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EXHIBIT 10.3
MANUFACTURING AND SUPPLY AGREEMENT
MANUFACTURING AND SUPPLY AGREEMENT ("Agreement") is entered into as of
June 30, 1997 ("Effective Date"), by and between XXXXX-XXXXXXX XXXXX
PHARMACEUTICALS INC., a Delaware corporation with its principal office at 000
Xxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 ("RPRPI"), and XXXXXX
LABORATORIES, INC., a Nevada corporation with its principal office at 000 Xxxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxx 00000 ("Xxxxxx").
R E C I T A L S:
WHEREAS, Xxxxx Pharmaceutical Products, Inc. ("RPPI"), an Affiliate of
RPRPI and Xxxxxx have entered into a License Agreement dated as of even date
herewith (the "License Agreement") granting to Xxxxxx an exclusive license of
all of RPPI's rights to market, advertise, promote, sell and distribute the
Product throughout the Territory (as each such term is defined below); and
WHEREAS, RPR and Xxxxxx desire to enter into this Agreement under which
RPRPI will supply all of Xxxxxx'x requirements of the Product to Xxxxxx, and
Xxxxxx will purchase all of its supply of the Product from RPRPI.
NOW THEREFORE, in consideration of the mutual covenants and
consideration set forth herein, the parties hereto, intending to be legally
bound, hereby agree as follows:
ARTICLE I
Definitions
1.1 Definitions. As used in this Agreement, the following terms shall
have the corresponding meanings set forth below:
"Act" shall mean the Federal Food, Drug and Cosmetic Act, as amended,
and the regulations promulgated under such Act.
"Affiliate" shall mean, when used with respect to a Person, any other
Person directly or indirectly controlling, controlled by, or under common
control with the subject Person; provided, however, that with respect to RPRPI,
only Xxxxx-Xxxxxxx Xxxxx Inc. ("RPR") and Persons directly or indirectly
controlled by RPR shall be an Affiliate of RPRPI for any provision of this
Agreement, or any of the Agreements contemplated hereby. For purposes of this
Agreement, "control" means the direct or indirect ownership of over 50% of the
outstanding voting securities of a person, or the right to receive over 50% of
the profits or earnings of a person.
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"Bankruptcy Event" shall mean the Person in question becomes insolvent,
or a receiver or custodian is appointed for such Person, or voluntary or
involuntary proceedings by or against such Person are instituted in bankruptcy
or under any insolvency law, or proceedings are instituted by or against such
Person for corporate reorganization or the dissolution of such Person, which
proceedings, if involuntary, shall not have been dismissed within sixty (60)
days after the date of filing, or such Person makes an assignment for the
benefit of its creditors, or substantially all of the assets of such Person are
seized or attached and not released within sixty (60) days thereafter.
"Designated Manufacturer" shall mean Centeon L.L.C., the party that, as
RPRPI's designee and on RPRPI's behalf, shall manufacture the Product for supply
by RPRPI to Xxxxxx hereunder.
"FDA" shall mean the Food and Drug Administration of the United States
Department of Health and Human Services, or any successor agency thereto.
"FDA Standards" shall mean the Act, the establishment license
requirements and the Current Good Manufacturing Practice regulations of the FDA
applicable to the Product or, insofar as the Product is concerned, the
manufacturing facility of the Designated Manufacturer, and all relevant
guidelines of the FDA.
"Improvement" to a Product shall mean any and all inventions,
discoveries, developments, modifications and improvements, whether or not
patented or patentable, relating to such Product which is reflected in a
mutually agreed, written change to the Product Specification.
"Jago License Agreement" shall mean that certain Diltiazem SR
Development and License Agreement, dated August 10, 1988, between RPR and Jago
Research AG, as amended.
"Labeling" shall mean all unit Product labels, package inserts, carton
imprints and all other markings on packaging for, or other similar materials
related to, the Product supplied hereunder to Xxxxxx that are defined as labels
or labeling under any applicable law or regulation.
"Labeling Specifications" shall mean those U.S. Labeling specifications
for the Products attached hereto as Exhibit 1.1, incorporated by reference
herein (excluding those labeling specifications required under the NDA for the
Product), and any amendments to such specifications which may be mutually agreed
upon by the parties in writing and which shall be incorporated herein.
"NDA" shall mean the "New Drug Application," as defined in the Act, for
the Product and all supplements thereto.
"Person" shall mean any corporation, partnership, joint venture, other
entity or natural person.
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"Product" shall mean the pharmaceutical preparation, whether branded
(i.e., sold under a trademark) or generic (i.e., sold not under a trademark),
consisting of diltiazem formulated for extended release using the delivery
technology licensed under the Jago License Agreement and currently marketed by
RPRPI in the U.S.A. under the Dilacor XR(R) trademark and any and all
Improvements thereon.
"Product Specifications" shall mean the Product specifications and
methods set forth as of the date hereof in the manufacturing and control
sections of the NDA heretofore submitted to and approved by the FDA for the
Product, including any Labeling requirements specified therein, and any
amendments to such specifications which may be mutually agreed upon by the
parties in writing and which shall be incorporated herein.
"Specifications" shall mean the Product Specifications and the Labeling
Specifications.
"Territory" shall mean the entire world, excluding New Zealand, the
Republic of Korea and North Korea.
ARTICLE II
Supply of the Product
2.1 Exclusive Supply of Product. Except as specifically provided by the
provisions of this Agreement, during the term of this Agreement, RPRPI shall
supply Xxxxxx with all of its requirements of the Product (in finished, packaged
form except as provided in Section 2.4(g)), and Xxxxxx shall purchase all of its
requirements of the Product from RPRPI, all in accordance with the terms hereof.
The parties acknowledge that RPRPI may cause some or all of its obligations
under this Agreement, including without limitation the manufacturing, testing,
packaging and shipping of the Product, to be performed on RPRPI's behalf by the
Designated Manufacturer; provided, however, that RPRPI shall be and remain fully
liable hereunder for the performance of all such obligations.
2.2 Forecasts, Orders, Prices and Terms.
(a) Upon execution of this Agreement and no later than June 15 of
each calendar year thereafter, Xxxxxx shall provide RPRPI in writing with a good
faith forecast and best estimate of Xxxxxx'x demand for the Product, by
presentation, for the next calendar year for budgeting purposes and for
determination of Standard Costs (as defined below).
(b) Xxxxxx shall provide RPRPI by the first day of each calendar
month with a written twelve (12) month rolling forecast and best estimate, by
month, of its requirements of Product. All forecasts shall be prepared in good
faith in order to facilitate RPRPI's, or its Designated Manufacturer's,
manufacture and shipment of the Product in compliance with this Agreement.
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(c) Concurrently with execution of this Agreement, Xxxxxx shall
submit and RPPI hereby accepts its firm purchase orders for shipment of Product
for the initial four months of this Agreement in accordance with Schedule 2.2(c)
hereof. Otherwise, firm purchase orders for Product shall be placed by Xxxxxx
with RPRPI not less than one hundred twenty (120) days lead time prior to the
shipment or other release date(s) requested by Xxxxxx unless RPRPI agrees to and
accepts an order for delivery in less than one hundred twenty (120) days. It is
expressly understood and agreed that, subject to the duties of Xxxxxx under the
License Agreement and Section 2.1 of this Agreement and subject to submitted
firm purchase orders, Xxxxxx has no obligation to order any minimum quantities
of Product; provided, however, RPRPI may require Xxxxxx to place orders in whole
number multiples of specified-size lots and/or in reasonable minimum batch
sizes. Each purchase order shall include (a) the quantity of Product to be
purchased; (b) the requested delivery date(s) therefor; (c) any relevant
shipping instructions; and (d) any other information dictated by the
circumstances of the order. All contrary, inconsistent or additional terms and
conditions of any purchase order, purchase order release, confirmation,
acceptance, invoice or any similar document shall be superseded by the
provisions of this Agreement and shall be disregarded and have no force or
effect.
(d) All purchase orders are subject to acceptance by RPRPI. So long
as Xxxxxx is not in default under this Agreement, RPRPI shall accept purchase
orders issued to it by Xxxxxx that are within forecast and the minimum order
lead time specified above, by written notification to Xxxxxx within ten (10)
days after receipt of such purchase order. RPRPI will use commercially
reasonable efforts to fill non-conforming orders, subject to the consent of the
Designated Manufacturer if required, but RPRPI reserves the right to charge
reasonable expedite fees and other surcharges as a condition to its accepting a
non-conforming order. Once accepted by RPRPI, a purchase order cannot be
canceled, accelerated or rescheduled, in whole or part, except with RPRPI's
written consent. Requests to increase an existing purchase order shall be
treated as a new purchase order for the incremental amount.
(e) RPRPI shall cause the Designated Manufacturer to manufacture
and ship Product pursuant to Xxxxxx'x purchase orders accepted by RPRPI.
(f) The purchase price for Product ("Purchase Price") purchased
from RPRPI shall be equal to (i) RPRPI's Standard Cost (as defined below) for
such Product, plus (ii) ten percent (10%) of the Standard Cost for such Product
(and also plus any applicable sales or use taxes, duties, VAT and other similar
taxes, unless Xxxxxx provides RPRPI with a valid resale certificate or other
proof of exemption). For purposes hereof, "Standard Cost" with respect to the
Product shall equal the costs determined in accordance with the methodology set
forth in Schedule 2.2 (f) attached hereto, as such schedule may be amended from
time to time in a writing signed by an authorized representative of both the
parties, and are subject to adjustment as set forth in Section 2.4(a).
(g) The charges applicable to each shipment of Product shall be
separately invoiced by RPRPI simultaneously with delivery by RPRPI to Xxxxxx of
a certificate of
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analysis relating to such shipment. Payment shall be made within thirty (30)
days after Xxxxxx'x receipt of an invoice.
(h) All shipments of the Product shall be shipped, at Xxxxxx'x
option, to Xxxxxx'x facilities in Corona, California or Copaigne, New York. All
shipments shall be Ex Works the manufacturing facility (Incoterms 1990), and
shall be accompanied by a packing slip which describes the Product, states the
purchase order number and shows the shipment's destination (as specified above).
Title and risk of loss shall transfer to Xxxxxx upon delivery of the goods to
the carrier for shipment as provided for herein at the Designated Manufacturer's
manufacturing facility. Xxxxxx shall designate a carrier and mode of shipment at
the time of entry of each purchase order with RPRPI; provided, however, that if
Xxxxxx fails to designate a carrier on its purchase order, RPRPI may select a
common carrier (shipment by ground) for the account and risk of Xxxxxx. For the
purposes of this Agreement, a timely shipment shall be a shipment made by RPRPI
or RPRPI's Designated Manufacturer, through Xxxxxx'x carrier, a common carrier,
or other method designated by and for the account and at the expense of Xxxxxx
of a quantity of Product equal to the amount specified in the applicable
purchaser order plus or minus five percent (5%) no later than ten (10) business
days after the shipment date set forth in such purchase order.
2.3 Records and Audit Rights.
(a) RPRPI shall maintain complete and accurate books and records
with respect to the Standard Costs payable by Xxxxxx under this Agreement and
the transactions contemplated herein, along with such other reconciliation and
other information as may be necessary to calculate and verify all consideration
paid or payable by Xxxxxx under this Agreement and the transactions contemplated
herein. Upon Xxxxxx'x reasonable request, RPRPI shall request from the
Designated Manufacturer documents and information necessary to determine the
Standard Costs payable by Xxxxxx hereunder.
(b) RPRPI shall maintain such books and records in accordance with
generally accepted accounting principles consistently applied and for a period
of three (3) years after the submission of each report required to be submitted
by RPRPI to Xxxxxx under this Agreement; provided, however, that if there is a
good faith dispute between the parties continuing at the end of any such three
(3) year period with respect to such books or records, then the time period for
RPRPI to maintain such books and records under dispute shall be extended until
such time as the dispute is finally resolved.
(c) Xxxxxx shall have the right itself or through an independent
accountant selected by it and acceptable to and approved by RPRPI (which
approval shall not be unreasonably withheld or delayed) to have access to the
relevant RPRPI records during reasonable business hours for the purposes of
verifying, inspecting or auditing, at Xxxxxx'x expense (except as provided for
in Section 2.3(d) below), the Standard Costs provided for in this Agreement for
any of the preceding three (3) years, but this right may not be exercised more
than once in any period of twelve consecutive months. Xxxxxx shall solicit or
receive only information relating to the accuracy of the information and
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the payments made. RPRPI shall be entitled to withhold approval of an accountant
which Xxxxxx nominates unless the accountant agrees to sign a confidentiality
agreement with Xxxxxx which shall obligate such accountant to hold the
information it receives from RPRPI in confidence, except for information
necessary for disclosure to Xxxxxx, necessary to establish the accuracy of the
reports and amounts paid to RPRPI. Such audit rights shall survive for three (3)
years after the expiration or termination of this Agreement.
(d) Any underpayment for Product shipped determined pursuant to
subparagraph (c) above shall be paid within thirty (30) days of the delivery of
a detailed written accountant's report to the parties hereto. Any overpayment
for Product shipped shall be credited to the next payment due from Xxxxxx. If no
further payments from Xxxxxx will be due then a refund will be made within sixty
(60) days of the audit. In the event of any such overpayment of ten percent
(10%) or more, RPRPI shall also at the same time reimburse Xxxxxx for the
out-of-pocket costs of the verification, inspection or audit conducted.
(e) The provisions of this Section 2.3 shall survive the expiration
or sooner termination of the term of this Agreement.
2.4 Labeling and Packaging.
(a) From and after such time as the NDA for the Product has been
transferred to Xxxxxx pursuant to the terms of the Inventory Purchase Agreement
of even date herewith, between Xxxxxx and RPRPI, Xxxxxx shall bear the sole
responsibility for ensuring the accuracy of the information contained in all
Labeling and for compliance of all such Labeling and the Labeling Specifications
with all applicable law in the Territory. RPRPI shall purchase sufficient
Labeling to cover the next full quarter's forecasted amount of Product. Should
Xxxxxx desire or be required to change any component of Labeling or to introduce
a new packaging component to which Labeling will be affixed, Xxxxxx shall so
inform RPRPI and shall be responsible for updating of the artwork or text, as
applicable, and providing it to RPRPI in camera-ready form and in compliance
with the Labeling Specifications. RPRPI shall make all necessary arrangements
for such Labeling to be printed and shall provide to Xxxxxx printer's proofs of
all Labeling for Xxxxxx'x review. Xxxxxx shall within fifteen (15) business days
of its receipt of such proofs either provide to RPRPI any necessary corrections
thereto or notify RPRPI of its approval of such proofs. Failure to notify RPRPI
of corrections within such fifteen (15) business days shall be deemed acceptance
for such proofs by Xxxxxx. Upon acceptance thereof by Xxxxxx, RPRPI shall return
all artwork provided by Xxxxxx to Xxxxxx. RPRPI shall be entitled to adjust its
Standard Costs for manufacturing Products hereunder, effective immediately upon
making such adjustment, to take account of all costs incurred in making changes
to Labeling and/or packaging as provided for in this Section 2.4(a), including
without limitation the costs of acquiring new Labeling in a timely manner to
meet Xxxxxx'x pending purchase orders and forecasted demand and the acquisition
and disposal costs associated with obsolete inventory of Labeling, films, plates
and packaging.
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(b) Notwithstanding anything to the contrary contained above, (i)
Xxxxxx, at its option and expense, may elect by written notice to RPRPI to
assume all responsibility for and perform all packaging and labeling with
respect to all samples of the Product, and (ii) in order to facilitate Xxxxxx'x
packaging and labeling of such samples, RPRPI will, upon request by Xxxxxx, ship
to Xxxxxx'x Corona, California or Copaigne, New York facility (as designated by
Xxxxxx) reasonable quantities of the Product in bulk form for packaging and
labeling as samples. If Xxxxxx elects this option, the parties will discuss and
mutually agree upon (such agreement not to be unreasonably withheld) the details
of the transfer of packaging and labeling responsibility for samples to Xxxxxx.
(c) In the event Xxxxxx obtains one or more Regulatory Approval(s)
to distribute Product conforming to the Product Specifications in
jurisdiction(s) in the Territory outside the U.S. and such Regulatory
Approval(s) require Product Labeling that differs from Labeling that conforms to
the Labeling Specifications, the parties will discuss in good faith an
appropriate means of having bulk Product packaged for distribution in such
jurisdictions.
2.5 Inspection of Product.
(a) RPRPI will, or will cause the Designated Manufacturer to,
conduct quality control testing and formal release of Product in accordance with
the RPRPI standard quality control procedures that are part of the Product
Specifications ("RPRPI-Standard QA"), and to provide Xxxxxx with a certificate
of analysis for all batches of Product shipped to Xxxxxx. Delivery of any
Product by RPRPI to Xxxxxx shall constitute a certification by RPRPI that the
Product conforms to the Product Specifications, except in the case of
quarantined shipments, described below. RPRPI may ship Product to Xxxxxx
directly from the Designated Manufacturer's facility, and Xxxxxx agrees to
accept delivery for Product, in quarantine. Xxxxxx shall store all Product in
controlled conditions as specified in the Specifications. In the event a
shipment is delivered in quarantine, Xxxxxx will extract and deliver to RPRPI or
the Designated Manufacturer samples of the quarantined shipment pursuant to
RPRPI-Standard QA, for quality control testing by RPRPI. Upon satisfactory
completion of such RPRPI-Standard QA, RPRPI will, or will cause the Designated
Manufacturer to, release such shipment by delivering to Xxxxxx a written notice
releasing such shipment, accompanied by a certificate of analysis pertaining to
such shipment. In the case of quarantined shipments, such release by RPRPI will
constitute a certification by RPRPI that the Product conforms to the Product
Specifications. RPRPI will have the right at reasonable times and on reasonable
notice to inspect Xxxxxx'x distribution center for compliance with the
aforementioned conditions for storage and treatment of quarantined shipments,
but such right may not be exercised more than once in any period of twelve
consecutive months unless RPRPI has a good faith reason to believe the Product
is not being handled and stored in accordance with the Product Specifications
and/or such facility is not in compliance in any material respect with FDA
Standards or other applicable law. Such inspection shall be conducted at RPRPI's
sole cost and expense in a manner so as reasonably to minimize disruption of
Xxxxxx'x business operations, provided that Xxxxxx shall reimburse RPRPI for
such costs if such inspection reveals a material non-compliance with Product
Specifications, FDA Standards or any applicable law.
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(b) Within fifteen (15) days after receipt of each shipment of
Product by Xxxxxx at the destination specified in the shipping instructions,
Xxxxxx agrees to inspect promptly each shipment to determine whether any portion
of it does not conform with the applicable purchase order, the Specifications or
the representations and warranties of RPRPI set forth in Sections 3.1(a) and (b)
hereof. In the event that any portion of any shipment fails to conform to the
applicable purchase order, the Specifications or the representations and
warranties of RPRPI set forth in Sections 3.1(a) and (b) hereof, Xxxxxx may
reject the non-conforming portion of Product by giving prompt written notice to
RPRPI within fifteen (15) days after Xxxxxx'x receipt of such shipment or, if
the shipment is a quarantined shipment as specified above, receipt of a
certificate of analysis as so specified; provided, however, that in no event
shall RPRPI be liable for any such noncompliance arising out of the shipment,
storage or handling of the Product following its delivery to the carrier at the
manufacturing facility. Such notice shall include a copy of Xxxxxx'x test
results and specify the manner in which Product fails to meet the applicable
purchase order, Specifications or representations and warranties. Failing such
notification, Xxxxxx shall be deemed to have accepted the shipment of Product,
except as to latent defects which could not have been detected in such 15 day
period. Such acceptance by Xxxxxx shall not be deemed to be a waiver by Xxxxxx
of any of the representations or warranties made by RPRPI in Sections 3.1(a) and
(b) hereof.
(c) Upon giving RPRPI such notification of non-conformance, Xxxxxx
shall provide RPRPI with a reasonable opportunity to inspect the Product and
make any appropriate adjustment or replacement. Any dispute regarding the proper
rejection of a shipment shall be submitted for testing to an independent
laboratory to be mutually agreed upon. The independent laboratory shall be
mutually agreed upon within seven (7) business days of RPRPI's receipt of the
notice of rejection. If the independent laboratory finds that the shipment in
question or any part of it did not comply in all material respects with the
Specifications or the representations and warranties of RPRPI set forth in
Sections 3.1(a) and (b) at the time of delivery to the carrier as required by
Section 2.2(g), or if the parties agree that there is a shortage or
non-compliance, RPRPI shall use commercially reasonable efforts to cause the
Designated Manufacturer forthwith to make up the shortage, if appropriate, or
replace any non-conforming Product, such new Product to be shipped to the same
destination as the original shipment at RPRPI's expense, and if RPRPI is unable
to cause the Designated Manufacturer to do so, it shall promptly refund any
money paid by Xxxxxx with respect to such undelivered or non-complying Product
and reimburse Xxxxxx for the costs of shipping such Product. Any non-conforming
Product shall, at RPRPI's direction and expense, either be returned by Xxxxxx to
RPRPI or destroyed by Xxxxxx (and certified as so destroyed by Xxxxxx). RPRPI's
supply of substitute Product which conforms to the Product Specifications, or as
the case may be, payment of the refund and reimbursement provided for herein,
shall satisfy and discharge any claims or potential claims of Xxxxxx against
RPRPI with respect to undelivered or non-complying Product in that shipment.
(d) With respect to disputes described in subparagraph (c) above,
the parties agree to be bound by the independent laboratory's report. Costs of
the independent laboratory's activities shall be borne by Xxxxxx if the Product
in question is found to comply with the Product Specifications and the
representations and warranties of RPRPI
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set forth in Sections 3.1(a) and (b), and by RPRPI if such Product is found not
to comply with the Product Specifications or the representations and warranties
of RPRPI set forth in Sections 3.1(a) and (b).
2.6 Inspection of the Product Facility.
(a) Xxxxxx shall have the right (but no more than once each
calendar year, unless Xxxxxx has a good faith reason to believe such facility is
not in compliance in any material respect with FDA Standards or other applicable
law), upon reasonable advance notice, during regular business hours and at times
mutually agreed upon, to inspect the facilities (including the facilities of the
Designated Manufacturer) being used by RPRPI for production of the Product to
assure compliance with applicable laws, rules and regulations, including without
limitation FDA Standards, applicable portions of the NDA for the Product and
RPRPI-Standard QA (collectively, "Relevant Standards"). Such inspection and
audit shall be conducted at Xxxxxx'x sole cost and expense in a manner so as to
minimize disruption of RPRPI's business operations.
2.7 Product Recalls. In the event any governmental agency having
applicable jurisdiction shall order, or in the event the parties mutually agree
that otherwise becomes necessary to perform, any corrective action or market
action with respect to the Product supplied hereunder, including any recall,
field correction, market withdrawal, stock recovery, customer notice or
restriction, caused by a breach by RPRPI of any of its representations or
warranties contained in Sections 3.1(a) and 3.1(b), then RPRPI shall be liable
for, and shall reimburse Xxxxxx for the reasonable, documented out-of-pocket
costs actually incurred by Xxxxxx in notifying its customers of such action and
replacing any Product recalled from its customers (including costs of shipment)
or from Xxxxxx'x inventory. Xxxxxx shall be liable for the costs of all other
such actions and shall indemnify RPRPI for the reasonable, documented
out-of-pocket costs actually incurred by RPRPI in connection therewith. If each
of RPRPI and Xxxxxx are partly liable for such action under the terms hereof,
each party shall be responsible for its proportionate share of such costs.
2.8 Confidentiality; Press Releases.
(a) Pursuant to the terms hereof, from time to time during the term
of this Agreement, each of Xxxxxx and RPRPI and/or its respective Affiliates (in
such capacity, the "Disclosing Party") have disclosed and will be disclosing to
the other party and/or its Affiliates (in such capacity, the "Receiving Party")
certain proprietary information, technical data, trade secrets and know-how of
the Disclosing Party including, without limitation, know-how, plans, designs,
methods, formulations, ingredients, samples, processes, machines, processing and
control information, Royalty-Bearing Product performance data, manuals, INDs,
NDAs, Regulatory Approvals, the content of any unpublished patent applications,
drawings, formulae, devices, structures, models, prototypes, data, test results,
photographs, film, techniques, apparatus, tapes, disks, unpublished trademarks,
trade names and copyrights, customer lists, supplier lists, operating methods
and procedures, marketing, distribution and sales methods and systems, sales
figures, projections, finances and other business information. The
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Receiving Party shall, during the term of this Agreement, and for seven (7)
years after the expiration or sooner termination of the term of this Agreement,
make no use of such confidential information except to advance the purposes of
this Agreement and of the agreements contemplated herein or therein or executed
concurrently herewith in accordance with its provisions, and shall use the same
efforts to keep secret and prevent the disclosure of such confidential
information to third parties as it would use with respect to its own
confidential information. Information disclosed by the Disclosing Party shall
remain the sole and absolute property of the Disclosing Party, subject to the
rights granted in this Agreement and the transactions contemplated herein. The
above restrictions on the use and disclosure of information shall not apply to
any information which: (i) is already known to the Receiving Party at the time
of disclosure, as demonstrated by competent proof; (ii) is or becomes generally
available to the public other than through any act or omission of the Receiving
Party in breach of this Agreement; (iii) is acquired by the Receiving Party from
a third party who is not, directly or indirectly, under an obligation of
confidentiality to the Disclosing Party with respect to same; (iv) is required
to be disclosed pursuant to applicable law, rule or regulation; (v) is required
to be disclosed to government regulatory authorities to obtain Regulatory
Approval for the Royalty-Bearing Products or to respond to a regulatory or
governmental inquiry concerning the Royalty-Bearing Products; or (vi) is
developed independently by the Receiving Party without use, direct or indirect,
of information that is required to be held confidential hereunder.
(b) Subject to compliance with the terms of the Jago License
Agreement, Xxxxxx shall be permitted to disclose to its distributors,
wholesalers and other direct customers such confidential information relating to
the Royalty-Bearing Products as Xxxxxx shall reasonably determine to be
necessary in order to effectively market and distribute the Royalty-Bearing
Products, provided that such entities undertake the same confidentiality
obligation as Xxxxxx has with respect to RPRPI's confidential information.
(c) Except as otherwise provided herein, neither party shall use
the name of the other for marketing, advertising or promotional claims without
the prior written consent of the other party.
(d) To the extent that Xxxxxx has exercised its right under Section
2.3(a) to require RPRPI to request documents from the Designated Manufacturer or
receives any other confidential information belonging to the Designated
Manufacturer, Xxxxxx agrees to be bound by the confidentiality provisions of the
supply agreement between RPRPI and the Designated Manufacturer as if it were a
party thereto.
(e) The provisions of this Section 2.7 shall survive the expiration
or sooner termination of this Agreement.
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ARTICLE III
General Terms and Conditions
3.1 Representations and Warranties of RPRPI. RPRPI represents and
warrants to Xxxxxx that:
(a) Subject to Xxxxxx'x liability with respect to the content of
Labeling under Section 2.4(a), all Product manufactured, supplied and shipped by
RPRPI, or on its behalf by the Designated Manufacturer, to Xxxxxx under this
Agreement shall be manufactured in accordance with and shall conform, at the
time of delivery to the carrier at the manufacturing facility, to the
Specifications and all applicable FDA Standards.
(b) Subject to Xxxxxx'x liability with respect to the content of
Labeling under Section 2.4(a), all Product supplied by RPRPI, or on its behalf
by the Designated Manufacturer, to Xxxxxx under this Agreement shall not, at the
time of delivery to the carrier at the manufacturing facility, be adulterated or
misbranded within the meaning of Section 301 of the Act, or be an article which
may not be introduced into interstate commerce under the provisions of Section
505 of the Act.
(c) All Product sold to Xxxxxx hereunder shall be, at the time of
delivery to the carrier at the manufacturing facility, free and clear of any
liens, title claims, security interests and encumbrances of any nature.
3.2 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR
OTHERWISE, AND EACH PARTY SPECIFICALLY (1) DISCLAIMS ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS
WHETHER USED ALONE OR IN COMBINATION WITH OTHER SUBSTANCES OR MATERIALS, AND (2)
RELEASES THE OTHER PARTY FROM, AND WAIVES, ANY AND ALL LIABILITY FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
ARTICLE IV
Indemnification
In order to distribute among themselves the responsibility for claims
arising out of this Agreement, and except as otherwise specifically provided for
herein, the parties agree as follows:
4.1 RPRPI shall defend, indemnify and hold Xxxxxx, its Affiliates,
successors and permitted assigns, and the respective officers, directors,
agents, employees and shareholders of each (collectively, "Xxxxxx Indemnitees")
harmless, from and against, any and all losses, obligations, liabilities,
penalties, damages, costs and expenses (including reasonable attorneys' fees),
which the Xxxxxx Indemnitees may incur or suffer as a result of third-party
suits or claims for illness, bodily injury or death to the extent they are
attributable to any breach by RPRPI of any representation or warranty made by
RPRPI in Section 3.1(a) or (b).
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4.2 If any action, claim, suit, proceeding or investigation arises as
to which a right of indemnification provided in this Article IV applies, the
Xxxxxx Indemnitee (the "indemnified party"), shall promptly notify the party
obligated under this Article IV to indemnify the indemnified party (the
"indemnifying party") thereof in writing, and allow the indemnifying party and
its insurers the opportunity to assume direction and control of the defense
against such action, claim, suit, proceeding or investigation, at its sole
expense, including without limitation, the settlement thereof at the sole option
of the indemnifying party or its insurers to the extent that the indemnified
party's liability is not thereby invoked. The indemnified party shall fully
cooperate with the indemnifying party and its insurer in the disposition of any
such matter and the indemnified party will have the right to participate in (but
not control) the defense of any action, claim, suit, proceeding or investigation
as to which this Article IV applies, with separate counsel at its election and
at its own expense. If the indemnifying party fails or declines to assume the
defense of any such action, claim, suit, proceeding or investigation within
thirty (30) days after notice thereof, the indemnified party may assume the
defense thereof for the account and at the risk of the indemnifying party. The
indemnifying party shall pay promptly to the indemnified party any losses,
obligations, liabilities, penalties, damages, judgments, reasonable costs and
expenses (including reasonable legal fees) to which the indemnity under this
Article IV applies, as incurred.
ARTICLE V
Term
5.1 Except as otherwise provided herein, the term of this Agreement
shall commence on the Effective Date and shall continue until June 30, 1999;
provided, however, that in the event the necessary approvals have not been
obtained in order to have the Product manufactured by an entity other than
RPRPI, Xxxxxx may extend the term of this Agreement for a single, additional
year by delivering written notice to RPRPI delivered at least one hundred eighty
(180) days prior to the scheduled termination date hereof.
5.2 The following shall survive the expiration or sooner termination of
the term of this Agreement: any payment obligations of the parties hereunder
accruing prior to the date of expiration or termination; the provisions of
Articles III and IV, and any other provision herein expressly surviving
expiration or termination or necessary to interpret the rights and obligations
of the parties in connection with the expiration or termination of the term of
this Agreement.
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ARTICLE VI
Events of Default
6.1 The occurrence of any one or more of the following acts, events or
occurrences shall constitute an "Event of Default" under this Agreement:
(a) either party becomes the subject of a Bankruptcy Event; or
(b) either party breaches any material provision of this Agreement
or the License Agreement, or defaults in the performance or observance of any
material provision of this Agreement or the License Agreement, and fails to
remedy such breach or default within one hundred eighty (180) days after receipt
of notice thereof (except in the case of a failure to pay any amounts due, in
which event the default if such payment is not received within 10 business days
of the due date, shall give rise to an Event of Default unless the parties
otherwise agree).
6.2 If RPRPI materially defaults in the performance of its obligations
hereunder to supply the Product, then Xxxxxx shall be relieved of its obligation
under Section 2.1 to purchase all of its requirements for the Product from RPRPI
during the applicable cure period under Section 6.1(b) (and thereafter if such
cure is not effectuated during the first 120 days of such cure period).
ARTICLE VII
Remedies
7.1 Immediately upon the occurrence of any Event of Default by RPRPI
pursuant to Section 6.1 (a) or (b), Xxxxxx shall have the right to terminate
this Agreement by delivering written notice thereof to RPRPI and pursue any and
all remedies available to Xxxxxx.
7.2 Immediately upon the occurrence of any Event of Default by Xxxxxx
pursuant to Section 6.1(a) or (b), RPRPI shall have the right to terminate this
Agreement by delivering written notice thereof to Xxxxxx and to pursue any and
all remedies available to RPRPI.
7.3 The parties expressly acknowledge that the remedy provisions
contained in this Section are reasonable, considering the intended nature and
scope of this Agreement, and considering the investments and undertakings
required on the part of the parties in connection herewith.
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ARTICLE VIII
Force Majeure
The obligations of RPRPI and Xxxxxx hereunder shall be subject to any
delays or non-performance caused by: acts of God, earthquakes, fires, floods,
explosion, sabotage, riot, accidents; regulatory, governmental, or military
action or inaction; strikes, lockouts or labor trouble; perils of the sea; or
failure or delay in performance by third parties, including suppliers and
service providers; or any other cause beyond the reasonable control of either
party ("Force Majeure Event"). The party which is not performing its obligations
under this Agreement as a result of any such event of Force Majeure shall use
commercially reasonable efforts to resume compliance with this Agreement as soon
as possible.
ARTICLE IX
Covenants of RPRPI
9.1 During the term of this Agreement, RPRPI or its Affiliates shall
maintain at all times, either itself or through the Designated Manufacturer, the
manufacturing capacity and capabilities which shall allow it to satisfy the
provisions of this Agreement and timely supply the Product to Xxxxxx in
accordance with the terms of this Agreement.
ARTICLE X
Miscellaneous
10.1 In making and performing this Agreement, the parties are acting
and shall act as independent contractors. Nothing in this Agreement shall be
deemed to create an agency, joint venture or partnership relationship between
the parties hereto. Neither party shall have the authority to obligate the other
party in any respect, and neither party shall hold itself out as having any such
authority. All personnel of RPRPI shall be solely employees of RPRPI and shall
not represent themselves as employees of Xxxxxx. All personnel of Xxxxxx shall
be solely employees of Xxxxxx and shall not represent themselves as employees of
RPRPI.
10.2 Neither RPRPI nor Xxxxxx may assign or otherwise transfer any of
its rights or obligations hereunder without the prior written consent of the
other party, which consent shall not be unreasonably withheld or delayed. No
such assignment shall relieve assignor of any of its obligations or liabilities
under this Agreement.
10.3 This Agreement shall inure to the benefit of and be binding upon
the parties hereto and their respective permitted successors and assigns.
Nothing contained herein shall give to any other Person any benefit or any legal
or equitable right, remedy or claim.
10.4 This Agreement may only be modified, amended or supplemented by an
instrument in writing executed by RPRPI and Xxxxxx.
10.5 No term or provision hereof will be considered waived by either
party, and no breach excused by either party, unless such waiver or consent is
in writing signed on
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behalf of the party against whom the waiver is asserted. No consent by either
party to, or waiver of, a breach by either party, whether express or implied,
will constitute a consent to, waiver of, or excuse of any other, different, or
subsequent breach by either party.
10.6 All notices, claims, certificates, requests, demands and other
communications hereunder shall be in writing and shall be delivered personally
or sent by facsimile transmission, air courier, or registered or certified mail,
return receipt requested, addressed as follows:
If to Xxxxxx: If to RPRPI:
Xxxxxx Laboratories, Inc. Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc.
000 Xxxxxx Xxxxxx 000 Xxxxxx Xxxx
Xxxxxx, Xxxxxxxxxx 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Fax: (000) 000-0000
Attn: Xx. Xxxxx Xxxx Attn: Vice President Industrial Operations,
the Americas
With copies to: With copies to:
X'Xxxxxx & Xxxxxx Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc.
00 Xxxxx XxXxxxx, Xxxxx 0000 000 Xxxxxx Xxxx
Xxxxxxx, Xxxxxxxx 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Attn: General Counsel
Attn: Xxxxxx X. Xxxxxxx Fax: (000) 000-0000
or to such other address as the party to whom notice is to be given may have
furnished to the other parties in writing in accordance herewith. Any such
communication shall be deemed to have been delivered (i) when delivered, if
delivered personally, (ii) when sent (with confirmation received), if sent by
facsimile transmission on a business day, (iii) on the first business day after
dispatch (with confirmation received), if sent by facsimile transmission on a
day other than a business day, (iv) on the second business day after dispatch,
if sent by air courier, and (v) on the fifth business day after mailing, if sent
by mail.
10.7 This Agreement shall become binding when any one or more
counterparts hereof, individually or taken together, shall bear the signatures
each of the parties hereto. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original as against the party
whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument.
10.8 The article and section headings contained in this Agreement are
for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
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10.9 This Agreement and any claims, disputes or causes of action
relating to or arising out of this Agreement, shall be construed in accordance
with and governed by the laws of the State of New York, without giving effect to
the conflict of laws principles thereof.
10.10 Any of the provisions of this Agreement which are determined to
be invalid or unenforceable in any jurisdiction shall be ineffective to the
extent of such invalidity or unenforceability in such jurisdiction, without
rendering invalid or unenforceable the remaining provisions hereof or affecting
the validity or enforceability of any of the provisions of this Agreement in any
other jurisdiction.
10.11 This Agreement and the other agreements contemplated hereby or
thereby or executed concurrently herewith embody the entire agreement and
understanding between the parties hereto with respect to the subject matter
hereof and supersede all prior agreements, commitments, arrangements,
negotiations or understandings, whether oral or written, between the parties
hereto and their respective Affiliates with respect thereto, including, without
limitation, that certain letter of intent, dated May 20, 1997, between RPR and
Xxxxxx. There are no agreements, covenants or undertakings with respect to the
subject matter of this Agreement and the other agreements contemplated hereby or
thereby other than those expressly set forth or referred to herein or therein
and no representations or warranties of any kind or nature whatsoever, express
or implied, are made or shall be deemed to be made herein by the parties hereto
except those expressly made in this Agreement and the other agreements
contemplated hereby or thereby.
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IN WITNESS WHEREOF, the parties hereto have executed this Amendment as
of date first above written.
XXXXXX LABORATORIES, INC. XXXXX-XXXXXXX XXXXX
PHARMACEUTICALS INC.
By: _______________________ By: _______________________
Its:_______________________ Its:_______________________
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