Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXHIBIT 10(F)
PERRIGO SUPPLY AGREEMENT
TABLE OF CONTENTS
PAGE
----
Article I - DEFINITIONS.................................................. 4
Article II - CONFIDENTIALITY............................................. 7
2.1 Confidentiality................................................. 7
Article III - SUPPLY OF FINISHED PRODUCT................................. 7
3.1 Supply.......................................................... 7
3.2 Regulatory Approval............................................. 7
3.3 Repackaging..................................................... 7
3.4 Sales by Purchaser.............................................. 7
3.5 Brand Name for [c.i.]........................................... 8
Article IV - MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS............. 8
4.1 Forecast........................................................ 8
4.2 Purchase Orders................................................. 8
4.3 Purchaser's Modification or Cancellation........................ 8
Article V - TESTING INSPECTION......................................... 8
5.1 Records......................................................... 8
5.2 Certificate of Analysis......................................... 9
5.3 Perrigo Testing................................................. 9
5.4 Purchaser Testing............................................... 9
5.5 Rejection....................................................... 9
5.6 Claims.......................................................... 9
Article VI - PRICES AND TERMS OF SALE.................................... 9
6.1 Price........................................................... 9
6.2 Invoice......................................................... 10
6.3 Inconsistent Terms.............................................. 10
6.4 Taxes........................................................... 10
6.5 Collection Costs and Interest................................... 10
Article VII - ROYALTIES.................................................. 10
7.1 Amount of Royalty............................................... 10
7.2 Intercompany Sales.............................................. 10
7.3 Royalties on Sales for Non-monetary Consideration............... 10
7.4 Currency........................................................ 10
Article VIII - WARRANTIES................................................ 11
8.1 Perrigo Warranties.............................................. 11
8.2 Purchaser Warranties............................................ 11
8.3 Recalls......................................................... 11
Article IX - INDEMNIFICATION............................................. 11
9.1 Indemnity by Purchaser.......................................... 11
9.2 Indemnity by Perrigo............................................ 11
9.3 Cooperation..................................................... 12
Article X - TERM AND TERMINATION......................................... 12
10.1 Term............................................................ 12
10.2 Termination..................................................... 12
10.3 Duties Upon Termination......................................... 12
10.4 Continuing Obligations.......................................... 13
Article XI - MISCELLANEOUS............................................... 13
11.1 Governing Law................................................... 13
11.2 Export of Finished Product...................................... 13
11.3 Notices......................................................... 13
11.4 Partial Invalidity.............................................. 13
11.5 Entire Agreement................................................ 13
11.6 Assignability................................................... 14
11.7 Successors and Permitted Assigns................................ 14
11.8 Excused Non-Performance......................................... 14
11.9 Announcements................................................... 14
11.10 Trademarks...................................................... 14
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EXHIBIT 10(F)
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (this "Agreement") made as of the 21st day of
October, 2005 (the "Effective Date"), by and between X. Xxxxxxx Company
("Perrigo"), having its principal offices at 000 Xxxxxxx Xxxxxx, Xxxxxxx,
Xxxxxxxx 00000 XXX and Sirius Laboratories, Inc ("Purchaser"), having its
principal office at 000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxx Xxxxx, Xxxxxxxx 00000.
RECITALS
1. Perrigo and the Purchaser are each engaged in the business of
manufacturing, marketing and selling various pharmaceutical products.
2. Perrigo and the Purchaser desire to enter into this Agreement to set
forth the terms and conditions of purchase and sale of Finished Products
(defined below) that Perrigo will manufacture and sell to the Purchaser and the
Purchaser will purchase from Perrigo.
3. Purchaser desires [c.i.] the Finished Product from Perrigo [c.i.]
(defined below) and desires to sell such [c.i.] to Third Parties.
4. Purchaser desires that Perrigo be the exclusive third party manufacturer
of the requirements of Finished Product to be incorporated into [c.i.] to
Purchaser and its Affiliated Companies, and Perrigo desires to be the exclusive
third party supplier to Purchaser and its Affiliates of their requirements for
Finished Product to be included in [c.i.].
5. Purchaser and its Affiliated Companies desire that Purchaser be granted
exclusive rights to purchase Finished Product to be incorporated into [c.i.] for
resale to third parties and Perrigo desires to grant Purchaser exclusive rights
to purchase Finished Product from Perrigo for to be incorporated into [c.i.] for
resale to third parties.
NOW, THEREFORE, IT IS AGREED between the parties as follows:
ARTICLE I - DEFINITIONS
1.1 "The Act" shall mean the Federal Food, Drug, and Cosmetic Act, as it
may be amended from time-to time, and regulations promulgated thereunder.
1.2 "Affiliate" as applied to Perrigo or Purchaser shall mean any legal
entity other than Perrigo or Purchaser, as the case may be, in whatever country,
organized, controlling, controlled by or under common control with Perrigo or
Purchaser. An entity is deemed to be in control of another entity (controlled
entity) if the former owns directly or indirectly at least [c.i.], of the
outstanding voting equity of the controlled entity (or other equity or ownership
interest if such controlled entity is other than a corporation) or otherwise has
the power to direct or cause the direction of the management of the controlled
entity.
1.3 [c.i.] means Purchaser's apparatus used for the purpose [c.i.]
including but not limited to those contained in the Finished Product, [c.i.] of
the human body.
1.4 "Batch" shall mean [c.i.] Units.
1.5 "cGMPs" shall mean all applicable current Good Manufacturing Practices
promulgated by the FDA.
1.6 "Contract Quarter" shall mean three (3) successive calendar months
during the term of this Agreement commencing on January 1, April 1, July 1 and
October 1. The first Contract Quarter shall commence on the Effective Date and
expire on the day before the commencement of the next Contract Quarter.
1.7 "Contract Year" shall mean a twelve (12) consecutive month period that
(a) for the First Contract Year, commences on the Effective Date and expires on
the day prior to the anniversary of the Effective Date if such date is the last
day of a Contract Quarter, or expires on the last day of the Contract Quarter in
which the Effective Date falls; and (b) for every Contract Year after the First
Contract Year, commences on the first day of the next Contract Quarter (the
"Anniversary Date") and each succeeding Anniversary Date during the term of this
Agreement.
1.8 "Drug" shall mean the chemical compound commonly referred to as
Clindamycin 1%.
1.9 "FDA" shall mean the United States Food and Drug Administration, or any
successor entity thereto.
1.10 "Facility" shall mean Xxxxxxx'x processing site located in Bronx, New
York, or such other Perrigo facility as agreed to by the parties.
1.11 "Finished Product" shall mean [c.i.]
1.12 [c.i.] means a [c.i.] designed and manufactured by Purchaser to be
sold to third parties marketed for the for [c.i.] on the [c.i.] that contains a
[c.i.].
1.13 "Net Sales Value" means the gross invoiced sales for [c.i.] [c.i.] by
Purchaser or its Affiliates or sub-licensees or its marketing partners, after
deduction of the following amounts:
(a) [c.i.], including [c.i.] to [c.i.] and excluding any [c.i.] in
relation to [c.i.] [c.i.];
(b) [c.i.] given or made for [c.i.] of previously sold [c.i.] [c.i.];
and
(c) any [c.i.] (including any [c.i.] on the [c.i.] and [c.i.].
1.14 "Marketing Quarter" shall mean three (3) successive calendar months
during the term of this Agreement commencing on the first day of the month of
the first commercial sale. The first Marketing Quarter shall commence on the
earlier of (a) May 1, 2006; or (b) the first day of the month of the first
commercial sale; and shall expire on the day before the commencement of the next
Marketing Quarter.
1.15 "Marketing Year" shall mean a twelve (12) consecutive month period
that (a) for the first Marketing Year, commences on the first day of the first
Marketing Quarter and expires on the day prior to the anniversary of the first
Marketing Quarter; and (b) for every Marketing Year after the First Marketing
Year, commences on the first day of the next Marketing Quarter (the "Anniversary
Date") and each succeeding Anniversary Date during the term of this Agreement.
1.16 "Processing" shall mean the manufacturing and packaging procedures to
be undertaken by Perrigo for Purchaser in order to create Finished Product
accordance with the Specifications. "Process", "Processing" and "Processed"
shall have comparable meanings as the context requires.
-5-
1.17 "Proprietary Information," unless otherwise agreed to in writing,
includes all information or data first communicated from one party (the
"Disclosing Party") to the other (the "Receiving Party"), whether in writing,
orally, by observation or other sensory detection, including, without
limitation, trade secrets, know-how, compilations, formulae, processes, business
plans, requirements, timelines, formulations, technical information, new product
information, methods of product delivery, development strategies, manufacturing
capabilities, test procedures and results, product samples, specifications,
material safety data sheets, marketing and business plans, as well as other
scientific, clinical, commercial and other information, data or techniques
considered confidential in nature. Proprietary Information shall not include
information which:
(a) at the time of disclosure, is properly in the public domain or
thereafter properly becomes part of the public domain by publication or
otherwise through no fault or act of the Receiving Party, it's Affiliates,
employees or agents;
(b) the Receiving Party can conclusively establish was properly in its
possession prior to the time of the disclosure to it;
(c) is independently made available to the Receiving Party in good
faith by a third party who has not violated a confidential relationship with the
Disclosing Party;
(d) is independently developed by the Receiving Party, without use of
the other party's information, data or materials, as evidenced by the Receiving
Party's written records;
(e) is required to be disclosed by legal process;
(f) is information which is required to be included in patent
applications filed hereunder or required to be provided to a government agency
in order for Purchaser to obtain approvals to market the Finished Product or for
Perrigo to make the Finished Product for Purchaser hereunder; provided, however,
that no Proprietary Information of Purchaser or Perrigo will be disclosed in any
such patent application or otherwise without the prior written consent of the
other party; or
(g) is information which is required to be disclosed to customers,
users and prescribers of Finished Product or which is reasonably necessary to
disclose in connection with the ethical marketing of Finished Product; provided,
however, that no Proprietary Information of a party will be so disclosed without
the prior written consent of the other party.
The exclusions enumerated above shall not apply to any specific information
merely because it is included in more general non-proprietary information nor to
any specific combination of information merely because individual elements, but
not the combination, are included in non-proprietary information.
1.18 "Specifications" shall mean the final specifications for the Finished
Product [c.i.], the written specifications for the product and package label
mutually agreed to by the parties, as well as any revised specifications and/or
additional specifications for the Finished Product implemented by Perrigo from
time to time in writing.
1.19 "Territory" means the United States of America, its territories and
possessions.
1.20 "Third Party" means any person, firm or corporate body other than
[Purchaser], Perrigo, a Purchaser Affiliate or a Perrigo Affiliate.
-6-
1.21 "Unit" means Finished Product retail packaged in a primary container
consisting of [c.i.] with (a) Purchaser's logo; (b) Purchaser's graphics; and
(c) the phrase "Dist. By: Sirius Laboratories, Inc., Xxxxxx Xxxxx, XX 00000" in
lieu of [c.i.]
ARTICLE II - CONFIDENTIALITY
2.1 Confidentiality. In connection with the process and the business
relationship contemplated by this Agreement, each party may disclose Proprietary
Information to the other. Proprietary Information and know-how represent such
party's valuable trade secrets and business assets. In consideration of the
mutual benefits that each party will receive, the disclosure to each party of
the Proprietary Information of the other and the mutual promises set forth in
this Agreement, the parties agree that all Proprietary Information will be held
in confidence for a period of [c.i.] and not used, disclosed to others or in any
way exploited for the Receiving Party's own benefit or for any purpose without
the Disclosing Party's prior written consent other than as permitted by this
Agreement. A party receiving Proprietary Information will use such information
only to carry out its obligations hereunder and will not use such information
for its own benefit or for the benefit of others or in any way inconsistent with
this Agreement. The parties also agree to restrict dissemination of Proprietary
Information to those of their employees and agents who have an actual need to
know, have been informed of the requirements of this Agreement and have a legal
obligation to protect the confidentiality of such Proprietary Information. The
parties further agree that all Proprietary Information disclosed by one party to
the other remains the sole property of the Disclosing Party and neither party
obtains any right or license of any kind (whether by implication or otherwise)
to Proprietary Information so disclosed. Upon written request, the parties will
promptly return all documents and copies referencing the other's Proprietary
Information, except for one copy of written materials, which may be retained in
the files of the Receiving Party's legal counsel. Each party hereby acknowledges
that unauthorized disclosure or use of the Proprietary Information could cause
irreparable harm and significant injury to the Disclosing Party, which may be
difficult to ascertain. Accordingly, each party agrees that the Disclosing Party
shall have the right to seek and obtain immediate injunctive relief from any
breach of this Agreement, in addition to any other rights or remedies it may
have.
ARTICLE III - SUPPLY OF FINISHED PRODUCT
3.1 Supply. Purchaser will purchase exclusively from Perrigo, and Perrigo
will be the exclusive, worldwide supplier to Purchaser for, all of Purchaser's
and its Affiliates' requirements of Finished Product or Drug that is delivered
[c.i.] for the term of this Agreement. Perrigo shall sell exclusively to
Purchaser Finished Product for the limited purpose of being sold [c.i.] the
Territory. Sales of Finished Product by Affiliates of Purchaser shall be deemed
to be made by Purchaser for this purpose, and Perrigo may assign to its
Affiliates, as appropriate, responsibilities for compliance or partial
compliance with its responsibilities hereunder.
3.2 Regulatory Approval. [c.i.] will be solely responsible for and will
obtain all governmental approvals, permits and licenses necessary or desirable
in connection with the testing, marketing, sale, advertising or distribution
[c.i.] the Territory.
3.3 Repackaging. [c.i.] warrants that the Finished Product may be [c.i.]
for sale to Third Parties in accordance with FDA and GMP requirements without
the need for additional regulatory filings with FDA. [c.i.] shall be solely
responsible for [c.i.] and making certain that [c.i.] shall be done in full
compliance with applicable GMPs.
3.4 Sales by Purchaser. [c.i.] shall only sell Finished Product [c.i.] in
the Territory and in full compliance with [c.i.]. [c.i.] warrants and covenants
that the relabeling, distribution, advertising and promotion of Finished Product
[c.i.] shall be in full compliance with FDA laws
-7-
and regulations. [c.i.] shall provide [c.i.] samples [c.i.] for [c.i.] approval
prior to [c.i.], such approval not to be unreasonably withheld. [c.i.] shall be
solely responsible for the development and implementation of sales and marketing
strategies [c.i.], including establishing the pricing [c.i.] (including, but not
limited to, trade incentives, etc.).
3.5 Brand Name for [c.i.]. [c.i.] shall be responsible and bear all costs
and expenses for the brand name and artwork to be used in connection with the
[c.i.] and the Finished Product to be sold [c.i.] and obtaining FDA and any
other necessary regulatory approval related thereto. [c.i.] shall coordinate the
approval of any such brand name with [c.i.] and [c.i.] shall have the ultimate
right to approve or reject any brand name and artwork that [c.i.] proposes to
use with the Finished Product. [c.i.] shall bear all costs associated with
obsolete packaging components that result from any such changes to the packaging
of the Finished Product.
ARTICLE IV - MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS
4.1 Forecast. On or before the first (1st) day of each calendar month,
beginning at least [c.i.] to the anticipated Commencement Date, Purchaser shall
furnish to Perrigo a written [c.i.] rolling forecast of the quantities of
Product that Purchaser intends to order from Perrigo during such period
("Rolling Forecast"). The [c.i.] of such Rolling Forecast shall constitute a
binding order for the quantities of Product specified therein ("Firm
Commitment") and the [c.i.] of the Rolling Forecast shall be non-binding, good
faith estimates.
4.2 Purchase Orders. Purchaser may only submit purchase orders for [c.i.].
On or before the first (1st) day of [c.i.], Purchaser shall submit a purchase
order for the Firm Commitment portion of the Processing, which specifies the
actual number of Batches of Finished Product to be Processed and the requested
delivery dates for each Batch ("Purchase Order"). Purchaser shall submit each
Purchase Order to Perrigo at least [c.i.] in advance of the delivery date
requested in the Purchase Order. In the event of a conflict between the terms of
any Purchase Order and this Agreement, this Agreement shall control.
Notwithstanding the foregoing, Perrigo shall use [c.i.] to supply Purchaser with
quantities of Product which are in excess of the quantities specified in the
Firm Commitment, subject to Xxxxxxx'x other supply commitments and manufacturing
and equipment capacity.
4.3 Purchaser's Modification or Cancellation.
(a) Purchaser may modify the delivery date, Specifications or quantity
of Product in such Purchase Order only by submitting a written change order
("Change Order") to Perrigo at least [c.i.] in advance of the earliest scheduled
Processing Date for the Processing covered by the Change Order. Such Change
Order shall be effective and binding against Perrigo only upon the written
approval of Perrigo, and notwithstanding the foregoing, Purchaser shall remain
responsible for the Firm Commitment portion of the Rolling Forecast.
(b) If Purchaser fails to place Purchase Orders sufficient to satisfy
the Firm Commitment, Purchaser shall, within [c.i.] of receipt of invoice, pay
to Perrigo the price for all Units that would have been Processed if Purchaser
had placed Purchase Orders sufficient to satisfy the Firm Commitment.
ARTICLE V - TESTING INSPECTION
5.1 Records. Before, during and after Processing of each Batch hereunder,
Perrigo shall, with respect to such Processing: (i) record and keep on file all
Batch record documentation, as well as samples of materials supplied by
Purchaser or Perrigo and used in Processing Drug into Finished Product; (ii)
monitor, record and retain documentation of the Processing conditions
-8-
and environment; and (iii) keep such records for such periods of time as are
required in the Specifications, cGMPs and any other legal requirements.
5.2 Certificate of Analysis. Within [c.i.] following the date of Perrigo
Quality Control release of a Batch, Perrigo shall supply Purchaser with an
analytical report (Certificate of Analysis) prepared in conformance with the
cGMPs.
5.3 Perrigo Testing. Perrigo shall conduct all FDA-required testing of raw
materials, packaging materials, bulk products, and Finished Product, including
but not limited to validation, release and stability testing that are required
by [c.i.] the Finished Product.
5.4 Purchaser Testing. Following Purchaser's receipt of Finished Product,
Purchaser may test samples of each Batch of Finished Product to confirm that all
the applicable standards and requirements contained in the Specifications have
been met. Purchaser may reject such Finished Product by giving oral notice of
rejection to Perrigo within [c.i.] following Purchaser's receipt of each Batch
of Finished Product. Such notice shall be promptly confirmed by Purchaser in
writing to Perrigo, such confirmation to be received no later than [c.i.] after
such oral notice.
5.5 Rejection. If Purchaser rejects any Batch of Finished Product,
Purchaser shall issue a purchase order for a replacement Batch to be delivered
by Perrigo [c.i.]. If, after [c.i.] of analysis and [c.i.], the parties have
failed to agree that such rejection was justified, or if justified, the root
basis for the rejection, then the parties shall employ a mutually agreed upon
independent laboratory to resolve the matter. Such independent laboratory shall
test samples of Finished Product and review records and test data previously
developed by the parties relating to the Finished Product, to ascertain whether
the Finished Product was actually off-Specification and/or the root basis for
the alleged failure of such Finished Product to meet the Specifications. The
findings of such independent laboratory shall be binding on both parties. If the
Finished Product is found to be within Specifications, or the reason that the
Finished Product was found to be off-Specification was the result of Purchaser's
negligence, [c.i.] of the tests and, for the purposes of paying Perrigo, shall
be deemed to have accepted the Batch in question. If Finished Product was found
to be off-Specification as a result of Processing or was otherwise the result of
Xxxxxxx'x negligence or failure to comply with cGMPs or failure to comply with
all Specifications, [c.i.] of the tests.
5.6 Claims.. In the event that there are clerical errors or other claims
involving Products, discovered after completion of a sale of Products, the party
discovering the error shall immediately notify the other party. The parties
agree that any claim or action arising out of or related to Products or to any
sale transaction between Perrigo and Purchaser, will be brought within [c.i.]
after the cause of action has accrued or be deemed waived. All claims must be
supported by adequate documentation, which must be supplied with the claim.
Failure to provide such documentation will result in denial of the claim.
ARTICLE VI - PRICES AND TERMS OF SALE
6.1 Price.
(a) Prices for Processing by Perrigo are set forth in Exhibit A.
(b) Processing prices are subject to adjustment by Perrigo [c.i.]
provided Perrigo provides Purchaser at least [c.i.] notice prior to such
adjustment.
(c) Upon mutual written agreement of the parties, Processing price
adjustments to Purchaser may be further increased or decreased [c.i.] any
Contract Year for each
-9-
succeeding Contract Year at least [c.i.] prior to such succeeding Contract Year
due to [c.i.] or [c.i.] which shall be passed on to Purchaser on [c.i.]
beginning on the first day of each Contract Year.
6.2 Invoice. Purchaser's payments to Perrigo shall be due [c.i.] following
Purchaser's receipt of Xxxxxxx'x invoice, which shall be dated and issued any
time after Perrigo has tendered to Purchaser the Finished Product to which the
invoice charges apply.
6.3 Inconsistent Terms. Purchase orders and invoices issued pursuant to
this Agreement and any other directions or instructions issued by either
Purchaser or Perrigo shall be consistent with this Agreement, and any additional
terms or conditions stated in any such purchase orders, invoices or other
directions or instructions shall not be binding upon the parties hereto unless
separately agreed to by the receiving party in writing. In the event of an
inconsistency between any such purchase orders, invoices or other directions or
instructions and the terms and conditions of this Agreement, the terms and
conditions of this Agreement shall prevail.
6.4 Taxes. Prices quoted [c.i.] taxes. Purchaser shall pay to Perrigo, in
addition to the purchase price, the amount of all [c.i.] which Perrigo [c.i.] in
connection with furnishing Products to Purchaser.
6.5 Collection Costs and Interest. In the event of Purchaser's default,
Purchaser agrees to [c.i.] in the collection of past due amounts owed by
Purchaser. Purchaser also agrees [c.i.], from the due date, [c.i.] per month or
the [c.i.].
ARTICLE VII - ROYALTIES
7.1 Amount of Royalty. In consideration of the license granted by Perrigo
to Purchaser, Purchaser shall pay to Perrigo a royalty (the "Royalty") equal to
the greater of: (a) [c.i.] percent ([c.i.]) of the Net Sales Value of Finished
Product; or (b) US[c.i.] per Unit. In addition, during each Marketing Year,
Purchaser shall pay to Perrigo an annual minimum royalty of US $250,000 (Minimum
Royalty shall be renegotiated in the event the parties desire to renew the
Agreement or extend the Agreement beyond the Initial Term). If Purchaser does
not purchase enough Units of Finished Product during any Marketing Year to pay
[c.i.], within [c.i.] after the end of such Marketing Year, Purchaser shall
[c.i.] between (x) [c.i.] and (y) the [c.i.] Royalty payments by Purchaser to
Perrigo for the Product during the just-concluded Marketing Year.
7.2 Intercompany Sales. Sales of Product between Purchaser and its
Affiliates shall be disregarded for the purposes of calculating royalties, and
in such cases royalties shall be payable only upon subsequent sales by the
relevant Purchaser Affiliate to a Third Party.
7.3 Royalties on Sales for Non-monetary Consideration. Subject to Section
7.2, if any Finished Product are sold or disposed of by Purchaser and/or its
Affiliates otherwise than in a bona fide arm's length sale exclusively for
money, then the Net Sales Value of such products shall be at [c.i.]
7.4 Currency. Payment of the royalties due from Purchaser hereunder shall
be [c.i.] as Perrigo shall elect to a bank account nominated in writing by
Perrigo. [c.i.] shall be made at the [c.i.] ruling on the last business day of
the Contract Quarter in respect of which the payment is due. The rate will be
the spot rate as published in the Financial Times.
-10-
ARTICLE VIII - WARRANTIES
8.1 Perrigo Warranties. Perrigo warrants that Products it sells to
Purchaser under this Agreement will, at the time of shipment, be manufactured
and packaged in compliance with the applicable requirements of the Federal Food,
Drug, and Cosmetic Act ("FFDCA") and not be adulterated or misbranded within the
meaning of the FFDCA; provided, however, Perrigo does not warrant against any
Products becoming adulterated or misbranded within the meaning of the FFDCA
after shipment to Purchaser by reason of causes beyond Xxxxxxx'x control.
Perrigo warrants that the goods sold hereunder shall be of Xxxxxxx'x standard
quality. Perrigo cannot be liable for damages resulting from any express
warranty unauthorized by Perrigo, bodily injury or chemical change in the form
of the product, or its use other than is specifically indicated in the product's
package insert. Liability of Perrigo to Purchaser for breach of contract,
negligence, or otherwise, shall not [c.i.] with respect to which any damages are
claimed. [c.i.]
8.2 Purchaser Warranties. Purchaser warrants that: (a) it has, and shall
have, good, complete and valid rights to utilize [c.i.] as contemplated by this
Agreement; (b) there are [c.i.], Finished Product or [c.i.] which would be
[c.i.] by Xxxxxxx'x performance of the Agreement and, to its knowledge, [c.i.]
or other proprietary rights of others [c.i.], Finished Product or [c.i.] which
would be [c.i.] by Xxxxxxx'x performance of this Agreement; (b) the Finished
Product may be [c.i.] for sale to Third Parties in accordance with FDA and GMP
requirements [c.i.] with FDA; (c) the [c.i.], distribution, advertising and
promotion of Finished Product [c.i.] shall be in full compliance with FDA laws
and regulations; and (d) it is free to enter into this Agreement; and, it has,
and will continue to have, the legal power, authority and right to grant the
exclusive rights set forth in Section 3.1 hereof and to perform its obligations
hereunder.
8.3 Recalls. Any decision to recall, withdraw or take a similar action with
respect to a Finished Product will be made by [c.i.]. If any recall, withdrawal,
or similar action with respect to a Finished Product results from the failure of
Finished Products sold by Perrigo to Purchaser to comply with the Product
Warranties then [c.i.]. If any recall results from [c.i.] or any other reason,
then [c.i.]. In the event that such recall results from the joint negligence of
Purchaser and Perrigo, [c.i.] shall be responsible for [c.i.]. In the event of
an FDA-initiated nationwide recall where the scope of the recall is directed at
all products containing any of the active ingredients in the Finished Product
and where the purpose of such recall is not attributable to the fault of either
Purchaser or Perrigo, [c.i.] shall be responsible for all [c.i.]. [c.i.]
ARTICLE IX - INDEMNIFICATION
9.1 Indemnity by Purchaser. The Purchaser shall defend, indemnify and hold
Perrigo (and Xxxxxxx'x affiliates and all of their respective officers,
directors, employees, and agents) harmless against and from [c.i.]
(collectively, "Losses") resulting from [c.i.] made, asserted or filed by [c.i.]
arising out of (1) the Purchaser's marketing, sale, distribution, handling or
use of the Finished Product [c.i.], (2) any [c.i.] by Purchaser or any packaging
or labeling component, design, artwork, graphics, copy or trade dress specified
or provided by the Purchaser (collectively, "Packaging") including, without
limitation, any allegation that any Packaging violates any applicable national,
federal, state, provincial, local or international law, rule or regulation or
infringes any intellectual property right of any third party, or (3) the
Purchaser's breach of any representation, warranty, covenant or other obligation
under this Agreement.
9.2 Indemnity by Perrigo. Perrigo shall defend, indemnify and hold the
Purchaser (and the Purchaser's affiliates and all of their respective officers,
directors, employees, and agents) harmless against and from any and all Losses
resulting from any [c.i.] made, asserted, or filed by [c.i.] arising out of (1)
any claim of personal injury or property damage to a third party to the extent
that such injury or damage is the result of the failure of any product that
Perrigo sells to the Purchaser to comply with the Product Warranties (as defined
in Xxxxxxx'x terms and
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conditions of sale), (2) any allegation that any Product that Perrigo sells to
the Purchaser (excluding the Packaging) infringes any United States patent,
trademark or copyright of any third party actually known by Perrigo and in
existence at the time of shipment of the product, or (3) Xxxxxxx'x breach of any
representation, warranty, covenant or other obligation under this Agreement,
other than those Losses for which Perrigo is entitled to indemnification from
the Purchaser under this Agreement.
9.3 Cooperation. Purchaser and Perrigo agree to the extent reasonably
practicable and consistent with normal insurance coverage to cooperate with each
other in the defense of any claims made by third party(ies) to which this
Article 9 applies. If either of the parties wishes to exercise its right to be
indemnified under Sections 9.1 and 9.2, such rights will be subject to the party
seeking indemnity:
(a) promptly notifying the indemnifier of the claim to be indemnified;
(b) allowing the indemnifier, if the indemnifier so requests, to
conduct and control (at the cost and expense of the indemnifier) the defense of
such a claim and any related settlement negotiations; and
(c) affording all reasonable assistance to the indemnifier (at the
cost and expense of the indemnifier) and making no admission prejudicial to the
defense of such a claim.
9.4 [c.i.]
9.5 This Article will survive any termination of this Agreement.
ARTICLE X - TERM AND TERMINATION
10.1 Term. Unless earlier terminated as provided for herein, this Agreement
shall take effect as of its full execution and shall run for an initial term
[c.i.] from the Anniversary Date (the "Initial Term"). This Agreement may be
renewed for [c.i.] Contract Years, provided that: (a) Purchaser has paid for
[c.i.] Units during each Marketing Year; (b) [c.i.] are commenced by the parties
at least [c.i.] prior to expiration of the Initial Term, and (c) the parties
agree to terms of renewal [c.i.].
10.2 Termination. Perrigo or Purchaser, as the case may be, shall have the
right to immediately terminate this Agreement if (i) the other party files a
petition in bankruptcy, or enters into an agreement with its creditors, or
applies for or consents to the appointment of a receiver or trustee, or makes an
assignment for the benefit of creditors, or suffers or permits the entry of an
order adjudicating it to be bankrupt or insolvent and such order is not
discharged within [c.i.]; (ii) if the other party materially breaches any of the
non-monetary provisions of this Agreement and such breach is not cured within
[c.i.] after the giving of written notice, the party claiming the breach shall
have the right to terminate this Agreement; or (iii) if the other party
materially breaches any of the monetary provisions of this Agreement and such
breach is not cured within [c.i.] after the giving of written notice, the party
claiming the breach shall have the right to terminate this Agreement; or (iv) if
any required license, permit or certificate required of the other party is not
approved and/or issued, or is revoked (including, but not limited to FDA and/or
EMEA revocation of marketing rights), by any applicable governmental regulatory
authority; provided that such other party may no longer appeal such decision or
reapply or otherwise pursue such permit, license or certificate.
10.3 Duties Upon Termination. In the event Purchaser breaches or terminates
this Agreement (other than as a result of a breach of this Agreement by Perrigo
or if Perrigo terminates this Agreement under Section 10.2 hereof), Purchaser
will also be required to pay
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Perrigo for its direct cost of all materials purchased by Perrigo for
Processing. Purchaser shall specify the location in the continental United
States to which delivery, at [c.i.] expense, of the foregoing is to be made.
Proprietary Information exchanged between Purchaser and Perrigo shall be
promptly returned upon termination of the Agreement.
10.4 Continuing Obligations. The rights and obligations of each of the
parties under the provisions of Articles II, XII, XIII, IX and X of this
Agreement shall continue notwithstanding the termination of this Agreement for
any reason.
ARTICLE XI - MISCELLANEOUS
11.1 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the laws of the [c.i.] without regard to its conflict of laws
provisions.
11.2 Export of Finished Product. Purchaser acknowledges that all Finished
Product provided by Perrigo hereunder are subject to the U.S. export control
laws and regulations. Purchaser will not export, reexport or otherwise dispose
of Finished Product provided pursuant to this Agreement except in strict
compliance with the letter and spirit of U.S. export laws and regulations,
including but not limited to the laws and regulations administered by the Bureau
of Export Administration ("BXA") of the U.S. Department of Commerce, the Office
of Foreign Assets Control ("OFAC") of the U.S. Department of the Treasury and
the Office of Defense Trade Controls of the U.S. Department of State.
11.3 Notices. Any and all notices provided for shall be sent to the
respective parties at the following addresses by certified or registered mail or
sent by a nationally recognized overnight courier service:
If to Perrigo: X. Xxxxxxx Company 000 Xxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Legal Department
Facsimile No.: 269.673.1386
If to Purchaser: Sirius Laboratories, Inc.
000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx: Chief Executive Officer
Facsimile No.: 847.968.2484
or to such other addresses as may be subsequently furnished by one party to the
other in writing. Any such notice shall be deemed effective from the date of
mailing.
11.4 Partial Invalidity. In the event one or more terms of this Agreement
are found to violate the provisions of any applicable statute, law or
regulation, the parties hereto shall negotiate in good faith to modify this
Agreement, but only to the extent necessary to make this Agreement valid and
enforceable, having full regard for applicable laws and the intent and purposes
of the parties entering into this Agreement.
11.5 Entire Agreement. This Agreement (together with the Confidentiality
Agreement dated May 10, 2005) and all Exhibits constitute the entire agreement
between the parties relating to the subject matter of this Agreement, and this
Agreement may not be varied except in writing signed by a duly authorized
representative of each party. Notwithstanding the foregoing to the contrary, the
parties will enter into local technical or quality agreements allocating the
respective responsibilities of the parties for cGMP compliance. To the extent
the terms of such local agreements conflict with the terms of this Agreement,
the terms of this Agreement shall prevail.
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11.6 Assignability. Neither party shall assign this Agreement other than to
Affiliates; however, in the event of any assignment, performance shall be
guaranteed by the assignor in form satisfactory to the other party.
11.7 Successors and Permitted Assigns. This Agreement shall be binding upon
and inure to the benefit of the permitted successors or permitted assigns of
Perrigo and Purchaser respectively.
11.8 Excused Non-Performance. Each of the parties shall be excused from the
performance of its obligations in the event such performance is prevented by a
cause beyond the reasonable control of such party, including without limitation,
act of God; regulation or law of any government or any agency thereof, including
any government, court-ordered or voluntary recall not attributable to the fault
of Purchaser or Perrigo; war; insurrection or civil commotion; destruction of
production facilities or materials by earthquake, fire, flood or storm; labor
disturbance; epidemic; or failure of suppliers, public utilities or common
carriers. Such excuse shall continue as long as the condition preventing the
performance continues, plus thirty (30) days after the termination of such
condition. Excused non-performance shall not include any act, omission or
circumstance arising from the negligent or willful act of the party claiming
excused non-performance, or lying within such party's reasonable commercial
ability to prevent.
11.9 Announcements. Neither party shall, without the other party's prior
written consent, make any announcement, press release or other disclosure
regarding this Agreement or that any business relationship exists between the
parties.
11.10 Trademarks. Except for use on Finished Product as provided in the
Specifications, Perrigo shall not use Purchaser's trademarks, service marks,
company name or logos on any other goods or products, or on any advertising or
promotional materials, without first obtaining the prior written consent of
Purchaser.
IN WITNESS WHEREOF, the parties have caused this Agreement to be entered
into by their duly authorized representatives as of the day and year first set
forth above.
X. XXXXXXX COMPANY SIRIUS LABORATORIES NC.
By: /s/ Xxxx Xxxxxx By: /s/ Xxxxx X. Xxxxxxx
--------------------------------- ------------------------------------
Its: Exec. Vice President Its: Vice Chairman
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EXHIBIT A
Prices of Finished Product
The price for Finished Product for [c.i.] shall be US[c.i.]/Unit.
Exhibit A-1
