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EXHIBIT 10.30
PRODUCT MANUFACTURING AGREEMENT
BETWEEN
SANTEN INCORPORATED
AND
XXXXXX-XXXXXXX COMPANY
FOR OFLOXACIN OTIC SOLUTION 0.3%
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PRODUCT MANUFACTURING AGREEMENT
This Product Manufacturing Agreement is made as of June 26, 1997 by and
between Santen Incorporated, a California corporation with its principal place
of business located 000 Xxxxxxx Xxxxx, Xxxx, Xxxxxxxxxx 00000 ("Santen"), and
Xxxxxx-Xxxxxxx Company, a Delaware corporation, with offices located at 000
Xxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("Xxxxxx-Xxxxxxx").
RECITALS:
X. Xxxxxx-Xxxxxxx has the knowledge, expertise, personnel, equipment and
the facilities to manufacture certain raw materials into pharmaceutical
products in conformance with detailed instructions, and in a manner which
complies with all applicable United States legal requirements.
X. Xxxxxx desires to engage Xxxxxx-Xxxxxxx, on a non-exclusive basis,
and Xxxxxx-Xxxxxxx agrees to accept Santen's non-exclusive agreement to perform
the product manufacturing services described in this Agreement, in accordance
with the terms and conditions set forth below.
Accordingly, with the intent to be bound hereby, the parties hereby agree
as follows:
1. DEFINITIONS.
When used in this Agreement, the capitalized terms listed in this Section
1 shall have the following meanings:
1.1 "AAI" means Applied Analytical Industries, Inc.
1.2 "Affiliate" means any entity controlling, controlled by or under
common control with a party to this Agreement. For purposes of this definition,
the term "control" shall mean the direct or indirect beneficial ownership of
50% or more of the voting or income interest in such entity.
1.3 "Agreement" means this Product Manufacturing Agreement, including any
exhibits or schedules hereto, as such may be amended from time to time, in
writing, by mutual agreement of the parties.
1.4 "BPS" means the bulk pharmaceutical substance known as "ofloxacin",
which is to be obtained by Xxxxxx-Xxxxxxx, only from Santen's vendors, solely
for use in the processing and testing of the Products hereunder.
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1.5 "BPS Lot" means the quantity of BPS produced by Santen's
vendor from one complete synthesis or manufacturing process.
1.6 "BPS Specifications" means the specifications set forth in
Exhibit A, which specifications may be amended by Santen and furnished to
Xxxxxx-Xxxxxxx, in writing, from time to time during the Term.
1.7 "Business Day" means Monday, Tuesday, Wednesday, Thursday or
Friday of any week other than such day which constitutes an official Japanese
or United States federal government holiday or such days which are part of
Xxxxxx-Xxxxxxx'x annual shutdown periods.
1.8 "Certificate of Analysis" means a certificate provided by
Santen's vendor for each BPS Lot, certifying that the BPS Lot meets the BPS
Specifications.
1.9 "Confidential Information" means the Santen Technical
Information and any other information or data disclosed by one party to the
other (including without limitation, information disclosed to Santen by Daiichi
Pharmaceutical Co., Ltd. ("DSK") or Daiichi Pharmaceutical Corporation ("DPC"))
that (i) is in written form and marked "Confidential" or (ii) if communicated
other than in written form, is described to be confidential and reduced to a
writing which is marked confidential and delivered to the receiving party
within thirty (30) days of disclosure.
1.10 "Effective Date" shall have the meaning specified in Section
16.1.
1.11 "Equipment" means the equipment to be provided by Santen to
Xxxxxx-Xxxxxxx during the Term, pursuant to the terms hereof, as more
particularly described on Exhibit B.
1.12 "FDA" means the United States Food and Drug Administration.
1.13 "Facility" means the manufacturing facility and the real
property underlying such manufacturing facility operated by Xxxxxx-Xxxxxxx
located at 000 Xxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000.
1.14 "Good Manufacturing Practices" shall have the meaning
specified in 21 C.F.R. Parts 210 and 211, as amended from time to time.
1.15 "Hazardous Substances" means any chemical, waste, compound,
element, material or substance, (i) which is or becomes defined as "extremely
hazardous", "hazardous", "toxic", "dangerous", or as "pollutant" or
"contaminant" or which otherwise is or becomes listed or regulated under any
applicable federal, state or local laws, regulatory or other requirements
pertaining to health safety or the environment; or (ii) the presence, release
or threatened release of which requires any investigation, containment,
removal, remediation or other response action of any kind whatsoever, such
Hazardous
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Substances to include, without limitation, gasoline, diesel fuel or other
petroleum hydrocarbons.
1.16 "Legal Label Text" means the exact wording and graphics set
forth in Exhibit D, provided, however, that the parties hereto acknowledge that
the Legal Label Text will be included in Exhibit D, following FDA approval of
the Product.
1.17 "Legal Requirements" means the MBR and any present and future
national, state or local laws (whether under statute, rule, regulation or
otherwise), requirements under permits, orders, decrees, judgments or
directives, requirements of the FDA or any other applicable governmental
authority, including without limitation, Good Manufacturing Practices.
1.18 "Master Batch Record or "MBR" shall mean the master batch
record provided by Santen to Xxxxxx-Xxxxxxx, as may be modified by Santen from
time to time, which shall include without limitation, instructions for
manufacturing, packaging, Legal Label Text and in process testing for the
Products.
1.19 "NDA" means the new drug application for the Product, approved
by the FDA.
1.20 "Process" or "Processing" means the act of compounding,
component preparation, filing, packaging, testing and any other pharmaceutical
manufacturing procedures, or any part thereof, involved in manufacturing the
Product from the BPS.
1.21 "Product Forecasts" shall have the meaning specified in
Section 6.1.
1.22 "Product" or Products" means the product in finished dosage
form commonly known as "Ofloxacin Otic Solution 0.3%, as specified in the
approved NDA and as more particularly described on Exhibit C.
1.23 "Product Lot" shall mean one production lot of Product based
on a starting input of BPS, as stated in the MBR (which the parties anticipate
shall be an average of 22,000 units and not in excess of 25,000 units, unless
efficiencies of Processing so permits).
1.24 "Product Specifications" means the manufacturing and quality
specification, including without limitation Legal Label Text and unit
descriptions, which the Product must meet in order for Santen to release the
Product for distribution, as approved by the FDA and set forth in Exhibit D,
which specifications may be amended by Santen and furnished to Xxxxxx-Xxxxxxx,
in writing, from time to time during the Term.
1.25 "Purchase Orders" shall have the meaning specified in Section
6.2.
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1.26 "Raw Materials" means those raw materials, including packaging
materials and other materials (other than BPS) listed in Exhibit E, together
with the quality designation therefor, to be used by Xxxxxx-Xxxxxxx for the
Processing hereunder, which list may be amended, in writing, by Santen from time
to time during the Term.
1.27 "Santen Technical Information" means all know-how of Santen related to
the Processing and the Products.
1.28 "Term" means the period of time as set forth in Section 16.2 below.
2. GENERAL SCOPE OF SERVICES.
Xxxxxx-Xxxxxxx shall, in accordance with this Agreement:
(a) Perform Processing services at the Facility, using the BPS, the Raw
Materials and the Equipment in accordance with applicable Legal
Requirements; and
(b) Cooperate fully with Santen, at Santen's cost, to permit AAI to
perform the quality control testing and analysis of the Products and
to permit Santen to perform quality assurance review of the Products
and of the Processing.
3. BPS SUPPLY.
3.1 Santen Delivery. Santen shall supply or shall arrange for third party
vendors chosen by Santen to supply to Xxxxxx-Xxxxxxx, at Xxxxxx'x expense, such
quantities of BPS which are sufficient for Xxxxxx-Xxxxxxx to Process the number
of batches set forth in any Purchase Orders placed by Santen, in accordance with
Section 6. Santen shall be responsible for the performance of, and quality of
materials delivered by all such third party vendors. Santen shall ensure that
its vendors provide BPS that is manufactured according to Good Manufacturing
Practices. Santen shall ensure that its vendors provide a material data safety
sheet for each BPS Lot.
3.2 Warranty: Inspection Period. Upon delivery of a BPS Lot, Santen or
Santen's vendor shall provide Xxxxxx-Xxxxxxx with an original Certificate of
Analysis with respect to such BPS Lot. Xxxxxx-Xxxxxxx shall sample and analyze
each BPS Lot in the manner prescribed by Santen for identification, appearance
and packaging integrity, within thirty (30) days after receipt thereof.
Xxxxxx-Xxxxxxx shall provide written notice to Santen of any shortage of BPS,
any failure of such BPS Lot to pass such testing, immediately upon becoming
aware thereof, but in any event within such thirty (30) day period.
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3.3 Shortages; Nonconforming BPS. Upon receipt of a written notice from
Xxxxxx-Xxxxxxx under Section 3.2, together with evidence satisfactory to Santen
of the alleged shortage, failure to pass the identification testing or other
damage, Santen shall, at Santen's expense, promptly arrange for the delivery of
additional BPS. Xxxxxx-Xxxxxxx shall, in accordance with Santen's instructions,
and at Santen's expense, ship any nonconforming BPS to a place designated by
Santen.
3.4 BPS Storage. Xxxxxx-Xxxxxxx shall maintain, at its expense, secure
storage areas for the BPS at the Facility. Such areas shall comply with Good
Manufacturing Practices and shall fully maintain the quality of the BPS.
Xxxxxx-Xxxxxxx shall take such other steps as shall be commercially reasonable
to fully maintain the BPS in the quality in which it was received.
3.5 Exclusive Use. Xxxxxx-Xxxxxxx shall not use the BPS for any purpose
other than for the Processing performed for Santen hereunder and the testing
conducted pursuant to Section 3.2. Without limiting the generality of the
foregoing, Xxxxxx-Xxxxxxx shall not sell or otherwise supply the BPS or a
product containing the BPS except as directed by Santen hereunder.
3.6 Retention of BPS Samples. Xxxxxx-Xxxxxxx shall retain and make
available to Santen or AAI, upon request by Santen, reserve samples of each BPS
Lot received, as specified by Santen in accordance with applicable Legal
Requirements. Xxxxxx-Xxxxxxx also shall retain and make available to Santen and
AAI, upon request by Santen, records of each shipment of BPS samples for a
period of five (5) years after receipt.
4. RAW MATERIALS.
Xxxxxx-Xxxxxxx shall, from time to time during the Term, procure from third
party suppliers a sufficient amount of Raw Materials, meeting the specifications
of Exhibit E, as necessary to meet Purchase Orders placed by Santen pursuant to
Section 6.
Xxxxxx-Xxxxxxx shall not use any Raw Materials which do not meet the
specifications of Exhibit E and shall not use any suppliers of Raw Materials who
have not been approved in advance by Santen.
5. EQUIPMENT.
5.1 Delivery and Installation. Upon commencement of the Term, Santen shall
arrange and pay for the delivery of the Equipment, as described in Exhibit B, at
the Facility. Xxxxxx-Xxxxxxx shall arrange for the installation and validation
of the Equipment at the Facility, at Santen's cost.
5.2 Maintenance; Sole Use. Xxxxxx-Xxxxxxx shall keep and maintain the
Equipment in a manufacture-ready state and in good service and repair.
Xxxxxx-Xxxxxxx shall maintain written documentation of all use, repair, service
and maintenance of the
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Equipment and shall perform such tests as may be requested by Santen following
each use of the Equipment at Santen's cost. Santen shall reimburse
Xxxxxx-Xxxxxxx for any repairs of the Equipment approved in advance by Santen,
promptly upon receiving satisfactory documentation from Xxxxxx-Xxxxxxx
regarding the costs incurred (provided that Xxxxxx-Xxxxxxx shall be responsible
for repair costs incurred due to Xxxxxx-Xxxxxxx'x negligence or willful acts).
The Equipment shall be used solely to perform the Processing hereunder, except
as otherwise directed by Santen.
5.3 Ownership; Return of Equipment. Santen shall at all times retain
title to the Equipment. Xxxxxx-Xxxxxxx shall not impose or permit to be imposed
any liens or encumbrances of any kind on the Equipment. Upon termination of this
Agreement, Xxxxxx-Xxxxxxx shall, at Santen's sole expense, deliver the Equipment
to its dock for shipping to Santen.
5.4 Notice of Ownership. Upon Santen's request, Xxxxxx-Xxxxxxx shall
sign and deliver to Santen a UCC financing statement or similar documents, as
requested by Santen, indicating that Santen is the owner of the Equipment, for
filing with appropriate governmental authorities.
6. PRODUCT FORECASTS AND PURCHASE ORDERS.
6.1 Forecasts.
On or before the first day of each calendar quarter during the Term,
Santen will provide Xxxxxx-Xxxxxxx with a written twelve (12) month rolling
forecast of the quantities of Product that Santen expects to order during each
of the next twelve (12) months. On or before the fifteenth (15) day of each
month of each calendar year during the Term, Santen will provide Xxxxxx-Xxxxxxx
with a written three-month rolling forecast of the quantities of Product that
Santen expects to purchase during each of the next three (3) months. The
three-month rolling forecast is firm and may not be changed, and shall be used
by Xxxxxx-Xxxxxxx, among other things, to determine the quantities of Raw
Materials to order to prepare for Processing the Product. Santen shall be
obligated to reimburse Xxxxxx-Xxxxxxx for any Raw Materials purchased in
reliance on such three-month forecast (all such forecasts are collectively
referred to herein as the "Product Forecasts").
6.2 Purchase Orders.
Santen shall submit a purchase order to Xxxxxx-Xxxxxxx referencing
this Agreement each month, at least twenty-eight (28) days prior to the
proposed start date of manufacture for the Product, and subject to the terms of
this Agreement, setting forth the number of Product Lots to be Processed, the
time upon which such Processing must be completed, and the amount to be paid by
Santen for such Processing (the "Purchase Order"). The Purchase Order shall be
in accordance with the three-month forecast set forth in Section 6.1. Upon
acceptance by Xxxxxx-Xxxxxxx, it shall be binding and
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become part of this Agreement; provided, however, that any additional terms and
conditions set forth on the Purchase Orders shall not become part of this
Agreement.
6.3 Minimum Order Size.
The minimum size of any order for Product shall be on Product Lot with
larger orders being in whole number increments of additional Product Lots.
7. PROCESSING.
7.1 Processing Standard.
Xxxxxx-Xxxxxxx shall perform Processing as necessary to fulfill all
Purchase Orders accepted by Xxxxxx-Xxxxxxx under Section 6.2, on a timely basis
in accordance with Article 6. The Processing shall be performed solely at the
Facility in accordance with applicable Legal Requirements. Xxxxxx-Xxxxxxx
warrants to Santen that the Products shall be Processed in accordance with the
MBR and other Legal Requirements. Xxxxxx-Xxxxxxx shall not, without Santen's
prior written approval, make any changes in the Processing, or in any equipment
(including the Equipment) which might affect the quality of the Product or
which would require submissions to or approvals from any regulatory authorities
regarding the Product.
7.2 Reports.
Xxxxxx-Xxxxxxx shall prepare, maintain and submit all documents or
reports required under applicable Legal Requirements or as requested by Santen
concerning the Processing or the Products, including a completed batch record,
which shall include, without limitation, audited Product Lot records, records of
environmental data, excursion reports, deviations, and other documents as
required by applicable Legal Requirements. Santen shall be provided a right of
prior review and approval prior to any submittal by Xxxxxx-Xxxxxxx of a report
or document to a governmental authority directly regarding the Processing or
the Products, except in such cases in which a governmental regulator demands
instant delivery of such report or document. Xxxxxx-Xxxxxxx will provide Santen
with notice of any applicable governmental deadline for the submission of a
particular report as soon as Xxxxxx-Xxxxxxx receives a request to provide such
report and will deliver a draft thereof for Santen's review as quickly as
possible. Santen will use its best efforts to review such draft report within
the time frame necessary to meet the applicable deadline. Xxxxxx-Xxxxxxx also
shall provide Santen with any reports, notices, documents, inspection requests
or other correspondence received from a third party, including any
governmental authority, regarding the Processing or the Products.
Xxxxxx-Xxxxxxx also shall fully cooperate with Santen in connection with any
regulatory inspection or products recall or similar event. Xxxxxx-Xxxxxxx
shall immediately (i.e., as soon as reasonably possible, but in no event later
than the earliest to occur of two (2) Business Days or one (1) Business Day
prior to the occurrence of such regulatory inspection) provide Santen with
notice of any upcoming regulatory inspections of the Facility regarding the
Product and shall provide Santen and representative of DSK and
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DPC with an opportunity to observe such inspections. Xxxxxx-Xxxxxxx shall
immediately (i.e., as soon as reasonably possible, but in no event later than
two (2) Business Days after Xxxxxx-Xxxxxxx receives notice thereof) forward to
Santen and DSK and DPC information on any adverse event or complaint related to
the Product, which is received by Xxxxxx-Xxxxxxx from any source.
7.3 Quality Assurance and Control.
7.3.1 Santen and AAI Roles. Xxxxxx-Xxxxxxx acknowledges that AAI has
been retained by Santen to perform quality control testing and analysis
regarding the Processing of Products performed by Xxxxxx-Xxxxxxx hereunder.
Xxxxxx-Xxxxxxx further acknowledges that, notwithstanding AAI's activities,
Xxxxxx-Xxxxxxx shall remain fully responsible for its obligations hereunder.
Santen and representatives of DSK and DPC shall be permitted to observe all
aspects of the Processing and to inspect the Facility where the Product is
being Processed, during reasonable business hours. Xxxxxx-Xxxxxxx shall at its
expense, reasonably cooperate with requests made by Santen regarding quality
control and quality assurance matters related to batch record deviations,
regulatory investigations or recalls. Without limiting the generality of the
foregoing, Xxxxxx-Xxxxxxx shall perform the testing required in the MBR and
will provide samples of Product and any documentation requested by Santen to
AAI, at AAI's place of business, so that AAI may perform quality control
testing and analysis on such samples.
7.3.2 Release of Products. Xxxxxx-Xxxxxxx shall now release any
Product Lot for shipment until Santen has confirmed in writing that (i) such
Product Lot has met the Product Specifications; and (ii) Santen has released
such Product Lot for distribution. Xxxxxx-Xxxxxxx shall store a Product Lot for
up to 45 days after Xxxxxx-Xxxxxxx'x quality assurance department approves such
Product Lot for shipment. After such 45-day period, Xxxxxx-Xxxxxxx shall
continue to store such Product Lot, provided that Santen shall pay storage fees
in the amount of $60.00 per pallet, per month.
7.3.3 Product Failure. Xxxxxx-Xxxxxxx shall immediately notify Santen
of any test results indicating a failure to meet the Product Specifications or
irregularities, deviations, environmental excursions or other problems
encountered while Processing Products hereunder and shall reasonably cooperate
with Santen in reaching a resolution of such matters. In the event that any
Product Lot is not Processed in accordance with the MBR or other applicable
Legal Requirements, Xxxxxx-Xxxxxxx shall, at Santen's request, perform new
Processing as necessary to fulfill any then outstanding Purchase Orders.
Xxxxxx-Xxxxxxx shall be fully responsible for the costs of any BPS or Raw
Materials required for such new Processing, subject to the limitation in
Section 15.3. Xxxxxx-Xxxxxxx shall retain and make available to Santen such
reserve samples of each Product Lot, as specified by Santen, in accordance with
applicable Legal Requirements. In addition, whether or not required by
applicable Legal Requirements, Xxxxxx-Xxxxxxx shall retain and make available
to Santen the foregoing samples of each Product Lot, for a period of five (5)
years after the expiration date of the Product Lot concerned.
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8. PRODUCT DELIVERY.
8.1 Product Delivery; Risk of Loss. Santen shall ensure that DSK arranges
for the shipment of Products from the Facility as soon as possible, via a
carrier selected by DSK, following Santen's release of such Product Lot, as
provided in Section 7.3.2. Title and risk of loss shall pass to Santen upon
Santen's release of the particular Product Lot, as provided in Section 7.3.2,
provided, however, that Xxxxxx-Xxxxxxx'x insurance under Section 10 shall
provide coverage so long as the Product remains at the Facility.
8.2 Packaging; Labeling. Xxxxxx-Xxxxxxx shall ensure that all Products are
properly packaged in accordance with the MBR. Xxxxxx-Xxxxxxx agrees that its
name may be used on a Product label, to the extent required by applicable Legal
Requirements.
9. PRICE AND PAYMENT.
9.1 Price. The total purchase price for each unit of Product purchased
hereunder, including applicable cost reimbursements, is as specified on Exhibit
C. To the extent of any future change in the Product, Xxxxxx-Xxxxxxx will
prescribe a corresponding change in the purchase price.
9.2 Method of Invoicing and Payment. The purchase price for each shipment
of Product Lot shall be paid by Santen in United Sates dollars within forty-five
(45) days of receipt of an invoice therefor from Xxxxxx-Xxxxxxx, which invoice
shall be provided when Xxxxxx-Xxxxxxx'x quality assurance department approves
the Product Lot concerned. Santen shall not be obligated to pay the applicable
invoice within such forty-five (45) day period if the batch record for the
applicable Product Lot is rejected or is being held pending further review or
investigation, prior to release by Santen. The batch records must be provided to
Santen at the same time that Xxxxxx-Xxxxxxx'x quality assurance department has
approved the Product Lot concerned, pursuant to Xxxxxx-Xxxxxxx'x Form 1880. The
batch records shall be accepted as accurate unless Santen notifies
Xxxxxx-Xxxxxxx in writing within forty-five (45) days after the delivery of such
batch records that Santen has determined that either the Product was not
Processed in accordance with the MBR or that the batch records are not complete.
If Santen rejects the Product due to a deficient batch record within the
foregoing time period, Santen shall provide Xxxxxx-Xxxxxxx with written notice
of such rejection and setting forth the basis for such rejection. If
Xxxxxx-Xxxxxxx fails to correct the deficiency within ten (10) days of the
notice or if Santen rejects the correction because the batch record remains
deficient, Santen, may at its option and in its sole discretion, either reject
the Product Lot in its entirety or request that Xxxxxx-Xxxxxxx correct the
deficiency. If Santen rejects the Product Lot, Xxxxxx-Xxxxxxx shall reimburse
Santen for one hundred percent (100%) of Santen's cost of the BPS contained in
such Product, subject to the limitation in Section 15.3.
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10. INSURANCE
1.01 Insurance Requirements. Xxxxxx-Xxxxxxx shall, at its expense,
maintain the following insurance policies during the Term and for such period
to provide coverage for loss or damage to the Equipment, BPS or Products and
for activities conducted by Xxxxxx-Xxxxxxx during the Term:
(a) Workers compensation and employers liability
insurance for Xxxxxx-Xxxxxxx employees, as prescribed
by applicable law, in an amount not less than the
applicable statutory requirements;
(b) Fire and casualty insurance to cover all BPS, Raw
Materials, Products and Equipment located at the
Facility and to cover Products (including any samples
thereof) while in transit, pursuant to this Agreement
(which policies shall name Santen as an additional
insured), in the amount of $1,000,000;
(c) Comprehensive general liability insurance, in the
amount of $1,000,000; and
(d) Errors and Omissions Insurance, in the amount of
$1,000,000.
10.2 Evidence of Insurance. Upon request, Xxxxxx-Xxxxxxx shall
provide Santen with certificates or other documentary evidence of the above
insurance.
11. CONFIDENTIAL INFORMATION.
11.1 Sole Use. Santen agrees to provide Xxxxxx-Xxxxxxx with
Confidential Information during the Term, solely to permit Xxxxxx-Xxxxxxx to
perform the Processing hereunder and for no other purpose. The parties shall
receive and maintain Confidential Information in accordance with this Section
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11.2 Maintain Confidentiality. Confidential Information received
by a party hereunder will be maintained in confidence by such party (a
"Receiving Party"), and the Receiving Party will exercise reasonable commercial
efforts to avoid disclosure of all or any portion of Confidential Information
except (a) in the case of Xxxxxx-Xxxxxxx, which shall have the right to
disclose Confidential Information to such of its employees who need access to
Confidential Information to perform the Processing under this Agreement and who
are bound to Xxxxxx-Xxxxxxx by written obligations and assurances at least as
stringent as those to which Xxxxxx-Xxxxxxx is bound under this Agreement or as
necessary to fulfill any governmental disclosure requirements; and (b) in the
case of Santen, to DSK or to DPC, or to the extent necessary to fulfill any
governmental disclosure requirements. The parties' confidentiality obligations
hereunder shall survive for a period of five (5) years following termination of
this Agreement.
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11.3 No Copies. The Receiving Party shall not make copies of
Confidential Information provided to it, or any portion thereof, except as
required to perform its obligations hereunder or to the extent necessary to
fulfill any governmental disclosure requirements and the Receiving Party shall,
upon the request of the other party, return to the other party all Confidential
Information furnished to the Receiving Party in written form, including
diagrams, charts, formulae, drawings. Notwithstanding the foregoing, the
Receiving Party may retain in its legal files, one copy of any Confidential
Information received from the other party.
11.4 Exceptions. The obligations of Sections 11.1, 11.2 and 11.3,
above, shall not apply with respect to any portion of Confidential Information,
(i) which was developed by the Receiving Party and was in the Receiving Party's
possession, prior to the first receipt thereof, directly or indirectly, from
the other party, as evidenced by written records, or (ii) which is now, or
hereafter becomes through no act or failure to act on the Receiving Party's
part, part of the public knowledge or is disclosed in a printed publication
available to the public; (iii) otherwise lawfully becomes available to the
Receiving Party from sources other than the other party; or (iv) which is
developed by the Receiving Party without the benefit of Confidential
Information, as evidenced by written records, or (v) which is required to be
disclosed by applicable law; provided, however, that the occurrence of any or
all of (i), (ii), (iii), (iv) or (v) shall not be construed to grant any
rights, express or implied, under any patent licensable by the other party.
Confidential Information shall not be deemed to be within one of the foregoing
exceptions if it is merely embraced by more general information available on a
non-confidential basis or in Xxxxxx-Xxxxxxx'x possession.
11.5 Provisional Remedies. The parties acknowledge that any breach
by the Receiving Party of its obligations under this Section 11 may result in
irreparable harm for which the other party may not have an adequate remedy at
law. Accordingly, if the Receiving Party breaches or threatens to breach any of
such obligations, the other party shall be entitled, without showing or proving
any actual damage sustained, to a temporary restraining order, preliminary
injunction, permanent injunction or other order compelling specific performance
or other appropriate remedies.
12. PROPRIETARY RIGHTS; LICENSE.
12.1 Santen Ownership. Santen owns all rights in and to all Santen
Technical Information. Xxxxxx-Xxxxxxx shall, at Santen's request, take such
actions and execute such documents as necessary or desirable, in Santen's sole
judgment, to create, maintain, enforce or defend Santen's rights in such Santen
Technical Information.
13. ENVIRONMENTAL COMPLIANCE.
13.1 Waste. All wastes from the Processing shall be recycled or
disposed only at duly licensed facilities. Transportation of wastes also shall
be conducted only by duly licensed entities. Santen shall provide applicable
MSDS and shall advise Xxxxxx-Xxxxxxx regarding the technical constituents of the
BPS and the Products as relevant to
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the selection of appropriate disposal options. Xxxxxx-Xxxxxxx shall dispose of
waste in accordance with its applicable environmental impact assessment for the
Facility. Xxxxxx-Xxxxxxx shall not, without Santen's prior written consent,
resell any used or unused BPS to any third party.
14. Representations and Warranties.
14.1 Xxxxxx-Xxxxxxx. Xxxxxx-Xxxxxxx warrants and represents that:
14.1.1 Corporate Authority. It has full power and authority
to execute, deliver and perform this Agreement. Xxxxxx-Xxxxxxx is a corporation
duly organized, validly existing and in good standing under the laws governing
its incorporation and has full corporate power and authority to execute,
deliver and perform this Agreement.
14.1.2 Due Execution; Enforceability. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action of Xxxxxx-Xxxxxxx. Xxxxxx-Xxxxxxx is qualified to do business
in all jurisdictions where such qualification is required for its performance
hereunder. This Agreement constitutes a legal, valid and binding agreement of
Xxxxxx-Xxxxxxx, enforceable against Xxxxxx-Xxxxxxx in accordance with its
terms, except as limited by bankruptcy, insolvency, receivership and similar
creditor's rights, laws in effect from time to time.
14.1.3 Compliance with Legal Requirements. Xxxxxx-Xxxxxxx
possesses and will during the Term possess the requisite skill, experience,
knowledge, personnel and Facility to perform the Processing and other
obligations of Xxxxxx-Xxxxxxx hereunder. Xxxxxx-Xxxxxxx further possesses and
is and will during the Term possess and be in compliance with all necessary
licenses, permits and approvals required for Xxxxxx-Xxxxxxx to perform the
Processing and its other obligations under this Agreement, other than the NDA
approval required to be obtained by Santen or any other third party.
Xxxxxx-Xxxxxxx has obtained and will at all times during the Term obtain and
maintain all such licenses, permits and approvals required by the FDA and
other governmental authorities for the operation of the Facility. The Facility
has been and will during the Term be in compliance with Good Manufacturing
Practices. Xxxxxx-Xxxxxxx is not in actual or alleged violation of any Legal
Requirements; nor is it or has it been the subject of any debarment action
under 21 CFR ss 335(a) or (b). Neither Xxxxxx-Xxxxxxx nor the Facility is or
has been the subject of any audit, inspection, suspension or enforcement action
under applicable Legal Requirements which could prevent Xxxxxx-Xxxxxxx from
fulfilling its obligations under this Agreement.
14.2 Santen. Santen warrants and represents that:
14.2.1 Corporate Authority. It has full power and authority
to execute, deliver and perform this Agreement; it is a corporation duly
organized, validly existing and in good standing under the laws governing its
incorporation and has full corporate power and authority to execute, deliver
and perform this Agreement; and
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14.2.2 Due Execution; Enforceability. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action of Santen; this Agreement constitutes a legal, valid and
binding agreement of Santen, enforceable against Santen in accordance with its
terms, except as limited by bankruptcy, insolvency, receivership and similar
creditor's rights, laws in effect from time to time.
14.2.3 NDA. An NDA for the Product has been filed.
14.2.4 Intellectual Property. To the best of Santen's
knowledge (i) the Processing required under the Master Batch Record does not
infringe upon any known patent, (ii) all trademarks used in the Legal Label
Text are owned by or can be legally used by DSK or DPC, and Santen will not
sell the Product to any other party; and (iii) the Legal Label Text complies
with the requirements of applicable governmental authorities.
15. Indemnity.
15.1 Xxxxxx-Xxxxxxx Indemnity. Xxxxxx-Xxxxxxx shall defend,
indemnify, save and hold harmless Santen and its customer, vendor, agents,
employees, shareholders, parent companies, Affiliates, directors and officers
and such parties' respective successors and permitted assigns ("Santen
Indemnitees"), from and against any and all damages, penalties, deficiencies,
suits, proceedings, actions, costs and expenses (including without limitation,
the fees and disbursements of attorneys and any consultants), which are
asserted against or incurred by any of the Santen Indemnitees as a result of a
claim or threatened claim by a third party, by reason of, arising out of, or in
connection with, in whole or in part, any of the following (except to the
extent arising from the negligence or willful misconduct of Santen):
(i) any actual or alleged breach of any representation,
warranty, or covenant of Xxxxxx-Xxxxxxx under this
Agreement (including without limitation, any failure
of Xxxxxx-Xxxxxxx to process the Product in
accordance with the MBR or other applicable Legal
Requirements);
(ii) any failure of Xxxxxx-Xxxxxxx to comply with
applicable Legal Requirements;
(iii) any loss, damage, degradation or contamination to any
Equipment, BPS or Products while such materials are
in the custody or control of Xxxxxx-Xxxxxxx prior to
delivery of the Products to a common carrier, as
provided in Section 8, or while in the custody or
control of any entity which ships the Products to
AAI;
(iv) any actual or alleged presence of Hazardous
Substances, on, under, within or migrating from, or
into the Facility and any adjacent property; and
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(v) any actual or alleged liability or responsibility for
any investigation, remediation, or other cleanup
activity arising from any Hazardous Substances which
Xxxxxx-Xxxxxxx, or any of its Affiliates by contract,
agreement, or otherwise arranged for disposal or
treatment or for transport for disposal or treatment,
whether at the Facility or any off-site facility.
15.2 Santen Indemnity. Santen shall defend, indemnify, save and
hold harmless Xxxxxx-Xxxxxxx and its agents, employees, shareholders, parent
companies, Affiliates, directors and officers and such parties' respective
successors and permitted assigns ("Xxxxxx-Xxxxxxx Indemnitees") from and against
any and all damages, losses, claims, liabilities, obligations, demands,
judgments, awards, settlements, expenses (including without limitation, the fees
and disbursements of attorneys and any consultants), which are asserted against
or incurred by any of the Xxxxxx-Xxxxxxx Indemnitees, as a result of a claim or
threatened claim by a third party, by reason of, arising out of, or in
connection with, in whole or in part, except as otherwise limited under this
Agreement, any of the following (except to the extent arising from the
negligence or willful misconduct of Xxxxxx-Xxxxxxx), (i) any actual or alleged
breach of any representation, warranty or covenant of Santen hereunder; (ii) the
sale, distribution, or use of the Product following delivery thereof to a common
carrier, as provided in Section 8; (iii) any claims for patent, copyright or
trademark infringement arising out of the Processing described in the MBR; and
(iv) any failure of the Legal Label Text to comply with applicable Legal
Requirements.
15.3 Limitation of Liability. Notwithstanding the provisions of
Section 15.2, in no event shall Xxxxxx-Xxxxxxx'x indemnification obligation to a
Santen Indemnitee hereunder exceed two hundred thousand dollars ($200,000) per
calender year of the Term.
15.4 Procedure for Idemnification. An indemnitee under this Section
15 shall promptly notify an indemnifying party of any matter for which the
indemnitee seeks indemnification. Upon receiving a demand for indemnification
from an indemnitee, the idemnifying party shall notify the indemnitee, within
fifteen (15) days, as to whether the idemnifying party shall defend the claim,
as provided in the preceding sentence, the indemnifying party shall have the
sole right to defend or settle the claim (subject to the provisions of the
succeeding sentences hereof) and the indemnitees shall not take any action or
incur any expense, retain its own counsel to monitor the indemnifying party's
defense of such claim, and provided further that the indemnitee shall have the
right to retain its own counsel, with the fees and expenses to be paid by the
idemnifying party if representation of the indemnitees by the counsel retained
by the indemnifying party would be inappropriate due to actual or potential
conflict of interest (as defined in the code of ethics of the state bar
applicable to such counsel) between the indemnitees and any other party
represented by such counsel in such proceedings. The idemnifying
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party shall consult with the indemnitee and keep it informed with respect to the
defense of such claim and, upon request, will provide indemnitee with a copy of
relevant documentation (at indemnitee's expense). The indemnitee shall cooperate
fully with the indemnifying party and its legal representatives in the
investigation of any claim for which the indemnitee has assumed the defense
thereof. The indemnifying party may not enter into any settlement without the
indemnitee's prior written consent, which shall not be unreasonably withheld. In
the event the indemnitee rejects a settlement which provides for a complete
release of liability in favor of the indemnitee, the indemnifying party shall
not be liable for any settlement amount in excess of the settlement so proposed.
If the indemnifying party fails to timely assume or diligently defend
any claim, the indemnitees shall have the right to assume control over such
defense or settlement, with the fees and expenses paid by the indemnifying
party, provided that no settlement, shall be entered into without
the indemnifying party's prior written consent, which shall not be unreasonably
withheld. In the event the indemnifying party rejects such a settlement, it
shall be liable to the indemnitee for the amount of the settlement so proposed
and any other losses or damages arising out of the refusal to so settle.
16. Terms of Agreement.
16.1 Effective Date. This Agreement shall become effective and
binding upon the parties as of the date first written above (the "Effective
Date").
16.2 Initial Term. Unless earlier terminated pursuant to Sections
16.4 or 16.5, this Agreement shall have an initial term of five (5) years (the
"Initial Term"). Thereafter, this Agreement shall be automatically renewed for
additional one year periods, in accordance with Section 16.3.
16.3 Renewal Term. Unless either party has provided the other with
written notice, no later than eighteen (18) months prior to the expiration of
the then existing term, that such party desires to terminate this Agreement
effective as of the date of expiration of such then existing term, the term of
this Agreement shall be deemed automatically renewed for an additional one-year
period (a "Renewal Term"). All Renewal Terms shall be upon the terms and
conditions set forth in this Agreement, except as otherwise agreed by the
parties in writing. All references to "Term" in this Agreement shall apply to
the Initial Term and any Renewal Term.
16.4 Termination for Breach. Notwithstanding any other provisions
of this Agreement, and subject to the procedures of Section 16.4.1, either party
may, without waiver of, or prejudice to any of its other rights and remedies
under this Agreement, under applicable law or otherwise, effect a termination of
this Agreement by written notice, at any time, if the other party breaches any
of its obligations under this Agreement.
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16.4.1. In the event of any alleged breach under Section 16.4, the
party declaring the breach shall provide the other party with written notice
setting forth the nature of the breach, and the recipient shall have a period of
thirty (30) days (or such shorter period if required under the circumstances and
specified in such notice) to cure such breach, provided however, that if the
nature of the alleged breach is such that it cannot reasonably be cured within
such time period, the non-breaching party may elect, in its sole discretion, and
without waiver of, or prejudice to any of its other rights and remedies under
this Agreement under applicable law or otherwise, to grant the breaching party
an additional extension of time to cure such breach. If the breaching party
fails to cure the breach within the applicable time period the non-breaching
party may terminate this Agreement, by written notice to the breaching party
which notice shall be effective immediately upon receipt.
16.5 Other Termination Rights This Agreement also may be terminated:
16.5.1. By mutual assent of the parties
16.5.2. By either party, in the event that a force majeure event as
provided in Section 17 has occurred and has continued for a period of one
hundred eighty (180) days;
16.5.3. By either party, upon the other party's filing of a
voluntary petition for bankruptcy, reorganization or arrangement under any state
statue, or upon assignment for the benefit of creditors, or upon the appointment
of a receiver or trustee with respect to such party or its assets, or upon the
filing of a petition of the kind referenced above, against a party or its assets
by a third party, which filing is made without the agreement of the subject
party and is not removed or dismissed within sixty (60) days of the date of such
filing.
16.5.4. By Santen, upon one hundred eight (180) days written
notice.
16.6 Actions Upon Termination.
16.6.1. Xxxxxx-Xxxxxxx Actions. Upon termination of this Agreement
Xxxxxx-Xxxxxxx shall, at Santen's request, deliver to Santen, at Santen's cost
(i) the Confidential Information; (ii) the Equipment; and (iii) any unused BPS.
Xxxxxx-Xxxxxxx also shall take all steps, as directed by Santen and at Santen's
cost, to effectuate an expeditious transfer of Processing operations to a new
entity and/or facility.
16.6.2. Santen Actions. Santen shall pay Xxxxxx-Xxxxxxx for any
Products ordered by Santen and processed by Xxxxxx-Xxxxxxx hereunder, on or
prior to the expiration of the Term, which have been Processed in accordance
with the MBR and shall pay for Products subject to binding Purchase Orders for
which Processing is scheduled to commence within the next succeeding thirty day
period, and shall pay for
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any Raw Materials purchased by Xxxxxx-Xxxxxxx in reliance on the three-month
forecast described in Article 6.
17. FORCE MAJEURE.
Either party shall be excused for the period of any suspension in the
performance of its obligations hereunder, when such party is prevented from
performing by cause or causes which are beyond such party's reasonable control
and which could not have been reasonably foreseen or prevented, including
without limitation, acts of God, civil commotion, war, invasion, rebellion,
hostilities, unavailability of BPS (subject to Section 3), strikes, delays in
the FDA review process or orders of FDA or other governmental authorities
pertaining to the subject matter of this Agreement (excluding, in each case, any
such events caused in whole or in part by the party claiming a force majeure
hereunder). The party making a claim of a force majeure event hereunder (an
"Affected Party") shall provide prompt written notice to the other party
describing the particulars of the occurrence, including an estimate of its
expected duration and the probable impact on the performance of the Affected
Party's obligations. The Affected Party also shall furnish periodic reports with
respect thereto. Notwithstanding the foregoing, (i) the permitted suspension of
the Affected Party's performance shall be of no greater scope and of no longer
duration than is reasonably required by the force majeure event; (ii) no
liability of either party which arose prior to the occurrence of the force
majeure event shall be excused because of such occurrence; (iii) the Affected
Party shall use reasonable efforts to continue to perform its obligations
hereunder and to cure or correct the force majeure event and to limit or
mitigate damages to the other party.
18. WAIVER.
The waiver by either party hereto of any breach of any provision hereof
shall not be deemed to be a waiver of any prior or subsequent breach of the same
or other provision of this Agreement.
19. ASSIGNMENT.
Neither this Agreement nor any of the rights or obligations of
Xxxxxx-Xxxxxxx hereunder may be assigned or subcontracted, whether by operation
of law or otherwise, without Santen's prior written consent. Any purported
assignment or subcontracting without such written consent shall be void and
unenforceable. Notwithstanding the foregoing, (i) Santen may assign this
Agreement or any of its rights and obligations hereunder to an Affiliate or in
connection with a merger of Santen into another entity or a sale of all or
substantially all of Santen's assets to a third party, and (ii) Xxxxxx-Xxxxxxx
may assign this Agreement in connection with a sale of all or substantially all
of its Sterile Products Division, provided, in each case, that the assignor and
assignee parties execute appropriate documentation satisfactory to the
non-assigning party regarding the full assumption of liabilities hereunder.
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20. PARTIES BOUND.
This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective successors in interest and permitted
assigns.
21. INDEPENDENT CONTRACTOR.
Nothing in this Agreement shall be construed to establish Santen or
Xxxxxx-Xxxxxxx as a partner, joint venturer, agent or other representative of
the other. Each is an independent company retaining complete control over and
complete responsibility for its own operations and employees. Nothing in this
Agreement shall be construed to grant either party any right or authority to
assume or create any obligation on behalf or in the name of the other; to
accept summons or legal process for the other; or to bind the other in any
manner whatsoever.
22. ENTIRETY OF AGREEMENT.
This Agreement constitutes the entire agreement between the parties hereto
pertaining to the subject matter hereof and supersedes all prior and
contemporaneous agreements, understandings, negotiations and discussions of the
parties, whether oral or written, and there are no warranties, representations
or other agreements between the parties in connection with the subject matter
hereof, except as specifically set forth herein. No supplement, modification,
waiver or termination of this Agreement shall be implied from any conduct of
the parties or trade custom or usage, but to be binding must be executed in
writing by the party to be bound thereby.
23. SURVIVAL.
The representations and warranties of the parties shall survive for a
period of three years following termination of this Agreement. Sections 3.6,
5.3, 7.3.3 (last sentence) 11 (except as limited therein) and 15 shall survive
termination of this Agreement.
24. COUNTERPARTS.
This Agreement may be executed in one or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.
25. SEVERABILITY.
If any provision of this Agreement shall be determined to be void or
unenforceable, the remaining provisions of this Agreement shall not be affected
thereby, and every other provision of this Agreement shall remain in full force
and effect and enforceable to the fullest extent permitted by law.
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26. HEADINGS.
The headings appearing in this Agreement are inserted only as a matter of
convenience and in no way define or limit the scope or intent of any section of
this Agreement.
27. NOTICES.
27.1 Form of Notice. Notices under this Agreement shall be given in writing
and delivered:
If to Santen to: Xx. Xxxxxxx Xxxxxxx
Santen Incorporated
000 Xxxxxxx Xxxxx
Xxxx, XX 00000
With a copy to: Xxxxxxxxx X. Xxxxxxx, Esq.
Xxxxxx & Xxxxx LLP
Xxx Xxxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxxxxxx, XX 00000
If to Xxxxxx-Xxxxxxx to: Xxxxxx-Xxxxxxx Sterile Products Operations
Xxxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attn: Vice President
With a copy to: Xxxxxx-Xxxxxxx Company
0000 Xxxxxxxx Xxxx
Xxx Xxxxx, Xxxxxxxx 00000
Attn: Counsel, Pharmaceutical Research
Division
or to such other address as may be designated by such party.
27.2 TIMING. Notices shall be deemed to have been given:
(a) On the same Business Day if the notice has been delivered by
hand or sent by facsimile with confirmation of receipt on or
prior to 5:00 p.m. as of the place of receipt, or on the
next succeeding Business Day if so delivered or sent after
5:00 p.m.; or
(b) On the next succeeding Business Day following receipt of a
notice sent by registered or certified U.S. mail, return
receipt requested or by a nationally recognized overnight
courier service, as evidenced by the return receipt card, or
other similar receipt properly endorsed by the receiving
party.
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28. FURTHER ASSURANCES.
The parties each agree to execute additional instruments and documents and
to do all such further things as the other party may reasonably require in
order to carry out the intent of this Agreement. In addition, the parties agree
to reasonably cooperate with one another in connection with the execution of
the other parties' obligations hereunder.
29. GOVERNING LAW.
The validity, construction and enforceability of this Agreement shall be
governed in all respects by the laws of the State of Michigan, applicable to
agreements negotiated, executed and performed in Michigan by Michigan parties.
THIS AGREEMENT HAS BEEN DULY EXECUTED AND DELIVERED BY THE UNDERSIGNED
AUTHORIZED OFFICERS OF BOTH PARTIES AS OF THE DATE FIRST WRITTEN ABOVE.
XXXXXX-XXXXXXX COMPANY SANTEN INCORPORATED
By: /s/ By: /s/ J. Xxxxxxx Xxxxxxx
---------------------------------- -------------------------------
Title: Vice President, G.M., PDSPO Title: Vice President, BC-D
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