Exhibit 10.13
PACKAGING AGREEMENT
This Agreement dated this 9th day of November, 2000, by and between
Packaging Coordinators, Inc., a Pennsylvania corporation (together with its
subsidiaries and affiliates, "PCI"), having its principal offices at 0000 Xxx
Xxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 and Orapharma, Inc., a Delaware
corporation ("Purchaser"), having its principal offices at 000 Xxxxx Xxxxx,
Xxxxxxxxxx, Xxxxxxxxxxxx 00000.
BACKGROUND
1. PCI specializes in packaging for the pharmaceutical industry and has
certain technical and commercial information and know-how.
2. Purchaser is a corporation that is developing and commercializing
pharmaceutical products.
3. Purchaser desires to engage PCI to provide certain services to
Purchaser in connection with the packaging of certain of Purchaser's
pharmaceutical products; provided, however, that Purchaser shall be responsible
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for the manufacture, sale and distribution of such products and PCI shall be
responsible solely for the packaging of such products.
4. Purchaser and PCI entered into a Quality Agreement on August 16/17,
2000. It is incorporated into this agreement by reference.
TERMS
In consideration of the mutual promises made by the parties hereto and for
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, intending to be legally bound, the parties hereto agree as
follows:
1. DEFINITIONS
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The following terms as used in this Agreement shall have the meanings set forth
in this Article unless the context clearly indicates to the contrary:
"Affiliate(s)" shall mean any corporation, firm, partnership or other
entity which controls, is controlled by or is under common control with a
party. For purposes of this definition, "control" shall mean the ownership
of at least fifty percent (50%) of the voting share capital of such entity
or any other comparable equity or ownership interest.
"Agency" shall mean any governmental regulatory authority involved in
regulating any aspect of the development, market approval, sale,
distribution or use of the Product, Packaging, Packaged Product or the sale
of any of the foregoing.
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"cGMP" shall mean all the laws, regulations and standards relating to the
manufacture of the Product and the Packaging, including but not limited to,
the FDA current Good manufacturing practices, as set forth in the Title 21
of the United States Code of Federal Regulations.
"Delivery Date" shall mean the date set forth in the relevant Purchase
Order on which PCI must supply Purchaser with Packaged Products, as
accepted by PCI pursuant to Section 5(d).
"Effective Date" shall mean the date this Agreement has been fully executed
by both parties.
"Facility" shall mean PCI's facility at 0000 Xxx Xxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx.
"FDA" shall mean the United States Food and Drug Administration.
"Force Majeure" shall mean any of the following events or conditions,
provided that such event or condition did not exist as of the date of
execution of this Agreement, was not reasonably foreseeable as of such date
and is not reasonably within the control of either party and prevents as a
whole or in material part, the performance by a party of its obligations
hereunder: acts of state or governmental action, orders, legislation,
regulations, riots, disturbance, war (declared or undeclared), prolonged
shortage of energy supplies, interruption of transportation, embargo
(inability to procure or shortage of supply materials, equipment or
production facilities), fire, earthquake, flood, hurricane, typhoon or
explosion.
"Package/Packaging" shall mean the filling of the dispenser and the
packaging of the Product pursuant to the Specifications.
"Packaged Product" shall mean the Product as contained in the Packaging.
"Product" shall mean the products of the Purchaser to be packaged which are
described in Appendix 1.
"Purchase Order" shall mean a written document issued by the Purchaser to
PCI in accordance with Section 5 hereof, authorizing PCI's performance of
Packaging and other related services pursuant to the terms of this
Agreement.
"Specifications" shall mean the packaging procedures, testing requirements,
materials standards, quality standards and product technical requirements
for the Packaging set forth in Appendix 2. The parties agree and
acknowledge that the Specifications will be developed and defined by the
Purchaser after the date of this Agreement and shall be subject to input,
review and approval by PCI. Each party agrees to act in good faith in
defining and finalizing the Specifications. Once finalized, the
Specifications will be appended to this Agreement as Appendix 2. The
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parties acknowledge that the Specifications may be revised and refined
during the term of this Agreement by mutual written agreement of PCI and
the Purchaser. If any such change results in obsolescence of any materials
specifically purchased by PCI for Packaging of the Product under this
Agreement prior to being notified in writing by Purchaser of the change in
the Specifications, and provided PCI is unable to use such materials in its
standard operations, Purchaser shall reimburse PCI for the actual cost of
all such materials. If any such change in the Specifications results in
other costs and expenses to PCI, then PCI shall provided Purchaser with a
revised packaging fee and Purchaser shall notify PCI whether it desires to
implement the change, and Purchaser shall be responsible for the costs and
expenses associated with implementation of such change.
2. ENGAGEMENT OF PCI
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PCI agrees to Package the Product and Purchaser agrees to purchase and pay
for the Packaging services on the terms and conditions set forth in this
Agreement.
3. PAYMENT AND SHIPPING
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(a) Shipping. All Packaged Products will be shipped F.O.B. the Facility
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and title and risk of loss of the Packaged Products shall pass to the Purchaser
upon delivery by PCI to a common carrier, provided, however, if the Packaged
Product (other than Packaged Product requiring transport via refrigerated
containers) is shipped to a destination within one hundred (100) miles of the
Facility, PCI shall deliver the Packaged Product at PCI's cost and insure such
risk in transit at PCI's expense. In all other instances, PCI shall ship the
Packaged Product on a common carrier selected by the Purchaser, as set forth
above.
(b) Payment. PCI shall invoice Purchaser concurrently with any shipment
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of the Packaged Products and Purchaser shall make full payment to PCI, at the
address specified on the invoice, no later than thirty (30) days from the date
of such shipment. If Purchaser has not made payment in full by the expiration
of such thirty (30) day period, PCI may, at its option, elect to: (i) charge a
late payment fee on such unpaid amount equal to [*] of such unpaid amount; (ii)
suspend any further deliveries hereunder until such invoice is paid in full;
and/or (iii) [*].
(c) Advance Payment. If at any time, [*], PCI shall have the right to
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require payment in advance before making any further shipment of the Packaged
Products. If Purchaser shall fail, within a reasonable time, to make such
payment in advance, or if Purchaser shall fail to make payment when due, PCI
shall have the right, at its option, to suspend any further deliveries hereunder
until such default is corrected, without thereby releasing Purchaser from its
obligations under this Agreement, or [*]. In the event PCI takes action to
suspend delivery [*], under this Section 3(c), the provisions of
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Section 18(b) shall not apply and PCI shall not be required to continue to
perform services pursuant to this Agreement.
(d) Failure to Take Delivery. If Purchaser fails to take delivery on any
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scheduled delivery date, Purchaser shall be billed at that time for all
unshipped Packaged Product, and on the first of each month thereafter for
reasonable administration and storage costs. If Purchaser does not instruct PCI
to ship products within seven (7) business days of Purchaser's actual notice or
notice by major overnight delivery service of completion of packaging for a
particular lot, PCI may, at its option, dispose of or otherwise use the Products
or Packaged Products and Purchaser shall be liable for the invoice value as if
such Packaged Products were shipped.
4. PRICE
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(a) Packaging Fees. The prices and other fees to be paid to PCI for the
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Packaging of the Products shall be as set forth Appendix 3, subject to
adjustment as set forth therein.
(b) Price Increases. If, at any time during the term of this Agreement,
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PCI's cost of materials increases, [*].
(c) Taxes. PCI shall bear and pay all federal, state and local taxes
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based upon or measured by its net income, and all franchise taxes based upon its
corporate existence, or its general corporate right to transact business. Any
other tax, however denominated and measured, imposed upon the Products or the
Packaged Products or upon their installation, or upon the storage, inventory,
sale, transportation, delivery, use or consumption of the Products shall be paid
directly by Purchaser, or if prepaid by PCI, shall be invoiced to Purchaser as a
separate item and paid by Purchaser to PCI.
5. FORECAST, PURCHASE AND SUPPLY
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(a) Purchase and Supply. During the term of this Agreement and subject to
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paragraph (d) of this Section 5, Purchaser shall purchase such quantities of
Packaged Product as shall be set forth on Purchase Orders submitted by Purchaser
to PCI under this Agreement.
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(b) Forecasts. On or before January 1 and July 1 of each year during the
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term of this Agreement, Purchaser will provide PCI with a written twelve (12)
month rolling forecast (commencing with the immediately following month) of the
quantity of Product which Purchaser expects to require from PCI during each of
the next twelve (12) months. The first three (3) months of the such rolling
forecast shall be binding upon Purchaser. Purchaser's first forecast shall
include (i) the required Delivery Date for the binding portion of the forecast,
(ii) the quantity of Product to be delivered and (iii) the lot numbers to be
applied to such Product. Purchaser's forecast shall take into account the
capacity limitations of PCI's facilities and equipment, as well as the
Production Equipment (as defined below) to be provided by Purchaser.
(c) Purchase Orders. Following the Effective Date, Purchaser will provide
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PCI with monthly Purchase Order(s) setting forth (i) the quantity of Packaged
Product ordered for delivery during the fourth full calendar month after the
date on which the Purchase Order(s) is deemed to be received, (ii) the
applicable Delivery Date(s) for such Purchase Order(s), (iii) the quantity of
Packaged Product to be delivered on the Delivery Date(s) in each form of
packaging and (iv) the lot numbers to be applied to such Packaged Product. Such
Purchase Order shall be delivered no later than the tenth day of each month.
(d) Orders Greater than Forecast. PCI shall use commercially reasonable
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efforts to supply the quantity of Product ordered, regardless of the quantity
forecast by Purchaser subject to the capacity limitations of PCI's Packaging
equipment, the Production Equipment (defined below), and the Facility. In the
event that PCI is unable to fill any order, PCI shall so notify Purchaser within
fifteen (15) days from its receipt of the Purchase Order.
(e) Amendment of Purchase Orders. PCI will use commercially reasonable
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efforts to accommodate a request to amend a Purchase Order to increase or
decrease the quantity of Product to be delivered.
(f) Cancellations. Purchaser may cancel any Purchase Order by providing
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PCI written notice at least ninety (90) days prior to the Delivery Date. In the
event that Purchaser cancels any order for Product, Purchaser shall reimburse
PCI for direct costs reasonably incurred by PCI in connection with performance
of such Purchase Order up to the time of receipt of such notice, as well as a
handling fee equal to [*] of such amount; provided that PCI shall credit any
such handling fee to additional Purchase Orders received pursuant to this
Agreement within twelve (12) months of the cancellation date.
(g) Terms of Agreement Govern. No modification or amendment to this
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Agreement shall be effected by or result from the receipt, acceptance, signing
or acknowledgment of any party's Purchase Orders, order acknowledgments,
invoices, shipping documents or other business forms containing terms or
conditions in addition to or different from the terms and conditions set forth
in this Agreement, and the terms of this Agreement shall supersede any provision
in any Purchase Order or other document that is in addition to or inconsistent
with the terms of this Agreement.
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6. COMPLIANCE WITH AGENCY REGULATIONS
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The parties agree to comply in all material respects with all laws and
regulations of any Agency. PCI shall be responsible for all the necessary
permits and licenses for Packaging of the Product; provided, however, that the
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Purchaser shall have sole responsibility for obtaining any permits or licenses
from any Agency necessary or required for the sale, marketing or entering into
commerce of any Product or Packaged Product.
7. FACILITY AND PRODUCTION EQUIPMENT
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(a) Packaging. PCI hereby agrees to perform the Packaging of the
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Product(s) at its Facility.
(b) Compliance with Laws. PCI will comply, in all material respects, with
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all local applicable laws, rules and regulations relating to the services to be
provided by PCI under this Agreement.
(c) Agency Inspection. PCI hereby agrees to advise the Purchaser promptly
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in writing of any proposed or unannounced inspection of the Product(s), Packaged
Products or Packaging process or procedures by any Agency and will, to the
extent practicable, permit the Purchaser to be present during any such
inspection. If the Purchaser is not present during such an inspection, PCI
shall promptly provide a report of the results of the inspection to the
Purchaser. PCI shall promptly provide Purchaser with a copy of any report,
citation, or the like provided to PCI by such Agency relating to Product(s),
Packaged Product(s) or the Package processes.
(d) Purchaser Technical Representative. During the term of this
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Agreement, Purchaser shall have the right to have one or more technical
representatives present in the area of the Facility where the Packaging is being
conducted during the Packaging process to (i) review the Packaging process; (ii)
review any relevant records in connection with such Packaging process and assess
its compliance with cGMP and the Specifications; and (iii) discuss any related
issues with PCI's personnel. Purchaser's technical representatives, when on-
site, shall comply with PCI's rules and regulations. Purchaser shall indemnify
and hold PCI and its Affiliates harmless from all liability, including claims
for workers' compensation, resulting from the presence of Purchaser's technical
representatives at the Facility.
(e) Production Equipment. Purchaser will provide to PCI certain packaging
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equipment (the "Production Equipment"), as described in Appendix 4, which shall
be used only for packaging Purchaser's Products unless Purchaser gives prior
written consent to PCI. Purchaser shall at all times own the Production
Equipment. PCI shall provide routine maintenance on the Production Equipment,
as established by the equipment manufacturer and/or cGMPs; provided, however,
that Purchaser shall be obligated to pay for all non-routine maintenance and
repairs to the Production Equipment unless caused by negligent operation thereof
by PCI.
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8. WARRANTIES
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(a) Limited Warranty. Subject to Sections 14 and 18(c), PCI warrants that
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the Packaging and the services provided hereunder shall comply, in all material
respects, with the Specifications and cGMPs. THE LIMITED WARRANTY SET FORTH IN
THIS SECTION 8 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE. EXCEPT FOR THE WARRANTIES EXPRESSED IN THIS SECTION 8, PCI MAKES NO
OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PACKAGING AND THE
PACKAGED PRODUCTS. IN ADDITION, PCI HEREBY DISCLAIMS LIABILITY FOR INCIDENTAL
OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO PACKAGING, PACKAGED PRODUCTS OR
THE PRODUCTS. NOTWITHSTANDING THE FOREGOING, THE DURATION OF ANY IMPLIED
WARRANTY WHICH MIGHT BE DEEMED TO EXIST BY OPERATION OF LAW SHALL BE LIMITED TO
SIX (6) MONTHS FROM THE DATE OF DELIVERY) OF PACKAGED PRODUCTS BY PCI.
(b) Testing of Packaged Products. PCI shall perform in-process quality
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control tests and testing for the release of packaging materials in accordance
with the Specifications and cGMPs. Purchaser, upon receipt of Packaged Products
from PCI, shall have thirty (30) business days to inspect such Packaged
Products. In the event Purchaser believes that the Packaged Products do not
conform, in all material respects, to the Specifications set forth in Xxxxxxxx
0, Xxxxxxxxx shall send to PCI, via overnight delivery service or certified
mail, return receipt requested, within five (5) business days of discovery of
the defect, a notice of rejection along with samples of the rejected Packaged
Products. Packaged Products that PCI agrees are defective or non-conforming
will, at PCI's option and expense, be repackaged and shipped to Purchaser or
credited toward Purchaser's purchase price. If PCI does not agree with
Purchaser's determination that the Packaged Products fail to conform, in all
material respects, with the Specifications, then after reasonable efforts to
resolve the disagreement, either party may submit the dispute to arbitration in
accordance with Section 19. Any Product that is not rejected within such thirty
(30) day period shall be deemed to have been accepted by Purchaser.
(c) Replacement of Defective Packaged Products. PCI shall replace, at its
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sole expense, all defective Packaging. THE OBLIGATION OF PCI TO REPLACE
DEFECTIVE PACKAGING, INCLUDING PACKAGED PRODUCTS, IN EXCESS OF THE NORMAL
PACKAGING LOSSES SHALL BE PURCHASER'S EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR
DEFECTIVE PACKAGED PRODUCTS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR USE. For losses of Packaging materials supplied by
Purchaser (or, to the extent required by this Agreement, Product) in excess of
normal Packaging losses, PCI shall pay to Purchaser, depending upon the
circumstances, either (a) the substantiated acquisition cost found on
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the invoice if such materials were purchased by Purchaser from an unrelated
third party; or (b) the substantiated direct costs of Purchaser (or its related
entities) for the Production of materials (which shall not include any profit or
xxxx-ups) if such materials were produced by Purchaser or any entity related,
directly or indirectly, to Purchaser.
(d) Supply of Products for Defective Packaging. In the event PCI is
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required to replace defective Packaging pursuant to paragraphs (b) or (c) of
this Section 8, Purchaser shall furnish to PCI, at PCI's expense, sufficient
quantities of the Products in order for PCI to replace such Packaging; provided,
however, that PCI shall not be required to incur expenses in excess of [*] in
the aggregate.
8A. RECALL, WITHDRAWAL, OR FIELD CORRECTION
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(a) If Purchaser reasonably decides or is required to initiate a product
recall, withdrawal, or field correction with respect to, or if there is any
governmental seizure of, any of the final Packaged Products which were held,
stored and/or packaged under this Agreement, Purchaser will notify PCI promptly
of the details regarding such action and provide copies of relevant
documentation concerning such action. PCI will provide reasonable assistance to
Purchaser in investigating any remedying of any such situation, but all
regulatory contacts and communications that are made and all activities and
final decisions concerning seizure, recall withdrawal, or field correction will
be conducted or made by Purchaser.
(b) If any such recall, withdrawal, field correction, or seizure occurs
due solely to (i) a failure of any Product and/or Packaged Product held, stored
or packaged by PCI hereunder to conform to cGMP, the Specifications set forth in
Appendix 2, any other specifications the parties agree on in writing or any
warranty or other requirement set forth in this Agreement, (ii) the failure of
PCI to comply in all material respects with any applicable law, regulation,
court order or decree, or (iii) the negligent or intentional wrongful act or
omission of PCI in connection with the packaging, holding and/or storage of
Purchaser's product and the final Packaged Product hereunder, then PCI shall
bear the full cost and expense of any such seizure, recall, withdrawal, or field
correction, including the reasonable fees and expenses of any technical
consultant reasonably needed to assist in such matters.
(c) If any such recall, withdrawal, field correction, or seizure occurs
due to any reason or cause other than those set forth in subsection (b) above,
then Purchaser shall bear the full cost and expense of any such seizure, recall,
withdrawal, or field correction including the reasonable fees and expenses of
any technical consultant reasonably needed to assist in such matters.
(d) If both parties contribute to the cause of a seizure, recall,
withdrawal, or field correction, the cost and expenses thereof will be shared in
proportion to each party's contribution to the problem(s). If the parties do
not reach an agreement on either the cause or proportional shares of
contribution of costs and expenses within 45 days, the parties agree to select
jointly an independent qualified testing laboratory to make such
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determinations and agree to be bound by such determination; with the costs of
such laboratory to be shared in proportion to each party's cause.
(e) Notwithstanding the foregoing, in no event shall PCI, in connection
with compliance with this Section 8A, be required to incur expenses in excess of
[*] in the aggregate.
9. REPRESENTATIONS AND WARRANTIES
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(a) Existence and Power. Each party hereby represents and warrants to the
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other party that such party (i) is duly organized, validly existing and in good
standing under the laws of the state in which it is organized, (ii) has the
power and authority and the legal right to own and operate its property and
assets, and to carry on its business as it is now being conducted, and (iii) is
in compliance with all requirements of applicable law, except to the extent that
any noncompliance would not materially adversely affect such party's ability to
perform its obligations under the Agreement.
(b) Authorization and Enforcement of Obligations. Each party hereby
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represents and warrants to the other party that such party (i) has the power and
authority and the legal right to enter into the Agreement and to perform its
obligations hereunder and (ii) has taken all necessary action on its part to
authorize the execution and delivery of the Agreement and the performance of its
obligations hereunder. The Agreement has been duly executed and delivered on
behalf of such party, and constitutes a legal, valid, binding obligation,
enforceable against such party in accordance with its terms.
(c) No Consents. Each party hereby represents and warrants to the other
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party that all necessary consents, approvals and authorizations of all Agencies
and other persons required to be obtained by such party in connection with
Agreement have been obtained.
(d) No Conflict. Each party hereby represents and warrants to the other
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party that the execution and delivery of the Agreement and the performance of
such party's obligations hereunder and thereunder (i) do not conflict with or
violate any requirement of applicable laws or regulations or any material
contractual obligation of such party and (ii) do not materially conflict with,
or constitute a material default or require any consent under, any material
contractual obligation of such party.
10. INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER
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(a) Intellectual Property. Purchaser represents and warrants to PCI that
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to the best of Purchaser's knowledge and belief, Purchaser has all necessary
authority and right, title and interest in and to any patents, inventions and
developments related to the Products and the manufacturing and Packaging of the
Products, and Purchaser hereby grants to PCI a non-exclusive, royalty-free
license to use any and all of such right, title and interest as may be necessary
for PCI to perform its obligations under this Agreement.
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(b) Drug Master Files. PCI agrees to provide Purchaser with a right to
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reference any Drug Master File ("DMF") filed with FDA or on behalf of PCI,
relating to PCI's manufacturing sites, facilities, operating procedures,
personnel, processes and/or materials to be used to package the Product. PCI
will file and properly maintain any and all required annual reports and
notices/supplements to the aforementioned DMFs. PCI will notify Purchaser
promptly in writing of any changes or modifications to the DMF.
(c) PCI agrees that any and all ideas, improvement, inventions and works
of authorship conceived, written or first reduced to practice wither by PCI's
employees alone or in conjunction with the Purchaser, if any, that are related
directly and exclusively to the Products (the "Purchaser Inventions") shall be
the sole and exclusive property of Purchaser and PCI hereby assigns to Purchaser
all right, title and interest in and to any and all such Purchaser Inventions.
(d) The Purchaser agrees that any and all ideas, improvements, inventions
and works of authorship regarding the packaging of pharmaceuticals conceived,
written or first reduced to practice in the performance of this Agreement that
are not directly and exclusively related to the Products (the "PCI Inventions")
shall be the sole and exclusive property of PCI and the Purchaser assigns to PCI
all right, title and interest in and to any and all such PCI Inventions. PCI
hereby grants to the Purchaser a non-exclusive, worldwide, royalty-free license
to use and practice such PCI Inventions for the manufacture by the Purchaser of
any of the Purchaser's products. Such license shall survive the termination or
expiration of this Agreement.
11. CONFIDENTIALITY
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(a) Confidentiality Agreement. PCI and the Purchaser agree to keep secret
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and confidential any and all information ("Proprietary Information") either
disclosed hereunder or through any prior disclosure and not to disclose such
Proprietary Information to any person or entity, except (i) to employees of each
party having a need to know the information in order to fulfill such party's
obligations hereunder; or (ii) as required by an applicable Agency. The parties
shall use the Proprietary Information solely for the purpose of carrying out the
obligations contained in the Agreement. The obligations imposed by this Section
shall not apply to any Proprietary Information:
(i) which at the time of disclosure is in the public domain;
(ii) which, after disclosure, becomes part of the public
domain by publication or otherwise, through no fault of
the receiving party;
(iii) which at the time of disclosure is already in the
receiving party's possession, except through prior
disclosure by PCI, the Purchaser or an Affiliate of
either of them, and such possession can be properly
documented by the receiving party in its written
records, and was not made available to the receiving
party by anyone owing an obligation of confidentiality
to the disclosing party;
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(iv) which is rightfully made available to the receiving party
from sources independent of the disclosing party;
(v) which is required to be disclosed in the course of
litigation or other legal or administrative proceedings;
or
(vi) which is required by law to be disclosed;
provided that in all cases the party receiving the Proprietary Information
shall, to the extent permitted, give the other party prompt notice of the
pending disclosure and shall cooperate in such other party's attempts, at such
other party's sole expense, to seek an order maintaining the confidentiality of
the Proprietary Information.
(b) Term of Confidential Agreement. The obligation of confidentiality and
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non-use set forth in this Article shall survive for a period of [*] years
beyond the termination or expiration of this Agreement.
(c) Ownership of Proprietary Information. Proprietary Information shall
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remain the exclusive property of the disclosing party. In no event shall any of
PCI's proprietary information, technology, know-how, intellectual property (or
rights thereto) become the property of the Purchaser.
12. TERM AND TERMINATION
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(a) Term. This Agreement, unless sooner terminated as provided below,
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shall begin on the Effective Date, and shall continue for a period of seven (7)
years, subject, however, to renewal or extension by mutual agreement of PCI and
the Purchaser.
(b) Termination Upon Notice. At any time after July 31, 2003, either
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party may terminate this Agreement or any Purchase Order at any time upon two
(2) years prior written notice to the other party.
(c) Immediate Termination. Either party shall have the right to
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immediately terminate this Agreement or any Purchase Order if (i) the other
party becomes insolvent, files a petition in bankruptcy, or applies for or
consents to the appointment of a receiver or trustee, or makes an assignment for
the benefit of creditors, or suffers or permits the entry of an order
adjudicating it to be bankrupt and such order is not discharged within thirty
(30) days; (ii) if either party materially breaches any of the provisions of
this Agreement or any Purchase Order and such breach is not cured within thirty
(30) days after the giving of written notice, the party claiming the breach
shall have the right to terminate this Agreement or any Purchase Order; or (iii)
if any required license, permit or certificate required of the other party is
not approved and/or issued, or is revoked, by any applicable Agency; provided
that such other party may no longer appeal such decision or reapply or otherwise
pursue such permit, license or certificate.
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(d) Duties Upon Termination. In the event of any termination, PCI shall
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promptly return (i) any remaining inventory of materials received from the
Purchaser or Purchaser's suppliers, (ii) all packaging components paid for by
the Purchaser, (iii) all remaining inventories of the Product, process, and (iv)
any other Product or material being stored for the Purchaser, to the Purchaser
at the Purchaser's expense. PCI shall have no obligation to return the
foregoing until all outstanding invoices sent by PCI to the Purchaser have been
paid in full. Purchaser shall also be required to pay, at the applicable price
set forth in Appendix 3, for completed but not yet shipped Packaged Products,
Packaged Products in process and Packaged Products shipped but not yet invoiced.
In the event Purchaser breaches or terminates this Agreement or any Purchase
Order (other than as a result of a breach of this Agreement or any Purchase
Order by PCI), the Purchaser will also be required to pay PCI for its direct
cost of all materials reasonably purchased by PCI for Packaging, together with a
handling charge equal to [*] of such costs. The Purchaser shall specify the
location in the continental United States to which delivery, at Purchaser's
expense, of the foregoing is to be made. Proprietary Information exchanged
between the Purchaser and PCI shall be promptly returned upon termination of the
Agreement.
(e) Continuing Obligations. The rights and obligations of each of the
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parties under the provisions of Sections 1, 3, 4, 6, 8, 8A, 9(e), 10, 11, 12(d)
and (e), 13, 14, 15, 16, 18, 19, 20 and 21(f) of this Agreement shall continue
notwithstanding the termination of this Agreement for any reason.
13. FORCE MAJEURE
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If PCI shall be delayed in making any delivery, or Purchaser shall be
delayed in taking any delivery, in each case in whole or in part, by reason of
Force Majeure (as defined herein), such delay shall be excused during the
continuance of and to the extent of such Force Majeure (except in respect of any
obligation to pay money); provided that if, as a consequence of any such Force
Majeure, the total demands for PCI's products or services cannot be supplied by
PCI, PCI may, at its option, allocate its available supply among Purchaser and
its other customers on such basis as PCI may deem fair and practicable, without
liability for any failure to perform this Agreement. The party claiming Force
Majeure shall promptly notify the other party of the termination of such event.
During the period that the performance by one of the parties of its obligations
under this Agreement has been suspended by reason of an event of Force Majeure,
the other party may likewise suspend the performance of all or part of its
obligations hereunder to the extent that such suspension is commercially
reasonable, except that Purchaser may not suspend its obligation to make payment
pursuant to Article 3 for Packaged Products previously delivered by PCI.
Delivery shall be made and taken as soon as reasonably possible after the
removal of such cause, and the time for performance of this Agreement shall be
extended for a period equal to the duration of such cause, and the time for
performance of his Agreement shall be extended for a period equal to the
duration of such cause, provided that if such delay exceeds six (6) months,
either party may terminate this Agreement, subject to the duties set forth in
Section 12(d).
14. INDEMNIFICATION AND INSURANCE
-----------------------------
____________________________
* Confidential Treatment Requested
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(a) Indemnification by Purchaser. Purchaser agrees to indemnify and hold
----------------------------
PCI and its Affiliates, and their respective agents, employees, officers,
directors, Affiliates and representatives harmless from and against any and all
costs, expense, liabilities, claims, damages, demands, actions, losses and fees,
including reasonable attorneys' fees and costs, arising from the manufacturing,
sale, distribution, possession or use of any Product or Packaged Product, other
than as a result of PCI's breach of this Agreement. Purchaser also agrees to
indemnify and hold harmless PCI and its agents, employees, officers, directors,
Affiliates and representatives from and against any and all costs, expense,
liabilities, claims, damages, demands, actions, losses and fees, including
reasonable attorneys' fees and costs, which arise from the use of any trademark,
trade name, copyright, patent or other right specified by Purchaser in the
manufacturing or Packaging of the Product, provided that such use is not part of
PCI's standard packaging procedures.
(b) Indemnification by PCI. PCI agrees to indemnify and hold Purchaser
----------------------
harmless from and against any and all costs, expense, liabilities, claims,
damages, demands, actions, losses and fees, including reasonable attorneys' fees
and costs, arising from PCI's willful misconduct or gross negligence in the
performance of Packaging or PCI's breach of this Agreement. PCI's
indemnification obligation hereunder is expressly subject to the provisions of
Section 8 and Section 18 of this Agreement.
(c) Procedure for Indemnification. Upon receiving notice of any claim for
-----------------------------
liability under this provision, the indemnified party shall promptly notify the
indemnifying party in writing; provided, however, that failure to give notice
shall not limit or otherwise reduce the indemnity provided for in this
Agreement. The indemnifying party may, in its sole discretion, assume and
conduct the legal defense of the indemnified party in any suit that could result
in claims under this provision. Unless made with the express written consent of
the indemnifying party, no sums paid by the indemnified party in settlement of
any lawsuit for alleged damages arising from the use of Products shall be
recoverable under this provision.
(d) Insurance. During the term of this Agreement, the Purchaser and PCI
---------
shall each procure and maintain in full force and effect, at its own cost and
expense, insurance against the risks specified in this Agreement in amounts not
less than the amounts specified herein. The Purchaser and PCI shall maintain
the following minimum coverage with respect to the matters covered by this
Agreement:
(i) PCI shall maintain workers' compensation insurance
in compliance with the workers' compensation laws
of the state or states in which PCI has employees
performing work under this Agreement and employer's
liability insurance with respect to such employees
with a minimum limit of [*] per occurrence. The
Purchaser shall maintain comparable insurance
coverage for any of its employees who at any time
are present at PCI's facility.
(ii) PIC and Purchaser shall each maintain commercial
general liability insurance including premises,
broad form property damage,
____________________________
* Confidential Treatment Requested
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contractual, products/completed operations
coverage, with a minimum limit of [*] for each
occurrence.
(iii) "All Risk" Property Insurance for property utilized
in the packaging of products (e.g., equipment and
raw materials), with a coverage of at least the
full replacement value; provided, however, that the
Purchaser shall maintain insurance for all Products
while in PCI's possession at the Facility and
Purchaser shall insure the Production Equipment at
all times while in the Facility.
15. NOTICES
-------
Notices or other communications required or permitted by this Agreement
shall be given in writing, and shall be deemed to have been given when deposited
in United States mail, return receipt requested and postage prepaid, or on the
day following delivery of such notice to a major overnight delivery service.
All notices shall be addressed to the parties as follows:
To PCI:
PCI Services
0000 Xxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
Attention: Xxxx Xxxxxxx
With a copy to:
Cardinal Health, Inc.
0000 Xxxxxxxx Xxxxx
Xxxxxx, XX 00000
Attn: General Counsel
____________________________
* Confidential Treatment Requested
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To Purchaser
OraPharma, Inc.
000 Xxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Attention: J. Xxxxxx Xxxxxx, Ph.D., V.P.
With a copy to:
Dechert Price & Xxxxxx
4000 Xxxx Atlantic Tower
0000 Xxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000-0000
Attn: Xxxxx Xxxxxxxx
16. CHOICE OF LAW The Laws of the Commonwealth of Pennsylvania
-------------
applicable to contracts made and to be performed in the Commonwealth of
Pennsylvania shall govern any dispute arising out of or under this Agreement.
17. ASSIGNMENT
----------
This Agreement is not assignable by either party, other than to any of its
Affiliates, without the written consent of the other party, which consent makes
specific reference to this Section 17.
18. REMEDIES
--------
(a) Remedies Upon Breach of Agreement. In the event of any breach of any
---------------------------------
provisions of this Agreement or any Purchase Order by Purchaser, PCI, at its
option, without prejudice to any other remedy or remedies which PCI may have
against Purchaser for such breach, including without limitation any rights PCI
may have under Section 3 hereof, may (i) without affecting in any way the
obligation of either party in respect of further shipments hereunder, suspend
any further deliveries until such default is cured, or (ii) terminate this
Agreement under Section 12(c) and declare any outstanding obligations of
Purchaser for shipments immediately due and payable.
(b) Limitation of Damages. PCI SHALL NOT BE LIABLE FOR ANY BREACH OF THIS
---------------------
AGREEMENT OR ANY PURCHASE ORDER ISSUED HEREUNDER OR OF ANY DUTY OR OBLIGATION
ARISING OUT OF OR RELATED HERETO OR THERETO, IN ANY AMOUNT INDIVIDUALLY AND IN
THE AGGREGATE IN EXCESS OF [*], AND PCI SHALL NOT BE LIABLE IN ANY EVENT FOR THE
____________________________
* Confidential Treatment Requested
-15-
VALUE OF THE PRODUCT OR FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, INCLUDING WITHOUT LIMITATION, LOST REVENUES OR PROFITS.
19. ARBITRATION
-----------
(a) Arbitration. Any claim, controversy or dispute arising out of or
-----------
relating to this Agreement or any interpretation or breach thereof or
performance thereunder, including without limitation any dispute concerning the
scope of this arbitration provision, shall be settled exclusively by submission
to final, binding and non-appealable arbitration ("Arbitration") for
determination, without any right by any party to a trial de novo in a court of
-- ----
competent jurisdiction, after a twenty-five (25) calendar day waiting period
(the "Waiting Period") subject to Section 19(j). During the Waiting Period, the
parties shall work reasonably and in good faith and shall use their best efforts
to resolve the claim, controversy or dispute amicably. The Arbitration and all
pre-hearing, hearing, post-hearing arbitration procedures, including those for
disclosure and challenge, shall be conducted in accordance with the Commercial
Arbitration Rules (the "Commercial Rules") of the American Arbitration
Association (herein referred to as the "Association") in Philadelphia,
Pennsylvania, or such other place as the parties may agree, as supplemented
hereby. In addition to the Commercial Rules, the parties shall also follow the
procedures described below.
(b) Notice of Demand to Arbitrate. Following the Waiting Period, the
-----------------------------
party seeking Arbitration shall give notice of a demand to arbitrate (herein
referred to as the "Demand") to the other party and to the Association. The
Demand shall include (i) the issues to be determined, (ii) a copy of this
arbitration provision, and (iii) to the extent the parties cannot agree on a
single arbitrator, the designation of one arbitrator, who shall have no prior or
existing personal or financial relationship with the designating party.
(c) Response. Within thirty days after receipt of the Demand, the other
--------
party shall give notice (herein referred to as the "Response") to the party that
demanded arbitration, and to the Association, of (i) any additional issues to be
arbitrated, (ii) its answer to the issues raised by the party that sent the
Demand, and (iii) its designation of a second arbitrator, who shall have no
prior or existing personal or financial relationship with the designating party.
If a Response designating a second arbitrator is not received within the above-
mentioned thirty (30) day period, the Association shall immediately designate
the second arbitrator.
(d) Designation of Third Arbitrator. The two arbitrators as designated
-------------------------------
pursuant to the foregoing provision shall then designate a third arbitrator
within ten days after the designation of the second arbitrator. If the two
arbitrators cannot agree on the designation of the third arbitrator within the
ten (10) day period allotted, the Association shall designate the third
arbitrator.
(e) Procedures of Arbitration. The arbitration panel as designated above
-------------------------
shall proceed with the Arbitration by giving notice to all parties of its
proceedings and hearings
-16-
in accordance with the Association's applicable procedures. Within 15 days
after all three arbitrators have been appointed, an initial meeting among the
arbitrators and counsel for the parties shall be held for the purpose of
establishing a plan for administration of the Arbitration, including: (i)
definition of issues; (ii) scope, timing and type of discovery, which may at the
discretion of the arbitrators include production of documents in the possession
of the parties, but may not, without the consent of the parties, include
depositions; (iii) exchange of documents and filing of detailed statements of
claims and preheating memoranda; (iii) schedule and place of hearings; and (iv)
any other matters that may promote the efficient, expeditious and cost-effective
conduct of the proceeding. The substantive law of the Commonwealth of
Pennsylvania shall be applied by the arbitrators to the resolution of the
dispute, provided that the arbitrators shall base their decision on the express
terms, covenants and conditions of this Agreement. The arbitrators shall be
bound to make specific findings of fact and reach conclusions of law, based upon
the submissions and evidence of the parties, and shall issue a written decision
explaining the basis for the decision and award. The award shall be made within
one year of delivery of the Response.
(f) No Modification. The parties agree that the arbitrators shall have no
---------------
power to alter or modify any express provision of this Agreement or to render
any award which, by its terms, effects any such alteration or modification.
(g) Discovery. Upon written demand to any party to the Arbitration for
---------
the production of documents and things (including computer discs and data)
reasonably, related to the issues being arbitrated, the party upon which such
demand is made shall promptly product, or make available for inspection and
copying, such documents or things without the necessity of any action by the
arbitrators, provided, however, that no such demand shall be effective if made
more than ninety (90) days after the receipt of the Response.
(h) Power to Grant Relief and Remedies. Subject to the limitations
----------------------------------
imposed by Section 19(f), the arbitrators shall have the power to grant any and
all relief and remedies, whether at law or in equity, that the courts in the
Commonwealth of Pennsylvania may grant and such other relief as may be available
under the Commercial Rules, other than punitive damages. Any award of the
arbitrators shall include pre-award and post-award interest at a rate or rates
considered just under the circumstances by the arbitrators. The decision of the
arbitrators shall be final and as an "award" within the meaning of the
Commercial Rules and judgment upon the arbitration award may be entered in the
United States District Court for the Eastern District of Pennsylvania
("Philadelphia District Court") or any other court having jurisdiction, as if it
were a judgment of that court. The parties to this Agreement expressly consent
to the jurisdiction of the Association, including, without limitation,
reasonable attorney's fees and the parties waive any objection they may have as
to jurisdiction and venue regarding the Philadelphia District Court.
(i) Fees and Expenses. The party which does not prevail in the
-----------------
Arbitration shall be responsible for all fees and expenses incurred in
connection with the Arbitration,
-17-
including without limitation, the reasonable attorney's fees and expenses
incurred by the prevailing party.
(j) Equitable Relief. Notwithstanding the foregoing, the parties
----------------
specifically reserve the right to seek a temporary judicial restraining order,
preliminary injunction, or other similar short term equitable relief, and grant
the arbitration tribunal the right to make a final determination of the parties'
rights, including whether to make permanent or dissolve such court order. No
party shall bring a civil action seeking enforcement of any other remedy founded
on this Agreement.
20. RELATIONSHIP OF THE PARTIES
---------------------------
Nothing contained in this Agreement shall create a joint venture or
partnership between the parties. PCI shall be an independent contractor in
performing its obligations. Neither party shall be liable for any of the debts
or obligations of the other and neither party shall have any authority or right
to act for or incur any liability of any kind, express or implied, on the name
of or on behalf of the other party.
21. MISCELLANEOUS
-------------
(a) Entire Agreement. This Agreement and all Purchase Orders issued
----------------
hereunder, and related documents, constitutes the entire agreement between the
parties pertaining to the subject matter hereof and supersedes all prior
agreements, understandings, negotiations and discussions, whether oral or
written, of the parties, and there are no warranties, representations or other
agreements between the parties except as specifically set forth herein. All
Appendices to this Agreement are part of this Agreement to the same effect as if
such terms had been included herein. The terms of this Agreement shall govern
in the event any term or provision set forth in any Appendix hereto is
inconsistent with this Agreement. No addition to or waiver or modification of
any provision of this Agreement shall be binding unless in writing and signed by
a duly authorized representative of each party.
(b) Counterparts, Signatures by Facsimile. This Agreement may be executed
-------------------------------------
in one or more counterparts, each of which shall be deemed to be one and the
same Agreement. Any facsimile signature of any party hereto shall constitute a
legal, valid binding execution hereof by such party.
(c) Titles. The headings appearing at the beginning of the numbered
------
Articles and at the beginning of paragraphs have been inserted for convenience
only and do not constitute any part of this Agreement.
(d) Modifications. No changes, modifications or waivers of any provision
-------------
of this Agreement shall be binding unless evidenced in writing and signed for
and on behalf of both parties by a duly authorized representative.
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(e) Severability. In the event that any provision of this Agreement shall
------------
be determined to be illegal or unenforceable, that provision will be limited or
eliminated to the minimum extent necessary so that this Agreement shall
otherwise remain in full force and effect and enforceable.
(f) Waiver. The failure on the part of any party to exercise or enforce
------
any rights conferred upon it hereunder shall not be deemed to be a waiver of any
such rights nor operated to bar the exercise or enforcement thereof at any time
or times thereof.
(g) No Strict Construction. The language used in this Agreement will be
----------------------
deemed to be the language chosen by the parties to express their mutual intent,
and no rules of strict construction will be applied against any party.
IN WITNESS WHEREOF, Purchaser and PCI have executed this Agreement on the
date first set forth above.
OraPharma, Inc. Packaging Coordinators, Inc.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ W. Xxx Xxxxxxx
----------------------- -----------------------
Name: Xxxxx X. Xxxxxxx Name: W. Xxx Xxxxxxx
Title: EVP & CFO Title: Sr. V.P. Sales & Mktg.
Date: 11-24-00 Date: 11-17-00
-19-
APPENDIX 1
Description Of Product
Product Name: Arestin
-20-
APPENDIX 2
Specifications
See Attached.
-21-
[PCI SERVICES LETTERHEAD]
November 2, 2000
Xx. Xxxxxxx Xxxxxxxxxx
OraPharma, Inc.
000 Xxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Dear Xxxx:
The following are additional prices and specifications associated with the
commercial production and packaging of Arestin (Minocycline PTS):
OraPharma will supply the following:
-----------------------------------
1. Bulk product (1 kg. batch size)
2. Dispenser tips and caps
3. Filling machines (10 active - 2 back-up)
4. Gauge blocks
PCI will supply the following:
-----------------------------
1. Pre-formed pouches
2. Thermoformed tray to hold 12 tips
3. Printed label (affixed to pouch)
4. Printed folding carton
5. Printed insert
6. 4 mg. desiccant packets
Packaging Component specifications as follows:
---------------------------------------------
Item - Pre-formed Pouch
Size - 5.026" x 9.625" finished pouch with recloseable zipper and rounded
corners
Material - .48 mil coated polyester/ .75 mil white LDPE/ 1.0 mil foil/ .75 mil
CRC-1/2.25 mil EVAPEF
Item - Thermoformed Tray
Size - 5 3/8 x 2 x 7/16
Material - .020 Pharmagrade PVC
Item - Printed Carton
Size - 5 3/16 x 1 1/2 x 9 13/16
Material - .018 SBS
Printing - 4 colors & coating
Die - $[*]
Prep & plates - $[*]
____________________________
*Confidential Treatment Requested
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Item - Printed Label
Size - 2 3/4 x 7
Material - 60# semi-gloss/ 40# SCK/AC-34TA (basic label) w/ 1 mil clear
polypropylene overlaminate
Printing - 4 colors
Die - $[*]
Prep & plates - $[*]
Item - Printed Insert
Flat Size - 18 x 7 1/2
Fold Size - 4 1/2 x 7 1/2
Material - 40# paper
Printing - 1 color front, 1 color back
Prep & plates - $[*]
Commercial Production Operation:
-------------------------------
1. Gauge dispenser tips
2. Fill tip with 4 mg. of product and cap
3. Snap 12 tips into thermoformed tray
4. Affix printed label to pouch
5. Insert 1 tray and 2 4 mg. desiccants into preformed pouch and seal
6. Erect carton and insert 2 filled pouches and 1 insert
7. Code carton and pack 10 cartons into corrugated shipper
Quantity & Pricing - See Attachment
-----------------------------------
[*]
Terms are Net 30 days.
Xxxx: if you have any questions regarding this proposal or require additional
information please feel free to call anytime.
Cordially,
PCI Services
/s/ Xxxx Xxxxx
Xxxx Xxxxx
Account Executive
cc: Xxxx Xxxxxxx - President - PCI Services
Xxx Xxxxxxx - Vice President of Sales - PCI Services
Xxxxx Xxxxx - Project Manager - PCI Services
Xxx Xxxxxxx - Vice President & CFO - OraPharma
Xxxxxx Xxxxxx - Controller - OraPharma
Xxx Xxxxxx - Vice President, Product Development & Mftg. - OraPharma
____________________________
* Confidential Treatment Requested
APPENDIX 3
Prices
A. The letter dated November 2, 2000 from Xxxx Xxxxx to Xxxxxxx Xxxxxxxxxx
including the pricing in attachment "OraPharma Cost Improvement Program" dated
10/30/2000. (attachment)
B. For the period from the date of this contract through [*] the price will be
fixed at $[*] per unit.
C. Beginning on [*] the price will be fixed at $[*] per unit. This price will
be reviewed on a quarterly basis beginning on June 1, 2001 to determine if it
can be lowered based on improved production processes or improved production
efficiencies, some of which are described in the letter referenced in this
Appendix 3 Item A.
D. Room charges for [*] will be an aggregate of $[*].
E. After [*] there will be a nonuse room charge of $[*] per day to be charged
in any month when the room is not used for production for [*]. There will be an
allowance of [*] after which the nonuse room charge will apply. In no event will
this nonuse room charge be assessed until after the room has been unused for
[*]. Further, the [*] will be extended if Purchaser is not permitted to use the
room by PCI.
____________________________
* Confidential Treatment Requested
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[PCI SERVICES LETTERHEAD]
November 2, 2000
Xx. Xxxxxxx Xxxxxxxxxx
OraPharma, Inc.
000 Xxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Dear Xxxx:
The following are additional prices and specifications associated with the
commercial production and packaging of Arestin (Minocycline PTS):
OraPharma will supply the following:
-----------------------------------
1. Bulk product (1 kg. batch size)
2. Dispenser tips and caps
3. Filling machines (10 active - 2 back-up)
4. Gauge blocks
PCI will supply the following:
-----------------------------
1. Pre-formed pouches
2. Thermoformed tray to hold 12 tips
3. Printed label (affixed to pouch)
4. Printed folding carton
5. Printed insert
6. 4 mg. desiccant packets
Packaging Component specifications as follows:
---------------------------------------------
Item - Pre-formed Pouch
Size - 5.026" x 9.625" finished pouch with recloseable zipper and rounded
corners
Material - .48 mil coated polyester/ .75 mil white LDPE/ 1.0 mil foil/ .75 mil
CRC-1/2.25 mil EVAPEF
Item - Thermoformed Tray
Size - 5 3/8 x 2 x 7/16
Material - .020 Pharmagrade PVC
Item - Printed Carton
Size - 5 3/16 x 1 1/2 x 9 13/16
Material - .018 SBS
Printing - 4 colors & coating
Die - $[*]
Prep & plates - $[*]
____________________________
* Confidential Treatment Requested
Item - Printed Label
Size - 2 3/4 x 7
Material - 60# semi-gloss/ 40# SCK/AC-34TA (basic label) w/ 1 mil clear
polypropylene overlaminate
Printing - 4 colors
Die - $[*]
Prep & plates - $[*]
Item - Printed Insert
Flat Size - 18 x 7 1/2
Fold Size - 4 1/2 x 7 1/2
Material - 40# paper
Printing - 1 color front, 1 color back
Prep & plates - $[*]
Commercial Production Operation:
-------------------------------
1. Gauge dispenser tips
2. Fill tip with 4 mg. of product and cap
3. Snap 12 tips into thermoformed tray
4. Affix printed label to pouch
5. Insert 1 tray and 2 4 mg. desiccants into preformed pouch and seal
6. Erect carton and insert 2 filled pouches and 1 insert
7. Code carton and pack 10 cartons into corrugated shipper
Quantity & Pricing - See Attachment
-----------------------------------
[*]
Terms are Net 30 days.
Xxxx: if you have any questions regarding this proposal or require additional
information please feel free to call anytime.
Cordially,
PCI Services
/s/ Xxxx Xxxxx
Xxxx Xxxxx
Account Executive
cc: Xxxx Xxxxxxx - President - PCI Services
Xxx Xxxxxxx - Vice President of Sales - PCI Services
Xxxxx Xxxxx - Project Manager - PCI Services
Xxx Xxxxxxx - Vice President & CFO - OraPharma
Xxxxxx Xxxxxx - Controller - OraPharma
Xxx Xxxxxx - Vice President, Product Development & Mftg. - OraPharma
____________________________
* Confidential Treatment Requested
Orapharma Cost Improvement Program
----------------------------------
[*]
____________________________
* Confidential Treatment Requested
OraPharma Projected Annual Volumes
----------------------------------
------------------------------------------------------------------------------
Contract Year Volume (finished cartons)
------------- -------------------------
------------------------------------------------------------------------------
[*] [*]
____________________________
* Confidential Treatment Requested
APPENDIX 4
List of Production Equipment
to be Supplied by OraPharma
A. MFG 18 station intermittent motion rotary pouch handling-filling-sealing
machine
B. Renen Filling Machines (qty 12)
X. Xxxxxxx Toledo Analytical Balance model number AT261 (qty 2)
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