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EXHIBIT 10.42
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
SUPPLY AGREEMENT
THIS AGREEMENT is made as of January 1, 2001 (the "Effective
Date") by and between Meridian Medical Technologies, Inc. ("Meridian"),
a Delaware corporation, having its principal place of business at 00000
Xxx Xxxxxxxx Xxxx, Xxxxxxxx, Xxxxxxxx 00000, and Xxx, X. X. ("Xxx"), a
Delaware limited partnership, having its principal place of business at
0000 Xxxx Xxxxxx Xxxxxxxxx Xxxxx, Xxxx, Xxxxxxxxxx 00000, the sole
general partner of which is Xxx, Inc., a Delaware corporation having its
principal place of business at 0000 Xxxx Xxxxxx Xxxxxxxxx Xxxxx, Xxxx,
Xxxxxxxxxx 00000.
W I T N E S S E T H
WHEREAS, EM Industries, Incorporated ("EMI"), an Affiliate (as
hereinafter defined) of Xxx, was the exclusive distributor of EpiPen(R)
and related products worldwide pursuant to certain distribution
agreements including an Agreement with Meridian, dated October 21, 1996;
WHEREAS, EMI appointed Xxx to act as its exclusive
sub-distributor of EpiPen(R) and related products worldwide pursuant to
a Master Agreement with Xxx, dated May 26, 1998, effective as of July 1,
1997;
WHEREAS, Xxx now desires to modify its status as an exclusive
sub-distributor under EMI and become the exclusive distributor in the
Territory (as hereinafter defined) of the Products (as hereinafter
defined) and of New Injection Technology (as hereinafter defined) should
such be developed and to the extent provided in Section 1e hereof;
WHEREAS, EMI has agreed to terminate its distributorship
arrangement with Meridian as of January 1, 2001 and sub-distributorship
arrangement with Xxx as of January 1, 2001; and
WHEREAS, EMI and Merck KGaA, an Affiliate of Xxx, have licensed
to Xxx the exclusive rights to use the trademark EpiPen(R) and related
trademarks in the Territory.
NOW, THEREFORE, in consideration of the premises, mutual
covenants, promises and agreements set forth herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby covenant, promise and agree as follows:
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CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
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DEFINITIONS
As used in this Agreement, the following terms, when
capitalized, shall have the meanings set forth below:
(a) "Act" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
Sections 301 et seq. (1998), as such may be amended from time to
time.
(b) "Active Ingredient" means Epinephrine, USP.
(c) "Affiliate" means, with respect to any Party, any corporation or
other entity which controls, is controlled by or is under the
common control with such Party. For purposes of this definition,
"control" shall mean direct or indirect ownership of more than
fifty percent (50%) of the voting interest or income interest in
a corporation or entity or such other relationship as, in fact,
constitutes actual control.
(d) "Annual Minimum" means the number of Regular Products Xxx is
required to order for delivery during a calendar year pursuant
to Section 2b.
(e) "Annual Minimum Capacity" means the multiplicative product of
the Annual Minimum for the current calendar year for the
applicable Product and "...".
(f) "Batch" or "Lot" means, with respect to a Product, each separate
and distinct quantity of such Product processed under continuous
and identical conditions and designated by a batch or lot number
and an expiration date by Meridian, and as defined in the
Current Good Manufacturing Practices.
(g) "Batch Record" means all manufacturing documentation collected
with respect to a Batch as agreed by the Parties pursuant to
Section 6b.
(h) "Certificate of Analysis" means a document(s) signed and dated
by a duly-authorized representative of the Quality Control
("QC") or Quality Assurance ("QA") Department of Meridian in
accordance with Sections 6a and 6b.
(i) "Competitive Product" shall have the meaning set forth in
Section 1d of this Agreement.
(j) "Confidential Information" means any proprietary or confidential
information of a Party, including any and all know-how, trade
secrets, pending patent applications, information, data,
results, procedures, methodology, technical and scientific
expertise which relate to the Products; business, financial,
marketing, manufacturing, sales, distribution and supply
information; information related to a Party's internal
organization, personnel, methods and procedures, facilities,
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
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capabilities, research, development, planning or products; and
any other information which would reasonably be considered to be
confidential.
(k) "Contact Person" shall have the meaning set forth in Section 14a
of this Agreement.
(l) "Current Good Manufacturing Practices" or "cGMPs" means the
requirements of the F.D.A. with regard to the manufacture of
finished pharmaceuticals as set forth in 21 C.F.R. Section 211,
as such may be amended from time to time.
(m) "Xxx Marks" means the Marks owned or licensed by Xxx specified
in Exhibit H, which is attached hereto and incorporated herein
by reference, and such other Marks as Xxx may from time to time
designate in writing at its sole discretion.
(n) "Effective Date" means the date that the Agreement shall
commence, as defined in the first paragraph of this Agreement.
(o) "F.D.A." means the United States Food and Drug Administration.
(p) "Losses" means any and all liabilities, damages, losses, costs
or expenses (including reasonable attorneys' fees and
disbursements) subject to indemnification under Section 9
hereof.
(q) "Xxxx" or "Marks" means a trade name, trademark, trade dress or
service xxxx.
(r) "Meridian Marks" means the Marks owned or licensed by Meridian
specified in Exhibit G, which is attached hereto and
incorporated herein by reference, and such other Marks as
Meridian may from time to time designate in writing at its sole
discretion.
(s) "NDA" means the New Drug Application, and all supplements and
amendments thereto, for any of the Products which have been
submitted to the F.D.A. by Meridian or its predecessor and any
equivalent filing in the Territory with an appropriate
regulatory authority.
(t) "New Injection Technology" means "...".
(u) "Non-Conforming Products" means Products that do not conform to
the requirements set forth under Section 3a(i) hereof.
(v) "Party" or "Parties" means Meridian and/or Xxx, as the case may
be.
(w) "Product" or "Products," as the case may be, means any type of
Epinephrine injection product manufactured by Meridian as of the
Effective Date, including, but not limited to, those products
set forth in Exhibit A, and such other Products
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has filed separately with the Securities and
Exchange Commission]
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as the Parties shall from time to time mutually agree to and
designate in writing; for purposes of this Agreement, any
Product or Products shall be deemed to include any modification
or improvement made upon such Product or Products during the
Term, including those modifications or improvements subject to
Section 11a hereof.
(x) "Prospective Country" shall have the meaning set forth in
Section 1b of this Agreement.
(y) "Purchase Order" means the order instructions made by Xxx in
writing for the Products in accordance with Section 4 of this
Agreement.
(z) "Regular Products" means the Products sold by Xxx (or its
sub-distributors) under the trademarks EpiPen(R) Sr. and
EpiPen(R) Jr. and any variations of the foregoing trademarks.
(aa) "Rolling Forecast" shall have the meaning set forth in Section
4c of this Agreement.
(bb) "Specifications" means any and all chemical, biological,
physical and descriptive criteria of the Products set forth in
(i) the NDA for the Products and (ii) Exhibit C; provided,
however, that Meridian shall notify Xxx of any proposed
additions or modifications to the criteria set forth in Exhibit
C and, upon Dey's written consent, the criteria constituting the
Specifications shall be supplemented and/or replaced by such
additions or modifications and such additions or modifications
shall be attached hereto as part of Exhibit C.
(cc) "Term" shall have the meaning set forth in Section 12 of this
Agreement.
(dd) "Territory" means the United States, Canada and worldwide.
(ee) "Third Party" means any person or entity other than the Parties
to this Agreement or any Affiliate of the Parties.
(ff) "United States" means the United States of America, its
possessions and territories.
(gg) Unless specified to the contrary, references to Sections and/or
Exhibits mean the particular Sections and/or Exhibits to this
Agreement. Wherever used in this Agreement:
(1) the words "include" or "including" shall be
construed as incorporating, also, "but not
limited to" or "without limitation";
(2) the word "day" means a calendar day unless
otherwise specified;
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Exchange Commission]
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(3) the word "law" (or "laws") means any applicable,
legally binding statute, ordinance, resolution,
regulation, code, guideline, rule, order,
decree, judgment, injunction, mandate or other
legally binding requirement of a government
entity; and
(4) the word "notice" shall mean notice in writing
(whether or not specifically stated) and shall
include notices, consents, approvals and other
written communications contemplated under this
Agreement.
SECTIONS
1. GRANT OF RIGHTS
a. EXCLUSIVE RIGHT AND SUB-DISTRIBUTORS. Meridian hereby grants to
Xxx the exclusive right and license to market, distribute and
sell the Products in the Territory. Xxx shall have the sole and
exclusive right to grant sublicenses to any sub-distributor with
respect to any of the rights granted to Xxx under this
Agreement; provided that any such sublicense shall not vary the
rights and obligations of the Parties under this Agreement
except as the Parties may otherwise agree.
b. NEW MARKETS. In the event that during the Term, Xxx desires to
market, sell or distribute the Products in any country in the
Territory in which the Products have not been licensed or
approved by the relevant governmental authorities for marketing,
distribution or sale prior to the Effective Date (a "Prospective
Country"), Xxx may do so pursuant to the following procedure:
(i) Xxx shall identify the Prospective Country to Meridian and
shall advise Meridian of the actions, if any, that will be
required of Meridian to comply with its obligations under this
Agreement with respect to the Prospective Country, (ii) Meridian
shall advise Xxx of the incremental costs, if any, expected to
be incurred by Meridian in manufacturing and preparing Products
for sale in the Prospective Country, including without
limitation capital improvements and the modification of the
design of Products, and (iii) if Xxx wishes to proceed to
market, sell or distribute the Products in the Prospective
Country, it shall agree to absorb the incremental costs so
identified by Meridian in a manner mutually agreeable to Xxx and
Meridian, and Xxx shall obtain, at its sole expense (or at the
expense of its sub-distributors), all applicable governmental
licenses and approvals required to qualify the Products for
marketing, sale or distribution in such Prospective Country.
Meridian hereby agrees to cooperate with Xxx, at Xxx'x request
and expense, in connection with the procurement by Xxx of any
such applicable governmental licenses and approvals.
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CONFIDENTIAL TREATMENT REQUESTED
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Exchange Commission]
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c. PROVISION OF REGULATORY INFORMATION. Upon Meridian's request,
Xxx shall provide Meridian with copies of any licenses,
approvals or other documents reasonably necessary for Meridian's
performance of its obligations under the Agreement. Meridian
hereby agrees to provide Xxx reasonable access to documents and
data that are needed by Xxx in connection with the pursuit of
any licenses or approvals in the Territory at no additional cost
to Xxx; provided that Meridian shall not be obligated to perform
additional studies or testing (including clinical trials) that
it otherwise would not have created or performed under the
Agreement.
d. "...".
e. "...".
f. "...".
2. SUPPLY
a. REQUIREMENTS. Xxx agrees to purchase from Meridian and Meridian
agrees to supply to Xxx all of Dey's requirements for the
Products during the Term in the Territory.
b. ANNUAL MINIMUM. Xxx agrees to order for delivery not less than
"..." units of Regular Products for each calendar year during
the Term; provided, however, that the Annual Minimum shall be
"..." units in the event that a branded (i.e., not deemed
bioequivalent to a Regular Product under applicable F.D.A.
regulations) auto injector that constitutes a Competitive
Product is approved by the F.D.A. and/or approved by any
appropriate regulatory authority in the Territory and offered
for sale by a party other than Xxx or an Affiliate of Xxx; and
provided, further, that the Annual Minimum shall be "..." units
in the event a generic (i.e., deemed bioequivalent to a Regular
Product under applicable F.D.A. regulations) auto injector that
constitutes a Competitive Product is approved by the F.D.A.
and/or approved by any appropriate regulatory authority in the
Territory and offered for sale by a party other than Xxx or an
Affiliate of Xxx.
c. TERMINATION OF EXCLUSIVE RIGHT. "..."
d. DISTRIBUTION FOLLOWING TERMINATION OF EXCLUSIVE RIGHT. "..."
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CONFIDENTIAL TREATMENT REQUESTED
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to Confidential Treatment Request, which the Company
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Exchange Commission]
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3. MANUFACTURE AND PRODUCTS SPECIFICATIONS
a. MANUFACTURE AND PRODUCT PACKAGING. Meridian shall design,
formulate, manufacture, fill, test, package, label, store and
ship all quantities of the Products in accordance with:
(i) the Specifications for the Products;
(ii) the applicable standard operating procedures of
Meridian, as they may be updated from time to
time by Meridian and, to the extent such updates
are required by any applicable regulatory
authority in the Territory, notified to Xxx;
(iii) Meridian's prevailing manufacturing and quality
assurance procedures;
(iv) the cGMPs and any other applicable United States
laws; and
(v) any applicable foreign country or international
laws of which Meridian has been notified,
subject in each case to such deviations, exceptions,
variations and omissions as are permitted under the
relevant Specifications, standard operating procedures,
prevailing manufacturing and quality assurance
procedures, cGMPs and applicable laws.
b. PROCESS VALIDATIONS. Meridian shall perform process validations
of the manufacturing processes in accordance with the
Specifications and all applicable laws in the Territory and
shall make records of such validations. All costs and expenses
necessary for such process validations which are required by the
cGMPs shall be paid by Meridian. All costs and expenses
necessary for such process validations which are not required by
the cGMPs, but are requested by Xxx or required by any country
in the Territory other than the United States in which Xxx (or a
sub-distributor) is marketing, distributing or selling the
Products or proposes to market, distribute or sell the Products,
shall be paid by Xxx. Meridian shall make such validation
records available to Xxx for review at Meridian's manufacturing
facility in accordance with Section 15a.
c. ARTWORK. Meridian shall be responsible for all costs related to
any and all labeling artwork, printing plates and dies to be
used in the production of labeling and packaging materials
(including translations) for the Products necessary or
appropriate to comply with all applicable laws in the Territory;
except that Xxx shall be responsible for the incremental, direct
costs of any labeling artwork, printing plates and dies to be
used in the production of labeling and packaging
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Exchange Commission]
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materials for any Products to be manufactured by Meridian which
are (i) necessary to comply with the laws of any country in the
Territory other than the United States or (ii) required as a
result of changes in labeling or packaging requested by Xxx (or
any of its sub-distributors).
d. LABELING. Meridian shall label all units of Products. Meridian
shall apply to each unit of Product a unique, identifying Lot
number, which shall not be used on any other Meridian products,
and an expiration date in accordance with the Specifications.
e. TESTING. Meridian shall, at its sole expense, be responsible for
the performance of all testing of the Products, including any
clinical trials, required by the cGMPs or any other applicable
United States law. In the event that any regulatory authority in
any of the countries in the Territory other than the United
States requires clinical trials or any testing of the Products
other than those required by the cGMPs or other applicable
United States law, Xxx shall bear the responsibility for the
performance of such clinical trials or tests at its sole
expense.
f. STABILITY. Meridian shall be responsible for the compatibility
of the formulation of the Active Ingredient with
Meridian-specified containers for the Products, including the
performance of stability studies to validate expiry dating in
accordance with the NDA, the Specifications and, subject to
Dey's obligations pursuant to Section 1b, any applicable law in
the Territory of which Meridian has been notified.
g. WASTE PRODUCT. Meridian hereby agrees that it will own all waste
product generated by Meridian in connection with the
formulation, manufacture, filling, packaging, labeling, testing
and storage of the Products and be responsible for the removal,
packaging, storage, receipt, transportation, handling and
disposal of any such waste product in accordance with all
applicable United States laws, foreign country or international
laws, including the Resource Conservation and Recovery Act, 42
U.S.C. Sections 6901 et. seq. ("RCRA"). Meridian hereby agrees
that it will also be responsible for the removal, packaging,
storage, receipt, transportation, handling and disposal of any
Non-Conforming Products in accordance with all applicable United
States laws, foreign country or international laws, including
RCRA.
h. CHANGES TO MANUFACTURING METHODS. Meridian shall provide Xxx
with reasonable advance notice in writing of any proposed
changes required to be reported to the F.D.A. or other
applicable government authorities in the Territory to the method
or procedures related to the manufacture or testing of the
Products or to the facilities associated with such manufacture
or testing.
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i. USE OF MARKS. Xxx hereby grants to Meridian during the Term a
nonexclusive and royalty-free license or sub-license in the
Territory to use the Xxx Marks solely in connection with the
Products for the limited purpose of packaging and labeling the
Products to fulfill a Purchase Order. Meridian hereby grants to
Xxx during the Term and for the applicable time period set forth
under Section 13c hereof a nonexclusive and royalty-free license
or sub-license in the Territory to use the Meridian Marks solely
in connection with the marketing, distribution and sale of the
Products. Neither Party shall create a unitary composite Xxxx
involving a Xxxx of the other Party without the prior written
approval of the other Party. Each Party shall display symbols
and notices clearly and sufficiently indicating the trademark
status and ownership of the Marks in accordance with applicable
trademark law and practice. Each Party acknowledges and agrees
that (i) the Marks of the other Party are and shall remain the
sole property of the other Party; (ii) it shall not now or in
the future contest the validity of the other Party's Marks; and
(iii) its utilization of the other Party's Marks will not create
in it, nor will it represent it has, any right, title or
interest in or to such Marks other than the licenses expressly
granted herein. Each Party agrees that its use of the other
Party's Marks shall conform to reasonable and customary quality
standards communicated in writing by the other Party and agrees
to supply to the other Party, upon request, a reasonable number
of samples or forms of any materials publicly disseminated by
the Party which utilize the other Party's Marks.
4. ORDERS AND FORECASTS
a. PURCHASE ORDERS. Orders shall be initiated by Xxx through the
submission to Meridian of Purchase Orders substantially in the
form of Exhibit F hereto specifying the Products to be supplied,
quantities of such Products, delivery dates and shipping
instructions. A Purchase Order shall be received by Meridian at
least "..." days prior to the earliest delivery date for a
shipment specified in such Purchase Order. Except as Meridian
may otherwise consent, Xxx shall place its orders in full batch
quantities of "..." units for EpiPen(R)Sr. and EpiPen(R) Jr. and
of "..." units for EpiPen(R)Trainer. For all other Products, the
Parties shall agree in good faith in writing to the number of
units that will constitute such a full batch quantity. A full
batch of units may be split up into not more than three parts to
satisfy the requirements of more than one jurisdiction in the
Territory without penalty to Xxx. All orders placed by Xxx shall
be subject to the terms and conditions of such Purchase Order
except that the paragraph captioned "Conditions" and the terms
and conditions referred to therein shall not apply; provided
that in the event of any inconsistency between the terms and
conditions of any Purchase Order and the provisions of this
Agreement, the provisions of this Agreement shall prevail in
accordance with Section 22.
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b. QUANTITY FULFILLMENT. Meridian shall deliver between ninety
percent (90%) and one hundred and ten percent (110%) of the
quantities of the Products requested by Xxx in each Purchase
Order that is consistent with the terms and conditions of this
Agreement. Shipment shall be directed to Xxx in Lot quantities
to such locations in the United States designated by Xxx in the
Purchase Order. All deliveries of Products hereunder shall be
F.O.B. Meridian's facility at 0000 Xxxxxxxx Xxxxx, Xx. Xxxxx, XX
00000, freight collect, utilizing the carrier designated by Xxx,
or shipped from any other location, provided that Xxx will have
no obligation to pay any freight charges in excess of the amount
Xxx would have paid had the Products been shipped from St.
Louis, MO. Delivery shall hereby be deemed to occur, and all
risk of loss shall pass to Xxx, upon Meridian's delivery of the
Products to Dey's designated carrier.
c. ROLLING FORECASTS. On a monthly basis not later than the fifth
(5th) calendar day of each month, Xxx shall provide Meridian
with non-binding forecasts for its anticipated purchase
requirements of the Products for the subsequent twelve (12)
month period beginning on the first (1st) day of the following
month (the "Rolling Forecast"). Meridian shall use commercially
reasonable efforts to supply any quantity of Product ordered by
Xxx in excess of the quantity set forth in the most recent
Rolling Forecast for such period of time as covered by the
Purchase Order.
d. ANNUAL MINIMUM CAPACITY. For each calendar year, Meridian shall
provide capacity to produce the Annual Minimum Capacity ratably
throughout the year.
e. CHANGES. If Xxx requests any changes to a Purchase Order, such
proposed changes shall be of no effect until Meridian confirms
in writing that it accepts such changes. Meridian shall approve
or disapprove any such changes within ten (10) calendar days of
receipt of such changes to a Purchase Order. Upon the approval
of changes, the Purchase Order as changed shall be deemed the
Purchase Order.
f. PRODUCTION DIFFICULTIES. With respect to all Purchase Orders for
Products not in excess of the Annual Minimum Capacity for the
then-current calendar year and consistent with the Rolling
Forecast, Meridian shall produce and ship all Products pursuant
to Dey's instructions set forth in the applicable Purchase Order
no later than fifteen (15) calendar days after the delivery date
specified on the Purchase Order. Should Meridian experience
production difficulties that may result in significant delay in
the aforesaid lead time, Meridian shall promptly advise Xxx of
the expected delay and shall meet with Xxx in good faith to seek
a solution that will assure Xxx a source of supply of the
Products that is in compliance with Meridian's obligations under
this Agreement.
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g. DELAYS. In the event that on two (2) or more occasions during
any twelve month period Meridian is unable to ship all or part
of any order of Products to Xxx within fifteen (15) calendar
days after the delivery date set forth in a Purchase Order,
Meridian hereby agrees to xxxxx Xxx a discount on the total
purchase price of such second and any subsequent delayed orders
equal to: (i) one percent (1%) for any delivery which occurs
more than fifteen (15), but less than thirty (30) calendar days,
after the requested delivery date or (ii) three percent (3%) for
any delivery that occurs thirty (30) calendar days or more after
the requested delivery date. The foregoing discount shall not
apply to orders for Products in excess of the Annual Minimum
Capacity or the Rolling Forecast, or if Meridian should
encounter production delays which are due to circumstances set
forth in Section 17 hereof; provided that Meridian notifies Xxx
of such delay promptly after the date Meridian becomes aware of
the occurrence giving rise to such delay, but in no event later
than three (3) business days prior to the delivery date set
forth in the Purchase Order.
h. CANCELLATION OF ORDER. Should Meridian be unable to deliver an
order, or any portion of an order, of Products not in excess of
the Annual Minimum and consistent with the Rolling Forecast
within thirty-five (35) calendar days after the delivery date
set forth in a Purchase Order, Xxx may cancel the Purchase Order
or the delayed portion of the Purchase Order, respectively;
provided, however, that Xxx may not do so if the delay is due to
circumstances set forth in Section 17 hereof and Meridian has
notified Xxx of such delay promptly after the date Meridian
becomes aware of the occurrence giving rise to such delay, but
in no event later than three (3) business days prior to the
delivery date set forth in the Purchase Order.
i. RESTRICTIONS ON SHIPMENT. In no event shall Meridian ship to Xxx
any Products with expiration dating three (3) months less than
the maximum approved dating for the Products at the time of
shipment, unless Xxx has agreed otherwise in writing. Meridian
shall use commercially reasonable efforts to supply Products
with maximum expiration dating to Xxx, unless (i) Xxx has agreed
otherwise in writing or (ii) there was a dispute as to whether
the Products were Non-Conforming Products that was decided in
favor of Meridian in accordance with Section 6c.
5. PRICE AND PAYMENT TERMS
a. PURCHASE PRICE. The purchase price for each Product shall be
based on the unit price specified for the Product. The unit
prices for each Product shipped through the last day of the
first calendar year, shall be as set forth in Exhibit D. Pricing
is for finished Products, packaged in accordance with the
packaging specifications
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set forth in Exhibit B. Promptly upon execution of this
Agreement, Xxx shall pay to Meridian "..." in immediately
available funds in settlement of all outstanding pricing
disputes that have arisen through December 31, 2000.
b. ANNUAL PRICE REVISIONS. Effective January 1, 2002, and at the
beginning of each subsequent calendar year, the unit prices may
be subject to revision, any such revision to be equal to the
change in the Urban Consumer Price Index (published by the
Bureau of Labor Statistics, United States Department of Labor)
during the previous calendar year; provided, however, that if
such increase exceeds five percent (5%) for any calendar year
the increase in unit prices shall be five percent (5%) plus
fifty percent (50%) of the increase that is in excess of five
percent (5%). The Parties shall agree in writing within thirty
(30) calendar days after the commencement of each new calendar
year to any annual price revision for the calendar year in the
form of a revised schedule detailing the unit prices for each
Product, such revised schedule to be attached hereto to Exhibit
D. With respect to Products scheduled to be delivered on or
after the first day of a calendar year and before the Parties
reach agreement upon the revised unit prices, a make-up payment
accounting for the difference between the amounts invoiced and
the amounts set forth in the revised Exhibit D shall be paid by
the owing Party within thirty (30) calendar days after the date
the Parties shall have agreed to the revised Exhibit D. If the
Bureau of Labor Statistics publishes a revision to the
previously published Urban Consumer Price Index for a previous
calendar year, the Parties shall promptly agree in writing upon
a revision to the unit prices reflecting the difference between
the original and revised Urban Consumer Price Index and a make
up payment, as applicable, to account for the resulting increase
or decrease to the unit prices for all Products which have been
delivered by Meridian to Xxx. Any amount unpaid following the
later of the date payment for Product otherwise would be due and
the date 30 days after publication of a new or revised Urban
Consumer Price Index shall bear interest at the prime rate
published in The Wall Street Journal from such date to the date
paid.
c. CHANGE IN MARKET CONDITIONS. "..."
d. CALCULATIONS. All calculations required pursuant to Section 5b
shall be performed by Xxx and shall be to the nearest xxxxx.
Meridian shall review such calculations. In the absence of
manifest error, such calculations shall be conclusive and
binding for all purposes of the Agreement.
e. INVOICES. Upon delivery of any Products to Xxx, Meridian shall
invoice Xxx for the purchase price of such Products, using the
unit price applicable as of the date of delivery of the Products
(or the date delivery was due in the case of delivery after the
date set forth in the applicable Purchase Order) and in
accordance with Sections 5a, 5b, 5c and 5d hereof.
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Exchange Commission]
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f. PAYMENT TERMS. Xxx shall pay each invoice within thirty (30)
days of the date of delivery by Meridian pursuant to Section 4b.
Unless otherwise provided for under the Agreement, Meridian
shall make all payments due under the Agreement within thirty
(30) days of the date such payment is requested by Xxx. Any
payments provided for in the Agreement which are not made when
due shall bear interest at a rate of one percent (1%) per month
until paid in full. Xxx shall have the right to set off any
amounts owed by Meridian to Xxx against any payments that Xxx is
obligated to make to Meridian under this Agreement.
g. CURRENCY OF PAYMENT. All payments made under this Agreement
shall be made in United States dollars.
6. MANUFACTURING STANDARDS, QUALITY ASSURANCE AND RECALLS
a. TESTING AND INSPECTION OF PRODUCTS. Prior to shipment of
Products to Xxx, Meridian shall test the Products to be shipped
to Xxx in accordance with the testing procedures described in
the Specifications. Meridian shall provide Xxx with a Batch
Record for each Batch or Lot of Products and a Certificate of
Analysis (each a "COA") certifying that each Batch or Lot was
manufactured and tested in accordance with the Specifications.
The COAs shall specify the number of units shipped from a given
Lot. Within one business day of shipment, Meridian shall fax
copies of the COAs and, within five business days of shipment,
Meridian shall send the originals of the COAs and copies of the
Batch Records by overnight courier to the Director of QA of Xxx.
b. FORM OF CERTIFICATES AND BATCH RECORDS. All COAs and Batch
Records submitted by Meridian to Xxx in accordance with this
Section 6 shall be in a format and of a content as mutually
agreed upon by the QA or QC Departments of Meridian and Xxx.
Each COA and Batch Record document shall be signed and dated by
a duly authorized official of Meridian's QA or QC Department.
c. NON-CONFORMING PRODUCTS. Xxx shall have a period of forty-five
(45) days from the date of receipt of the Products to inspect
any shipment of the Products for non-conformance because (i) the
Products apparently are Non-Conforming Products or (ii) any act
or omission of Meridian known to Xxx has caused the Products to
be Non-Conforming Products. In the event of any such
non-conformance, Xxx shall send a written notice of
non-conformance to Meridian within such forty-five (45) day
period, which notice shall specify the manner in which such
Products are Non-Conforming Products. Meridian shall have a
period of twenty (20) days of the date of receipt of such
written notice to inspect such Products. If Meridian disagrees
that the Products are Non-Conforming Products, Meridian shall
send a written notice to Xxx within such twenty (20) day period,
which notice shall specify the nature of Meridian's disagreement
with Dey's notice of non-
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has filed separately with the Securities and
Exchange Commission]
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conformance, and the Parties shall meet within ten (10) days of
such notice to discuss and attempt in good faith to resolve the
matter. If the Parties are unable to resolve the matter within
fifteen (15) days after their initial meeting, the Parties shall
submit the question of non-conformance to an independent
laboratory and/or consultant mutually agreeable to Meridian and
Xxx for resolution and the resolution by such independent
laboratory or consultant shall be binding on both Parties. If
the independent laboratory or consultant determines that the
Products are Non-Conforming Products, or if Meridian agrees that
the Products are Non-Conforming Products, Meridian shall notify
Xxx whether the Non-Conforming Products should be destroyed or
returned to Meridian, shall reimburse Xxx for any costs
associated with the destruction or return of Non-Conforming
Products in accordance with Section 6e and shall promptly
replace the Non-Conforming Products with conforming Products at
no cost to Xxx unless the Parties agree that Meridian instead
will reimburse Xxx for any amounts paid by Xxx for such
Non-Conforming Products pursuant to Section 5f; provided that
should the Parties agree that Meridian will provide
reimbursement for rather than replace the Non-Conforming
Products, the number of Non-Conforming Products so delivered by
Meridian to Xxx shall count towards Dey's Annual Minimum
requirements set forth under Section 2b hereof. Xxx shall not be
liable to pay any unpaid invoices relating to such
Non-Conforming Products until such Non-Conforming Products have
been replaced. If the independent laboratory or consultant
determines that the Products were not Non-Conforming Products,
Xxx shall accept the Products; provided that the three month
period specified with respect to such Products in Section 4i
shall be shortened by a period of time equal to the period from
the date of shipment to the date of such determination.
Notwithstanding the foregoing, if it is determined at a later
date that the Products do not conform to the requirements set
forth in Section 3a hereof, such Products shall be deemed
Non-Conforming Products.
d. TITLE TO NON-CONFORMING PRODUCTS. With regard to Dey's return of
any Non-Conforming Products, the title shall revert to Meridian
or its designee upon their destruction or delivery by Xxx to a
Meridian-approved carrier for return shipment.
e. COSTS RELATED TO NON-CONFORMING AND CONFORMING PRODUCTS. Within
thirty (30) days after an independent laboratory or consultant
determines that Products are Non-Conforming Products pursuant to
Section 6c or if Meridian agrees that a shipment of Products are
Non-Conforming Products after contending that such Products were
not Non-Conforming Products, Meridian shall issue a credit memo
to or reimburse to Xxx, at Dey's sole discretion, an amount
equal to the sum of (i) freight charges payable by Xxx for the
shipment of the Non-Conforming Products; (ii) any amounts
payable by Xxx for testing by an independent laboratory and/or
consulting services as to such Non-Conforming Products; (iii)
any amounts incurred by Xxx for the destruction of the
Non-Conforming
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Exchange Commission]
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Products; and (iv) any applicable transit insurance premium,
taxes, duties or other similar costs directly related to the
Non-Conforming Products; provided, however, that Meridian shall
not be responsible for any overhead costs that would have been
incurred by Xxx had Xxx not contended that the Products were
Non-Conforming Products. In lieu of making any payment to Xxx
for Non-Conforming Products pursuant to this Section 6e,
Meridian instead may provide Xxx with Products having value
based on the originally invoiced unit prices equal to the amount
of such payment at no additional cost to Xxx. The number of
Non-Conforming Products so delivered by Meridian to Xxx shall
count towards Dey's Annual Minimum requirements set forth under
Section 2b hereof. Within thirty (30) days after an independent
laboratory or consultant determines that Products are not
Non-Conforming Products pursuant to Section 6c or if Xxx agrees
that a shipment of Products are not Non-Conforming Products
after contending that such Products are Non-Conforming Products,
Xxx shall reimburse Meridian for the amounts paid by Meridian
for testing by an independent laboratory and/or consulting
services pursuant to Section 6c.
f. RECALL BY MERIDIAN. In the event Meridian shall initiate a
recall, Product withdrawal or field correction of any Product,
whether or not such recall has been requested or ordered by the
F.D.A. or any other applicable regulatory authority in the
Territory, Meridian shall notify Dey's Director of QA.
g. RECALL BY XXX. In the event Xxx believes that a recall, Product
withdrawal or field correction of any Products may be necessary
and/or appropriate, Xxx shall immediately notify Meridian and
the Parties shall cooperate with each other in determining in
good faith the necessity and nature of any action to be taken.
h. RECALL PROCEDURES. Meridian shall make all contacts with the
F.D.A. or any other applicable regulatory authority in the
United States and shall be responsible for all necessary
activities, other than activities relating to contacting Dey's
customers or other purchasers or users of the Products, in
connection with a recall, Product withdrawal or field correction
in the United States. Xxx will fully cooperate in providing to
Meridian all information reasonably requested by Meridian that
is materially relevant to any submission Meridian may make to
the F.D.A. or any other applicable regulatory authority in the
United States in connection with such recall, Product withdrawal
or field correction. With respect to any recall, Product
withdrawal or field correction outside the United States, the
Parties shall mutually agree upon their respective
responsibilities and the responsibilities of Dey's
sub-distributors and other Third Parties; provided, however,
that Xxx shall be responsible for coordinating all of the
necessary activities relating to contacting Dey's customers or
other purchasers or users of the Products in connection with any
recall, Product withdrawal or field correction in any
jurisdiction in the Territory. Meridian shall fully cooperate
with Xxx and
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Exchange Commission]
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shall provide to Xxx all information reasonably requested by Xxx
that is materially relevant to the conduct of such activities.
Meridian shall reimburse Xxx for all direct costs reasonably
incurred by Xxx in the performance of its obligations under this
Section 6h hereof, and Xxx shall provide to Meridian a statement
of such costs; provided, however, that (i) Meridian shall not be
responsible for any overhead costs that would have been incurred
by Xxx in the absence of a recall, (ii) such reimbursement shall
not preclude Meridian from disputing any such costs and (iii)
such costs may be charged to Meridian by debit memo or
otherwise, but Meridian may satisfy its reimbursement
obligations to Xxx by providing Product ordered by Xxx at the
price as set forth in Exhibit D as then in effect.
i. COSTS OF RECALLS. Meridian shall reimburse Xxx for all direct
costs, including Third Party costs, reasonably incurred by Xxx
in connection with any recall, Product withdrawal or field
correction that is initiated as a result of the formulation,
manufacture, filling, packaging, testing, labeling, or storage
of the Products by Meridian prior to the delivery by Meridian of
the Products to Dey's carrier. Xxx shall reimburse Meridian for
all direct costs, including Third Party costs, reasonably
incurred by Meridian in connection with any recall, Product
withdrawal or field correction that is initiated as a result of
the actions or omissions of Xxx or its subdistributors,
sublicensees or common carriers.
j. COSTS ASSOCIATED WITH CERTAIN RECALLS. "..."
k. CERTAIN LEGACY PRODUCTS. Solely with respect to Sections 6 and
9, the Products shall be deemed to include the Epi E-Z Pen and
Epi E-Z Pen Jr. products previously manufactured by Meridian and
marketed, distributed and sold by Xxx or its sub-distributors or
their respective predecessors.
7. ADVERSE REPORTS
Each Party shall promptly notify the other, in writing, of any adverse
reports, reactions, claims, actions, suits, investigations,
arbitrations, other legal proceedings or Third Party complaints which
(i) concern the marketability, safety or effectiveness of the Products;
(ii) might result in potential liability for either Party; or (iii)
might necessitate action on behalf of either Party or the provision of
any information relating to the failure of the Products to meet the
Specifications or other requirements of Section 3a, including Meridian's
standard operating procedures. The Parties shall cooperate with each
other to determine in good faith the proper actions to take with respect
to any such notice.
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has filed separately with the Securities and
Exchange Commission]
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8. REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS
a. MERIDIAN'S REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS.
Meridian makes the following representations, warranties and
covenants:
(i) it is authorized to enter into this Agreement and this
Agreement constitutes the legal, valid and binding
obligation of Meridian enforceable in accordance with
its terms;
(ii) it is aware of no legal or other restriction, limitation
or condition which might materially and adversely affect
its ability to perform hereunder;
(iii) it is in good standing under the laws of the state in
which it is incorporated, with full corporate power and
authority to carry on its business as now conducted, and
is duly authorized to do business in any state of the
United States or foreign jurisdictions where its
ownership or leasing of property or the conduct of its
business requires such qualification and where the
failure to so qualify would have a material adverse
effect on its assets, properties, financial condition,
results of operations or business;
(iv) the Products supplied to Xxx hereunder will be
manufactured, packaged, stored and tested in accordance
with the requirements of Section 3a;
(v) the Products manufactured and shipped to Xxx hereunder
will not be adulterated or misbranded within the meaning
of the Act and will not be articles which may not be
introduced into interstate commerce under the provisions
of the Act;
(vi) the information it provides to any regulatory authority
pursuant to its obligations under this Agreement will be
true and correct in all material respects and will
comply in all material respects with applicable laws and
regulations in the United States and applicable laws and
regulations elsewhere in the Territory of which it is
notified;
(vii) good title to all Products sold and delivered to Xxx
under this Agreement shall pass to Xxx, free from any
security interest or other lien or encumbrance created
by Meridian;
(viii) the execution, delivery and performance of this
Agreement by Meridian will not, with or without notice,
the passage of time or both, result in any violation of,
be in conflict with or constitute a default under any
material contract, obligation or commitment to which
Meridian is a party or by which it is bound; and
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Exchange Commission]
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(ix) as of the Effective Date of this Agreement, to the
knowledge of Meridian, there are no adverse actions,
suits or claims pending or threatened against Meridian
or any of its Affiliates in any court or before any
governmental body or agency in the Territory with
respect to the Products other than those set forth in
Exhibit X.
x. XXX'X REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS. Xxx
makes the following representations, warranties and covenants:
(i) it is authorized to enter into this Agreement and this
Agreement constitutes the legal, valid and binding
obligation of Xxx enforceable in accordance with its
terms;
(ii) it is aware of no legal or other restriction, limitation
or condition which might materially and adversely affect
its ability to perform hereunder;
(iii) it has full partnership power and authority to carry on
its business as now conducted and is duly authorized to
do business in any state of the United States or foreign
jurisdictions where its ownership or leasing of property
or the conduct of its business requires such
qualification and where the failure to so qualify would
have a material adverse effect on its assets,
properties, financial condition, results of operations
or business;
(iv) it shall, in performing its obligations hereunder,
comply in all material respects with the requirements of
the NDA and with all applicable United States and
foreign laws;
(v) the Products supplied to Xxx hereunder will be stored in
accordance with Dey's standard operating and quality
assurance procedures and industry standards;
(vi) the execution, delivery and performance of this
Agreement by Xxx will not, with or without notice, the
passage of time or both, result in any violation of, be
in conflict with or constitute a default under any
material contract, obligation or commitment to which Xxx
is a party or by which it is bound;
(vii) it shall not market or otherwise promote, and it shall
instruct its sub-distributors not to market or otherwise
promote, the Product for any use not specified on the
Product's label or otherwise permitted under applicable
law;
(viii) it shall provide Meridian with a copy of any promotional
materials it distributes with, or in connection with,
the Products to the extent
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Exchange Commission]
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reasonably necessary to allow Meridian to comply with
filing and other requirements under the NDA and
applicable law; and
(ix) as of the Effective Date of this Agreement, to the
knowledge of Xxx, there are no adverse actions, suits or
claims pending or threatened against Xxx or any of its
Affiliates in any court or before any governmental body
or agency in the Territory with respect to the Products
other than those set forth in Exhibit E.
c. WARRANTY DISCLAIMER
THE FOREGOING WARRANTIES ARE IN LIEU OF ANY OTHER EXPRESS OR
IMPLIED WARRANTIES REGARDING THE PRODUCTS, INCLUDING THE
WARRANTIES OF MERCHANTABILITY, SUITABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR OTHERWISE (IRRESPECTIVE OF ANY PREVIOUS
COURSE OF DEALING BETWEEN THE PARTIES OR CUSTOM OR USAGE OF
TRADE). NEITHER PARTY MAKES ANY OTHER WARRANTIES, EXPRESS OR
IMPLIED, EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, AND
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE HEREBY DISCLAIMED.
9. INDEMNIFICATION, INSURANCE AND LIMITATION OF LIABILITY
a. INDEMNIFICATION BY MERIDIAN. Meridian shall indemnify, defend
and hold harmless Xxx and its Affiliates and their respective
partners, officers, directors, and employees from and against
any and all Losses resulting from any claim, action, suit,
investigation, arbitration or other proceeding made by a Third
Party or brought against Xxx or such Third Party to the extent
such Losses (i) are caused by Meridian's negligence or willful
misconduct; (ii) are caused by Meridian's breach of its
representations and warranties set forth hereunder; (iii) are
caused by Meridian's material breach of any of the covenants or
other provisions of this Agreement; (iv) relate to a claim that
Dey's marketing, distribution or sale of Products pursuant to
this Agreement infringes a Third Party's proprietary rights; (v)
are caused by or arise out of the design, formulation,
manufacture, filling, packaging, testing, labeling or use of the
Products; (vi) are otherwise caused by or arise out of the
shipment or storage of the Products prior to their delivery to
Xxx or its designated carrier; or (vii) relate to a claim
existing as of the Effective Date of the Agreement as set forth
in Exhibit E to the extent such claim arises from a Product
recalled prior to the Effective Date; provided, however, that
the foregoing indemnity obligation shall not apply to the extent
such Losses are covered by Dey's indemnity obligation under
Section 9b hereof.
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Exchange Commission]
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b. INDEMNIFICATION BY XXX. Xxx will indemnify, defend and hold
harmless Meridian and its Affiliates and their respective
officers, directors and employees from and against any and all
Losses resulting from any claim, action, suit, investigation,
arbitration or other proceeding made by a Third Party or brought
against Meridian or such Third Party to the extent such Losses
(i) are caused by Dey's negligence or willful misconduct, except
to the extent such Losses are caused by the breach of Meridian's
representations and warranties under Section 8 hereof; (ii) are
caused by Dey's breach of any of its representations and
warranties set forth herein; (iii) are caused by Dey's material
breach of any of the covenants or other provisions of this
Agreement; (iv) are caused by or arise out of the marketing,
distribution or sale of the Products by Xxx; (v) relate to a
claim that Meridian's use of the Xxx Marks pursuant to this
Agreement infringes a Third Party's proprietary rights; or (vi)
are otherwise caused by or arise out of the shipment or storage
of the Products after their delivery to Xxx or its designated
carrier; provided, however, that the foregoing indemnity
obligation shall not apply to the extent such Losses are covered
by Meridian's indemnity obligation under Section 9a hereof.
c. INDEMNIFICATION PROCEDURES. The obligations and liabilities of
the indemnifying Party (the "Indemnifying Party") shall be
subject to the following terms and conditions:
(i) If a Party entitled to indemnification hereunder (the
"Indemnified Party") becomes aware of any matter it
believes is indemnifiable hereunder involving any claim,
action, suit, investigation, arbitration or other
proceeding against the Indemnified Party by any Third
Party (each an "Action"), the Indemnified Party shall
give the Indemnifying Party prompt written notice of
such Action. Such notice shall (i) provide the basis on
which indemnification is being asserted; (ii) be
accompanied by copies of all relevant pleadings, demands
and other papers related to the Action and in the
possession of the Indemnified Party; and (iii) indicate
the amount (estimated, if necessary) of Losses that have
been or may be suffered by the Indemnified Party. The
Indemnifying Party shall have a period of ten (10)
business days after delivery of such notice to respond.
(ii) If the Indemnifying Party elects to defend the Action or
does not respond within the requisite ten (10) business
day period, the Indemnifying Party shall be obligated to
defend the Action, at its own expense, and by counsel
reasonably satisfactory to the applicable insurance
carriers. The Indemnified Party shall cooperate, at the
expense of the Indemnifying Party, with the Indemnifying
Party and its counsel in the defense and the Indemnified
Party shall have the right to participate fully, at its
own expense, in the defense of such Action.
Notwithstanding any participation
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Exchange Commission]
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by the Indemnified Party such defense shall be
controlled by counsel to the Indemnifying Party.
(iii) If the Indemnifying Party responds within the required
ten (10) business day period and elects not to defend
such Action, or if the Indemnifying Party fails to
respond or to timely defend, contest or otherwise
protect against any Third Party claim, the Indemnified
Party shall be free, without prejudice to any of the
Indemnified Party's rights hereunder, to compromise or
defend (and control the defense of) such Action. In such
case, the Indemnifying Party shall (i) cooperate, at its
own expense, with the Indemnified Party and its counsel
in the defense against such Action; (ii) have the right
to participate fully, at its own expense, in the defense
of such Action; and (iii) pay all the reasonable legal
fees of the Indemnified Party. Notwithstanding any
participation by the Indemnifying Party such defense
shall be controlled by counsel to the Indemnified Party.
(iv) Notwithstanding any other provision of this Agreement,
the Indemnifying Party shall be required to provide or
pay for, as the case may be, no more than a single law
firm per Action and such local counsel as is reasonably
necessary to defend the Action.
(v) The Indemnifying Party shall not be liable for any
settlement of any litigation or proceeding effected
without the written consent of the Indemnifying Party
and its insurance carriers. The Indemnifying Party shall
not, without the Indemnified Party's written consent,
settle or compromise any such Third Party claim or
consent to entry of any judgment which would impose an
injunction or other equitable relief upon the
Indemnified Party or which does not include as an
unconditional term thereof the release by the claimant
or the plaintiff of the Indemnified Party from all
liability in respect of any such claim.
(vi) In calculating Losses there shall be deducted (i) any
insurance recovery in respect thereof (and no right of
subrogation shall accrue hereunder to any insurer) and
(ii) any recoveries from Third Parties pursuant to
indemnification or otherwise with respect thereto;
provided, however, that nothing herein shall require an
Indemnified Party to bring an action against any Third
Party as a condition to seeking indemnification
hereunder. Any Party receiving indemnity shall assign to
the Indemnifying Party all of its claims for recovery
against Third Parties as to such Losses, whether by
insurance coverage, contribution claims, subrogation or
otherwise.
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(vii) The judgment or decree of a court shall be deemed final
when the time for appeal, if any, shall have expired and
no appeal shall have been taken or when all appeals
taken shall have been finally determined. The
Indemnified Party shall have the burden of proof in
establishing the amount of Losses suffered by it.
(viii) In any case where an Indemnified Party recovers from
Third Parties any amount in respect of a matter with
respect to which an Indemnifying Party has indemnified
it pursuant to this Section 9, such Indemnified Party
shall promptly pay over to the Indemnifying Party the
amount so recovered (after deducting therefrom the full
amount of the expenses incurred by it in procuring such
recovery), but not in excess of the sum of (i) any
amount previously so paid by the Indemnifying Party to
or on behalf of the Indemnified Party in respect of such
matter and (ii) any amount expended by the Indemnifying
Party in pursuing or defending any claim arising out of
such matter.
(ix) An Indemnified Party shall, to the extent practicable
and reasonably within its control and at the request and
expense of the Indemnifying Party, make commercially
reasonable efforts to mitigate any damages of which it
has adequate notice with respect to a matter that may be
subject to indemnification hereunder. The Indemnifying
Party shall have the right, but not the obligation, and
shall be afforded the opportunity by the Indemnified
Party to the extent reasonably possible, to make
commercially reasonable efforts to minimize damages
before such damages actually are incurred by the
Indemnified Party.
(x) With respect to any matter as to which indemnification
is provided pursuant to this Section 9 (other than any
claim for equitable or injunctive relief), such
indemnification shall be the sole remedy available to
the Indemnified Party.
d. INSURANCE. Meridian shall maintain product liability and
umbrella insurance coverage in an aggregate amount not less than
$25,000,000 naming Xxx as an additional insured and shall
promptly provide to Xxx from time to time with a certificate of
insurance upon request. Meridian shall give Xxx prompt notice of
any notice of cancellation that it receives from the relevant
insurance carriers. In the event of material changes in the cost
or availability of insurance coverage relating to the Products,
the Parties agree to meet and in good faith discuss what
actions, if any, should be taken to deal with the new
conditions.
e. LIMITATION OF LIABILITY. THE PARTIES HERETO WAIVE AS AGAINST
EACH OTHER ANY CLAIMS TO LOST PROFITS, EXEMPLARY,
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Exchange Commission]
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PUNITIVE, INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL
DAMAGES, EACH OF WHICH IS HEREBY EXCLUDED BY AGREEMENT OF THE
PARTIES REGARDLESS OF WHETHER OR NOT EITHER PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT (I) TO THE
EXTENT SUCH DAMAGES ARE RECOVERED BY A THIRD PARTY THROUGH A
CLAIM SUBJECT TO INDEMNIFICATION PURSUANT TO SECTION 9, (II)
SUCH DAMAGES ARE CLAIMED BY XXX AS A RESULT OF MERIDIAN'S
PROTRACTED REFUSAL TO SUPPLY THE PRODUCTS OR PRODUCTS THAT
CONFORM TO THE REQUIREMENTS SET FORTH IN SECTION 3a(i) IN
CIRCUMSTANCES NOT EXCUSED BY SECTION 17 OR (III) SUCH DAMAGES
ARE CLAIMED BY MERIDAN AS A RESULT OF DEY'S PROTRACTED REFUSAL
TO MARKET, PROMOTE OR DISTRIBUTE THE PRODUCT IN CIRCUMSTANCES
NOT EXCUSED BY SECTION 17.
10. CONFIDENTIAL INFORMATION
a. DISCLOSURE AND USE CONDITIONS. Each Party acknowledges that
Confidential Information may be disclosed to one Party by the
other Party during the Term. Subject to Sections 10b and 10d, a
recipient of Confidential Information shall during the Term and
for a period of three (3) years after the termination or
expiration of the Agreement:
(i) receive, maintain and hold Confidential Information in
strict confidence and shall use the same level of care
in safeguarding it that it uses with its own
confidential material of a similar nature;
(ii) take such steps as may be necessary to prevent the
disclosure of Confidential Information to others; and
(iii) not use Confidential Information, other than strictly
for meeting its obligations or pursuing its rights
hereunder, without first having obtained the disclosing
Party's written consent to such utilization.
b. DISCLOSURE AND USE CONDITIONS NOT APPLICABLE. The commitments
set forth in Section 10a above shall not extend to any portion
of Confidential Information which:
(i) the recipient Party can demonstrate was at the time of
disclosure already in the public domain other than as a
result of actions or failure to act of the recipient
Party, its officers, directors or employees, in
violation hereof;
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Exchange Commission]
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(ii) was rightfully known by the recipient Party (as shown by
its written records) prior to the date of disclosure to
the recipient Party in connection with this Agreement;
(iii) is independently developed by the recipient Party
without the aid, application or use of any information
which it is obligated to maintain as confidential under
this Section 10; or
(iv) was received by the recipient Party on an unrestricted
basis from a source which is not under a duty of
confidentiality to the disclosing Party.
c. OWNERSHIP OF INTELLECTUAL PROPERTY. Neither this Agreement nor
any disclosure made hereunder by either Party shall be deemed,
by implication or otherwise, to vest in the recipient any
license or ownership right to or under any patents, copyrights,
know-how, trade secrets or other intellectual property (except
as set forth under Sections 1a and 3i or as otherwise provided
for by this Agreement) owned by the disclosing Party.
d. COMPELLED DISCLOSURE. Notwithstanding Section 10a, a Party may
disclose Confidential Information to the extent required by
applicable law or by a court or other governmental authority,
provided that it will give the other Party prompt notice of such
requirement so that the other Party may seek a protective order
or the appropriate remedy concerning such disclosure and will
(i) take all reasonably necessary steps requested by the other
Party to defend against the enforcement of such court order by
government parties and (ii) permit the other Party to intervene
and participate with counsel of its choice in any proceeding
relating to the enforcement thereof.
e. RETURN OF CONFIDENTIAL INFORMATION. At any time upon termination
or expiration of this Agreement, or upon request by the
disclosing Party, the recipient Party shall return to the
disclosing Party (i) all Confidential Information, including any
copies (with the exception of a single copy of all Confidential
Information thereof which may be kept by the recipient Party to
establish the extent of disclosure of Confidential Information
by the disclosing Party) and (ii) all documents, drawings,
sketches, models, designs, data, memoranda, tapes, records and
any other material whatsoever developed by the recipient Party
which relates to such Confidential Information, including all
copies and/or any other form of reproduction and/or description
thereof made by the recipient Party (with the exception of a
single copy of all Confidential Information thereof which may be
kept by the recipient Party to establish the extent of
disclosure of Confidential Information by the disclosing Party);
provided that the disclosing Party may direct the recipient
Party, and the recipient Party shall promptly destroy, any such
25
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-25-
Confidential Information which would otherwise be returned
pursuant to this Section 10e.
11. PATENT PROSECUTION, ENFORCEMENT AND INFRINGEMENT
a. PATENT PROSECUTION. Meridian hereby agrees, at its sole expense,
to take all actions reasonably necessary to diligently prosecute
and maintain any patents or patent applications relating to the
Products, including any modifications or improvements thereof,
in the Territory. The Parties shall mutually determine whether
and where additional patent applications embodying a Product, if
any, will be filed and prosecuted and where each patent
embodying a Product will be maintained.
b. ENFORCEMENT. If either Party receives notice or otherwise
becomes aware that any Third Party is infringing or threatens to
infringe upon the patent, trademark or other intellectual
property rights of Meridian or Xxx relating to the Products,
then such Party shall notify the other Party of such matter
within ten (10) days after obtaining notice thereof, unless suit
has been brought against such Party, in which case notice shall
be given within five (5) days after such Party's receipt of
service thereof. The Parties hereby agree to meet promptly after
receipt of the foregoing notification and jointly determine in
good faith the appropriate course of action, including (i) the
evaluation of the merits of such claim; (ii) the prosecution or
settlement of any such claim; and (iii) the Parties' respective
responsibilities for the costs related to any such action.
c. INFRINGEMENT. If either Party receives notice or otherwise
becomes aware that any Third Party claims that any of the
Products infringes upon such Third Party's patent, trademark or
other intellectual property rights, then such Party must notify
the other Party of such matter within ten (10) days after
obtaining notice thereof, unless suit has been brought against
such Party, in which case notice shall be given within five (5)
days after each Party's receipt of service thereof. The Parties
hereby agree to meet promptly after receipt of the foregoing
notification and jointly determine in good faith the appropriate
course of action, including (i) the evaluation of the merits of
such claim; (ii) the defense or settlement of any suit so
brought; (iii) a determination of whether to obtain a license
for such Third Party's intellectual property right; (iv) the
Parties' respective responsibilities for the costs related to
any such action; and (v) a determination of whether to modify
the Products to avoid such claim. If both Parties are defendants
in any such action, and either Party concludes that there may be
legal defenses available to it which are different from,
additional to or inconsistent with those available to the other,
that Party shall have the right to select separate counsel to
participate in the defense of such action on its behalf and such
Party shall bear the cost and expense of such separate defense.
26
CONFIDENTIAL TREATMENT REQUESTED
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-26-
12. TERM
This Agreement shall be effective as of the Effective Date and, unless
and until earlier terminated in accordance with Section 13 hereof, shall
continue in full force and effect until December 31, 2010 (the "Term").
Three (3) years prior to the end of the Term the Parties shall meet and
negotiate exclusively with each other for a period of up to six (6)
months with respect to renewing the Agreement and the length of such
renewal term. If the Parties agree in writing to renew the Agreement,
then the renewal term shall be as set forth in such written agreement.
13. TERMINATION
a. TERMINATION FOR BREACH. In the event either Party breaches any
material provision of this Agreement and fails to cure such
breach either as specified in this Agreement or, if no cure is
specified, within sixty (60) days after receiving written notice
of the breach from the nonbreaching Party, the nonbreaching
Party may terminate this Agreement immediately upon written
notice to the breaching Party. The right to terminate under this
Section 13a shall be in addition to, and not in lieu of, all
other rights and remedies the nonbreaching Party may have at law
or in equity.
b. TERMINATION WITHOUT CAUSE. This Agreement may be terminated
without cause by mutual written agreement of the Parties.
c. EFFECT OF TERMINATION. Any termination or expiration of this
Agreement shall not release the Parties from liabilities and
obligations accrued as of the termination date hereof. In the
event of termination or expiration of this Agreement, Meridian
shall continue to honor each order for Products as specified in
any Purchase Order dated prior to the termination date and Xxx
shall have the right to continue to sell and distribute the
Products until such time as Dey's inventory of the Products is
fully depleted. In the event of termination or expiration of
this Agreement, Meridian may supply the Products to any Third
Party after (i) a period of six (6) months following the
termination or expiration date, (ii) Xxx has depleted its entire
remaining inventory of the Products, or (iii) Meridian agrees in
writing to purchase Dey's remaining inventory of the Products at
Dey's cost, whichever occurs earlier.
In addition, if this Agreement is terminated for any reason
other than by (i) a material breach by Meridian, (ii) mutual
agreement of the Parties in accordance with Section 13b hereof
or (iii) the expiration of this Agreement, Xxx shall pay
Meridian for all direct costs which can be documented by
Meridian relating to the packaging, labeling and other materials
already ordered by Meridian to fulfill no more than three (3)
months of Dey's requested requirements as estimated in the
27
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-27-
most recently dated Rolling Forecast prior to the termination
date; provided that any such direct costs payable by Xxx shall
be related to the manufacture of only the Products and shall
hereby be deemed to exclude any costs related to the provision
of labor or overhead; and provided further that no such direct
costs shall be payable by Xxx if the subject of such costs may
be utilized by Meridian in any way whatsoever to perform its
obligations to a Third Party. In addition, in such case Xxx
shall pay Meridian for all filled and packaged units in process
at Meridian to fulfill Dey's orders set forth in any open
Purchase Orders dated prior to the termination date.
14. RELATIONSHIP MANAGEMENT
a. CONTACT PERSONS. Each Party shall from time to time appoint one
individual to be the designated contact person with respect to
any matter related to this Agreement (a "Contact Person"). A
Party may change its designated Contact Person by notifying the
other Party of the new Contact Person.
b. ESCALATION OF DISPUTES FOR RESOLUTION. In the event of a dispute
regarding any right or obligation under this Agreement or of a
failure to reach agreement within a reasonable time with respect
to any matter that this Agreement requires the Parties to
mutually agree upon, the Parties shall attempt to resolve the
dispute pursuant to this Section 14b prior to pursuing any
remedies available to them in law or equity. Either Party may
escalate a dispute for resolution in accordance with this
Section 14b by notifying the other Party of the decision to
escalate the dispute. Upon receipt of the notice, the Parties
shall arrange a meeting as soon as practicable between the
Parties' respective Contact Persons at a mutually convenient
place (or an alternate employee of equivalent or greater rank in
the event the Contact Person is unavailable during the period of
such dispute). Over a period not to exceed ten (10) business
days, the Contact Persons shall meet two (2) times (or more upon
agreement of the Parties) and engage in good faith negotiations
to resolve such dispute. If the Contact Persons are unable to
resolve such dispute at such meetings, then each Party shall
promptly escalate the dispute to an appropriate executive
management level within its organization and shall continue to
engage in good faith negotiations to resolve such dispute. If a
dispute relates to financial matters, the appropriate executive
management level shall be the chief financial officer ("CFO") of
each Party. If the dispute is not resolved within ten (10)
business days after it was escalated to the executive management
level or CFO, then each Party shall escalate the dispute to each
Party's chief executive officer ("CEO") and shall continue to
engage in good faith negotiations to resolve such dispute. If
the CEOs are not able to resolve such dispute within ten (10)
business days after the date when the dispute was escalated to
them, then either Party may pursue any remedies available to it
at law or equity consistent with Section 20 hereof.
28
CONFIDENTIAL TREATMENT REQUESTED
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-28-
15. INSPECTION
a. INSPECTION BY XXX. During the Term of this Agreement, Xxx, its
subdistributors and sublicensees and applicable regulatory
authorities shall have the right, during normal business hours,
for reasonable periods of time and on reasonable prior written
notice, to have its employees or its authorized consultants
inspect Meridian's facilities used for the design, formulation,
manufacture, packaging, filling, labeling, testing, storing and
shipping of the Products for the purpose of determining whether
Meridian is complying with all applicable law in the Territory
and the provisions of this Agreement. Such inspection shall be
at Dey's sole expense.
b. INSPECTION BY MERIDIAN. Xxx shall permit employees or authorized
consultants of Meridian to inspect Dey's facilities used for the
distribution of Products during Dey's normal business hours, for
reasonable periods of time and on reasonable prior written
notice, for the purpose of determining whether Xxx is complying
with all applicable law in the Territory relating to the
distribution of the Products and the provisions of this
Agreement. Such inspection shall be at Meridian's sole expense.
16. ASSIGNMENT
This Agreement shall not be assigned by either Party without the prior
written consent, such consent not to be unreasonably withheld, of the
other Party, except that a Party may assign its rights and obligations
under this Agreement to any Affiliate or any corporation, firm or other
business entity with or into which it may merge or consolidate or to
which it may sell or transfer all or substantially all of its assets;
provided that such entity merging or consolidating with or into such
assigning Party or purchasing all or substantially all of such assigning
Party's assets may not be a competitor of the other Party.
17. FORCE MAJEURE
Neither Party shall be responsible for any delay or failure to perform
its obligations under this Agreement, in whole or in part, if occasioned
by strikes, work stoppages, or boycotts; riots, insurrections or
revolutions; embargoes; war; fires, earthquakes, floods, explosions,
droughts, snow emergency or any other natural catastrophes; or by any
other causes beyond the control of that Party. In the event of force
majeure, the Party affected thereby shall give the other Party prompt
written notice of the existence of force majeure, the causes thereof and
an estimate of the reasonably anticipated delay that may be caused
thereby and prompt notice of the termination of the force majeure event.
The Parties
29
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-29-
hereby agree that a Product recall or withdrawal is not an event of
force majeure hereunder.
18. ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the Parties with
respect to the manufacture, supply, marketing, distribution and sale of
the Products and there are no understandings of any kind except as
expressly set forth herein. No modification of the Agreement shall be of
any force or effect unless in writing and signed by both Parties hereto.
This Agreement supersedes all prior agreements between or among the
Parties.
19. NOTICES
All notices required or permitted by the terms of this Agreement by
either Party shall be given by prepaid, registered or certified mail,
confirmed overnight carrier or confirmed facsimile to the address of the
Party as set forth below or to such other address as may, from time to
time, be designated in writing by such other Party.
If to XXX: Xxx, X.X.
0000 Xxxx Xxxxxx Xxxxxxxxx Xxxxx
Xxxx, XX 00000
Fax: 0-000-000-0000
Attention: Xx. Xxxxxxx X. Xxxx
President and CEO
If to MERIDIAN: Meridian Medical Technologies, Inc.
00000 Xxx Xxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Fax: 0-000-000-0000
Attention: Xx. Xxxxx X. Xxxxxx
Chairman, President and CEO
20. GOVERNING LAW AND VENUE
This Agreement shall be construed and interpreted according to the laws
of the State of New York without regard to any conflict of law
principles that would require the application of the laws of any other
jurisdiction. The Parties hereby consent to the nonexclusive
jurisdiction of and venue in any federal or state court of competent
30
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-30-
jurisdiction located in the State of New York for the adjudication of
any disputes arising under this Agreement.
21. WAIVER
A waiver by either Party of any term or condition of the Agreement in
any one instance shall not be deemed or construed to be a waiver of such
term or condition for any similar instance in the future of any
subsequent breach hereof. None of the rights, remedies, undertakings and
obligations hereunder shall be a limitation of any other remedy, right
undertaking, obligation or agreement of either Party.
22. INTERPRETATION
If there is any inconsistency between the provisions of this Agreement
and any Purchase Order or other document passing between the Parties,
the provisions of this Agreement shall be determinative.
23. SEVERABILITY
Any provision of this Agreement which is prohibited or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the
extent of such prohibition or unenforceability without invalidating the
remaining provisions hereof or affecting the validity or enforceability
of such provision in any other jurisdiction.
24. HEADINGS
Headings in this Agreement are included herein for convenience of
reference only and have no legal effect.
25. INDEPENDENT CONTRACTORS
Nothing herein shall create any association, partnership, joint venture
or the relation of principal and agent between the Parties hereto, it
being understood that Meridian is manufacturing and supplying the
Products as an independent contractor, and neither Party shall have the
authority to bind the other or the other's representatives in any way.
26. SUCCESSORS AND ASSIGNS
This Agreement shall be binding upon and inure to the benefit of the
Parties and their permitted assigns.
31
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-31-
27. SURVIVAL OF PROVISIONS
All of the Parties' rights and obligations relating to payment and all
of their rights and obligations under Xxxxxxxx 0x, 0x, 0x, 0x, 0 through
9, 10, 13c, and 17 through 27 shall survive the expiration or
termination of the Agreement.
[REMAINDER OF THIS PAGE LEFT INTENTIONALLY BLANK]
32
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-32-
IN WITNESS WHEREOF, Meridian and Xxx have caused this Supply Agreement to be
executed as of the Effective Date.
XXX, X.X.
By its general partner, Xxx, Inc.
By: /s/ Xxxxxxx X. Xxxx
--------------------------------
Xxxxxxx X. Xxxx
President and CEO
MERIDIAN MEDICAL TECHNOLOGIES, INC.
By: /s/ Xxxxx X. Xxxxxx
--------------------------------
Xxxxx X. Xxxxxx
Chairman, President and CEO
Agreed and Accepted:
EM INDUSTRIES, INCORPORATED
By: /s/ Xxx Xxxxxxxxx
----------------------------
Name: Xxxxxx X. Xxxxxxxxx
Title: President & CEO
33
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-33-
EXHIBIT A
PRODUCTS
PRODUCT NAME
FASTJEKT EPIPEN JR International
CANADIAN EPIPEN JR Canada
CANADIAN EPIPEN SR Canada
FASTJEKT EPIPEN SR International
ALK EPIPEN SR International
ALK EPIPEN JR International
EPIPEN JR NDC 00000-000-00
EPIPEN SR NDC 00000-000-00
EPIPEN TRAINERS
EPIPEN SR TWO-PAK NDC 00000-000-00
EPIPEN JR TWO-PAK NDC 00000-000-00
34
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to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-34-
EXHIBIT B
PACKAGING CONFIGURATIONS
A. EpiPen(R) Single Unit Shelf Carton With PI's
Twelve (12) Cartons Per Shipper Case
B. EpiPen(R)Jr. Single Unit Shelf Carton With PI's
Twelve (12) Cartons Per Shipper Case
C. EpiPen(R)Trainer 165 Trainers Per Box
Six (6) Boxes of 165 Per Shipper Case
D. EpiPen(R)Sr. Two-Pak Each carton contains 2 EpiPen(R)Sr.
Injectors and 1 EpiPen(R)Trainer With PI's
Packaged 6 cartons per shipper
E. EpiPen(R)Jr. Two-Pak Each carton contains 2 EpiPen(R)Jr.
Injectors and 1 EpiPen(R)Trainer With PI's
Packaged 6 cartons per shipper
35
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-35-
EXHIBIT C
1. PRODUCT SPECIFICATIONS
Product Specifications are attached hereto as Appendix I
2. LABELING SPECIFICATIONS
A. EpiPen(R) DESCRIPTION
Auto Injector Label
Patient Insert
Shelf Carton
Tray
Shipper Case
Physician Insert
Combined Physician Insert
B. EpiPen(R)Jr. DESCRIPTION
Auto Injector Label
Patient Insert
Shelf Carton
Tray
Shipper Case
Combined Physician Insert
C. EpiPen(R)Trainer DESCRIPTION
Trainer Label
D. EpiPen(R)Sr. Two-Pak DESCRIPTION
Auto Injector Label
Patient Insert
Trainer Label
Trainer Insert
Physician Insert
Dual Pack Carton
Shipper Case
36
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-36-
E. EpiPen(R)Jr. Two-Pak DESCRIPTION
Auto Injector Label
Patient Insert
Trainer Label
Trainer Insert
Physician Insert
Dual Pack Carton
Shipper Case
37
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-37-
APPENDIX I
EpiPen Auto-Injector
Epinephrine Injection
1:1,000; 0.3 mL/dose
Sampling: "..."
Critical Defects Definition - "..."
Major Defects Definition - "..."
Minor Defects Definition - "..."
VISUAL AUDIT (BASIC UNIT)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
MAJOR LIMITS - "..."
1. "..."
MAJOR LIMITS - "..."
1. "..."
MAJOR LIMITS - "..."
1. "..."
38
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-38-
EpiPen Auto-Injector
Epinephrine Injection
1:1,000; 0.3 mL/dose
Sampling: "..."
FUNCTIONALITY TESTING (ASSEMBLED AUTOINJECTOR)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
8. "..."
9. "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
39
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-39-
3. "..."
40
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-40-
EpiPen Auto-injector
Epinephrine Injection
1:1,000; 0.3 mL/dose
Sampling: "..."
FINAL PRODUCT INSPECTION I (MOISTURE & FINAL INSPECTION)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
MAJOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
FINAL PRODUCT INSPECTION II (LABEL/TUBE & CAP)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
41
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-41-
EpiPen Auto-Injector
Epinephrine Injection
1:1,000; 0.3 mL/dose
Sampling: "..."
FINAL PRODUCT INSPECTION III (PACKAGING)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
MINOR LIMITS - "..."
1. "..."
42
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-42-
EpiPen Auto-Injector
Epinephrine Injection
1:1,000; 0.3 mL/dose
FINISHED PRODUCTION SPECIFICATION
------------------------------------------------------------------------------------------
TEST METHOD SPECIFICATION
------------------------------------------------------------------------------------------
Epinephrine Assay "..." "..."
------------------------------------------------------------------------------------------
Identification B "..." "..."
------------------------------------------------------------------------------------------
pH "..." "..."
------------------------------------------------------------------------------------------
Identification A "..." "..."
------------------------------------------------------------------------------------------
Degradation Products "..."
------------------------------------------------------------------------------------------
- Adrenochrome "..."
------------------------------------------------------------------------------------------
- Adrenolutin "..."
------------------------------------------------------------------------------------------
- Total Other Impurities "..."
------------------------------------------------------------------------------------------
- Total Impurities "..."
------------------------------------------------------------------------------------------
Sodium Metabisulfite "..." "..."
------------------------------------------------------------------------------------------
Particulate Matter "..." "..."
------------------------------------------------------------------------------------------
Color and Clarity "..." "..."
------------------------------------------------------------------------------------------
Sterility "..." "..."
------------------------------------------------------------------------------------------
Bacterial Endotoxin Content "..." "..."
------------------------------------------------------------------------------------------
Activation Force "..." "..."
------------------------------------------------------------------------------------------
Volume Dispensed "..." "..."
------------------------------------------------------------------------------------------
Dispensing Time "..." "..."
------------------------------------------------------------------------------------------
Exposed Needle Length "..." "..."
------------------------------------------------------------------------------------------
43
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["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-43-
EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000; 0.3 mL/dose
Sampling: "..."
Critical Defects Definition - "..."
Major Defects Definition - "..."
Minor Defects Definition - "..."
VISUAL AUDIT (BASIC UNIT)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
MAJOR LIMITS - "..."
1. "..."
MAJOR LIMITS - "..."
1. "..."
MAJOR LIMITS - "..."
1. "..."
44
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-44-
EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000; 0.3 mL/dose
Sampling: "..."
FUNCTIONALITY TESTING (ASSEMBLED AUTOINJECTOR)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
8. "..."
9. "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
45
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-45-
EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000; 0.3 mL/dose
Sampling: "..."
FINAL PRODUCT INSPECTION I (MOISTURE & FINAL INSPECTION)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
MAJOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
FINAL PRODUCT INSPECTION II (LABEL/TUBE & CAP)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
46
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-46-
EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000; 0.3 mL/dose
Sampling: "..."
FINAL PRODUCT INSPECTION III (PACKAGING)
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
MINOR LIMITS - "..."
1. "..."
47
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-47-
EpiPen Auto-Injector
Epinephrine Injection
1:2,000; 0.3 mL/dose
FINISHED PRODUCT SPECIFICATION
------------------------------------------------------------------------------------------
TEST METHOD SPECIFICATION
------------------------------------------------------------------------------------------
Epinephrine Assay "..." "..."
------------------------------------------------------------------------------------------
pH "..." "..."
------------------------------------------------------------------------------------------
Identification A "..." "..."
------------------------------------------------------------------------------------------
Identification B "..." "..."
------------------------------------------------------------------------------------------
Degradation Products "..."
------------------------------------------------------------------------------------------
- Adrenochrome "..."
------------------------------------------------------------------------------------------
- Adrenolutin "..."
------------------------------------------------------------------------------------------
- Total Other Impurities "..."
------------------------------------------------------------------------------------------
- Total Impurities "..."
------------------------------------------------------------------------------------------
Sodium Metabisulfite "..." "..."
------------------------------------------------------------------------------------------
Particulate Matter "..." "..."
------------------------------------------------------------------------------------------
Color and Clarity "..." "..."
------------------------------------------------------------------------------------------
Sterility "..." "..."
------------------------------------------------------------------------------------------
Bacterial Endotoxin Content "..." "..."
------------------------------------------------------------------------------------------
Activation Force "..." "..."
------------------------------------------------------------------------------------------
Volume Dispensed "..." "..."
------------------------------------------------------------------------------------------
Dispensing Time "..." "..."
------------------------------------------------------------------------------------------
Exposed Needle Length "..." "..."
------------------------------------------------------------------------------------------
48
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-48-
Canadian EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000, 0.3 mL/dose
Sampling: "..."
Critical Defects Definition - "..."
Major Defects Definition - "..."
Minor Defects Definition - "..."
FINAL PRODUCT INSPECTION I
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
8. "..."
9. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
49
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-49-
Canadian EpiPen Jr. Auto-Injector
Epinephrine Injection
1:2,000, 0.3 mL/dose
Sampling: "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
MAJOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
MINOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
50
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-50-
Canadian EpiPen Auto-Injector
Epinephrine Injection
1:1,000, 0.3 mL/dose
Sampling: "..."
Critical Defects Definition - "..."
Major Defects Definition - "..."
Minor Defects Definition - "..."
FINAL PRODUCT INSPECTION I
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
8. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
51
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-51-
Canadian EpiPen Auto-Injector
Epinephrine Injection
1:1,000, 0.3 mL/dose
Sampling: "..."
MAJOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
MAJOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
MINOR LIMITS - "..."
1. "..."
MINOR LIMITS - "..."
1. "..."
52
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-52-
International EpiPen Auto-Injector
Epinephrine Injection
Sampling: "..."
Critical Defects Definition - "..."
Major Defects Definition - "..."
Minor Defects Definition - "..."
FINAL PRODUCT INSPECTION I
CRITICAL LIMITS - "..."
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
CRITICAL LIMITS - "..."
1. "..."
2. "..."
MAJOR LlMITS - "..."
1. "..."
2. "..."
3. "..."
MINOR LIMITS - "..."
1. "..."
2. "..."
MINOR LIMITS - "..."
1. "..."
53
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-53-
EXHIBIT D
UNIT PRICES
Unit prices for Products delivered in accordance with Section 5a of the
Agreement or Section 2d of the Agreement shall be as follows until modified in
accordance with Section 5 of the Agreement:
ITEM ORDER QUANTITY UNIT PRICE
------- -------------- ----------
EpiPen(R)Sr. "..." "..."
EpiPen(R)Jr. "..." "..."
Canadian EpiPen(R)Sr. "..." "..."
Canadian EpiPen(R)Sr. "..." "..."
Canadian EpiPen(R)Sr. "..." "..."
Canadian EpiPen(R)Jr. "..." "..."
Canadian EpiPen(R)Jr. "..." "..."
Canadian EpiPen(R)Jr. "..." "..."
ALK/Foreign EpiPen(R)Sr. "..." "..."
ALK/Foreign EpiPen(R)Sr. "..." "..."
ALK/Foreign EpiPen(R)Sr. "..." "..."
ALK/Foreign EpiPen(R)Jr. "..." "..."
ALK/Foreign EpiPen(R)Jr. "..." "..."
ALK/Foreign EpiPen(R)Jr. "..." "..."
EpiPen(R)Trainer "..."
EpiPen(R)Sr. Two-Pak "..." "..."
EpiPen(R)Jr. Two-Pak "..." "..."
54
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-54-
EXHIBIT E
PENDING OR THREATENED CLAIMS
1. "..."
2. "..."
3. "..."
4. "..."
5. "..."
6. "..."
7. "..."
8. "..."
--------------------------------------------------------------------------------
* "..."
55
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-55-
EXHIBIT F
XXX PURCHASE ORDER
[XXX PURCHASE ORDER FORM]
56
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-56-
EXHIBIT G
MERIDIAN MARKS
MERIDIAN MEDICAL TECHNOLOGIES
MERIDIAN
57
CONFIDENTIAL TREATMENT REQUESTED
["..."indicates that material has been omitted pursuant
to Confidential Treatment Request, which the Company
has filed separately with the Securities and
Exchange Commission]
-57-
EXHIBIT H
XXX MARKS
EPIPEN
EPIPEN JR
XXX AND TRIANGLE XXXX
EPI EZ PEN
EPI EZ PEN JR
