EXHIBIT 10.1
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O.E.M. SUPPLY AGREEMENT
THIS AGREEMENT, made effective this _____ day of______, 1996, by and
between Sherwood Medical Company, doing business as Xxxxxxxx-Xxxxx & Xxxx, a
corporation organized and existing under the laws of the State of Delaware,
having an office at 0000 Xxxxx Xxxxxx, Xx. Xxxxx, Xxxxxxxx 00000 (hereinafter
referred to as "Sherwood-D&G") and Univec, Inc., a corporation organized and
existing under the laws of the State of New York, having an office at 000
Xxxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxx Xxxx 00000 (hereinafter referred to as
"Customer").
SECTION 1. DEFINITIONS
As used in this Agreement, the following terms shall be deemed to have the
following meanings:
1(a) "Contract Year" shall mean each twelve (12) month period during the
term of the Agreement beginning with the Commencement Date.
1(b) "Products" shall mean hypodermic syringe component sets, each
consisting of a syringe barrel with or without a permanently pre-attached
cannula and sheath or a separate hooded needle, and a plunger tip (a "Component
Set); and single-use syringe plungers ("Plungers"), each as more fully described
in Exhibit A hereto, and as amended from time to time in writing by the parties.
1(c) "Specifications" shall mean the specifications and protocols set forth
in Exhibit B attached hereto.
1(d) "Sufficient Production Capacity" shall mean having sufficient
manufacturing facilities, equipment, staff, raw materials and shipping
facilities to manufacture and deliver to Customer at least fifty million
(50,000,000) Component Sets during each Contract Year.
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SECTION 2. PURCHASE AND SALE OF PRODUCTS
2(a) In accordance with the terms and conditions of this Agreement,
Sherwood-D&G shall manufacture and sell the Products to Customer, and Customer
shall purchase the Products from Sherwood-D&G.
2(b) Sherwood-D&G shall maintain Sufficient Production Capacity at all
times during the term of this Agreement. Upon receipt of written purchase orders
from Customer using Customer's standard form of purchase Order, Sherwood-D&G
shall manufacture and deliver Component Sets and Plungers in accordance with
such written purchase orders, provided, however, notwithstanding anything to the
contrary herein, Sherwood-D&G shall only be obligated to manufacture and deliver
an average of four million one hundred sixty-six thousand six hundred
sixty-seven (4,166,667) Component Sets and the quantity of acceptable Plungers
that it has the capacity and capability to manufacture, as set forth in Section
2(c) hereof, each month against such purchase orders during the term of this
Agreement. Sherwood-D&G shall keep Customer informed of its capacity and
capability to manufacture acceptable Plungers. Nothing contained herein shall
require Customer to order any minimum quantity of Products at any time during
the term of this Agreement.
2(c) Sherwood-D&G shall exert reasonable business efforts to manufacture
and deliver to Customer the quantity of acceptable Plungers ordered by Customer
each month up to an average of eight million three hundred thirty-three thousand
three hundred thirty-three (8,333,333) Plungers per month. Beginning on the
Commencement Date, Sherwood-D&G and Customer shall cooperate to develop mutually
acceptable Specifications for the Plungers that will allow the greatest yield
from Sherwood-D&G's plunger mold while functioning in a reasonably acceptable
manner in Customer's assembly process without sacrificing the quality of the
finished product. Specifically, Sherwood-D&G shall exert its reasonable business
efforts to refine its plunger mold and manufacturing process for the Plungers to
increase its capacity and capability
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to manufacture acceptable Plungers and Customer shall exert its reasonable
business efforts to refine its syringe assembly process to accept such Plungers.
2(d) Customer may place its orders on Customer's purchase order forms,
specifying shipping instructions and destinations. Any terms and conditions
included in any such purchase order form of Customer or any acknowledgment or
other form of Sherwood-D&G shall be of no force and effect and shall form no
part of the agreement between the parties. Minimum order quantities are ten
million (10,000,000) Component Sets or Plungers. Minimum shipment quantities are
two million (2,000,000) Component Sets or Plungers. Sherwood-D&G shall satisfy
all purchase orders promptly after receipt of Customer's written purchase order
or, except for the quantities of Products set forth in Section 2(b) which may
not be objected to or rejected, shall object to or reject any such purchase
order within fifteen (15) days after receipt thereof. Any purchase order for the
Products received by Sherwood-D&G and not objected to or rejected within fifteen
(15) days after receipt shall be deemed accepted by Sherwood-D&G. Delivery shall
be required by Customer no sooner than ninety (90) days from receipt of
Customer's written purchase order. Customer shall provide Sherwood-D&G with six
(6) month non-binding forecasts of purchases of the Products sixty (60) days in
advance of each six (6) month period throughout the term of this Agreement.
Within thirty (30) days of receipt of such non-binding forecasts from Customer,
Sherwood-D&G shall notify Customer in writing whether, in its sole judgment, it
has available production capacity to supply Customer with more than twenty-five
million (25,000,000) Component Sets during the applicable six (6) month period
covered by such forecast. If Customer desires to purchase from Sherwood-D&G in
excess of twenty-five million (25,000,000) Component Sets during such six (6)
month period, it shall, within fifteen (15) days of receipt of the notice of
sufficient available capacity from Sherwood-D&G, issue to Sherwood-D&G binding
purchase orders for such additional Component Sets up to the available capacity
set forth in Sherwood-D&G's notice. The parties agree that said purchase orders
for such additional Component Sets shall be binding on both Sherwood-D&G and
Customer for the quantities set
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forth therein. All purchase orders and forecasts shall be sent to Sherwood-D&G
in accordance with Section 10 hereof.
SECTION 3. TERM OF AGREEMENT
3(a) This Agreement shall commence on the effective date first written
above (the "Commencement Date") and, unless sooner terminated or extended in
accordance with the provisions of Sections 3(b) or 6 hereof, shall continue for
a period of five (5) years (the "Initial Term") from the initial delivery and
acceptance of commercial quantities of Products.
3(b) In the event that Sherwood-D&G exercises the option set forth in
Section 9 hereof to enter into the Non-Exclusive License Agreement (U.S.), the
Initial Term shall continue from the Commencement Date until the greater of (A)
five (5) years or (B) the sooner to occur of (i) market introduction and
commercial sale by Sherwood-D&G of Licensed Product (as defined in the
Non-Exclusive License Agreement (U.S.), or (ii) two and one-half (2-1/2) years
from execution of the Non-Exclusive License Agreement (U.S.) by both of the
parties hereto.
SECTION 4. PRICE AND PAYMENT TERMS
4(a) For all Products purchased from Sherwood-D&G for delivery to Customer
during the first twelve (12) months of the Initial Term, Customer shall pay to
Sherwood-D&G the price for each of the Products set forth in Exhibit A
(hereinafter referred to as the "Product Purchase Price"), FOB Sherwood-D&G's
manufacturing facility. All prices are exclusive of sales, use and other taxes.
All export, import and other duties, tariffs and customs shall be paid by
Customer. If exemption is claimed by Customer from any of the foregoing,
Customer shall furnish to Sherwood-D&G satisfactory proof of such exemption. For
the first fifty million (50,000,000) Components Sets and Plungers ordered by
Customer, Sherwood-D&G shall maintain an inventory of a ninety (90) day supply
of such Products (or such lesser amount as may be requested from
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time to time by Customer) until needed by Customer, with payment terms of net
sixty (60) days from date of shipment. Thereafter, payment terms are net thirty
(30) days from date of shipment.
4(b) Sherwood-D&G shall have the right to revise the prices set forth in
Exhibit A not more often than once during any twelve (12) month period
commencing twelve (12) months after the Commencement Date, by giving Customer
thirty (30) days written advance notice. Such revisions in price shall not
exceed the actual changes in the cost to Sherwood-D&G for parts, materials,
labor and overhead directly related to the manufacture, packaging and labeling
of the Products, utilizing generally accepted accounting principles, but in no
event will any price increase for any Product exceed five percent (5%) in any
twelve (12) month period. Customer may, at its option, request verification of
such increases by independent certified public accountants, reasonably
acceptable to Sherwood-D&G. In no event shall any such upward price revision
take into account any amount with respect to any lease payments or amortization
charges or any increase in maintenance, overhead or any other cost or expense
relating to the plunger mold leased by Sherwood-D&G from Customer to make the
Plunger.
4(c) Customer will be charged and will pay to Sherwood-D&G a surcharge
equal to fourteen and nine hundred twenty-five thousandths percent (14.925%) of
the invoice price of Products ordered and received by Customer up to a maximum
invoiced amount of Six Million Seven Hundred Thousand Dollars ($6,700,000) of
Product purchases. Sherwood-D&G will give Customer a discount on Product
Purchase Prices by a credit equal to the amount of the surcharge on invoiced
amounts up to a maximum aggregate of Three Million Three Hundred Fifty Thousand
Dollars ($3,350,000) of Product purchases. No surcharge shall be applied to
invoiced amounts in excess of an aggregate amount of Six Million Seven Hundred
Thousand Dollars ($6,700,000) and no credits shall be applied to invoiced
amounts in excess of an aggregate amount of Three Million Three Hundred Fifty
Thousand Dollars ($3,350,000). In no event shall
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Customer pay or be required to pay more than Five Hundred Thousand Dollars
($500,000) in surcharges net of the above credits.
SECTION 5. WARRANTIES, COVENANTS AND INDEMNIFICATION
5(a) Sherwood-D&G warrants that it has title to all Products sold to
Customer hereunder free of all liens and encumbrances of any kind or nature.
Sherwood-D&G further warrants and guarantees that at the time of shipment of
Products to Customer pursuant to Customer's purchase orders, the Products shall
conform to the Specifications and shall have been manufactured in accordance
with all applicable federal, state and local laws, including the Federal Food,
Drug and Cosmetic Act, as amended, and the regulations issued thereunder.
5(b) The parties represent and warrant that they have the full right to
enter into this Agreement and that this Agreement does not conflict with any
other agreements so long as the other terms of this Agreement are met.
5(c) THE FOREGOING WARRANTIES OF THE PARTIES ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Except as
otherwise provided herein, in no event will either party be liable for any
indirect, special, consequential, incidental or contingent damages in connection
with the purchase, use or sale of the Products. Notwithstanding anything to the
contrary contained herein, in the event that Sherwood-D&G fails to deliver to
Customer Products meeting the Specifications, on a timely basis, as required by
any Customer purchase orders delivered to and accepted by Sherwood-D&G pursuant
to this Agreement, Customer shall be entitled, in addition to any other remedy
available to it, to recover the profits that Customer would have made on the
sale of single-use syringes that would have incorporated such Products had such
Products been delivered.
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5 (d) Upon notification by Customer to Sherwood-D&G that there has been or
may be a claim threatened or suit for damages instituted against Customer for
personal injury or property damage related to use of the Products, Sherwood-D&G,
its successors and assigns shall defend, indemnify and save harmless Customer,
its employees, officers, subsidiaries and affiliated companies, their successors
and assigns, against such claim or suit if based upon or arising out of an
alleged defect in the Product, unless such claim or suit is based upon or arises
out of an alleged defect (i) in the design of the Product, provided that the
design of the Product (less the Plunger) is not defective as used by
Sherwood-D&G for its standard line of hypodermic syringes, or (ii) created by
the combination of the Component Sets with the Plunger, or (iii) caused by the
assembly process in which the Component Sets and Plungers are assembled into
complete single-use syringes; or is otherwise based upon or arises out of any
negligent or intentional acts or omissions of Customer. It shall be prima facie
evidence that a Product is defective if it fails to meet the Specifications.
Sherwood-D&G shall maintain comprehensive General Liability Insurance, including
contractual and product liability, in amounts not less than $1,000,000 per
occurrence and $3,000,000 annual aggregate on a date of occurrence basis (not a
date of claim basis). Upon request, Sherwood-D&G shall submit a certificate
evidencing such insurance to Customer,, which certificate shall provide that the
insurance policy evidenced thereby may not be canceled or reduced in amount
without thirty (30) days prior notification to Customer. In the event of any
claim or suit arising under this indemnity, prompt notice thereof shall be given
to Sherwood-D&G, which shall have the right to conduct and control the defense
in respect thereto, but Customer may have counsel present at its own expense and
shall be entitled to participate in the defense. Customer shall cooperate with
Sherwood-D&G in such defense as requested by Sherwood-D&G, at the expense of
Sherwood-D&G. If Sherwood-D&G shall timely fail or refuse
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to assume such defense, Customer may employ counsel with respect thereto and all
reasonable fees and expenses of such counsel shall be paid by Sherwood-D&G.
5 (e) Upon notification by Sherwood-D&G to Customer that there has been or
may be a claim threatened or suit for damages instituted against Sherwood-D&G
for personal injury or property damage related to use of the Products, Customer,
its successors and assigns shall defend, indemnify and save harmless
Sherwood-D&G, its employees, officers, subsidiaries and affiliated companies,
their successors and assigns, against such claim or suit if based upon or
arising out of an alleged defect (i) in the design of the Product, provided that
the design of the Product (less the Plunger) is not defective as used by
Sherwood-D&G for its standard line of hypodermic syringes, or (ii) created by
the combination of the Component Sets with the Plunger, or (iii) caused by the
assembly process in which the Component Sets and Plungers are assembled into
complete single-use syringes; or is otherwise based upon or arises out of any
negligent or intentional acts or omissions of Customer. Customer shall maintain
comprehensive General Liability Insurance, including contractual and product
liability, in amounts not less than One Million Dollars ($1,000,000.00) per
occurrence and Three Million Dollars ($3,000,000.00) annual aggregate on a
date-of-occurrence basis (not a date of claim basis). Upon request, Customer
shall submit a certificate evidencing such insurance to Sherwood-D&G, which
certificate shall provide that the insurance policy evidenced thereby may not be
canceled or reduced in amount without thirty (30) days prior notification to
Sherwood-D&G. In the event of any claim or suit arising under this indemnity,
prompt notice thereof shall be given to Customer, which shall have the right to
conduct and control the defense in respect thereto, but Sherwood-D&G may have
counsel present at its own expense and shall be entitled to participate in the
defense. Sherwood-D&G shall cooperate with Customer in such defense as requested
by Customer, at the expense of Customer. If Customer shall timely fail or refuse
to assume such
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defense, Sherwood-D&G may employ counsel with respect thereto and all reasonable
fees and expenses of such counsel shall be paid by Customer.
5(f) Customer, its successors, assigns and legal representatives, shall
forever defend, indemnify and save harmless Sherwood-D&G, its employees and
officers, their successors, assigns and customers against all damages, claims,
demand, seizures, injunctions, judgments, third party attorneys' fees and costs
of any kind for any actual or alleged infringement, including willful
infringement, of any patent, registered design, copyright or other industrial
property right, including rights arising from confidential disclosures or
relationships, because of the manufacture, use and/or sale of the Plunger or the
combination by or for Customer of Component Sets with the Plunger or any other
components or devices, but not with respect to the Component Sets per se. In the
event of any claim or suit arising under this indemnity, prompt notice thereof
shall be given to Customer, which shall have the right to conduct and control
the defense in respect thereto, but Sherwood-D&G may have counsel present at its
own expense and shall be entitled to participate in the defense. Sherwood-D&G
shall cooperate with Customer in such defense as requested by Customer, at the
expense of Customer.
5(g) Sherwood-D&G, its successors, assigns and legal representatives, shall
forever defend, indemnify and save harmless Customer, its employees and
officers, their successors, assigns and customers against all damages, claims,
demand, seizures, injunctions, judgments, third party attorneys' fees and costs
of any kind for any actual or alleged infringement, including willful
infringement, of any patent, registered design, copyright or other industrial
property right, including rights arising from confidential disclosures or
relationships, because of the manufacture, use and/or sale of the Component Sets
per se, but not with respect to the Plunger or to any combination of the
Component Sets with the Plunger or with any other components or devices. In the
event of any claim or suit arising under this indemnity, prompt notice thereof
shall be given
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to Sherwood-D&G, which shall have the right to conduct and control the defense
in respect thereto, but Customer may have counsel present at its own expense and
shall be entitled to participate in the defense. Customer shall cooperate with
Sherwood-D&G in such defense as requested by Sherwood-D&G, at the expense of
Sherwood-D&G.
SECTION 6. TERMINATION
6 (a) Either party may terminate this Agreement by giving written notice to
the other party in the following circumstances:
(i) following thirty (30) days notice in the event the other party
commits any material breach of any obligation of this Agreement
which is not cured within said thirty (30) day period; or
(ii) immediately upon giving notice in the event a petition of
bankruptcy is filed against the other party which is not vacated
or stayed within ninety (90) days, or in the event the other
party makes a general assignment for the benefit of creditors, or
a receiver is appointed for the other party.
6 (b) Termination of this Agreement shall not affect any rights or
obligations accrued prior to the effective date of such termination, including,
but not limited to, Customer's obligation to pay for Products ordered and
shipped to Customer. Notwithstanding the foregoing, the right to exercise the
option pursuant to Section 9 hereof shall be suspended immediately upon the
giving of notice of termination by Customer pursuant to this Section 6 and such
option shall terminate and cease to be exercisable on the thirtieth (30th) day
after the date of such notice unless Sherwood-D&G shall have cured the breach or
other cause for such notice of termination. The provisions set forth in Section
5 hereof shall survive termination of this Agreement. The rights provided in
this Paragraph shall be in addition and without prejudice to any other rights
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which the parties may have with respect to any breach or violation of the
provisions of this Agreement.
6(c) Waiver by either party of a single default or breach or of a
succession of defaults or breaches shall not deprive such party of any right to
terminate this Agreement pursuant to the terms hereof upon the occasion of any
subsequent default or breach.
SECTION 7. RETURNS AND CREDITS
Sherwood-D&G shall furnish Customer with a written certificate for each lot
of Products shipped to Customer, stating that the Products in that lot,
identified by lot number, conform to the Specifications. If the Products are not
of United States origin, Sherwood-D&G shall attempt, but shall not be required,
to inform Customer of the country or countries of manufacture. Customer, within
thirty (30) days of receipt, shall have the right to reject any lots or units
which, by inspection, fail to meet the Specifications, and to receive credit
therefor. Rejected lots of Products will be shipped to Sherwood-D&G's
manufacturing facility with an identified rejection criteria, freight collect.
SECTION 8. FORCE MAJEURE
If either party is prevented from performing any of its obligations
hereunder (other than the payment of money) for unforeseeable and unavoidable
causes beyond its control and without its fault or negligence, which wholly or
partially prevent the manufacture, delivery, transportation, receipt, sale or
use of the Products, including but not limited to fire, strike, explosion, flood
or other acts of God, the inability of a vendor to supply approved raw materials
(unless caused by the negligence or the intentional acts or omissions of the
party seeking to avail itself of this provision) or any act or order of any
governmenta1 agency, such party shall not be liable to the other party for
breach of this Agreement, provided the party so affected gives prompt notice of
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such cause to the other party and exercises due diligence to remove the cause as
soon as reasonably practical.
SECTION 9. OPTION
9(a) In consideration for the transfer by Sherwood-D&G to Customer of all
of Sherwood-D&G's right, title and interest in and to the production mold for
the Plunger, including the mold inserts and the mold base, as evidenced by the
Xxxx of Sale attached hereto as Exhibit D, Customer grants to Sherwood-D&G an
option, exercisable (subject to Section 6(c) hereof) at any time prior to the
sooner to occur of termination of this Agreement or three and one-half (3-1/2)
years from the Commencement Date (hereinafter referred to as the "Option
Period"), to enter into the Non-Exclusive License Agreement (U.S.) attached
hereto as Exhibit C. Subject to Section 6(c) hereof, Sherwood-D&G may exercise
its option to enter into the Non-Exclusive License Agreement (U.S.) at any time
during the Option Period by executing a copy of same and returning it to
Customer together with the applicable license fee in accordance with Section 3
of the Non-Exclusive License Agreement (U.S.). Upon receipt of the signed
Non-Exclusive License Agreement (U.S.) and payment in full of the applicable
license fee, Customer will execute the Non-Exclusive License Agreement (U.S.)
and return a fully executed copy to Sherwood-D&G.
9(b) If, during the period beginning eighteen (18) months after the
Commencement Date and ending on expiration of the Option Period, Customer
receives a bona fide written offer from an unrelated third party to exclusively
license the Licensed Patent Rights (as defined in the Non-Exclusive License
Agreement (U.S.)), Customer shall notify Sherwood-D&G of the receipt of said
offer by providing a true copy thereof to Sherwood-D&G. Upon receipt of said
written offer, Sherwood-D&G shall, within thirty (30) days of receipt, notify
Customer of its intent either:
(i) to exercise the option to enter into the Non-Exclusive License
Agreement (U.S.) pursuant to Section 9(a) hereof; or
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(ii) to enter into an exclusive license with Customer on the same terms as
set forth in the offer (but including the Movern Patents if not
included in the bona fide offer); or
(iii) to terminate its option rights hereunder in consideration of the
payment by Customer to Sherwood-D&G of the greater of One Hundred
Thousand Dollars ($100,000.00) or the balance of the surcharge amount
payable under Section 4(c) hereof as of the date of Sherwood-D&G's
notice to Customer hereunder.
If Sherwood-D&G elects Section 9(b)(i), it shall execute the Non-Exclusive
License Agreement (U.S.) and return it to Customer with the applicable license
fee in the manner set forth in Section 9(a); if Sherwood-D&G elects Section
9(b)(ii), the parties shall, as soon as practicable and in any event prior to
the expiration of the bona fide offer, negotiate and execute an exclusive
license agreement on the same terms as set forth in the third-party offer; or if
Sherwood-D&G elects Section 9(b)(iii), the parties shall agree on the balance of
the surcharge amount payable under Section 4(c) hereof and that amount, but not
less than One Hundred Thousand Dollars ($100,000.00), shall be paid to
Sherwood-D&G within ten (10) days of Sherwood-D&G's election, and the option of
Section 9 shall terminate and be of no further force and effect.
SECTION 10. DISTRIBUTION AGREEMENT
Sherwood-D&G and Customer agree to negotiate in good faith the terms of a
non-exclusive distribution agreement to become effective after the exercise of
the option and immediately upon Sherwood-D&G's introduction to the market and
commercial sale of a single-use syringe under the Non-Exclusive License
Agreement (U.S.). The parties shall commence negotiations regarding the terms of
the distribution agreement immediately upon execution of this
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Agreement and shall diligently and in good faith negotiate such terms in an
effort to reach agreement with respect thereto within thirty (30) days after the
date hereof.
SECTION 11. NOTICES
All notices specified in this Agreement shall be given in writing and shall
be effective when either served by personal delivery or facsimile transmission,
or on the day following timely delivery for next-day delivery to a national
overnight courier service guaranteeing next-day delivery, or five (5) days after
being addressed to the other party at the address specified below and deposited
first class mail. Unless otherwise specified in accordance with the provision of
this Section, the addresses of the parties shall be:
Univec, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxxx Xxxx, Xxx Xxxx 00000
Attention: Xxxx Xxxxxxxxxx
Facsimile No. 516/739-3343
and
Sherwood Medical Company
0000 Xxxxx Xxxxxx
Xx. Xxxxx, Xxxxxxxx 00000
Attention: Vice President, OEM Sales
Facsimile No. 314/241-0232
SECTION 12. MISCELLANEOUS PROVISIONS
12(a) This document constitutes the entire Agreement between the parties,
there being no warranties, representations or conditions of any kind or nature
between the parties except as set forth herein. This Agreement may not be
changed or modified except by an instrument in writing duly signed by the
parties hereto. The December 22, 1994 OEM Supply Agreement between the parties
is hereby expressly terminated and canceled, together with all rights and
obligations of the parties with respect thereto. The parties hereto, their
respective employees, officers, directors, subsidiaries, successors and assigns,
hereby waive, release and discharge
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each other, and any of their past, present or future shareholders, employees,
officers, directors, parents, subsidiaries, affiliates, successors, assigns,
agents or representatives, from any and all claims, liabilities, damages and
demands whatsoever, in law or in equity, known or unknown, arising out of the
December 22, 1994 OEM Supply Agreement, all modifications thereto, or any other
prior agreement between the parties, oral or written, express or implied,
relating to the supply by Sherwood-D&G to Customer of the Products or any other
products. This Agreement supersedes all prior agreements and arrangements,
written or oral, between the parties hereto with respect to the subject matter
hereof.
12(b) This Agreement may not be assigned by either party without the
written consent of the other except to a subsidiary or in the case of a sale or
transfer of all or substantially all of its business by way of acquisition,
consolidation or merger. Notwithstanding the foregoing, this Agreement shall be
binding upon the respective successors and assigns of either party hereto.
12(c) The laws of the State of New York, without regard to principles of
conflicts of laws shall govern the interpretation and all disputes arising out
of this Agreement.
12(d) Nothing contained in this Agreement shall permit either party to
incur any debts or liabilities on behalf of the other party except as
specifically provided in this Agreement. The parties are and will remain at all
times independent contractors, and no agency or employment relationship exists
between them.
12(e) The headings and captions contained herein are for reference only and
shall not constitute a substantive part of this Agreement.
12(f) If any part of this Agreement is rendered void, invalid or
unenforceable by a court of competent jurisdiction after the expiration or
waiver of all rights to appeal, such shall not affect the validity or
enforceability of any other provisions of this Agreement except those where the
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invalid or unenforceable provisions comprise an integral part of or are
otherwise clearly inseparable from the intent and purpose of this Agreement. In
the event any provision is held invalid or unenforceable, the parties will
attempt to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid or unenforceable provision in light of
the intent of this Agreement and, upon so agreeing, shall incorporate such
substitute provision in this Agreement.
12(g) The parties agree that the prevailing party in any litigation under
this Agreement shall be entitled to recover, as part of its judgment, its
reasonable attorneys' fees and any related costs and expenses.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate originals by their duly authorized representatives.
CUSTOMER: UNIVEC, INC. SHERWOOD MEDICAL COMPANY
d/b/a XXXXXXXX - XXXXX & XXXX
By: /s/ Xxxx Xxxxxxxxxx By: /s/ Xxxxx XxXxxxxxxx
-------------------------------- ---------------------------
(Signture) (Signature)
Xxxx Xxxxxxxxxx Xxxxx XxXxxxxxxx
-------------------------------- ---------------------------
(Print Name) (Print Name)
Title: C.E.O Sr VP Marketing
------------------------------ ---------------------------
Date: 6/7/96 5/31/96
------------------------------ ---------------------------
H:\XXXXX\AGMT\UNIVEC.CLN
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EXHIBIT A
PRODUCTS AND PRICING
---------------------------------------------------------------------------------------
Product
Products*** Purchase Price*
---------------------------------------------------------------------------------------
5551-791600 1cc barrel, private label with preattached 27ga x 1/2"
cannula and sheath, non-sterile, bulk packed #
---------------------------------------------------------------------------------------
5551-761025 or 5551-500019 1cc plunger tip, non-sterile, bulk packed
(with or without silicone) #
---------------------------------------------------------------------------------------
1cc Tuberculin, Luer Slip, barrel only, private labor, non-sterile,
bulk packed
#
Hooded needle, 20-27ga x 1/2"-1", non-sterile, bulk packed
---------------------------------------------------------------------------------------
Univec design single-use Plungers, non-sterile, bulk packed #
---------------------------------------------------------------------------------------
* A one-time die cost of $1,500.00 will be paid by Customer for each private
label barrel.
** 1" cannula and other gauges and cannula lengths will be made available to
Customer when Sherwood-D&G has production capacity and capability to
manufacture. Sherwood-D&G currently has the capacity to also manufacture 28
and 29 gauge by 1/2" cannula. (Product Purchase Price may vary.)
*** 1cc sliding sleeve safety syringe barrel, private label, non-sterile, bulk
packed, may be added as a Product provided that Sherwood-D&G has production
capacity and capability to manufacture and the parties agree on the Product
Purchase Price therefor.
---------
# Confidential treatment has been sought by the Company for the omitted
portions and such material has been filed separately with the Commission.
SL-1888
5/29/96
EXHIBIT B
SPECIFICATIONS
Barrels, Hooded Needles and Plunger Tip - See attached.
Plunger - To be mutually agreed upon by the parties and attached hereto.
SCHEMATIC DEPICTING OPERATION, SPECIFICATIONS,
AND MATERIAL OF EPOXY 1CC TUBERCULIN SYRINGE
CANNULA CANNULA SHEATH
GAGE D.D. I.D. COLOR
---------------------------------------------------------------------
27 .0160/.0165 .0075/.0090 DK. ORANGE
---------------------------------------------------------------------
28 .0140/.0145 .0065/.0080 DK. ORANGE
---------------------------------------------------------------------
29 .0130/.0135 .0065/.0080 DK. ORANGE
---------------------------------------------------------------------
NOTES:
1. MATERIAL: BARREL-POLYPROPYLENE
SHEATH-POLYETHYLENE
CANNULA-STAINLESS STEEL TUBING, AISI TYPE 304
EPOXY-THERMAL
LUBRICANT-SHERWOOD CONFIDENTIAL
SHERWOOD
MEDICAL
MIAMI, FLORIDA
---------------------------------
TITLE
ASSEMBLY-BARREL, CANNULA, SHEATH
1CC EPOXY SYRINGE, U-100 INSULIN
CUSTOMER DISTRIBUTION ONLY
---------------------------------
. Used for DWG No. Rev.
Scale 2/1 B-91353 ---
---------------------------------
SCHEMATIC DEPICTING OPERATION, SPECIFICATIONS,
AND MATERIAL OF EPOXY 1CC INSULIN SYRINGE
CANNULA CANNULA SHEATH
GAGE D.D. I.D. COLOR
---------------------------------------------------------------------
27 .0160/.0165 .0075/.0090 YELLOW
---------------------------------------------------------------------
28 .0140/.0145 .0065/.0080 RED/XXXXX
---------------------------------------------------------------------
29 .0130/.0135 .0065/.0080 CLEAR
---------------------------------------------------------------------
NOTES:
1. MATERIAL: BARREL-POLYPROPYLENE
SHEATH-POLYETHYLENE
CANNULA-STAINLESS STEEL TUBING, AISI TYPE 304
EPOXY-THERMAL
LUBRICANT-SHERWOOD CONFIDENTIAL
SHERWOOD
MEDICAL
MIAMI, FLORIDA
---------------------------------
TITLE
ASSEMBLY-BARREL, CANNULA, SHEATH
1CC EPOXY SYRINGE, TUBERCULIN
CUSTOMER DISTRIBUTION ONLY
---------------------------------
. Used for DWG No. Rev.
Scale 2/1 B-91354 ---
---------------------------------
EXHIBIT B
QUALITY ASSURANCE CLASSIFICATION CD 1003
SHERWOOD MEDICAL OF DEFECTS MANUAL REV O
NORFOLK NEBRASKA COMPONENTS DATE O5/23/96
--------------------------------------------------------------------------------
DOCUMENT COORDINATOR Q. A. MANAGER EFFECTIVE
DATE
--------------------------------------------------------------------------------
TITLE: UNIVEC EPOXY SYRINGE SUBASSEMBLY (B/C/S)
I. VISUAL EVALUATION
------------------
Zero magnification unless otherwise specified
CL-1 Defects 0.065% A.Q.L.
--------------------------
1. Split or hole in sheath which may allow loss of sterility
CL-2 Defects 0.250% A.Q.L.
--------------------------
1. Water in assembled unit
2. Blood on syringe assembly
3. Missing point
4. Needle piercing sheath
5. Damaged or hook on point
6. Graduation printing error which will cause a volume error in excess of
+/-.02ml or +/-2 units (insulin only)
CL-3 Defects 0.400% A.Q.L.
--------------------------
1. Incomplete or incorrect assembly
2. Damaged product components (non-functional)
3. Flash which renders unit unserviceable
4. Graduation printing
a. Printing not legible
b. High or low graduation lines which cause volume to be out of
specification
c. Complete lack of printing of numbers; i.e. 1, 2, etc.
d. Non-printing of two or more graduations
5. Hole, split or crack in barrel which permits leakage
6. Impossible to remove sheath from syringe barrel
7. Epoxy flake on free length (attached)
8. Split cannula
9. Bent cannula
10. Primary grind only
11. Xxxx on lancet point
12. Mixed needle lengths or gage
13. Corrosion on cannula
14. Any defect visually obnoxious; i.e. hair, insect, etc.
15. Foreign material in fluid pathway
16. Missing, incorrect or illegible lot number of product identification -
packaging material
CL-4 Defects 1.500% A.Q.L.
--------------------------
1. Foreign material on outside of syringe
2. Damage components (functional but less than desired)
3. Fingernail flash exceeds 1/32" or parting line flash exceeding 1/16"
total
4. Non-printing of one graduation
5. Epoxy spillover on cannula not to exceed 1/16"
6. Printing smeared but legible
7. Globs (hardened lubricant) on cannula
8. Light xxxx on lancet point
1
UNAPPROVED COPY
EXHIBIT B
QUALITY ASSURANCE CLASSIFICATION CD 1003
SHERWOOD MEDICAL OF DEFECTS MANUAL REV O
NORFOLK NEBRASKA COMPONENTS DATE O5/23/96
CL-5 Defects 6.500% A.Q.L.
--------------------------
1. Poor workmanship
2. Excessive lubricant, droplets or pools visible through the barrel
3. Inclusions in parts
4. Fractures exceeding 5/8" in length (sheath only)
5. Incomplete epoxy fill in barrel (recessed below flush)
6. Excessive epoxy that migrates over half the distance of the rib
II. PHYSICAL EVALUATION
-------------------
CL-1 Defects 6.500% A.Q.L.
--------------------------
1. Pull test of cannula below three (3) pounds
CL-2 Defects 0.250% A.Q.L.
--------------------------
1. None defined
CL-3 Defects 0.400% A.Q.L.
--------------------------
1. Leakage in fluid pathway
2. Clogged or partially clogged needle
3. Cleanliness of neddle: O.D. of cannula
4. Pull test of cannula below five {5) pounds
5. No lubricant on cannula
CL-4 Defects 0.500% A.Q.L.
--------------------------
1. Pull test of sheath from barrel exceeds (7) seven pounds
2. Cannula does not meet straightness specification
3. Constriction
4. Partial lubricant on cannula
CL-5 Defects 6.500% A.Q.L.
---------------------------
1. Long or short cannula free length
END OF PROCEDURE
UNAPPROVED COPY
2
EXHIBIT B
SCHEMATIC OF BARREL-LUER SLIP
NOTES:
1. MATERIAL: BARREL-POLYPROPYLENE
2. DIA. "A" TO BE A MIN. OF .002 SMALLER THAN DIA. "B".
SHERWOOD
MEDICAL
MIAMI, FLORIDA
---------------------------------
TITLE
1CC BARREL-LUER SLIP
PRINTED-TUBERCULIN
CUSTOMER DISTRIBUTION ONLY
---------------------------------
. Used for DWG No. Rev.
Scale NONE B-91355 ---
---------------------------------
EXHIBIT B
QUALITY ASSURANCE CLASSIFICATION CD 1005
SHERWOOD MEDICAL OF DEFECTS MANUAL REV O
NORFOLK NEBRASKA COMPONENTS DATE O5/23/96
DOCUMENT COORDINATOR Q A MANAGER EFFECTIVE
DATE
TITLE: UNIVEC REGULAR LUER TIP PRINTED BARREL
I. VISUAL EVALUATION
------------------
(Zero Magnification Unless Otherwise Specified)
CL-1 Defects 0.065% A.Q.L
--------------------------
1. None Defined
CL-2 Defects 0.250% A.Q.L.
--------------------------
l. Water in units
2. Blood in units
CL-3 Defects 0.400% A.Q.L.
--------------------------
1. Incomplete or incorrect assembly
2. Damaged product components (non-functional)
3. Flash which renders unit unserviceable.
4. Graduation printing
4.1 Printing not legible
4.2 High or low graduation lines which cause volume to be out of
specification
4.3 Complete lack of printing of numbers; i.e. 1, 2, etc.
4.4. Non-printing of two or more graduations
5. Hole, split or crack in barrel which permits leakage
6. Any defect visually obnoxious; i.e. hair, insect, etc. Foreign
material in fluid pathway
7. Missing, incorrect or illegible lot number or product identification -
packaging material
CL-4 Defects 1.500% A.Q.L.
--------------------------
1. Foreign material on outside of barrel
2. Damaged component (functional but less than desired)
3. Fingernail flash exceeds 1/32" or parting line flash exceeding 1/16"
total
4. Absence of top line or one whole graduation line
5. Printing clarity or numerals and lettering and graduations must be
visible and legible at 18". Questionable unreadable printing will be
judged with a plunger rod inside the barrel
6. Crazing visible at 18"
7. The printing of the unit of measurement must be in full evidence (ml,
cc, oz, etc.)
CL-5 Defects 6.500% A.Q.L.
--------------------------
1. Poor workmanship
2. Printing not in line with flat of flange
3. Printing smeared but legible
UNAPPROVED COPY
1
EXHIBIT B
QUALITY ASSURANCE CLASSIFICATION CD 1005
SHERWOOD MEDICAL OF DEFECTS MANUAL REV O
NORFOLK NEBRASKA COMPONENTS DATE O5/23/96
II. PHYSICAL EVALUATION
-------------------
CL-1 Defects 0.065% A.Q.L.
--------------------------
1. None Defined
CL-2 Defects 0.250% A.Q.L.
--------------------------
1. None Defined
CL-3 Defects 0.400% A.Q.L.
--------------------------
1. Printing on syringe barrel does not pass the ink permanency test
2. Syringe printing volume check exceeds the +/- 1.5% of syringe volume
plus 2.0% expelled volume at each major graduation (audit)
3. Failed leak test ( standard luer taper)
CL-4 Defects 1.500% A.Q.L.
--------------------------
1. None defined
CL-5 Defects 6.500% A.Q.L.
---------------------------
1. None defined
END OF PROCEDURE
UNAPPROVED COPY
2
EXHIBIT B
SCHEMATIC DEPICTING DIAMETER, MATERIAL AND GENERAL SPECIFICATIONS
NOTES:
1. MATERIAL: BLACK RUBBER COMPOUND:
SHERWOOD
MEDICAL
MIAMI, FLORIDA
---------------------------------
TITLE
PLUNGER TIP-1cc SYRINGE
CUSTOMER DISTRIBUTION ONLY
---------------------------------
. Used for DWG No. Rev.
Scale xxxx B-xxxxx ---
---------------------------------
EXHIBIT B
QUALITY ASSURANCE CLASSIFICATION CD 1004
SHERWOOD MEDICAL OF DEFECTS MANUAL REV 0
NORFOLK NEBRASKA COMPONENTS DATE 05/23/96
UNAPPROVED COPY
--------------------------------------------------------------------------------
DOCUMENT COORDINATOR Q.A. MANAGER EFFECTIVE
DATE
--------------------------------------------------------------------------------
TITLE: UNIVEC SYRINGE RUBBER PLUNGER TIP
I. VISUAL EVALUATION
-----------------
Zero magnification unless otherwise specified
CL-1 Defects 0.065% A.Q.L.
-------------------------
1. None defined
CL-2 Defects 0.250% A.Q.L.
-------------------------
1. None defined
CL-3 Defects 0.400% A.Q.L.
-------------------------
1. Cleanliness - foreign matter or particles, grease, etc.
2. Malforms, voids and no fills (applicable to face and first ring)
3. Splits and pin holes
4. Trim in excess of ring O.D.
5. Water on units
6. Any defect visibly obnoxious; i.e. hair, insects, etc.
7. Concentricity
CL-4 Defects 1.500% A.Q.L.
-------------------------
1. Missing, incorrect or illegible lot number or product
identification - packaging material
CL-5 Defects 6.500% A.Q.L.
-------------------------
1. Poor workmanship
2. Inclusions
II. PHYSICAL EVALUATION
-------------------
CL-1 Defects 0.065% A.Q.L.
-------------------------
1. None defined
CL-2 Defects 0.250% A.Q.L.
-------------------------
1. None defined
CL-3 Defects 0.400% A.Q.L.
-------------------------
1. Leakage of water beyond the first ring during leak test. Test
conducted when visual examination is not conclusive
2. Concentricity exceeds .020 T.I.R. (dimensional check to be
conducted when visual examination is not conclusive)
CL-4 Defects 1.500% A.Q.L.
-------------------------
1. None defined
CL-5 Defects 6.500% A.Q.L.
-------------------------
1. None defined
END OF PROCEDURE
EXHIBIT B
[SCHEMATIC DEPICTING OPERATION, MATERIAL AND
SPECIFICATIONS OF M500E HOODED NEEDLE]
NOTES:
1. MATERIAL:
CANNULA-AISI TYPE 000.XX.
HUB-POLYPROPYLENE
SHEATH-POLYPROPYLENE-CLEAR
EPOXY-U.V. ADHESIVE OR THERMAL EPOXY
LUBRICANT-SHERWOOD CONFIDENTIAL,5-1038
2. EPOXY MAXIMUM PROTRUSION 3/32".
3. 18 GA. NEEDLES TO USE THERMAL EPOXY ONLY.
----------------------------------------------------------------------------------------------------------------------------
NEEDLE | FREE | "A" OVERALL | "B" SHEATH | | HUB |
DESCPIPTION | LENGTH | MIN. | MAX. | MIN. | MAX. | | COLOR | REMARKS
============================================================================================================================
18 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | GREEN |
----------------------------------------------------------------------------------------------------------------------------
18 x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | GREEN |
----------------------------------------------------------------------------------------------------------------------------
19TW x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | LIME |
----------------------------------------------------------------------------------------------------------------------------
19TW x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | LIME |
----------------------------------------------------------------------------------------------------------------------------
20 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | PINK |
----------------------------------------------------------------------------------------------------------------------------
20 x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | PINK |
----------------------------------------------------------------------------------------------------------------------------
21 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | LAVENDER |
----------------------------------------------------------------------------------------------------------------------------
21 x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | LAVENDER |
----------------------------------------------------------------------------------------------------------------------------
22 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | BLUE |
----------------------------------------------------------------------------------------------------------------------------
22 x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | BLUE |
----------------------------------------------------------------------------------------------------------------------------
25 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | ORANGE |
----------------------------------------------------------------------------------------------------------------------------
25 x 5/8 A | 5/8" +- 3/64 | 1.736 | 1.791 | 1.600 | 1.620 | | | RED |
| 5/8" - 1/16 | | | | | | | |
----------------------------------------------------------------------------------------------------------------------------
25 x 1" A | 1" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | RED |
----------------------------------------------------------------------------------------------------------------------------
20 x 1" B | 1" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | PINK |
----------------------------------------------------------------------------------------------------------------------------
18 x 3/4" B | 3/4" +- 1/16 | 1.736 | 1.791 | 1.600 | 1.620 | | | GREEN |
----------------------------------------------------------------------------------------------------------------------------
18 x 5/8" B | 5/8" + 3/64 | 1.736 | 1.791 | 1.600 | 1.620 | | | GREEN |
| 5/8" - 1/16 | | | | | | | |
----------------------------------------------------------------------------------------------------------------------------
20 x 5/8" B | 5/8" + 3/64 | 1.736 | 1.791 | 1.600 | 1.620 | | | PINK |
| 5/8" - 1/16 | | | | | | | |
----------------------------------------------------------------------------------------------------------------------------
27 x 1/2" I | 1/2" + 3/64 | 1.736 | 1.791 | 1.600 | 1.620 | | | YELLOW |
| 1/2" - 1/16 | | | | | | | |
----------------------------------------------------------------------------------------------------------------------------
27 x 1 1/2" A | 1 1/2" +- 1/16 | 2.226 | 2.291 | 2.090 | 2.120 | | | YELLOW |
----------------------------------------------------------------------------------------------------------------------------
SHERWOOD
MEDICAL
DELANO, FLORIDA
---------------------------------
TITLE
CUSTOMER DISTRIBUTION
M500E HOODED NEEDLE
---------------------------------
. Based on DWG No. Rev.
O.E.M.
Scale None B-90415 G
---------------------------------
EXHIBIT B
|----------------------------------------------------
[LOGO] SHERWOOD MEDICAL |TITLE |SPEC. NO. | REV.
CLASSIFICATIONS OF | |CD-2114 | B
DEFECTS |CLASSIFICATIONS OF DEFECTS |SHEET 1 of 3 |
| EPOXY HOODED NEEDLES |--------------------
| |ISSUE
| |DATE 9/19/88
-------------------------------------------------------------------------------
Compiled by: | APPROVALS AND DATE
DeLand Mfg. |-----------------------------------------------------------
7-22-88 | 7-27-88 | 8-16-88 | 8-24-88 | |
| | | | |
X. Xxxxxx | [illegible] | [illegible] | [illegible] | |
-------------------------------------------------------------------------------
I. VISUAL EVALUATION (ZERO MAGNIFICATION UNLESS OTHERWISE SPECIFIED)
-----------------------------------------------------------------
CL-1 DEFECTS. 0.065% A.Q.L.
---------------------------
1. Split or hole in sheath which may allow loss of sterility
CL-2 DEFECTS: 0.25% A.Q.L.
---------------------------
1. Blood on needle assembly
2. Needle piercing sheath
3. Missing point
4. Hook or severe point damage
5. Reversed cannula
6. No visible epoxy
CL-3 DEFECTS: 0.4% A.Q.L.
--------------------------
1. Incorrect or incomplete assembly
2. Damaged product components (non-functional)
3. Split cannula
4. Mixed cannula
5. Bent cannula
6. Corrosion on cannula
7. Any defect visibly obnoxious i.e., hair, insect, etc.
8. Slivers, loosely attached metallic material or debris in cannula bevel
or inside hub
9. Preliminary grind only
10. Xxxx on lancet point
11 Incomplete or geometrically unacceptable grind
12. Hee1 of bevel improperly dulled
CL 4 DEFECTS: 1.5% A.Q.L.
--------------------------
1. Foreign material on outside of hub or cannula
2. Damaged components (functional but less than desired)
3. Light xxxx on lancet point
4. Globs (hardened lubricant)
5. Mixed bevels
6. Attached epoxy splatter or solid above 3/32" on cannula free length
(1" free length or less)
RELEASE FOR PRODUCTION
THIS PRINT INCORPORATES THE LATEST APPROVED
SPECIFICATIONS AND SUPERSEDES ALL PREVIOUS ISSUES
NOTICE: SHERWOOD CONFIDENTIAL
EXHIBIT B
|----------------------------------------------------
[LOGO] SHERWOOD MEDICAL |TITLE |SPEC. NO. | REV.
CLASSIFICATIONS OF | |CD-2114 | B
DEFECTS |CLASSIFICATION OF DEFECTS |SHEET 3 of 3 |
| EPOXY HOODED NEEDLES |--------------------
| |ISSUE
| |DATE 9/19/88
-------------------------------------------------------------------------------
REVISION | RELEASE NO. | DESCRIPTION | APPROVALS
----------|-----------------|------------------------------------|-------------
| | |
- | DR-4331 |RELEASED TO PRODUCTION | G.E. 9-19-88
| | |
A | DR-4742 |DELETED III. BIOLOGICAL EVALUATION | G.E. 3-23-91
| | |
B | DR-4840 |UNIVERSAL VISUAL EVALUATION | [ILLEGIBLE]
| |0.XX 4 ITEM 6 WAS:EPOXY SPLATTER OR | 8-20-91
| | SOLID ABOVE 3/32" ON CANNULA FREE|
| | LENGTH (ATTACHED) |
| |2.ADDED CL 5 ITEM 6 |
| | |
| | |
| | PRELIMINARY |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
USED ON USED ON USED ON
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
EXHIBIT B
|----------------------------------------------------
[LOGO] SHERWOOD MEDICAL |TITLE |SPEC. NO. | REV.
CLASSIFICATIONS OF | |CD-2114 | B
DEFECTS |CLASSIFICATION OF DEFECTS |SHEET 2 of 3 |
| EPOXY HOODED NEEDLES |--------------------
| |ISSUE
| |DATE 9/19/88
-------------------------------------------------------------------------------
CL-5 DEFECTS: 6.5% A.Q.L.
------------
1. Poor workmanship
2. Fractures in sheath exceeding 5/8" in length
3. Inclusions in plastic parts
4. Foreign material on outside of sheath
5. Excessive epoxy on outside of hub
6. Attached epoxy splatter or solid above 3/32" on cannula free length
(1 1/4 free length or longer)
II. PHYSICAL EVALUATION
---------------------
CL-1 DEFECTS: 0.065% A.Q.L.
-------------
1. Pull test of cannula to hub below three (3) pounds
CL-2 DEFECTS: 0.25% A.Q.L.
-------------
NONE
CL-3 DEFECTS: 0.4% A.Q.L.
-------------
1. Clogged or partially clogged needle
2. Pull test of cannula below specification (over three (3) pounds)
3. Cleanliness of needle: OD of cannula
4. Leakage at cannula junction or luer taper
5. No lubricant on cannula
CL-4 DEFECTS: 1.5% A.Q.L.
-------------
1. Cannula does not meet straightness specification
2. Partial lubricant on cannula
3. Tight sheath to hub fit
CL-5 DEFECTS: 6.5% A.Q.L.
-------------
1. Long or short cannula free length
APPLICATION SPECIFICATIONS
--------------------------
The following documents form a part of this specification:
CD 2001 - Definitions of Monoject Quality Requirements.
PRELIMINARY
EXHIBIT D
XXXX OF SALE
THIS XXXX OF SALE is made, executed and delivered as of ____________, 1996,
by Sherwood Medical Company, doing business as Xxxxxxxx - Xxxxx & Xxxx, a
Delaware corporation ("Sherwood-D&G"), to Univec, Inc., a New York corporation
("Customer"). Unless otherwise defined herein, capitalized terms used in this
Xxxx of Sale shall have the meanings given to them in the OEM Supply Agreement
(the "Agreement"), dated as of the date hereof, between Sherwood-D&G and
Customer.
Sherwood-D&G hereby conveys, grants, bargains, sells, transfers, sets over,
assigns, delivers and confirms unto Customer, its successors and assigns
forever, the 128 cavity plunger mold, including the mold base and the inserts,
Sherwood-D&G Asset No. 1713 (the "Mold"), used by Sherwood-D&G to mold the
Plungers, as described in the Agreement. TO HAVE AND TO HOLD the Mold, unto
Customer, its successors and assigns, to its and their own use forever.
Sherwood-D&G further covenants and agrees that it will do, execute and
deliver, or will cause to be done, executed and delivered, all such further
acts, transfers, assignments and conveyances, confirmations, powers of attorney,
assurances and consents, conveying and confirming unto Customer of all the
rights, title and interests of Sherwood-D&G in and to the Mold, as Customer
shall reasonably require.
Sherwood-D&G does hereby bind itself, its successors, heirs and assigns to
forever warrant and defend transfer to title to the Mold unto Customer, its
successors and assigns, against any person claiming the same, or any part
thereof.
1
IN WITNESS WHEREOF, Sherwood-D&G has caused this Xxxx of Sale to be
executed as of the day and year first above written.
SHERWOOD MEDICAL COMPANY,
D/B/A XXXXXXXX - XXXXX & XXXX
By:___________________________
Title:________________________
STATE OF MISSOURI )
) ss.
COUNTY OF ST. LOUIS )
On this ________day of_______, 1996, before me, the undersigned notary
public, personally appeared ___________, known to me to be the person whose name
is subscribed to the within instrument and acknowledged that he executed the
same for the purposes therein contained.
In witness whereof, I hereunto set my hand and official seal.
----------------------------
Notary Public
2
EXHIBIT C
NON-EXCLUSIVE LICENSE AGREEMENT (U.S.)
THIS AGREEMENT, made effective as of the ____ day of_______ 199_, by and
between SHERWOOD MEDICAL COMPANY, a corporation incorporated under the laws of
the State of Delaware of the United States of America, doing business as
Xxxxxxxx-Xxxxx & Xxxx and having its principal offices at 0000 Xxxxx Xxxxxx, Xx.
Xxxxx, Xxxxxxxx 00000 (hereinafter referred to as "Sherwood"), and UNIVEC, INC.,
a corporation incorporated under the laws of the State of New York, having
offices at 000 Xxxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxx Xxxx 00000 (hereinafter
referred to as "Licensor");
WITNESSETH:
WHEREAS, Licensor owns an invention relating to single-use syringes
(hereinafter defined and referred to as "Licensed Invention") which is disclosed
in an Application for United States Letters Patent identified as Serial Number
08/237,749 filed on April 25, 1994, entitled "Single Use Syringe" (hereinafter
further identified, defined and referred to as the "Licensed Patent
Application"); and
WHEREAS, Licensor has entered into a License Agreement (hereinafter
referred to as the "Movern License") effective June 17, 1994 between Licensor
and Xxxxx Xxxxxx whereby Licensor is granted exclusive rights under certain
United States patents (hereinafter referred to as the "Movern Patents")
including the right in Licensor to grant non-exclusive sublicenses under the
Movern Patents; and
WHEREAS, Sherwood is desirous of securing, and Licensor is willing to grant
to Sherwood, a non-exclusive license to make, have made for it, use and/or sell
in the hereinafter defined Licensed Territory, the Licensed Invention under said
Licensed Patent Application and/or utilizing any know-how heretofor developed by
Licensor relating to the Licensed Invention, all upon the terms and conditions
hereinafter provided.
NOW, THEREFORE, in consideration of the mutual covenants contained herein,
Sherwood and Licensor agree as follows:
SECTION 1. DEFINITIONS
As used in this Agreement, the following terms shall be deemed to have the
following meanings:
1 (a) "Licensed Invention" shall mean the invention claimed and/or
disclosed in the Licensed Patent Application, as herein defined.
1 (b) "Licensed Patent Application" shall mean the application for United
States Letters Patent, Serial Number 08/232,749 filed on April 25, 1994 by Xxxx
Xxxxxxxxxx and Xxxxx Xxxxxxxx entitled "Single Use Syringe".
1 (c) "Licensed Patent Rights" shall mean (i) the Licensed Patent
Application, (ii) any other patent applications filed by the Licensor on the
Licensed Invention in the Licensed Territory, (iii) any divisional,
continuation, continuation-in-part, or substitute patent applications filed by
the Licensor on the Licensed Invention in the Licensed Territory, (iv) any
patents that shall issue on any of the above-described patent applications, (v)
any reissues, reexaminations and extensions of the above, and (vi) any patent
application or patent filed and/or issued in the Licensed Territory on any
invention which embraces the Licensed Invention and which is owned or controlled
by Licensor before or during the term of this Agreement or which is licensed to
the Licensor during the term of this Agreement with a right to sublicense
(excluding the Movern Patents).
1 (d) "Licensed Product", singular or plural, shall mean:
(i) any product made and/or sold in the Licensed Territory and claimed in
any pending claim in any pending patent application of the Licensed
Patent Rights in the Licensed Territory, or claimed in any valid,
enforceable claim in any unexpired patent of the Licensed Patent
Rights in the Licensed Territory, or
(ii) any product made and sold, or sold and used, in the Licensed Territory
employing, or intended to be utilized employing, a process or method
claimed in any pending claim in any pending patent application of the
Licensed Patent Rights in the Licensed Territory, or claimed in any
valid, enforceable claim in any unexpired patent of the Licensed
Patent Rights in the Licensed Territory.
1 (e) "Net Sales" shall mean the total or gross xxxxxxxx for sales or other
transfers of Licensed Products by Sherwood, any sublicensees and/or any Related
Companies, as hereinafter defined, in any arm's-length transactions to unrelated
third-party distributors, retailers or end users, less the following deductions
where factually applicable: (i) discounts and rebates allowed and taken, in
amounts customary to the trade; (ii) outbound transportation and insurance
charges separately billed to the customer or prepaid; (iii) special outbound
packing separately billed to the customer or prepaid; (iv) sales, excise, use,
turnover, inventory, value-added and similar taxes
2
and/or duties imposed upon and with specific reference to the particular sales
of Licensed Products, but not including net income tax; (v) free samples and
replacements in amounts refunded or credited upon purchase price on returned or
defective Licensed Products; and (vi) the purchase price of any Licensed
Products or components of Licensed Products purchased from Licensor or any
source designated by Licensor. Sales shall be accounted for when invoiced and
credits and refunds shall be accounted for when allowed.
1 (f) "Licensed Know-how" shall mean any and all data, technology,
drawings, documentation, and other proprietary and confidential information
owned, acquired or developed by or for Licensor before or during the term of
this Agreement that relate to the Licensed Invention, the design and/or
manufacture thereof (excluding any such data, technology, drawings,
documentation and other information relating to the design and/or construction
of the SMT Machine), and/or the Licensed Products.
1 (g) "Licensed Territory" shall mean the United States of America and its
territories and possessions.
1 (h) "Related Company", singular or plural, shall mean any parent,
subsidiary or affiliate company of Sherwood, or any subsidiary or affiliate of
any parent or subsidiary of Sherwood.
l(i) "Sherwood Developments" shall mean any modifications of or
improvements to the Licensed Invention or the Licensed Product, whether patented
or not, made, owned, acquired or developed by Sherwood or made for Sherwood by
another, and/or licensed to Sherwood by another with the right to sublicense,
before or during the term of this Agreement.
SECTION 2. WARRANTY; COVENANT
2 (a) Licensor warrants that Licensor is the owner of the entire right,
title and interest in and to the Licensed Invention, the Licensed Patent Rights
and the Licensed Know-how, that no license embracing said Invention, Patent
Rights and/or Know-how has heretofore been granted, that Licensor has the right
to grant the licenses granted in Section 4 hereof, that to Licensor's best
knowledge and belief the Licensed Patent Rights are, or will be, valid and
enforceable, and that manufacture, use and/or sale of the Licensed Invention
will not infringe any patent presently known to Licensor.
2 (b) Licensor warrants that Licensor has disclosed or will timely disclose
to Sherwood any and all Licensed Know-how presently owned or heretofore
developed by Licensor, and warrants and agrees that Licensor will timely
disclose to Sherwood any additional Licensed Know-how that Licensor may own,
acquire or develop during the term of this Agreement.
3
2 (c) Licensor warrants that Licensor will cooperate in prosecution and
maintenance of the Licensed Patent Rights. The responsibility for directing
payment of any patent maintenance fees shall be in Licensor. Licensor further
warrants that after execution of this Agreement, any fee payable to the United
States Patent and Trademark Office for any of the Licensed Patent Rights will
not be paid based on a claim of small entity status and that Licensor will
instruct Licensor's attorneys to that effect, and that Licensor will provide to
Sherwood, within thirty (30) days of any request by Sherwood, any information
and copies of any records that Licensor has concerning conception and/or first
reduction to practice of the Licensed Invention and the dates thereof. Licensor
further warrants that Licensor will instruct Licensor's attorneys (i) to pay any
maintenance fee for the Licensed Patent Rights, (ii) to keep Sherwood informed
of the status of the Licensed Patent Rights, (iii) to provide Sherwood with
copies of all official papers relating to the filing, prosecution and
maintenance of such Licensed Patent Rights, (iv) to promptly notify Sherwood of
issuance of any patent included in the Licensed Patent Rights, and (v) to
counsel with Sherwood attorneys in an effort to secure the broadest possible
patent protection on the Licensed Invention that is reasonably available.
However, Licensor shall have the right to control and finally decide any matters
in regard to preparation, filing, prosecution and/or maintenance of the Licensed
Patent Rights.
2 (d) Licensor represents and warrants that Licensor and any direct or
ultimate parent entities of Licensor do not have total assets and/or annual net
sales of Ten Million Dollars ($10,000,000.00) or more within the meaning of
Title 11 of the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976 (15 U.S.C.
ss. 18a) and the regulations promulgated thereunder, 16 C.F.R. 801.1 et seq.
2 (e) Sherwood warrants, covenants and agrees that it shall timely disclose
to Licensor any and all information relating to Sherwood Developments, including
without limitation, all data, technology, drawings, documentation, and other
proprietary and/or confidential information.
SECTION 3. INITIAL PAYMENT
3 (a) Upon execution of this Agreement, Sherwood will pay to Licensor the
sum of One Thousand Dollars ($ 1,000.00) in full payment for the non-exclusive
license to utilize the Licensed Know-how granted in Paragraph 4(a) hereof.
3 (b) Additionally, upon execution of this Agreement, Sherwood will pay to
Licensor the sum of One Hundred Thousand Dollars ($100,000.00) as an advance
payment of, and offsettable against, any payments due under Paragraphs 5(a),
5(b) and 5(c) hereof.
4
SECTION 4. LICENSES GRANTED
4(a) Licensor hereby grants to Sherwood and Sherwood hereby accepts a
paid-up non-exclusive license to utilize the Licensed Know-how in perpetuity to
make, have made for it, use and/or sell the Licensed Invention, and/or the
Licensed Products in the Licensed Territory.
4(b) Licensor hereby grants to Sherwood and Sherwood hereby accepts a
non-exclusive license under the Licensed Patent Rights and a non-exclusive
sub-license under the Movern Patent to make, have made for it, use and/or sell
the Licensed Invention and/or the Licensed Products in the Licensed Territory.
4(c) Sherwood hereby grants to Licensor and Licensor hereby accepts a
perpetual, fully paid, royalty free, non-exclusive license to make, use and/or
sell the Sherwood Developments or products incorporating the Sherwood
Developments.
SECTION 5. ROYALTIES
5 (a) As consideration for the non-exclusive license herein granted in
Paragraph 4(b) hereof, Sherwood agrees to pay to Licensor an earned royalty
equal to five percent (5 %) of Net Sales of Licensed Products invoiced for sale
by Sherwood. Such royalty payment shall be mailed to Licensor within sixty (60)
days (the "Royalty Payment Date") after the end of each six-month period ending
June 30 and December 31 (each a "Royalty Reporting Period") of each year (each,
a "Royalty Year") during the term of this Agreement.
5 (b) It is understood that this Agreement includes no obligation on the
part of Sherwood, expressed or implied, to commercialize Licensed Product, to
sell any specific number of Licensed Products, or to do so in any set period of
time. However, if Sherwood shall either (i) fail to introduce to the market and
make commercial sales of Licensed Product within two (2) years from the
effective date of this Agreement, or (ii) fail to sell any Licensed Product for
a continuous period of five (5) years at any time during the term of this
Agreement, then in either event, Licensor shall have the option, upon sixty (60)
days written notice to Sherwood, to terminate this Agreement.
5 (c) In the event that any of the Licensed Patent Rights in the Licensed
Territory is finally declared abandoned, lapsed, unenforceable or, in whole or
in part, invalid to the extent that no claim of the Licensed Patent Rights
survives which claims Licensed Products made and/or sold by Sherwood or any
Related Company within the Licensed Territory, then thereafter, Sherwood shall
not be required to pay any royalty under this Agreement. In the event that a
valid, enforceable patent claiming Licensed Products made and/or sold by
Sherwood or any Related Company in the Licensed Territory is not granted to
Licensor within three (3) years after the effective date of this Agreement,
then, unless otherwise mutually agreed in writing or unless and until a valid,
enforceable patent claiming Licensed Products is subsequently granted to
Licensor within the Licensed Territory, Sherwood shall thereafter only be
required to pay to Licensor
5
one-half (1/2) the applicable royalty set forth in Paragraph 5(a) hereof on the
Net Sales in the Licensed Territory of products previously meeting the
definition of Licensed Products under Paragraph 1 (d) hereof for the remainder,
if any, of a period of three (3) years from the date of first sale of Licensed
Products by Sherwood or Related Company. Sherwood and any sublicensees shall
thereafter be deemed to have a fully paid-up, royalty-free non-exclusive license
under the Licensed Patent Rights within the Licensed Territory, unless and until
a valid, enforceable patent claiming Licensed Products is subsequently granted
to Licensor, in which event the obligation to pay a full royalty under Paragraph
5(a) hereof for the future shall be reinstated.
5 (d) Sherwood shall have the right to deduct from any payments due to
Licensor under Paragraphs 5(a), 5(b) and/or 5(c) hereof, the full amount of any
payments required to be made and actually made by Sherwood with respect to any
rights under the Movern Patents or the Movern License in connection with the
Licensed Invention, the Licensed Patent Rights or this Agreement.
SECTION 6. ROYALTY CALCULATION, REPORTS AND RECORDS
6 (a) Sherwood agrees, and will require any Related Companies to agree,
to keep true and accurate records adequate to establish any royalty payable
under this Agreement and to permit an independent certified public accountant
selected by Licensor and reasonably acceptable to Sherwood, to inspect, on a
confidential basis and at Licensor's expense, said records once annually at
reasonable times upon reasonable notice, but only within a period of three (3)
years after the last day of the Royalty Reporting Period to which such records
relate. On the Royalty Payment Date, Sherwood shall provide to Licensor a report
(a "Royalty Report") for each Royalty Reporting Period, setting forth the earned
royalty due and payable on Net Sales, if any, of Sherwood and/or any Related
Companies of Licensed Products during such Royalty Reporting Period, accompanied
by payment of all amounts shown to be so due and payable, if any.
6 (b) Earned royalty, as provided in Paragraph 5(a) hereof, shall accrue
upon the first sale of Licensed Product to an unrelated third-party distributor,
retailer or end user.
6 (c) Only a single royalty under Paragraph 5(a) hereof shall be payable to
Licensor for each specific unit of Licensed Product regardless of the number of
countries in which manufacture, importation, sale, resale and/or use is made by
Sherwood, any Related Companies and/or any direct or indirect customer thereof.
Nothing herein is intended nor shall it be construed to xxxxx Xxxxxxxx any right
to sell or export or manufacture for sale to any place outside the Licensed
Territory. Each Royalty Report shall contain a certification that no sale of
Licensed Product was made outside the Territory by Sherwood during the Royalty
Reporting Period to which such Royalty Report relates.
6 (d) All taxes, assessments and fees of any nature levied by any
governmental entity in the Licensed Territory of this Agreement on the sale of
Licensed Products by Sherwood, or any Related Company shall be paid by Sherwood,
or any Related Company for its account. However,
6
if an income or other tax is levied on the recipient of any royalty under this
Agreement by any governmental entity and is legally required to be withheld from
the payment of royalty from Sherwood or from any Sherwood sublicensee and/or
Related Company to Sherwood, such tax shall be paid by Sherwood, its sublicensee
and/or Related Company for the account of Licensor, in which event an official
receipt will be secured evidencing such payment, the receipt forwarded to
Licensor, and the amount of such tax deducted from royalty paid to Licensor.
6(e) The provisions herein as to payment of royalties shall not apply to
Licensed Products embodying only the subject matter of claims of the Licensed
Patent Rights which have become abandoned, lapsed, expired or which have been
finally declared invalid or unenforceable.
SECTION 7. PATENT ENFORCEMENT AND DEFENSE
7(a) If Sherwood obtains notice or knowledge that a third party is
infringing or misappropriating any patent, trademark, copyright or other
proprietary rights with respect to the Licensed Patent Rights, the Movern
Patent, the Licensed Invention or the Licensed Products, Sherwood shall promptly
notify Licensor of such infringement or misappropriation. Sherwood agrees to
cooperate with Licensor in the conduct of any litigation which Licensor or its
licensors may elect to undertake with respect to such infringement or
misappropriation. Sherwood shall have the right but not the obligation to be
represented in such litigation by its own counsel at its own cost and expense.
7(b) Licensor shall not be obligated to undertake by litigation or
otherwise the collection of any claim against any person for loss of, damage to,
or governmental taking of the Licensed Invention, the Licensed Patent
Application, the Licensed Patent Rights or the Licensed Products, but Licensor
will cooperate with Sherwood at Sherwood's expense if Sherwood elects to pursue
such claims.
7(c) Licensor shall indemnify and hold Sherwood harmless from and against
any liabilities, losses, damages, expenses (including without limitation
reasonable attorneys' fees and expenses), causes of action, suits, claims, or
judgments asserted by third parties (a "Third Party Claim") against Sherwood
arising out of a Third Party Claim with respect to the infringement or
misappropriation of a patent or other proprietary rights, which may be asserted
by such third party, because of Sherwood's making, using or selling the Licensed
Invention or the Licensed Products pursuant to and in accordance with the terms
and conditions of this Agreement, provided that Sherwood shall give Licensor (i)
prompt written notice of the institution or the assertion of a Third Party Claim
for which indemnity is or will be claimed hereunder and (ii) to the extent
permitted by law, the opportunity to take over, control, settle and defend such
Third Party Claim, at the sole expense of Licensor and with counsel selected by
Licensor. Sherwood has the right but not the obligation to be represented in any
such Third Party Claim by its own counsel, at its own cost and expense, provided
that such right does not prejudice the right of Licensor to take over, control,
settle and defend such Third Party Claim to the extent permitted by law. If
making, using or selling the Licensed
7
Invention or the Licensed Products, or part thereof is enjoined for any reason
whatsoever during the term of this Agreement, Licensor has the right at its own
expense to (i) procure for Sherwood the right to continue to make, have made for
it, use and/or sell the Licensed Invention and the Licensed Products, or part
thereof which is the subject of such injunction, or (ii) to terminate this
Agreement without further obligation of either party to the other. This Section
7 contains Sherwood's sole and exclusive remedy and Licensor's only obligations
with respect to the infringement or misappropriation of a patent or other
proprietary right which may be asserted by an owner thereof or any other person
having an interest therein.
7(d) Licensor shall not indemnify Sherwood, hold Sherwood harmless or
defend Sherwood in respect of any claim of infringement or misappropriation
where such infringement or misappropriation is the result of any modification or
change in the Licensed Invention or Licensed Products (including but not limited
to the Sherwood Developments) which departs in any manner from the terms of the
Licensed Patent Rights.
SECTION 8. PATENT NOTICE MARKING
Sherwood shall, and shall require each Related Company, to xxxx all
Licensed Products with the number of any applicable patent or other
identification of the Licensed Patent Rights in accordance with the provisions
of 35 U.S.C. ss.287.
SECTION 9. FORCE MAJEURE
Neither party to this Agreement shall be responsible to the other party for
nonperformance or delay in performance of any terms or conditions of this
Agreement due to acts of God, acts of governments, wars, riots, strikes,
accidents in transportation, or other causes beyond the reasonable control of
the parties. Failure to pay money shall not be excused under this Section.
SECTION 10. TERM OF AGREEMENT
Unless this Agreement shall be terminated by either party pursuant to the
provisions hereof, this Agreement shall remain in force and effect during the
pendency and until the expiration of the last-to-expire of the Licensed Patent
Rights in the Licensed Territory, at which time this Agreement will expire.
However, Sherwood and any Related Companies shall thereafter have a fully
paid-up, royalty-free non-exclusive license to make, have made for it, use
and/or sell the Licensed Invention and any other invention claimed in the
Licensed Patent Rights without limitation.
SECTION 11. TERMINATION
11 (a) In the event that either party hereto shall fail to comply with any
of its material obligations under this Agreement after the other party shall
have given thirty (30) days written notice of such failure to the first party,
which notice shall fully specify the obligation with which
8
the first party has not complied, then the other party, by further written
notice to the first party, may terminate this Agreement.
11(b) All rights and licenses granted under or pursuant to this Agreement
by Licensor to Sherwood are, and shall otherwise be deemed to be, for purposes
of Section 365(n) of Title 11 U.S. Code (the "Bankruptcy Code"), licenses and
rights to "intellectual property" as defined under Section 101 of the Bankruptcy
Code. The parties agree that Sherwood, as a licensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy Code. Licensor shall also have the right to terminate this
Agreement in the event of the filing of a voluntary or involuntary petition of
bankruptcy of Sherwood.
11 (c) Sherwood may terminate this Agreement at any time on thirty (30)
days notice in writing to Licensor.
SECTION 12. ASSIGNABILITY
12(a) This Agreement may be assigned by Licensor and shall inure to the
benefit of its successors, assigns or other legal representatives. Without the
prior written consent of Licensor, which may be withheld for any or no reason
whatsoever, Sherwood may not assign any rights arising under this Agreement
except to a Related Company or to the successor in interest to the entire
syringe business of Sherwood which, in any case, expressly assumes, in writing,
the obligations hereunder.
12(b) Licensor agrees to notify Sherwood in writing within thirty (30) days
of any change in ownership or transfer of rights in any of the Licensed Patent
Rights from any owner to any third party.
SECTION 13. NOTICES AND PAYMENTS
13(a) Any notice, request, consent, demand or other communication given or
required to be given under this License shall be effective only if in writing
and shall be sent by one of the following means to the addressee at the address
set forth in Sections 13(b) below (or at such other address as shall be
designated in accordance with this Section 13, and shall be deemed conclusively
to have been given: (i) on the first business day following the day timely
deposited with an international or national overnight courier, with the cost of
delivery prepaid, assuming proof of delivery; (ii) on the third business day
following the day duly sent by certified or registered mail, postage prepaid and
return receipt requested; (iii) on the first business day after it is otherwise
actually delivered to the addressee by courier; or (iv) on the first business
day after the day it is duly sent by both confirmed facsimile transmission and
one of the forms provided in (i), (ii) or (iii) above, with the cost of
transmission prepaid.
9
13(b) The addresses and facsimile telephone numbers of the parties and
those persons receiving copies are as follows:
To Lessor: Univec, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxxx Xxxx, Xxx Xxxx 00000
Attention: Xxxx Xxxxxxxxxx
Facsimile No.: 000-000-0000
Telephone No.: 000-000-0000
Copy to: Sazer, Xxxxxxx & Xxxxxx LLP
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Attention: Xxxx Xxxxx, Esq.
Facsimile No.: 000-000-0000
Telephone No.: 000-000-0000
To Lessee: Xxxxxxxx-Xxxxx & Xxxx
0000 Xxxxx Xxxxxx
Xx. Xxxxx, Xxxxxxxx 00000-0000
Attention: Vice President -- OEM Sales
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
Copy to: Xxxxxxxx-Xxxxx & Xxxx
0000 Xxxxx Xxxxxx
Xx. Xxxxx, Xxxxxxxx 00000-0000
Attention: Corporate Counsel
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
13(c) All payments to be made hereunder shall be sent to Univec, Inc. at
000 Xxxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxx Xxxx 00000, Attention: President.
SECTION 14. APPLICABLE LAW; JURISDICTION
The parties hereto agree that this Agreement shall be considered to have
been made in, and shall be construed and interpreted in accordance with the law
of, the State of New York, without regard to any principles of conflicts of
laws. The parties further agree that the courts of the State of New York shall
have exclusive jurisdiction over any dispute arising hereunder.
10
SECTION 15. TECHNICAL AND OTHER INFORMATION; CONFIDENTIALITY
15(a) To the best of Licensor's knowledge, any Licensed Know-how disclosed
under this Agreement is correct. However, nothing herein shall be construed to
indicate that Licensor in any manner guarantees the correctness of the Licensed
Know-how, or that Licensor assumes any liability whatsoever for any products or
parts thereof manufactured and sold by Sherwood in accordance with said Licensed
Know-how, or as a result of the use thereof. Sherwood shall assume all such
liabilities and hold Licensor harmless from any liability resulting from the
manufacture, use and sale of the Licensed Products under this Agreement, except
as herein provided.
15(b) Subject to the provisions of this Agreement, until the end of five
years after the expiration of the last-to-expire of the Licensed Patent Rights
in the Licensed Territory, Sherwood shall respect and ensure respect for the
strict confidentiality of all aspects of the information, data, studies,
processes and secrets pertaining to the Licensed Know-how and shall not disclose
nor allow the same to be disclosed to any other person without the prior written
consent of Licensor. In furtherance hereof, Sherwood hereby covenants and agrees
that it shall:
(1) not disclose any Licensed Know-how or permit access to any
Licensed Know-how by any person except as reasonably required to fulfill
its obligations under this Agreement; and
(2) take all reasonable measures deemed necessary or expedient to
ensure respect for the confidentiality and continued protection of the
Licensed Know-how and to prevent unauthorized access to the Licensed
Know-how or possession, reproduction, modification, use or distribution
thereof, and in particular to take appropriate measures, by agreement or
otherwise, to ensure that its employees and former employees are prevented
from doing anything that Sherwood is prohibited from doing pursuant to this
Agreement.
15(c) The obligations of Sherwood under this Section 15 shall not apply to
any Licensed Know-how that:
(1) is now, or comes to be publicly known through no breach of this
Agreement by Sherwood; or
(2) can be established by documentary evidence that prior to
disclosure by Licensor, was in Sherwood's possession without restriction on
disclosure imposed by any third party (and not in violation of any
obligation by such third party directly or indirectly to Licensor to keep
such information confidential); or
(3) is disclosed to Sherwood on a non-confidential basis by a third
party having no obligation of confidentiality, directly or indirectly, to
Licensor in regard thereto.
11
15(d) Sherwood shall use its reasonable business efforts to assure that all
information relating to Sherwood Developments disclosed to Licensor pursuant to
this Agreement shall be correct. However, nothing herein shall be construed to
indicate that Sherwood in any manner guarantees the correctness of the Sherwood
Developments, or that Sherwood assumes any liability whatsoever for any products
or parts thereof manufactured and sold by Licensor in accordance with said
Sherwood Developments, or as a result of the use thereof. Licensor shall assume
all such liabilities and hold Sherwood harmless from any liability resulting
from the manufacture, use and sale of the Sherwood Developments under this
Agreement, except as herein provided.
15(e) Subject to the provisions of this Agreement, until the end of five
years after the expiration of the last-to-expire of the Licensed Patent Rights
in the Licensed Territory, Licensor shall respect and ensure respect for the
strict confidentiality of all aspects of the information, data, studies,
processes and secrets pertaining to the Sherwood Developments and shall not
disclose nor allow the same to be disclosed to any other person without the
prior written consent of Sherwood. In furtherance hereof, Licensor hereby
covenants and agrees that it shall:
(1) not disclose any Sherwood Developments or permit access to any
Sherwood Developments by any person except as reasonably required to
fulfill its obligations under this Agreement; and
(2) take all reasonable measures deemed necessary or expedient to
ensure respect for the confidentiality and continued protection of the
Sherwood Developments and to prevent unauthorized access to the Sherwood
Developments or possession, reproduction, modification, use or distribution
thereof, and in particular to take appropriate measures, by agreement or
otherwise, to ensure that its employees and former employees are prevented
from doing anything that Licensor is prohibited from doing pursuant to this
Agreement.
15(f) The obligations of Licensor under this Section 15 shall not apply to
any Sherwood Developments that:
(1) is now, or comes to be publicly known through no breach of this
Agreement by Licensor; or
(2) can be established by documentary evidence that prior to
disclosure by Sherwood, was in Licensor's possession without restriction on
disclosure imposed by any third party (and not in violation of any
obligation by such third party directly or indirectly to Sherwood to keep
such information confidential); or
(3) is disclosed to Licensor on a non-confidential basis by a third
party having no obligation of confidentiality, directly or indirectly, to
Sherwood in regard thereto.
12
SECTION 16. MISCELLANEOUS
16(a) Upon the termination of this Agreement, Sherwood and any Related
Companies shall have the right to dispose of all Licensed Products then on hand,
including work in process, and to meet all pending orders for Licensed Products.
All earned royalties which would otherwise be payable pursuant to Paragraph 5(a)
of this Agreement, had such termination not become effective, shall be paid with
respect to all such Licensed Products when sold as though this Agreement had not
been terminated.
16(b) Neither termination nor expiration of this Agreement shall terminate
Sherwood's obligation to pay all earned royalties which shall accrue through the
date of such expiration or termination. Sherwood's obligation to report royalty
due and to submit its books and records for inspection as provided in Paragraph
6(a) hereof shall continue until Sherwood's royalty obligations shall have been
fully determined and discharged by proper payment.
16(c) This Agreement contains all of the agreements and understandings made
between the parties hereto concerning Licensed Products in the Licensed
Territory, and any prior agreements, express or implied, relating to the subject
matter hereof are expressly superseded and canceled. No amendment of this
Agreement shall be effective unless in writing and signed by the parties hereto.
16(d) This Agreement may be executed in one or more counterparts which
taken together shall constitute one and the same agreement.
13
IN WITNESS WHEREOF, the parties have executed this Agreement effective on
the day and year first above written.
SHERWOOD MEDICAL COMPANY,
doing business as XXXXXXXX-XXXXX & XXXX
By: ATTEST:
____________________________ __________________________
____________________________ By: _____________________________
(Type or Print Name)
Title: ____________________________
Date:
____________________________
UNIVEC, INC.
By: ATTEST:
____________________________ __________________________
____________________________ By: _____________________________
(Type or Print Name)
Title: ____________________________
Date:
____________________________
14
