Exhibit 10.67
EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT
THIS EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT (this "Agreement"), is
made as of June 11, 2004, by and between Leiner Health Products, LLC, (a
Delaware limited liability company) having offices at 901 East 233rd Street,
Carson, California 90745 ("Leiner"), and Impax Laboratories, Inc. (a Delaware
corporation), having offices at 30831 Huntwood Avenue, Hayward, California and
3735 Castor Avenue Philadelphia, Pennsylvania ("Impax").
WHEREAS, Impax has received the United States Food and Drug
Administration's ("FDA") final abbreviated new drug application ("ANDA")
approval for the manufacture and sale of loratadine ten milligram (10 mg) orally
disintegrating tablets (the bioequivalent to Claritin(R) redi-dose(TM)) (the
"Product"); and
WHEREAS, Impax desires to provide Product exclusively to
Leiner, other than as set forth herein, to enable Leiner to market and sell the
Product under a private label, over-the-counter, within the Territory, for all
indications except for pediatric use, as provided herein; and
WHEREAS, Leiner desires to obtain Product exclusively from
Impax to enable Leiner to market and sell over-the-counter, for all indications
except for pediatric use, private label Product within the Territory, all
subject to the terms and conditions set forth herein.
NOW, THEREFORE, the parties agree as follows with the intent to be
legally bound:
1. DEFINITIONS. For purposes hereof, the following terms shall have the
meanings set forth below:
"Act" means the Federal Food, Drug, and Cosmetic Act, as amended from
time to time, and the rules and regulations promulgated thereunder.
"Affiliate" means, with respect to any Person, any other Person
controlled by, controlling or under common control with such Person, where
control means more than 50% ownership or voting rights of a Person or the power
to direct the management or policy of a Person.
"API" means the active pharmaceutical ingredient, loratadine HCl.
"cGMP" means the current Good Manufacturing Practices regulations of
the FDA (as in effect from time to time) in 21 C.F.R. pts. 210 and 211, as
applicable, to the manufacture, processing, packaging, handling, storage and
control of the Product in the Territory, as same may be supplemented and/or
amended from time to time during the term of this Agreement.
"Commercially Reasonable Efforts" means efforts and resources normally
used by a Person for a compound or product owned by it or to which it has
rights, which is of similar market potential as the Product and at a similar
stage in its product life, taking into account the competitiveness of the
marketplace, the proprietary position of the compound or product, the regulatory
structure involved, the profitability of the applicable products, and other
relevant factors. It is anticipated that the level of effort and resources may
change at different times during the product life cycle of a compound or
product.
"Competing Product" means any finished pharmaceutical product available
for sale in the over-the-counter marketplace that contains the same active
ingredients in the same or a similar dosage form and strength as the Product in
a rapid dissolve or orally disintegrating dosage form bioequivalent to
Claritin(R) redi-dose(TM).
"Confidential Information" means any information which in any way shall
relate to a disclosing party, including, without limitation, its products,
business, know-how, methods, trade secrets and technology, or to any Affiliate
of such party, that shall be furnished to or obtained by the other party in
connection with this Agreement. Confidential Information shall not include any
information that: (i) at the time of disclosure, is generally available to the
public; (ii) after the time of disclosure, becomes generally available to the
public, except as a result of a breach of this Agreement by the recipient of
such information; (iii) prior to the time of disclosure, becomes available to
the recipient of such information from a third party which is not legally or
contractually prohibited from disclosing such Confidential Information;
provided, that such Confidential Information was not acquired, directly or
indirectly, from the disclosing party or its Affiliates; (iv) the recipient of
which can demonstrate was developed by or for such recipient independently of,
and without the use of, the Confidential Information disclosed by the disclosing
party or its Affiliates hereunder; or (v) is required to be disclosed by legal
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or judicial process; provided, in each case, the party so disclosing information
timely informs the other party, uses its commercially reasonable efforts to
limit the disclosure required by such legal or judicial process, and permits the
other party to attempt, by appropriate legal means, to limit such disclosure.
"First Commercial Sale" means the first sale of the Product by Leiner
under this Agreement in an arms' length transaction to an unaffiliated third
party.
"Impax's Manufacturing Cost" means Impax and its Affiliates' standard
manufacturing costs related to the Product and consumable bulk and other product
materials, including packaging and labeling materials, plus [XXX]* percent
([XXX]*%) to cover all indirect and overhead costs, plus all taxes, duties,
insurance and transportation costs incurred to deliver the Product in accordance
with the terms of this Agreement, in each case determined in accordance with
Impax's customary cost accounting policies and practices and in a manner
consistent with U.S. generally accepted accounting principles.
"Ineligible Person" means any Person who is prohibited by any law, rule
or regulation or by any order, directive or policy from selling the Product or
any other pharmaceutical product within the Territory or who is listed by any
United States federal agency as debarred, suspended, proposed for debarment or
otherwise ineligible for federal programs in the United States or other
jurisdictions within the Territory.
"Leiner Facility" means the facility and warehouse to be used by Leiner
to process, package, label and/or store the Product.
"Leiner's Packaging Costs" means Leiner and its Affiliates' actual
direct packaging and labeling costs plus [XXX]* percent ([XXX]*%) to cover all
indirect and overhead costs, in each case determined in accordance with Leiner's
customary cost accounting policies and practices and in a manner consistent with
U.S. generally accepted accounting principles and the calculations set forth on
Exhibit 6.2.
"Net Sales" means, for any given period, that dollar amount determined
by deducting the following reasonable and customary deduction items from the
gross invoiced sales price billed for the Product sold by Leiner and its
Affiliates in the Territory to unaffiliated third parties in arms length
transactions during the applicable period: (i) trade, quantity or cash
discounts, service allowances and independent brokers or agents' commissions, if
any, actually allowed or paid during the applicable period; (ii) credits or
allowances for the Product, if any, actually given or made on account of price
and shelf adjustments, returns, off-invoice promotional discounts (but excluding
all free goods provided to customers), rebates, chargebacks, any and all
federal, state or local government rebates or discounts whether in existence now
or enacted at any time hereafter, volume reimbursements, and the gross amount
billed for all rejected Product or Product recalled, seized or destroyed
(voluntarily or at the request of any government agency, subdivision or
department) during the applicable period; (iii) to the extent not included in
Impax's Manufacturing Costs, any tax, excise or other government charge upon or
measured by the production, sale, transportation, delivery or use of the Product
during the applicable period; and (iv) to the extent not included in Impax's
Manufacturing Costs, any surcharge, levy, tax, or assessment mandated by any
federal, state or local government or administrative agency during the
applicable period to fund a compensation program or reserve for persons injured
by the Product, in each case determined in accordance with U.S. generally
accepted accounting principles. For purposes of clarification, the items
identified in clauses (i) and (ii) above, shall only be deducted from the gross
invoiced sales price if, and only to the extent, they are paid to customers with
respect to sales of the Product, and not for services or other unrelated
activities that would not be included in a gross to net sales calculation under
U.S. generally accepted accounting principles.
"Net Profit" means Net Sales of the Product in the Territory during the
applicable measurement period less: (i) Impax's Manufacturing Cost applicable to
such period; and (ii) Leiner's Packaging Cost applicable to such period.
Notwithstanding the foregoing, if in any period the amounts set forth in (i)
through (ii) above reduce Net Profit to zero or below, then these amounts shall
be deducted until Net Profit is zero and the balance of the costs shall be
deducted against Net Profits in future periods until such amounts have been
fully deducted; provided that such carryover costs for the Product may not be
deducted once the Agreement is terminated.
"Paragraph IV Litigation" means any litigation commenced in respect of
the Product in accordance with and within the time specified by Section
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* Filed under an application for confidential treatment.
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505(j)(5)(B)(iii) of the Act following the manufacturer's submission to the FDA
of a certification in accordance with Section 505(j)(2)(A)(vii)(IV) of the Act
solely with regard to claims of infringement, invalidity and unenforceability of
any patent(s) in respect of the Product.
"Person" means an individual, corporation, partnership, limited
liability company or other entity.
"Plant" means the facility and warehouse used by Impax to manufacture,
package and/or store the Product.
"Specifications" means the terms and conditions applicable to the
Product and described in the ANDA for the Product, as the same may be
supplemented or amended from time to time.
"Territory" means all of the states comprising the United States of
America, plus the District of Columbia, the Commonwealth of Puerto Rico, the
U.S. Virgin Islands, Guam, Samoa and any other jurisdiction which is a United
States government protectorate wherein an ANDA approved by the FDA is required
to sell the Product in such jurisdiction. The term "Territory" specifically
includes any companies located within the above-stated areas that maintain or
otherwise supply entities outside of the Territory, and such international sales
are intended to be included within the Territory, provided such Product meets
with all legal and regulatory requirements of such country.
2. LICENSE RIGHT AND FEES. (a) Impax grants to Leiner and its
Affiliates in accordance with the terms and conditions of this Agreement, the
exclusive license (even as to Impax and its Affiliates) to market, sell and
distribute ("Market") the Product for all indications except for pediatric use,
in the Territory for the Term (as herein defined) and Leiner accepts the grant
of such exclusive Marketing license from Impax. Notwithstanding the exclusive
Marketing license set forth herein, Impax shall be permitted to manufacture and
sell the Product in the Territory to Novartis Consumer Health, Inc. ("Novartis")
pursuant to the terms of a License Agreement and Supply Agreement entered into
between Impax and Novartis, and nothing in this Agreement shall be deemed to
limit, in any way, the ability of Impax to fulfill its obligations under the
agreements with Novartis. Leiner is specifically prohibited from Marketing the
Product for pediatric use and shall use its commercially reasonable efforts
(which includes, without limitation, ceasing to sell the Product to customers if
it knows or has reason to believe such customer is Marketing or selling the
Product for pediatric use) to prevent its customers from Marketing the Product
for pediatric use. If in any year during the Initial Term Leiner shall fail to
order for delivery during such year at least [XXX]* ([XXX]*) tablets of the
Product, the license granted herein shall revert to a non-exclusive license. If
Leiner shall fail to order for delivery at least [XXX]* ([XXX]*) tablets of the
Product during any Renewal Term, Leiner shall have no further rights to renew
this Agreement.
(b) Neither Leiner nor its Affiliates shall, directly or
indirectly during the Term, Market any Competing Product in the Territory.
(c) In consideration of the Marketing exclusivity granted to
Leiner as provided hereby, upon the latter of June 1, 2004 or execution of this
Agreement, Leiner shall pay to Impax the sum of $[XXX]* in immediately available
funds, which Impax shall refund Leiner in full if Impax shall have failed to
supply Leiner with at least [XXX]* tablets by [XXX]*.
3. MANUFACTURE AND DISTRIBUTION.
3.1 MANUFACTURE AND SUPPLY BY IMPAX.
(a) Subject to the provisions of Section 4.1, Impax shall use
its Commercially Reasonable Efforts to timely manufacture and supply to Leiner
one hundred percent (100%) of Leiner's purchase order requests for the Product
in bulk form or blister packs, upon the terms and conditions set forth herein
and pursuant to the forecasts referred to in Section 4.1.
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* Filed under an application for confidential treatment.
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(b) As long as this Agreement is in effect and subject to the
provisions of Section 2(a), Section 3.2 and Section 3.3, Impax shall exclusively
supply Leiner with its entire production of Product for the term of this
Agreement.
3.2 PURCHASE AND MARKETING BY LEINER.
(a) Leiner shall use its Commercially Reasonable Efforts to
Market and sell the Product over-the-counter, for adult use only, in the
Territory, such efforts to be no less than the efforts used by Leiner in
relation to its other products.
(b) Leiner will obtain all of its requirements of the Product
in the Territory from Impax, for a period of twelve (12) months, commencing upon
the date of First Commercial Sale.
(c) Leiner will obtain not less than eighty percent (80%) of
its annual requirements of the Product in the Territory from Impax, pursuant to
this Agreement, for the remainder of the term of this Agreement, after
expiration of the first twelve-(12) month period provided in sub-paragraph (b)
above, except as otherwise set forth herein.
(d) Leiner shall neither promote in any manner pediatric use
of the Product nor Market the Product intended for pediatric use. This shall not
affect the approved ANDA label copy.
(e) If at any time after the First Commercial Sale, Impax has
credible evidence that Leiner is not using Commercially Reasonable Efforts to
Market the Product in accordance with this Agreement, Impax shall notify Leiner
and if Leiner does not begin to use Commercially Reasonable Efforts to continue
to Market the Product within twenty (20) days after such notice, then Impax, at
its option, and as its sole and exclusive remedy, may, upon written notice to
Leiner, convert the manufacture and supply of the Product, as provided in
Section 3.1, to a non-exclusive arrangement, and, in any case, Impax may
allocate its supply of Product among its customers in any manner it deems
desirable.
3.3 CONTINUITY OF SUPPLY.
(a) Notwithstanding Section 3.2 above, Impax acknowledges
Leiner's need for continuity of supply and homogenous appearance and content of
the Product. Therefore, in the event that (i) Impax notifies Leiner of its
inability to ship Products or (ii) subject to the provisions of Section 4.1,
over a rolling two (2) month period, Impax is unable to supply ninety percent
(90%) of Product ordered by Leiner hereunder prior to sixty (60) days after
Leiner's requested delivery date, Leiner may purchase replacement product from a
third party source to make up for any deficiency in supply of the Product by
Impax. Leiner will use Commercially Reasonable Efforts to limit contractual
obligations to purchase such replacement product, but in the event it is unable
to do so, Leiner may continue to purchase replacement product for the term of
such contract and that volume shall be deducted from Leiner's aforestated
purchase obligations with Impax. The foregoing provisions shall be Leiner's
exclusive remedy for the failure of Impax to timely supply Product to Leiner. If
Leiner exercises its rights under this Section 3.3, and so long as Leiner is
purchasing replacement product from a third party pursuant to this Section,
Impax shall be relieved of its exclusivity obligations hereunder. If Impax shall
fail to deliver to Leiner at least [XXX]* ([XXX]*) tablets of the Product during
any year of the Initial Term, Leiner, upon notification to Impax, may terminate
this Agreement in which event this Agreement shall be deemed terminated and of
no further force and effect and neither Party shall have any further liability
to the other hereunder, other than those liabilities specifically referred to in
this Agreement.
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* Filed under an application for confidential treatment.
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4. PURCHASING; DELIVERY.
4.1 FORECASTS. Attached as Exhibit 4.1 is Leiner's preliminary
non-binding forecast for each year of the Initial Term (defined in Section 11).
Leiner shall also provide to Impax a non-binding twelve (12)-month rolling
forecast, updated on a quarterly basis, of Leiner's estimated requirements of
the Product, the first such forecast to be provided at least three (3) months
before the First Commercial Sale, which shall be no later than [XXX]*. Subject
to Sections 3.2 and 4.2, Leiner shall be bound to only purchase the Product
pursuant to purchase orders submitted by it to Impax, provided that the quantity
of Product specified in the first three (3) months of such forecast shall
constitute a binding purchase order. If Leiner fails to give Impax rolling
forecasts as specified above after ten (10) days prior written notice by Impax
of such failure, the prior three (3) months rolling forecast shall apply and be
binding. All purchase orders for a Product shall specify the delivery date
therefor, which delivery date shall be no sooner than ninety (90) days following
the receipt of such order by Impax.
4.2 PURCHASE ORDERS Leiner shall place orders for the Product
with Impax using Leiner's standard form of purchase order. This Agreement shall
constitute a non-cancelable purchase of [XXX]* tablets to be delivered at any
time, but by no later than [XXX]*. Each purchase order submitted to Impax by
Leiner shall specify the requested delivery date, which shall not be less than
ninety (90) days after the date such order is received by Impax. Each purchase
order placed shall constitute a firm obligation to purchase the ordered
quantities of the Product. Impax shall give Leiner written notice of its
inability, if applicable, to ship quantities so ordered within fifteen (15) days
after receipt of such purchase order. In the event such notice is not received
by Leiner, such purchase order shall be deemed accepted. If Impax notifies
Leiner that it is unable to fill such purchase order, it shall indicate the
portion of such purchase order Impax cannot supply by the requested delivery
date and specify alternative delivery dates. The terms and conditions of this
Agreement shall be controlling over any conflicting terms and conditions stated
in Leiner's purchase order or Impax's invoice or confirmation. Any other
document which shall conflict with or be in addition to the terms and conditions
of this Agreement is hereby expressly rejected (unless the parties shall have
mutually agreed to the contrary in writing in respect of a particular instance).
4.3 DELIVERY, EXPIRY DATING.
(a) Impax shall deliver Product in either bulk tablets or
blister strips, as requested by Leiner in the applicable purchase order and as
addressed in the container closure as approved by the FDA.
(b) All Products shall be delivered in bulk containers, F.O.B.
the Leiner Facility, and risk of loss and title to the Product shall pass to
Leiner upon delivery of the Product to the Leiner Facility. Impax shall arrange
for shipping and/or transportation of the Product to the Leiner Facility and pay
all shipping and related costs, including insurance, and any customs duties and
other taxes related to delivery of the Product to Leiner. Until so delivered to
the Leiner Facility, Impax shall ensure that the Product is transported,
handled, stored and delivered in accordance with the Specifications, applicable
cGMP, all applicable FDA requirements and all federal, state and local laws of
the U.S., Guam, Puerto Rico and the U.S. Virgin Islands.
(c) Impax shall include in each shipment of the Product
hereunder a certificate of analysis that shall certify that the Product
contained in such shipment complies with the Specifications. Upon delivery of
the Product, the Product shall have a minimum of twenty (20) months prior to
expiry.
5. PACKAGING.
5.1 PACKAGING BY IMPAX. Impax shall package the Product in
bulk containers or in blister strips then placed in bulk containers, as
requested by Leiner in its purchase order requests for the Product, upon the
terms and conditions set forth herein and pursuant to the forecasts referred to
in Section 4.1. Impax shall provide Leiner with label copy and insert and/or
outsert copy and artwork as approved by the FDA.
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5.2 PACKAGING BY LEINER. Leiner shall further package the
Product into appropriate configurations and stock keeping units (SKUs) for sale
to its customers. Leiner shall ensure that the Product is packaged with labels,
product inserts or outserts and other labeling conforming to applicable cGMP,
the Product ANDA including, without limitation, approved labeling and other FDA
requirements and all other applicable rules and regulations. Concurrently with
the execution of this Agreement, the Parties will execute the Labeling Agreement
attached hereto as Exhibit 5.2. Leiner shall not be financially or otherwise
responsible for the labels and artwork that are contained on the labels of the
bulk Product supplied by Impax to Leiner pursuant hereto.
6. PAYMENT TERMS.
6.1 IMPAX'S MANUFACTURING COST. The price to be paid by Leiner
for Product hereunder (the "Price") shall be equal to Impax Manufacturing Cost
and shall initially be as set forth in Exhibit 6.1 attached hereto and
incorporated herein. Each April and October of each year during the Term, the
parties shall review Impax's Manufacturing Costs and if there shall have been a
change during the preceding six (6) month period, the parties shall revise
Impax's Manufacturing Cost used in determining Net Profit accordingly. Any such
change shall be implemented in June following the review in April and in
January following the review in October.
6.2 LEINER'S PACKAGING COST. Leiner's Packaging Cost for the
Product shall initially be as set forth in Exhibit 6.2 as attached hereto and
incorporated herein. Simultaneously with the review regarding Impax's
Manufacturing Costs as set forth above, the parties shall review Leiner's
Packaging Costs and if there shall have been a change during the preceding six
(6) month period, the parties shall revise Leiner's Packaging Costs used in
determining Net Profit accordingly. Any such change shall be implemented in June
following the review in April and in January following the review in October.
6.3 INVOICING AND PAYMENT. Impax shall invoice Leiner for the
Price of the Product promptly after delivery of such Product. The Price shall be
due and payable by Leiner to Impax within thirty (30) days after delivery of the
Product to the Leiner Facility. In addition to its other rights and remedies,
Impax shall have the right to assess interest on amounts past due by more than
twenty (20) days at the rate of one and one half percent (1 1/2%) per month, or
the highest rate permissible by law, if lower.
6.4 ALLOCATION OF NET PROFITS. Leiner shall pay Impax, within
thirty (30) days of the end of each calendar quarter, an amount equivalent to
[XXX]* percent ([XXX]*%) of the Net Profits attributable to the sales of the
Product during the previous quarter. Such payment shall be accompanied by a
written statement setting forth in reasonable detail the basis for and
calculation of Net Profits, for each month prior to the immediately preceding
quarter including, without limitation, Net Sales and Leiner's Packaging Costs.
In addition, Leiner shall provide such statement by the tenth (10th) business
day of the following month.
7. QUALITY ASSURANCE.
7.1 FACILITY MAINTENANCE; INSPECTION; REPORTS.
(a) Impax shall permit Leiner to conduct reasonable periodic
visits to the Plant upon reasonable notice during normal business hours (no more
than once annually during the Term), subject to confidentiality obligations set
forth in Section 13, to discuss manufacturing and supply issues and for general
inspection purposes.
(b) Leiner shall provide Impax access to the portions of the
Leiner Facility where Product is packaged or stored upon reasonable notice,
during normal business hours (no more than once annually during the Term) and
subject to confidentiality obligations set forth in Section 13.
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* Filed under an application for confidential treatment.
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(c) Each party shall promptly provide the other with an
unredacted copy (except identifying information regarding entities for whom such
party is obligated to protect as confidential) of any FDA Form 483 Establishment
Inspection Report, NDA Field Alert Report, Warning Letter, or Notice of
Violation Letter relating to the Product and any responses or other
correspondence relating thereto.
(d) Each party shall notify the other Party of any Out of
Specification ("OOS") testing results within one (1) business day.
7.2 FILING REQUIREMENTS AND MAINTENANCE.
(a) Impax shall promptly comply with all FDA filing and
reporting requirements with respect to the Product, including, without
limitation, all filing and reporting necessary to maintain the ANDA. Impax shall
be responsible for all stability studies as may be necessary or advisable
regarding storage of the Product in bulk containers or blisters.
(b) Leiner shall be responsible for compliance with all FDA
and other regulatory requirements concerning its labeling, packaging and
marketing activities including, without limitation, all stability studies
relating to Product packaged by it, except as stated on the bulk packaging of
the Product or as otherwise approved in writing by Impax.
8. WARRANTIES, INDEMNIFICATION AND INSURANCE.
8.1 REPRESENTATIONS, WARRANTIES AND COVENANTS.
(a) Impax makes the following representations, warranties and
covenants:
(i) Impax has obtained final FDA approval to
market the Product and is otherwise entitled
and enabled to manufacture, distribute, and
market the Product;
(ii) The Product (1) shall be manufactured,
labeled, packaged, stored and transported
(prior to Leiner's receipt of Product) in
conformance with all applicable requirements
of the FDA (including cGMP) and with all
applicable laws, (2) shall be manufactured,
labeled and packaged in conformance with the
Specifications, (3) shall not be adulterated
or misbranded within the meaning of the Act,
and (4) shall not be a product which would
violate any section of the Act if introduced
into interstate commerce;
(iii) Impax shall provide Leiner with all
appropriate documentation regarding shipping
and storage of Products; and
(iv) Impax shall retain all lot numbers and
records as required by the FDA.
(b) LEINER makes the following representations, warranties and
covenants:
(i) Product (1) shall be further packaged and
labeled, stored and marketed in conformance
with all applicable requirements of the FDA
(including cGMP) and with all applicable
laws, rules and regulations, (2) shall be
stored, further packaged and labeled in
conformance with the Specifications, (3)
shall not, by Leiner's or its Affiliates'
actions, be adulterated or misbranded within
the meaning of the Act, and (4) shall not,
by Leiner's or its Affiliates' actions, be a
product which would violate any section of
the Act if introduced into interstate
commerce; and
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(ii) LEINER shall retain all lot numbers and
records as required by the FDA.
(c) Each party represents, warrants and covenants to the other
that:
(i) such party is not debarred under the Generic
Drug Enforcement Act of 1992 and that it
does not and will not use in any capacity
the services of any Person debarred under
the Generic Drug Enforcement Act of 1992;
neither such party, nor, to the best of its
knowledge, any of its employees, agents or
contractors, has engaged in any activity
which could lead to it becoming debarred
under the Generic Drug Enforcement Act of
1992; and
(ii) such party is duly authorized to execute and
deliver this Agreement and consummate the
transactions contemplated hereby, and this
Agreement constitutes the valid and binding
obligation of such party.
(d) Each party agrees to notify the other within 24 hours of
its receipt of a Form 483 report, or warning letter (or similar form or notice
from a government oversight authority) with respect to the matters contemplated
by this Agreement.
(e) Each party agrees to notify the other within 24 hours of
its receipt of a notice of an FDA inspection regarding the Product, or if no
advance notice is given, immediately at the beginning of such inspection.
(f) EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THE
AGREEMENT, IMPAX MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, CONCERNING THE PRODUCTS, OR THE MERCHANTABILITY OR FITNESS THEREOF FOR
ANY PURPOSES.
8.2 INDEMNIFICATION.
(a) Impax agrees to indemnify, defend and hold harmless, and
to pay and reimburse Leiner, its Affiliates, and its and their respective
employees, agents and representatives, from and against any and all third party
claims and losses, damages and liabilities, including reasonable attorneys' fees
(collectively, "Losses"), relating thereto, incurred by any of them solely to
the extent relating to the subject matter of this Agreement and arising out of,
relating to or occurring as a result of Impax's willful misconduct, negligence
or the material breach of any representation, warranty or covenant made by Impax
in this Agreement, or in any manner related to the Product (other than the
Marketing of the Product by Leiner and Leiner's packaging obligations), unless
and to the extent such is due to Leiner's willful misconduct or negligent acts
or omissions with respect to the Product and relating to this Agreement.
(b) Leiner agrees to indemnify, defend and hold harmless, and
to pay and reimburse, Impax, its Affiliates, and its and their respective
employees, agents and representatives, from and against any and all third party
claims and Losses, relating thereto, incurred by any of them solely to the
extent relating to the subject matter of this Agreement and arising out of,
relating to or occurring as a result of Leiner's willful misconduct, negligence
or the material breach of any representation, warranty or covenant made by
Leiner in this Agreement, or in any way related to the Marketing and/or
packaging of the Product by Leiner, including, without limitation, the pediatric
use marketing prohibition set forth in Section 2(a), unless and to the extent
such is due to Impax's willful misconduct or negligent acts or omissions with
respect to the Product and relating to this Agreement.
(c) If Leiner, Impax or any other indemnitee (in each case an
"Indemnified Party") receives any written claim which it believes is the subject
of indemnity hereunder, the Indemnified Party shall, as soon as reasonably
practicable after forming such belief, give notice thereof to the other party
(the "Indemnifying Party"), including all particulars of such claim to the
extent known to the Indemnified Party; provided that the failure to give timely
notice to the Indemnifying Party as contemplated hereby shall not release the
Indemnifying Party from any liability to the Indemnified Party except to the
extent the Indemnifying Party is materially prejudiced in defending any claim by
such failure. The Indemnifying Party shall assume the defense of such claim with
counsel of its choice reasonably satisfactory to the Indemnified Party, and at
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the cost of the Indemnifying Party. The Indemnified Party may participate in the
action through counsel of its choice, but the cost of such counsel shall be at
the expense of the Indemnified Party (unless the Indemnified Party is required
to retain counsel due to a non-waivable legal conflict). If the Indemnifying
Party does not so assume the defense of such claim, or, having assumed such
defense fails to vigorously prosecute such defense, the Indemnified Party may
assume such defense, with counsel of its choice, to be paid or reimbursed by the
Indemnifying Party.
(d) The Indemnified Party shall render all reasonable
assistance to the Indemnifying Party, and all reasonable out-of-pocket costs of
such assistance shall be promptly paid or reimbursed by the Indemnifying Party.
(e) No such claim shall be settled and no admission may be
made other than by the party defending the same, and then only with the consent
of the other party, which shall not be unreasonably withheld; provided that the
Indemnified Party shall have no obligation to consent to any settlement of any
such claim which imposes on the Indemnified Party any liability or obligation
which will not be assumed and performed in full by the Indemnifying Party.
(f) EXCEPT IN THE EVENT OF AND TO THE EXTENT OF LOSSES AWARDED
TO A THIRD PARTY IN CONNECTION WITH THE INDEMNIFICATION PROVISIONS SET FORTH IN
THIS SECTION 8.2, THE INDEMNIFYING PARTY SHALL NOT BE LIABLE TO THE INDEMNIFIED
PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL DAMAGES OR LOST PROFITS,
WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE,
ARISING OUT OF THE MANUFACTURE, STORAGE, SHIPPING, TRANSPORTATION, DELIVERY,
LABELING, SALE, MARKETING, DISTRIBUTION OR USE OF THE PRODUCT.
8.3 INSURANCE. Each of Leiner and Impax shall maintain, during
the Term (and any renewal thereof) and for three (3) years thereafter, general
liability insurance, including coverage for product liability and contractual
liability, in an amount not less than $10,000,000 per occurrence with a carrier
authorized to issue such insurance coverage in the United States, with the other
party named as an additional insured. Each party will furnish to the other, upon
request, a certificate of insurance evidencing compliance with the requirements
of this Section. Each party shall notify the other of any cancellation or
material change in such insurance not less than thirty (30) days prior to the
date of such cancellation or change. Nothing contained in this section shall
limit, or be deemed to limit, the liability or responsibility of Impax or Leiner
or any Person acting on behalf of Impax or Leiner for payment of damages
resulting from its acts, omissions, or other conduct or operations under this
Agreement.
8.4 PARAGRAPH IV LITIGATION. Solely with respect to matters
related to this Agreement, Impax will (a) undertake the defense of legal matters
relating to the Paragraph IV Litigation with regard to the Product and (b) be
fully responsible for the legal fees and expenses resulting directly from the
Paragraph IV Litigation and have ultimate decision making authority with regard
to the Paragraph IV Litigation, except to the extent such expenses, fees,
damages and other costs relate to, or arise out of, the willful misconduct or
negligence of Leiner, or a breach by Leiner of any representation, warranty or
covenant hereunder. Impax shall indemnify Leiner, its Affiliates, officers,
directors and employees for any and all expenses, fees, damages and other costs
incurred related to such Paragraph IV Litigation.
9. NON-COMPLIANT PRODUCTS.
9.1 ACCEPTANCE AND REJECTION. Leiner shall give written notice
to Impax of any non-compliance of the Product with the terms of this Agreement,
promptly upon the earlier of (i) its becoming aware of such non-compliance or
(ii) the date it should have become aware of such non-compliance. Failure to
provide such notice within thirty (30) days after knowledge of such
non-compliance shall constitute acceptance thereof. Any notice by Leiner that
any Product does not comply with the terms and conditions hereof shall be
accompanied by a true and correct copy of the results of any tests conducted by
Leiner thereon. Leiner and Impax shall cooperate in good faith to resolve any
disputes arising therefrom and in the event that the parties shall be unable to
resolve such dispute within thirty (30) calendar days from the date of Impax's
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receipt of Leiner's notice of such non-compliance, the parties shall submit such
dispute to a mutually agreed-upon independent laboratory. The determination by
such laboratory shall be final and binding and the costs therefor shall be borne
by the non-prevailing party. Leiner shall not dispose of any Product claimed to
be non-compliant until final resolution of any dispute with respect thereto or
Impax's written consent. In the event Leiner requests Impax's consent to destroy
a reasonable percentage of disputed Product and Impax declines, Impax will pay
one hundred percent (100%) of the storage costs allocated to such Product if
Leiner is the prevailing party in the dispute. If Leiner is not the prevailing
party, Leiner shall pay one hundred percent (100%) of the storage costs. Impax
shall promptly replace any non-compliant Product, with compliant Product, at
Impax's sole cost and expense.
9.2 PRODUCT COMPLAINTS AND ADVERSE DRUG EXPERIENCES. Leiner
shall be responsible for handling all Product complaints promptly and for
notifying Impax of all such complaints promptly. Leiner shall notify Impax of
any report of an adverse drug experience concerning the Product within two (2)
business days of receipt of such report and provide Impax with such information
as required by applicable law and/or as reasonably requested by Impax.
9.3 PRODUCT RECALL.
(a) Subject to Section 9.3(b), in the event of any recall or
seizure of the Product (the Recalled Product"), (as to which Impax shall have
the right to make all final decisions regarding any such recall or seizure, with
the approval of Leiner, which approval shall not be unreasonably withheld or
delayed), other than that arising out of, relating to, or occurring as a result
of, any act or omission by Leiner, Impax shall be solely responsible for such
Recalled Product and
(i) for all Recalled Product shipped to Leiner but not
yet processed, Impax shall, at Impax's option,
replace the Recalled Product or refund the
applicable Impax Manufacturing Cost paid by
Leiner;
(ii) for all Recalled Product that is Leiner's
work-in-process, Impax shall pay Leiner's
Packaging Cost plus reimburse Leiner for the
applicable Impax Manufacturing Cost paid by
Leiner; and
(iii) for all Recalled Product that has been shipped to
Leiner's customer(s), Impax shall reimburse Leiner
for all returns, minus Leiner's share of
associated Net Profits,
plus reimburse Leiner for all verifiable transportation costs, if any, taxes
incurred, other than taxes on income, insurance, handling and reasonable and
verifiable out-of-pocket costs incurred by Leiner in respect of the return of
such Recalled Product.
(b) Subject to Section 9.3 (a), in the event of any recall or
seizure of any Product arising out of, relating to or occurring as a result of
any act or omission by Leiner, Leiner shall be solely responsible for Impax's
Manufacturing Costs, transportation expenses and taxes incurred (other than
taxes on income), insurance, handling and reasonable and verifiable
out-of-pocket costs incurred by Impax in respect of the return of such recalled
or seized Product.
(c) For purposes of this section, "recall" shall mean (i) any
action by Impax, Leiner or any of their respective Affiliates to recover title
to or possession of any Product sold or shipped and/or (ii) any decision by
Leiner not to sell or ship Product to third parties which would have been
subject to recall if it had been sold or shipped, in each case taken in the good
faith belief that such action was appropriate under the circumstances. For
purposes of this section, "seizure" shall mean any action by any governmental
agency or authority to detain or destroy Product.
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(d) Impax and Leiner shall keep the other informed of any
notification or other information, whether received directly or indirectly,
which might affect the marketability, safety or effectiveness of the Product, or
which might result in liability or otherwise necessitate action on the part of
either party, or which might result in recall or seizure of the Product,
including, but not limited to, an OSS or any NDA Field Alert. Impax will be
responsible for assuring that such recall is completed with the FDA, unless the
recall is due to Leiner's action or omissions in which event Leiner will be so
responsible.
10. AUDIT.
10.1 LEINER'S RIGHT TO AUDIT. Impax shall maintain true and
complete books of account containing an accurate record of all data necessary
for proper assessment of Impax's Manufacturing Cost for the Product. Impax shall
provide Leiner with the right, through an independent certified public
accountant (except any to whom Impax has a reasonable objection), to examine
such books of account related to such cost at any time, (on one occasion with
respect to any calendar year) on reasonable prior written notice, within two (2)
years after the end of the calendar year in which the Products that are the
subject of such payment were delivered for sale in the Territory for the purpose
of verifying the accuracy of such cost. Impax may require such accountant to
execute a reasonable confidentiality agreement as a condition to providing
access to its books and records. In the event that such certified public
accountant shall have questions which are not in their judgment answered by such
books and records, the accountant shall have the right to confer with
representatives of Impax, including its Chief Financial Officer. The parties
agree that information furnished to Leiner as a result of any such examination
shall be limited to a written statement by such certified public accountant to
the effect that they have reviewed the books of account maintained by or on
behalf of Impax and either (a) Impax's calculations are correct or (b) setting
forth any required adjustments thereto. Subject to Section 15.1, Impax and
Leiner agree to be bound by the final result of such audit. If any such audit
shows any overpayment by Leiner, a correcting refund shall be made within
forty-five (45) days after receipt of the written statement described above and,
if such overpayment shall exceed five (5%) percent of any amount payable
hereunder or $10,000, whichever is greater, Impax shall bear all reasonable
costs of the audit.
10.2 IMPAX'S RIGHT TO AUDIT. Leiner shall maintain true and
complete books of account containing an accurate record of all data necessary
for proper assessment of the Net Profit payments. Impax shall have the right,
through an independent certified public accountant (except any to whom Leiner
has a reasonable objection), to examine Leiner's books of account related to
such payment at any time, (on one occasion with respect to any calendar year)
on reasonable prior written notice, within two (2) years after the end of the
calendar year in which the Products that are the subject of such payment were
delivered for sale in the Territory for the purpose of verifying the accuracy
of such payment. Leiner may require such accountant to execute a reasonable
confidentiality agreement as a condition to providing access to its books and
records. In the event that such certified public accountant shall have
questions which are not in their judgment answered by such books and records,
the accountant shall have the right to confer with representatives of Leiner,
including its Chief Financial Officer. The parties agree that information
furnished to Impax as a result of any such examination shall be limited to a
written statement by such certified public accountant to the effect that they
have reviewed the books of account of Leiner and either (a) Leiner's
calculations are correct or (b) setting forth any required adjustments thereto,
subject to Section 15.1. Impax and Leiner agree to be bound by the final result
of such audit. If any such audit shows any underpayment by Leiner, a correcting
payment shall be made within forty-five (45) days after receipt of the written
statement described above and, if such underpayment shall exceed five (5%)
percent of any amount payable hereunder or $10,000, whichever is greater,
Leiner shall bear all reasonable costs of the audit.
11. TERM. This Agreement is effective on the date hereof and
shall continue for a period of thirty-six (36) months from the date of First
Commercial Sale (the "Initial Term"); provided, however, that this Agreement
shall terminate automatically if there shall be no First Commercial Sale by
[XXX]*.
- --------------------
* Filed under an application for confidential treatment.
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Thereafter, this Agreement shall be automatically renewed for four (4)
successive twelve (12)-month periods (each, a "Renewal Term"), unless a party
shall otherwise notify the other in writing at least six (6) months prior to the
expiration date of the Initial Term or any Renewal Term. The Initial Term and
Renewal Terms are collectively referred to herein as the "Term".
12. TERMINATION.
12.1 TERMINATION. In addition to the termination provision set
forth in Section 11, this Agreement may be terminated during the Initial Term or
any Renewal Term upon the occurrence of the following events:
(a) Infringement. Either party may terminate this Agreement
upon twenty (20) days written notice to the other if, based upon the opinion of
qualified counsel, such party believes that the Product or API infringes the
intellectual property rights of a third party.
(b) Breach. If either party commits a breach or default in any
material respect in the performance or observance of any of its obligations
under this Agreement and such breach or default is not cured within thirty (30)
days after receipt by such party of the written notice from the non-breaching
party specifying the breach or default, then the non-breaching or non-defaulting
party may terminate this Agreement with immediate effect by giving written
notice to the breaching or defaulting party.
(c) Bankruptcy. This Agreement shall automatically terminate
upon the initiation of any proceeding in bankruptcy, reorganization or
arrangement for the appointment of a receiver or trustee to take possession of
the assets of a party hereto or similar proceeding under the law for release of
creditors by or against a party hereto, or if a party hereto shall make an
assignment for the benefit of its creditors.
(d) Force Majeure Event. If, as a result of a Force Majeure
Event, a party does not perform its obligations hereunder for any consecutive
period of sixty (60) days, the other party shall have the right to terminate
this Agreement in its entirety upon providing written notice to the
non-performing party, such termination to be effective within ten (10) days of
such notice.
(e) Ineligible Person. (i) In the event that Leiner or Impax
or an Affiliate of either of them shall become an Ineligible Person with respect
to the Product, such party shall promptly notify the other in writing and shall
keep the other apprised of its reasonable best efforts to have the status as an
Ineligible Person removed, and the other party may terminate this Agreement upon
thirty (30) days prior written notice unless the status as an Ineligible Person
is removed within such period. (ii) Leiner or Impax may terminate this
Agreement, without penalty, upon thirty (30) days' prior written notice to the
other party if (otherwise than by reason of a breach of its obligations
hereunder) it is legally prohibited from performing its obligations hereunder or
it or one of its Affiliates shall become an Ineligible Person in respect of the
Product (and it has made its reasonable best efforts to remove the prohibition
or its status as an Ineligible Person) and such prohibition or status as an
Ineligible Person has continued uninterrupted for a period of 120 days.
(f) Form 483. The non-receiving party may terminate this
Agreement upon ninety (90) days notice if the other party has received a Form
483 report regarding Product or the manufacturing facilities therefor and it has
not complied with such Form 483 within a reasonable time thereafter and is not
diligently pursuing corrective action in response thereto or is not actively
contesting the deficiencies noted in the Form 483.
12.2 POST-TERMINATION.
(a) Upon the expiration or termination of this Agreement for
any of the above reasons, and subject to the ongoing confidentiality obligations
under Section 13 of this Agreement, the parties shall be permitted to continue
in their respective businesses as if the Agreement has not been entered into at
all, except that Leiner shall be allowed to sell its current inventory of the
Product (including product shipped but not yet received), contingent upon
payment of any Net Profits payments due to Impax upon such post-termination
sales.
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(b) Expiration or termination of this Agreement shall not
relieve the parties of any obligations accruing prior to the effective date
thereof or resulting therefrom. All payment obligations due pursuant to this
Agreement shall survive termination of this Agreement.
13. CONFIDENTIALITY.
13.1 TREATMENT OF CONFIDENTIAL INFORMATION. Except as required
by applicable laws and regulations or as otherwise provided in this Section 13,
during the Term and any Renewal Term, and for a period of five (5) years after
the termination or expiration of this Agreement, each party shall hold in strict
confidence, and may not use for purposes other than this Agreement, exploit or
disclose to a third party (except as specifically set forth herein or with the
express prior written consent of the other party) any and all Confidential
Information of the other party.
13.2 LIMITS ON DISCLOSURE.
(a) Without limiting the generality of the foregoing, each
party may disclose Confidential Information, to those employees who need to
receive the Confidential Information in order to further the activities
contemplated in this Agreement. Each party shall take sufficient precautions to
safeguard the Confidential Information. Each party understands and agrees that
the disclosure of Confidential Information may result in serious and irreparable
damage to the other party, that the remedy at law or any breach of this covenant
may be inadequate, and that the party seeking redress hereunder shall be
entitled to injunctive relief, without prejudice to any other rights and
remedies to which such party may be entitled.
(b) It is acknowledged that Confidential Information may be
obtained by a party from the other party not only in writing or other tangible
form (including electronic), but also through discussions between each party's
respective representatives, demonstrations, observations and memorization and
other intangible methods.
(c) The above notwithstanding, each party shall have the right
with the exercise of discretion, and insofar as practical under written
confidentiality agreements having provisions no less stringent than those
contained herein, to make disclosures of such portions of Confidential
Information to third party consultants, attorneys, contractors, advisors,
Affiliates and governmental agencies where, in the recipient's reasonable
judgment, such disclosure is beneficial to development, approval or marketing of
the Product pursuant to this Agreement.
(d) Except as otherwise set forth in this Agreement, upon the
expiration or termination of this Agreement and at the written request of the
disclosing party, the receiving party shall return all Confidential Information
of the disclosing party (including all copies, excerpts and summaries thereof
contained on any media) or destroy such Confidential Information at the option
of the disclosing party, with one copy retained by legal counsel.
(e) Each party and the respective employees, representatives
and other agents of such party may disclose to any and all persons, without
limitation of any kind, the tax treatment and tax structure of the transaction
and all materials of any kind (including opinions or other tax analyses) that
are provided to such party relating to such tax treatment and tax structure.
14. FORCE MAJEURE.
14.1 EFFECTS OF FORCE MAJEURE. No party hereto shall be held
liable or responsible for failure or delay in fulfilling or performing any of
its obligations under this Agreement (other than the payment of money) if such
failure or delay is caused by, without limitation, acts of God, acts of the
public enemy, fire, explosion, flood, drought, war, terrorists, riot, sabotage,
embargo, strikes or other labor disputes, or by any other event or circumstance
of like or different character to the foregoing beyond the reasonable control
and without the fault or negligence of the affected party, or by intervention of
governmental agency (a "Force Majeure Event"). Such excuse shall continue as
long as the Force Majeure Event continues. Upon cessation of such Force Majeure
Event, such party shall promptly resume performance hereunder.
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14.2 NOTICE OF FORCE MAJEURE. Each party agrees to give the
other party prompt written notice of the occurrence of any Force Majeure Event,
the nature thereof and the extent to which the affected party will be unable to
perform its obligations hereunder. Each party further agrees to use reasonable
commercial efforts to correct (if it is amenable to correction) the Force
Majeure Event as quickly as possible and to give the other parties, including
Leiner, prompt written notice when it is again fully able to perform such
obligations.
14.3 ALLOCATION OF CAPACITY. Notwithstanding anything to the
contrary contained in this Agreement, Leiner acknowledges that the Agreements
which Impax has entered into with Novartis requires Impax to accommodate any
Novartis request for Product and that throughout the term of such Agreements,
Novartis shall be a preferred customer and has priority over all other parties,
including Leiner and its Affiliates, with regard to the supply of the Product.
14.4 RIGHT OF FIRST OFFER. Upon the termination or expiration
of the agreements with Novartis, and subject to any and all rights of Novartis
under such agreements (including any and all rights continuing after the
expiration or termination of such agreements), Leiner shall have the right of
first offer for complete exclusivity regarding loratadine ten milligram (10 mg)
orally disintegrating tablets to be sold without prescription, for all uses
including adult and pediatric use. The parties shall negotiate the terms of such
agreement in good faith for a period of thirty (30) days after such termination
or expiration and if a definitive agreement is not entered into within such time
period, Leiner's rights set forth in this Section 14.4 shall terminate and be of
no further force and effect.
15. MISCELLANEOUS.
15.1 DISPUTE RESOLUTION. The parties recognize that a bona
fide dispute as to matters may, from time to time, arise during the term of this
Agreement which relates to a party's rights and/or obligations hereunder. In the
event of the occurrence of such a dispute, either party may, by notice to the
other party, have such dispute referred to their respective officers, designated
below, or their successors, for attempted resolution by good faith negotiation
within thirty (30) days after such notice is received. Such designated officers
are initially as follows:
For Leiner: Robert M. Fisher, Senior Vice President
For Impax: David S. Doll, Senior Vice President
If no agreement is reached within 30 days of the referral to such officers, then
such controversy or claim shall be settled by arbitration in accordance with the
Commercial Arbitration Rules of the American Arbitration Association, such
arbitration to be held on an expedited basis either in San Francisco,
California, if such dispute is initiated by Leiner or in Los Angeles County,
California, if such arbitration is initiated by Impax. Judgment upon the award
rendered by the arbitrator(s) shall be final, binding and conclusive as between
the parties and may be entered in any court having jurisdiction thereof. The
arbitrators shall have the discretion, to be exercised in accordance with
applicable law, to allocate among the parties the arbitrators' fees and
litigation costs, and the arbitrators shall also have authority to shift the
prevailing party's attorney's fees to the non-prevailing party. The obligation
to arbitrate under this Section 15.1 shall not apply to any proceedings that
seek equitable or injunctive relief under this Agreement.
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15.2 GOVERNING LAW. This contract shall be governed by, and
construed in accordance with, the laws of the State of Delaware, without giving
effect to principles of conflicts of law. In connection with any action at law
or in equity including any action which seeks injunctive relief, commenced
hereunder, each of the undersigned consents to the jurisdiction of the state
and federal courts located in Delaware and agree that service of process by
certified mail, return receipt requested, shall constitute personal service for
all purposes hereof. The parties hereby irrevocably waive all rights to a jury
trial under any dispute under this Agreement.
15.3 INDEPENDENT CONTRACTORS. The relationship between the parties
Impax on the one hand and Leiner on the other hand, is that of independent
contractors and nothing herein shall be deemed to constitute the relationship of
partners, joint venturers nor of principal and agent between Impax and Leiner.
Neither party shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other party or to bind
the other party to any contract, agreement or undertaking with any third party.
15.4 ASSIGNMENT. This Agreement may be assigned by either party in
connection with any sale, merger or other business combination involving all or
substantially all of the parties' assets or stock. Except as set forth in the
preceding sentence, neither this Agreement nor any other rights nor obligations
hereunder shall be assigned, delegated or subcontracted by either party by
operation of law or otherwise without the prior written consent of the other
party.
15.5 PAYMENT CURRENCY. All amounts invoiced and all payments made
hereunder shall be in U.S. dollars. Any cost or expense that forms the basis of
a payment hereunder which was incurred in a currency other than U.S. dollars
shall be converted into its U.S. dollar equivalent in accordance with the usual
procedures therefor used by the Person incurring such cost or expense.
15.6 NO IMPLIED WAIVER. No failure or delay on the part of the
parties hereto to exercise any right, power or privilege hereunder or under any
instrument executed pursuant hereto shall operate as a waiver; nor shall any
single or partial exercise of any right, power or privilege preclude any other
or further exercise thereof or the exercise of any other right, power or
privilege.
15.7 NOTICE. All notices required to be given hereunder shall be
in writing and shall be given by personal delivery, via facsimile transmission,
by a nationally recognized overnight carrier or by registered or certified mail,
postage prepaid with return receipt requested. Notices shall be addressed to the
parties as follows:
If to Leiner: Leiner Health Products, LLC
901 East 233rd Street
Carson, California 90745
Attn: President
Facsimile No.: (310) 952-7763
With a copy to:
Leiner Health Products, LLC
901 East 233rd Street
Carson, California 90745
Attn: Legal Department
Facsimile No.: (310) 835-9458
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If to Impax: Impax Laboratories, Inc.
121 New Britain Boulevard
Chalfont, PA 18914
Attn: David Doll, Senior Vice President
Facsimile No.: (215) 933-0333
with a copy to:
Blank Rome LLP
18th & Cherry Streets
One Logan Square
Philadelphia, PA 19103
Attn: Ronald Fisher, Esq.
Facsimile No.: (215) 832-5479
Notices delivered personally shall be deemed communicated as of actual receipt;
notices sent via facsimile transmission shall be deemed communicated as of
receipt by the sender of written confirmation of transmission thereof; notices
sent via overnight courier shall be deemed received as of one business day
following sending; and notices mailed shall be deemed communicated as of three
business days after proper mailing. A party may change his or its address by
written notice in accordance with this section, but such notice shall be deemed
communicated as of actual receipt.
15.8 AMENDMENTS. Any amendment or modification of this Agreement
shall be valid only if made in writing and signed by all parties hereto.
15.9 COUNTERPARTS. This Agreement may be executed in counterparts,
each of which shall be deemed an original and all of which shall constitute a
single document.
15.10 ENTIRE AGREEMENT. This Agreement, including the Exhibits
hereto which are incorporated herein as if set forth in their entirety at the
point of reference thereto, constitutes the entire understanding between the
parties with respect to the subject matter hereof and supersedes all prior
contracts, agreements and understandings related to the same subject matter
between the parties. The parties make no representations or warranties, except
as expressly provided herein. The parties intend this Agreement to be a
complete statement of the terms of their understanding. No change or
modification of any of the provisions hereof shall be effective unless in
writing and signed by an authorized officer of each of the parties.
15.11 BENEFIT; BINDING EFFECT. This Agreement shall be binding
upon and shall inure to the benefit of the parties hereto and their respective
successors and permitted assigns.
15.12 SURVIVAL. Notwithstanding anything to the contrary contained
in this Agreement, the provisions of Sections 1, 8, 9, 10, 12.2, 13, and 15
shall survive any termination of this Agreement.
15.13 FURTHER ASSURANCES. The parties hereto agree that they shall
take all appropriate actions, including, without limitation, the execution or
filing of any documents or instruments, which may be reasonably necessary to
carry out the intent and accomplish the purposes of any of the provisions
hereof.
15.14 SEVERABILITY. In the event that any provision of this
Agreement or part thereof shall be held invalid or unenforceable for any reason
by a court of competent jurisdiction, such provision or part thereof shall be
considered separate from the remaining provisions of this Agreement, which shall
remain in full force and effect. Such invalid or unenforceable provision shall
be deemed revised to effect, to the fullest extent permitted by law, the intent
of the parties as set forth therein.
15.15 PRESS RELEASES; DISCLOSURES. Except those required by
applicable law, any and all press releases, publicity or other form of public
written disclosures relating to this Agreement shall be mutually agreed to by
the parties (the consent of a party not to be unreasonably withheld or unduly
delayed and in any event a party shall respond within two (2) business days of
receiving a request, failing which it shall be deemed to have consented)
including, if applicable, the time of release of such public written disclosures
as well as the content of such public written disclosures. For releases or
announcements required by applicable law, the party making the release or
announcement shall, before making any such release or announcement, afford the
other party a reasonable opportunity to review and comment. Any copy of this
Agreement to be filed with the Securities and Exchange Commission or any other
governmental entity shall be redacted to the fullest extent permitted by
applicable law; provided, however, in the event that the Securities and Exchange
Commission or other governmental entity, as applicable, objects to the redaction
of any portion of this Agreement after the initial submission, the filing party
shall inform the other party of the objections and shall in good faith respond
to the objections in an effort to limit the disclosure required by the
Securities and Exchange Commission or governmental entity, as applicable.
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IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed as of the date first above written by their duly
authorized representatives.
LEINER HEALTH PRODUCTS, LLC
By: /s/ Gale K. Bensussen
---------------------------------
Name: Gale K. Bensussen
Title: President
Date:
LEINER HEALTH PRODUCTS, LLC
By: /s/ Robert M. Fisher, Jr.
---------------------------------
Name: Robert M. Fisher, Jr.
Title: Senior Vice President
Date:
IMPAX LABORATORIES, INC.
By: /s/ David Doll
---------------------------------
Name: David Doll
Title: Senior Vice President
Date:
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