Document:

Supply Agreement

 

Exhibit 10.109

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request. Omissions are designated as [***].
A complete version of this exhibit has been filed separately with the Securities and Exchange
Commission.

SUPPLY AGREEMENT

     This Supply Agreement (“Agreement”) is dated as of the 4th day of September, 2003 by and
between Andrx Pharmaceuticals, Inc., a Florida Corporation (“hereinafter referred to as “ANDRX”)
with offices located at 4955 Orange Dr., Davie, FL, 33314 and Pfizer Inc., a Delaware corporation
(hereinafter referred to as “PFIZER”), with offices located at 235 East 42nd Street, New
York, New York l0017-5755.

     WHEREAS, ANDRX, and/or certain of its Affiliates, have filed with the FDA two Abbreviated New
Drug Applications, ANDA Nos. 76-159 and 76-621, seeking approval to engage in the commercial
manufacture, use, offer for sale and sale of Glipizide Extended-release Tablets in 10 mg dosage
strength (ANDA No. 76-159), and in 5 mg and 2.5 mg dosage strengths (ANDA No. 76-621)
(collectively, “ANDRX ANDA Products”); and

     WHEREAS, ANDRX and certain of its Affiliates have entered into a Settlement Agreement with
PFIZER and ALZA CORPORATION pursuant to which PFIZER and ANDRX are entering into this Agreement,
which provides that ANDRX, for the term stated herein, may market, sell, and distribute on a
non-exclusive basis (except as hereinafter provided) the Products (as hereinafter defined) for
PFIZER.

     NOW, THEREFORE, in consideration of the premises set forth and covenants
exchanged herein and other good and valuable consideration, the sufficiency and receipt of which
are hereby acknowledged, ANDRX and PFIZER intending to be legally bound agree as follows:

 

 

	I.	 	DEFINITIONS

	 	1.1	 	“Affiliate(s)” shall mean any corporation, association, company, organization
or other entity that directly or indirectly through one or more intermediaries,
controls, is controlled by, or is under common control with ANDRX or PFIZER, as the
case may be. For purposes of this definition, control means the ability, directly or
indirectly, through ownership of securities, by agreement, or by any other method, to
direct more than fifty percent (50%) of the outstanding equity votes of any entity,
whether or not represented by securities, or to otherwise control the management
decisions of any entity.
	 
	 	1.2	 	“Agreement” shall have the meaning set forth in the first sentence hereof.
	 
	 	1.3	 	“Alza/Pfizer License Agreement” shall mean the Development and U.S. License
Agreement dated November 5, 1993 between ALZA CORPORATION and PFIZER INC.
	 
	 	1.4	 	“ANDRX” shall have the meaning set forth in the first sentence hereof.
	 
	 	1.5	 	“ANDRX Activities” shall have the meaning set forth in Section 8.1 hereof.
	 
	 	1.6	 	“ANDRX ANDA Products” shall have the meaning specified in the first recital.
	 
	 	1.7	 	“cGMPs” shall mean Current Good Manufacturing Practices as defined in 21 CFR
§210 et seq., as amended from time to time.
	 
	 	1.8	 	“Calendar Quarter” shall mean those three (3) month periods beginning on
January 1, April 1, July 1, and October 1.
	 
	 	1.9	 	“COA” shall have the meaning set forth in Section 5.1 hereof.

 

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	 	1.10	 	“Commencement Date” shall mean January 1, 2004 or such earlier date as ANDRX
receives FDA approval for a product described in either its ANDA No. 76-159 or its
ANDA No. 76-621; provided, however, that in no event shall the Commencement Date be
earlier than November 25, 2003.
	 
	 	1.11	 	“Commercially Reasonable Efforts” shall mean that degree of effort, expertise
and resources that a person of ordinary skill, ability and experience in the matters
addressed herein would utilize and otherwise apply with respect to fulfilling the
obligations assumed hereunder.
	 
	 	1.12	 	“Confidential Information” shall have the meaning set forth in Section 9.1
hereof.
	 
	 	1.13	 	“FDA” shall mean the Food and Drug Administration of the United States.
	 
	 	1.14	 	“FFDCA” shall mean the Federal Food, Drug and Cosmetic Act, as amended, 21
U.S.C. §301 et seq., and any related federal and/or state law or regulation pertaining
to the safety, effectiveness, adulteration, misbranding, mishandling, packaging,
labeling or storage of pharmaceutical ingredients, finished pharmaceutical products,
and/or medical devices that may be applicable to the Product during the term of this
Agreement.
	 
	 	1.15	 	“Firm Order” shall mean a firm, binding, written order for Product to be
manufactured by PFIZER, specifying quantities and delivery schedules for each Product.
Firm Orders must be in full lot size quantities as described in Exhibit A.
	 
	 	1.16	 	“GAAP” means generally accepted accounting principles in the United States of
America, consistently applied.

 

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	 	1.17	 	“Indemnified Party” shall have the meaning set forth in Section 8.3 hereof.
	 
	 	1.18	 	“Indemnifying Party” shall have the meaning set forth in Section 8.3 hereof.
	 
	 	1.19	 	“Initial Term” shall have the meaning set forth in Section 7.1 hereof.
	 
	 	1.20	 	“Intellectual Property” shall mean all intellectual property owned by, or
licensed to a Party including, without limitation, patents, patent applications,
continuations-in-part, divisionals, trade secrets, know-how, copyrights, trade names,
trademarks, and trade dress.
	 
	 	1.21	 	“Law” shall mean any local, state or federal rule, regulation, statute or law
relevant to the manufacture, distribution and/or sale of the Product, and to any other
matters set forth herein.
	 
	 	1.22	 	“Losses” shall mean any liabilities, damages, costs or expenses, including
reasonable attorneys’ fees, incurred by any Party that arise from any claim, lawsuit
or other action by a Third Party.
	 
	 	1.23	 	“Marketing Allowance” shall mean [***] percent of gross sales, except that
for sales made by Anda, Inc., an Affiliate of ANDRX LLC, Anda Pharmaceuticals Inc., an
Affiliate of ANDRX LLC, and Valmed Pharmaceutical, Inc., an affiliate of ANDRX, doing
business under the names Value in Pharmaceuticals or V.I.P. (collectively, “ANDRX
Distribution Affiliate”), the Marketing Allowance shall be [***] percent of gross
sales. Notwithstanding the foregoing, the [***]% Marketing Allowance on sales through
an ANDRX Distribution Affiliate shall not be applicable to any sales to large
warehousing chains, managed care organizations, wholesalers and distributors and shall
apply only to sales to independent pharmacies, buying

 

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	 	 	 	groups, nonwarehousing chains and physicians. Exhibit B to this Agreement provides
a specific (but not exclusive) list of accounts that shall not receive the [***]%
Marketing Allowance.
	 
	 	1.24	 	“MSDS” shall have the meaning set forth in Section 5.1 hereof.
	 
	 	1.25	 	“NDA” shall mean the PFIZER New Drug Application, and any supplements
thereto, relating to Glucotrol XL® in 10 mg dosage strength, 5 mg dosage strength or
2.5 mg dosage strength, as applicable.
	 
	 	1.26	 	Net Sales” shall mean the gross amount invoiced to Third Parties for the
Product for product received by Third Parties in the Territory, less provisions for:

	 	(a)	 	reasonable and customary trade discounts, promotional
allowances, cash discounts, customer refunds and credits, returns, customer
and government rebates and any other similar allowances which effectively
reduce the net selling price;
	 
	 	(b)	 	actual chargebacks, retroactive price or shelf stock
adjustments and price equalizations; and
	 
	 	(c)	 	the Marketing Allowance.

Such amounts will be determined in accordance with GAAP, except for the treatment
of (b) above, which shall be treated on a cash basis.

	 	1.27	 	“Party” or “Parties” shall mean ANDRX or PFIZER, or both of them, depending
upon the context in which such word may appear.

 

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	 	1.28	 	“Person” means a natural person, a corporation, a partnership, a trust, a
joint venture, a limited liability company, any governmental authority or any other
entity or organization.
	 
	 	1.29	 	“Pfizer” shall have the meaning set forth in the first sentence hereof.
	 
	 	1.30	 	“PFIZER Activities” shall have the meaning set forth in Section 8.2 hereof.
	 
	 	1.31	 	“Product” or “Products” shall mean PFIZER’S NDA extended-release glipizide
pharmaceutical product, in 2.5 mg, 5mg and 10 mg dosage strengths. Products shall not
mean any product sold by PFIZER under the trademark Glucotrol® or Glucotrol XL® or any
ANDRX ANDA products.
	 
	 	1.32	 	“Reporting Period” shall mean a three-month period corresponding to a
Calendar Quarter.
	 
	 	1.33	 	“Settlement Agreement” shall mean the Agreement dated as of September 4, 2003
by and among PFIZER, ALZA CORPORATION, ANDRX CORPORATION, ANDRX PHARMACEUTICALS, INC.
and ANDRX PHARMACEUTICALS, LLC, which provides that the Parties shall enter into this
Agreement.
	 
	 	1.34	 	“Specifications” shall mean all product, regulatory, manufacturing, quality
control, and quality assurance procedures, processes, practices, standards,
instructions and specifications comprising PFIZER’s FFDCA approval applicable to the
manufacture and packaging of Products as set forth in the NDA, and such other FDA
and/or other regulatory requirements as may be applicable.

 

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	 	1.35	 	“Territory” shall mean the United States of America, together with its
territories and possessions.
	 
	 	1.36	 	“Third Party” shall mean any Person that is neither a party to this Agreement
nor an Affiliate of a party to this Agreement.
	 
	 	1.37	 	“Transfer Price” shall mean for each Product the price set forth in Exhibit
A, as may be modified by agreement of the Parties pursuant to Paragraph 4.1 hereof.

	II.	 	SCOPE OF AGREEMENT

	 	2.1	 	Pursuant to the terms and conditions of this Agreement, ANDRX shall purchase
from PFIZER all of its requirements of Products. PFIZER shall sell such Products to
ANDRX on a non-exclusive basis; provided, however, that PFIZER shall sell and ANDRX
shall be entitled to market, sell, promote and/or distribute Products on an exclusive
basis (except as to PFIZER’s branded Glucotrol XL® product) for a period beginning on
the Commencement Date and ending 180 days thereafter (“Exclusivity Period”), which
date shall be extended if for any reason, including Force Majeure, PFIZER is unable to
supply quantities of the Products to ANDRX pursuant to a Firm Order by the number of
days that PFIZER is unable to supply pursuant to such Firm Order. After the expiration
of the Exclusivity Period, the Agreement will continue on a non-exclusive basis for
the remainder of its term. Notwithstanding the foregoing, if ANDRX markets any ANDRX
ANDA Product prior to the end of the Exclusivity Period, the Exclusivity Period shall
immediately terminate with respect to such ANDRX ANDA

 

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	 	 	 	Product upon the first commercial sale of such ANDRX ANDA Product to a Third Party
(as evidenced by invoices, transfer documents, shipping documents or the like to
such Third Party). It is the understanding of the Parties that after the
expiration of the Exclusivity Period, PFIZER shall have the right to sell Products
to Third Parties provided in any such case, it does not adversely affect PFIZER’s
ability to manufacture or supply the Products to ANDRX as provided in this
Agreement.
	 
	 	2.2	 	ANDRX shall not promote or distribute the Products outside the Territory or
to any purchaser, distributor or distributee that ANDRX knows or reasonably should
know, intends to utilize, resell or redistribute the Products outside the Territory.
ANDRX shall use Commercially Reasonable Efforts to promote the Products, exercising
substantially the same diligence and adhering to substantially the same standards it
employs with respect to its other products, provided however, that ANDRX shall not be
deemed to have failed to abide by or have failed to perform in accordance with the
foregoing standard or promotional effort if (1) ANDRX is prevented from performing or
hindered in its performance of such standard by any act or omission of PFIZER; or (2)
by virtue of ANDRX’s sale or marketing of the ANDRX ANDA Products. The exercise of a
right specifically conferred by this Agreement shall not, by itself, constitute either
a failure by ANDRX to satisfy its obligation, pursuant to this section, to use
Commercially Reasonable Efforts to promote the Products, or an act or omission by
PFIZER that prevents or hinders ANDRX from satisfying that obligation.

 

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	 	2.3	 	ANDRX will have the right in its sole discretion to establish the price at
which the Products will be sold to Third Parties.

	III.	 	FORECASTS AND SUPPLY

	 	3.1 	(a)	 	ANDRX shall provide PFIZER with a Firm Order for the period from the date
hereof up to and including March 31, 2004, which Firm Order shall be attached as
Schedule A. PFIZER shall supply the quantities set forth on Schedule A for each
Product in accordance with the delivery schedule set forth therein, provided that the
initial delivery date is no less than [***] days following receipt by PFIZER of
approved label copy and tablet imprinting directions from ANDRX. PFIZER shall use
Commercially Reasonable Efforts to supply Products to ANDRX as set forth in Schedule A
no later than the Commencement Date. To the extent such Firm Order is not sufficient
to meet ANDRX’s actual requirements for any Product for such period, PFIZER shall use
its Commercially Reasonable Efforts to supply ANDRX with its requirements beyond the
amounts set forth on Schedule A. For periods after March 31, 2004, Firm Orders shall
be filled by PFIZER in accordance with the provisions of Section 3.1(b) and (c).
	 
	 	 	(b)	 	Except as provided in Section 3.1(a), within [***] after the
beginning of each Calendar Quarter (commencing with the first Calendar Quarter
of 2004), ANDRX shall give to PFIZER a forecast of ANDRX’s estimated quarterly
requirements of the Products for the following [***]. [***] forecast delivered
to PFIZER pursuant to the preceding sentence shall represent ANDRX’s
reasonable estimates of the quantity of the Products

 

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	 	 	 	that ANDRX will require during [***] to which such forecast applies, and the
forecast of its requirements of the Products during the first quarter of such
[***] period shall be reflected in a Firm Order accompanying such forecast.
	 
	 	(c)	 	Notwithstanding the foregoing, except as provided for below,
any Firm Order (except for the first Firm Order), for any Product placed for a
Calendar Quarter in accordance with Section 3.1(b) shall be between [***] of
the most recent forecast estimated quantity for such Product for such Calendar
Quarter provided by ANDRX to PFIZER in accordance with this Section 3.1,
except that Firm Orders shall not be required to be between [***] of the most
recent forecast in any Calendar Quarter in which a new generic glipizide
extended release product enters the market. If requested by ANDRX, PFIZER
shall use its Commercially Reasonable Efforts to supply an amount exceeding
[***] of the most recent forecast estimated quantity for a Product.
	 
	 	(d)	 	PFIZER shall promptly notify ANDRX in writing if at any time
PFIZER has reason to believe that PFIZER will not be able to fill at [***] of
a Firm Order for any Product in accordance with the delivery schedule
specified therein by ANDRX and pursuant to the terms and conditions of this
Agreement. PFIZER shall deliver Product to ANDRX pursuant to each Firm Order
no more than [***] after ANDRX’s requested delivery date, provided that such
Firm Orders are delivered to PFIZER at [***] to ANDRX’s requested delivery
date.

 

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	 	(e)	 	During any period in which PFIZER does not or cannot for any
reason supply all of ANDRX’s requirements of the Products pursuant to a Firm
Order, then PFIZER will supply ANDRX on a [***] before producing Products for
any Third Party or for its own branded Glucotrol XL® product or generic
Product. [***]
	 
	 	(f)	 	In the event ANDRX intends to manufacture and/or market any
of the ANDRX ANDA Products, it shall have the right to do so without
terminating this Agreement. In such event, ANDRX shall give PFIZER [***]
prior written notice of its intention to do so. Upon the effective date of
such written notice, PFIZER shall be relieved of its obligations to
manufacture and supply Products for ANDRX, other than the fulfillment of Firm
Orders. ANDRX will remain obligated to purchase previously provided Firm
Orders. If ANDRX ceases providing Firm Orders to PFIZER and then later wishes
to resume purchase of any of the Products pursuant to this Agreement, PFIZER
and ANDRX will discuss in good faith the feasibility of such request. If
PFIZER determines, in its sole discretion, that it has the resources and
capacity to accommodate ANDRX’s request, then ANDRX shall provide PFIZER with
a new Firm Order for such Products with a delivery date [***] from receipt by
PFIZER of the Firm Order.
	 
	 	(g)	 	All forecasts to be provided or delivered by ANDRX to PFIZER
pursuant to this Section 3.1 shall be in writing.

 

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	 	3.2	 	PFIZER agrees to accept all Firm Orders submitted in accordance with and on
the terms set forth in this Agreement. No terms and conditions contained in any Firm
Order, acknowledgment, invoice, bill of lading, acceptance or other preprinted form
issued by either Party shall be effective to the extent they are inconsistent with or
modify the terms and conditions contained herein.
	 
	 	3.3	 	All Products sold pursuant to this Agreement shall be delivered FCA
(INCOTERMS 2000) [***]. ANDRX shall bear the cost of shipping and insurance.
	 
	 	3.4	 	PFIZER will manufacture, package, label, store, and ship the Products in
accordance with Specifications set forth in the NDA for such Product as such NDA may
be amended from time to time, and, as to tablet printing designation and label copy,
in accordance with ANDRX’s reasonable instructions to PFIZER. ANDRX shall be promptly
and fully advised of any new instructions or specifications required by the FDA or the
FFDCA. In the event that PFIZER cannot reasonably manufacture Products in accordance
with ANDRX’s instructions and Specifications, PFIZER shall promptly so advise ANDRX.

	IV.	 	PAYMENTS AND REPORTS

	 	4.1 	(a) 	 	ANDRX shall remit payment for shipments of Products sent by PFIZER to
ANDRX in U.S. dollars [***]. The invoice shall reflect the Transfer Price on date of
shipment by PFIZER for each Product. The Transfer Price for the first twelve (12)
month period for each Product is set forth on Exhibit A attached hereto. [***] prior
to the end of the initial twelve (12)

 

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	 	 	 	month period and each twelve (12) month period thereafter, ANDRX and PFIZER
agree to discuss in good faith the establishment of a new Transfer Price.
Additionally, either party may request a new Transfer Price from time to time
for good cause or, in any case, if the Reconciliation Statement (defined in
4.2(a) below) reflects a discrepancy of [***] or greater, then the Parties
shall adjust the Transfer Price in an amount which the Parties determine in
good faith reflects an appropriate Transfer Price based upon then existing
market conditions.
	 
	 	(b) 	 	If, in any Reporting Period, the Net Sales price per bottle, multiplied by
[***], is less than the amounts set forth below, the parties will discuss in
good faith any amendments to the Agreement necessary to make the Agreement
economically viable for both parties

10 mg Product — price per bottle (100) [***]

(500) [***]

5 mg Product — price per bottle (100) [***]

(500) [***]

2.5 mg Product — price per bottle (30) [***]

	 	4.2 	(a)	 	Within [***] of the end of each Reporting Period, ANDRX will determine
the quantity of each Product sold by ANDRX during the Reporting Period, and the
corresponding Net Sales and aggregate Transfer Price associated with the units of
Products sold by ANDRX during the Reporting Period and provide such information to
PFIZER (“Reconciliation Statement”). Additionally, ANDRX will provide PFIZER with
ending inventory quantities for each Product as of the end of each Reporting Period.

 

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	 	(b)	 	In the event that [***] of Net Sales for all Products for
such Reporting Period is in excess of the corresponding aggregate Transfer
Price for Products sold in the Reporting Period, ANDRX shall pay to PFIZER the
amount of such excess. Such payment by ANDRX shall be made within [***] after
delivery of the Reconciliation Statement to PFIZER.
	 
	 	(c)	 	In the event that the corresponding aggregate Transfer Price
for all such Products in such Reporting Period is in excess of [***] of the
Net Sales for all Products for such Reporting Period, either (1) ANDRX shall
pay to PFIZER [***] of the Net Sales for all Products sold by ANDRX during
such Reporting Period as reflected in the Reconciliation Statement in lieu of
the Transfer Price or (2) if all or any part of the Transfer Price was
previously paid by ANDRX, PFIZER shall pay to ANDRX the amount by which the
Net Sales for all Products sold by ANDRX during such Reporting Period, as
reflected in the Reconciliation Statement, exceeds the Transfer Price. In the
case of overpayments described in (2) above, PFIZER shall make such payment to
ANDRX within [***] of the delivery of the Reconciliation Statement to PFIZER.
	 
	 	(d)	 	ANDRX shall keep complete and accurate books and records
setting forth gross sales, Net Sales, aggregate Transfer Price, and amounts
payable to PFIZER hereunder. ANDRX shall permit PFIZER at PFIZER’s expense, by
independent certified public accountants employed by PFIZER and acceptable to
ANDRX, to examine such books and records at any reasonable time, [***]
following the rendering of the reports, accountings

 

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	 	 	 	and payments that are the subject of the examination. As a condition to such
examination, such independent accountants shall execute a written agreement,
reasonably satisfactory to ANDRX, obligating such accountants to maintain in
confidence all information disclosed to such accountants during the examination
and all information generated by such accountants pursuant to the examination.
Such accountants shall not disclose to PFIZER any of ANDRX’s cost data.
Notwithstanding the foregoing, such accountants shall be permitted to issue a
written statement to PFIZER and ANDRX to the effect that they have reviewed the
books and records of ANDRX and either (a) that the amounts of the payments made
to PFIZER are in conformity with the books and records and the applicable
provisions of this Agreement, or (b) that adjustments of specified amounts
should be made.
	 
	 	(e)	 	If ANDRX and PFIZER are unable to agree upon any amount
payable to either party under this Agreement, then they agree to retain a
mutually acceptable independent certified public accounting firm, from among
the then five (5) largest independent public accounting firms practicing in
the Territory, to review the relevant books and records and to submit to the
parties its written determination as to the amount in dispute and the basis
for its determination. The determination by the independent accounting firm
will be binding on the parties absent manifest error. Each party shall pay
one-half of the fees and expenses of the independent accounting firm for such
determination. If any such examination shows any underpayment

 

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	 	 	 	or overpayment, a correcting payment or refund shall be made within [***] days
after receipt of such written statement.

	V.	 	PRODUCT TESTING/INSPECTION

	 	5.1	 	PFIZER shall perform quality assurance testing with respect to the Products
sold hereunder, including stability testing, so that the Products conform with the
Specifications. PFIZER shall provide to ANDRX a certificate for the Product
describing the Product, product number, lot number and expiration date, the physical,
chemical, biological or other testing results and specifications relating to the
Product and certifying that the Product meets the Specifications to ANDRX in the form
of a Certificate of Analysis (hereinafter “COA”). PFIZER will also provide ANDRX with
Material Safety Data Sheets (hereinafter “MSDS”) as required for the Products, and
updates of same as necessary. ANDRX will permit PFIZER’s personnel, upon reasonable
notice, to visit at reasonable intervals, and for reasonable durations during regular
business hours, any ANDRX facility used for the storage and distribution of the
Products and will allow such personnel to review and make copies of any relevant
records in connection therewith.
	 
	 	5.2	 	ANDRX shall have a period of [***] from the later of (a) the date of ANDRX’s
receipt of the Products in accordance with Section 3.4 hereof, or (b) the date of
ANDRX’s receipt of the COA’s applicable to such Product, to inspect any shipment of a
Product to determine whether such shipment conforms to the Specifications. If ANDRX
determines that a Product does not conform to the Specifications, it shall notify
PFIZER, immediately, if

 

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	 	 	 	possible, but no later than [***] after determining a Product doesn’t conform to
the Specifications. ANDRX’s failure to notify PFIZER within the stipulated period
will be deemed, for purposes of this Agreement, as ANDRX’s acceptance of such
shipment and shall constitute a waiver of any claims ANDRX may have against PFIZER
with respect to such shipment subject, however, to ANDRX’s right to reject such
Product for latent defects discovered by ANDRX or ANDRX’s customer(s) after such
stipulated period has expired. If PFIZER agrees that a Product does not conform to
the Specifications, ANDRX shall return the non-conforming Product to PFIZER, at a
location designated by PFIZER and at PFIZER’s expense. PFIZER, at no expense to
ANDRX, shall use Commercially Reasonable Efforts to replace any non-conforming
Product within the shortest possible time.
	 
	 	5.3	 	In the event PFIZER does not agree with ANDRX’s determination that a Product
fails to meet Specifications, the Parties shall, in good faith, attempt to resolve
such dispute. In the event the Parties cannot resolve said dispute among themselves
they may submit the matter to an independent Third Party testing laboratory agreeable
to both ANDRX and PFIZER for a binding opinion. The expenses of obtaining the binding
opinion shall be equally shared by ANDRX and PFIZER. In the event that the Parties do
not agree to submit the dispute to a testing laboratory, the Parties shall remain free
to pursue any legal, equitable or administrative remedies to which they may be
entitled.

 

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	VI.	 	REGULATORY AND MEDICAL INQUIRY

	 	6.1	 	PFIZER shall remain responsible for maintaining and fulfilling all regulatory
requirements in the Territory with respect to a Product that are imposed by Law upon
PFIZER as the manufacturer of the Product and the holder of the NDA in connection
therewith. ANDRX shall be responsible for obtaining, maintaining and fulfilling all
regulatory requirements in the Territory with respect to a Product that are imposed by
Law upon ANDRX in connection with ANDRX’s marketing, distribution and sale of such
Product. Each Party will, on a timely basis, provide the other Party with all
information that such Party has that the other Party does not have that is reasonably
necessary and relevant to either Party’s obligations in fulfilling such requirements.
ANDRX and PFIZER shall cooperate, to the fullest extent, to ensure that the Parties
comply with such regulatory requirements, including but not limited to the prompt
reporting of adverse drug experience information and other post-marketing reports as
are required to be filed with the FDA or its equivalent; provided, however, that this
provision shall not be interpreted to require PFIZER to disclose to ANDRX any
Intellectual Property owned by any Third Party, regardless of whether PFIZER has
access to such Intellectual Property. ANDRX shall submit to PFIZER all complaints,
adverse drug experience reports and other medical inquiries associated with a Product
within [***] of ANDRX’s receipt of such reports. PFIZER will be responsible for
fulfilling any regulatory requirements with respect to such events, including but not
limited to the filing of all Form FD 2253’s, and will make any necessary

 

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	 	 	 	contact with the FDA regarding the subject matter of same. The Parties will
cooperate in good faith to develop a procedure for handling adverse drug experience
reports.
	 
	 	6.2	 	In the event ANDRX or PFIZER shall be required or requested by any
governmental authority (or shall voluntarily decide) to recall a Product because such
Product may violate any Laws or for any other reason, the Parties shall cooperate
fully with one another in connection with any recall. The Parties agree that if either
Party reasonably believes a voluntary recall is necessary, the other Party shall not
object to such recall. If a recall is due to PFIZER’s negligence, willful misconduct
or breach of this Agreement, PFIZER shall reimburse ANDRX for the Transfer Price paid
by ANDRX for such recalled Product, all of the reasonable costs and expenses actually
incurred by ANDRX in connection with the recall, including, but not limited to, the
costs of retrieving Products already delivered to customers, the costs and expenses
ANDRX is required to pay for notification, shipping and handling charges, and such
other costs as may be reasonably related to the recall. If a recall is due to ANDRX’s
negligence, willful misconduct or breach of this Agreement, ANDRX shall remain
responsible for the Transfer Price for the recalled Product and shall reimburse PFIZER
for all the reasonable costs and expenses described above actually incurred by PFIZER
in connection with such recall including administration of the recall and such other
actual costs as may be reasonably related to the recall. If a recall results from a
cause other than the negligence, willful misconduct or breach of this

 

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	 	 	 	Agreement of or by ANDRX or PFIZER, the Parties shall share all costs of the
recall, including the Transfer Price in the following percentage, PFIZER [***] and
ANDRX [***] Prior to any reimbursements pursuant to this Section, the Party
claiming any reimbursement shall provide the other Party with reasonably acceptable
documentation of all reimbursable costs and expenses. Neither party shall be
liable to the other for consequential damages or lost profits.
	 
	 	6.3	 	ANDRX shall be responsible for filing and maintaining all documentation and
other information as required by each and every state and locality (hereinafter
“State”) for the purpose of listing each Product on each such State’s formulary or
other similar authority, and for obtaining such other approvals as may be necessary to
sell such Products in the Territory. PFIZER shall provide ANDRX with such assistance
as reasonably necessary to obtain such listings including taking such steps on ANDRX’s
behalf as may be required under any State’s laws, regulations or procedures. ANDRX
will pay Medicaid and other applicable rebates required by law or contract.
	 
	 	6.4	 	Notwithstanding anything to the contrary set forth elsewhere herein, ANDRX
shall have the right, without PFIZER’s prior approval, to promote and publicize the
Products in its customary fashion, and may publicize such information about the
Products as it usually and customarily provides for its own products utilizing its
usual and customary channels of communication, and its standard forms, which may be
revised from time to time. PFIZER shall not distribute any promotional materials that
relate to ANDRX without the

 

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	 	 	 	prior written consent of ANDRX. ANDRX will not use the PFIZER name or any PFIZER
trademark without PFIZER’s prior written consent.

	VII.	 	TERM AND TERMINATION

	 	7.1	 	The term of this Agreement shall begin on the Commencement Date and shall
terminate on the fifth anniversary of the Commencement Date (the “Initial Term”);
provided, however, that, subject to the succeeding sentence, the Parties may extend
this Agreement for up to two additional terms of two years each on the same terms and
conditions by mutual written consent of the Parties. At any time after the expiration
of the Initial Term, either party may terminate this Agreement upon [***] advance
written notice.

	 	7.2	 	(a) If either Party shall at any time materially fail to abide by or fail to
perform in accordance with any of the material provisions of this Agreement, the
other Party shall have the right to terminate this Agreement upon [***] days’ notice
to the allegedly defaulting Party specifying the default complained of, setting forth
the underlying reasons for its belief a default has occurred and the remedy sought.
The Party allegedly in default may cure the asserted breach or file a lawsuit within
the notice period; provided, however, that before a Party shall be entitled to file a
lawsuit, the parties shall meet and in good faith attempt to resolve the dispute. If a
lawsuit is filed, the Agreement shall continue in full force and effect as if the
alleged breach had not occurred, pending the outcome of such litigation.

 

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	 	(b)	 	If either Party (i) institutes or has instituted against it
any insolvency, receivership, bankruptcy or other proceedings for the
settlement of that Party’s debts, and such proceedings are not dismissed
within [***], (ii) makes an assignment for the benefit of creditors, or (iii)
dissolves or ceases to do business, the other Party may terminate this
Agreement without notice.

	 	7.3	 	This Agreement shall be subject to immediate termination by either Party in
the event the manufacture, distribution or sale of any Product would materially
contravene any applicable Law or administrative order; provided, however, no
termination shall occur if the manufacture, distribution or sale of such Product can
be brought into compliance with such Law within a reasonable period of time following
the notice of non-compliance or violation.
	 
	 	7.4	 	Termination of this Agreement for any reason shall be without prejudice to:

	 	(a)	 	PFIZER’s right to receive all payments due from ANDRX as of
the effective date of such termination, if any;
	 
	 	(b)	 	ANDRX’s right to sell such Product remaining in its
inventory; and
	 
	 	(c)	 	Any other legal, equitable, or administrative remedies as to
which a Party is or may become entitled.

	VIII.	 	INDEMNIFICATION AND INSURANCE

	 	8.1	 	ANDRX shall defend, indemnify and hold harmless PFIZER, its Affiliates and
the respective officers, directors, agents and employees of each from and against any
Losses resulting from or arising out of ANDRX’s storage, handling, marketing,
promotion, distribution, and/or delivery of the Products,

 

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	 	 	 	the execution by ANDRX of this Agreement, the performance or breach by ANDRX of its
representations, warranties or obligations under this Agreement or the negligence
or willful misconduct of ANDRX, its employees or its agents (collectively “ANDRX
Activities”), except to the extent such Losses result from PFIZER Activities (as
defined in Section 8.2).
	 
	 	8.2	 	PFIZER shall defend, indemnify and hold harmless ANDRX, its Affiliates and
the respective officers, directors, agents and employees of each from and against any
Losses resulting from or arising out of PFIZER’s design, manufacturing, testing,
packaging, storage, handling, and labeling (other than labeling at ANDRX’s request) of
the Products, the execution by PFIZER of this Agreement, the performance or breach by
PFIZER of its representations, warranties or obligations under this Agreement, or the
negligence or willful misconduct of PFIZER, its employees or its agents (collectively
“PFIZER Activities”), except to the extent such Losses result from ANDRX Activities
(as defined in Section 8.1).
	 
	 	8.3	 	A Party seeking indemnification (“Indemnified Party”) shall notify, in
writing, the other Party or Parties (“Indemnifying Party”) within [***] days of the
assertion of any claim or discovery of any fact upon which the Indemnified Party
intends to base a claim for indemnification. An Indemnified Party’s failure to so
notify the Indemnifying Party shall not, however, relieve such Indemnifying Party from
any liability under this Agreement to the Indemnified Party with respect to such claim
except to the extent that such Indemnifying Party is actually denied, during the
period of delay in notice, the

 

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	 	 	 	opportunity to remedy or otherwise mitigate the event or activity(ies) giving rise
to the claim for indemnification and thereby suffers or otherwise incurs additional
liquidated or other readily quantifiable damages as a result of such failure. The
Indemnifying Party, while reserving the right to contest its obligations to
indemnify hereunder, shall be responsible for the defense of any claim, demand,
lawsuit or other proceeding in which the allegations, if proved, would trigger the
Indemnifying Party’s obligations under Section 8.1 or 8.2. The Indemnified Party
shall have the right at its own expense to participate jointly with the
Indemnifying Party in the defense of any such claim, demand, lawsuit or other
proceeding, but the Indemnifying Party shall have the right to settle, try or
otherwise dispose of or handle such claim, demand, lawsuit or other proceeding on
such terms as the Indemnifying Party shall deem appropriate, subject to any
reasonable objection of the Indemnified Party. Any settlement agreed to by the
Indemnifying Party over the objection of the Indemnified Party may provide only
monetary relief and may not include any admission of liability.
	 
	 	8.4	 	Each Party will provide each other Party with evidence of insurance
reflecting the comprehensive general liability and products liability programs each
has in effect and name the other Party as an additional insured with respect to sale
of the Products.

	IX.	 	CONFIDENTIAL INFORMATION

	 	9.1	 	Confidential information is any information relating to the business or
business plans of a Party including, without limitation, know-how, formulas,

 

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	 	 	 	trade secrets, clinical or non-clinical data, processes, specifications, suppliers
or customers (“Confidential Information”). Except as provided below and in
paragraph 5 of the Settlement Agreement, during the term of this Agreement and for
five (5) years thereafter, no Party and no Affiliate of a Party shall release to
any Third Party any Confidential Information of any other Party or any information
with respect to the existence and terms of this Agreement without the prior written
consent of each other Party. Except as (a) required by statute, ordinance,
regulation or by court order, (b) necessary or advisable in the opinion of the
disclosing Party’s counsel, to comply with any reporting or disclosure requirements
of the Securities and Exchange Commission, the New York Stock Exchange, NASDAQ or
any governmental agency or other regulatory body, (c) required pursuant to
compulsory legal process, (d) necessary for the exercise of the rights granted to
the Parties under this Agreement, or (e) appropriate, in PFIZER’s discretion, in
its commercial relationship with ALZA CORPORATION, no Party hereto will make any
public announcement or disclosure to Third Parties of this Agreement, or any of the
terms hereof, without the prior written approval of the other Parties. With
respect to disclosure permitted pursuant to clause (e) above, PFIZER shall require,
in writing, that the recipient of such information keep such information
confidential to the same extent it protects its own confidential information. If a
Party is disclosing information relating to this Agreement, or any of the terms
hereof, to comply with statutory or regulatory reporting or disclosure or legal
process requirements, such Party intending to make such

 

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	 	 	 	disclosure shall give each other Party at least [***] prior notice in writing of
the content of the intended disclosure, unless such statutory or regulatory
reporting or legal process disclosure requirements would require earlier
disclosure, in which event, the notice shall be provided as early as practicable.

	X.	 	REPRESENTATIONS AND WARRANTIES

	 	10.1	 	PFIZER hereby represents and warrants to ANDRX as follows:

	 	(a)	 	PFIZER is a corporation duly organized and validly existing
under the laws of the State of Delaware;
	 
	 	(b)	 	PFIZER has the requisite corporate authority to execute and
deliver this agreement and to perform its obligations hereunder;
	 
	 	(c)	 	Any Product delivered by PFIZER to ANDRX shall, at the time
of shipment have been manufactured, packaged, stored and shipped by PFIZER in
conformity with cGMPs, Specifications, and any other applicable Laws, and
shall not be adulterated, misbranded or otherwise violative of the FFDCA or
other applicable Laws;
	 
	 	(d)	 	The execution and performance of PFIZER’s obligations
hereunder, are not and will not be in violation of or in conflict with any
material obligation it may have to any Third Party;
	 
	 	(e)	 	PFIZER is not debarred and PFIZER has not and will not use in
any capacity the services of any person debarred under subsection 306(a) or
(b) of the Generic Drug Enforcement Act of 1992. If at any time this
representation and warranty is no longer accurate, PFIZER shall immediately
notify ANDRX of such fact; and

 

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	 	(f)	 	PFIZER has and will maintain throughout the term of this
Agreement all permits, licenses, registrations and other forms of governmental
authorization and approval as required by Law in order for PFIZER to execute
and deliver this Agreement and to perform its obligations hereunder in
accordance with all applicable Laws.

	 	10.2	 	ANDRX hereby represents and warrants to PFIZER as follows:

	 	(a)	 	ANDRX is a corporation duly organized and in good standing
under its jurisdiction of organization.
	 
	 	(b)	 	ANDRX has the requisite corporate authority to execute and
deliver this Agreement and to perform its obligations hereunder;
	 
	 	(c)	 	The execution and performance of ANDRX obligations hereunder,
are not and will not be in violation of or in conflict with any material
obligations it may have to any Third Party;
	 
	 	(d)	 	ANDRX is not debarred, and ANDRX has not and will not use in
any capacity the services of any person debarred, under subsections 306(a) or
(b) of the Generic Drug Enforcement Act of 1992. If at any time this
representation and warranty is no longer accurate, ANDRX shall immediately
notify PFIZER of such fact; and
	 
	 	(e)	 	ANDRX has and will maintain throughout the term of this
Agreement all permits, licenses, registrations and other forms of governmental
authorization and approval as required by Law in order for ANDRX to execute
and deliver this Agreement and to perform its obligations hereunder in
accordance with all applicable Laws.

 

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	 	10.3	 	ANDRX and PFIZER, in performing their respective obligations hereunder, shall
comply in all material respects with all applicable Laws. In the event PFIZER receives
notice of an inspection or other notification by a governmental entity, including FDA,
directly relating to the Product, ANDRX promotional materials or other matters within
the scope of this Agreement, PFIZER shall notify ANDRX as soon as practicable, and
provide to ANDRX, within [***], copies of all relevant documents, including FDA Forms
482, 483 warning letters and other correspondence and notifications, as ANDRX may
reasonably request. ANDRX and PFIZER agree to cooperate with each other during any
inspection, investigation or other inquiry by FDA or any other governmental entity,
including providing information and/or documentation, as requested by FDA or other
governmental entity.

	XI.	 	NOTICES

	 	11.1	 	Any notices or reports required or permitted under this Agreement shall be
deemed to have been given for all purposes if mailed by first class certified or
registered mail, by overnight delivery service with mailed confirmation of receipt or
transmitted electronically by facsimile with mailed confirmation copy to the following
address of such Party:

	 	 	 	 	 	 
	 	For ANDRX:

Scott Lodin, Esq.

General Counsel

	 	 	Andrx Corporation

4955 Orange Drive

Davie, FL 33314

Attn: Office of the General Counsel

Facsimile No.: (954)
585-1723	 
	 

 

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	 	For PFIZER:

	 	 	Pfizer Inc. 235 East 42nd Street New York, New York

10017-5755 Attn: General Counsel — U.S.

Pharmaceuticals

Facsimile No.: (212) 573-1445	 
	 

	 	 	 	or to such other addresses as shall have been subsequently furnished by written
notice to the other Parties.

	XII.	 	GOVERNING LAW AND PARTIES BOUND

	 	12.1	 	The validity and interpretation of this Agreement and the legal relations of
the Parties to it shall be governed by the internal laws, and not the law of
conflicts, of the State of New York. The parties acknowledge and agree not to contest
that the courts of the State of New York have personal jurisdiction over them with
respect to any action that may be taken hereunder, and venue shall lie in such courts
as to any such action.
	 
	 	12.2	 	This Agreement shall be binding upon and inure to the benefit of the Parties
and their successors and assigns. This Agreement and the rights granted herein may not
be assigned by any Party without the prior written consent of the other Parties except
to an Affiliate or to a successor or assignee of all or substantially all of one
Party’s pharmaceutical business or assets.

	XIII.	 	FORCE MAJEURE

	 	13.1	 	No Party shall be liable to another for its failure to perform any of its
obligations hereunder caused by contingencies beyond its control, including

 

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	 	 	 	acts of God, fire, flood, wars, acts of terrorism, sabotage, strike and government
actions (other than actions prohibiting the sale of the Products resulting from
PFIZER’s failure to supply Products in compliance with the Specifications or cGMPs
(i.e., failure to comply with 21 C.F.R. Parts 210 and 211) or otherwise resulting
from PFIZER’s failure to comply with any applicable requirement of Law). Any Party
asserting its inability to perform any obligation hereunder for any such
contingency shall promptly notify the other Party of the existence of any such
contingency and shall use its Commercially Reasonable Efforts to re-commence its
performance of such obligation a soon as commercially practicable.

	XIV.	 	NO ORAL MODIFICATIONS

	 	14.1	 	No change, modification, amendment or waiver of any obligation, term or
provision contained herein shall be valid or enforceable unless same is reduced to
writing and signed by a duly authorized representative of each of the Parties to be
bound hereby.

	XV.	 	INDEPENDENT CONTRACTORS

	 	15.1	 	This Agreement shall not constitute or give rise to any employer-employee,
agency, partnership or joint venture relationship among or between the Parties, and
each Party’s performance hereunder is that of a separate, independent entity.

	XVI.	 	NO IMPLIED RIGHTS

	 	16.1	 	Nothing in this Agreement shall be deemed or implied to be the grant by one
Party to any other of any right, title or interest in the Product, Intellectual

 

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	 	 	 	Property or any other proprietary right of any other Party except as is expressly
provided for herein.

	XVII.	 	SEVERABILITY

	 	17.1	 	To the extent any provision or term set forth herein is or becomes
unenforceable by operation of Law, such unenforceability shall not affect the
remaining provisions of this Agreement. The Parties agree to renegotiate in good faith
any provision or term held to be unenforceable and to be bound by the mutually agreed
substitute provision.

	XVIII.	 	MODIFICATION BY OPERATION OF LAW

	 	18.1	 	If any of the terms or provisions of this Agreement are in or come into
conflict with any applicable Law within the Territory then such term or provision
shall be deemed inoperative to the extent it may conflict therewith and shall be
deemed to be modified to conform with such Law unless such modification would render
the affected provision inconsistent with or contrary to the intent of the Parties.
However, in the event the terms and conditions of this Agreement are materially
altered as a result of this subsection, the Parties shall in good faith attempt to
renegotiate said terms and conditions to resolve any disputes related thereto.

	XIX.	 	CAPTIONS

	 	19.1	 	Article and section headings are provided for convenience only and are not to
be used in construing the intent of the Parties.

	XX.	 	SURVIVORSHIP

 

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	 	20.1	 	The provisions of Sections 6.l, 7.4, 8.1, 8.2, 8.3, and Articles IV, IX, XI,
XII, and XX survive any expiration or termination of this Agreement.

	XXI.	 	ENTIRE AGREEMENT

	 	21.1	 	This Agreement, including the Exhibits attached hereto, contains the entire
agreement among the Parties relating to the matters described herein and supersedes
all prior drafts or understandings.

 

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	XXII.	 	WAIVER

	 	22.1	 	The waiver by any Party to this Agreement of a breach of any provision set
forth herein or of any right contained herein shall not operate as or be construed as
a continuing waiver or a waiver of any subsequent breach or right granted herein.

	XXIII.	 	SINGULAR AND PLURAL

	 	23.1	 	The singular form of any noun or pronoun shall include the plural when the
context in which such a word is used is such that it is apparent the singular is
intended to include the plural or vice versa.

	XXIV.	 	COUNTERPARTS

	 	24.1	 	This Agreement may be executed in counterparts each of which is to be
considered an original and taken together as one and the same document.

	XXV.	 	DOCUMENT PREPARATION

	 	25.1	 	The Parties acknowledge that this Agreement is a product of negotiations and
that no inference should be drawn regarding the drafting or preparation of this
document.

 

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     IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in
duplicate by their duly authorized representatives in the places provided below:

	 	 	 
	ANDRX PHARMACEUTICALS, INC.

	 	PFIZER INC.
	 
	 	 
	By: /s/ Scott Lodin

	 	By:
	 

	 	 
	Name: Scott Lodin

	 	Name:
	 

	 	 
	Title: E.V.P. and General Counsel

	 	Title:
	 

	 	 

34<PAGE>

                                                                  Exhibit 10.35

                               LUMINEX CORPORATION

                         FORM OF AMENDMENT TO EXECUTIVE
                              EMPLOYMENT AGREEMENTS

     THIS AMENDMENT TO EMPLOYMENT AGREEMENT is made by and between ___________
(the "Executive") and LUMINEX CORPORATION, a Delaware corporation (the
"Company") effective as of March _____, 2006 (the "Amendment Effective Date").

                                   WITNESSETH:

     WHEREAS, the Company entered into an Employment Agreement (the "Employment
Agreement") with the Executive dated as of _________;

     WHEREAS, the Company and the Executive desire to amend the Employment
Agreement such that no payments due thereunder would cause Executive to incur
any additional tax under Section 409A of the Internal Revenue Code of 1986, as
amended;

     NOW, THEREFORE, for the reasons set forth above, the Company and the
Executive hereby amend the Employment Agreement as follows:

     1. Six Month Delay for Certain Payments. The following new Section 4.8
shall be inserted into the Employment Agreement:

          "4.8 Six Month Delay of Certain Payments. In the event the payment of
     any amounts payable pursuant to this Section __________ hereof within six
     months of the date of Executive's termination of employment would cause
     Executive to incur any additional tax under Section 409A of the Internal
     Revenue Code of 1986, as amended, then payment of such amounts shall be
     delayed until the date that is six months following Executive's termination
     date (the "Earliest Payment Date"). If this provision becomes applicable,
     it is anticipated that payments that would have been made prior to the
     Earliest Payment Date in the absence of this provision would be paid as a
     lump sum on the Earliest Payment Date and the remaining severance benefits
     or other payments would be paid according to the schedule otherwise
     applicable to the payments."

     2. Certain Definitions. Capitalized terms used in this Amendment not
otherwise defined herein shall have the same meaning as set forth in the
Employment Agreement.

     3. Counterparts. This Amendment may be executed in counterparts, each of
which shall be an original but all of which shall constitute but one document.

<PAGE>

     IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the
date first stated above.

                                           LUMINEX CORPORATION

                                           By:
                                               ---------------------------------
                                           Its:
                                               ---------------------------------

                                           -------------------------------------
                                           [NAME]

                                        2

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