EXHIBIT 10.31
NON EXCLUSIVE DISTRIBUTION AGREEMENT
EXCLUSIVE SUPPLY AGREEMENT
This Agreement, entered into as of the 13th day of September,
1994, by and between MOVA PHARMACEUTICAL CORPORATION ("MOVA"), a
Puerto Rico corporation, having offices in Caguas, Puerto Rico, and
PAR PHARMACEUTICAL, INC., a New York corporation, having offices in
One Ram Ridge Road, Spring Valley, New York 10977 ("PAR").
WITNESSETH:
WHEREAS, MOVA manufactures and sells pharmaceutical products and
has represented that it has developed a generic version of cimetidine
(defined hereinafter as the "Product"); and
WHEREAS, PAR distributes a line of generic versions of branded
pharmaceutical products such as the Product; and
WHEREAS, PAR would like to distribute the Product as manufactured
by MOVA and MOVA is willing to supply the Product to PAR for such
purpose, all upon the terms and conditions of this Agreement;
NOW, THEREFORE, in consideration of the foregoing premises, which
are hereby incorporated as substantive part of this Agreement, and in
consideration of the performance of the mutual covenants and promises
herein contained, MOVA and PAR have agreed as follows:
ARTICLE 1 - DEFINITIONS
-----------------------
1.1 The Product. The "Product" shall mean cimetidine (300mg.,
-----------
400mg., and 800mg.) and any future dosage strength for which the FDA
approves an Abbreviated New Drug Application with an AB rating when
compared with the corresponding strength of Tagemet (cimetidine)
tablets.
1.2 The ANDA. The "ANDA" shall mean the Abbreviated New Drug
--------
Application for the Product which has been submitted to the FDA by
MOVA, including any amendments or supplements thereto.
1.3 The FDA. The "FDA" shall mean the United States Food and Drug
-------
Administration.
1.4 Patents. The "Patents" shall mean any issued patents or patent
-------
rights held by third parties which would be infringed by the
manufacture, use or sale of the Product to be sold by MOVA to PAR
pursuant to the terms of this Agreement.
2
1.5 Patents Expiration Day. The "Patents Expiration Day" shall mean
----------------------
the day on which all of the Patents have expired or are no longer in
effect.
1.6 Availability Date. The "Availability Date" shall mean the date
-----------------
on which MOVA is first legally permitted and able to ship commercial
quantities of the Product in the interstate commerce of the USA.
1.7 Approval Date. The "Approval Date" shall mean the date on which
-------------
MOVA is in receipt of all required regulatory approvals for the
manufacture and sale of the Product.
1.8 Purchase Term. The "Purchase Term" shall mean the five (5) year
-------------
period that begins on the date the first order for Product is shipped
after the Approval Date.
1.9 Average Selling Price. The "Average Selling Price" shall mean the
---------------------
actual Net Sales of Product by shelf keeping unit sold by PAR to
unrelated third parties per calendar quarter divided by the total
number of units of each shelf keeping unit of Product sold in the said
calendar quarter.
1.10 Net Sales. "Net Sales" shall mean the gross sales for each shelf
---------
keeping unit of Product less the following:
(i) trade, quantity or cash discounts, if any, allowed or paid;
(ii) chargebacks, shelf stock adjustments, returns, credits or
allowances, if any, given or made on account of Products
previously delivered; and
(iii) Federal, State or local government rebates whether in
effect now or enacted at any time during the term of this
Agreement.
1.11 Net Profit. "Net Profit" shall mean the Net Sales for each shelf
----------
keeping unit of Product less the Base Price as specified in Exhibit A
hereof.
1.12 Purchase Price. The "Purchase Price" shall mean the base price as
--------------
specified in Exhibit A hereof, plus a percent of Actual Net Profits
per shelf keeping unit to be determined as follows:
(i) [ ] % in the event the Availability Date occurs by
Patents Expiration Day;
(ii) [ ] % in the event the Availability Date occurs
within the first sixty (60) days following the
Patents Expiration Day;
3
(iii) [ ] % in the event the Availability Date occurs
during the second sixty (60) days following the
Patents Expiration Day; or
(iv) [ ] % in the event the Availability Date occurs
more than one hundred twenty (120) days following the
Patents Expiration Day.
1.13 Base Price. "The Base Price" shall mean the base price per shelf
----------
keeping unit as specified in Exhibit A hereof. The Base Price set
forth in Exhibit A shall remain firm through December 31, 1994. The
Base Price will be adjusted on January 1st. every year, commencing on
January 1, 1995 for the annual change in the CPI for the previous
year.
1.14 USA. The "USA" shall mean the United States of America and the
---
District of Columbia, its territories and possessions, excluding the
Commonwealth of Puerto Rico and the U.S. Virgin Islands.
1.16 Affiliate. "Affiliate" shall mean, with respect to either party,
---------
all corporations or other business entities which, directly or
indirectly, are controlled by, control or are under the common control
with that party. For this purpose, the meaning of the word "control"
shall include, but not be limited to, ownership of more than fifty
percent (50%) of the voting shares or interest of such corporation or
other business entity.
1.17 CPI. "CPI" shall mean the Consumer Price Index published by the
---
Puerto Rico Department of Labor.
1.18 Competitive Product. "Competitive Product" shall mean versions
-------------------
of the Product which are manufactured by other pharmaceutical
companies for which the FDA approves an Abbreviated New Drug
Application with an AB rating when compared with the corresponding
strength of Tagemet (cimetidine) tablets.
1.19 Active Ingredient. "Active Ingredient" shall mean Cimetidine as
-----------------
defined in the USP.
ARTICLE 2 - SUPPLY
------------------
2.1 Purchase and Sale. Subject to the terms and conditions of this
-----------------
Agreement, MOVA shall supply and PAR shall purchase from MOVA
substantially all of PAR's requirements for the Product in the USA
from the Approval Date and throughout the Purchase Term. PAR shall
not purchase the Product or any product having the same active
ingredient, strength and indication as the Product, from any party
other than MOVA after the Approval Date and throughout the
4
Purchase Term except that PAR may purchase the Product or any such
product from any party pursuant to Paragraph 2.4 and Article 14
hereunder. It is understood and agreed that PAR may purchase the
Product from third parties before the Approval Date, including
accepting shipments of the Product made after the Approval Date
pursuant to orders submitted by PAR before the Approval Date. PAR
shall have the non-exclusive right to sell, market and distribute the
Product in the USA. It is understood and agreed further that PAR may,
but is not obligated to, purchase the Product for sale in countries
outside of the USA. Notwithstanding the foregoing purchase
obligations, if as a result of a merger, acquisition or other similar
extraordinary corporate transaction PAR becomes an Affiliate of a
corporate entity (a "Merger Party") who at the time of such
transaction either manufactures or has filed an ANDA for the
manufacture of a Competitive Product, then PAR may purchase such
Competitive Product from the Merger Party one (1) year after giving
MOVA written notice of such intent, and provided further that, within
ninety (90) days from the date of the merger, acquisition or other
similar extraordinary transaction, PAR notifies MOVA of the occurrence
of such transaction and of its intent of purchasing the Competitive
Product from the Merger Party. At the time of such notice, the
restrictions contained in Paragraph 2.7 hereof, with respect to sales
by MOVA to certain parties, shall no longer be applicable.
2.2 Forecasts. As early as reasonably possible (but no later than
---------
thirty (30) days prior to the date which MOVA notifies PAR should be
the Availability Date) and thirty (30) days prior to every calendar
quarter thereafter, PAR shall give to MOVA a written forecast of the
quantities of the Product, including quantities for each strength and
unit size of the Product, and delivery dates that PAR anticipates it
will order from MOVA during the two (2) calendar quarters following
the date of the written forecast. Such forecast shall not create a
binding obligation on the part of either MOVA or PAR, except as
provided in Paragraph 2.3 hereof. However, PAR shall use all
reasonable efforts to make each forecast as accurate as possible. PAR
shall promptly advise MOVA of any significant changes in its estimated
forecast of Product.
2.3 Orders. PAR shall submit written purchase orders to MOVA for the
------
quantities of the Product, including the quantity of each strength and
unit size and delivery dates, which PAR desires to purchase under this
Agreement. For the first three (3) month period of each forecast
given by PAR pursuant to Paragraph 2.2 hereof, PAR shall submit
purchase orders to MOVA for at least the greater of: seventy-five
percent (75%) of the forecasted quantities for that period on the then
current forecast or fifty percent (50%) of the forecasted quantities
for that period as shown on the immediately preceding forecast. If
applicable, each purchase order shall specify the country in which the
Product is to be resold by PAR. Regardless of the quantities ordered,
MOVA shall use all reasonable efforts to deliver the full quantities
of the Product (each strength and unit size) ordered by
5
PAR. Deliveries of the Product ordered by PAR to the destination
designated by PAR will be made within sixty (60) days following the
date on which PAR submitted the purchase order unless a later delivery
date has been specified by PAR.
2.4 Inability to Supply. Within thirty (30) days following its
-------------------
receipt of each forecast according to Paragraph 2.2 hereof, MOVA shall
advise PAR in writing if it is unable to supply the entire quantity
forecasted. PAR shall have the right to purchase from third parties
such quantities of the Product for which MOVA shall have advised that
it will be unable to supply, for as long as MOVA's inability to supply
continues.
2.5 Shipments. Delivery shall be f.o.b. Caguas, Puerto Rico, freight
---------
and insurance prepaid by MOVA. Product shall be shipped by MOVA
according to PAR's instructions, to PAR's facility at One Ram Ridge
Road, Spring Valley, NY 10977; provided, however, that should PAR
-------- -------
instruct MOVA to ship to another location, MOVA shall do so and PAR
shall reimburse for any incremental costs involved.
2.6 Purchase Price and Payment. MOVA shall invoice PAR the Base
---------------------------
Price for all shelf keeping units in each shipment of Product
delivered to PAR. Such amount shall be payable sixty (60) days from
receipt of the invoice therefor. At the end of each calendar quarter,
PAR shall determine and advise MOVA of the Actual Net Profits obtained
from the sale of the Product by PAR during such calendar quarter.
Within twenty (20) days after the end of each such quarter, PAR shall
pay to MOVA, the difference between the Base Price and the Purchase
Price times the actual number of shelf keeping units actually sold
during said calendar quarter. Payment will be made only with respect
to Product actually shipped by PAR during such calendar quarter. In
addition, within thirty (30) days after the end of each calendar
quarter, PAR shall provide MOVA with a report of the number of units
of Product shipped and returned, gross sales of Product and Net Sales
of Product during such calendar quarter and the number of units of
Product inventory remaining under PAR's control at the end of such
calendar quarter.
2.7 Sales to certain customers. Throughout the term of this
--------------------------
Agreement, MOVA agrees not to knowingly sell the Product to the
customers listed in Exhibit B hereof. MOVA shall not knowingly sell
the Product to any third party to whom PAR shall have sold the Product
under PAR's label within the sixty (60) day period immediately
following the Availability Date, provided however, that such
-------- -------
restriction shall end one (1) year after the end of the aforementioned
sixty (60) day period.
2.8 Conflicting Terms. In ordering and delivering the Product, PAR
-----------------
and MOVA may use their standard forms, but nothing in such forms shall
be construed to
6
amend or modify the terms of this Agreement and in case of conflict
herewith, the terms of this Agreement shall control.
ARTICLE 3 - QUALITY
-------------------
3.1 Quality Control. Prior to each shipment of the Product, MOVA
---------------
shall perform such quality control procedures to verify that each
shipment of the Product made under this Agreement conforms to the
specifications for the Product contained in the approved ANDA and
otherwise complies with the representations and warranties given by
MOVA in Article 4 hereof. Each shipment of the Product shall be
accompanied by a quality assurance analytical data sheet (the "Q.A.
Certificate of Analysis").
3.2 Rejection. PAR shall have thirty (30) days following the day on
---------
which it receives a shipment to reject same because all or part of the
shipment fails to conform to the applicable specifications or
otherwise fails to conform to the representations and warranties given
by MOVA herein, by giving written notice to MOVA specifying the manner
in which all or part of such shipment fails to meet the foregoing
requirements. If PAR rejects a shipment before the date on which
payment therefor is due according to Paragraph 2.6 hereof, it may
withhold payment for that shipment or the rejected portion thereof.
All shipments or portions thereof not rejected by PAR before such date
shall be paid for in accordance with Paragraph 2.6 hereof. All
shipments or portions thereof which PAR rejected but, as determined
pursuant to Paragraph 3.4 hereof, did not have the right to reject,
shall be paid within fifteen (15) days following the day on which such
determination was made, unless PAR had paid earlier. In the event PAR
rejects a shipment or portion thereof within such thirty (30) day
period in accordance with the terms hereof but after payment therefor
had been made, PAR shall be entitled to recoup the payment amount by,
at PAR's election, MOVA's issuing a prompt refund or by PAR's
offsetting such amount against the payment of future invoices or other
payments that may become due hereunder. The representations and
warranties given by MOVA hereunder shall survive any failure to reject
by PAR under this Paragraph.
3.3 Recalls. If the Product is recalled pursuant to FDA regulation
-------
or other applicable laws and returned as a result of any such recall
and such recall is due to MOVA's negligence or willful misconduct or a
breach of any representation or warranty of MOVA hereunder, then MOVA
shall bear all incremental out-of-pocket direct costs in connection
with the recall, including, but not limited to, all notification
letters and all shipping expenses. In no event shall MOVA be
responsible for any indirect expenses incurred by PAR. If the
recalled Product is to be destroyed, MOVA, at PAR's request, shall
replace free of charge said Product or issue a credit to PAR's account
or refund payment to PAR. If the recalled Product is to be reworked,
MOVA shall bear all costs of reworking said
7
product. If the Product is recalled and such recall is due to PAR's
negligence or willful misconduct or a breach of any representation or
warranty of PAR hereunder, then PAR shall bear all incremental out-of-
pocket direct costs in connection with the recall, including, but not
limited to, all notification letters and all shipping expenses. In no
event shall PAR be responsible for any indirect expenses incurred by
MOVA.
3.4 Disputes. If MOVA disputes PAR's right to reject all or part of
--------
any shipment of the Product as set forth in Paragraph 3.2 or 3.3
hereof, such dispute shall be resolved by an independent approved FDA
testing organization or consultant of recognized repute within the
U.S. pharmaceutical industry mutually agreed upon by the parties, the
appointment of which shall not be unreasonable withheld or delayed by
either party. The determination of such entity with respect to all or
part of any shipment of the Product shall be final and binding upon
the parties, but only as to the reasons given by PAR in rejecting the
shipment or portion thereof and shall have no effect on any matter for
which said entity did not render a determination. The fees and
expenses of the third party making the determination shall be paid by
the party against which the determination is made.
3.5 Obligation to Inform the Other. Parties agree to keep each other
------------------------------
regularly and fully informed of any notification or other information,
whether received directly or indirectly, which might in any way affect
the marketability, safety or effectiveness of the Product, or which
might result in potential liability for either party, or which might
necessitate action on the part of either party, or which might result
in recall of the Product, or which might otherwise in any way affect
either of the parties' interest with respect to the distribution or
use of the Product. Nothing contained in this Paragraph shall
obligate either party to provide the other with any information other
than information regarding the quality of the Product.
3.6 Inspections. Upon reasonable notice given to MOVA, PAR shall
-----------
have the right to have a reasonable number of its employees inspect
any facility at which the Product to be sold to PAR hereunder is
manufactured, packaged, stored or shipped.
3.7 Packaging. MOVA shall supply the Product to PAR in bulk and in
---------
finished bottles bearing the PAR label as specified by PAR and
approved by the FDA or such other labeling specified by PAR for the
Product to be sold outside of the USA.
ARTICLE 4 - REPRESENTATIONS AND WARRANTIES
------------------------------------------
MOVA hereby covenants, represents and warrants to PAR that:
(a) on the date of shipment, all of the Product sold by MOVA to
PAR
8
hereunder will comply with the specifications for the Product
contained in the approved ANDA, conform with the information shown on
the Q.A. Data Sheet and, when applicable, the sample provided for the
particular shipment according to Paragraph 3.1 hereof;
(b) all of the Product sold by MOVA to PAR hereunder shall have
been manufactured, packaged and stored and shipped in conformance
with all applicable current Good Manufacturing Practices which
are in force or hereinafter adopted by the FDA or any successor
agency thereto;
(c) on the date of shipment, all of the Product shipped by MOVA
to PAR hereunder will not be adulterated or misbranded within the
meaning of the Federal Food, Drug and Cosmetic Act, as amended
and in effect at the time of shipment (the "Act"), or within the
meaning of any applicable state or municipal laws in the USA
under which such terms have the same meaning as set forth under
the Act;
(d) on the date of shipment, all of the Product sold by MOVA to
PAR hereunder may be legally distributed or sold in the USA;
(e) title to all the Product sold by MOVA to PAR hereunder shall
pass to PAR as provided herein free and clear of any security
interest, lien or other encumbrance;
(f) the Product sold hereunder shall have been manufactured,
packaged and stored in facilities which are approved by the FDA
at the time of such manufacture, packaging and storage, to the
extent such approval is required by law;
(g) to the best of MOVA's knowledge and belief, the manufacture,
use or sale of the Product sold by MOVA to PAR hereunder shall
not constitute an infringement of any Patents; and
(h) to the best of MOVA's knowledge and belief, MOVA and its
employees, affiliates and agents have never been (i) debarred or
(ii) convicted of a crime for which a person can be debarred,
under Section 306(a) of the U.S. Federal Generic Drug Enforcement
Act of 1992 ("Section 306(a) or (b)") and, to the best of MOVA's
knowledge and belief, MOVA and its employees, affiliates and
agents has ever been threatened to be (i) debarred or (ii)
indicted for a crime or otherwise engaged in conduct for which a
person can be debarred under Section 306(a) or (b), and it will
promptly notify PAR in the event of any such debarment,
conviction, threat or indictment.
9
ARTICLE 5 - APPROVALS
---------------------
5.1 ANDA. MOVA shall be responsible for obtaining the approval of
----
the ANDA by the FDA and in so doing shall exercise what it in good
faith believes to be reasonable commercial effort to obtain such
approval at the earliest possible date.
5.2 Inspections by Government Agencies. Without limiting the
----------------------------------
generality of Paragraph 5.1 hereof, MOVA shall permit the FDA to
conduct whatever inspections of the facilities at which the Product is
to be manufactured, packaged and/or stored and shall cooperate with
the FDA during any such inspections.
5.3 Administration of the ANDA and other Approvals. MOVA shall be
----------------------------------------------
responsible for maintaining the ANDA and any other approvals current
and in effect. In so doing, MOVA shall comply with all applicable
requirements of the FDA and counterpart governmental agencies outside
of the USA.
5.4 Product Complaints. Each party shall immediately inform the
------------------
other of product quality, health or safety related concerns or
inquiries that raise potentially serious and unexpected quality,
health or safety concerns. All such other information not involving
the above described situation shall be transmitted to the other party
within three (3) business days following receipt.
ARTICLE 6 - ADJUSTMENTS
------------------------
6.1 Price Protection. Notwithstanding any provision herein to the
----------------
contrary, if at any time MOVA makes sales of the Product to any other
party within the USA or for resale in the USA, except sales to
federal, state and local government agencies, at a price lower than
one hundred twenty-five percent (125%) of the Base Price to PAR then
in effect under this Agreement, the Base Price to PAR then in effect
under this Agreement shall be reduced to eighty percent (80%) of such
lower price given to the other party for so long as MOVA continues to
make such sales to such other party at such lower price, unless sale
to PAR at such lower price would violate the provisions of any
pertinent law, order or regulation.
6.2 Adjustment. In the event that PAR's average selling price for
----------
the Product to any other party becomes less than [ ] per bottle of
100 tablets for 300 mg tablets adjusted on January 1st. every year,
commencing on January 1, 1995 for the annual change in the CPI (with
comparable limits for other strengths as set forth in Exhibit A), the
parties shall negotiate such modification to this Agreement as may be
necessary to enable each to perform thereunder on terms fair and
reasonable under the circumstances and if no agreement thereon can be
reached within a reasonable time, either party may terminate this
agreement by giving ninety (90) days prior notice.
10
6.3 Independent Prices. Each of the parties shall establish the
------------------
prices at which it sells the Product to its customers independently of
the other party.
6.4 Active Ingredient Cost Fluctuations. In the event that the cost
-----------------------------------
of the Active Ingredient purchased from third parties by MOVA, as
defined in Exhibit A, increases or decreases by more than 10% at any
time, such change shall be added or deducted to the Base Prices paid
by PAR to MOVA according to Paragraph 2.6 hereof. MOVA shall provide
PAR with the necessary information to verify the changes in the cost
of the Active Ingredient.
ARTICLE 7 - INDEMNIFICATION
---------------------------
7.1 MOVA's Obligation to Indemnify. MOVA agrees to indemnify,
------------------------------
defend, and hold harmless PAR, its affiliates and subsidiaries and
their respective employees against any and all claims, losses, damages
and liabilities, including reasonable attorneys' fees and costs
associated with a recall of the Product as defined in Paragraph 3.3
hereof, incurred by any of them arising out of any breach of any
obligation hereunder or any representation or warranty by MOVA
hereunder or any act or omission of MOVA in connection with its
obligations hereunder.
7.2 PAR's Obligation to Indemnify. PAR agrees to indemnify, defend
-----------------------------
and hold harmless MOVA, its affiliates and subsidiaries and their
respective employees against any and all claims, losses, damages and
liabilities, including reasonable attorneys' fees and costs associated
with a recall of the Product as defined in Paragraph 3.3 hereof,
incurred by any of them arising out of any breach of any obligation
hereunder or any representation or warranty by PAR hereunder or any
act or omission of PAR in connection with its obligations hereunder.
7.3 Obligations of the Party Seeking to be Indemnified. If PAR or any
---------------------------------------------------
of its affiliates or subsidiaries or MOVA or any of its affiliates or
subsidiaries (in each case an "Indemnified Party") receive any written
claims which it believes is the subject of indemnity hereunder by MOVA
or PAR, as the case may be (in each case an "Indemnifying Party"), the
Indemnified Party shall, as soon as reasonably practicable after
forming such belief, give notice thereof to the Indemnifying Party,
including full 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 that the Indemnifying Party is injured by such delay.
The Indemnifying Party shall have the right, by prompt notice to the
Indemnified Party, to assume the defense of such claim with counsel
reasonably satisfactory to the Indemnified Party, and at the cost of
the Indemnifying Party. If the Indemnifying Party does not assume the
11
defense of such claim, or, having done so, does not diligently pursue
such defense, the Indemnified Party may assume such defense, with
counsel of its choice, but for the account of the Indemnifying Party.
If the Indemnifying Party so assumes such defense, the Indemnified
Party may participate therein through counsel of its choice, but the
cost of such counsel shall be for the account of the Indemnified
Party. The party not assuming the defense of any such claim shall
render all reasonable assistance to the party assuming such defense,
and all out-of-pocket costs of such assistance shall be for the
account of the Indemnifying Party. No such claim shall be settled
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 and liability or obligation which cannot be assumed
and performed in full by the Indemnifying Party.
7.4 Insurance. Each party and its Affiliates shall carry products
---------
liability insurance in an amount at least equal to [ ] with an
insurance carrier reasonably acceptable to the other party. Such
insurance shall cover the indemnifications set forth in Article 7
hereof. Each party shall name the other party as additional insured
under such policy. A copy of such policy or policies shall be
delivered to the other party within ten (10) days prior to the date
any such Product is first commercially sold by such party, and shall
provide among other things, that such insurance shall not be canceled
or modified without giving the other party at least thirty (30) days
prior written notice.
ARTICLE 8 - CONFIDENTIALITY
---------------------------
8.1 Each party shall at all times maintain as confidential any know-
how or other business information received from the other party under
this Agreement during the term of this Agreement, shall only use such
information in furtherance of this Agreement shall only disclose such
information to those of its employees with a need to know in
furtherance of this Agreement, provided, however, that nothing
-------- -------
contained herein shall prevent a party from submitting information to
a governmental instrumentality in connection with seeking approval to
market the Product. Said obligation of confidentiality shall not
apply, however, to any information which:
(a) was known to the receiving party, as evidenced by its written
records, prior to receipt from the other party;
(b) is in the public domain at time of receipt or subsequently
enters the public domain through no breach of this Agreement by
the receiving party;
(c) after the date of receipt from the disclosing party, is
received without
12
cover of secrecy from a third party with a bona fide right to disclose
without violating any right of the disclosing party; or
(d) is independently developed by the receiving party without the
aid, application or use of any information for which it is
obligated to maintain as confidential according to this
Paragraph.
The respective obligations of MOVA and PAR under this Paragraph shall
be in effect during the term of this Agreement and for the three (3)
years thereafter.
ARTICLE 9 - RECORDS
-------------------
9.1 PAR shall keep appropriate and complete records in sufficient
detail so that the payments due hereunder can be properly ascertained.
PAR shall, on the request of MOVA, permit a certified public
accountant, selected by MOVA and to whom PAR has no reasonable
objection, to have access during normal business hours, to such books
and records as may be necessary to determine, in respect of any
accounting period ending not more than three (3) years prior to the
date of such request, the correctness of any payment under this
Agreement. Any such accountant shall not disclose any information to
MOVA except that which specifically relates to the payment obligations
hereunder.
ARTICLE 10 - TERM, TERMINATION
------------------------------
10.1 Term. This Agreement shall become effective as of the date first
----
written above and shall remain in full force and effect through the
end of the Purchase Term.
10.2 Termination for Cause. This Agreement may be terminated at any
---------------------
time by either party:
(a) upon breach of this Agreement by the other party, on sixty
(60) days' prior written notice to the breaching party, this
notice to become effective at the end of such sixty (60) day
period unless the breach is sooner cured by the breaching party;
or
(b) upon bankruptcy or insolvency of the other party or placing
of the business of such party in receivership.
10.3 Termination Upon Merger. If PAR exercises its right under
-----------------------
Paragraph 2.1 to purchase a Competitive Product from a Merger Partner
MOVA may terminate this Agreement at any time after one (1) year from
the time such notice is given by PAR by giving PAR ninety (90) days'
prior written notice.
13
10.4 Waiver. Failure to terminate this Agreement following a breach
------
or failure to comply with terms and conditions of this Agreement shall
not be deemed a waiver of the non breaching party's defenses, rights
or causes of action arising from such or any future breach or
noncompliance.
ARTICLE 11 - TRADE NAMES AND TRADEMARKS
---------------------------------------
11.1 PAR and MOVA hereby acknowledge that they do not have, and shall
not acquire by virtue of this Agreement, any rights to or in any
goodwill, trademark, trade name, copyright, patent or other property
of the other, nor in any of the other's trademarks or trade names
appearing on the label or packaging materials of the Product. PAR and
MOVA each agrees to do nothing by act or omission which would impair,
the rights, ownership and title to the other, including its
Affiliates, in the aforementioned.
ARTICLE 12 - NOTICES
--------------------
12.1 Any notice required or permitted to be given or made under this
Agreement by either of the parties to the other shall be in writing
and delivered to the other party at its address indicated below or to
such other address as the addressee shall have theretofore furnished
in writing to the addressor by hand, courier or by registered or
certified mail (postage prepaid) or by telefax, provided all telefax
notices shall be promptly confirmed, in writing, by registered or
certified mail (postage prepaid):
If to MOVA:
MOVA Pharmaceutical Corporation
P. O. Box 8639
Caguas, Puerto Rico 00626
Telefax: (809) 258-6405
Attention: Joaquin B. Viso
President
With a Copy to:
Ledesma, Palou & Miranda
Hato Rey Tower, Suite 1103
268 Munoz Rivera Avenue
Hato Rey, Puerto Rico 00918
Telefax: (809) 754-6344
Attention: Silvestre M. Miranda
14
If to PAR:
Par Pharmaceutical, Inc.
One Ram Ridge Road
Spring Valley, New York 10977
Telefax: (914) 425-7907
Attention: Ken Sawyer
President
All notices shall be effective as of the date received by the
addressee.
ARTICLE 13 - NON ASSIGNABILITY
------------------------------
13.1 This Agreement and the rights of the parties hereunder shall not
be assignable nor shall the obligations of either party be delegable,
except as to affiliates of PAR or MOVA, without the prior written
consent of the other party, which consent shall not be unreasonably
withheld. In the event either party seeks and obtains the other
party's consent to assign or delegate its rights or obligations to
another party, or in the event of an assignment or delegation to an
affiliate, the obligations of the assignee or transferee must be
guaranteed in writing by the party who is the assignor or transferor.
ARTICLE 14 - FORCE MAJEURE
--------------------------
14.1 Force Majeure. No failure or omission by the parties in the
-------------
performance of any obligation according to this Agreement shall be
deemed a breach of this Agreement or create any liability if the same
shall arise from any cause or causes beyond the control of the party,
including, but not limited to, strikes, riots, war, acts of God,
invasion, fire, explosion, floods, delay of carrier, shortage or
failure in the supply of materials, energy shortage and acts of
government or governmental agencies or instrumentalities.
14.2 Obligations of the Parties in case of Force Majeure. In the
---------------------------------------------------
event that due to force majeure either party hereto shall be delayed
or hindered in or prevented from the performance of its duties or
doing acts required under the terms of this Agreement, the performance
of such act, except for the obligation to pay amounts due under this
Agreement, shall be excused for the period of the delay.
Notwithstanding the aforementioned, the party subject to force majeure
shall take all reasonable steps to resolve the condition(s) forming
the basis of force majeure.
ARTICLE 15 - MISCELLANEOUS
--------------------------
15.1 Governing Law. This Agreement shall be governed by, and
-------------
construed in
15
accordance with, the laws of the Commonwealth of Puerto Rico.
15.2 Independent Contractor. The parties shall be considered
----------------------
independent contractors, and neither the making of this Agreement nor
the performance of any of the provisions hereof shall be construed to
make either party an agent, employee or legal representative of the
other, nor shall this Agreement be deemed to establish a joint venture
or partnership.
15.3 Public Announcements. MOVA and PAR shall consult with each other
--------------------
before issuing any press releases or otherwise making any public
statements with respect to this Agreement and neither of them shall
issue any press release or make any public statement prior to
obtaining the other party's approval, which approval shall not be
unreasonably withheld, except that no such approval shall be necessary
to the extent disclosure may be required by law.
15.4 Severability. Should any section, or portion thereof, of this
------------
Agreement be held invalid by reason of any law, statute or regulation
existing now or in the future in any jurisdiction by any court of
competent authority or by a legally enforceable directive of any
governmental body, then such section or portion thereof shall be
validly reformed so as to approximate the intent of the parties as
nearly as possible and, if unreformable, shall be deemed divisible and
deleted with respect to such jurisdiction; this Agreement shall not
otherwise be affected.
15.5 Taxes. Each party shall be responsible for its own taxes.
-----
15.6 Entire Agreement. The terms and provisions contained in this
----------------
Agreement, including the Exhibit hereto, constitute the entire
agreement between the parties and shall supersede all previous
communications, representations, agreements or understandings, either
oral or written, between the parties with respect to the subject
matter hereof. No agreement or understanding varying or extending
this Agreement shall be binding upon either party hereto, unless set
forth in a writing which specifically refers to this Agreement, signed
by duly authorized officers or representatives of the respective
parties, and the provisions hereof not specifically amended thereby
shall remain in full force and effect.
16
IN WITNESS WHEREOF, MOVA and PAR have executed this Agreement in
duplicate as of the day and year first above written.
MOVA PHARMACEUTICAL PAR PHARMACEUTICAL, INC.
CORPORATION
By:/s/Joaquin B. Viso By:/s/Kenneth I. Sawyer
------------------------- -----------------------
Joaquin B. Viso Ken Sawyer
President President
EXHIBIT A
---------
PRICING SCHEDULE
Minimum Average
---------------
Strength Size Base Price Selling Price
- ---------- ---- ---------- ---------------
300 mg 100s [ ] [ ]
500s [ ] [ ]
400 mg 100s [ ] [ ]
500s [ ] [ ]
800 mg 60s [ ] [ ]
250s [ ] [ ]
Per 1,000 tablets (bulk)
300 mg [ ]
400 mg [ ]
800 mg [ ]
The Base Price and the Minimum Average Selling Price will be adjusted
on January 1st, every year, commencing on January 1, 1995 for the
annual change in the CPI.
Cost of Active Ingredient [ ]
MOVA/PAR
NON EXCLUSIVE DISTRIBUTION AGREEMENT
EXCLUSIVE SUPPLY AGREEMENT
Example of the provisions of Paragraph 6.1 Price Protection
Using 300 mg. 100's
Scenario 1 Scenario 2 Scenario 3 Scenario 4
Price to third party Price to third party Price to third party Price to third party
is higher than [ ]% of is higher than [ ]% of is higher than [ ]% of is higher than [ ]% of
Base Price Base Price Base Price Base Price
Base Price to PAR [ ] [ ] [ ] [ ]
[ ]% of Base Price to Par [ ] [ ] [ ] [ ]
Price to third party [ ] [ ] [ ] [ ]
Adjusted Base Price to PAR [ ] [ ] [ ] [ ]
([ ]% of price to third
party)
EXHIBIT B
---------
PRIVATE LABEL CUSTOMERS
[ ]