EXHIBIT 10.12
SUPPLY AGREEMENT
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THIS AGREEMENT is made as of the 18th day of October, 2004, by and
between Sigma-Aldrich Fine Chemicals, an operating division of Sigma-Aldrich
Inc., having an office at 3050 Spruce Street, St. Louis, MO 63103 ("Seller"),
and Vascular Solutions, Inc., having an office at 6464 Sycamore Court,
Minneapolis, MN 55369 ("Buyer").
WHEREAS, Seller has the experience and capability to manufacture and
supply thrombin solution from bovine plasma as further described in Attachment
1, and
WHEREAS, Buyer desires to have available on a coordinated continuing
basis a supply of said product,
NOW, THEREFORE, in consideration of the premises and mutual covenants
and conditions contained herein, the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
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For the purposes of this Agreement, the following words and phrases
shall have the following meanings:
1.1 "Affiliate" shall mean with respect to any specified Person,
any other Person that directly or indirectly through one or
more intermediaries, controls, or is controlled by, or is
under common control with, the Person specified. For purposes
of this definition, "control" including, with correlative
meanings, the terms "controlled by" and "under common control
with" means ownership directly or indirectly of more than
fifty percent (50%) of the equity capital having the right to
vote for election of directors in the case of a corporation
and more than fifty percent (50%) of the beneficial interest
in the case of a business entity other than a corporation.
1.2 "Agreement" shall mean this Supply Agreement.
1.3 "GMP shall mean that the Product will be manufactured in
accordance with ICH Q7A to be used in preparation of a "drug
product" as defined in accordance with 21CFR211.
** The appearance of a double asterisk denotes confidential information that has
been omitted from the exhibit and filed separately, accompanied by a
confidential treatment request, with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
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1.4 "Contract Year" shall mean the period of twelve (12) months
from and including the Effectiveness Date and each subsequent
consecutive period of twelve (12) months during the
continuance of this Agreement.
1.5 "Effectiveness Date" shall mean the earlier of the date that
Buyer receives approval from the FDA for the inclusion of
Seller's Product in at least one of Buyer's hemostasis
products for sale in the United States and January 1, 2007.
1.6 "FDA" shall mean the United States Food & Drug Administration,
or any successor organization.
1.7 "Government Approvals" shall mean any approvals, licenses,
permits, registrations or authorizations, howsoever called, of
any United States or foreign regulatory agency, department,
bureau or other government entity necessary for Seller's
manufacture, use, storage, transport or sale of the Product.
1.8 "Lot" shall mean a manufacturing lot of the Product with a
sufficient quantity of components to result in a final yield
of at least ** units of the Product.
1.9 "QSR's" shall mean the Quality System Regulations of the FDA.
1.10 "Person" shall mean any individual, corporation, company,
limited liability company, partnership, business trust,
business association, governmental entity, governmental
authority or other legal entity.
1.11 "Product" shall mean thrombin solution from bovine plasma as
described in Attachment 1 attached hereto and/or alternatively
termed the API or Active Pharmaceutical Ingredient.
1.12 "Specifications" shall mean the specifications for the Product
set out in Attachment 1 attached hereto, as shall be amended
from time to time by mutual written agreement of the parties.
1.13 "Term" shall mean from the date of this Agreement to the
expiration of the Tenth Contract Year, unless extended or
terminated as provided for herein.
ARTICLE II
PURCHASE AND DELIVERY
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2.1 During the Term of this Agreement, Seller agrees to
manufacture and sell and Buyer agrees to purchase the Product
on the terms and conditions stated in this Agreement
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2.2 Purchase orders for the Product will be placed on Buyer's
standard purchase order form then in effect. All terms and
conditions of this Agreement shall supersede any terms or
conditions of Buyer's or Seller's ordering or shipment forms
which modify or are otherwise inconsistent with the terms and
conditions of this Agreement. All shipments of Product will be
supplied by Seller in accordance with the Specifications in
Attachment 1.
2.3 All Product sold by Seller to Buyer shall be F.O.B. St. Louis,
Missouri. Seller shall retain title and bear the risk of loss
on the Product until such time as a shipment has been
delivered to the carrier designated by Buyer or, if no such
designation has occurred, Seller's regular carrier.
2.4 Seller shall package and ship the Product in a commercially
reasonable manner in accordance with Buyer's reasonable
instructions. At Buyer's option, Seller will procure insurance
on the shipments against damage to or loss of the Product. Any
such shipping insurance so provided by Seller will be
subsequently billed to Buyer, and Buyer will reimburse Seller
for the actual costs of such insurance. No partial shipments
shall be made without Buyer's written consent.
2.5 In the event that any portion of the shipment of the Product
received by Buyer fails to conform to the Specifications,
Buyer may reject the non-conforming Product shipment by giving
written notice to Seller within ninety (90) days of Buyer's
receipt of the Product, which notice shall specify the manner
in which the Product fails to meet the Specifications. In the
event a Product defect could not have been ascertained by
Buyer upon reasonable inspection of the Product and analysis
thereof, then the ninety (90) day time period referred to
herein shall not apply provided that (i) Buyer notifies Seller
promptly upon having reason to know of such Product defect
(but in any event no later than twelve (12) months from date
of delivery) and (ii) the limitation on remedy and liability
set out in Paragraph 2.8 shall apply with respect thereto.
2.6 In the event Seller does not agree that any such Product
failed to meet the Specifications and Seller and Buyer cannot
reach agreement with respect to such Product, Seller will
submit the question of whether the Product failed to meet the
Specifications to an independent laboratory selected by Seller
and approved by Buyer for determination. The findings of such
laboratory shall be binding upon Seller and Buyer and the cost
of such determination shall be paid by the party in error.
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2.7 Subject to Sections 2.5 and 2.6, Seller shall replace any
Product not conforming to the Specifications forthwith, at its
expense, or if it is unable to make prompt replacement, Seller
shall either credit Buyer's account or refund any payment made
on the nonaccepted Product, depending on Buyer's account
balance, within forty-five (45) days of Seller's receipt of
notice of Buyer's non-acceptance. Buyer shall return, at
Seller's expense, the nonaccepted Product to Seller.
2.8 Except as provided for under Paragraph 6.5 regarding Seller's
indemnification obligations for third party claims, the
remedies described in Section 2.5 and 2.7 shall be Buyer's
sole remedy and Seller's only liability to Buyer hereunder
with respect thereto.
2.9 By the beginning of each calendar quarter (January 1, April 1,
July 1 and October 1), Buyer shall submit to Seller (i) a
binding order setting forth the quantities, delivery dates and
shipping instructions for Product delivery for the calendar
quarter commencing three months following such date, and (ii)
a non-binding forecast for delivery of Product for the next
following twelve (12) months. Binding orders shall be
considered firm and non-cancelable, however, Buyer may request
an increase to a binding order and Seller agrees to use
commercially reasonable efforts to supply such additional
Product in accordance with the terms and conditions of this
Agreement. The forecast will be used to determine the volume
purchase price for the Contract Year, which shall be adjusted
immediately if the actual amount of purchases during such
Contract Year exceeds or is less than the forecasted amount.
2.10 Each purchase order issued by Buyer shall be in full
increments of one (1) Lot.
2.11 Seller agrees that during the Term of this Agreement, Seller
and its Affiliates will not directly or indirectly sell the
Product or any derivative of the Product in or as a component
of a hemostatic product for medical use. The foregoing
restriction shall be conditioned upon and subject to Buyer's
continuing purchase of at least three (3) Lots of the Product
each Contract Year during the Term of this Agreement. In the
event that Buyer fails to purchase at least three (3) Lots of
Product during any such Contract Year, Seller shall not be
obligated to the foregoing restriction and at its sole
discretion may terminate this Agreement upon thirty (30) days
written notice to Buyer.
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ARTICLE III
QUALITY STANDARDS
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3.1 All raw materials are defined by engineering drawings or
specifications. Approved vendors must be designated on the
drawings/specs. Raw materials will be supplied by Seller.
Seller will use standard operating procedures which define the
sampling methodology and the analytical methods used to assure
that the raw materials meet the defined specifications. Seller
will notify Buyer in writing of any changes to the
specifications, sampling or test methods of raw materials or
any changes in approved vendors.
3.2 Seller shall be responsible for and shall provide all
packaging materials and printed materials associated with the
Product. This includes, but is not limited to, container
labels, container cartons and packaging material. Seller shall
be responsible for compliance with all Federal, State and
Local laws and regulations concerning packaging and labeling
materials, and for obtaining any necessary regulatory
approvals of printed materials, artwork and copy. Seller shall
obtain prior approval from Buyer before revising any printed
packaging components, primary container components and any
Buyer-supplied packaging components used in the Product.
3.3 Materials not found to meet Specifications will be considered
non-conforming. Seller shall determine the future usability of
non-conforming materials. Actions taken to investigate the
non-conformance and to justify the release of the batch of
material must be fully documented. Copies of all documentation
associated with non-conformance of materials used shall be
maintained by Seller.
3.4 The manufacturing process or traveler shall be maintained by
the Document Control / Quality Control group within Seller.
These documents shall be reviewed and approved by Buyer
according to Buyer's requirements. Listed on Buyer's Purchase
Order will be the types of changes to the manufacturing
process or traveler that require approval by Buyer prior to
implementation. Each Lot of product produced must be assigned
a unique batch or lot number. Any deviation from the specified
manufacturing process must be documented in the batch record
or traveler. Seller shall have a system to document the
deviation, the investigation that was undertaken and the
conclusion drawn from that investigation. The documentation
associated with any deviation in the manufacturing process
shall become part of the batch record.
3.5 Seller is responsible for ensuring that equipment is routinely
calibrated, inspected, maintained and qualified for use.
Calibration must be traceable to national or international
standards and the calibration status must be clearly
identified on the equipment.
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3.6 Buyer must be provided with a copy of the top-level history
record (traveler/batch record) for the Product manufactured,
if so requested by Buyer. Seller agrees to maintain all
records that support this document (e.g.,
inspection/acceptance records for subassemblies and
components) for the Term of this Agreement.
3.7 All in-process and finished Product testing shall be conducted
by Seller using validated test methods. Upon reasonable
request, Seller shall provide Buyer with a certificate of
analysis indicating each test parameter, test method, test
result and the corresponding acceptance criteria for each
batch/lot of product manufactured or packaged, as well as a
statement indicating that all associated documentation has
been reviewed and approved by the appropriate quality control
unit.
3.8 Seller is responsible for obtaining and maintaining file
samples.
3.9 Seller will allow GMP audits to be performed by approved
representatives of Buyer during normal business hours upon
reasonable advance notice and not to exceed two per year.
Buyer reserves the right to request additional audits of
Seller in the event that special circumstances require
additional investigation, such as product recalls or other
quality assurance issues.
3.10 Process/product and cleaning validation shall be performed by
Seller using protocols developed according to industry
standards. Seller shall be responsible for conducting the
validation studies and maintaining validation reports. Seller
is responsible for operating within validated parameters.
3.11 Seller agrees to manufacture in a manufacturing environment
such that the particulate and microbial levels are within the
Specifications. If no Specifications are defined, then no
particular manufacturing environment requirements are
necessary beyond applicable GMP guidelines. Where particulate
and microbial levels are required for the Product, then the
facilities and raw materials used during the manufacturing and
packaging process shall be monitored for these factors. Seller
shall be responsible for the establishment and institution of
a monitoring program to assure that the Product will meet the
required particulate and microbial levels and shall maintain
the records obtained from this monitoring program.
3.12 Buyer shall maintain distribution records which contain all of
the appropriate information as specified in 21 CFR, Section
211.198. Handling and documentation of returned product from
end-users is the responsibility of Buyer.
3.13 Buyer is responsible for investigating and handling complaints
from end-users. Seller shall cooperate with Buyer's
investigations, including providing manufacturing-related
records as they relate to the investigation.
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3.14 Seller warrants that all federal environmental and safety
requirements are being and will be followed at its facilities.
Buyer shall have the right to inspect at reasonable times
during normal business hours, and on reasonable prior notice,
the operations, records and facilities of Seller wherein
Products are manufactured, tested and stored for shipping for
the purpose of quality assurance auditing and to evaluate
compliance with applicable environmental and occupational
health and safety laws and regulations.
3.15 Seller shall notify Buyer of significant incidents relating to
production of the Product, including but not limited to the
following (i) fatalities and/or significant injuries or
occupations illnesses; (ii) incidents resulting in property
damage of $50,000 or more; (iii) environmental releases
reportable to regulatory agencies; (iv) regulatory agency
inspections alleging non-compliance; and (v) request for
information, notices of violations or other communication from
a governmental agency relating to environmental or
occupational health and safety compliance.
3.16 At Buyer's request, Seller shall provide copies of all
relevant environmental licenses and permits pertaining to its
operation and shall notify Buyer of any change in status.
3.17 At Buyer's request, Seller will provide Buyer with copies of
all applicable insurance certificates.
3.18 Unless otherwise stated in this Agreement, Seller is
responsible for compliance to all Federal, State and Local
laws and regulations as they apply to Seller's business.
3.19 Seller shall cooperate with Buyer's reasonable requests for
information and assistance in all FDA and international
regulatory filings, audits and approvals. Seller shall
promptly notify Buyer of any announced or unannounced FDA or
foreign authority inspection relating to the manufacture of
the Product. Seller shall permit a representative of Buyer to
be present at Seller's facilities during any inspection
relating to the manufacture of the Product. Seller shall
immediately provide Buyer with copies of any resulting
document of action (FDA Form 483 inspectional observation
report, regulatory letters, etc.) resulting from these audits.
Should either Seller or Buyer receive any such document of
action related to the Product, it shall immediately notify the
other and shall provide to the other an opportunity to the
extent feasible under the circumstances to provide input to
any response to any such document of action. Seller shall
cooperate with Buyer to address any GMP deficiencies noted
during any FDA audit.
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ARTICLE IV
PRICING
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4.1 During the First Contract Year, Buyer will pay Seller the
purchase price specified in Attachment 2 for each Lot of
Product ordered and shipped to Buyer. The prices for each
Contract Year subsequent to the First Contract Year shall be
adjusted for inflation, effective the first day of such
Contract Year. The adjusted price will be the price for the
prior Contract Year plus an inflation factor equal to the
12-month average percentage increase in total compensation for
private industry workers for the period ending the most recent
December 31 as indicated on Table 3 of the EMPLOYMENT COST
INDEX published by the Bureau of Labor Statistics of the
United States Department of Labor or, if the EMPLOYMENT COST
INDEX should cease to be published, any comparable category in
a comparable index agreeable to both parties, in any case
multiplied by the prior Contract Year's price.
4.2 Seller shall invoice Buyer on each shipment of the Product,
and payment shall be made in all cases net 30 days from the
date of shipment. Any invoiced amounts due but not paid from
and after the date due shall accrue a service charge of 1% per
month or the maximum rate allowed by law, whichever is lower.
Such prices do not include, and Buyer shall pay for, any
excise, sales, use or like taxes resulting from the sale of
the Product to Buyer.
4.3 In addition to the adjustment provided in Section 4.1 of this
Agreement, Seller may implement an increase to the purchase
price if (i) Buyer requires a change to the manufacturing
processes, testing requirements or raw materials for the
Product, (ii) Seller is required to make a change to the
manufacturing processes, testing requirements or raw materials
for the Product, or (iii) the cost of raw materials for the
Product increases. The amount of increase to the purchase
price will be equal to the actual amount of increased cost to
Seller, and will apply to all quantity levels of the purchase
price as listed on Attachment 2. If Seller increases the
purchase price pursuant to this Section 4.3, Seller will send
a price increase notice to Buyer, together with documentation
of the cost increase, and such price increase shall take
effect immediately for any future binding orders placed by
Buyer.
ARTICLE V
DEVELOPMENT WORK
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5.1 Seller and Buyer agree and understand that development work
will be required to be performed to allow Seller's manufacture
of the Product, and that successful completion of this
development work will be required prior to ordering any
Product under this Agreement.
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5.2 Seller agrees to perform the development or transfer of the
appropriate analytical methods for raw material, in-process
and release testing to the GMP facility. This work will
include reformatting of Standard Operating Procedures to GMP
quality control format and instrumentation, validation of
methods and performing raw material acceptance testing and
final release testing. The development work specified in this
Section 5.2 will be performed at a total cost of ** to be paid
by Buyer to Seller upon completion of this phase of
development work.
5.3 Seller agrees to conduct development trials to establish
whether Seller can produce material that meets the
Specifications by a process that includes the isolation of a
partially purified intermediate. This development work will
determine the suitability of the intermediate regarding
stability and yield and also define critical parameter limits
for the process. Upon successful completion, a draft batch
record (Seller's Master Manufacturing Formula) will be
written, and the process transferred to the GMP facility.
Progression of the project requires agreement of Seller and
Buyer of successful completion of the development work
specified in this Section 5.3. The development work specified
in this Section 5.3 will be performed at a total cost of ** to
be paid by Buyer to Seller upon completion of this phase of
development work.
5.4 Seller will use its best reasonable efforts to complete the
development work specified in Sections 5.2 and 5.3 within five
(5) months from the date of this Agreement. Buyer understands
that the completion of the work is subject to several
uncertainties which may extend this planned completion date.
5.5 Upon completion of the development work specified in Sections
5.2 and 5.3, Seller will undertake the production of one (1)
batch of ** units of Product in Seller's GMP facility meeting
the Specifications. The production of one (1) batch of **
units of Product will be performed by Seller at a total cost
of ** to be paid by Buyer to Seller upon delivery of the same.
All work will be performed using controlled documents, and
Seller's QC group will perform release tests.
5.6 Upon successful completion of the work outlined in Section
5.5, Seller shall manufacture and sell to Buyer three (3) Lots
of Product at the pricing set forth in Attachment 2. Seller
will use its best efforts to manufacture the first Lot in
accordance with the Specifications in a manner to make the
Product suitable for use by Buyer; however, no assurance is
made that the Product from the first Lot will be in full
accordance with the Specifications. All Lots of Product
manufactured after the first Lot must be according to the
Specifications in order to make the Product suitable for use
by Buyer. During and upon successful completion of
manufacturing the third Lot of Product, Seller shall validate
its processes at a cost to Buyer of **. In the event that the
Seller requires Product manufacturing to be relocated to
another facility following completion of process validation
work, Seller agrees to cover the cost of any additional
validations required as a result of the relocation Upon
completion of process validations, Seller shall promptly
perform
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the stability studies outlined in Attachment 3 at Buyer's cost
as outlined in Attachment 3.
5.7 Seller will use its best reasonable efforts to complete (i)
the development work specified in Section 5.5 within two (2)
months following the completion of the development work
specified in Sections 5.2 and 5.3, and (ii) the manufacturing
work specified in Section 5.6 within ten (10) months
thereafter. Buyer understands that the completion of the work
is subject to several uncertainties which may extend this
planned completion date.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
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6.1 Each party represents and warrants to the other that the
execution of this Agreement and the full performance and
enjoyment of the rights of Seller and Buyer under this
Agreement will not breach or in any way be inconsistent with
the terms and conditions of any license, contract,
understanding or agreement, whether express, implied, written
or oral between the warranting party and any third party.
6.2 Seller represents and warrants that, to the best of its
knowledge as of the date of this Agreement, no patents, patent
applications if issued, or any other proprietary rights of any
third party would be infringed by the manufacture, use or sale
of the Product.
6.3 Seller warrants that all Product supplied pursuant to this
Agreement shall be free from defects in materials and
workmanship, shall be of merchantable quality, shall conform
to the requirement of applicable federal and state regulatory
requirements, shall have all necessary Government Approvals
and shall meet the Specifications. At Buyer's request, Seller
shall certify in writing that it is in substantial compliance
with all applicable environmental and occupational health and
safety laws and regulations.
6.4 SELLER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. BUYER
IS SOLELY RESPONSIBLE FOR DETERMINING THAT THE PRODUCT
PROVIDED BY SELLER HEREUNDER IS OF GOOD QUALITY, FREE FROM
DEFECTS, CONFORMS TO THE SPECIFICATIONS AND IS MERCHANTABLE.
6.5 Subject to Section 6.6, Seller shall indemnify, defend and
hold harmless Buyer from all actions, losses, claims, demands,
damages, costs and liabilities (including reasonable
attorneys' fees) to which Buyer is or may become subject
insofar as they arise out of or are alleged or claimed to
arise out of (i) personal injury, death
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or property damage sustained by any person(s) resulting from
the use of any Product manufactured by Seller, (ii) any breach
by Seller of any of its obligations under this Agreement or
warranties of Seller, or (iii) any negligent or willful act or
omission by Seller or its employee, agents or subcontractors.
6.6 Subject to Section 6.5, Buyer shall indemnify, defend and hold
harmless Seller from all actions, losses, claims, demands,
costs and liabilities (including reasonable attorney's fees)
to which Seller is or may become subject insofar as they arise
out of or are alleged or claimed to arise out of (i) any
breach by Buyer of any of its obligations under this
Agreement, (ii) any negligent or willful act or omission by
Buyer or its employees, agents or subcontractors, (iii)
personal injury, death or property damage sustained by any
person(s) resulting from the use of Product manufactured by
Buyer or by a third party at the direction of Buyer, or (iv)
any labeling, advertising or promotional materials used by
Buyer.
6.7 A party entitled to indemnification hereunder agrees to give
prompt written notice to the indemnifying party after the
receipt by such party of any written notice of the
commencement of any action, suit, proceeding or investigation
or threat thereof made in writing for which such party will
claim indemnification pursuant to this Agreement and cooperate
fully with the indemnifying party in conducting such defense.
Unless, in the reasonable judgment of the indemnified party, a
conflict of interest may exist between the indemnified party
and the indemnifying party with respect to a claim, the
indemnifying party may assume the defense of such claim with
counsel reasonably satisfactory to the indemnified party. If
the indemnifying party is not entitled to, or elects not to,
assume the defense of a claim, it will not be obligated to pay
the fees and expenses of more than one counsel with respect to
such claim. The indemnifying party will not be subject to any
liability for any settlement made without its consent, which
shall not be unreasonably withheld.
6.8 The provisions and obligations of this Article VI shall
survive any termination of this Agreement.
ARTICLE VII
RECALLS AND RETURNS
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7.1 In the event of a recall involving any Buyer finished product
containing Product supplied hereunder is required by a
governmental agency or authority of competent jurisdiction or
if recall is deemed advisable by Buyer, such recall shall be
promptly implemented and administered by Buyer in a manner
which is appropriate and reasonable under the circumstances
and conformity with accepted trade practices. Subject to
Paragraph 7.2, in the event that a recall is required as a
result of Buyer's breach of its obligations hereunder, all
costs and expenses incurred in connection therewith will be
borne by Buyer. Subject to
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Paragraph 7.2, in the event that a recall is required as a
result of Seller's breach of its obligations hereunder, all
costs and expenses incurred in connection therewith shall be
borne by Seller.
7.2 Notwithstanding anything in this Agreement to the contrary, in
the event of any recall, neither party shall be liable to the
other party for special, incidental or consequential damages,
loss of profit or loss of use, whether a claim arises in tort
or contract. The limitation on liability provided for herein
shall apply even in the event of the fault, negligence or
strict liability of the party that may be responsible for the
liability associated with such recall or the Products
recalled.
7.3 The provisions and obligations of this Article VII shall
survive any termination of this Agreement.
ARTICLE VIII
CONFIDENTIALITY
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8.1 During the term of this Agreement each party may disclose
information to the other party that is of a confidential or
proprietary nature. Information which is designated in writing
to be confidential or, if disclosed orally, reduced to writing
and designated as confidential within thirty (30) days of such
disclosure (Confidential Information) shall be maintained in
confidence by the receiving party and not disclosed to third
parties except upon the disclosing party's prior written
consent. It shall be understood, however, that Confidential
Information shall not include, and the obligations of
confidentiality and nondisclosure shall not apply to,
disclosed information that:
a) is or becomes publicly available through no fault of
the receiving party;
b) is disclosed without restriction to the receiving
party by a third party entitled to disclose it;
c) is already known to the receiving party at the time
of disclosure by the disclosing party as shown by its
prior written records;
d) is developed independently by an employee or
consultant of the receiving party who had no
knowledge of disclosures made under this Agreement;
or
e) is required to be disclosed in compliance with a
governmental regulation or judicial or administrative
process.
8.2 No right or license, either expressed or implied, under any
patent or other intellectual property right is granted
hereunder.
8.3 The obligations of confidentiality and non-disclosure shall
remain in effect and survive for a period of five (5) years
from the termination of this Agreement.
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ARTICLE IX
TERM AND TERMINATION
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9.1 Unless sooner terminated in accordance with its terms, this
Agreement shall terminate upon the completion of the Tenth
Contract Year. This Agreement shall be automatically extended
for up to five (5) additional successive one year terms unless
one party delivers notice of termination at least one year
prior to the scheduled termination of this Agreement.
9.2 If either party defaults in the performance or observation of
any of its material obligations under this Agreement, the
non-defaulting party may terminate this Agreement if such
default is not cured within thirty (30) days after written
notice thereof, which notice shall contain a specific
identification of the default. Failure to terminate this
Agreement for any default or breach shall not constitute a
waiver by the aggrieved party of its right to sue for damages
or its right to terminate this Agreement for any other default
or breach.
9.3 If Buyer fails to purchase at least three (3) Lots of Product
in any Contract Year, Seller may terminate this Agreement if
Buyer has not corrected such deficiency by issuing a
definitive purchase order to Seller within thirty (30) days
after written notice thereof.
9.4 Either party may terminate this Agreement upon written notice
in the event that the other party files for bankruptcy,
liquidation, dissolution, or takes similar action seeking
protection against creditors under insolvency laws, or has
entered against it involuntarily a decree in bankruptcy or
similar decree which remains in effect for sixty (60) days.
9.5 This Agreement may be terminated upon the mutual written
agreement of the parties.
9.6 Expiration or earlier termination of this Agreement will not
extinguish rights or obligations previously accrued or vested.
9.7 Upon the expiration of this Agreement or its earlier
termination, Seller will use its best efforts to assist Buyer
in the transfer of relevant manufacturing technology and
information not considered to be Seller's proprietary
information to another qualified manufacturing site and Buyer
will pay Seller for all such efforts in an amount mutually
agreed upon by the parties prior to transfer of information.
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ARTICLE X
TRADEMARKS AND TRADE NAMES
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10.1 Buyer and Seller hereby acknowledge that neither party now has
and shall not hereafter acquire, any interest in any of the
other party's trademarks, trade names, service marks or logos
appearing on the labels or packaging materials containing the
Product. No party shall, without the prior written consent of
the affected party, use in advertising, publicity or
otherwise, the name, trademark, logo, symbol or other image of
the other party.
10.2 Neither party will issue or disseminate any press release or
statement, nor initiate any communication of information
regarding the existence or the terms of this Agreement,
written or oral, to the communications media or a third party
without the prior written consent of the other party.
10.3 The obligations of this Article shall remain in effect and
survive the termination of this Agreement.
ARTICLE XI
ASSIGNMENT AND AMENDMENT
------------------------
11.1 This Agreement may not be assigned by either party without the
prior written consent of the other, except that either party
may assign this Agreement to any corporation with which it may
merge or consolidate, or to which it may transfer all or
substantially all of its assets to which this Agreement
relates, without obtaining the consent of the other party,
provided the assignee agrees to be bound, in written notice
sent to the other party, by the terms and conditions of this
Agreement. Subject to the foregoing, this Agreement shall be
binding upon and shall inure to the benefit of the parties
hereto and their respective successors and assigns.
11.2 Except as otherwise provided herein, this Agreement may not be
amended, supplemented or otherwise modified except by an
instrument in writing signed by both parties.
ARTICLE XII
NOTICES
-------
12.1 Any notice provided for under this Agreement shall be in
writing, shall be deemed to have been sufficiently provided
and effectively made as of the delivery date if
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hand-delivered, or as of the date received if sent by courier
service or mailed by registered or certified mail, postage
prepaid, and addressed to the receiving party at its
respective address as follows:
If to Buyer:
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis, MN 55369
Attn: Chief Executive Officer
If to Seller:
Sigma-Aldrich Fine Chemicals
3050 Spruce Street
St. Louis, MO 63103
ARTICLE XIII
INDEPENDENT CONTRACTOR
----------------------
13.1 The relationship of the parties under this Agreement is that
of the independent contractors and not as agents of each other
or parties or joint venturers, and neither party shall have
the power to bind the other in any way with respect to any
obligation to any third party unless a specific power of
attorney is provided for such purpose. Each party shall be
solely responsible for its own employees and operations.
ARTICLE XIV
FORCE MAJEURE
-------------
14.1 Neither party shall be liable to the other for failure to
perform its obligations under this Agreement where such
failure is caused by strikes, fires, embargoes, any
governmental act or regulation, acts of God, acts of war,
insurrection, riot or civil disturbance, or any other cause
not under the control of the defaulting party. If any event of
force majeure should occur, the affected party shall promptly
give notice thereof to the other party, and the affected party
shall use its best effort to cure or correct any such event of
force majeure.
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ARTICLE XV
MISCELLANEOUS
-------------
15.1 Should one of the provisions of this Agreement become or prove
to be null and void, such will be without effect on the
validity of this Agreement as a whole. Both parties will,
however, endeavor to replace the void provision by a valid one
that in its economic effect is most consistent with the void
provision. Both parties must agree to any such replacement
provision in writing.
15.2 This Agreement shall be governed by and construed in
accordance with the laws of the State of Missouri without
regard to principles of conflicts of laws.
15.3 This Agreement constitutes the entire understanding between
the parties regarding the subject matter hereof and neither
Buyer nor Seller has relied on any representation not
expressly set forth or referred to in this Agreement.
15.4 Each party hereto agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as
may be necessary or appropriate in order to carry out the
purposes and intent of this Agreement.
15.5 The waiver by either party of a breach of any provision
contained herein shall be in writing and shall in no way be
construed as a waiver of any succeeding breach of such
provision or the waiver of the provision itself.
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IN WITNESS WHEREOF, the duly authorized representatives of the parties
hereto have caused this Agreement to be executed in duplicated originals.
VASCULAR SOLUTIONS, INC. SIGMA-ALDRICH FINE CHEMICALS
By: _______________________ By: ___________________________
Name: _______________________ Name: ___________________________
Title: _______________________ Title: ___________________________
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Attachment 1 - Specifications
The Product shall consist of one Lot of thrombin solution from bovine
plasma, with an expected final yield of at least ** units of thrombin per Lot.
Seller shall attempt to maximize the final yield of each Lot, and Seller shall
not decrease the amount of source material in any Lot without the approval of
Buyer. Each Lot shall contain a Certificate of Analysis from Seller in the Form
attached hereto and a Certificate of U.S. Origin of the bovine material.
Finished specifications of the Product are as follows:
---------------------------------------------- ----------------------------------- ------------------- ----------------
TEST DESCRIPTION [Test Code] SPECIFICATION SPECIFICATION TESTING
RANGE LABORATORY
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
---------------------------------------------- ----------------------------------- ------------------- ----------------
** ** ** **
-----------------------------------------------------------------------------------------------------------------------
**
-----------------------------------------------------------------------------------------------------------------------
Each Lot shall be stored either as a frozen liquid or lyophilized
powder at a concentration of ** unit aliquots per container. Lot shall be
shipped in bulk to Buyer at a monitored temperature of less than ** with
appropriate protective packaging.
**
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CERTIFICATE OF ANALYSIS, TO BE ON COMPANY LETTER HEAD
Certificate of Analysis
DESCRIPTION __________________________
PART NUMBER __________________________
LOT NUMBER __________________________
QUANTITY ______________________________ EXPIRATION DATE ___________
- -------------------------------------------------- ----------------------------------- -------------------
TEST DESCRIPTION SPECIFICATION Result
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
** **
- -------------------------------------------------- ----------------------------------- -------------------
Sigma Aldrich certifies that the above test results are correct, and conform to
the specification requirements defined above.
Attached is the material of animal origin certifications for this specific lot
of Thrombin. These certifications meet the requirements set forth in EN 12442.
- -----------------------------------
Quality Assurance Date
Sigma Aldrich Fine Chemicals
CERTIFICATE OF ANALYSIS, TO BE ON COMPANY LETTER HEAD
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CERTIFICATE OF MATERIAL OF ANIMAL ORIGIN
Certificate Number _________________
Country in which animal was slaughtered ____________________
Country of Origin ____________________
Approval Number of Slaughterhouse ____________________
Establishment Name and Location ____________________
Material of (Animal Species) ____________________
Age of Animal ____________________
Nature of tissue or Organ ____________________
Packaging Materials used ____________________
Number of Containers/Packages ____________________
Name of Veterinarian ____________________
Collection Dates ____________________
- ----------------------------------------------------
Quality Assurance Date
Sigma Aldrich Fine Chemicals
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Attachment 2 - Pricing
The price for each of the first three Lots of Product purchased
pursuant to Section 5.6 shall be **; provided, however, that if the first Lot of
Product as manufactured is not suitable for Buyer's commercial use, the price of
the first Lot of Product shall be lowered to an amount equal to Seller's actual
costs of manufacture of the first Lot of Product and a fourth Lot of Product
shall be manufactured at a price of **. In addition, with the purchase price of
the first Lot of Product Buyer shall pay Seller an amount equal to ** for
one-time equipment expenses for the purchase of equipment dedicated to the
production of the Product. The equipment purchased with this one-time payment
shall be as follows:
**
**
The price for each subsequent Lot of Product purchased under this
Agreement through the end of the First Contract Year shall be determined
according to the following table:
- ------------------------------------- ----------------------------------
TOTAL NUMBER OF LOTS PURCHASED IN
THE CONTRACT YEAR PRICE PER LOT
- ------------------------------------- ----------------------------------
1 **
- ------------------------------------- ----------------------------------
2 **
- ------------------------------------- ----------------------------------
3 **
- ------------------------------------- ----------------------------------
4 **
- ------------------------------------- ----------------------------------
5-6 **
- ------------------------------------- ----------------------------------
7-8 **
- ------------------------------------- ----------------------------------
9 or more **
- ------------------------------------- ----------------------------------
The price for Product purchased in each Contract Year after the First
Contract Year shall be adjusted pursuant to Sections 4.1 and 4.3 of this
Agreement.
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Attachment 3
------------
CORPORATE QUALITY CONTROL
-------------------------
Stability Studies
-----------------
STUDY DESIGN
o ACCELERATED: 0, 1, 2, 3, AND 6 MONTHS AT 2-8 (DEGREE)C
o LONG-TERM: 0, 3, 6, 9, 12, 18, AND 24 MONTHS AT -20 (DEGREE)C
ASSUMPTIONS
o ACCELERATED AND LONG TERM WILL BE RUN CONCURRENTLY.
o RELEASE TESTING WILL BE USED FOR TIME 0.
o STABILITY STUDIES BEGIN WITHIN 4 WEEKS OF RELEASE.
o DOES NOT INCLUDE INTERMEDIATE CONDITION TESTING AND STORING OR
ADDITIONAL TESTING OF SAMPLE.
o DEGRADATION STUDIES: PERFORMED PRIOR TO STABILITY STUDIES
UNLESS OTHERWISE SPECIFIED
DELIVERABLES:
o SUBMISSION AND APPROVAL OF LONG TERM AND ACCELERATED PROTOCOLS
BEFORE STABILITY STUDIES BEGIN
o DATA TABLES AVAILABLE AT EACH INTERVAL AS REQUESTED
o FINAL REPORT AT THE COMPLETION OF EACH PROTOCOL
ESTIMATED TIME REQUIREMENTS FOR STABILITY STUDIES FOR 1 LOT
- --------------------------------- --------------------- -------------------
ACCELERATED LONG-TERM
- --------------------------------- --------------------- -------------------
** ** **
- --------------------------------- --------------------- -------------------
** ** **
- --------------------------------- --------------------- -------------------
**
- --------------------------------- --------------------- -------------------
**
- --------------------------------- --------------------- -------------------
**
- --------------------------------- --------------------- -------------------
** ** **
- --------------------------------- --------------------- -------------------
HOURS TO COMPLETE STUDY ** **
- --------------------------------- --------------------- -------------------
HRS. TO PREPARE PROTOCOL ** **
- --------------------------------- --------------------- -------------------
HRS. TO LAUNCH STUDY ** **
- --------------------------------- --------------------- -------------------
HRS. TO PREPARE INTERIM REPORTS ** **
- --------------------------------- --------------------- -------------------
HRS. TO PREPARE FINAL REPORT ** **
- --------------------------------- --------------------- -------------------
TOTAL HRS. FOR ALL PHASES OF ** **
STUDY
- --------------------------------- --------------------- -------------------
**
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Summary For Stability Studies
-----------------------------
o ESTIMATED COST FOR ACCELERATED STUDY: **
o ESTIMATED COST LONG-TERM STUDY: **
o ESTIMATED COST FOR ACCELERATED AND LONG-TERM STUDIES = **
DEGRADATION STUDIES - POSSIBLE FORCED DEGRADATION PROCESSES AND TESTING
**
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