SUPPLY AGREEMENT
Exhibit 10.5
THIS SUPPLY AGREEMENT (the “Agreement”) dated as of September 15 2003, by and between X.
XXXXX MEDICAL INC., a Pennsylvania corporation having offices at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxxxxx 00000 (“X. Xxxxx”) and Integrated Biosciences,
Inc., having offices at 0000 XxxXxxx
Xxxxx Xxxxx 000, Xxxxxxxxxx, XX 00000 (“Company”).
The parties hereto, intending to be legally bound hereby, agree as follows:
1.
Definitions. When used in this Agreement, capitalized terms, including their plural
form, shall have the following meanings:
1.1 “Product” means, individually and collectively, the products listed in Exhibit Ahereto,
as further described in the contract documents.
1.2 “Specifications” means the Product specifications, attached as Appendix B, C, D
and E hereto.
2. Scope
of Work. Company shall provide to X. Xxxxx products meeting specifications set forth in
exhibits and in accordance with individual purchase orders placed by Xxxxx for delivery of
product(s).
3. Contract
Documents. The documents listed below are incorporated herein
by reference:
a) Exhibit A — Commercial requirements product matrix-Syringes
b) Exhibit B — Product specifications
c) Exhibit C — Process/QA specifications
d) Exhibit D — Manufacturing specifications
e) Exhibit E — Siliconize Prices
f) Exhibit F — Memorandum of Understanding
b) Exhibit B — Product specifications
c) Exhibit C — Process/QA specifications
d) Exhibit D — Manufacturing specifications
e) Exhibit E — Siliconize Prices
f) Exhibit F — Memorandum of Understanding
4. Supply of Product. During the term of this Agreement and any extension or renewal
thereof, and subject to the terms and conditions of this Agreement, Company shall manufacture
and supply to X. Xxxxx, and X. Xxxxx shall purchase from Company, the Product that X. Xxxxx may
order pursuant to the terms of this Agreement. The ordering of Products shall be by means of
individual purchase orders issued by X. Xxxxx’x authorized procurement personnel. Binding
purchase orders shall be issued with at least thirty (30) days notice prior to the required
delivery dates thereunder, and shall specify the name, product code, quantities of each of the
Products to be purchased, required delivery dates, and shipping instructions.
5. Price
and Payment. The price of the Products shall be as set forth
in Exhibit A hereto,
and shall remain firm for the term of this Agreement. Company shall bear all federal, state and
local taxes based upon or measured by its net income or its business. Company shall invoice X. Xxxxx
with any shipment of Products and X. Xxxxx shall make payment to Company, at the address specified
on the invoice, no later than the later of forty-five (45)days from
the receipt of the invoice
6.
Delivery. All shipments of Products shall be made on the Delivery Date, X.X.X.
X. Xxxxx’x delivery point on the purchase order. Cost of Freight shall be be prepaid by Company
and added to invoice. If defective product is received and
disposition determined by X. Xxxxx and
Company is to use as is due to schedule contraints, X. Xxxxx will 100% inspect product for useable
product. The time needed to perform 100% inspection will be charged Company at a rate of $25.00
/hr. X. Xxxxx will not be required to pay for any defective product
7. Product Specifications; Etc. Any changes in the Specifications for any of the Products
shall be mutually approved in writing in advance by the parties prior to the incorporation of any
such change in any production units. Company agrees to promptly incorporate and validate with
assistance of X. Xxxxx all agreed-upon changes, consistent with good manufacturing practices. If
Product does not meet Specifications, then X. Xxxxx shall have a
right, in addition to its other remedies at law or equity, to terminate this Agreement without any
liability to Company. X. Xxxxx may, from time to time, send representatives to Company’s
manufacturing facility or its suppliers’ facilities to observe, audit and inspect the production
facilities, and Company will allow X. Xxxxx’x representatives reasonable access to all
manufacturing records for the Product so as to ensure that Company is in compliance with the
applicable government regulations and the Specifications.
8. Warranties. Company represents, warrants and covenants to X. Xxxxx that the Products delivered
under this Agreement shall be free from defects in material
workmanship shall comply in all respects
with the applicable Specifications for such product and shall be manufactured in accordance with
all applicable laws, regulations, and directives. X. Xxxxx shall notify Company in writing if it
determines that any Product fails to meet the warranties set forth herein and at X. Xxxxx’x option,
Company will, at Company’s expense, immediately repair or replace the defective Product, or
reimburse X. Xxxxx the purchase price of such defective Product Company shall bear all freight cost
and risk of loss or damage to returned and replacement Products while in transit. THE WARRANTIES
PROVIDED IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
9. Compliance with Laws. Company represents, warrants and covenants to X. Xxxxx that it
shall, at all times, comply with all applicable laws, rules and regulations and standards
applicable to manufacturing of the Products. Any provision required to be included in a contract
of this type by any applicable and valid federal, state or local law, ordinance, rule or
regulation shall be deemed to be incorporated herein, and Company agrees to comply with all
applicable laws and regulations in connection with its obligations hereunder.
10. Insurance. Company represents and warrants to X. Xxxxx that it is currently insured and
covenants that at all times during the term of this Agreement it will maintain from a qualified
insurance including without limitation, a comprehensive general liability insurance policy,
product liability insurance, personal injury insurance and contractual liability coverage which is
sufficient to adequately protect against the risks associated with its ongoing business, including
the risks which might possibly arise in connection with the
transactions contemplated by this
Agreement, in an amount of at least $1,000,000 per single claim (with a deductible amount of no
greater than $10,000). Company, at the time of signing, shall furnish X. Xxxxx with a Certificate
of Insurance evidencing that such insurance is in full force and effect, and providing that
X. Xxxxx will be provided written notice at least sixty (60) days in advance of any material
change, cancellation or termination of insurance. Such insurance shall be on an occurrence-made
basis, shall name X. Xxxxx, as an additional insured All such policies shall contain an endorsement
that they shall be primary in all instances regardless what, if any, like coverages are carried by
X. Xxxxx.
11. Indemnification. Company hereby indemnifies and agrees to defend and hold X. Xxxxx, its
offices, directors, agent and employees (individually and collectively, “X. Xxxxx Parties”)
harmless from and against any and all damages, liabilities, penalties, losses or expenses
including, without limitation, legal fees, arising out of or resulting from any claims, actions,
demands or proceedings asserted by a third party (“Claim”) which results from or arises out of (i)
Company’s breach of any warranty, representation or agreement of Company in this Agreement (iii)
and the death of, or bodily injury to, any person on account of the acts or omissions of Company
Parties.
12. Term; Termination; Event of Default & Remedies.
12.1 This Agreement shall commence on the date set forth above and shall continue until Sept 2
2004, unless sooner terminated in accordance with the provisions hereof. Thereafter, this
Agreement may be extended under terms mutually agreed upon by both parties and formalized in
writing.
12.2 In addition, this Agreement may be terminated as follows:
(a) By either party, effective upon delivery of a termination notice, if the other party (i)
files in any court pursuant to any statute of the United States or of any individual state, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement or at the
appointment of a receiver or
trustee of the party of its assets, (ii) is served with an involuntary petition against it, filed
in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days
after filing thereof, (iii) is a party to any dissolution or liquidation, (iv) makes an
assignment for the benefit of creditors, or (v) discontinues its operations for any reason
whatsoever.
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(b) By X. Xxxxx, immediately upon written notice to Company, if Company assigns or transfers
this Agreement or any of its obligations hereunder to any party, including without limitation, any
successor in interest through merger, sate of stock, assets, business line, or otherwise.
(c) By either party, in the event that the other party fails to perform or otherwise breaches
any of its obligations hereunder, by giving notice of its intent to terminate and stating the
grounds therefore. The party receiving such notice shall have thirty (30) days from the receipt
thereof to cure the failure or breach at which time this Agreement
shall terminate if said failure
or breach has not been cured to the reasonable satisfaction of the other party. In no event,
however, shall such notice of intention to terminate, or actual termination by the nonbreaching
party, be deemed as a waiver of any other rights or remedies which such party may have as a
consequence of such failure or breach, and such party shall have all other rights and remedies
available at law or in equity.
10.3 Termination of this Agreement shall not relieve either party from its duty to discharge
all obligations accruing prior to such termination, including parties’ obligations pursuant to any
purchase order outstanding on the date of such termination and for payment for any Product
delivered prior to the termination hereof. Notwithstanding Subsection 10.2(c), upon any breach,
default or failure to perform by one party hereunder, the other party may continue to operate under
this Agreement while pursuing any remedy it may have at law or equity, so long as such
non-breaching party continues to meet all of its obligations under this Agreement, but only to the
extend that the breach, default or failure to perform does not adversely and materially affect any
such obligation of the non-breaching party.
10.4 Upon termination of this Agreement for any reason whatsoever, (i) X. Xxxxx shall return to
Company all confidential information and documents relating to or containing confidential
information, together with all copies made thereof and extracts made therefrom, and (ii) Company
shall return to X. Xxxxx all confidential information and documents relating to or containing
confidential information, together with all copies made thereof and extracts made therefrom;
provided that the parties shall be entitled to retain one copy of the Confidential Information in
their legal department files for the purpose of insuring compliance with any applicable
governmental rules and regulations.
13. Limitation of Liability. Except for the obligations of indemnification hereunder, or
as otherwise expressly provided herein neither party shall be liable to the other party for any
indirect, special, punitive, incidental or consequential damages from any cause whatsoever,
regardless if any remedy herein fails, including without limitation, damages for loss of profits or
opportunity costs.
14. Force Majeure. If either party becomes unable to perform any of its obligations
hereunder, in whole or in part, by reason of an act of God, acts of civil or military authorities or
fires, floods, wars and riots or civil disturbances (a “Force Majeure”), such failure of
performance shall be excused during the continuance of and to the extent of such Force Majeure
event. Each party will promptly notify the other of any occurrence of an event of Force Majeure and
of the termination thereof. X. Xxxxx may terminate this Agreement if the Force Majeure event will
exceed thirty (30) days.
15. Miscellaneous Terms and Conditions.
15.1 Each party agrees to hold in confidence and refrain from using, distributing,
disseminating or disclosing to others any information of the other party that is designated by the
discloser as “confidential” other than pursuant to this
Agreement. The restrictions set forth in
the preceding sentence shall not apply to confidential information that a receiving party proves:
(a) was, at the time of disclosure hereunder, in the public domain or becomes at a later date
reasonably available to the public through no fault of the recipient; (b) was in the possession
of recipient prior to disclosure hereunder, as evidence by recipient’s written or tangible
evidence: (c) was disclosed to recipient by a third party that has an independent right to
disclose the information; (d) was independently developed by recipient as evidenced by competent
proof; or (e) was required to be disclosed by judicial order, statute or governmental regulation,
provided that the disclosing party is given reasonable prior written notice of any such required
disclosure. This Section shall survive termination of this Agreement and any extension thereof,
for a period of three (3) years.
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15.2 The parties hereto shall be deemed to have the status of independent contractors, and
shall have the relationship of buyer and seller. Nothing in this Agreement shall be deemed to
place the parties in the relationship of partners, licensor-licensee, principal-agent or joint
venturers. Neither party shall have any right or authority to create or assume any obligation or
to bind the other party in any manner whatsoever.
15.3 Neither party shall assign this Agreement or their rights hereunder without the prior
written consent of the other party, provided that this Section shall
not apply to an assignment by
X. Xxxxx to an affiliated Company or any successor to its business. This Agreement shall inure to
the benefit of, and be binding upon, the permitted assigns and successors of the parties hereto.
15.4 Any notice or request required or permitted to be given under or in connection with this
Agreement shall be in writing and shall be deemed given only if delivered personally, sent by
registered or certified mail, return receipt requested, or by overnight delivery service to the
applicable address set forth above or such other address as a party may have specified in a notice
duly given to the other party as provided herein,
15.5 This Agreement, including the Appendixes and exhibits attached hereto, and X. Xxxxx’x
purchase orders (and any future addenda, or amendments referencing this Agreement) contains the
entire agreement and understanding between the parties with respect to the subject matter hereof
and supersedes all prior proposals and agreements between the parties, whether oral or written, and
there are no other promises or representations relating to the subject matter hereof that is not
incorporated herein. No addition to or waiver or modification of any provision of this Agreement
shall be binding unless in writing and signed by a duly authorized representative of each party.
Without limiting the generality of the foregoing, no modification or amendment shall be effected by
or result from the receipt, acceptance, signing or acknowledgment of any order acknowledgments,
invoices, shipping documents or other business forms containing terms or conditions in addition to
or different from the terms and conditions set forth in this Agreement or X. Xxxxx’x purchase
orders. Such documentation is permitted only as a convenience to the parties, and all such
documentation shall be governed and superceded by the terms and conditions of this Agreement and
X. Xxxxx’x purchase orders. Any failure by either party to
enforce any of their respective rights
herein shall not be deemed a waiver of such rights, and it may, from time to time, and at its
option, enforce any of its rights hereunder, notwithstanding any course of dealing or performance.
Notwithstanding the termination of this Agreement, the rights and obligations of the parties set
forth in the provisions of Sections 6, 8, 9, 10,11 and 13 of this Agreement shall survive the
termination of this Agreement in accordance with their terms.
15.6 For the purpose of
implementing Section 1861 (v)(I)(I) of the Social Security Act, as
amended, and any written regulations thereto, Company agrees to comply with the following statutory
requirements governing the maintenance of documentation to verify the cost of services rendered
under this Agreement:
(a) Until the expiration of four (4) years after the furnishing of services pursuant to
the Agreement, Company shall make available, upon written request, to X. Xxxxx, the Secretary
of HHS, or the Comptroller General of the U.S., or any of their duly authorized
representatives, the contract, and books, documents, and records of Company that are
necessary to certify the nature and extent of such costs, and
(b) If Company carries out any of the duties of the Agreement through a subcontract,
with a value or cost of $10,000 or more over a 12-month period, with a related organization,
such subcontract shall contain a clause to the effect that until the expiration of four (4)
years after the furnishing of such services pursuant to such subcontract, the related
organization shall make available, upon written request, to X. Xxxxx, the Secretary, or the
Comptroller General or any of their duly authorized
representatives, the subcontract, and books, documents, and records of such
organization that are necessary to verify the nature and extent of such costs.
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15.7 Seller shall not maintain or provide racially segregated facilities for employees at any
establishment under its control. Seller agrees to adhere to the requirements set forth in Executive
Orders 11246 and 11375. Seller Agrees to comply with all state and federal Equal Employment
Opportunity, Immigration, and Affirmation Action requirements
including 42 U.S.C. 2000 (e) et seq.,
The Civil Rights Act of 1964, The Civil Rights Act of 1991, 503 and 504 of the Rehabilitation Act
of 1973, 204 of the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, The Americans with
Disability Act and the Immigration Reform Act of 1985 and any amendments and applicable regulations
pertaining thereto.
15.8 Each party represents and warrants that (i) it has the right to enter into this Agreement
and to perform all of its obligations hereunder, and (ii) this Agreement, when executed and
delivered, will be a legal valid, and binding obligation of such party, enforceable against such
party in accordance with its terms. Any ambiguities in this Agreement will not be interpreted
against the drafting party.
15.9 The provisions of this Agreement shall be severable from each other and from the rest of
this Agreement, and in the event that any portion of this Agreement shall be held invalid, void,
unenforceable, or ineffective by a court of competent jurisdiction, the remaining portions thereof
shall remain in full force and effect. If any of the terms of provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or provisions shall be deemed
inoperative to the extent that they may conflict therewith, and shall be deemed to be modified to
conform with such statute or rule of law. The Headings in this Agreement are included for ease of
reference only and shall have no legal effect.
15.10 This Agreement shall be governed and interpreted in accordance with the laws, but not
the laws of conflict of laws, of the Commonwealth of Pennsylvania. Any controversy or claim arising
out of or relating to this Agreement, or the breach thereof (“Claim”), shall be settled by
arbitration pursuant to the Federal Arbitration Act, 9 U.S.C. §
1, et seq., in accordance with the
Commercial Arbitration Rules of the American Arbitration Association. The decision of the
arbitrator(s) shall be final and binding upon the parties and judgment upon the award may be
entered in any court having jurisdiction thereof. Each party shall pay its own attorneys’ fees and
expenses, except that the cost of arbitration shall be split between the parties involved, and mat
if a prevailing party in court is required to initiate proceedings to enforce the award or confirm
judgment, the prevailing party shall be entitled to recover its costs and attorneys’ fees
associated with such action.
15.11 This Agreement may be executed by facsimile signatures and in one or more counterparts,
each of which shall be deemed to be an original and one and the same Agreement.
IN WITNESS WHEREOF, the parries hereto have executed and delivered this Agreement as of the
date set forth above.
X. XXXXX MEDICAL INC. | |||||||||||
By:
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/s/ Xxxxxxx Xxxxxxxxx | 9/29/03 | By: | /s/ Xxxxxx X. Xxxxxxxxx, Xx. | |||||||
Title: Vice Present, Strategic Purchasing | Title: Chairman | ||||||||||
By:
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/s/ Xxxx Xxxxxxx | 9/29/03 | By: | ||||||||
Title: Commodity Manager, Strategic Purchasing | Title: |
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FIRST AMENDMENT TO SUPPLY AGREEMENT
THIS FIRST AMENDMENT TO SUPPLY AGREEMENT (this “Amendment”) is made and entered into as of this
20th day of January 2005, by and between X. Xxxxx MEDICAL INC. (“X. Xxxxx”) and INTEGRATED
BIOSCIENCES, INC. (“Company”).
BACKGROUND
X. X. Xxxxx and Company entered into a Supply Agreement dated as of September
15, 2003 (the “Supply Agreement”), pursuant to which Company agreed to manufacture and sell to
X. Xxxxx Products ordered from time to time; and
X. X. Xxxxx and Company desire to extend the term of the Supply Agreement and otherwise amend
the Supply Agreement, as set forth herein.
NOW THEREFORE, intending to be legally bound hereby, the parties agree as follows:
AGREEMENT
1 | Background Provisions: Defined Terms. The Background paragraphs set forth above
are hereby incorporated in this Amendment as if fully set forth herein. Any capitalized terms
not defined in this Amendment shall have the same meanings ascribed to such terms in the
Supply Agreement. |
2 | Amendments to Supply Agreement. The Supply Agreement is hereby amended as
follows: |
a. | The third sentence of Section 7 is hereby amended by deleting the reference to
“Company” and replacing such deleted reference with “X. Xxxxx”, effective as of
September 15, 2003. |
b. | Section 11 is hereby amended by deleting the reference to “Company Parties” and
replacing such deleted reference with “Company, its officers, directors, employees, agents
and/or subcontractors”, effective as of September 15, 2003. |
c. | Section 12.1 is hereby amended by deleted the reference to “2004” and replacing such
deleted reference with “December 31, 2006”, effective as of September 1, 2004. X. Xxxxx
shall the option to extend this agreement for two (2) additional years by providing
supplier written notice of such extension at least 60 days prior to December 31,2006. |
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d. | The following new Section 16 is hereby added to the Supply Agreement immediately following
Section 15.11: |
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“16. X. Xxxxx
Property. All the printers and other equipment described on Schedule
16 attached to the First Amendment to Supply Agreement dated as of January 20, 2005
(collectively, the “X. Xxxxx Property”) shall be clearly marked and remain the personal property
of X. Xxxxx and shall be kept free of liens and encumbrances. Company shall (i) be responsible
for the maintenance of the X. Xxxxx Property; (ii) hold the X. Xxxxx Property at Company’s own
risk; and (iii) not modify the X. Xxxxx Property without the permission of X. Xxxxx. In addition,
Company shall only use the X. Xxxxx Property for the following purposes (i) for the manufacture,
labeling and/or packaging of the Products for X. Xxxxx; and (ii) for the manufacture, labeling
and/or packaging of non-X. Xxxxx products (the “Non-X. Xxxxx Products”) only to the extent (aa)
such Non-X. Xxxxx Products are not syringes or components of syringes; (bb) Company’s supply of
such Non-X. Xxxxx Products do not and will not conflict with or affect Company’s fulfillment of
X. Xxxxx’x orders for Products; and (cc) such Non-X. Xxxxx Products are not competitive with the
Products or any other product manufactured or sold by X. Xxxxx. Company shall redeliver the
X. Xxxxx Property to X. Xxxxx in the same condition as originally received by Company plus
improvements paid for by X. Xxxxx upon the earlier of (i) termination of this Agreement; (ii)
Company’s breach of or default under this Agreement and/or the Xxxx of Sale from Company dated
18 January 2005 (transferring certain printers from Company to X. Xxxxx); or (iii) if X. Xxxxx, in
its sole discretion, provides Company with an option to match an offer from a third party to
supply X. Xxxxx with at least a majority of the Products on more favorable terms to X. Xxxxx than
the terms on which such Products are supplied hereunder and Company fails to match such third
party offer. X. Xxxxx makes no representations or warranties regarding the suitability of the
X. Xxxxx Property for the manufacture of any Non-X. Xxxxx Products and Company hereby agrees to
indemnify and hold X. Xxxxx harmless from and against any and all damages, liabilities, losses or
expenses, including legal expenses, arising from Company’s use of the X. Xxxxx Property for the
manufacture, labeling, packaging and/or sale of any Non-X. Xxxxx Products.” |
e. | Exhibit A is hereby amended and restated in its entirety by the Exhibit A attached to this
Amendment, effective as of October 18, 2004. |
f. | Exhibit F is hereby deleted in its entirety effective as of September 15, 2003. |
g. | The Appendix D attached to this Amendment is hereby incorporated in to the Supply
Agreement. |
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h. | The following new Sections 17, 18, 19, 20 and 21 are hereby added to the Supply Agreement
immediately following Section 16 of the Supply Agreement: |
17. Company shall manufacture, package, label, test, prepare and deliver the Products in
accordance with Good Manufacturing Practices, applicable laws, the Specifications and such other
specifications as are from time to time mutually agreed upon in writing by the parties hereto.
Company shall not (i) make any process/product changes that would alter the chemical, biological
or physical properties of the Product or any regulatory filings related to the Product or (ii)
make any change in the Specifications, without X. Xxxxx’x prior written consent. If at any time
during the term of this Agreement, X. Xxxxx desires to modify the Specifications, X. Xxxxx shall
have the right upon ninety (90) days prior written notice to Company, to modify or change the
Specifications, subject to Company’s approval, which approval shall not be unreasonably withheld
or delayed; provided that X. Xxxxx shall have the right to terminate this Agreement if Company
does not approve any requested change.
18. The parties shall promptly and fully advise each other of any instructions, recommendations
or specifications required by the FDA or any other government regulatory agency concerning the
Products. Company will notify X. Xxxxx and X. Xxxxx shall notify Company of any actions that
Company or X. Xxxxx, as the case may be, intends to take in response to government regulatory
agency requirements concerning the Products. Disclosures by any party to the other parties may
be modified to protect such disclosing party’s proprietary information and technology.
19. Quality Control and Assurance
19.1 Company will provide to X. Xxxxx a Certificate of Compliance and/or a Certificate of
Analysis for each delivery of Product. The Certificate of Compliance and/or Certificate
of Analysis shall state compliance with Good Manufacturing Practices and the
Specifications, provide documentation of test results and methods supporting such
compliance and shall be in a form acceptable to X. Xxxxx.
19.2 Company shall maintain the Device History File and/or Batch Production Control
Records for the Products. Company shall retain samples from each lot in numbers that may
be required for post-distribution testing in a manner consistent with its standard
operating procedure and for a period of one (1) year past the supplier ship date to B
Xxxxx.
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19.3 Company shall perform such quality control and quality assurance testing as
is required by the Specifications, this Agreement and Applicable Laws. At X. Xxxxx’x
request, Company will provide all supporting documentation (including the complete
batch record) to X. Xxxxx for Company’s manufacturing processes showing compliance to
Good Manufacturing Practices and such other information needed by X. Xxxxx’x quality
assurance personnel. It is understood between the parties hereto that all critical
processes affecting the purported identity, strength, quality or purity of the
Product being manufactured, assembled and/or packaged shall be qualified and
maintained in a validated state, and the scope and extent of the necessary
validation documentation shall be determined by X. Xxxxx. X. Xxxxx shall be notified
in advance of any validation studies, and the completed studies shall be made
available to X. Xxxxx upon request.
20. It is understood that X. Xxxxx may, from time to time, send representatives to Company’s
manufacturing facility or its suppliers’ facilities to observe, audit and inspect the
production facilities, and Company will allow X. Xxxxx’x representatives access to all
applicable manufacturing records for the Products so as to ensure that Company is in
compliance with Applicable Laws and the Specifications. Said observation, audit, and/or
inspection of Company shall be during normal working hours, of reasonable duration, and at
the sole expense of X. Xxxxx. As soon as reasonably practicable, Company will correct, to the
reasonable satisfaction of X. Xxxxx, any non-compliance with the above practices, regulations
or Specifications that are discovered and brought to its attention as a result of such
inspections. Company will provide X. Xxxxx with a copy of all FDA or other regulatory agency
correspondence relating to the Product, including without limitation any FDA Form 483 or
warning letters relating to the manufacturing facility. Such information will be provided to
X. Xxxxx within five (5) days of Company’s receipt of the same.
21. In the event that a recall order is issued or requested on a Product or a X. Xxxxx
product incorporating a Product by an entity having authority and jurisdiction in the matter
or in the event that X. Xxxxx makes the decision to recall a Product or a X. Xxxxx product
incorporating a Product and it is determined by X. Xxxxx that such recall arises from (i) a
failure of a Product to meet the warranties in Section 8 of the contract or (ii) a breach of
this Agreement by Company, then Company shall credit X. Xxxxx’x account for the Products
recovered and returned to it as a result of any action (or destroyed at Company’s request)
and Company shall bear all costs of any recall, report of correction or removal activities
and shall be responsible for X. Xxxxx’x damages in connection therewith
3 | Incorporation: Ratification. Other than as specifically set forth in this
Amendment, the terms and conditions of the Supply Agreement shall remain in full force and
effect without modification, and are hereby ratified and affirmed. Without limiting the
foregoing, the parties agree and confirm that the Supply Agreement has not terminated and/or
expired since its original execution as of September 15, 2003. This Amendment is made a part
of the Supply Agreement and the Supply Agreement is hereby incorporated herein. All references
to the Supply Agreement shall mean the Supply Agreement as modified by this Amendment. |
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4 | Entire Agreement. The Supply Agreement, as amended by this Amendment, contains
the entire agreement and understanding between the parties with respect to the subject matter
hereof and supersedes all prior proposals and agreements between the parties, whether oral or
written, and there are no other promises or representations relating to the subject matter
hereof that is not incorporated herein |
IN WITNESS WHEREOF, the parties have executed and delivered this Amendment as of the day and
year first above written.
X. XXXXX MEDICAL INC. | INTEGRATED BIOSCIENCES, INC. | |||||||
By:
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/s/ Xxxxxxx Xxxxxxxxx | By: | /s/ Xxxxxx X. Xxxxxxxxx, Xx. | |||||
Name: Xxxxxxx Xxxxxxxxx | Name: Xxxxxx X. Xxxxxxxxx, Xx. | |||||||
Title: Vice President, Strategic Purchasing | Title: President | |||||||
Date:
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2/21/05 | Date: | 1/20/05 | |||||
By: |
/s/ Xxxx Xxxxxxx | |||||||
Title: Commodity Manager | ||||||||
Date: |
2/21/05 | |||||||
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SCHEDULE 16
Equipment | ||||||
Description | Model # | Serial # | Associated Items | |||
Apex Rotary Syringe Barrel Printer
|
C-50 | 76102 | mandrel tooling and print plates | |||
Imtram Rotary Pad Syringe Barrel Printer
|
GS200 | 97B02 | barrel fixtures and print pads |
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Second AMENDMENT
TO SUPPLY AGREEMENT
TO SUPPLY AGREEMENT
This Second Amendment to Supply Agreement (“Amendment”) is made and entered into as of
this 2nd day of March, 2009, by and between X. Xxxxx MEDICAL INC. (“Company”) and INTEGRATED
BIOSCIENCES, INC. (“Supplier”).
BACKGROUND
X. | X. Xxxxx MEDICAL, INC. and INTEGRATED BIOSCIENCES, INC. entered into a Supply
Agreement dated September 15, 2003 (the “Supply Agreement”), pursuant to which
INTEGRATED BIOSCIENCES, INC. agrees to provide assembled syringes for Company. |
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X. Xxxxx MEDICAL, INC. and INTEGRATED BIOSCIENCES, INC. amended the above Agreement on
February 21, 2005. |
X. | X. Xxxxx MEDICAL INC. and INTEGRATED BIOSCIENCES, INC. desire to
modify the amended Supply Agreement, as set forth herein. |
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NOW THEREFORE, intending to be legally bound hereby, the parties agree as follows: |
AMENDMENTS
1. | Extend term of Agreement for one additional Year. The amended
expiration date will be December 31, 2009. |
2. | 2009 unit price will be per attached. |
3. | All other terms of original Agreement and the 1st Amendment
will remain in effect. |
IN WITNESS WHEREOF, the parties have executed and delivered this Amendment
as of the day and year first above written.
X. XXXXX MEDICAL, INC. | ||||
By: | /s/ Xxxxx Xxxxxx | |||
Name: Xxxxx Xxxxxx | ||||
Title: Corporate Commodity Manager | ||||
INTEGRATED BIOSCIENCES, INC. | ||||
By: | /s/ Xxxx X. Xxxxx | |||
Name: Xxxx X. Xxxxx | ||||
Title: Vice-President of Finance and Administration |
Integrated
BioSciences, Inc.
Price list for X. Xxxxx January 1 , 2009-December 31, 2009
Price list for X. Xxxxx January 1 , 2009-December 31, 2009
Work | ’08 -09 | |||||||||||
Center | Size | Part Number | Description | Pricing | ||||||||
25.00 | S2001382 | 25ML PRINTED BARREL | $ | 2.0360 | ||||||||
S2002604 | SIL, 0-RING GASKET | $ | 0.0245 | |||||||||
S2002679 | SIL, LATEX FREE DISK | $ | 0.0189 | |||||||||
S2002693 | SIL, HMOSTAS DUCKBILL VALVE SM BLUE | $ | 0.0268 | |||||||||
S2002694 | SIL, HMOSTAS DUCKBILL VALVE LGE BLU | $ | 0.0380 | |||||||||
S200568002 | SIL INTRODUCER GASKT, LG BODY, SLIT | $ | 0.0721 | |||||||||
SA101 |
1.25 | S2112071 | 1.25CC SYR ASSY, 10% XXXXX XXXXXX | $ | 0.4102 | |||||||
SA101 |
1.25 | S2112072 | 1.25CC SYR ASSY, LATEX FREE | $ | 0.2682 | |||||||
SA101 |
1.25 | S2114210 | 1.25CC SYR ASSY, NO PRINT, FEMALE | $ | 0.1706 | |||||||
SA101 |
1.25 | S2114241S | 1.25CC SYR ASSY, NO PRINT, NATURAL | $ | 0.2340 | |||||||
SA101 |
1.25 | S2114247S | 1.25CC SYR ASSY, NO LOGO LATEX FREE | $ | 0.2798 | |||||||
SA101 |
1.25 | S2114312 | 1.25CC SYR ASSY, NO PRINT, MALE, ATRX | $ | 0.2180 | |||||||
SA101 |
1.25 | S2115002 | 1.25CC SYR ASSY, FOREMOST DENTAL | $ | 0.2725 | |||||||
SA101 |
1.25 | S2115005 | 1.25CC SYR ASSY, ARROW INTL | $ | 0.2725 | |||||||
SA101 |
1.25 | S2115016 | 1 1/4CC SYR ASSY, NO LOGO | $ | 0.2682 | |||||||
SA102 |
0.75 | S2040755 | CNTRLD STK SYR, 3/4CC, LATEX FREE | $ | 0.4743 | |||||||
SA102 |
0.75 | S2040800 | 0.75CC CONT STK SYR, LATEX FREE | $ | 0.4743 | |||||||
SA102 |
1.00 | S2111005 | 1CC CONT STK SYR, LATEX FREE | $ | 0.3891 | |||||||
SA102 |
1.50 | S2112053 | 1.5CC CONT STK SYR, CATHEX, LATXFRE | $ | 0.4611 | |||||||
SA102 |
1.50 | S2112070 | 1.5CC CONT STK ASSY, BECTN-DICKNSON | $ | 0.4653 | |||||||
SA102 |
1.25 | S2112073 | 1.25CC CONT STK SYR ASSY LATEX FREE | $ | 0.4672 | |||||||
SA102 |
1.50 | S2112074 | 1.5CC CONT STK SYR ASSY, LATEX FREE | $ | 0.4653 | |||||||
SA102 |
1.25 | S2114209 | 1.25CC CONT STK SYR, LATEX FREE | $ | 0.4672 | |||||||
SA102 |
1.50 | S2116009 | 1.5ML CONT STK SYR ASSY, LATEX FREE | $ | 0.4723 | |||||||
SA102 |
1.50 | S2116010 | 1.5CC CONT STK ASSY, NAT PLUNGER | $ | 0.4653 | |||||||
SA102 |
1.50 | S2116011 | 1.5CC CONT STK SYR ASSY, ACKRAD | $ | 0.4653 | |||||||
SA102 |
1.50 | S2116012 | 1.5CC CONT STK ASSY, WHITE PLNGRER | $ | 0.4974 | |||||||
SA102 |
2.00 | S2117045 | 2CC CONTROLLED STROKE, LATEX FREE | $ | 0.4726 | |||||||
SA102 |
3.00 | S2131002 | 3CC SYR ASSY,BLK PLNGR W/GREY TIP | $ | 0.1677 | |||||||
SA102 |
3.00 | S2132021 | 3CC SYRINGE, NO PRINT — LATEX FREE | $ | 0.3283 | |||||||
SA102 |
3.00 | S2132205 | 3CC LUER LOCK SYR ASSY, PULPDENT | $ | 0.2495 | |||||||
SA102 |
5.00 | S2171060 | 5CC ASSY, CLEAR (P5-0) | $ | 0.4314 | |||||||
SA104 |
10.00 | S2112030 | 10CC HV SYR ASSY, BLUE W/BLACK TIP | $ | 0.8250 | |||||||
SA104 |
10.00 | S2112033 | 10CC HV SYR ASSY, YELO W/BLACK TIP | $ | 0.8301 | |||||||
SA104 |
10.00 | S2112034 | 10CC HV SYR ASSY, RED W/BLACK TIP | $ | 0.8225 | |||||||
SA104 |
10.00 | S2112042 | 10CC HV SYR ASSY, BLUE W/BLACK TIP | $ | 0.8110 | |||||||
SA104 |
10.00 | S2112043 | 10CC HV SYR ASSY, GREEN W/BLACK TIP | $ | 0.8155 | |||||||
SA104 |
10.00 | S2112044 | 10CC HV SYR ASSY, YELO W/BLACK TIP | $ | 0.8301 | |||||||
SA104 |
10.00 | S2112045 | 10CC HV SYR ASSY, RED W/BLACK TIP | $ | 0.8225 | |||||||
SA104 |
10.00 | S2112046 | 10CC HV SYR ASSY, WHITE W/BLACK TIP | $ | 0.8273 | |||||||
SA104 |
10.00 | S2112055 | 10CC SYR ASSY, FLOSEAL POWDER | $ | 0.4684 | |||||||
SA104 |
10.00 | S2112056 | 10CC SYR ASSY, FLOSEAL MIXING | $ | 0.4684 | |||||||
SA104 |
10.00 | S2112080 | 10CC HV SYR ASSY, BLUE, NO LOGO LF | $ | 0.8243 | |||||||
SA104 |
10.00 | S2112081 | 10CC HV SYRINGE, GREEN W/GREY TIP | $ | 0.8288 | |||||||
SA104 |
10.00 | S2112082 | 10CC HV SYR ASSY, YELO, NO LOGO LF | $ | 0.8294 |
Work | ‘08 -09 | |||||||||||
Center | Size | Part Number | Description | Pricing | ||||||||
SA104 |
10.00 | S2112083 | 10CC HV SYR ASSY, RED W/GREY TIP | $ | 0.8217 | |||||||
SA104 |
10.00 | S2112084 | 10CC HV SYR ASSY, WHITE, NO LOGO LF | $ | 0.8265 | |||||||
SA104 |
10.00 | S2112085 | 10CC HV SYR, RED NITRO, NO LOGO LF | $ | 0.8217 | |||||||
SA104 |
10.00 | S2112087 | 10CC HV SYR, YELO, LOCAL, NO LOGO | $ | 0.8294 | |||||||
SA104 |
10.00 | S2112088 | 10CC HV SYR ASSY, BLUE, HEPARIN | $ | 0.8243 | |||||||
SA104 |
10.00 | S2191010 | P10-0 SYR ASSY, NO PRINT, NO CAP A | $ | 0.3752 | |||||||
SA104 |
10.00 | S2192030 | 10CC SYR ASSY, DOUBLE SCALE, NO CAP | $ | 0.4408 | |||||||
SA104 |
20.00 | S2112047 | 20CC HV SYR, BLUE, GRADS, LATEXFREE | $ | 0.9712 | |||||||
SA104 |
20.00 | S2112048 | 20CC HV SYR-GREEN, GRADS, LATEXFREE | $ | 1.0500 | |||||||
SA104 |
20.00 | S2112049 | 20CC HV SYR, YELO, GRADS, LATEXFREE | $ | 1.0641 | |||||||
SA104 |
20.00 | S2112050 | 20CC HV SYR, RED, GRADS, LATEXFREE | $ | 0.9726 | |||||||
SA104 |
20.00 | S2112051 | 20CC HV SYR, WHT, GRADS, LATEXFREE | $ | 0.9754 | |||||||
SA102 |
3.00 | S2132030 | 3CC SYR ASSY, NO CAP, P3-0-L | $ | 0.3864 | |||||||
SA102 |
5.00 | S2171100 | SYR ASSY, P5-0 ‘A’ | $ | 0.3198 | |||||||
SA104 |
10.00 | S2112054 | 10CC HIGH VALUE SYRINGE, WHITE | $ | 0.7834 | |||||||
SA104 |
20.00 | S2221025 | SYR ASSM, P20-0 NO CAP | $ | 0.0000 | |||||||
SA104 |
20.00 | S2223012 | ASSM 20CC LL SYR - RING CONTROL | $ | 0.0000 |