer Price shall be reflected in any BIOVECTRA
invoices issued for Product shipped after the effective date of
adjustment.
5.3
Purchase Orders. SyntheMed shall provide BIOVECTRA 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, forty five (45) days prior to
the
date of manufacture, to issue binding, written change orders to increase or
decrease the quantity of such Purchase Orders. BIOVECTRA 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, BIOVECTRA shall acknowledge such receipt in
writing.
5.5
Shipping. BIOVECTRA 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 and agreed to by BIOVECTRA.
*** 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
BIOVECTRA to SyntheMed upon acceptance of the shipment by the carrier at
Designated facility.
5.6
Invoices. BIOVECTRA shall invoice SyntheMed for the aggregate Product
manufactured
6
per
Purchase Order, and SyntheMed shall pay each invoice within ***; provided,
however, that all invoices rendered pursuant to the terms of this Agreement
during calendar year 2006 shall be paid by SyntheMed within ***. All payments
shall be in United States currency.
5.7
Tax
Witholding. If SyntheMed in good faith concludes that tax withholdings under
the
laws of any country are required with respect to payments to BIOVECTRA, it
shall
withhold the required amount and pay it to the appropriate Governmental
Authority, and shall promptly provide BIOVECTRA with original receipts or other
evidence reasonably required and sufficient to allow BIOVECTRA 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 BIOVECTRA unless and until SyntheMed
shall have been notified by BIOVECTRA of completion of Product manufacture
and
has reviewed and approved the BIOVECTRA testing results. SyntheMed will be
afforded full opportunity to test the Product to ensure compliance with the
Product Specifications. Notwithstanding the above, such testing shall take
place
within thirty (30) days of completion of Product manufacture and BIOVECTRA’s
Certificate of Conformance and Certification to SyntheMed. 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
delivery of Product manufactured by BIOVECTRA shall be accompanied by
BIOVECTRA'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 BIOVECTRA of the existence
and
nature of any Product which does not comply with the Product Specifications
and
BIOVECTRA shall have a reasonable opportunity, not to exceed five (5) business
days from receipt of notification, to inspect such non-compliant Product.
SyntheMed shall have no obligation to pay for any Product that is subject to
such a claim of non-compliance. If BIOVECTRA fails to timely inspect or if
such
inspection confirms such non-compliance, BIOVECTRA shall promptly replace such
non-compliant Product at its own cost and expense. In the case of non-compliant
Product previously shipped by BIOVECTRA, unless BIOVECTRA 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 BIOVECTRA shall promptly reimburse SyntheMed for
***.
6.3
If,
after BIOVECTRA’s inspections of such Product, the parties disagree as to the
Product’s conformance to the Specifications 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. All costs associated with such third-party testing
shall
be at BIOVECTRA’s expense should the Product be determined by the independent
third party laboratory to be non-compliant, and at SyntheMed’s expense should
the Product be determined to be compliant. 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 BIOVECTRA 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.
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6.4
In
the event of an audit by a Regulatory Authority at SyntheMed which involves
any
Product, SyntheMed shall notify BIOVECTRA of such audit promptly after receiving
notice thereof. Pursuant to such notice of audit, BIOVECTRA shall supply
SyntheMed with quality control documents related to the Product portion of
the
Commercial Product, within one business day if reasonable, from a request by
SyntheMed.
6.5
BIOVECTRA 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,and shall promptly advise SyntheMed of any scheduled
or
unscheduled 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. BIOVECTRA, at BIOVECTRA'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. BIOVECTRA 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
BIOVECTRA 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 BIOVECTRA shall assist and cooperate with each other in giving
effect to any "Recall," as that term is defined in 21 CFR 810.2. BIOVECTRA
shall
be responsible for the cost of replacing any Product of any Recall caused by
BIOVECTRA's shipment of Products that did not meet Product Specifications and
the costs associated with return and reshipment of Product to a SyntheMed
designated facility. BIOVECTRA 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 Commercial Product
design, or other acts not attributable to BIOVECTRA 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.
6.8
BIOVECTRA 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 BIOVECTRA’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 8 hereof. Such Review shall be
made during regular business hours, upon reasonable notice and at reasonable
intervals. BIOVECTRA 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
BIOVECTRA shall cooperate with SyntheMed to provide any authorizations,
documents, information, testing protocols and procedures relating to the
manufacture and delivery of Product in BIOVECTRA'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 notwithstanding, any required work which
falls outside the scope of the work reasonably contemplated by the parties
under
this Agreement, shall be performed at a price to be negotiated between the
parties.
6.10
Each
party shall keep and maintain complete and accurate records necessary for
regulatory
8
compliance
for a period of at least five (5) years after the expected life of the Product
or ten (10) years from the date of creation (whichever is less), including
all
records that ensure the ability to perform complete lot tracing of
Product.
6.11
The
signed SyntheMed Quality Agreement (schedule 5) 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
BIOVECTRA 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 BIOVECTRA 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, BIOVECTRA 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 8 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 BIOVECTRA and SyntheMed consent to such
public disclosure regarding the business relationship of the other party as
BIOVECTRA, SyntheMed or their counsel deem 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
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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, both parties 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,
BIOVECTRA 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)
the
Quality Agreement, (b) the pertinent rules and regulations of the QSR and ISO
13485; (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 BIOVECTRA 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
BIOVECTRA and SyntheMed each represent and warrant for itself that (i) it is
duly
10
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, either party may assign this Agreement to any
of
its affiliates, or in connection with the sale of substantially all of its
assets which relate to this Agreement provided that in no event shall any such
assignment release either party from its responsibilities under this Agreement
unless the assignee has agreed in writing to assume all the obligations of
the
other 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
BIOVECTRA 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 *** 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
11
obligation,
which matured prior to the effective date of termination, or which by their
terms are intended to continue.
14.
INDEMNIFICATION
14.1
BIOVECTRA 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 BIOVECTRA to ship Product that meets the
Product Specifications or that is not manufactured in compliance with Quality
Agreement, and QSR; (ii) any BIOVECTRA breach of a representation, warranty,
covenant or obligation in this Agreement; or (iii) any negligence or willful
misconduct of BIOVECTRA 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 BIOVECTRA and any of its
officers, directors, affiliates, employees, sales agents, successors and
permitted assigns (each, a "BIOVECTRA 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 BIOVECTRA
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
12
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:
000
Xxxxxxxxx-Xxxxx Xxxxxxxx
Xxxxx
000
Xxxxxx,
XX 00000
Fax:
000-000-0000
Attention:
President
If to
BIOVECTRA:
Diagnostic
Chemicals Limited bda BioVectra
00
XxXxxxxxxx Xxxxxx
Xxxxxxxxxxxxx,
XXX
X0X
0X0,
Xxxxxx
Fax:
000-000-0000
Attention:
President & CEO
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
13
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
Arbitration.
a. The
parties will attempt in good faith to resolve through negotiation any dispute,
claim or controversy arising out of or relating to this Agreement. Any party
may
initiate negotiations by providing written notice in letter form to the other
party, setting forth the subject of the dispute and the relief requested. The
recipient of such notice will respond in writing within five (5) business days
with a statement of its position on and recommended solution to the dispute.
If
the dispute is not resolved by this exchange of correspondence, then
representatives of each party with full settlement authority will meet at a
mutually agreeable time and place within ten (10) business days of the date
of
the initial notice in order to exchange relevant information and perspectives,
and to attempt to resolve the dispute. If the dispute is not resolved by these
negotiations, the matter will be submitted to the American Arbitration
Association ("AAA") for resolution.
b. Any
dispute, claim or controversy arising out of or relating to this Agreement
or
the breach, termination, enforcement, interpretation or validity thereof,
including the determination of the scope or applicability of this Agreement
to
arbitrate, shall be determined by arbitration in New York, New York. The
arbitration shall be administered by AAA pursuant to its then-current
Comprehensive Arbitration Rules. Judgment on any arbitration award may be
entered in any court having jurisdiction thereof and shall be final and binding
upon the parties.
c.
Notwithstanding the foregoing, nothing in this Section 15.10 shall be construed
as limiting in any way the right of a party to seek injunctive relief with
respect to any actual or threatened breach of this Agreement from a court of
competent jurisdiction.
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.
14
IN
WITNESS WHEREOF, the parties have executed this Agreement through their
duly
authorized representatives as of the date first written above.
|
DIAGNOSTIC
CHEMICAL LIMITED dba BIOVECTRA
|
||
|
By:
/s/
Xxxxxx X. Xxxxxx
|
By:
/s/
Xxx Xxxxx
|
|
|
Name: Xxxxxx
Xxxxxx
|
Name: Xxx
Xxxxx
|
|
|
Title:
President
& CEO
|
Title:
President
& CEO
|
|
|
Date:
June
14,2007
|
Date:
June
12, 2007
|
15
LIST
OF
SCHEDULES
Schedule
1 Product
Specification
Schedule
2 Rolling
Forecast (Material Forecast)
Schedule
3 Pricing
Schedule
Schedule
4 Certification
of Compliance (example)
Schedule
5 Quality
Agreement
16
Schedule
1
17
|
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.
3.1 ***
3.2 ***
3.3 ***
3.4 ***
3.4.1 ***
3.4.2 ***
3.4.3 ***
3.5 ***
3.6 ***
3.7 ***
3.8 ***
18
3.9 ***
3.9.1 ***
3.9.2 ***
3.9.3 ***
3.10
***
3.11 ***
3.12 ***
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
|
19
Schedule
2
20
REPEL-CV
Raw Material Powder Forecast
***
***
21
SCHEDULE
3
22
***
***
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
***
***
23
SCHEDULE
4
24
***
25
SCHEDULE
5
26
SYNTHEMED
QUALITY AGREEMENT
This
Quality Agreement (the "Agreement") is made as of November 10, 2006 between
SyntheMed, Inc. and Biovectra with its principal office at 00
XxXxxxxxxx Xx.,Xxxxxxxxxxxxx, XX X0X 0X0, Xxxxxx.
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
Powder (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
Biovectra
shall give all reasonable access to its facilities to satisfy all applicable
regulatory audit requirements. Any such audits will determine if Biovectra
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
Biovectra
shall manufacture the Agreement Product according to the methods agreed to
by
SyntheMed. The information/specifications to be provided to Biovectra 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
27
3.
Change
control
Biovectra
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, Biovectra shall be excused
from
all performance hereunder.
4.
Documentation
Biovectra
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. Biovectra will provide control of all documentation as required
under all applicable regulations and as part of the Biovectra quality system.
5.
Raw
Material Purchasing/Testing
Biovectra
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. Biovectra will also be responsible for the
qualification of all vendors that supply the ingredients for the Agreement
Product.
6.
In-Process
Controls
Biovectra
shall be responsible for any agreed upon quality control testing required during
the manufacture of the Agreement Product. Biovectra shall advise SyntheMed
of
any significant changes prior to their implementation in the in-process controls
(ref section 3 above).
7.
Finished
Product Testing
Biovectra
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.
Biovectra 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
Biovectra
shall assist as needed in ensuring the generation of the stability data for
the
Agreement Product.
9.
Storage.
Delivery and Transportation
Biovectra
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. Biovectra shall utilize agreed upon means for
transportation for delivery of the Agreement Product to SyntheMed or its
designee.
10.
Release
Procedure
Biovectra
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. Biovectra
shall provide:
|
10.1
|
A
Certificate of Analysis listing all test results for each batch of
Agreement Product
|
|
10.2
|
Certification
that all manufacturing was completed in accordance with agreed upon
procedures
|
|
10.3
|
Any
other details or documents which may be agreed from time to time
between
the Quality Departments of Biovectra and SyntheMed.
|
|
10.4
|
Information
and copies of investigation reports relating to a) critical batch
deviations that would have an impact on the critical quality attributes
or
were associated with critical process parameters, b) out of specification
results or c) non-compliances with regulatory requirements. These
shall be
communicated as soon as practicable to the Director, Quality Systems
at
SyntheMed.
|
11. Retention
Samples
Biovectra
shall keep adequate retention samples of the Agreement Product and raw materials
as agreed to with SyntheMed.
28
12. Rejection
and Reprocessing
Prior
to
shipment of each batch supplied and where applicable, Biovectra 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 Biovectra for any reason,
Biovectra must advise SyntheMed of the occurrence thereof and any other relevant
details.
Rework
or
reprocessing of the Agreement Product is not permitted without the consent
of
SyntheMed. (The term 'rework/reprocessing' excludes any re-inspection activities
that are specified in Company's approved procedures).
13. Recalls
and Complaints
Biovectra
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, Biovectra’s
responsibility is limited to supplying appropriate information relevant to
any
alleged product defect prompting such recall action.
14. Batch
records
Biovectra
shall keep original copies of all records of manufacture for at least five
(5)
years from the date of manufacture, and shall notify SyntheMed before disposing
of such records.
Biovectra
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
Biovectra
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
Biovectra
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
|
Biovectra
|
|
Date:
12-01-2006
|
Date:
12-11-2006
|
|
Name:
/s/
Xxxx Xxxxxx
|
Name:
/s/
Xxx Xxxxx
|
|
|
|
|
Title:
Dir Quality Systems & RA
|
Title:
President
& CEO
|
29
