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 AGREEMENT
AMIDE PHARMACEUTICALS, INC.
AND
SIRIUS LABORATORIES, INC.
TABLE OF CONTENTS
PAGE
----
I. DEFINITIONS..............................................................................................1
II. MANUFACTURE AND SUPPLY OF PRODUCT........................................................................3
2.1 Regulatory Responsibility.......................................................................3
2.2 Manufacture and Purchase........................................................................4
2.3 Raw Materials...................................................................................5
2.4 Commencement of Manufacturing for New Product...................................................5
2.5 Purchase Orders.................................................................................5
2.6 Rejected Product................................................................................6
2.7 Product Price...................................................................................7
III. SHIPMENT AND RISK OF LOSS................................................................................8
3.1 Shipment........................................................................................8
3.2 Delivery Terms..................................................................................8
3.3 Claims..........................................................................................8
IV. TERM AND TERMINATION.....................................................................................8
4.1 Term............................................................................................8
4.2 Termination.....................................................................................9
4.3 Payment on Termination..........................................................................9
4.4 Survival........................................................................................9
V. CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE....................................................9
5.1 Certificates of Analysis........................................................................9
5.2 Stability Testing..............................................................................10
5.3 Additional Validation Work or Additional Testing...............................................10
VI. WARRANTIES AND REPRESENTATIONS..........................................................................10
6.1 Conformity with Specifications.................................................................10
6.2 Compliance with the Act........................................................................10
6.3 Conformity with FDA regulations and CGMP's.....................................................10
6.4 Compliance of Packaging and Labeling with Laws and Regulations.................................10
6.5 Access to AMIDE's Facilities...................................................................11
6.6 Corporation Bound..............................................................................11
6.7 Additional Representations and Warranties......................................................11
VII. PRODUCT RECALLS AND PRODUCT DESTRUCTION.................................................................12
7.1 Product Recall.................................................................................12
7.2 Product Destruction............................................................................13
VIII. FORCE MAJEURE: FAILURE TO SUPPLY........................................................................13
8.1 Force Majeure Events...........................................................................13
PAGE
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8.2 Failure to Supply..............................................................................13
IX. IMPROVEMENTS............................................................................................14
9.1 Changes by SIRIUS..............................................................................14
9.2 Changes by AMIDE...............................................................................14
9.3 Changes by Law or Regulatory Authorities.......................................................14
9.4 Notice.........................................................................................14
9.5 Obsolete Inventory.............................................................................14
9.6 Disposal Costs.................................................................................15
X. CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS.................................................15
10.1 Confidential Information.......................................................................15
10.2 Trademarks and Trade Names.....................................................................15
XI. INDEMNIFICATION.........................................................................................16
11.1 Indemnification by AMIDE.......................................................................16
11.2 Indemnification by SIRIUS......................................................................16
11.3 No Waiver......................................................................................17
11.4 Insurance......................................................................................17
11.5 Patent and Other Intellectual Property Rights..................................................17
XII. GENERAL PROVISIONS......................................................................................18
12.1 Notices........................................................................................18
12.2 Entire Agreement; Amendment....................................................................18
12.3 Waiver.........................................................................................18
12.4 Assignment.....................................................................................18
12.5 Governing Law and Arbitration..................................................................19
12.6 Severability...................................................................................19
12.7 Modification By Operation Of Law...............................................................19
12.8 Headings, Interpretation.......................................................................19
12.9 Singular And Plural............................................................................19
12.10 Document Preparation...........................................................................19
12.11 Counterparts...................................................................................19
12.12 Independent Contractors........................................................................19
12.13 Implied Rights.................................................................................20
12.14 Parties Relationship...........................................................................20
12.15 Right to Purchase Product Formulation..........................................................20
This Supply Agreement (the "Agreement") is made as of this 18th day of
May, 2001 by and between Sirius Laboratories, Inc., an Illinois corporation
headquartered at 000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxx Xxxxx, XX 00000
(hereinafter referred to as "SIRIUS"), and Amide Pharmaceuticals, Inc, a New
Jersey Corporation with its principal place of business at 000 Xxxx Xxxx Xxxxxx,
Xxxxxx Xxxxx, Xxx Xxxxxx 00000 (hereinafter referred to as "AMIDE")
(collectively, the "Parties").
RECITALS
A. SIRIUS is the innovator of a pharmaceutical product to be known as
NICOMIDE(TM) (hereinafter the "Product"), which is a vitamin-mineral product
that can, at SIRIUS's option, be marketed either as a prescription
pharmaceutical nutritional supplement that does not require FDA marketing
approval, or as a non-prescription dietary supplement;
B. AMIDE manufactures pharmaceutical products for itself and others;
C. SIRIUS has developed a formulation (the "Formulation") for the
Product, and SIRIUS desires AMIDE to Manufacture and Sell the Product to SIRIUS;
D. AMIDE has the capability to Manufacture and Sell the Product to
SIRIUS; and
E. the Parties desire to enter into a supply agreement for the
Manufacture and sale of the Product;
NOW, THEREFORE, in consideration of the mutual covenants, promises, and
conditions contained herein, and for other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, the Parties agree as follows:
I. DEFINITIONS
1.1 "Act" means the Federal Food, Drug and Cosmetic Act, as amended, and
regulations promulgated thereunder.
1.2 "Affiliate(s)" shall mean any corporation, association, company,
organization or other entity which directly or indirectly controls, is
controlled by or is under common control with one of the Parties. For purposes
of this definition, control means the ability, directly or indirectly, through
ownership of securities, by agreement, or by any other method, to direct more
than [c.i.] percent ([c.i.]%) of the outstanding equity votes of any entity,
whether or not represented by securities, or to otherwise control the management
decisions of any entity.
1.3 "Commercialization" shall mean the sale, distribution, marketing and
promotion of the Product by SIRIUS.
1.4 "DSHEA" shall mean the Dietary Supplement Health and Education Act of 1994
and any related federal and/or state rule, regulation, statute or law pertaining
to the safety, effectiveness, adulteration, mishandling, packaging, labeling or
storage of dietary supplement ingredients and/or finished dietary supplement
products that may be applicable to the Product during the term of this
agreement.
1.5 "FDA" shall mean the United States Food and Drug Administration, or any
successor entity thereto.
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1.6 "Forecasted Needs" means SIRIUS's estimate of Product to be ordered from
AMIDE for [c.i.] following the [c.i.] in which such estimate is provided.
1.7 "Formulation" means the Product as detailed on Exhibit A, or as amended from
time to time by SIRIUS in accordance with this Agreement.
1.8 "Intellectual Property" shall mean patents, patent applications,
continuations, continuations-in part, divisionals, reissues, reexaminations,
trade names, trademarks, and trade dress.
1.9 "Label", "Labeled", or "Labeling" means all labels and other written,
printed, or graphic matter upon: (i) the Product or any container or wrapper
utilized with the Product or (ii) any written material accompanying the Product.
1.10 "Law" shall mean any local, state or federal rule, regulation, statute or
law relevant to the manufacture, distribution and/or sale of the Product, and to
any other matters set forth herein.
1.11 "Losses" shall mean any [c.i.], including [c.i.], incurred by either Party
which arise from any [c.i.].
1.12 "Manufacture" means the activities undertaken to create the Product from
its Raw Materials in accordance with the Specifications (as hereinafter defined)
including but not limited to Product creation, testing, packaging, and labeling.
1.13 "Manufacturing Cost" shall mean [c.i.] (as hereinafter defined), [c.i.].
1.14 "Manufacturing Fee" means the fee paid by SIRIUS to AMIDE for services
required to Manufacture Product. The Manufacturing Fee is quoted in single final
Product unit increments (i.e. by the bottle or sample carton) The Manufacturing
Fee shall include services for [c.i.] The Manufacturing Fee does not include,
without limitation, any [c.i.]. These services are in addition to the
Manufacturing Fee and shall be billed [c.i.] at [c.i.] not to exceed [c.i.].
Manufacturing Fee also does not include any [c.i.] or [c.i.]. These items are
billed separately in accordance with paragraph 2.2 below.
1.15 "Market Year" means a period of twelve (12) months commencing on the date
of the launch by SIRIUS of Product Manufactured by AMIDE.
1.16 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.
1.17 "Packaging" means all primary containers, cartons, shipping cases, inserts
or any other like material used in packaging or otherwise accompanying the
Product.
2
1.18 "Product" or "Products" whenever used herein shall mean the pharmaceutical
product or products identified on Exhibit A. Each dosage strength shall be
considered a separate Product.
1.19 "Raw Materials" means the active ingredients, excipients and any other
components necessary to create and package the Product.
1.20 "Active Raw Materials" shall mean niacinimide, folic acid and zinc.
1.21 "Sell" (for SIRIUS) means the activities undertaken to commercialize,
market, promote and sell the Product in the market. Sell by AMIDE means the
Manufacture and sale of the Product to SIRIUS.
1.22 "Specifications" means all regulatory, manufacturing, quality control, test
methods and quality assurance procedures, processes, practices, standards,
instructions and specifications comprising AMIDE's manufacturing and packaging
of the Product and such other FDA and/or other regulatory requirements as may be
applicable, including the specifications for Raw Materials and manufacturing
procedures of the Product as either submitted by AMIDE and approved in writing
by SIRIUS or covered under AMIDE'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 AMIDE'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 AMIDE and SIRIUS via a Product Change Request ("PCR")
in accordance with Section IX below.
II. MANUFACTURE AND SUPPLY OF PRODUCT
2.1 REGULATORY RESPONSIBILITY.
(a) AMIDE shall remain responsible for maintaining and fulfilling all
regulatory requirements with respect only to the Manufacture of Products that
are imposed by Law upon AMIDE as the manufacturer of the Products.
(b) SIRIUS shall perform all necessary regulatory filings and will
obtain all necessary registrations in the United States, with the FDA or other
relevant government agencies, as required by law, for Manufacture of the
Product. SIRIUS shall be solely and exclusively responsible for obtaining,
maintaining and fulfilling all regulatory requirements with respect to the
Products that are imposed by Law upon SIRIUS in connection with SIRIUS's
Commercialization and sale of the Products. SIRIUS shall, on a timely basis,
provide AMIDE with all information that is reasonably necessary and relevant to
assist AMIDE in fulfilling all of its regulatory obligations.
(c) AMIDE shall advise SIRIUS orally or in writing within [c.i.] days
if an authorized agent of the FDA or other governmental agency visits AMIDE's
manufacturing facility and requests or requires information or changes which
directly pertain to the Product or which may negatively impact AMIDE's ability
to continue to manufacture SIRIUS's Product under this Agreement. FDA audit time
specific to Product [c.i.]. AMIDE shall notify SIRIUS of any FDA determination
regarding failure to comply with CGMP.
3
(d) AMIDE shall report adverse drug experience information within
[c.i.] hours of receipt by AMIDE. AMIDE shall provide other post
Commercialization reports as are required to be filed with the FDA or its
equivalent. All telephone calls received by AMIDE relating to the Product shall
be referred to SIRIUS. SIRIUS shall be responsible for fulfilling any and all
regulatory requirements with respect to such events, including but not limited
to the filing of all required forms, contact and follow-up with the patient or
reporter of the event, and will make any necessary contact with the FDA
regarding the subject matter of same.
(e) SIRIUS, in performing its obligations hereunder, shall materially
comply with all applicable Laws. If SIRIUS receives notice of an inspection or
other notification by a governmental entity, including FDA, relating to
Products, promotional materials or other matters, SIRIUS shall notify AMIDE on
the same day such notice or notification is received, and provide to AMIDE,
within [c.i.] hours, copies of all relevant documents, warning letters and other
correspondence and notifications relating to Products. SIRIUS agrees to
cooperate with AMIDE during any inspection, investigation or other inquiry by
FDA or any other governmental entity, including providing information and/or
documentation, as requested by FDA or other governmental entity. SIRIUS also
agrees to discuss any response to observations or notifications received and to
give AMIDE an opportunity to comment on any proposed response before it is made.
In the event of disagreement concerning the form or content of such response,
however, AMIDE shall be responsible for deciding the appropriate form and
content of any response with respect to any of its cited activities and SIRIUS
shall be responsible for deciding the appropriate form and content of any
response with respect to any of its cited activities.
2.2 MANUFACTURE AND PURCHASE.
(a) AMIDE will Manufacture, Package, Label, store, and ship the Product
in accordance with the Specifications.
(b) SIRIUS shall designate AMIDE as its manufacturer and SIRIUS shall
purchase [c.i.] of SIRIUS's Forecasted Needs of Product from AMIDE.
(c) Nothing herein shall be construed to prohibit SIRIUS from
qualifying a secondary manufacturing facility, however, SIRIUS shall not utilize
such secondary manufacturing facility unless and until one of the following
occurs:
(i) [c.i.]; or
(ii) [c.i.]
(d) Subject to the terms and conditions of this Agreement, AMIDE agrees
that it will manufacture for and provide to SIRIUS, and SIRIUS agrees that it
will purchase from AMIDE, [c.i.] requirements of the Products, identified in
Exhibit A attached hereto, as follows:
(i) [c.i.] until [c.i.], AMIDE shall Manufacture and sell and
SIRIUS shall purchase [c.i.] of SIRIUS's annual requirements;
(ii) [c.i.] for the [c.i.] AMIDE shall Manufacture and sell
and SIRIUS shall purchase [c.i.] of SIRIUS's annual requirements; and
4
(iii) [c.i.] for the [c.i.], AMIDE shall Manufacture and sell
and SIRIUS shall purchase [c.i.] of SIRIUS's annual requirements.
(e) With respect to years in which SIRIUS is [c.i.] of SIRIUS'S annual
requirements from AMIDE, SIRIUS [c.i.] may purchase from AMIDE and AMIDE shall
Manufacture in excess of the minimum required, [c.i.] of the annual
requirements. If SIRIUS does not achieve or maintain the minimum volumes listed
in Schedule A, [C.I.] may, [c.i.], adjust [c.i.].
2.3 RAW MATERIALS.
(a) [c.i.], will select [c.i.] the Raw Materials, including active
ingredients and excipients, for the Manufacture of the Product.
(b) SIRIUS shall provide AMIDE with Specifications (including art
proofs) for Packaging and Labeling, and [C.I.] shall purchase, [c.i.], Packaging
and Labeling in accordance with the Specifications. If SIRIUS requires patient
booklets or other promotional materials (hereinafter collectively, "Promotional
Materials") to be included in Packaging of Product, SIRIUS shall supply such
Promotional Materials to AMIDE for prior approval and upon AMIDE's written
approval, AMIDE shall obtain such Promotional Materials [c.i.]. Approval in this
section (b) shall mean only AMIDE's [c.i.] that AMIDE can logistically and
physically include such Promotional Material as part of the manufacturing of
Product. Nothing herein shall be deemed or construed to represent that AMIDE has
read, reviewed or confirmed the accuracy of the Promotional Material.
2.4 COMMENCEMENT OF MANUFACTURING FOR NEW PRODUCT.
No later than [c.i.] prior to the initial Market Year of the Product,
SIRIUS agrees to notify AMIDE in writing of its delivery requirements, including
firm orders for same, for the [c.i.] and shall provide its Forecasted Needs in
writing for [c.i.] in order to ensure timely delivery of Product for initial
sale and marketing.
2.5 PURCHASE ORDERS.
(a) SIRIUS agrees to purchase from AMIDE [c.i.] Product Manufactured
for SIRIUS by AMIDE in accordance with SIRIUS's purchase orders [c.i.] to the
extent such Product meets the Specifications.
(b) SIRIUS will transmit orders for Product to AMIDE using a mutually
acceptable order entry system. All orders shall include the precise quantity of
Product, the dates by which the ordered Product must be ready for shipment, and
any additional information reasonably necessary to ensure proper shipment of
Product.
(c) At the [c.i.] and thereafter at the [c.i.], SIRIUS shall provide
AMIDE with specific data as to its Forecasted Needs for the following [c.i.]. It
is understood and agreed that with respect to any forecasts issued to AMIDE by
SIRIUS pursuant to the terms hereof, the forecast for the [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 AMIDE
shall meet those dates, [c.i.]. [C.I.] may, [c.i.], Manufacture Product up to
[c.i.] prior to the requested delivery date in order to accommodate fluctuations
in production demands. The [c.i.] of the
5
period addressed in the forecast shall be utilized by AMIDE for purposes of Raw
Material acquisition on behalf of SIRIUS and AMIDE production planning. Although
AMIDE shall [c.i.] [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, AMIDE
may order the [c.i.] to support up to [c.i.] of SIRIUS's Forecasted Needs, or
the [c.i.] quantity, whichever is [c.i.]. Should [C.I.] subsequently [c.i.] will
be [c.i.] for the [c.i.] of any material purchased by AMIDE on SIRIUS's behalf.
Any such material which is subsequently rendered [c.i.] that required to support
up to [c.i.] of SIRIUS's Forecasted Needs shall be [c.i.].
(d) SIRIUS shall issue written purchase orders for Product to AMIDE at
least [c.i.] to the requested delivery date if the requirements are [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) AMIDE will only be required to meet the delivery dates confirmed to
SIRIUS by AMIDE, in writing, so long as said dates [c.i.] from receipt of
SIRIUS's purchase order. This Agreement allows for up to [c.i.] per batch of
Product. Additional destinations may be accommodated for a shipping preparation
fee [c.i.].
2.6 REJECTED PRODUCT.
(a) SIRIUS may reject any Product which fails to meet the
Specifications. SIRIUS shall, within [c.i.] days after its receipt of any
shipment of Product and related Certificate of Analysis of Product batch (as
described in paragraph 5.1 hereof), notify AMIDE 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 AMIDE shall specify
why the Product batch failed to perform to Specifications. AMIDE shall have an
opportunity to [c.i.] said Product batch. All Product shall be submitted to
inspection and evaluation in accordance with AMIDE's SOP's to determine whether
or not said Product meets the Specifications. As to any such Product batch
(including phases of or complete batches of bulk product) which is determined to
fail the Specifications and may be rejected by SIRIUS or AMIDE ("Rejected
Product"), AMIDE shall [c.i.] for the Manufacture of Product. If requested,
AMIDE shall [c.i.] with SIRIUS for the [c.i.] of Rejected Product.
Notwithstanding the foregoing, in the case of any nonconformity which is not
readily apparent or discoverable upon reasonable inspection within such [c.i.]
period, any claim of nonconformity with respect thereto shall not be deemed
waived and delivery of Product shall not be deemed to have been accepted if
SIRIUS notifies AMIDE as soon as practicable, but not later than [c.i.],
following the date upon which SIRIUS learns of such nonconformity.
(b) If there is a conflict between the test results of AMIDE and the
test results of SIRIUS with respect to any shipment of Product, batch samples of
such Product batch shall be submitted [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 12.5(b) below.
6
(c) For the [c.i.] validation batches of Product produced by AMIDE, or
if a Rejected Product is due to SIRIUS supplied information, formulations or
materials, [C.I.] shall bear [c.i.] of [c.i.] for Rejected Product, including
the [c.i.] of Rejected Product. If the [c.i.] registration batches or [c.i.]
validation batches of Product fails to meet Specifications [C.I.] shall bear
[c.i.] of [c.i.] to and [c.i.] the Rejected Product [c.i.]. Thereafter, in the
event a Rejected Product is due to the failure of AMIDE 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.] supplied by [C.I.] and [c.i.].
If the Product does not meet final specifications, but such failure is not due
to either SIRIUS supplied information or AMIDE's failure to follow written
procedures, [C.I.] shall bear [c.i.] with [C.I.] bearing [c.i.] related to
Rejected Product.
2.7 PRODUCT PRICE.
(a) The initial Manufacturing Fees to be paid by SIRIUS to AMIDE are
listed in Schedule A. The parties hereto agree that the Manufacturing Fees set
out in Schedule A shall be [c.i.], at [c.i.]. If the parties are unable to agree
on a [c.i.] at least [c.i.] prior to the start of a [c.i.], then this Agreement,
effective the first day of January of the [c.i.], shall continue in force with
[c.i.] to reflect the change in the [c.i.] during the [c.i.] until such time
[c.i.] can be completed. Prices for new Product or new Product sizes, not
initially included in Exhibit A, [c.i.] and AMIDE and SIRIUS shall [c.i.] with
respect to prices at the time said new Product or new Product sizes are added to
Exhibit A. If [c.i.], final pricing for any of the above will be settled in
accordance with paragraph 12.5(b) below.
(b) Price of materials to be paid by SIRIUS to AMIDE ("Quoted Price of
Material") shall be listed in an amendment to Schedule A within [c.i.] of
commencement of regular production of the applicable Product. Quoted Price of
Material is calculated as [c.i.] is defined as [c.i.]) plus [c.i.] for [c.i.].
Quoted Price of Material does not include, without limitation, [c.i.]. These
items will be invoiced to SIRIUS at AMIDE's [c.i.] on a net thirty (30) basis.
SIRIUS agrees to reimburse AMIDE for any such authorized expenditures made on
SIRIUS's behalf. AMIDE's Quoted Price of Material will be adjusted [c.i.] and
Schedule A shall be amended accordingly. If, however, the cost of a Raw Material
[c.i.], AMIDE shall notify SIRIUS and, with [c.i.] for said material to SIRIUS
to compensate for [c.i.]. Upon reasonably written request, AMIDE shall provide
to SIRIUS the [c.i.].
(c) Payment for all deliveries of Product and services shall be made in
U.S. dollars, [c.i.], after date of AMIDE's invoice therefor. Invoices shall be
generated upon either: (i) [c.i.]; or (ii) [c.i.] from AMIDE, [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 [c.i.] for [c.i.]. Thereafter, following the expiration of
[c.i.], AMIDE, [c.i.], may [c.i.]
7
on future orders and to [c.i.] or [c.i.] of Product if SIRIUS's account is not
current. Such [c.i.] shall not be considered a breach of this Agreement by
AMIDE. If [c.i.], a [c.i.] paid by SIRIUS to AMIDE will be required prior to
AMIDE Manufacturing Product. In addition, a [c.i.] Manufacturing Fee [c.i.]
prior to AMIDE manufacturing any Product and [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 reasonable
means SIRIUS instructs, provided that shipment is made in accordance with all
relevant Laws. Product will be shipped to SIRIUS or its designee immediately
upon release, [c.i.]. At SIRIUS's request, AMIDE may, [c.i.], hold Product in
AMIDE's warehouse [c.i.]. Product held at AMIDE will be [c.i.] in accordance
with paragraph 2.6(c) above. If SIRIUS requests AMIDE to make any miscellaneous
small shipments less than [c.i.] of a standard batch size of Product, Raw
Material, or other items on SIRIUS's behalf, SIRIUS agrees to reimburse AMIDE
for any shipping charges incurred.
3.2 DELIVERY TERMS.
The purchase price of Products in Schedule A hereof shall [c.i.].
[C.I.] will bear all risk of loss, delay, or damage in transit, as well as cost
of freight and insurance.
3.3 CLAIMS.
The weights, tares and tests affixed by AMIDE's invoice shall govern
unless established to be incorrect. Claims relating to quantity, weight and loss
or damage to any Product sold under this Agreement shall be waived by SIRIUS
unless made within [c.i.] of receipt of Product by SIRIUS. In the event any
damage is caused to Product during shipping such damage shall be reported to
AMIDE in writing by SIRIUS within [c.i.] of receipt of Product, the failure of
which shall be deemed an acceptance of such damaged Product.
IV. TERM AND TERMINATION
4.1 TERM.
(a) This Agreement shall commence on the first day of the month
following the mutual signing of this document and will continue for five (5)
years thereafter (the "Term"), unless sooner terminated pursuant to its terms.
This Agreement may be extended by mutual written agreement of the Parties. For
the purposes of this Agreement, the term shall include any extensions.
(b) For the purposes of this Agreement, receipt and acceptance by AMIDE
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 only 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. Nothing herein shall be deemed or construed to obligate AMIDE to accept
such Purchase Orders upon the expiration of this Agreement.
8
4.2 TERMINATION.
This Agreement may be terminated at any time upon the occurrence of any
of the following events:
(a) If the other party has breached this Agreement and has failed to
cure such breach within [c.i.] after written notice thereof.
(b) Upon insolvency, assignment for the benefit of creditors, or the
initiation of bankruptcy proceedings by or against the other party.
(c) If either Party changes ownership. Change of ownership shall mean
the transfer of more than [c.i.] of a Company's Stock to an entity other than an
person who is not currently an owner or entity which owns [c.i.] of such Party.
If either Party shall become a public company that shall not constitute a change
of ownership.
(d) If SIRIUS determines to discontinue marketing the Product, SIRIUS
shall give AMIDE at least [c.i.] advance written notice of such decision to
discontinue.
4.3 PAYMENT ON TERMINATION.
Upon the termination or cancellation of this Agreement for any reason
other than [c.i.] hereof, and without prejudice to any other rights and remedies
and defenses available to either Party hereunder, [C.I.] agrees to reimburse
[C.I.] at [c.i.] for any [c.i.] [c.i.] and for which [c.i.], if said orders are
[c.i.] and [c.i.] by [c.i.], as well as for [c.i.] commenced by, and [c.i.] of,
[C.I.] in connection with the performance of this Agreement. With respect to any
[c.i.] and [c.i.] ordered for manufacture of Product for which [C.I.] can
reasonably [c.i.], [C.I.] shall [c.i.] its [c.i.] [c.i.] of such [c.i.]). Within
[c.i.] of termination and at SIRIUS's written request, AMIDE shall furnish
SIRIUS with a [c.i.] of all materials in inventory, and shall ship such
materials and the applicable invoice therefor to SIRIUS at [c.i.] and per
SIRIUS's reasonable written instructions. SIRIUS [c.i.] upon receipt [c.i.].
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 II, VI, VII, X and XI hereof shall survive
the termination or cancellation of this Agreement for any reason.
V. CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
5.1 CERTIFICATES OF ANALYSIS.
AMIDE 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.
AMIDE 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.]
9
5.2 STABILITY TESTING.
AMIDE shall perform its standard stability test program as defined in
AMIDE's SOP's or as separately agreed to in accordance with a PCR for each
Product. SIRIUS shall receive a copy of AMIDE's Annual Report for each Product
as long as AMIDE is continuing to produce such Product for SIRIUS and [c.i.]. If
SIRIUS elects to perform its own stability testing on the Product, SIRIUS agrees
to provide AMIDE with a copy of the results from such testing [c.i.].
5.3 ADDITIONAL VALIDATION WORK OR ADDITIONAL TESTING.
If AMIDE is required by regulatory authority to perform additional
validation studies subsequent to validation performed on initial validation
batches or additional testing in order to legitimately continue to engage in the
Manufacture of the Product for SIRIUS, AMIDE and SIRIUS shall [c.i.] to reach an
agreement on a written project protocol in order to satisfy said requirement. If
the parties cannot reach agreement on a written project protocol addressing the
regulatory requirement, [c.i.]
VI. WARRANTIES AND REPRESENTATIONS
6.1 CONFORMITY WITH SPECIFICATIONS.
AMIDE warrants that all Product sold and delivered pursuant to this
Agreement will have been Manufactured and Packaged in accordance with the
Specifications.
6.2 COMPLIANCE WITH THE ACT.
Upon acceptance of the Specifications [c.i.], it shall bear [c.i.] for
the validity of all Specifications. 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, test methods, and
studies [c.i.]
6.3 CONFORMITY WITH FDA REGULATIONS AND CGMP'S.
Subject to the provisions set forth in paragraphs 6.2 and 6.4 hereof,
AMIDE represents and warrants that all Product manufactured, packaged, held for
sale, stored, sold and shipped pursuant to this Agreement shall have been
Manufactured, packed, stored and shipped by AMIDE in compliance with applicable
FDA regulations and current Good Manufacturing Practices as that term is defined
under the Act, the Specifications and all other applicable Laws, and shall not
be adulterated, mismarked or otherwise be violative of any Laws.
6.4 COMPLIANCE OF PACKAGING AND LABELING WITH LAWS AND REGULATIONS.
SIRIUS warrants that all 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 Packaging and Labeling shall be the [c.i.] responsibility
of SIRIUS, provided that [c.i.] such [c.i.] and [c.i.] as provided in paragraph
2.3(b) hereof, except [C.I.] shall bear responsibility [c.i.] caused by [C.I.].
For purposes of this section 6.4, packaging failures shall mean only [c.i.] to
(1) [c.i.] to Product or (2) include [c.i.] with [c.i.].
10
6.5 ACCESS TO AMIDE'S FACILITIES.
SIRIUS shall have access to AMIDE's facilities at [c.i.] AMIDE's
compliance with current Good Manufacturing Practices and the Act ("Audits").
Such access shall in no way gives SIRIUS the right to any of AMIDE'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. Upon Termination for any reason,
AMIDE shall make available to SIRIUS all batch, testing and manufacturing
records relating to Product.
6.6 CORPORATION BOUND.
Each of the Parties hereto represents and warrants that: (i) it is a
corporation duly organized, existing, and in good standing under the laws of its
state of organization; (ii) it has all requisite legal and corporate power and
authority to enter into this Agreement; (iii) when executed by the corporate
officers whose names appear on the signature page hereof, this Agreement shall
be a valid and binding obligation of the Parties enforceable in accordance with
its terms, subject to laws of general application relating to bankruptcy,
insolvency, and the relief of debtors; and (iv) the execution and delivery of
this Agreement and consummation of the transactions contemplated hereby will not
constitute a breach or default under any other agreement to which it is party or
by which it is bound.
6.7 ADDITIONAL REPRESENTATIONS AND WARRANTIES.
AMIDE hereby represents and warrants to SIRIUS as follows:
(a) AMIDE is a corporation duly organized and validly existing under
the laws of the State of New Jersey;
(b) AMIDE has the requisite corporate authority to execute and deliver
this agreement and to perform its obligations hereunder;
(c) Any Products delivered by AMIDE to SIRIUS shall, at the time of
shipment have been manufactured, packaged, stored and shipped by AMIDE in
conformity with CGMPs, Specifications, and any other applicable Laws, and shall
not be adulterated, misbranded or otherwise violative of the FFDCA or other
applicable Laws;
SIRIUS hereby represents and warrants to AMIDE as follows:
(a) SIRIUS is a corporation duly organized and in good standing under
the laws of the State of Illinois;
(b) SIRIUS's Product formulation and labeling and any changes thereto
shall comply with the FFDCA and/or DSHEA in all respects;
(c) Upon termination of this Agreement or the expiration of the natural
term as set forth in paragraph 4.1 hereinabove, SIRIUS shall [c.i.] as described
and set forth in paragraph 11.4, retroactive to the Commencement Date. In the
event for any reason whatever SIRIUS elects not to [c.i.] as required
hereinabove, which election shall be deemed a breach of this Agreement, and any
other subsequent agreement parties may enter into, SIRIUS shall notify AMIDE as
required hereinabove of such election in order to permit [c.i.]. SIRIUS
acknowledges and agrees that AMIDE's [c.i.] shall ultimately be payable [c.i.],
together with [c.i.] and [c.i.] and
11
[c.i.] that may be required to compel SIRIUS to pay for such expenses and costs
incurred by AMIDE in recouping from SIRIUS its payment for the Tail.
(d) SIRIUS has the requisite corporate authority to execute and deliver
this Agreement and to perform its obligations hereunder;
(e) The execution and performance of SIRIUS's obligations hereunder,
are not and will not be in violation of or in conflict with any obligations,
contracts or agreements it may have with any third party;
(f) SIRIUS is not debarred and SIRIUS has not and will not use in any
capacity the services of any person debarred under subsections 306(a) or (b) of
the Generic Drug Enforcement Act of 1992. If at any time this representation and
warranty is no longer accurate, SIRIUS shall immediately notify AMIDE of such
fact;
(g) SIRIUS has and will maintain throughout the term of this Agreement
all federal, state and local permits, licenses, registrations and other forms of
governmental authorization and approval as required by Law in order for SIRIUS
to execute and deliver this Agreement and to perform is obligations hereunder in
accordance with all applicable Laws;
(h) SIRIUS represents and warrants that it has [c.i.] the [c.i.] of the
Product which is intended to be Commercialized and it has no knowledge that the
use of Product will cause any adverse effects on such users; that there is no
evidence that the use of Product will or has the propensity to cause Adverse
Drug Events as that term is defined at 21 CFR 314.80a; that it knows of no and
has no reason to expect such use of Product or its component parts h as the
potential to cause short-term or long-term effects on the human body or its
systems other than those indicated on the label.
SIRIUS, in performing its obligations hereunder shall materially comply
with all applicable Laws. In the event SIRIUS receives notice of an
inspection or other notification by a governmental entity, including
FDA, relating to its Product, promotional materials or other matters,
SIRIUS shall notify AMIDE on the same day such notice or notification
is received, and provide to AMIDE, within [c.i.] hours, copies of all
relevant documents, including FDA Forms 482, 483 warning letters and
other correspondence and notifications relating to Products. SIRIUS
agrees to cooperate with AMIDE during any inspection, investigation or
other inquiry by FDA or any other governmental entity, including
providing information and/or documentation, as requested by FDA or
other governmental entity. SIRIUS also agrees to discuss any response
to observations or notifications received and to give the other Party
an opportunity to comment on any proposed response before it is made.
In the event of disagreement concerning the form or content of such
response, however, AMIDE shall be responsible for deciding the
appropriate form and content of any response with respect to any of its
cited activities and SIRIUS shall be responsible for deciding the
appropriate form and content of any response with respect to any of its
cited activities.
VII. PRODUCT RECALLS AND PRODUCT DESTRUCTION
7.1 PRODUCT RECALL.
(a) If SIRIUS or AMIDE shall be required or requested by any
governmental authority (or shall voluntarily decide) to recall any Products
because such Products may violate any Laws or for any other reason, the Parties
shall cooperate fully with one another in connection with any recall. If a
recall is due to [c.i.] or [c.i.] in this Agreement, [C.I.] shall [c.i.] or
[c.i.] for
12
all direct costs incurred by [C.I.] including the cost of [c.i.], all [c.i.]
recalled product and [c.i.] involved in administering such recall. If a recall
is due to [c.i.], [C.I.] shall [c.i.] for [c.i.] associated with such recalled
Products and [c.i.] for [c.i.] and [c.i.] described above [c.i.] in connection
with such recall including [c.i.] of the recall and such [c.i.] as may [c.i.] to
the recall.
(b) For the purposes of this Agreement, the expenses of the recall
shall be the expenses of [c.i.] the [c.i.], and [c.i.]. In the event of a
recall, no press releases, interviews or statements shall be made without the
prior written approval of both Parties.
7.2 PRODUCT DESTRUCTION.
(a) Destruction of a rejected or recalled Product shall be in
accordance with all applicable Laws and regulations and the party conducting the
destruction [c.i.] hereto for [c.i.] relating to a failure to dispose of such
Product in accordance with such laws and regulations. The party conducting the
destruction shall also provide to the other party hereto all manifests and other
applicable evidence of proper destruction as may be requested by applicable Law.
The parties agree that any dispute concerning the operation or effect of this
paragraph will be resolved in accordance with paragraph 12.5(b) hereof. If AMIDE
does not receive disposition instructions from SIRIUS within [c.i.] days from
date of obsolescence, obsolete inventory remaining at AMIDE's facilities may be
[c.i.], unless AMIDE fails to [c.i.] any such inventory.
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, inability to obtain or
delays of transportation facilities, 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.
Upon the occurrence of a force majeure event, the party failing or
delaying performance shall promptly notify the other party, in writing, setting
forth the nature of the force majeure, its expected duration and how such
party's performance is affected. The failing or delaying party shall resume
performance of its obligations hereunder as soon as practicable after the force
majeure event ceases. However, if any such disability exists for [c.i.], the
party not under such disability may terminate this Agreement by giving such
other party [c.i.] prior written notice of termination, and this Agreement shall
terminate.
8.2 FAILURE TO SUPPLY.
If AMIDE fails to supply all or part of any shipment of Product ordered
by SIRIUS within [c.i.] after the delivery date specified on the applicable
purchase order for such shipment,
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SIRIUS at its sole discretion, may require AMIDE to supply the undelivered
Product at a future date [c.i.]. If the order [c.i.], AMIDE will [c.i.] or
[c.i.] of SIRIUS applicable to such order.
IX. IMPROVEMENTS
9.1 CHANGES BY SIRIUS.
If SIRIUS at any time requests a change in writing 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 and agreed upon by both AMIDE and
SIRIUS; (ii) [C.I.] shall adjust, [c.i.] (but [c.i.] shall be without [c.i.]),
the [c.i.], if necessary, and Schedule A shall be amended accordingly; and (iii)
[C.I.] shall pay [C.I.] for the [c.i.] with such change including, but not
limited to, any additional development work required, charged at [c.i.] in
accordance with Section _____ contained herein.
9.2 CHANGES BY AMIDE.
Unless mandated by law or any Regulatory Agency, AMIDE agrees that any
changes developed by AMIDE, which may be incorporated into the Product shall
require the written approval of SIRIUS via a PCR prior to such incorporation,
which approval shall not be unreasonably withheld. At the time of such
incorporation, such changes shall become part of the Specifications. It is also
agreed that any regulatory fillings incident to any such change shall be [c.i.].
9.3 CHANGES BY LAW OR REGULATORY AUTHORITIES.
At the time of such change as required because of any law or Regulatory
Authority, such changes shall become part of the Specifications. If AMIDE 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 he manufacture of said Product for SIRIUS, such studies
shall be conducted in accordance with paragraph 5.3 herein. Due to said changes,
AMIDE shall [c.i.]. Such [c.i.] shall be effective [c.i.] in writing by [C.I.]
and, if necessary, Schedule A shall be amended accordingly.
9.4 NOTICE.
Notwithstanding the foregoing, AMIDE shall provide written notice to
SIRIUS of any changes to Product Specifications.
9.5 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.] to [C.I.] by [C.I.] at [c.i.], plus [c.i.]. At
such time and unless otherwise agreed by AMIDE, AMIDE will ship the obsolete
inventory to SIRIUS for destruction by SIRIUS. SIRIUS shall bear [c.i.] of all
destruction costs related to said obsolete inventory.
14
9.6 DISPOSAL COSTS.
AMIDE reserves the right to [c.i.], related to Manufacture of the
Product, unless [c.i.] relates to nonconforming batches due to the failure of
AMIDE to follow established written procedures, or failure to timely ship and
become obsolete, or are due to a Recall, in which event Section 7.2 hereof is
applicable.
X. CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS
10.1 CONFIDENTIAL INFORMATION.
All confidential information furnished by SIRIUS to AMIDE, or by AMIDE
to SIRIUS, during the term of this Agreement, relating to the subject matter
hereof, 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 through no fault of the receiving party; 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 acknowledged that AMIDE manufactures pharmaceutical
products or itself and third parties, [c.i.] however, AMIDE shall not provide
nor Manufacture the Product with the Formulation for itself or for any third
party.
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.
15
(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. INDEMNIFICATION
11.1 INDEMNIFICATION BY AMIDE.
During the term of this Agreement and for [c.i.] after termination,
whichever is later, AMIDE will indemnify, defend and hold SIRIUS, its officers,
directors, employees and agents, harmless from and against any and [c.i.],
resulting from [c.i.] made or suits brought against SIRIUS which arise [c.i.].
In addition, AMIDE will defend, indemnify and hold harmless SIRIUS, its
officers, directors, employees and agents against any and [c.i.], or its [c.i.]
of any obligation under this Agreement. Upon the filing of any such claim or
suit, SIRIUS shall [c.i.] notify AMIDE thereof and shall permit AMIDE, [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 AMIDE and its attorneys to reasonably observe
and/or participate in all aspects of the defense of such claims or suits. [c.i.]
11.2 INDEMNIFICATION BY SIRIUS.
During the term of this Agreement, or for [c.i.] after this Agreement
is terminated, whichever is later, SIRIUS shall indemnify, defend and hold AMIDE
harmless from and against any Losses resulting from or arising out of [c.i.];
the [c.i.], the [c.i.] under this Agreement or the negligence or willful
misconduct of SIRIUS, its employees or its agents (collectively "SIRIUS
Activities").
In the event AMIDE seeks indemnification, it shall notify, in writing,
SIRIUS within [c.i.] of the assertion of any claim or discovery of any fact upon
which AMIDE intends to base a claim for indemnification. AMIDE'S failure to so
notify SIRIUS shall not, however, [c.i.] under this Agreement to AMIDE with
respect to such claim except to the extent that SIRIUS is actually denied,
during the period of delay in notice, the opportunity to remedy or otherwise
mitigate the event or activity(ies) giving rise to the claim for indemnification
and thereby suffers or otherwise incurs additional liquidated or other readily
quantifiable damages as a result of such failure. SIRIUS shall [c.i.] for the
[c.i.] of any claim, demand, lawsuit or other proceeding in connection with
which AMIDE claims indemnification hereunder. AMIDE shall have the right [c.i.]
to participate jointly with SIRIUS in the defense of any such claim, demand,
lawsuit or other proceeding, but with respect to any issue involved in such
claim, demand, lawsuit or other proceeding with respect to which SIRIUS has
acknowledged its obligation to indemnify AMIDE hereunder, SIRIUS shall have the
right to select counsel, settle, try or otherwise dispose of or handle such
claim, demand, lawsuit or other proceeding on such terms as SIRIUS shall deem
appropriate, subject to prior written approval of AMIDE, which shall not be
unreasonably withheld.
16
11.3 NO WAIVER.
In providing the indemnification of Sections 11.1 and 11.2 hereof,
neither party waives any defenses or rights of subrogation which could be
alleged or asserted by a party or its insurance carrier.
11.4 INSURANCE.
(a) Each Party shall, throughout the term of this Agreement, [c.i.] and
[c.i.] from a qualified insurance company with a Financial Rating by AM Best of
not less than [c.i.] and [C.I.], comprehensive general liability insurance,
including standard Products liability insurance designating the other party as
an additional insured (the "Policy") and covering such party for the risks
ascribed herein. Such Policy shall provide protection against any and all
claims, demands and causes of action arising out of any defects, alleged or
otherwise, of the Product or any material used in connection therewith or any
use thereof. The amount of coverage shall be [c.i.] combined single limit
coverage, for each occurrence for bodily injury and/or for property damage. Each
party shall furnish to the other a certificate of insurance evidencing such
insurance Policy upon request. SIRIUS shall not at any time Commercialize
Products or otherwise act pursuant to this Agreement unless such insurance
Policy is in effect. Any and all changes including cancellation of the Policy
may be made only [c.i.] written notice to the other party. If at any time during
the Term, SIRIUS elects to cease sale of Product, its operations or discontinues
the Policy, or if AMIDE shall cease Manufacture of the Product, such party shall
so notify the other in writing within [c.i.] of such determination and such
party [c.i.] to the other in writing and proof evidencing that it has [c.i.]. In
addition, the Policy shall permit the other party to [c.i.], in the event a
party breaches this Agreement and [c.i.]. If the Policy deductible is greater
than [c.i.], the party shall provide evidence to the other, in writing prior to
Commercializing Product, that it has substantial resources to pay for such
deductible.
(b) Upon termination of this Agreement or the expiration of its Term as
set forth in Section IV hereinabove, [c.i.] shall acquire [c.i.] as described
and set forth in paragraph 11.4, retroactive to the Commencement Date unless
satisfactory insurance as required in 11.4(a) hereinabove is already placed with
such Party. If for any reason a Party elects [c.i.] as required hereinabove,
which [c.i.] this Agreement, and any other subsequent agreement the parties may
enter into, the Party shall notify the other, as required hereinabove of such
election in order to permit the other [c.i.]. The Parties acknowledge and agree
that the [c.i.] shall ultimately [c.i.] Party, together with interests, legal
fees and expenses and court costs that may be required to compel a Party [c.i.]
and [c.i.] in recouping [c.i.]. Each Party shall name the other as an additional
named insured [c.i.].
11.5 PATENT AND OTHER INTELLECTUAL PROPERTY RIGHTS.
(a) [C.I.] represents that [c.i.], the [c.i.] of the Product or sales
of Product [c.i.] or [c.i.] and that [c.i.] from [c.i.] arising from claims that
[c.i.], or [c.i.] and any other [c.i.] used by [C.I.] in connection with [c.i.]
or other [c.i.] rights of a third party.
17
(b) [C.I.] shall indemnify, defend and hold [C.I.] harmless from all
[c.i.] arising out of any [c.i.] brought against [C.I.] based upon [c.i.].
XII. GENERAL PROVISIONS
12.1 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 AMIDE: Amide Pharmaceuticals, Inc.
Attention: Xxxxxx Xxxxx - President
000 Xxxx Xxxx Xxxxxx
Xxxxxx Xxxxx, Xxx Xxxxxx 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
If to SIRIUS: Sirius Laboratories, Inc.
Attention: Xxxxx X. Xxxxxxx - President & CEO
Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxx Xxxxx, XX 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
12.2 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 AMIDE'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.
12.3 WAIVER.
No waiver by either party of any default shall be effective unless in
writing, nor shall any such waiver operate as or be construed as a continuing
waiver or a waiver of any other default or of the same default on a future
occasion.
12.4 ASSIGNMENT.
This Agreement shall be binding upon and inure to the benefit of the
successors or 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 Product, shall not
release the original party hereto from their duties and obligations under this
Agreement.
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12.5 GOVERNING LAW AND ARBITRATION.
The validity and interpretation of this Agreement and the legal
relations of the Parties to it shall be governed by the internal laws, and not
the law of conflicts, of the [c.i.]. Venue shall lie with federal courts of
[c.i.] with respect to any action which may be taken hereunder.
12.6 SEVERABILITY.
If any term or provision of this Agreement shall violate any applicable
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. The Parties agree to renegotiate in
good faith any provision or term held to be unenforceable and to be bound by the
mutually agreed substitute provision.
12.7 MODIFICATION BY OPERATION OF LAW.
If any of the terms or provisions of this Agreement are in or come into
conflict with any applicable Law, then such term or provision shall be deemed
inoperative to the extent it may conflict therewith and shall be deemed to be
modified to conform with such Law unless such modification would render the
affected provision inconsistent with or contrary to the intent of the Parties.
However, if the terms and conditions of this Agreement are materially altered as
a result of this subsection, the Parties shall in good faith attempt to
renegotiate said terms and conditions to resolve any disputes related thereto.
Should they be unable to agree on suitable substitute language, the issue shall
be referred to arbitration pursuant to Article 12.5.
12.8 HEADINGS, INTERPRETATION.
The headings used in this Agreement are for convenience only, are not a
part of this Agreement, and are not to be used in construing the intent of the
parties.
12.9 SINGULAR AND PLURAL.
The singular form of any noun or pronoun shall include the plural when
the context in which such a word is used is such that it is apparent the
singular is intended to include the plural or vice versa.
12.10 DOCUMENT PREPARATION.
The Parties acknowledge that this Agreement is a product of
negotiations and that no inference should be drawn regarding the drafting or
preparation of this document.
12.11 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.
12.12 INDEPENDENT CONTRACTORS.
This Agreement shall not constitute or give rise to any
employer-employee, agency, partnership or joint venture relationship among or
between the Parties, and each Party's performance hereunder is that of a
separate, independent entity.
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12.13 IMPLIED RIGHTS.
Nothing in this Agreement shall be deemed or implied to be the grant by
one party to the other of any right, title or interest in the Product,
Intellectual Property or any other proprietary right of the other except as is
expressly provided for herein.
12.14 PARTIES RELATIONSHIP.
Nothing in this Agreement shall create among the Parties a partnership,
joint venture or principal-agent relationship and, for the avoidance of doubt,
SIRIUS and AMIDE now confirm and accept (for itself and as agent on behalf of
its affiliates) that it is an independent contractor trading for and on its own
behalf.
12.15 RIGHT TO PURCHASE PRODUCT FORMULATION.
A. If SIRIUS, for any reason, elects to sell its right to the
Formulation of Product to any party, AMIDE shall have the right of first refusal
to purchase the Formulation of Product according to the following terms:
(i) Notice of Sale. SIRIUS shall advise AMIDE in writing of its
election to (1) sell the Formulation of Product or (2) accept offers for
purchase of Product Formulation, and such notice shall include the material
terms and conditions of any such sale or offer to purchase the Formulation of
Product.
(ii) Acceptance. AMIDE shall have [c.i.] to advise SIRIUS of its intent
to exercise AMIDE's right of first refusal and purchase the Formulation of
Product on substantially similar terms and conditions ("AMIDE's Acceptance").
(iii) Additional Offers. If AMIDE rejects SIRIUS's notice of sale or
SIRIUS receives offers to purchase the Formulation of Product on different terms
and conditions ("Additional Offer"), SIRIUS shall notify AMIDE in writing of all
such Additional Offers that it wishes to accept and shall give AMIDE the right
of first refusal to purchase the Formulation of Product on substantially similar
terms and conditions as such Additional Offer. AMIDE shall have [c.i.] to advise
SIRIUS of AMIDE's intent to purchase the Formulation of Product on substantially
similar terms and conditions as the Additional Offer.
B. Condition Precedent to Right to Purchase Product Formulation.
Section 12.5A shall apply only in the event SIRIUS elects to sell the
Formulation of Product exclusive from the sale of any other formulations it may
own or control. In the event SIRIUS elects to sell Product Formulation together
with any other formulations, it shall have not duties or obligations under
Section 12.15A.
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. AMIDE PHARMACEUTICALS, INC.
By: Xxxxx X. Xxxxxxx By: Xxxxxx X. Xxxxx
------------------------------------------------- ---------------
Its: President Its: President
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EXHIBIT A
NICOMIDE TABLETS PRICING INFORMATION
AMIDE CONFIDENTIAL
Product No.: 235 Product No.: 235
------------------------------------------------------------ ---------------------------------------------------------
NDC: 00000-000-00 NDC: 00000-000-00
------------------------------------------------------------ ---------------------------------------------------------
Batch Size: [c.i.] tablets Batch Size: [c.i.] tablets
------------------------------------------------------------ ---------------------------------------------------------
Bottle Count: 5 Bottle Count: 60
------------------------------------------------------------ ---------------------------------------------------------
Inner casepack: 6 bottle/sample carton Casepack: 12 bottles/casepack
------------------------------------------------------------ ---------------------------------------------------------
Outer casepack: 36 cartons/casepack
------------------------------------------------------------ ---------------------------------------------------------
Price/Bottle: [c.i.] Price/Bottle: [c.i.]
------------------------------------------------------------ ---------------------------------------------------------
21
