EXHIBIT 4.40
MANUFACTURING AGREEMENT
THIS MANUFACTURING AGREEMENT (the "Agreement") is entered into as of
September 24, 1997 by and between Duramed Pharmaceuticals, Inc. ("Duramed") and
Xxxxxx-Xxxxxxx Company ("Warner").
WHEREAS, Duramed has the necessary facilities, equipment, personnel
and professional experience to manufacture the HRT products for clinical and
commercial use; and
WHEREAS, Warner desires to have Duramed manufacture and package the
Product (as defined herein) on a non-exclusive basis.
NOW, THEREFORE, in consideration of the above and of the mutual
covenants contained herein and for other good and valuable consideration,
receipt of which is hereby acknowledged, the parties agree as follows:
1. DEFINITIONS
"Active Ingredients" shall mean ethinyl estradiol and norethindrone
acetate.
"Affiliate" shall mean any Person that directly, or indirectly through
one or more intermediaries, controls, is controlled by, or is under common
control with the Person specified. As used herein the term "control" means
possession of the power to direct, or cause the direction of, the management
and policies of a corporation or other entity whether through the ownership of
voting securities, by contract or otherwise.
"Batch" shall mean 4,000,000 tablets of the Product.
"Batch Fee" shall mean the fee set forth in Section 5.1(a).
"Batch Release Date" shall mean the date on which a Certificate of
Compliance is issued by Duramed.
"Certificate of Compliance" shall mean a written certification from
Duramed to Warner that a Batch has been manufactured according to the NDA,
cGMPs, the Production Batch Record and the Packaging Batch Record and that
Duramed's quality assurance department has reviewed the Production Batch Record,
Packaging Batch Record and certificate of analysis from the Laboratory in
connection with a given Batch and found the Batch to meet all Specifications and
to be acceptable for commercial distribution.
"cGMPs" shall mean the current Good Manufacturing Practices applicable
to pharmaceutical products for human use in the United States and similar
regulations applicable to pharmaceutical products for human use in other
countries.
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"Contract Quarter" shall mean a three-month period commencing on the
first day of each January, April, July, and October of a Contract Year during
the term of this Agreement, provided, however, that the first Contract Quarter
shall begin on the date of in which Phase II commences and end on the ensuing
March 31st, June 30th, September 30th, or December 31st, as appropriate.
"Contract Year" shall mean a twelve-month period commencing on the
commencement of Phase II and on each anniversary of such date; provided,
however, that the first Contract Year shall begin on the date on which Phase II
commences and end one year thereafter, the second Contract Year and all
subsequent Contract Year shall begin on the anniversary date of such date and
end one year thereafter.
"DMF" shall mean the Type 1 Drug Master File, if applicable, to be
filed by Duramed with the FDA that defines the Duramed Facility and the systems
in such facility.
"Duramed Facility" shall mean Duramed's pharmaceutical manufacturing
facility, including the HRT Facility, located in Cincinnati, Ohio.
"Effective Date" shall mean the date of this Agreement as first above
written.
"FDA" shall mean the United States Food and Drug Administration.
"Guaranty Agreement" shall have the meaning set forth in Section 2.1.
"Hazardous Waste" shall mean waste arising from the Manufacture and
Packaging of the Product that is defined as "Hazardous" by applicable federal,
state, provincial or local laws or regulations.
"HRT Facility" shall mean that portion of Duramed's pharmaceutical
manufacturing facility designed primarily for the manufacture of products
containing hormones, located in Cincinnati, Ohio.
"Labeling" shall mean any and all printed labels, labeling and package
inserts for the Product.
"Laboratory" shall mean the laboratory designated, approved and
contracted by Warner in connection with testing the Product, including, but not
limited to AvTech Laboratories in Kalamazoo Michigan, and Duramed's own
laboratory located in the Duramed Facility.
"Laws" shall mean all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of any Regulatory Authority.
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"Lease Agreement" shall have the meaning set forth in Section 2.2.
"Manufacture" or "Manufacturing" shall mean the acts of material and
component receipt, storage and preparation, delumping, charging, mixing,
blending, granulating, drying, compressing, testing and any other
pharmaceutical manufacturing procedures, or any part thereof, involved in
manufacturing the Product.
"Master Batch Record" shall mean the document, reviewed and singed by
Warner, containing the formula (listing Raw Materials), compounding process,
manufacturing process (listing Packaging Components), and in process and
finished Product specifications for the Product, as the same may be amended
from time to time in accordance with Section 8.1.
"MSDS" shall mean the Material Safety Data Sheets for the Raw
Materials and the finished Product.
"NDA" shall mean the New Drug Application for the Product filed by
Warner with the FDA, including any supplements thereto.
"Package" and "Packaging" shall mean the acts of inspecting, placing
the Labeling on and with the Product, and packing of the Product into
containers.
"Packaging Batch Record" shall mean the Duramed document created as
and after each Batch is Packaged that reflects and incorporates all relevant
packaging aspects of the Master Batch Record.
"Packaging Components" shall mean the suitable bottles, blister cards,
caps and liners and packaging boxes and shipping containers in which the
Product is contained as identified in the NDA and the Packaging Batch Record.
"Person" shall mean any natural person, corporation, general
partnership, limited partnership, proprietorship, other business organization,
trust, union, association or Regulatory Authority.
"Phase I" shall mean the period beginning on the Effective Date and
ending on the date of commencement of Phase II.
"Phase II" shall mean the date on which the parties mutually agree to
commence Manufacture of the first validation Batch and ending on the date of
termination or expiration of this Agreement.
"PPI Adjustment" shall have the meaning set forth in Section 3.2(b).
"Product" shall mean the pharmaceutical product containing the Active
Ingredients as described in the NDA.
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"Production Batch Record" shall mean the Duramed document created as
and after each Batch is Manufactured that reflects and incorporates all aspects
of the Master Batch Record.
"Raw Materials" shall mean the Active Ingredients and excipients
necessary for Manufacturing the Product as listed in the NDA and the Master
Batch Record.
"Regulatory Authorities" shall mean any court, tribunal, arbitrator,
agency, commission, official or other instrumentality of any federal, state,
county, city or other political subdivision, domestic or foreign, including,
but not limited to, the FDA.
"Shared Space" shall mean the area defined as such in the Lease
Agreement and as identified on Schedule A.
"Special Waste" shall mean waste arising from the Manufacture and
Packaging of the Product hereunder, including Labeling, that contains or has
come into contact with the Product or Raw Materials, including without
limitation, rejected Product, rejected or unusable Raw Materials, disposable
Manufacturing equipment (including filters used in Manufacturing and
Packaging), wash rinse and previously used or discarded protective clothing.
Special waste does not include Hazardous Waste or Wastewater which is
discharged under a National Pollutant Discharge Elimination System (NPDES)
Permit or discharged to a publicly owned treatment works (POTW).
"Specifications" shall mean the specifications for the finished
Product as set forth in the NDA, the Master Batch Record, analytical procedures
and/or material and intermediate specifications.
"Target Yield" shall have the meaning specified in Section 7.1.
"Warner Equipment" shall have the meaning set forth in Section 3.1.
"Warner Property" shall have the meaning set forth in Section 10.1.
"Warner Space" shall have the meaning set forth in Section 3.1.
"Waste" shall mean all wastes which arise from the Manufacture and
Packaging of Product hereunder which are not Hazardous Waste or Special Waste,
as defined herein.
"Work in Process" shall mean the Raw Materials with respect to a Batch
between the time that Duramed begins dispensing such Raw Materials in
accordance with the Production Batch Record and ending immediately prior to the
Batch Release Date.
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2. ADDITIONAL AGREEMENTS
2.1 Guaranty. As of the date of execution of this Agreement, Warner
shall enter into a Guaranty Agreement with The Provident Bank ("Provident")
in which Warner guarantees an Eight Million Five Hundred Thousand Dollar
($8,500,000) loan to Duramed (the "Guaranty Agreement"). A copy of the Guaranty
Agreement is attached hereto as Schedule B.
2.2 Lease. As of the date of execution of this Agreement, the parties
shall enter into a Lease Agreement in which Warner leases the Warner Space and
Shared Space from Duramed at a fair rental value specified therein (the "Lease
Agreement"). A copy of the Lease Agreement is attached hereto as Schedule C.
2.3 Agreement. As of the date of execution of this Agreement, Warner and
Duramed shall enter into an agreement concerning the indebtedness of Duramed to
Provident secured by the real estate on which the Duramed Facility is located
and the other matters set forth therein. A copy of such agreement is attached
hereto as Schedule D.
2.4 License. As of the date of execution of this Agreement, Warner hereby
grants Duramed a royalty-free, exclusive license to use the Warner Space and
Shared Space during the term of this Agreement for the purpose specified herein
and the Manufacture of other pharmaceutical products, including products
manufactured for third parties or pursuant to joint venture arrangements with
third parties. Duramed shall not have the right to sublicense, transfer or
assign such license to any Person without the prior written consent of Warner,
which consent shall not be unreasonably withheld.
3. SITE QUALIFICATION
3.1 Facility Modification and Equipment Installation. (a) Warner shall
provide Duramed with the equipment listed on Schedule E (the "Warner
Equipment"). A section of the HRT Facility, as set forth on Schedule A and in
the Lease Agreement, will be dedicated exclusively for the Manufacture of the
Product for Warner (the "Warner Space"). In accordance with Section 3.2, Warner
shall pay all expenses associated with the establishment of the Warner Space
and Shared Space as an FDA approved site to Manufacture and Package the Product
in accordance with this Agreement, including the relocation and installation of
equipment and the process qualification and validation.
(b) At Warner's sole cost and expense, Warner shall provide technical
personnel to assist Duramed in the transfer of technical know-how relating to
the Manufacture and Packaging of the Product. Upon reasonable prior notice to
Warner, Duramed shall also be allowed access to Warner's own facilities to
observe Warner's own Manufacturing processes as it relates to the Product.
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3.2 Fees. (a) As of the Effective Date and until the date of
commencement of Phase II, Warner shall pay Duramed the following costs with
respect to the qualification of the Duramed Facility as an FDA approved site
to Manufacture and Package the Product:
(i) for Duramed's in-house labor costs in accordance with the
hourly rate schedule set forth on Schedule F; provided that
such labor is necessary and reasonable; and
(ii) the actual cost of outside professional services to Duramed
plus 20%; provided that such services are approved by Warner
in advance and performed in accordance with Warner's
instructions and the terms of this Agreement; and
(iii) the actual cost of Raw Materials, Packaging Components and
Labels; in the event that invoices are not submitted
directly to Warner in accordance with Section 4.3.
(b) The amounts to be reimbursed pursuant to Sections 3.2(a)(i), (ii)
and (iii) shall be due and payable thirty (30) calendar days after Warner's
receipt of an invoice and reasonable documentation to verify the amounts
requested thereby. Duramed shall keep complete and accurate records to verify
all amounts requested in such invoices, including third party receipts and
employee logs, which records shall be made available for inspection by Warner
during normal business hours at the Duramed Facility upon seventy-two (72)
hours notice. All such records will be retained by Duramed for at least two (2)
years after payment of the relevant invoice by Warner. If Phase II has not
begun within one year from the Effective Date, the in-house labor costs set
forth on Schedule F shall be increased by an amount equal to the annual percent
increase in the Producer Price Index (the "PPI Adjustment") as published by the
United States Department of Labor, Bureau of Labor Statistics. The PPI
Adjustment will be an amount equal to the average increase in the PPI over the
immediately preceding twelve (12) month period. If the PPI is not available for
any period, the most similar available index shall be used.
3.3 Responsibilities. The various responsibilities of each of the
parties with respect to site qualification, validation of the Product and the
Manufacture and Packaging of the Product are set forth on Schedule G hereto.
4. SUPPLY
4.1 Forecasts. On or before the 1st day of each Contract Quarter,
Warner will provide Duramed with written 12 month rolling forecast of the
quantities of Product that Warner will purchase during each of the next 12
months. On or before the 1st day of each month of each Contract Year, Warner
will provide Duramed with a written three (3) month rolling forecast of the
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quantities of Product that Warner expects to purchase during each of the next
three (3) months (a "Firm Order"). Each Firm Order shall include delivery dates
and all delivery dates shall respect the lead-time of three (3) weeks in
accordance with Duramed's instructions. Warner may adjust any Firm Order
hereunder upon at least sixty (60) days notice prior to the first day of the
period to which such Firm Order applies; provided that such adjusted Firm Order
is between eighty percent (80%) and one hundred twenty percent (120%) of the
most recent Firm Order provided to Duramed pursuant to this Section. Duramed
shall acknowledge receipt of each forecast and Firm Order within five (5) days
of the receipt thereof.
(b) The minimum size of any order for Product shall be one
production lot or Batch with larger orders being in whole number multiples of a
Batch.
4.2 Controlling Provisions. In ordering and delivering, Warner and
Duramed may employ their standard forms, but nothing in those forms shall be
construed to modify or amend the terms of this Agreement and in case of
conflict herewith, this Agreement shall control.
4.3 Raw Materials and Packaging Components. Duramed will purchase
Raw Materials, Packaging Components and Labels from the vendors specified in
the NDA as reasonably required for Manufacturing and Packaging the Product at
the best available prices. Duramed will instruct such vendors to submit
invoices for all such material directly to Warner and Warner shall pay the same
on a timely basis. Duramed will not change vendors or Specifications nor
substitute materials without the prior written approval of Warner.
4.4 Labeling. Warner shall be responsible for ensuring that the
Labeling conforms to all applicable Laws. Warner shall review the proofs for
the Labeling and all Labeling shall be pre-approved by Warner pursuant to
Warner's internal procedures. The approved Labeling will be purchased by
Duramed and shipped directly from the vendor to Duramed. Duramed shall place
the Labeling on the Product as specified by Warner.
4.5 Verification. Unless otherwise agreed by the parties, as of the
commencement of Phase II, Duramed shall inspect and test all Raw Materials,
Packaging Components and Labeling according to the test methods provided by
Warner, and Duramed will certify that the materials received meet the
Specifications set forth in the NDA, the Master Batch Record and the applicable
vendor certificates of analysis and any other applicable documents. Warner
reserves the right to review and modify Duramed's testing methods and
procedures. Duramed shall notify Warner immediately in the event that Duramed
learns that any of such material fails to meet such Specifications, if the
applicable vendor certificates of analysis contain any errors, or if Duramed
discovers any other information indicating that the Raw Materials, Packing
Components or Labeling have not been manufactured, prepared or stored in
accordance with cGMPs. In
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the event of such a failure or error, the parties will mutually agree as to the
return of such material, the reordering of replacement material, and, if
necessary, the rescheduling of the Manufacture and Packaging of the Product.
5. PAYMENT TERMS AND DELIVERY
5.1 Batch Fee. (a) During the term of this Agreement, Warner
shall pay Duramed a Batch Fee indicated on Schedule H; such Batch Fee includes
Duramed's in-house labor costs in Manufacturing and Packaging the Product.
Beginning with the first Contract Year and for each Contract Year thereafter,
Duramed may increase the Batch Fee by an amount equal to the PPI Adjustment.
The PPI Adjustment will be an amount equal to the average increase in the PPI
over the immediately preceding twelve (12) month period. If the PPI is not
available for any period, the most similar available index shall be used.
(b) Upon expiration of Contract Year five, Duramed reserves the
right to increase the Batch Fees for the remaining Contract Years, provided
that Duramed can demonstrate to Warner that such increase is necessary to pass
on actual cost increases ascribable to Duramed's direct, in-house labor and
overhead costs, as determined in accordance with U.S. GAAP, for the Manufacture
of the Product by providing documentation reasonably satisfactory to Warner.
5.2 Minimum Purchase. As of the date of commencement of Phase II,
Warner agrees to purchase the minimum number of Batches set forth on Schedule H
(the "Minimum Purchase"). Upon expiration of Contract Year three (3), the
parties shall negotiate additional Minimum Purchase amounts for the remaining
Contract Years. If the parties are unable to reach agreement on the Minimum
Purchase amounts, the amount indicated for Contract Year three (3) shall remain
in effect.
5.3 Shipping. The Products shall be shipped from the Duramed
Facility to Warner's premises or to such other location as Warner may from time
to time direct, in writing. Warner shall pay the costs of shipping and all
insurance applicable thereto. Duramed acknowledges that time is of the essence
with respect to delivery of the Products hereunder.
5.4 Storage. Subject to the timely receipt of the test results
specified in Section 6.1, Duramed shall store the Product at the Duramed
Facility at no cost for up to forty-five (45) days after the date that relevant
samples are submitted to the Laboratory for testing. During such time, Warner
shall be responsible for insuring the Product. After such forty-five (45) day
period, Duramed shall have no obligation to store the Product and may ship the
product to Warner, at Warner's expense.
5.5 Invoice. On or after the commencement of Phase II, Duramed
shall invoice Warner for the Batch Fee applicable to the Batch Manufactured and
Packaged, which shall reflect the actual number of bottles or blisters
Packaged. All invoices shall be
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due and payable thirty (30) calendar days after Warner's receipt of both the
invoice and a copy of the complete and accurate Certificate of Compliance.
5.6 Rejection of Production Batch. Notwithstanding Section 6.1, Warner
shall not be obligated to pay any invoice if the applicable Batch is rejected by
Warner within forty-five (45) days of Warner's receipt of the invoice and
Certificate of Compliance by reason of such Batch's non-conformance with the
requirements of this Agreement. The Batch shall be accepted unless Warner
notifies Duramed in writing within such forty-five (45) day period that Warner
has determined that the Batch does not conform to the Specifications or that the
Batch is not acceptable. If Warner rejects the Batch within the foregoing time
period, Warner shall provide Duramed with verbal notice as soon as possible and
follow up with written notice of such rejection within ten (10) days of the
rejection setting forth the basis for such rejection. If Duramed fails to
correct the deficiency within ten (10) days of receipt of the written notice or
if Warner rejects the correction, Warner, may, at its option and in its sole
discretion, either reject the Batch in its entirety or request that Duramed
correct the deficiency. Duramed's obligation to pay the cost of any correction
shall be governed by Section 6.5.
5.7 Sales and Use Taxes. Warner shall be responsible for the payment of
any sales and use taxes on the Product delivered by Duramed to Warner.
6. TESTING AND INSPECTION OF PRODUCT
6.1 Testing. Duramed will perform all in-processing testing during the
Manufacture of the Product and immediately following Manufacture of a Batch,
but in no event later than two (2) business days after manufacture, Duramed
shall ship, at Warner's expense, representative samples of such Batch taken
during Manufacturing and Packaging in accordance with the Production Batch
Record to the Laboratory for purposes of analytical testing and release
testing. Warner will pay the costs of such testing by the Laboratory and the
results of such testing will be sent to both Warner and Duramed within
twenty-four (24) hours after completion. Duramed will review all relevant
analytical and manufacturing data and issue a Certificate of Compliance to
Warner. Duramed is responsible for all release decisions relating to the
Product; provided, however, that Warner has the right to review and comment on
whether a given Batch should be released prior to the applicable Batch Release
Date and Duramed shall accept Warner's reasonable comments with respect thereto.
6.2 Stability Testing. Immediately following a Batch Release Date, but
in no event later than two (2) business days, Duramed will ship twice the
amount of samples required for stability testing to the Laboratory for the
purpose of stability testing the Product as required by the NDA. Duramed shall
provide samples from each validation lot, and, on an annual
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basis, provide samples from one lot of each presentation of the Product as
directed by Warner and pursuant to the NDA. Warner will have all responsibility
for, and shall, perform all required stability testing on the Product at its
own facility.
6.3 RETAINED SAMPLES. Duramed will retain samples in accordance
with cGMPs, all applicable Laws and as otherwise reasonably directed by Warner.
6.4 DEVIATION AND DEFECTS. In the event of procedural deviation
or other deviation from the Production Batch Record or an Out-of-Specification
test result noted in the Raw Materials, Packaging Components, or finished
Product or during Manufacturing or Packaging, Duramed will notify Warner within
twenty-four (24) hours. Unless otherwise obligated by Law or impractical due to
the requirement of an immediate response, Duramed shall consult with Warner
before taking action in connection with these events. Duramed shall, at its
sole expense, identify and correct any Product defects, or adverse conditions
(such as a spill), that are caused by Duramed's failure to perform its
responsibilities under this Agreement. During the term of this Agreement and
for a period of five (5) years following the Batch Release Date for each Batch,
Duramed shall notify Warner, in writing, within one (1) business day in the
event Duramed discovers or has reason to believe there are any cGMP violations
by Duramed or any vendor that might have impacted the Product, which violations
may be reportable to the Regulatory Authorities or if there are any defects in
the Production Batch Records or the Batch.
6.5 FAILURE TO MEET SPECIFICATIONS. If any Product does not
conform to the Specifications and such non-conformance is due to Duramed's
negligence, Duramed shall pay Warner an amount equal to (i) the Batch Fee is
previously paid by Warner for such Product, and (ii) Warner's actual cost for
Raw Materials, Packaging Components and Labeling contained in or utilized in
connection with the Manufacture and Packaging of such Product. Duramed shall
reinitiate Manufacturing pursuant to this Agreement or substitute Product
conforming to the Specifications as soon as reasonably possible following
receipt of the Raw Materials but in no event later than thirty (30) days
following the date of the receipt by Duramed of Raw Material, or, if Duramed is
unable to obtain all required Raw Materials and Packaging Components from
suppliers, the commencement of such thirty (30) day time period shall be
extended for such time period as is necessary for Duramed to obtain the same.
Warner shall pay to Duramed a Batch Fee for such replacement Product in
accordance with this Agreement. Duramed shall be solely responsible for
disposing of the non-conforming product, the cost of which shall be borne
exclusively by Duramed.
7. INVENTORY AND YIELD
7.1 TARGET YIELD. The Batch Fee is based upon Duramed achieving a
certain number of bottles (or blisters) of Product per Batch (the "Target
Yield"). Within ten (10) days after the end of each Contract Quarter, Duramed
shall provide Warner with a
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report showing the actual number of bottles (or blisters) of Product produced in
each Batch accepted by Warner during such Contract Quarter. If the mean yield
for all such Batches (the "Mean Yield") is less than the Target Yield, Duramed
shall credit Warner with an amount equal to the product of (a) Warner's actual
cost of Raw Materials, Packaging Components and Labels utilized in such Batch
multiplied by (b) the difference between the Target Yield and the Mean Yield
multiplied by (c) the number of Batches accepted by Warner during such Contract
Quarter. The Target Yield shall initially be set at the Mean Yield achieved in
the first twenty (20) successful Batches of the Product and shall be reset at
the beginning of each Contract Year to the Mean Yield achieved in all Batches
accepted by Warner during the preceding Contract Year. In addition, the Target
Yield may be revised by mutual agreement of the parties in writing whenever
significant changes are made to the Manufacturing process. Duramed shall use its
best efforts to achieve the highest practical yield on all Batches.
8. MAINTENANCE OF RECORDS AND REPORTS
8.1 Change Control. The Master Batch Record, analytical procedures,
Specifications, other control documents relating to the Product, and any changes
to such documents, must be approved, in advance, by Warner in writing. Warner
has sole discretion as to whether the proposed change should be made.
8.2 Document Retention. For a minimum of one (1) year after expiration
of any given Batch, or for any period reasonably specified by Warner, Duramed
shall keep and maintain records sufficient to substantiate and verify its duties
and obligations relating to Manufacturing and Packaging with respect to such
Batch, including Production Batch Records, records of purchase orders received,
certificates of analysis from vendors for Raw Materials received, Product
Manufactured and Packaged, Work in Process, Raw Material and Product analyses,
file samples and all other documents required by applicable Law. Duramed shall
permanently retain all documents relating to any validation associated with the
Product. Duramed shall also retain, as required by applicable Law or as
reasonably requested by Warner, any records relating to regulatory compliance,
environmental, health or safety and quality assurance and quality control of the
Product for a period of time reasonably specified by Warner. Duramed shall make
all such records available for inspection by Warner or its representatives
during the term hereof and during such retention period thereafter, and shall
allow Warner to copy such records as Warner may designate.
8.3 Duramed Unable to Comply. Subject to the requirements set forth in
Section 11.9, if Duramed determines it is technically unable to comply with any
proposed revision of either the Master Batch Record or the Specifications
without additional expense, Warner may choose in its sole discretion either to
withdraw the proposed revision or accept an increase in the Batch Fee arising
therefrom; provided, that Duramed can provide satisfactory documentation
evidencing such increase.
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9. TRADEMARKS
9.1 Use of Warner Trademarks. The Labeling shall bear one or more Warner
trademarks. Nothing contained herein shall give Duramed any right to use any
Warner trademark except on the Product and Duramed shall not obtain any right,
title or interest in any Warner trademark by virtue of this Agreement or its
performance of services hereunder.
10. TITLE
10.1 Title. (a) At all times during the term of this Agreement, title
to all Raw Material, Packaging Components, Labeling, Work in Process, Product
and Warner Equipment, labels, labeling, trademarks, copyrights, any Warner
procedures used in connection with Manufacturing or Packaging, batch records,
Master Batch Records, Production Batch Records, Packaging Batch Records,
analytical procedures and Specifications shall remain in Warner (collectively,
the "Warner Property"). Duramed shall clearly identify the Warner Property as
being owned by Warner and shall use the same degree of care in handling and
storing the Warner Property as it uses for its own property. Warner may at its
sole discretion for any reason notify Duramed that it wishes to take possession
of any Warner Property and Duramed shall permit Warner or its representatives to
do so during regular business hours and upon reasonable advance notice.
(b) Duramed shall acquire no right, title or interest in the Warner
Property. Except with Warner's prior written consent, the Warner Property may be
used by Duramed only to satisfy its obligations under this Agreement. Duramed
shall not take or permit any action inconsistent with Warner's ownership
interest in the Warner Property, including but not limited to the imposition of
any lien or other encumbrance thereon, the conveyance of any interest therein,
or any use thereof, except as authorized by the terms of this Agreement. If
Duramed fails to keep Warner's title free and clear of all liens, encumbrances
and interests, Duramed will be responsible for all costs associated with
securing the release of any such liens, encumbrances and interests on the Warner
Property.
11. QUALITY CONTROL
11.1 Compliance. Duramed shall strictly comply with the Master Batch
Record, the Production Batch Record, the Packaging Batch Record, applicable
analytical procedures, Warner's directions regarding the Manufacturing and
Packaging of the Product, Duramed's standard operating procedures, cGMPs and all
other applicable Laws. In addition, Duramed shall comply with Warner's quality
requirements as set forth in Schedule I.
11.2 Validation. All validation protocols and reports are subject to the
prior approval of Warner.
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11.3 Contamination. During the term of this Agreement, Duramed shall
take all appropriate measures to prevent contamination of the Product in
accordance with cGMPs. In the event that contamination of the Product occurs,
Duramed shall comply with cGMPs and follow Warner's instructions with respect to
the remediation of such problem. At all times during the term of this Agreement,
Duramed shall not manufacture, package or store any naproxen, penicillin or
cephalosporin in the Duramed Facility.
11.4 Cleaning Procedures. All equipment used by Duramed in connection
with the Manufacture and Packaging of the Product, including both the Warner
Equipment and equipment provided by Duramed in the Shared Space, will be cleaned
by Duramed in accordance with cleaning verification procedures prior to
validation and cleaning validation procedures thereafter; such procedures shall
comply with FDA requirements and cGMPs. Duramed shall utilize Warner's cleaning
procedure methods on Warner Equipment and Duramed equipment used in connection
with the Product, unless Duramed can demonstrate to the reasonable satisfaction
of Warner that its cleaning procedures are equivalent to the Warner procedures.
All such cleaning procedure protocols are to be prepared, approved and executed
by Duramed and Warner reserves the right to review and comment on such
procedures.
11.5 Warner Equipment. All Warner Equipment will be used by Duramed
solely in connection with the Manufacture of the Product, and Duramed will use
its best efforts to ensure that no other product comes in contact with the
Warner Equipment.
11.6 Packaging Equipment. (a) In Packaging the Product, Duramed shall
operate the equipment using the change parts provided by Warner and Duramed
shall clean the packaging equipment in accordance with the cleaning validation
procedures which comply with FDA requirements and cGMPs. Warner's change parts
to the packaging equipment will be used by Duramed only in Packaging the Product
and Duramed will use its best efforts to ensure that no other product comes in
contact with the Warner change parts. Duramed will develop, approve and execute
qualification and packaging validation protocols for the Product.
(b) In the event that the Packaging Components are changed by Warner from
bottles to blister cards and the existing Duramed blister packaging line has
insufficient capacity to Package the Product in accordance with the forecast,
the parties shall install an additional blister packaging line at the Duramed
Facility, at Warner's sole cost and expense. Such Packaging Equipment shall be
included in the Warner Equipment and subject to the requirements of Sections
11.4 and 11.5.
11.7 Man in the Plant. Duramed shall permit Warner or its duly
authorized representatives to observe and consult with Duramed during the
Manufacturing and Packaging, including the quality control testing and analysis,
of any Batch of the Product. Duramed shall provide sufficient office space in
the
13
Duramed Facility to enable such Warner representatives to perform the
consultation.
11.8 Inspections and Audits. Duramed shall permit Warner or its duly
authorized representatives to enter the Duramed facility upon reasonable notice
and at reasonable intervals to inspect and audit all equipment, facilities,
operations, procedures and records (including without limitation records
relating to environmental, health and safety, quality assurance, and regulatory
compliance) relating to the Product or to the system support used to Manufacture
the Product, and to pre-approve, audit and certify Duramed's laboratory where
in-process testing and quality control testing of Raw Materials, Packaging
Components and Labels is conducted under this Agreement.
11.9 Non-Compliance. In the event that Warner discovers that Duramed's
methods and/or procedures for Manufacturing and/or Packaging are not in
compliance with the NDA, the Master Batch Record, the analytical procedures, the
Specifications or cGMPs, Duramed will immediately correct, at Duramed's expense,
any such deficiencies; provided, that, Warner shall pay for any expenses
incurred by Duramed in connection with changes in or corrections to its existing
procedures which are necessary to meet Warner's requirements rather than those
changes needed to comply with applicable Law.
11.10 No Relief. The observation and consultation by Warner or its
representatives under Sections 11.7 or otherwise, and the inspections and audits
by Warner or its representatives under Section 11.8 or otherwise shall not in
any way serve as a limitation on any of Duramed's obligations or liabilities nor
relieve Duramed of any responsibilities that it has under this Agreement or
otherwise and shall not operate as a waiver or release; provided, however, that
any Duramed Manufacturing or Packaging practice observed by Warner or its
representative that affects the acceptability of the Product shall be
immediately reported to Duramed in writing during such observation or
consultation by Warner.
12. REGULATORY MATTERS
12.1 NDA. Warner shall be responsible for obtaining the NDA and all
other FDA approvals or approvals of any other Regulatory Authority relating to
the Product. Warner shall pay any applicable user fee for such registrations and
shall own the NDA. In the event that the Product is intended for sale outside
the United States, Warner shall pay any additional costs incurred by Duramed in
complying with such foreign Laws.
12.2 Submissions to Regulatory Authorities. As soon as possible after a
request is made by Warner, Duramed will provide Warner with copies of any
information concerning the Product, including its documentation, data and other
information with respect to the Manufacturing, Packaging and marketing of the
Product and the Duramed Facility as shall be necessary for submission to the
Regulatory Authorities by Warner. Duramed
14
shall also make available its cooperation and consultation if reasonably
requested by Warner or required by the Regulatory Authorities for the
development of additional data or the performance of studies concerning the
Product, and Warner shall pay Duramed's reasonable costs therefor in accordance
with the labor charges set forth on Schedule F. Duramed shall also provide
information concerning its Manufacturing processes and quality control
procedures with respect to the Product. Duramed shall provide to Warner all
documentation, data and information referred to in this Section reasonably in
advance of their required submission to allow for Warner's review and comment.
Duramed shall use its best efforts to satisfactorily resolve all Warner
comments prior to submission if such submission is to be made by Warner.
12.3 Inspections. Duramed shall allow representatives of Regulatory
Authorities to inspect and audit the Duramed Facility with respect to the
Product and shall notify Warner immediately of any inspection or audit upon the
arrival at the Duramed Facility of any inspector or auditor of a Regulatory
Authority that may involve the Product. Warner shall have the option of having
its representatives present at any such inspection or audit by any Regulatory
Authorities or meeting with such Regulatory Authorities to discuss the results
of such inspection or audit. Duramed shall notify Warner in writing of the
results of such inspection or audit immediately after such inspection or audit
has occurred, including without limitation providing to Warner copies of any
document (e.g., FDA Form 483 inspection observation report, regulatory letters,
etc.) resulting therefrom, to the extent relevant to the Product and/or the
Duramed Facility. If any Regulatory Authority determines that Duramed is not in
compliance with any applicable Law, Duramed shall immediately inform Warner of
its corrective action plans to comply with such Law to the extent the Product is
or may be affected, and shall continue to keep Warner informed of its progress
until compliance has been attained.
12.4 Communications. (a) Warner shall be solely responsible for all
communications with Regulatory Authorities with respect to the Product. Duramed
shall, immediately upon receipt by Duramed of any communication from any
Regulatory Authority relating to the Product, forward a copy or description of
the same to Warner and respond to all inquiries by Warner relating thereto. If
Duramed is advised by its legal counsel that it must communicate with any
Regulatory Authority with respect to the Product, then Duramed shall so advise
Warner immediately and, unless prohibited by Law, provide Warner in advance with
a copy of any proposed written communication and comply with any and all
reasonable instructions of Warner concerning any meeting or written or oral
communication with any Regulatory Authority.
(b) Duramed shall not make any changes to any regulatory filings or
documents that relate to the Product or that affect the Product without Warner's
prior written approval, except for the DMF or any other filings required by Law,
in which case
15
Duramed will contact Warner immediately upon such decision. Duramed shall notify
Warner immediately of any adverse finding by any Regulatory Authority that
relates to the Product or that affects the Product.
12.5 Modifications to Equipment and Facility. Duramed shall not modify
any parts of the Duramed Facility used for Manufacturing, Packaging or storage
of the Product if such modifications impact the DMF or otherwise affect the
Product or the NDA, unless approved in advance in writing by Warner. Duramed
shall not implement any material changes relating to the Product without
obtaining Warner's prior written approval. A material change is defined as any
change that (a) impacts the regulatory commitments made to Regulatory
Authorities for the Product; (b) may require re-validation; (c) affects the
quality, purity, identity or strength of the Raw Materials, Packaging Components
or the finished Product; (d) is or may be reportable to the Regulatory
Authorities; or (e) would necessarily result in changing or modifying the
Specifications, test methods, sampling procedures, standard operating
procedures, or the Master Batch Record with respect to the Product. Duramed
shall pay for any expenses associated with any modifications and material
changes initiated by Duramed.
12.6 Responsibility for Compliance. Duramed shall comply with the NDA and
all applicable Laws, injunctions, orders and decrees, and shall maintain in
effect all required governmental permits, licenses, orders, applications
(including, without limitation, the NDA, the DMF and approvals with respect to
the Duramed Facility) and approvals regarding the Product and the use of the
Duramed Facility to Manufacture, Package and store the Product, and Duramed
shall Manufacture, Package, store and otherwise handle the Product in accordance
with all such permits, licenses, orders, applications and approvals.
12.7 Drug Experience Reports and Complaints. (a) Duramed shall give
Warner written notice within four (4) days of initial receipt by Duramed of any
information Duramed receives regarding the safety of the Product, including any
confirmed or unconfirmed information on adverse events possibly associated with
the use of the Product. Warner shall provide Duramed with a copy of any adverse
events reports submitted by Warner to the FDA as soon as practicable thereafter.
(b) Duramed shall notify Warner of any complaint or investigation relating
to the Product promptly upon receipt of any of the foregoing and, in any event,
no later than ninety-six (96) hours following receipt thereof and shall follow
Warner's instructions accordingly; provided, that, all complaints concerning
suspected or actual Product tampering, contamination or mix-up (e.g. wrong
ingredients) shall be delivered to Warner within twenty-four (24) hours of
Duramed's receipt of the same. Warner will be responsible, at its cost, for
handling product complaints. Duramed will provide assistance in responding to
any complaints including reviews of retained samples and Production Batch
Records as well as the testing of Products engendering a
16
complaint and retained samples if required. The costs of such testing shall be
borne by Warner; provided, however, that if it is determined that the Product
complaint was directly or indirectly caused by Duramed's negligence, Duramed
shall reimburse Warner for the reasonable actual costs of such testing.
13. RECALLS
13.1 Responsibility. Warner shall have sole discretion in determining
whether any Product must be recalled by reason of failure to meet any
requirements of any Regulatory Authority or any other requirements of applicable
Law. Warner shall have the sole responsibility to effect any such recall.
Duramed shall cooperate as reasonably required in Warner's efforts in accordance
with Sections 13.2 and 13.3 below.
13.2 Warner's Responsibility. If the failure to meet applicable legal
requirements resulting in a recall is not caused, directly or indirectly, by the
negligence of Duramed, then Warner shall reimburse Duramed for any costs
reasonably expended by Duramed to effect the recall in accordance with the labor
charges set forth on Schedule F.
13.3 Duramed's Responsibility. If the failure to meet applicable legal
requirements resulting in a recall is caused, directly or indirectly, by
Duramed's negligence, Duramed shall reimburse Warner for (i) any Batch Fees and
shipping fees paid to Duramed by Warner for recalled Product and for any Product
that cannot be shipped due to the condition requiring the recall, (ii) 100% of
Warner's cost of Raw Materials, Packaging Components and Labels contained in or
utilized in the Manufacture and Packaging of the Product (to the extent the same
cannot be reworked or otherwise revised) and for any Product that cannot be
shipped due to the condition requiring the recall; (iii) the out-of-pocket costs
incurred in executing the recall.
14. HEALTH AND SAFETY MATTERS
14.1 Information. During the term of this Agreement, Warner shall
disclose to Duramed health and safety information in the form of MSDS related
to the Manufacture and Packaging of the Product hereunder. At its sole
discretion, Warner may provide any other information known to Warner which it
believes may be helpful to Duramed in carrying out its obligations hereunder.
14.2 Health and Safety Procedures. Duramed shall be solely responsible
for implementing and maintaining health and safety procedures for the
Manufacturing, Packaging and handling of the Raw Materials, Wastes, including
Hazardous and Special Wastes, Packaging Components and Product as provided
herein. Such procedures shall comply with all applicable Laws (including without
limitation federal, state and local health and safety Laws). Warner shall have
no responsibility for developing, implementing or overseeing Duramed's health
and safety program.
17
14.3 MSDS. Duramed shall comply with the procedures set forth in the
MSDS associated with the Raw Materials and the Product and shall implement a
health and safety program which addresses all components of the MSDS. In the
event that the MSDS is amended, Warner shall promptly provide Duramed with all
such amendments.
14.4 Training. Duramed shall educate and train all affected employees
and contractors about the potential hazards associated with the handling of the
Raw Materials and Waste, including Hazardous and Special Waste, and the
Manufacturing, Packaging, analyzing and handling of the Product and the
Packaging Components, and on the proper use of engineering controls, process
equipment and personal protective equipment as referenced in the MSDS. Duramed
shall make the MSDS available to all such employees and contractors. Duramed
shall maintain records of such training in accordance with applicable Law and,
upon reasonable request, shall make such records available to Warner. The Master
Batch Record shall specify procedures and protections that are required in
connection with Manufacturing and Packaging. Other than providing the
information set forth in Section 14.1, Warner shall have no responsibility for
educating, training, or ensuring knowledge of any Duramed employees and
contractors about the potential hazards associated with the handling of the Raw
Materials, Packaging Components and Waste, including the Hazardous and Special
Waste and the analyzing, handling, Manufacturing and Packaging of the Product,
and on the proper use of engineering controls, process equipment and personal
protective equipment as referenced in the MSDS.
14.5 Audit Rights. Warner retains the right to conduct periodic
assessments of Duramed's operations at mutually agreeable times and upon
reasonable advance notice to Duramed, and all non-priviledged records pertaining
thereto, including Duramed's industrial hygiene monitoring reports, to assure
Duramed's compliance with all applicable health and safety requirements
hereunder, including implementation of a health and safety program which
addresses issues identified in the MSDSs provided by Warner regarding the
Manufacture of Product hereunder. Warner shall have the right to make copies of
such health and safety documentation. Warner shall inform Duramed of any health
and safety issues identified in its assessment, as provided in Section 14.6
herein, but shall have no obligation to implement corrective action with regard
thereto.
14.6 Responsiveness. If Warner personnel in the Warner Space or Shared
Space, or, as a result of their assessment as provided in Section 14.5, observe
any employees of Duramed acting in violation of the MSDS information provided by
Warner or the Master Batch Record, Warner shall notify Duramed and Duramed shall
take such prompt action as Duramed deems appropriate to respond to such
observations. Warner shall document the observations in writing and Duramed
shall document the response in writing.
18
14.7 Cooperation. Both parties acknowledge the importance of the various
health and safety considerations to the Manufacture of Product hereunder and the
efficient operation of the Duramed Facility. To the extent necessary to
encourage a safe, efficient and healthy work environment, or to respond to any
regulatory or safety concern, the parties agree to mutually cooperate with each
other on all matters in which cooperation is necessary.
15. ENVIRONMENTAL MATTERS
15.1 Waste Materials. The collection, handling and disposal of all
Waste, including Hazardous Waste and Special Waste, shall be the responsibility
of Duramed and the cost for providing such services shall be included in the
Batch Fee. As part of the services, Duramed shall collect, handle, package,
label and store, treat or dispose of Waste, including Hazardous Waste and
Special Waste, in a proper and lawful manner, protective of the environment,
natural resources and the public health and shall comply with all federal, state
or local Laws governing such activity. All Wastes generated as a result of the
manufacturing process shall be handled and disposed of by Duramed through a
responsible waste contractor. Duramed, with Warner's cooperation, shall be
responsible for developing and implementing all procedures necessary to prevent
diversion of Product and Labeling from the waste stream, including rendering the
Product unsalable. Duramed shall immediately notify Warner by telephone at
000-000-0000 and Warner's Corporate Security (telephone 000-000-0000) if at any
time it believes that the Product or Labeling has been lost or stolen.
15.2 Air Permits. Control of air emissions from Duramed's air emissions
systems shall be the responsibility of Duramed and Duramed has obtained or shall
obtain, at its cost, such air permits as shall be necessary to allow such
emissions to be in compliance with all applicable Laws.
15.3 Environmental Permits, Licenses and Authorizations. Duramed shall
be responsible for obtaining and shall obtain and acquire all necessary
environmental or other licenses, certificates, approvals or permits from local,
state and federal agencies and any private permissions, whether original
documents or modifications to existing documents, which are necessary to perform
the services in connection with any Manufacturing of the Products and shall
provide copies thereof to Warner upon request by Warner. Duramed shall provide
Warner with immediate verbal notice, confirmed in writing within twenty-four
(24) hours, in the event of revocation or modifications of any license,
certificate, approval, or permit which in any way impacts Duramed's ability to
provide services or use the Duramed Facility as set forth in this Agreement. To
the extent necessary for the implementation of this Section, each party agrees
to cooperate fully with the other in providing information or documents relevant
to any permit or modification required to perform the services.
19
15.4 Wastewater Treatment. Duramed shall perform an assessment to
determine the impact of the Manufacture of Product hereunder on the treatment
capacity of any on-side wastewater treatment system which may exist at the
Duramed Facility or on any current wastewater discharge permit requirements, as
appropriate. Any permit modifications or enhancements to existing treatment
systems which may be required solely as a result of activities hereunder shall
be undertaken by Duramed at Warner's expense.
15.5 Hazardous and Special Wastes. In the event any current or future
Raw Materials, Packaging Components, Work in Process items, finished Products or
Wastes resulting from the Manufacture of the Product hereunder are deemed
Hazardous or Special Waste, then Duramed shall be responsible for obtaining all
necessary environmental or other licenses, certificates, approvals or permits
from local, state or federal agencies, and any private permissions which are
necessary in connection with the proper handling, storage, treatment or disposal
of such Hazardous or Special Waste generated as a result of the Manufacture of
the Product in the Duramed Facility. All costs and expenses relating to the
proper handling, storage, treatment or disposal of such Hazardous or Special
Waste, including the cost of obtaining any required licenses, certificates,
approvals or permits (or permit modifications) shall be borne solely by Duramed.
Duramed shall provide Warner with immediate notice of the revocation or
modification of any licenses, certificates, approvals or permits which affects
the handling, storage, treatment or disposal of the Hazardous or Special Waste
generated by Duramed or Duramed's use of the Duramed Facility with respect to
the Product. Duramed shall also prepare and execute, as the generator of the
Hazardous or Special Waste, all shipping documents and waste manifests required
under applicable Laws and shall maintain all records for the term and in the
manner required by all applicable Laws with respect to the Hazardous or Special
Waste.
15.6 Hazardous or Special Waste Disposal. For all Hazardous Wastes and
Special Wastes which are generated during the term of this Agreement, Duramed
shall be responsible for contracting with a Hazardous or Special Waste
contractor authorized to handle, transport and dispose of the Hazardous Waste or
Special Waste, as appropriate, at an appropriate disposal facility. Both the
Contractor and the disposal facility shall be duly licensed and authorized to
handle the Hazardous or Special Waste, as appropriate, and shall be mutually
acceptable to both Duramed and Warner and confirmed in writing. Duramed shall
handle, package and label said Hazardous Waste or Special Waste in a lawful and
proper manner, which is protective of the environment, natural resources and the
public health and shall comply with all federal, state or local Laws governing
such activity. Storage of all Hazardous and Special Waste generated during the
Manufacture of the Product will be in an accumulation area established by
Duramed in the Duramed Facility, which complies with all regulatory
requirements. Duramed agrees to require the disposal contractor to make periodic
and timely pick-
20
ups of said Hazardous and Special Wastes and shall not allow such waste
materials to remain on-site for any period of time in excess of that required
by Law or as required in order to xxxxx a safety or health hazard arising from
said hazardous waste.
15.7 AUDIT RIGHTS. Warner retains the right to conduct an assessment of
Duramed's operations at mutually agreeable times and upon reasonable advance
notice to Duramed, to assure Duramed's compliance with all applicable
requirements hereunder, including waste handling, packaging, storing,
transportation and disposal activities as they relate to disposal of Waste,
Hazardous Waste and Special Waste generated as a result of the Manufacture of
the Product, and any and all non-privileged records pertaining thereto, and
shall have the right to make copies thereof. Duramed and Warner will inform
each other promptly of any environmental or regulatory issues of which either
party becomes aware that could jeopardize Duramed's ability to Manufacture the
Product pursuant to this Agreement or that could result in imposition of fines,
penalties or other liabilities.
15.8 ENVIRONMENTAL INDEMNIFICATION. Duramed shall be responsible for any
liability arising under any applicable environmental requirement, including
those liabilities arising from the generation, handling, treatment or disposal
of any Wastes, including Hazardous Waste or Special Wastes, or wastewater
discharges or emissions of air contaminants associated with the Manufacture of
Product hereunder, and shall defend, indemnify and hold Warner harmless from
and against any liabilities, claims, penalties, forfeitures, suits and costs
and expenses relating thereto (including costs of defense, settlement and
reasonable attorney fees), which Warner may hereafter incur, become responsible
for, or pay out as a result of death or bodily injury to any person,
destruction or damage to any property, contamination or impairment or adverse
effects on the environment and natural resources, or threat of same, and any
other cause resulting from the generation, handling, treatment, transportation
or disposal of the Waste, including Hazardous Waste or Special Waste, or any
wastewater discharges or emissions of air contaminants associated with the
Manufacture of the Product hereunder.
15.9 COOPERATION ON ENVIRONMENTAL MATTERS. Both parties acknowledge the
importance of the various environmental considerations to their respective
operations and the efficient operation of the Duramed Facility. To the extent
necessary to encourage safe, efficient and environmentally acceptable facility
operations or to respond to any regulatory or safety concern, the parties agree
to mutually cooperate with each other on all matters in which cooperation is
necessary. Additionally, neither party shall take or permit any action, or fail
to take any required action, which will have the effect of (a) placing the
other party in jeopardy of permit non-compliance or regulatory sanctions or (b)
in any way impeding the ability of such other party to operate within its
portion of the Duramed Facility.
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16. REPRESENTATIONS, WARRANTIES AND COVENANTS
16.1 Duramed's Warranties. Duramed hereby represents, warrants and
covenants as follows:
(a) The Product shall be Manufactured, Packaged and shipped in accordance
with the NDA, the Master Batch Record, the Production Batch Record, analytical
procedures, any applicable regulations of the Regulatory Authorities and cGMPs
and terms of this Agreement.
(b) Duramed shall comply with all cGMP requirements and any other
applicable Laws to prevent cross contamination and contamination of the Product
at the Duramed Facility.
(c) Duramed shall comply in all respects with any applicable Law,
injunction, decree or governmental requirement applicable to the Manufacture of
the Product or the handling, treatment, transportation or disposal of the
Waste, including Hazardous and Special Waste.
(d) Duramed shall maintain in effect all required governmental permits,
licenses, orders, applications and approvals necessary for the Manufacturing
and Packaging, and Duramed shall Manufacture and Package in accordance with all
such permits, licenses, orders, applications and approvals.
(e) Duramed will dedicate the Warner Space to the Manufacture of the
Product, and will allocate sufficient areas in the Duramed Facility as Shared
Space for the Product.
(f) Duramed shall insure that adequate steps are taken to protect the
Product from contamination from ingredients contained in other products
manufactured in the Duramed Facility.
(g) Duramed shall use its best efforts to supply the Product to Warner as
requested by Warner.
(h) Product shipped to Warner will not be adulterated or misbranded
within the meaning of the Federal Food Drug and Cosmetic Act ("FFDCA") or other
applicable Law.
(i) Duramed shall utilize the Warner Space and Shared Space in accordance
with the terms of the Lease Agreement.
(j) Duramed has not and will not use in any capacity the services of any
Person debarred under the Generic Drug Enforcement Act 21 U.S.C. Section
335(k)(1) and has not used any Person who has been convicted of a crime as
defined under the Generic Drug Enforcement Act in connection with the services
rendered to Warner.
16.2 Warner's Warranties. Warner hereby represents, warrants and
covenants as follows:
(a) The Manufacture of the Product as set forth in the
22
Master Batch Record does not infringe any known patent.
(b) Warner owns all rights to the Warner trademark(s) used in the
Labeling.
(c) The Labeling complies, or will comply, with all requirements of the
Regulatory Authorities.
(d) During the term of this Agreement, Warner has disclosed to Duramed
health and safety information in the form of MSDS related to the Manufacture
and Packaging of the Product hereunder.
(e) Prior to Warner's sale of the Product to the public, Warner shall
have received all necessary approvals for the Manufacture and sale of the
Product as required by applicable Law, and such approvals shall be in full
force and effect at all times during which Product Manufactured by Duramed is
sold to the public by Warner.
16.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, WARNER AND DURAMED MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES
OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
16.4 Limitation of Liability. Notwithstanding any other provision of this
Agreement, and as a separately bargained-for consideration by both parties,
neither Duramed nor Warner shall be liable to the other for any lost profits or
indirect, incidental, special, punitive, exemplary or consequential damages
with respect to action or inaction under, performance or nonperformance of, or
breach of, or any other matter or matters related to or contemplated by, this
Agreement.
17. FORCE MAJEURE
17.1 Excusing Performance. The occurrence of an event which materially
interferes with the ability of a party to perform its obligations or duties
hereunder which is not within the reasonable control of the party affected, not
due to malfeasance, and which could not with the exercise of due diligence have
been avoided ("Force Majeure"), including, but not limited to, fire, accident,
labor difficulty, strike, riot, civil commotion, act of God, delay or errors by
shipping companies or change in Law shall not excuse such party from the
performance of its obligations or duties under this Agreement, but shall
merely suspend such performance during the continuation of Force Majeure. The
party prevented from performing its obligations or duties because of Force
Majeure shall promptly notify the other party hereto (the "Other Party") of the
occurrence and particulars of such Force Majeure and shall provide the Other
Party, from time to time, with its best estimate of the duration of such Force
Majeure and with notice of the termination thereof. The party so affected shall
use its best efforts to avoid or remove such causes of nonperformance. Upon
termination of Force
23
Majeure, the performance of any suspended obligation or duty shall promptly
recommence. Neither party shall be liable to the other party for any direct,
indirect, consequential, incidental, special, punitive or exemplary or other
damages arising out of or relating to the suspension or termination of any of
its obligations or duties under this Agreement by reason of the occurrence of
Force Majeure. In the event that Force Majeure has occurred and is continuing
for a period of at least six (6) months, the Other Party shall have the right
to terminate this Agreement upon thirty (30) days notice.
18. INDEMNIFICATION
18.1 Warner's Indemnification. Warner shall defend, indemnify and hold
harmless Duramed, its officers, agents, employees and Affiliates from any loss,
claim, action, damage, expense or liability (including defense costs and
attorneys' fees) asserted by a third party ("Claim") arising out of or related
to (a) any injury to Warner employees while at the Duramed Facility, (b) the
negligent handling, possession, use or sale of the Product following delivery
to Warner, (c) patent infringement of a third party's patent by the Manufacture
as set forth in the Master Batch Record, (d) use or sale of the Product by any
third party, or (e) Warner's failure to provide the MSDS information set forth
in Section 14.1 hereof; except to the extent any Claim set forth herein is
based on, arises out of, is engendered by or is due to the negligence or wilful
misconduct of Duramed or its Affiliates, officers, agents or employees.
18.2 Duramed's Indemnification. Notwithstanding the environmental
indemnity provided in Section 15.8 herein, Duramed shall defend, indemnify and
hold harmless Warner, its officers, agents, employees and Affiliates from any
Claim arising out of or relating to (a) liabilities associated with the
environmental contamination of a Duramed Facility or any disposal facility
utilized by Duramed for the disposal of Waste, including Hazardous or Special
Waste, (b) Duramed's negligence in Manufacturing, Packaging or storing the
Product or (c) the negligence or wilful misconduct of Duramed or its officers,
agents or employees, including but not limited to any injury to Duramed
employees or independent contractors due to the failure to follow the
procedures set forth in the MSDSs, except to the extent any Claim set forth
herein is based on, arises out of, is engendered by or due to (i) Warner's
failure to provide the MSDS information set forth in Section 14.1 hereof, and
(ii) the negligence or wilful misconduct of Warner or its Affiliates, officers,
agents or employees.
18.3 Procedures. Provided that prompt notice is given of any Claim, the
indemnifying party promptly will defend, contest or otherwise protect against
the same at its own cost and expense. The indemnified party may, but will not
be obligated to, participate at its own expense in a defense thereof by counsel
of its own choosing, but the indemnifying party shall be entitled to control
the defense unless the indemnified party has relieved the indemnifying party
from liability with respect to
24
the particular matter. Except as otherwise set forth herein, the indemnified
party shall not, except at its own cost and expense, compromise or settle, or
seek to compromise or settle, any Claim. If the indemnifying party fails
timely to defend, contest or otherwise protect against any Claim, the
indemnified party may, but will not be obligated to, defend, contest or
otherwise protect against the same, and make any compromise or settlement
thereof and recover the entire costs thereof from the indemnifying party,
including reasonable attorneys' fees, disbursements, and all amounts paid as a
result of such Claim or the compromise or settlement thereof. The indemnified
party shall cooperate and provide such assistance as the indemnifying party may
reasonably request in connection with the defense of the matter subject to
indemnification.
18.4 Insurance. Warner and Duramed each hereby represent to the other
that it is sufficiently insured against any liability arising under this
Agreement and each party agrees to provide a certificate of insurance or the
most recent audited consolidated financial statements of it and its ultimate
parent company on the other party's written request.
19. TERM AND TERMINATION
19.1 Term. This Agreement shall commence as of the Effective Date and
shall continue for a period of ten (10) Contract Years from the date of
commencement of Phase II, unless sooner terminated as provided in Section 19.2.
This Agreement shall be automatically renewed for additional periods of two (2)
years each unless either party gives written notice to the other party of its
intention not to renew this Agreement at least twenty-four (24) months prior to
the expiration of any renewal term.
19.2 Termination. This Agreement may be terminated, without recourse to
any court:
(a) By either party upon prior written notice to the other party, with
immediate effect, in the event of:
(i) an assignment by the other party for the benefit of
creditors;
(ii) the admitted insolvency of the other party;
(iii) the institution of voluntary proceedings by the other party
in bankruptcy, insolvency or moratorium or the filing of an
involuntary petition in bankruptcy which is not dismissed
within ninety (90) days of filing, or the appointment of a
receiver, or a winding-up or dissolution or reorganization
of the other party;
25
(iv) the taking of any action by the other party under an act for
relief from creditors; or
(b) By either party upon thirty (30) days' prior written notice to the
other party in the event of a failure of such other party to perform or observe
a material obligation imposed by this Agreement, unless such failure is cured
or the parties have reached agreement on a corrective action plan to cure such
failure prior to the end of such thirty (30) day period.
(c) By Warner upon thirty (30) days' prior written notice to Duramed, in
the event of the following:
(i) the NDA is not filed with the FDA; provided that Warner pays
Duramed the termination payment specified in Section 19.4
below; or
(ii) the Product is not approved by the FDA; provided that Warner
pays Duramed the termination payment specified in Section
19.4 below; or
(iii) the market demand in the United States is substantially
below the projected forecast such that the actual amount
of Batches required by Warner is 50% less than the
Minimum Purchase amounts specified in Section 5.2; provided,
that Warner pays Duramed the termination payment specified
in Section 19.4 below; or
(iv) contamination of the Product in the Duramed Facility which
contamination cannot be remedied or corrected in accordance
with cGMPs; or
(v) an attempted assignment of this Agreement by Duramed
without the prior written consent of Warner; or
(vi) Duramed's regulatory license to manufacture the Product is
suspended, revoked, canceled or expires without renewal or
replacement; or
(vii) in the event of the direct or indirect change in ownership
or control or corporate reorganization of Duramed, which
results in a new party or group assuming control of
Duramed; or
(d) By mutual agreement of the parties.
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19.3 Lease Agreement. Warner and Duramed agree that the Lease Agreement
shall be terminated as set forth below:
(a) Without further action, upon the termination of this Agreement by
Warner pursuant to Sections 19.2(a), (b), or (c);
(b) Without further action, upon the termination of this Agreement by
Duramed pursuant to Section 19.2(b); or
(c) Upon the expiration of five (5) years from the Effective Date, at the
option of Duramed, upon thirty (30) days' prior notice to Warner, if, at the
time of such notice of cancellation, each of the following conditions has been
satisfied and remains satisfied at the time of termination:
(i) the Guaranty Agreement shall have been terminated, with the effect
that Warner shall have no further liability with respect to such Guaranty
Agreement;
(ii) for each of Duramed's past two (2) fiscal years, Duramed shall
have had net earnings equal to at least Ten Million Dollars ($10,000,000)
and Net Cash Provided by Operating Activities of Six Million Dollars
($6,000,000), as reported in the Consolidated Statement of Cash Flows
included in Duramed's audited financial statements for such fiscal years;
(iii) at the end of Duramed's most recent fiscal year, Duramed shall
have stockholders equity of at least Forty Million Dollars ($40,000,000),
as indicated by its audited financial statements for such year; and
(iv) Duramed shall have removed, at its sole cost and expense, all
PCB transformers located on its property in Cincinnati, Ohio to the mutual
satisfaction of Warner and Duramed.
If, at the expiration of twenty-four (24) months from the Effective Date,
Duramed is able to demonstrate to the reasonable satisfaction of Warner that
the requirements set forth 19.3(c)(i)-(iv) are in the process of being
substantially fulfilled, the five (5) year limitation set forth in Section
19.3(c) shall be re-examined by the parties.
19.4 Termination Payment. In the event of termination by Warner in
accordance with Section 19.2(c)(i), (ii) and (iii) and Section 19.2(d), Warner
shall pay Duramed as follows:
(i) If the termination occurs within one (1) year of the Effective Date,
Warner shall pay Duramed $100,000 per month from the time of such termination
until the expiration of twenty-four (24) months from the Effective Date; or
(ii) If the termination occurs in the second year from Effective Date,
Warner shall pay Duramed $100,000 per month from the time of such termination
until the expiration of twenty-four
27
(24) months from the Effective Date and the Minimum Purchase specified in
Section 5.2 and $30,000 per month for the first Contract Year; or
(iii) If the termination occurs after the commencement of Phase II, Warner
shall pay Duramed the Minimum Purchase specified in Section 5.2 and $30,000 per
month from the time of such termination for the remainder of said Contract Year
and the succeeding Contract Year in addition to the Minimum Purchase for the
succeeding Contract Year.
19.5 Effect of Termination or Expiration. (a) Upon expiration or
termination of this Agreement:
(i) Inventory. Duramed shall furnish to Warner a complete inventory of
all Warner Property on hand.
(ii) Product and Work in Process. Product manufactured pursuant to and
commenced by Duramed against Firm Orders from Warner shall be
delivered by Duramed to Warner and paid for in accordance with such
purchase orders. If the termination is by Duramed due to a breach of
this Agreement by Warner or by Warner pursuant to Section 19.2,
Warner shall pay Duramed for Work in Process on a time and materials
basis to be agreed upon between the parties; provided, however, that
Duramed can reasonably demonstrate that the Work in Process has been
Manufactured in accordance with the Master Batch Record up to the
point of termination, and provided, further, that the fee shall not
exceed the Batch Fee applicable to such Work in Process. If the
termination is by Warner due to a breach of this Agreement by
Duramed, Warner may elect to cancel any Work in Process and owe no
money for such Work in Process or elect to require Duramed to
complete the Work in Process and upon the Batch Release Date, pay
Duramed the Batch Fee.
(iii) Raw Materials and Other Materials. Raw Materials, Packaging
Components and Labeling not necessary to complete Work in Process
shall, at Warner's option, either be disposed of by Duramed in
accordance with Section 15.1 or returned to Warner at Warner's
expense in accordance with Warner's instructions.
(iv) Equipment. At Warner's option, Warner shall either (i) pay all costs
of disassembling, removing and shipping all Warner Property, all of
which work shall be done in accordance with Warner's instructions;
or (ii) surrender title of Warner Property to Duramed. In addition,
Warner shall pay all costs necessary to restore the Duramed Facility
to its original condition with the exception of normal wear and
tear. All work carried out in accordance herewith shall not
interfere with the other ongoing production at the Duramed Facility.
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(b) The rights of either party against the other which may have accrued up
to the date of such termination or expiration under this Agreement shall remain
unaffected except as provided in this Section.
(c) With the exception of the termination payments specified in Section
19.4, neither party shall be liable to the other for damages, indemnity or
compensation solely on account of termination or expiration of this Agreement,
with or without cause, as provided herein, whether such damages, indemnity or
compensation might be claimed for loss through commitments on obligations or
leases, loss of investment, loss of present or prospective profits, loss of
goodwill, or any other loss caused by termination or expiration of this
Agreement as provided herein.
20. ASSIGNMENT
20.1 Assignment. Neither party may assign this Agreement nor any portion
hereof nor delegate its performance hereunder without the prior written consent
of the other party.
20.2 Change in Control. In the event of the direct or indirect change in
ownership or control or corporate reorganization of Duramed, which results in a
new party or group assuming control of Duramed, or in the event of a sale of
substantially all assets or the HRT Facility, this Agreement shall be binding
upon all successors, permitted assigns and purchasers of such assets.
21. ADDITIONAL TERMS
21.1 Confidentiality. All confidential and/or proprietary information of a
party disclosed to the other party shall be held in confidence and not
disclosed by the other party to any third party or used outside the scope of
this Agreement, except that either party, as the case may be, may disclose such
information to its affiliates or its employees, all of whom are under a similar
obligation of secrecy, in furtherance of the purposes of this Agreement;
provided, however, that the aforesaid obligation of confidentiality assumed by
both parties hereunder shall not apply to any confidential information
(collectively, with proprietary information, referred to as "Information" for
purposes of this Section 21.1) which was or becomes available to the other
party, as the case may be, on a non-confidential basis from a source that is not
under an obligation (whether contractual, legal or fiduciary) to the other party
to keep such information or data confidential. Notwithstanding the foregoing, as
used herein, "Information" shall include all of the terms of this Agreement
including, but not limited to, the information set forth in the Schedules. If
the party receiving Information of the other party (the "Receiving Party") is
requested in any judicial or administrative proceeding or by any Regulatory
Authority to disclose any Information of the other party (the
29
"Disclosing Party"), the Receiving Party shall give the Disclosing Party prompt
notice of such request so that the Disclosing Party may seek an appropriate
protective order. The Receiving Party shall cooperate fully with the Disclosing
Party in obtaining such an order. If in the absence of a protective order the
Receiving Party is nonetheless compelled to disclose Information of the
Disclosing Party, the Receiving Party may make such disclosure without
liability hereunder, provided that the Receiving Party gives the Disclosing
Party written notice of the Information to be disclosed as far in advance of
its disclosure as is practicable and, upon the Disclosing Party's request and
at its expense, the Receiving Party will use its best efforts to obtain
reasonable assurances that confidential treatment will be accorded to such
Information. The obligations of confidentiality in this Section 21.1 shall
survive the expiration or earlier termination of this Agreement.
Notwithstanding anything to the contrary in this Agreement, neither party
shall be required to provide legally privileged information to the other party.
21.2 Public Statements. Neither party shall use or refer to, without the
other party's prior written consent, the name of such other party in any public
statements, whether oral or written, including, but not limited to, shareholder
reports, communications with stock market analysts, press releases or other
communications with the media. Notwithstanding the foregoing, if such public
statement is required by Law or ruling of any Regulatory Authority, the
procedures set forth in Section 21.1 shall govern such disclosure.
21.3 Independent Contractor. At all times during the term of this
Agreement and any renewals hereof, 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.
21.4 Notices. Any notice required or permitted to be given hereunder shall
be deemed sufficient if sent by facsimile letter or overnight courier or
delivered by hand to Warner or Duramed at the respective addresses and
facsimile numbers set forth below or at such other address and facsimile number
as either party hereto may designate. If sent by facsimile letter, notice shall
be deemed given when the transmission is completed if the sender has a
confirmed transmission report. If a confirmed transmission report does not
exist, then the notice will be deemed given when the notice is actually
received by the person to whom it is sent. If delivered by overnight courier,
notice shall be deemed given when it has been signed for. If delivered by hand,
notice shall be deemed given when received.
All correspondence to Warner shall be addressed as follows:
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
30
amended, supplemented or modified only by a written instrument duly executed by
or on behalf of each party hereto.
21.9 Headings. The descriptive headings are inserted for convenience
of reference only and are not intended to be part of or to affect the meaning
of or interpretation of this Agreement.
21.10 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original, but all of which
together shall constitute a single agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the day and year first above written.
DURAMED PHARMACEUTICALS, INC. XXXXXX-XXXXXXX COMPANY
XXXXX X. XXXXXXX XX. XXXXXXX X. WILD
________________________________ ______________________________________
Name: Xxxxx X. Xxxxxxx Name: Xx. Xxxxxxx X. Wild
Title: Vice President Title: Vice President and President
Pharmaceutical Sector
Subscribed and Sworn To Before Me, In My
Presence, This 24 Day Of Sept., 1997
A Notary Public In and For The County
of Xxxxxx, State of New Jersey.
/s/ XXXXXX X. XXXX
XXXXXX X. XXXX
Notary Public of New Jersey
My Commission Expires Dec. 29, 1998
/S/ XXXXXXX XXXX XXXXXX
XXXXXXX XXXX XXXXXX
Notary Public, State of Ohio
My Commission has no expiration date
Section
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