Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
SUPPLY AND DEVELOPMENT AGREEMENT
TABLE OF CONTENTS
PAGE
----
I DEFINITIONS......................................................... 1
1.1 Act........................................................... 1
1.2 Product(s).................................................... 1
1.3 FDA........................................................... 1
1.4 Forecasted Needs.............................................. 1
1.5 Label, Labeled, or Labeling................................... 1
1.6 Market Year................................................... 2
1.7 Packaging..................................................... 2
1.8 Specifications................................................ 2
1.9 Material Safety Data Sheet.................................... 2
1.10 Manufacturing Fee............................................. 2
II PRODUCT MANUFACTURE AND SUPPLY...................................... 2
2.1 Manufacture and Purchase...................................... 2
2.2 Supply of Materials........................................... 3
2.3 Materials Testing............................................. 4
2.4 Material Safety Data Sheets................................... 4
2.5 Commencement of Manufacturing for New Products................ 4
2.6 Purchase Orders............................................... 4
2.7 Rejected Products............................................. 5
2.8 Product Price................................................. 6
III SHIPMENT AND RISK OF LOSS........................................... 6
3.1 Shipment...................................................... 6
3.2 Delivery Terms................................................ 6
3.3 Claims........................................................ 6
IV TERM AND TERMINATION................................................ 7
4.1 Term.......................................................... 7
4.2 Termination................................................... 7
4.3 Payment on Termination........................................ 7
4.4 Survival...................................................... 7
V CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE............... 8
5.1 Certificates of Analysis...................................... 8
5.2 Stability Testing............................................. 8
5.3 Additional Validation Work or Additional Testing.............. 8
5.4 FDA Inspection................................................ 8
5.5 NDA's, ANDA's, & 510(k)'s..................................... 8
VI WARRANTIES.......................................................... 8
6.1 Conformity with Specifications................................ 8
6.2 Compliance with the Act....................................... 9
6.3 Conformity with FDA regulations and cGMP's.................... 9
6.4 Compliance of Packaging and Labeling with Laws and
Regulations................................................ 9
6.5 Access to HARMONY's Facilities................................ 9
6.6 Disclaimer.................................................... 9
VII PRODUCT RECALLS..................................................... 9
VIII FORCE MAJEURE: FAILURE TO SUPPLY.................................... 10
8.1 Force Majeure Events.......................................... 10
8.2 Failure to Supply............................................. 10
IX IMPROVEMENTS........................................................ 10
9.1 Changes by SIRIUS............................................. 10
9.2 Changes by HARMONY............................................ 10
-i-
9.3 Changes by Regulatory Authorities............................. 10
9.4 Obsolete Inventory............................................ 10
9.5 Disposal Costs................................................ 11
X CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS.............. 11
10.1 Confidential Information...................................... 11
10.2 Trademarks and Trade Names.................................... 12
XI RESEARCH & DEVELOPMENT SERVICES..................................... 12
11.1 R&D Services.................................................. 12
11.2 New Product Development....................................... 13
XII INDEMNIFICATION..................................................... 13
12.1 Indemnification by HARMONY.................................... 13
12.2 Indemnification by SIRIUS..................................... 13
12.3 Patent and Other Intellectual Property Rights................. 14
12.4 Conditions of Indemnification................................. 14
12.5 Evidence of Liability Insurance............................... 14
XIII General Provisions.................................................. 14
13.1 Notices....................................................... 14
13.2 Entire Agreement; Amendment................................... 15
13.3 Waiver........................................................ 15
13.4 Obligations to Third Parties.................................. 15
13.5 Assignment.................................................... 15
13.6 Governing Law and Arbitration................................. 15
13.7 Severability.................................................. 16
13.8 Headings, Interpretation...................................... 16
13.9 Counterparts.................................................. 16
13.10 Independent Contractor........................................ 16
SCHEDULE A 18............................................................
SCHEDULE A-4............................................................. 20
SCHEDULE A-5............................................................. 23
-ii-
SUPPLY AND DEVELOPMENT AGREEMENT
This Manufacturing Agreement (the "Agreement") is made as of this 18th day
of September, 2001 by and between Sirius Laboratories, Inc., a Corporation duly
organized and existing under the laws of the State of Illinois with a place of
business at 000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxx Xxxxx, XX 00000 (hereinafter
referred to as "SIRIUS"), and Harmony Laboratories, a North Carolina Corporation
with a place of business at 0000 xxxxx Xxxx Xxxxxx, Xxxxxx, Xxxxx Xxxxxxxx 00000
(hereinafter referred to as "HARMONY").
WITNESSETH:
WHEREAS, SIRIUS is engaged in the distribution and sale of certain
pharmaceutical products; and
WHEREAS, HARMONY is engaged in the manufacture, distribution and sale of
such products and has the capability of manufacturing like products for third
parties; and
WHEREAS, SIRIUS desires HARMONY to manufacture and sell the Products more
specifically described in Schedule A to SIRIUS, and HARMONY desires to do so.
NOW, THEREFORE, in consideration of the mutual covenants hereinafter
expressed, the parties agree as follows:
I DEFINITIONS
1.1 ACT
"Act" means the Federal Food, Drug and Cosmetic Act, as amended, and
regulations promulgated thereunder.
1.2 PRODUCT(S)
"Product(s)" means product(s) as listed in Schedule A manufactured,
packaged, labeled and/or finished by HARMONY to meet the Specifications (as
hereinafter defined).
1.3 FDA
"FDA" means the United States Food and Drug Administration, or any
successor entity thereto.
1.4 FORECASTED NEEDS
"Forecasted Needs" means SIRIUS's estimate of Products to be ordered from
HARMONY for each of the [c.i.] following the [c.i.] in which such estimate is
provided.
1.5 LABEL, LABELED, OR LABELING
"Label", "Labeled", or "Labeling" means all labels and other written,
printed, or graphic matter upon: (i) Product or any container or wrapper
utilized with Product or (ii) any written material accompanying Product.
1.6 MARKET YEAR
"Market Year" means a period of twelve (12) months commencing on the date
the launch of Product manufactured by HARMONY.
1.7 PACKAGING
"Packaging" means all primary containers, cartons, shipping cases, inserts
or any other like material used in packaging, or accompanying, Product.
1.8 SPECIFICATIONS
"Specifications" means the specifications for raw materials and
manufacturing procedures of the Products as agreed to in writing by the Parties
or covered under HARMONY's Standard Operating Procedures ("SOP's"). The
Specifications shall include, without limitation: (i) raw material
specifications (including approved suppliers, art proofs, chemical, micro, and
packaging specifications); (ii) sampling requirements (i.e., lab, chemical, and
micro); (iii) compounding module, including compounding process and major
equipment; (iv) intermediate specifications; (v) packaging module (including
packaging procedures, torque and fill weights); (vi) finished Product
specifications release criteria including HARMONY's Acceptable Quality Limits
("AQL's"); (vii) stability specifications; and (viii) test methods.
Specifications shall be established and/or amended from time to time upon the
written agreement of both HARMONY and SIRIUS via a Product Change Request
("PCR") in accordance with Section IX below.
1.9 MATERIAL SAFETY DATA SHEET
"Material Safety Data Sheet" ("MSDS") means written or printed material
concerning a hazardous chemical which is prepared in accordance with the
regulations promulgated by the Occupational Safety & Health Administration, or
any successor entity thereto.
1.10 MANUFACTURING FEE
"Manufacturing Fee" means the fee paid by SIRIUS to HARMONY for services
required to manufacture and package Products. The Manufacturing Fee is quoted in
single final Product unit increments (i.e. by the bottle or tube.) The
Manufacturing Fee shall include [c.i.] for [c.i.] The Manufacturing Fee does not
include, without limitation, [c.i.]. Except as noted above, these [c.i.] are
[c.i.] and shall be [c.i.] in accordance with Section XI contained herein. In
addition, the Manufacturing Fee does not include [c.i.]. These items are billed
separately in accordance with paragraph 2.8 and 2.2 below.
II PRODUCT MANUFACTURE AND SUPPLY
2.1 MANUFACTURE AND PURCHASE.
Subject to the terms and conditions of this Agreement, HARMONY agrees that
it will manufacture for and provide to SIRIUS, and SIRIUS agrees that it will
purchase from HARMONY, its [c.i.] of each of the Products, identified in
Schedule A attached hereto, as follows:
- From the date of each U.S. Product launch until [c.i.] thereafter,
HARMONY shall manufacture and SIRIUS shall purchase [c.i.];
-2-
- Thereafter, for [c.i.] HARMONY shall manufacture and SIRIUS shall
purchase at least 50% of SIRIUS's annual requirements of such Product;
and
- Thereafter, for [c.i.], HARMONY shall manufacture and SIRIUS shall
purchase [c.i.].
With respect to [c.i.] in which SIRIUS is [c.i.] to purchase [c.i.] from
HARMONY, SIRIUS [c.i.] may purchase from HARMONY and HARMONY shall manufacture
[c.i.].
In the event that [c.i.] does not [c.i.] may, in its sole discretion,
adjust the [c.i.] to [c.i.].
SIRIUS shall pay HARMONY for Products as defined in paragraph 2.7 below.
HARMONY shall manufacture Products in accordance with the Specifications or
pursuant to exceptions approved by SIRIUS, and in sufficient quantity to meet
SIRIUS's Forecasted Needs for the length of this Agreement.
2.2 SUPPLY OF MATERIALS.
(a) If SIRIUS is to supply any material for manufacture of Products as
set forth under this Section, SIRIUS shall notify HARMONY, in writing,
specifying which materials it intends to supply. SIRIUS shall provide HARMONY
with said material [c.i.] along with Certificates of Analysis and MSDS sheets
relating to same, [c.i.] to HARMONY's scheduled production of Product requiring
said material and in sufficient amounts for HARMONY's manufacture of Product
[c.i.] necessary to support [c.i.] or the [c.i.] whichever [c.i.]. SIRIUS
supplied material [c.i.] shall be either subject to [c.i.] or [c.i.]. All SIRIUS
supplied material shall be shipped to HARMONY [c.i.]. In the event SIRIUS ships
or causes to ship such material [c.i.], HARMONY, [c.i.], may either [c.i.] or
[c.i.], which shall be [c.i.]. HARMONY is hereby authorized by SIRIUS to [c.i.]
any portion of SIRIUS supplied material [c.i.]. [c.i.] shall be responsible for
the supply and quality of said materials. [c.i.] shall be responsible for [c.i.]
and [c.i.] of [c.i.] material [c.i.]. For each lot of materials supplied by
SIRIUS, HARMONY shall perform the quality control and inspection tests as agreed
to in the Specifications unless SIRIUS and HARMONY have made arrangements in
writing for Pre-Approved material. [c.i.] shall have the right to reject any
Pre-Approved material which [c.i.] in accordance with paragraph 2.3 below.
HARMONY warrants that it will maintain, for the benefit of SIRIUS, complete and
accurate records of the inventory of all such SIRIUS supplied raw materials.
HARMONY will use [c.i.] to avoid the commingling of SIRIUS supplied raw
materials with any other raw materials and to avoid use of SIRIUS raw materials
obtained pursuant to this Agreement for any purpose not [c.i.] to the completion
of this Agreement. If requested by SIRIUS, HARMONY will provide to SIRIUS a
[c.i.] report limited to [c.i.] inventory balance of each SIRIUS supplied/owned
material stored at HARMONY. This reporting will be supplied exclusively on
[c.i.].
(b) HARMONY shall be responsible for supply, [c.i.], of all other
commodities necessary for the manufacture of Products which are not supplied by
SIRIUS pursuant to Section 2.2 above.
(c) SIRIUS shall provide HARMONY with Specifications (including art
proofs) for Packaging and Labeling, and HARMONY shall purchase, [c.i.] Packaging
and Labeling in accordance with the Specifications.
(d) All HARMONY supplied materials [c.i.] on the respective [c.i.] for
Product, into which the material was converted, and [c.i.], all in accordance
with the provisions of paragraph 2.7 below.
-3-
2.3 MATERIALS TESTING.
All raw materials and packaging supplies shall, when received by HARMONY,
be submitted to analysis and evaluation in accordance with HARMONY's SOP's to
determine whether or not said materials meet the Specifications. The [c.i.]
shall be borne by [c.i.], except for [c.i.]. HARMONY agrees to maintain and,
[c.i.] make available records of all such analyses and evaluations.
2.4 MATERIAL SAFETY DATA SHEETS.
Prior to HARMONY's receipt and testing, and as a condition precedent of any
testing or formulation work by HARMONY pursuant to this Agreement, SIRIUS shall
provide MSDS sheets to HARMONY for Products and all components necessary for the
manufacture of Products, except that HARMONY shall be responsible for MSDS
sheets of components purchased by HARMONY [c.i.] pursuant to this Agreement. Any
components or Products requiring disposal shall be presumed hazardous unless
otherwise provided in the MSDS information provided.
2.5 COMMENCEMENT OF MANUFACTURING FOR NEW PRODUCTS.
No later than [c.i.] the commencement of the initial Market Year of a new
Product, SIRIUS agrees to notify HARMONY of its delivery requirements, including
[c.i.], for the [c.i.] and shall provide its Forecasted Needs for the first
Market Year in order to ensure timely delivery of Product for initial sale and
marketing.
2.6 PURCHASE ORDERS.
(a) SIRIUS agrees to purchase from HARMONY all Products manufactured
for SIRIUS by HARMONY in accordance with the terms of this Agreement to the
extent such Products meet the Specifications or exceptions approved by SIRIUS.
(b) Products shall be ordered by SIRIUS by the issuance of separate,
pre-numbered purchase orders in increments of [c.i.]. HARMONY will supply SIRIUS
with the estimated batch yield of each Product. [c.i.] HARMONY may update these
estimates based upon actual manufacturing experience.
(c) At the initiation of the first Market Year for each Product and
thereafter at the end of [c.i.] SIRIUS shall provide HARMONY with specific data
as to its Forecasted Needs for such Product for the [c.i.]. It is understood and
agreed that with respect to any forecasts issued to HARMONY by SIRIUS pursuant
to the terms hereof, the forecast for [c.i.] thereof shall constitute a firm
order for Products, regardless of receipt of SIRIUS's actual purchase order, and
shall specify the requested delivery dates thereof and HARMONY shall meet those
dates, [c.i.]. HARMONY may, [c.i.] produce and deliver Product up to [c.i.] to
the requested delivery date in order to accommodate fluctuations in production
demands. The [c.i.] of the period addressed in the forecast shall be utilized by
HARMONY for purposes of raw material acquisition on behalf of SIRIUS and HARMONY
production planning. Although HARMONY shall [c.i.] the raw material inventory
purchased on behalf of SIRIUS, certain raw materials may have long lead times,
require a minimum order quantity, and/or present a substantial economic order
quantity. Therefore, HARMONY may order the [c.i.] to support up to [c.i.] of
SIRIUS's Forecasted Needs, or the [c.i.], whichever is [c.i.]. Should [c.i.]
subsequently [c.i.] will be [c.i.] for any [c.i.]. Any such material which is
[c.i.] of that required to support up to [c.i.] of SIRIUS's Forecasted Needs may
be subject to [c.i.] and [c.i.] according to the terms provided in Section 2.8
below.
-4-
(d) SIRIUS shall issue written purchase orders for Products to HARMONY
at least [c.i.] to the requested delivery date if the requirements are at or
below [c.i.] of the most recently supplied Forecasted Needs for such period, and
at least [c.i.] to the requested delivery date if the requirements exceed
[c.i.].
(e) SIRIUS's purchase orders shall designate the desired quantities of
Products, delivery dates and destinations. HARMONY shall fill and ship all
orders of Products in accordance with SIRIUS's instructions. If SIRIUS's
purchase order is not received in accordance to paragraph 2.5 (d) above, then
HARMONY will use [c.i.] to meet SIRIUS's requested delivery dates. However,
HARMONY will only be required to meet the delivery dates confirmed to SIRIUS by
HARMONY, in writing, so long as said dates are [c.i.] from receipt of SIRIUS's
purchase order. A Purchase Order may specify up to [c.i.] shipping destinations
per batch of Product. Additional destinations can be accommodated only upon
[c.i.].
2.7 REJECTED PRODUCTS.
(a) SIRIUS may reject any Product which fails to meet the
Specifications. SIRIUS shall, within [c.i.] after its receipt of any shipment of
Product and related Certificate of Analysis of Product batch (as described in
paragraph 5.1 hereof), notify HARMONY in writing of any claim relating to
rejected Product batch and, failing such notification, shall be deemed to have
accepted such Product batch. Such notice to HARMONY shall [c.i.] the ways in
which the Product batch failed to perform to Specifications. HARMONY shall have
an opportunity to [c.i.] said Product batch and dispute SIRIUS rejection
according to the provisions provided in this Section 2.7. All Products shall be
submitted to inspection and evaluation in accordance with HARMONY's SOP's to
determine whether or not said Products meet the Specifications. As to any such
Product batch (including phases of or complete batches of bulk product) which is
determined by [c.i.] to fail the Specifications and may which is rejected by
[c.i.] ("Rejected Product"), HARMONY shall [c.i.] [c.i.]. If requested, HARMONY
shall [c.i.] with SIRIUS for [c.i.] of Rejected Product.
(b) In the event of a conflict between the test results of HARMONY and
the test results of SIRIUS with respect to any shipment of Product batch, sample
of such Product batch shall be submitted by [c.i.] to an independent laboratory
[c.i.] for testing against the Specifications under procedures employed in the
Specifications. The fees and expenses of such laboratory testing shall be
[c.i.]. If results from the independent laboratory are inconclusive, final
resolution will be settled in accordance with paragraph 13.6 (b) below.
(c) For the [c.i.] registration batches and [c.i.] validation batches
of a Product produced by HARMONY, or in the event a Rejected Product is due to
SIRIUS supplied information, formulations or materials, [c.i.] shall bear [c.i.]
costs [c.i.] for Rejected Product including cost of [c.i.]. In the event that
the [c.i.] registration batches or [c.i.] validation batches of Product fails to
meet specifications due to HARMONY's gross negligence, [c.i.] shall bear [c.i.]
of [c.i.] for the Rejected Product including [c.i.]. Thereafter, in the event a
Rejected Product is due to the failure of HARMONY to comply with applicable
written procedures, and such failure affects the marketability of the Product,
[c.i.] shall bear [c.i.] of the [c.i.]. In the event the Product does not meet
final specifications, but such failure is not due to either SIRIUS supplied
information or HARMONY's failure to follow written procedures, [c.i.] shall bear
[c.i.] with [c.i.] shall bear [c.i.]. Destruction of rejected Product shall be
in accordance with all applicable laws and regulations and [c.i.] shall
indemnify [c.i.] for any liability, costs or expenses, including attorney's fees
and court costs, relating to a failure to dispose of such Product in accordance
with such laws and regulations. [c.i.] shall also provide to [c.i.] all
manifests and other applicable evidence of proper destruction as may be
requested by applicable law.
-5-
2.8 PRODUCT PRICE.
(a) The initial Manufacturing Fees for each Product to be paid by
SIRIUS to HARMONY are listed in Schedule A. The parties hereto agree that the
Manufacturing Fees for each Product set out in Schedule A shall be [c.i.]. If
the parties are [c.i.] for any Product then this Agreement, effective [c.i.],
shall continue in force with [c.i.] until such time as [c.i.]. Prices for new
Products or new Product sizes, not initially included in Schedule A, [c.i.] and
[c.i.] and [c.i.] shall [c.i.] with respect to prices at the time said new
Products or new Product sizes are added to Schedule A.
(b) Price of materials for each Product to be paid by SIRIUS to
HARMONY ("Quoted Price of Material") shall become a part of Schedule A within
[c.i.] of commencement of regular production of the applicable Product upon
written notice delivered to SIRIUS by HARMONY. Quoted Price of Material is
calculated as [c.i.]. Quoted Price of Material shall be invoiced on the invoice
for the Product into which the material was converted. Quoted Price of Material
does not include, without limitation, [c.i.]. These items will be invoiced to
SIRIUS [c.i.]. HARMONY's Quoted Price of Material will be adjusted [c.i.] and
Schedule A shall be amended accordingly. In the event, however, the cost of a
raw material [c.i.], HARMONY shall notify SIRIUS and, with [c.i.], [c.i.] for
said material to SIRIUS to compensate for the [c.i.]. Upon written request,
HARMONY shall provide to SIRIUS the [c.i.].
(c) Payment of all amounts due hereunder shall be made in U.S.
dollars, [c.i.], after date of HARMONY's invoice therefor. Invoices for
Manufacturing Fees shall be generated upon [c.i.] (i) [c.i.] or (ii) [c.i.]
Product from HARMONY; [c.i.]. Total invoice shall be equal to the quantity of
Product [c.i.] times the Total Price per unit, [c.i.], as listed in Schedule A.
A [c.i.] of [c.i.] of total invoice can [c.i.] each month [c.i.]. If any invoice
has not been paid following the expiration of [c.i.], HARMONY, at its sole
discretion, has the right to [c.i.] on future orders and [c.i.] of Product if
SIRIUS's account is not current. Such [c.i.] shall not be considered a breach of
this Agreement by HARMONY. In the event [c.i.], a [c.i.] [c.i.] paid by SIRIUS
to HARMONY will be required prior to HARMONY ordering raw materials. In
addition, [c.i.] Manufacturing Fee [c.i.] prior to HARMONY manufacturing any
Product and the [c.i.] must be [c.i.] prior to shipment.
III SHIPMENT AND RISK OF LOSS
3.1 SHIPMENT.
Shipment of Product shall be in accordance with whatever means SIRIUS
instructs, provided that shipment is made in accordance with all relevant
statutory requirements. Product will be shipped to SIRIUS or its designee
immediately upon release, [c.i.]. At SIRIUS's request, HARMONY may, [c.i.] hold
Product in HARMONY's Warehouse [c.i.]. Product held at HARMONY will be [c.i.] in
accordance with paragraph 2.7 (c) above.
3.2 DELIVERY TERMS.
The purchase price of Products in Schedule A hereof shall be [c.i.]. [c.i.]
will bear [c.i.], or [c.i.], as well as [c.i.].
3.3 CLAIMS.
The weights, tares and tests affixed by HARMONY's invoice shall govern
unless established to be incorrect. Claims relating to quantity, weight and loss
or damage to any
-6-
Product sold under this Agreement shall be waived by SIRIUS unless made within
[c.i.] [c.i.] of receipt of Product by SIRIUS.
IV TERM AND TERMINATION
4.1 TERM.
This Agreement shall commence on the first day of the month following the
mutual signing of this document and will continue until the expiration of the
Fifth (5th) Market Year, individually, for each respective Product as identified
along with its term in Schedule A, unless sooner terminated pursuant to
paragraphs 4.2 or 8.2 below. This Agreement may be extended by mutual written
agreement between both parties and Schedule A shall be amended accordingly to
reflect extended terms. In the absence of a written agreement to extend this
Agreement, receipt and written confirmation of acceptance by HARMONY of SIRIUS's
purchase order for Products beyond the term of this Agreement shall constitute
extension of this Agreement as it applies to the accepted purchase order with
all other terms and conditions of this Agreement in full effect except that the
term shall only be through completion of the accepted purchase order.
4.2 TERMINATION.
This Agreement may be terminated at any time upon the occurrence of either
of the following events:
(a) The failure of either party to comply with its obligations herein,
which failure is not remedied within [c.i.] [c.i.] after written notice thereof.
(b) Notice by either party to the other upon the insolvency or
bankruptcy of the other party.
4.3 PAYMENT ON TERMINATION.
In the event of the termination or cancellation of this Agreement for any
reason other than HARMONY's breach hereof, and without prejudice to any other
rights and remedies available to HARMONY hereunder, SIRIUS agrees [c.i.] for any
[c.i.] [c.i.], if said orders are [c.i.] and [c.i.] by supplier, (b) for [c.i.]
commenced by HARMONY, and (c) for [c.i.] in connection with the performance of
this Agreement ((a), (b), and (c) being refered to collectively as the [c.i.].
With respect to any [c.i.], HARMONY shall [c.i.] SIRIUS [c.i.] of such [c.i.]
and [c.i.]. Within [c.i.] of termination and at SIRIUS's written request,
HARMONY shall furnish SIRIUS with a [c.i.] of all [c.i.], and shall ship [c.i.]
and the applicable invoice therefor to SIRIUS at [c.i.] [c.i.] and per SIRIUS's
instructions. [c.i.] shall [c.i.] upon reciept.
4.4 SURVIVAL.
Termination of this Agreement under paragraph 4.2 or due to expiration or
cancellation shall not relieve either party of obligations or liability for
breaches of this Agreement incurred prior to or in connection with termination,
expiration or cancellation. Sections VI, VII, IX, X, XI and XII hereof shall
survive the termination or cancellation of this Agreement for any reason.
-7-
V CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
5.1 CERTIFICATES OF ANALYSIS.
HARMONY shall test each lot of Product purchased pursuant to this Agreement
before delivery to SIRIUS. Each Certificate of Analysis shall set forth the
items tested, specifications and test results for each lot delivered. HARMONY
shall send one (1) Certificate of Analysis to SIRIUS at the time of the release
of Product. Extraordinary reporting or documentation, outside this Agreement,
[c.i.].
5.2 STABILITY TESTING.
HARMONY shall perform its standard stability test program as defined in
HARMONY's SOP's or as separately agreed to in accordance with a PCR for each of
the Products contained herein. SIRIUS shall receive a copy of HARMONY's Annual
Report for each Product as long as [c.i.] and for as long as [c.i.]. If SIRIUS
elects to perform its own stability testing on Product, SIRIUS agrees to provide
HARMONY with a copy of the results from such testing [c.i.].
5.3 ADDITIONAL VALIDATION WORK OR ADDITIONAL TESTING.
It is agreed between the parties hereto that if HARMONY is required by
regulatory authority to perform additional validation studies subsequent to
validation performed on initial registration batches or additional testing in
order to legitimately continue to engage in the development and manufacture of
the Product for SIRIUS, HARMONY and SIRIUS shall [c.i.] to reach an agreement on
a written Project Protocol in order to satisfy said requirement. In the event
the parties cannot reach agreement on a written Project Protocol addressing the
regulatory requirement, [c.i.].
5.4 FDA INSPECTION.
HARMONY shall advise SIRIUS within [c.i.] if an authorized agent of the FDA
or other governmental agency visits HARMONY's manufacturing facility and
requests or requires information or changes which [c.i.] or which [c.i.]. FDA
audit time specific to Products will be [c.i.].
5.5 NDA'S, ANDA'S, & 510(K)'S.
SIRIUS agrees to provide HARMONY [c.i.] with copies of any sections of
NDA's, ANDA's, 510(k)'s or other regulatory filings applicable to the Products
manufactured and/or tested by HARMONY, and copies of any changes in or updates
of same as they, from time to time, hereafter occur.
VI WARRANTIES
6.1 CONFORMITY WITH SPECIFICATIONS.
HARMONY warrants that all Products sold and delivered pursuant to this
Agreement will have been manufactured in accordance with the Specifications for
the finished goods at the time of release or pursuant to exceptions approved by
SIRIUS at the time of manufacture and shipment.
-8-
6.2 COMPLIANCE WITH THE ACT.
[c.i.] shall bear [c.i.] for the validity of all test methods and
appropriateness of all Specifications, except that [c.i.] shall bear
responsibility for those test methods and Specifications developed by [c.i.]. In
addition, [c.i.] shall bear [c.i.] for all regulatory approvals, filings, and
registrations and adequacy of all validation, stability, and preservative
efficacy studies, except that [c.i.] shall bear [c.i.] for adequacy of all
validation, stability, and preservative effectiveness studies performed by
[c.i.]. SIRIUS further warrants that it has obtained any and all necessary
approvals from all applicable regulatory agencies necessary to manufacture and
distribute all Products under this Agreement.
6.3 CONFORMITY WITH FDA REGULATIONS AND CGMP'S.
Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof,
HARMONY warrants that all Products manufactured, held for sale, sold and shipped
pursuant to this Agreement shall have been manufactured and shipped by HARMONY
in compliance with applicable FDA regulations and current Good Manufacturing
Practices as that term is defined under the Act.
6.4 COMPLIANCE OF PACKAGING AND LABELING WITH LAWS AND REGULATIONS.
SIRIUS warrants that all Specifications, Labeling copy and artwork
approved, designated or supplied by SIRIUS shall be in compliance with all
applicable laws and governmental regulations. Compliance with all federal,
state, and local laws and regulations concerning Specifications, Packaging and
Labeling [c.i.] shall be the [c.i.], provided that [c.i.] purchases such
Packaging and Labeling as provided in paragraph 2.2 (c) hereof. SIRIUS hereby
represents and warrants to HARMONY that all SIRIUS [c.i.], and agrees to [c.i.]
for any [c.i.] [c.i.] by any of them in connection therewith.
6.5 ACCESS TO HARMONY'S FACILITIES.
SIRIUS shall have access to HARMONY's facilities at [c.i.] for the [c.i.]
HARMONY's compliance with current Good Manufacturing Practices and the Act. Such
access shall in no way give SIRIUS the right to any of HARMONY's confidential or
proprietary information. Further, [c.i.] shall be limited to [c.i.] per calendar
year and [c.i.] employees of SIRIUS who are subject to the same requirements of
confidentiality as SIRIUS.
6.6 DISCLAIMER.
[c.i.]
VII PRODUCT RECALLS
In the event (i) any government authority issues a request, directive or
order that Product be recalled, or (ii) a court of competent jurisdiction orders
such a recall, or (iii) HARMONY reasonably determines after consultation with
SIRIUS that the Product should be recalled because the Product does not conform
to Specifications at the time of shipment by HARMONY, or (iv) SIRIUS reasonably
determines after consultation with HARMONY that the Product should be recalled
for any reason, the parties shall take all appropriate corrective actions
reasonably requested by the other party hereto or by any government agency. In
the event that such recall results [c.i.] under this Agreement, [c.i.] shall be
responsible for the expenses of the recall. In the event the recall results from
[c.i.] under this Agreement, [c.i.] shall be responsible for the expenses of the
recall. For the purposes of this Agreement, the expenses of the recall shall be
the expenses of [c.i.].
-9-
VIII FORCE MAJEURE: FAILURE TO SUPPLY
8.1 FORCE MAJEURE EVENTS.
Failure of either party to perform its obligations under this Agreement
shall not subject such party to any liability to the other if such failure is
caused by acts such as, but not limited to, acts of God, fires, explosion,
flood, drought, war, riot, sabotage, embargo, strikes, compliance with any court
order or regulation of any government entity acting with color of right or by
any other cause beyond the reasonable control of the parties, whether or not
foreseeable.
8.2 FAILURE TO SUPPLY.
If HARMONY fails to supply all or part of any shipment of Products ordered
by SIRIUS within [c.i.] the delivery date specified on the applicable purchase
order for such shipment, which shall be in accordance with paragraph 2.5 hereof,
SIRIUS at its sole discretion, may require HARMONY to supply the undelivered
Products at a future date [c.i.].
IX IMPROVEMENTS
9.1 CHANGES BY SIRIUS.
If SIRIUS at any time requests a change to Product and [c.i.] such change
is reasonable with regard to Product manufacture; (i) such change shall be
incorporated within the Master Batch Record and/or Specifications via a written
PCR reviewed signed by both HARMONY and SIRIUS; (ii) HARMONY shall adjust,
[c.i.] the price of Product, if necessary, and Schedule A shall be amended
accordingly; and (iii) SIRIUS shall [c.i.] HARMONY [c.i.] including, but not
limited to, any [c.i.], charged at [c.i.] in accordance with Section XI
contained herein.
9.2 CHANGES BY HARMONY
HARMONY agrees that any changes developed by HARMONY, which may be
incorporated into the Product shall require the written approval of SIRIUS via a
PCR prior to such incorporation. At the time of such incorporation, such changes
shall become part of the Specifications. It is also agreed that any regulatory
filings incident to any such change shall be the [c.i.].
9.3 CHANGES BY REGULATORY AUTHORITIES.
HARMONY agrees that any changes required by regulatory authority, shall be
incorporated into the Product as evidenced by the written approval of SIRIUS via
a PCR prior to such incorporation. At the time of such incorporation, such
changes shall become part of the Specifications. If HARMONY is required by
regulatory authority to perform validation studies for purposes of validating
new manufacturing process or cleaning procedures or new raw material and
finished Product assay procedures with respect to Product in order to continue
to engage in the manufacture of said Product for SIRIUS, such studies shall be
conducted in accordance with paragraph 5.3 herein. Due to said changes, HARMONY
shall [c.i.]. Such [c.i.] shall be [c.i.] which shall not be [c.i.] and, if
necessary, Schedule A shall be amended accordingly.
9.4 OBSOLETE INVENTORY.
Any SIRIUS-specific inventory including, but not limited to, [c.i.]
rendered obsolete as a result of [c.i.] changes requested by SIRIUS or by
changes [c.i.] shall be [c.i.], provided that such
-10-
inventory was purchased [c.i.]. At such time and unless otherwise agreed by
HARMONY, HARMONY will ship the obsolete inventory to SIRIUS for destruction by
SIRIUS. [c.i.] shall bear [c.i.] of all destruction costs related to said
obsolete inventory. The destruction shall be in accordance with all applicable
laws and regulations and SIRIUS shall indemnify HARMONY for any [c.i.] relating
to SIRIUS's failure to dispose of such inventory in accordance with such laws
and regulations. SIRIUS shall also provide HARMONY with all manifests and other
applicable evidence of proper destruction as may be requested by HARMONY or
required by applicable law. If HARMONY does not receive disposition instructions
from SIRIUS within [c.i.], obsolete inventory remaining at HARMONY's facilities
may be [c.i.].
9.5 DISPOSAL COSTS.
HARMONY reserves the right to [c.i.], related to manufacture of the
Products, unless [c.i.] relates to nonconforming batches due to the failure of
HARMONY to follow established written procedures.
X CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS
10.1 CONFIDENTIAL INFORMATION.
All confidential information furnished by SIRIUS to HARMONY, or by HARMONY
to SIRIUS, during the term of this Agreement, shall be kept confidential by the
party receiving said confidential information, except for purposes authorized by
this Agreement, and shall not be disclosed to any person or firm, unless
previously authorized in writing to do so, for a period of not less than [c.i.]
following the date of disclosure. The party receiving said confidential
information may, however, disclose the same to its responsible officers and
employees who require said information for the purposes contemplated by this
Agreement, provided that said officers and employees shall have assumed like
obligations of confidentiality. It is understood that all confidential
information provided by either party shall be identified or marked as such. Any
oral communications which are to be considered confidential shall be reduced to
writing and identified as confidential within [c.i.] after disclosure.
Any other provisions hereof to the contrary notwithstanding, it is
expressly understood and agreed by the parties hereto that the obligations of
confidence and nonuse herein assumed shall not apply to any information which:
(1) is at the time of disclosure or thereafter so becomes a part of the
public domain; or
(2) was otherwise in the receiving party's lawful possession prior to
disclosure as shown by its written record; or
(3) is hereafter disclosed to the receiving party by a third party
purporting not to be in violation of an obligation of confidentiality
to the disclosing party relative to said information; or
(4) is by mutual agreement of the parties hereto released from a
confidential status; or
(5) is required to be disclosed pursuant to regulatory or legal
requirements.
It is, further, understood and agreed that HARMONY manufactures products
for itself and third parties, [c.i.].
-11-
10.2 TRADEMARKS AND TRADE NAMES.
(a) Each party hereby acknowledges that it does not have, and shall
not acquire, any interest in any of the other party's trademarks or trade names
unless otherwise expressly agreed to in writing.
(b) Each party agrees not to use any trade names or trademarks of the
other party, except as specifically authorized by the other party in writing
both as to the names or marks which may be used and as to the manner and
prominence of use.
XI RESEARCH & DEVELOPMENT SERVICES
11.1 R&D SERVICES.
(a) From time to time, SIRIUS may request, in writing, that HARMONY
evaluate, develop, manufacture, test and/or provide price quotations for certain
new items which may become Products (hereinafter referred to as "Research
Products") on behalf of SIRIUS. Upon receipt of such a request, HARMONY shall
determine, [c.i.] whether it desires to perform such services for SIRIUS. If
HARMONY elects to perform such services, HARMONY shall so notify SIRIUS within
[c.i.] of its receipt of SIRIUS's request. To the extent that HARMONY agrees to
perform any services hereunder for SIRIUS, HARMONY shall only be obligated to
[c.i.] and to [c.i.] to accomplish the desired results as outlined in a mutually
agreed upon Project Protocol. Nothing herein shall obligate HARMONY to achieve
any specific results and HARMONY makes no warranties or representations that it
will be able to achieve the desired results.
(b) Should HARMONY agree to perform any services hereunder, HARMONY
shall submit a written development proposal in the form of a Project Protocol to
SIRIUS identifying [c.i.]. [c.i.] shall include, but not be limited to, [c.i.].
If this [c.i.] is acceptable to SIRIUS and SIRIUS so notifies HARMONY by
approving the Project Protocol in writing, HARMONY shall begin work as outlined
in the Protocol. It is understood between both parties that, during any
development project, unforeseen circumstances may evolve, including, but not
limited to, termination of any further activity due to unacceptable results,
significant reevaluation due to marginal results, etc. HARMONY will promptly
notify SIRIUS of any such unforeseen circumstances before proceeding at which
time SIRIUS and HARMONY may mutually agree to amend, completely revise or
terminate the Project Protocol. [c.i.] will be obligated to [c.i.].
(c) [c.i.] involved will be billed to SIRIUS [c.i.]. The foregoing
development costs shall be paid to HARMONY in accordance with [c.i.] procedures
regardless of whether HARMONY is able to accomplish the results which SIRIUS
requested. All invoices shall be paid by SIRIUS in accordance with paragraph 2.7
above. On or before [c.i.] of the development of a finished product prototype
(which shall include final primary container selection filled with Research
Product), HARMONY will provide an [c.i.]. HARMONY may also provide an [c.i.],
should specifications be known for these items at such time. The [c.i.] shall
automatically be adjusted [c.i.] based upon [c.i.].
(d) In consideration of its expertise in the design and manufacture of
the Research Products, and its familiarity with the component materials best
suited to the manufacture of the Research Products, [c.i.] shall be responsible
for the acquisition of selected components of the Research Products. All raw
materials delivered to [c.i.] and [c.i.] in accordance with paragraph 11.1 (c)
of this Agreement are the sole and exclusive property of SIRIUS.
-12-
(e) Any SIRIUS-specific inventory including, but not limited to,
[c.i.] shall be either shipped to SIRIUS or destroyed, which ever SIRIUS so
directs. SIRIUS shall bear [c.i.] of all [c.i.] related to said obsolete
inventory. In the event SIRIUS elects to destroy obsolete inventory, the
destruction shall be in accordance with all applicable laws and regulations and
[c.i.] for any [c.i.] relating to SIRIUS's failure to [c.i.]. SIRIUS shall also
provide HARMONY with all manifests and other applicable evidence of proper
destruction as may be requested by HARMONY or required by applicable law. If
HARMONY does not receive disposition instructions from SIRIUS within [c.i.] from
date of obsolescence, [c.i.] remaining at HARMONY's facilities [c.i.].
(f) HARMONY warrants that it will perform services on all Research
Projects in accordance with mutually-acceptable terms, conditions and time lines
of the Project Protocol and furthermore, will adhere to relevant Good Laboratory
Practices and Good Manufacturing Practices of the U.S. Food and Drug
Administration.
11.2 NEW PRODUCT DEVELOPMENT.
In addition to the foregoing, if from time to time, HARMONY develops a new
Research Product for SIRIUS and SIRIUS elects to market, sale, license, or
transfer such Product, HARMONY shall have the right to manufacture the
percentages of SIRIUS'S annual requirements of such Product according to the
schedule listed in Paragraph 2.1 above. It is agreed that such manufacturing
requirements shall be binding upon any assignee, licensee, or other third party
marketing the new Research Product. The price which SIRIUS (or any applicable
third party) shall pay to HARMONY for such Product shall be based upon the
[c.i.] provided in good faith by HARMONY under paragraph 11.1 (c) above subject
to revision for final packaging configuration and final negotiation between
HARMONY and SIRIUS, plus [c.i.] incurred by HARMONY for the Product all in
accordance with paragraph 2.7 herein.
XII INDEMNIFICATION
12.1 INDEMNIFICATION BY HARMONY.
HARMONY will indemnify and hold SIRIUS, its officers, directors, employees
and agents, harmless from and against any and [c.i.] resulting from any [c.i.]
made or suits brought against SIRIUS which arise from [c.i.]. In addition, to
the extent covered by liability insurance referred to in Paragraph 12.5 below,
HARMONY will defend, indemnify and hold harmless SIRIUS, its officers,
directors, employees and agents against any and [c.i.]. Upon the filing of any
such claim or suit, SIRIUS shall immediately notify HARMONY thereof and shall
permit HARMONY, [c.i.] to handle and control such claim or suit; provided,
however, that SIRIUS may, [c.i.], retain such additional attorneys as it may
deem necessary, which attorneys will be permitted by HARMONY and its attorneys
to reasonably observe and/or participate in all aspects of the defense of such
claims or suits. [c.i.]
12.2 INDEMNIFICATION BY SIRIUS.
SIRIUS will indemnify and hold HARMONY its officers, directors, employees
and agents harmless from and against [c.i.] resulting from any [c.i.] HARMONY
which arise out of the [c.i.] of an item or items of the Products which HARMONY
manufactured hereunder and which at the time of delivery to SIRIUS [c.i.]. In
addition, to the extent covered by liability insurance referred to in Paragraph
12.5 below, SIRIUS will defend, indemnify and hold harmless HARMONY, its
officers, directors, employees and agents against [c.i.] in [c.i.] any [c.i.] on
the part of SIRIUS. Upon the filing of any such claim or suit, HARMONY shall
immediately notify SIRIUS thereof and shall permit SIRIUS, [c.i.] to handle and
control such claim or suit. Upon
-13-
the filing of any such claim or suit, HARMONY shall immediately notify SIRIUS
thereof and shall permit SIRIUS, [c.i.] to handle and control such claim or
suit; provided, however, that HARMONY may, [c.i.] retain such additional
attorneys as it may deem necessary, which attorneys will be permitted by SIRIUS
and its attorneys to reasonably observe and/or participate in all aspects of the
defense of such claims or suits. [c.i.]
12.3 PATENT AND OTHER INTELLECTUAL PROPERTY RIGHTS.
(a) [c.i.] further warrants that [c.i.] or [c.i.] will not [c.i.] and
that [c.i.] will indemnify, defend and hold HARMONY harmless from any damage,
judgment, loss, cost or other reasonable expense (including reasonable
attorney's fees) arising from claims that [c.i.] and any other [c.i.] used
[c.i.] in connection with [c.i.] or other [c.i.] rights of a third party.
(b) [c.i.] shall indemnify and hold [c.i.] harmless from all costs,
damages and expense (including reasonable attorney's fees) arising out of any
suit or action brought against [c.i.] based upon a claim that [c.i.] or other
[c.i.] rights.
12.4 CONDITIONS OF INDEMNIFICATION.
If either party expects to seek indemnification from the other under
paragraphs 12.1, 12.2, or 12.3 hereof, it shall promptly give notice to the
other party of any such claim or suit threatened, made or filed against it which
forms the basis for such claim of indemnification and shall cooperate fully with
the other party in the defense of all such claims or suits. No settlement or
compromise shall be required to be indemnified by any party unless such
indemnifying party gives its prior written consent to such settlement or
compromise.
12.5 EVIDENCE OF LIABILITY INSURANCE.
It is further agreed that each party hereto shall furnish to the other
evidence of products and contractual liability insurance coverage affording not
less than [c.i.] [c.i.] each occurrence combined single limit, bodily
injury/property damage and [c.i.] aggregate liability limits. Each insurer shall
name the other as an additional insured, as their interests may appear. Such
evidence of insurance coverage can be in the form of the original policy or
Certificate of Insurance which shall provide that the insurer has assumed the
liability as provided for herein. In addition, such insurers shall warrant that
such insurance will not be changed or canceled without at least [c.i.] prior
written notice to the respective indemnities.
The parties agree that upon first approval by FDA for commercialization of
any Sirius Products covered by this Agreement, insurance coverage will be
reevaluated and, if necessary adjusted [c.i.].
XIII GENERAL PROVISIONS
13.1 NOTICES.
Any notices permitted or required by this Agreement shall be sent by telex
or fax or by certified or registered mail and shall be effective the earlier of
the date received or three (3) days after deposit in the U.S. mail, if sent and
addressed as follows or to such other address as may be designated by either
party in writing:
If to HARMONY: HARMONY Laboratories, Ltd.
Attention: President
X.X. Xxx 00
-14-
0000 Xxxxx Xxxx Xxxxxx
Xxxxxx, XX 00000
If to SIRIUS: Sirius Laboratories, Inc.
Attention: Chief Executive Xxxxxxx
Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxx Xxxxx, XX 00000
13.2 ENTIRE AGREEMENT; AMENDMENT.
The parties hereto acknowledge that this document sets forth the entire
agreement and understanding of the parties and supersedes all prior written or
oral agreements or understandings with respect to the subject matter hereof, and
shall supersede any conflicting portions of HARMONY's quotation, acknowledgment
and invoice forms and SIRIUS's Purchase Order and other written forms. No
modification of any of the terms of this Agreement, or any amendments thereto,
shall be deemed to be valid unless in writing and signed by the party against
whom enforcement is sought. No course of dealing or usage of trade shall be used
to modify the terms and conditions herein.
13.3 WAIVER.
No waiver by either party of any default shall be effective unless in
writing, nor shall any such waiver operate as a waiver of any other default or
of the same default on a future occasion.
13.4 OBLIGATIONS TO THIRD PARTIES.
Each party warrants and represents that proceeding herein is not
inconsistent with any contractual obligations, express or implied, undertaken
with any third party.
13.5 ASSIGNMENT.
This Agreement shall be binding upon and inure to the benefit of the
successors and permitted assigns of each of the parties and may not be assigned
or transferred by either party without the prior written consent of the other,
which consent will not be unreasonably withheld. Any assignments, including but
not limited to, sale, transfer, or license of brand or Products, shall not
release the original party hereto from their duties and obligations under this
Agreement. For the purposes of this Agreement, the terms "subsidiaries" and
"affiliates" shall mean any entity controlling, controlled by, or under common
control with, either of the parties hereto.
13.6 GOVERNING LAW AND ARBITRATION.
(a) The validity, interpretation and effect of this Agreement shall be
governed by and construed under the laws of the [c.i.]
(b) The parties agree to attempt to settle any disputes that arise in
connection with this Agreement through [c.i.] efforts. The parties agree that
any dispute that arises in connection with this Agreement which is not settled
through [c.i.] efforts shall be settled by arbitration which shall be in
accordance with the [c.i.]. Such arbitration shall be held in the [c.i.]. There
shall be [c.i.] arbitrators, [c.i.] and a [c.i.] so chosen. The decision of the
arbitrators [c.i.] all parties and [c.i.]. The costs of arbitration, including
reasonable attorney's fees, shall be borne by [c.i.].
-15-
13.7 SEVERABILITY
In the event that any term or provision of this Agreement shall violate any
applicable statute, ordinance, or rule of law in any jurisdiction in which it is
used, or otherwise be unenforceable, such provision shall be ineffective to the
extent of such violation without invalidating any other provision hereof.
13.8 HEADINGS, INTERPRETATION.
The headings used in this Agreement are for convenience only and are not a
part of this Agreement.
13.9 COUNTERPARTS.
This Agreement may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
original.
13.10 INDEPENDENT CONTRACTOR.
In performing its services hereunder, HARMONY shall act as an independent
contractor.
-16-
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to
be executed by their duly authorized officers as of the date first above
written.
SIRIUS LABORATORIES, INC. HARMONY LABORATORIES, INC.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ JM
--------------------------------- ------------------------------------
Its: President Its: President
-------------------------------- -----------------------------------
Date: 9/17/01 Date: 9/12/01
------------------------------- ----------------------------------
-17-
SCHEDULE A
PRODUCTS
For this Schedule A, the definition of the Product shall be SIRIUS's Nicosyn
brand which contains sodium sulfacetamide 10% and sulfur 5%.
MANUFACTURING FEE
The Manufacturing Fee for Nicosyn will be:
6 GRAM SAMPLE UNIT
- 6 Gram Tube Sample Unit - [c.i.] per unit which shall include the
Product filled in a screened single color tube with a standard cap.
Any additional packaging will have additional charges.
- Per sample unit prices will include all components in the Xxxx of
Materials for Product provided to Harmony by Sirius and signed by both
Parties. Any change in the Xxxx of Material may result in a change in
per unit costs.
45 GRAM STOCK UNIT
- 45 Gram Tube Stock Unit - Prices will [c.i.] on the [c.i.]. The price
schedule will be as follows:
- [c.i.] batch (approximately [c.i.] units) - [c.i.] per unit.
- [c.i.] batches (approximately [c.i.] units) - [c.i.] per unit.
- [c.i.] batches (approximately [c.i.] units) - [c.i.] per unit.
- Per stock unit prices will include all components in the Xxxx of
Materials for Product provided to Harmony by Sirius and signed by both
Parties. Any change in the Xxxx of Material may result in a change in
per unit costs.
[C.I.]
SIRIUS will [c.i.] the following [c.i.] during the [c.i.]
- 6 Gram Sample Units - [c.i.] (approximately [c.i.] units)
- 45 Gram Stock Units - [c.i.] (approximately [c.i.] units)
[C.I.]
SIRIUS will pay to HARMONY [c.i.] associated with the [c.i.] of Nicosyn. [c.i.]
will be [c.i.] and will include the services listed below. Additional use of the
services below [c.i.] will be billed at [c.i.].
- [c.i.]
- [c.i.]
- [c.i.]
- [c.i.]
- [c.i.]
-18-
SIRIUS LABORATORIES, INC. HARMONY LABORATORIES, INC.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ JM
--------------------------------- ------------------------------------
Its: President Its: President
-------------------------------- -----------------------------------
Date: 9/17/01 Date: 9/18/01
------------------------------- ----------------------------------
-19-
SCHEDULE A-4
PRODUCTS
For this Schedule A-4, the definition of the Product shall be SIRIUS's AVAR GEL
(all sizes and packaging), AVAR GREEN (all sizes and packaging), and AVAR
CLEANSER (all sizes and packaging) (Collectively the "AVAR LINE").
MANUFACTURING FEE
The Manufacturing Fee for the AVAR LINE will be:
AVAR GEL:
- The total finished foods Manufacturing Fee will be [c.i.] per trade
unit for the [c.i.] and the [c.i.] per unit [c.i.]. The total finished
goods Manufacturing Fee for the sample unit will be [c.i.] per unit
for the [c.i.] and then [c.i.] per unit [c.i.].
- Sirius will provide a final, approved Xxxx of Materials that will
define all packaging and labeling requirements for this project ("Xxxx
of Material"). The quote provided in this Schedule A-4 assumes the
final approved Xxxx of Materials will include:
- Trade Package
- Container: 45 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Standard
- Shipper: Packed in standard shipper of 12 units per case.
- Sample Package
- Container: 6 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Display carton containing 10 tubes each with
package insert
- Shipper: Packed in standard shipper of 36 display cartons
per case.
- Shipping terms are [c.i.]
- Purchase orders shall be submitted a minimum of [c.i.] in advance of
the requested ship date.
AVAR GREEN:
- The total finished goods Manufacturing Fee will be [c.i.] per trade
unit for the [c.i.] and then [c.i.] per unit [c.i.]. The total
finished goods Manufacturing Fee for the sample unit will be [c.i.]
per unit for the [c.i.] and then [c.i.] per unit [c.i.].
- Sirius will provide it final, approved Xxxx of Materials that will
define all packaging and labeling requirements for this project. The
quote provided in this Schedule A-4 assumes the final approved Xxxx of
Materials will include:
-20-
- Trade Package
- Container: 45 xx xxxxx HDPE COEX tube
- Closure, Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Two inserts per package, one standard and
one patient instruction.
- Shipper: Packed in standard shipper of 12 units per case
- Sample Package
- Container: 6 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Two inserts per package, one standard and
one patient instruction.
- Shipper: Packed in standard shipper of 12 units per case
- Shipping terms are [c.i.]
- Purchase orders shall be submitted a minimum of [c.i.] in advance of
the requested ship date.
AVAR CLEANSER
- The total finished goods Manufacturing Fee will be [c.i.] per trade
unit for the [c.i.] and then [c.i.] per unit [c.i.]. The total
finished goods Manufacturing Fee for the sample unit will be [c.i.]
per unit for the [c.i.] and then [c.i.] per unit [c.i.].
- Sirius will provide a final, approved Xxxx of Materials that will
define all packaging and labeling requirements for this project. The
quote provided in this Schedule A-4 assumes the final approved Xxxx of
Materials will include:
- Trade Package
- Container: 8 oz white Boston round PET 24/410 bottle
- Closure: 24/410 white LDP @ 2 cc output pump
- Label: Wrap-around label printed by supplier
- Unit Carton: Standard printed
- Package Insert: Standard
- Shipper: Packed in standard shipper of 12 units per case.
- Sample Package
- Container: 6 xx xxxxx HDPE COEX tube
- Closure: precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Display carton containing 10 tubes each with
package insert
- Shipper Packed in standard shipper of 36 display cartons per
case.
- Shipping terms are [c.i.]
- Purchase orders shall he submitted a minimum of [c.i.] in advance of
the requested ship date.
-21-
[C.I.]
SIRIUS will [c.i.] the following [c.i.] during [c.i.] following the signing of
this agreement:
- [c.i.] production batches of each product from the AVAR LINE.
ADDITIONAL COSTS
- SIRIUS will be responsible for [c.i.]. SIRIUS will provide the art
work to Harmony in a format acceptable for commercial printing.
- SIRIUS will be responsible for any [c.i.] for the Theraplex Products.
SIRIUS LABORATORIES, INC. HARMONY LABORATORIES, INC.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ JM
--------------------------------- ------------------------------------
Its: President Its: President
-------------------------------- -----------------------------------
Date: 4/10/03 Date: 4/01/03
------------------------------- ----------------------------------
-22-
SCHEDULE A-5
PRODUCTS
For this Schedule A-5, the definition of the Product shall be SIRIUS's AVAR E
(all sizes and packaging), AVAR E GREEN (all sizes and packaging) (Collectively
the "AVAR E LINE").
MANUFACTURING FEE
The Manufacturing Fee for the AVAR E LINE will be:
AVAR GEL:
- The total finished foods Manufacturing Fee will be [c.i.] per trade
unit for the [c.i.] and the [c.i.] per unit [c.i.]. The total finished
goods Manufacturing Fee for the sample unit will be [c.i.] per unit
for the [c.i.] and then [c.i.] per unit [c.i.].
- Sirius will provide a final, approved Xxxx of Materials that will
define all packaging and labeling requirements for this project ("Xxxx
of Material"). The quote provided in this Schedule A-5 assumes the
final approved Xxxx of Materials will include:
- Trade Package
- Container: 45 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Standard
- Shipper: Packed in standard shipper of 12 units per case.
- Sample Package
- Container: 6 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Display carton containing 10 tubes each with
package insert
- Shipper: Packed in standard shipper of 36 display cartons
per case.
- Shipping terms are [c.i.]
- Purchase orders shall be submitted a minimum of [c.i.] in advance of
the requested ship date.
AVAR GREEN:
- The total finished goods Manufacturing Fee will be [c.i.] per trade
unit for the [c.i.] and then [c.i.] per unit [c.i.]. The total
finished goods Manufacturing Fee for the sample unit will be [c.i.]
per unit for [c.i.] and then [c.i.] per unit [c.i.].
- Sirius will provide it final, approved Xxxx of Materials that will
define all packaging and labeling requirements for this project. The
quote provided in this Schedule A-5 assumes the final approved Xxxx of
Materials will include:
-23-
- Trade Package
- Container: 45 xx xxxxx HDPE COEX tube
- Closure, Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Two inserts per package, one standard and
one patient instruction.
- Shipper: Packed in standard shipper of 12 units per case
- Sample Package
- Container: 6 xx xxxxx HDPE COEX tube
- Closure: Precapped white ribbed
- Label: Screen printed by supplier
- Unit Carton: Standard printed
- Package Insert: Two inserts per package, one standard and
one patient instruction.
- Shipper: Packed in standard shipper of 12 units per case
- Shipping terms are [c.i.]
- Purchase orders shall be submitted a minimum of [c.i.] in advance of
the requested ship date.
MINIMUM PURCHASE QUANTITIES
SIRIUS will guarantee to purchase the following product minimums during [c.i.]
following the signing of this agreement:
- [c.i.] production batches of each product from the AVAR E LINE.
ADDITIONAL COSTS
- SIRIUS will be responsible for [c.i.]. SIRIUS will provide the art
work to Harmony in a format acceptable for [c.i.].
- SIRIUS will be responsible for any [c.i.][c.i.] for the Theraplex
Products.
SIRIUS LABORATORIES, INC. HARMONY LABORATORIES, INC.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ Xxxxxxx X.
--------------------------------- ------------------------------------
Its: President Its: VP Finance
-------------------------------- -----------------------------------
Date: 10/21/03 Date: 10/21/03
------------------------------- ----------------------------------
-24-
