Exhibit 10.13.3
---------------
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE COMMISSION.***
CONFIDENTIAL TREATMENT
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement is entered into effective as of Tuesday
March 6th, 2003, by and between INyX Pharma Ltd., a company organized under the
laws of England and Wales ("INyX"), and ▇▇▇▇▇▇▇ Laboratories, Inc., a New York
corporation (the "Customer").
BACKGROUND
A. The Customer desires to use INyX's facilities, resources and expertise to
manufacture the Products, as defined below, and INyX desires to act as a
contract manufacturer of the Product(s) agreed to by both Parties in accordance
with the terms and conditions set forth in this Agreement;
B. INyX and the Customer wish to enter into this manufacturing and supply
agreement on the terms and conditions set forth in this Agreement, for the
consideration set forth in this Agreement.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants
set forth below, INyX and the Customer agree as follows:
AGREEMENT
ARTICLE 1
DEFINITIONS
-----------
For the purposes of this Agreement, the following capitalized terms shall have
the following meanings:
"Affiliate" means any corporation or other business entity controlled by,
controlling or under common control with a Party hereto. For this purpose
"control" shall mean direct or indirect beneficial ownership of fifty percent
(50%) or more of the voting stock, or a fifty percent (50%) or more interest in
the income of, such corporation or other business entity.
"Batch" shall have the meaning set forth in the Quality Agreement.
"Certificate of Analysis" means a summary of the quality control testing, as
described in the Product Specifications, performed by INyX for Finished Product
supplied under this Agreement.
"Change" shall have the meaning set forth in the Quality Agreement.
"Commercially Reasonable Efforts" means, with respect to a Party, the efforts of
such Party that are reasonable in light of the size of the present and potential
markets for the Products (as reasonably determined by such Party) and consistent
with such Party's efforts used in similar activities regarding other products of
similar market potential.
"Confidential Information" shall have the meaning set forth in Section 7.3 of
this Agreement.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
"Customer Representative" means the person designated by the Customer who shall
be primarily resident on site at INyX's facility. As of the date of this
Agreement, *** is designated as the Customer Representative.
"Date of Manufacture" shall have the meaning set forth in the Quality Agreement.
"Dermatological Products" shall have the meaning set forth in Section 4.3.
"Development Agreement" means any separate agreement entered into by the Parties
with respect to a potential Product that is not yet ready to be manufactured on
a commercial scale, including the requirements surrounding production of units
of Product and Placebo appropriately labeled for use in the Customer's clinical
trials (in amounts to be specified by the Customer, as required). Each such
Development Agreement shall, when executed, be appended to this Agreement as an
Exhibit E.
"DMF" means the Drug Master File for a Product, as filed by INyX with the FDA.
"FDA" means the Food and Drug Administration of the United States of America.
"Finished Product" shall have the meaning set forth in the Quality Agreement.
"IND" means an Investigational New Drug Application for a Product, as filed by
the Customer with the FDA.
"INyX" means INyX Pharma Ltd.
"Initial Term" shall have the meaning set forth in Section 10.1.
"Labeling" means the primary container label, secondary packaging, package
insert, shelf pack and shipper label specific to a finished Product manufactured
in accordance with cGMPs and the Customer's instructions.
"Losses" shall have the meaning set forth in Section 11.1.
"Manufacturing Standards" means the specifications for manufacturing, packaging,
labeling and storing the Products set forth in the Product Specifications, the
master batch record, cGMPs, MSDSs, and all other applicable U.S. laws and
regulations.
"MSDS" means material safety data sheets.
"NDA" means a New Drug Application for a Product, as filed by the Customer with,
and approved by the FDA.
"Party" means INyX or the Customer and "Parties" means both INyX and the
Customer, as the context requires.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
"Placebo" means a Product adjusted to be formulated without the active
ingredient.
"Product Specifications" means the specifications provided by the Customer in
writing for the manufacture of any Product and accepted by INyX from time to
time, and includes all such specifications as may be required pursuant to
applicable regulatory laws.
"Product(s)" means Dermatological Products and the products described on Exhibit
A to this Agreement for commercial sale, as it may be properly amended from time
to time by agreement of the Parties, and which is incorporated by this reference
as though fully set forth in this paragraph.
"Quality Agreement" means the Agreement set forth as Exhibit C to this Agreement
and incorporated by this reference as though fully set forth in this Agreement.
"Regulatory Authority" means the FDA or any equivalent or additional
governmental or regulatory agencies having jurisdiction with respect to INyX,
INyX's facilities, or the Products.
"▇▇▇▇▇▇▇" means ▇▇▇▇▇▇▇ Laboratories, Inc.
"Unique Materials" shall have the meaning set forth in Section 3.12 of this
Agreement.
ARTICLE 2
PRODUCT SPECIFICATIONS AND MANUFACTURE
--------------------------------------
2.1 Manufacture of Products
-----------------------
During the term of this Agreement, and subject to the terms and conditions of
this Agreement, INyX shall formulate, fill and package the Products in
accordance with their respective Product Specifications, according to the terms
of this Agreement and the Quality Agreement, as they may be amended from time to
time.
2.2 Conformance to Product Specifications
-------------------------------------
Products (and jointly approved for the purposes of this section, the Placebo)
shall conform to the Product Specifications, the terms of the Quality Agreement,
and all specifications provided in the Customer's IND or NDA. Notwithstanding
the foregoing, if the Customer accepts Product in accordance with the provisions
of this Agreement and the Quality Agreement, this Section 2.2 shall be deemed to
have been satisfied.
2.3 Labeling
--------
INyX will label and package Product in finished form, pursuant to a firm
purchase order accepted by INyX as described in Section 3.4, provided, however,
that the Customer shall be responsible for the origination of artwork and text,
as well as final approval before manufacture, of the Labeling.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
2.4 Raw Materials
-------------
INyX shall source all raw materials used in manufacture of the Products firstly
from sources designated by the Customer. The Customer shall purchase the raw
materials and deliver same to INyX. INyX and the Customer agree to jointly
develop a procedure for testing raw materials that meets all FDA requirements,
prior to the Customer's issuance of its first order for Products hereunder.
2.5 Batch Testing; Certificate of Authenticity
------------------------------------------
INyX shall test, or cause to be tested, in accordance with the Product
Specifications, each batch of Product manufactured pursuant to this Agreement
before delivery to the Customer. Prior to each shipment of Product, INyX shall
provide to the Customer a Certificate of Analysis attesting to the quality of
each batch contained within the shipment, including review and approval by the
appropriate quality control unit of all batch production and control records.
INyX shall maintain and provide the Customer with such documentation as may be
required for compliance with FDA and other applicable regulators.
2.6 Good Manufacturing Practice
---------------------------
INyX shall manufacture, store and prepare all Products for shipping in
accordance with the current Good Manufacturing Practices ("cGMPs") of the FDA,
and the equivalent manufacturing requirements of the European Regulatory
Authorities, in an FDA inspected and ISO9000 certified facility, currently
envisioned to be INyX's facility in Runcorn, U.K. INyX may not change
manufacturing of Products to an alternate facility without first obtaining the
Customer's written approval, including the approvals required pursuant to the
Quality Agreement, such approvals not to be unreasonably withheld.
2.7 DMF
---
To the extent required, INyX shall maintain a DMF, like filing or relevant
registration certificate, suitable for INyX's manufacture of Products, with the
applicable regulatory agencies (including FDA) and shall ensure that its "active
status" is maintained. INyX shall use Commercially Reasonable Efforts to timely
accomplish, and bear the costs of, preparing for regulatory inspection, approval
and associated filings required for the manufacture of Products. The Customer
shall directly pay or reimburse INyX for any fees and payments to such
regulatory agencies required for such inspection, approval and associated
filings (e.g., any FDA inspection fee); it is understood that the Customer is
not responsible for fees and payments related to the general operation of INyX's
business or facilities. INyX will provide letter(s) granting the Customer and
its designees the right of cross-reference to the DMF. INyX reserves the right
to cancel such letter(s) in case of termination of this Agreement; provided
that, any such letter(s) are first offered to be transferred to the Customer and
the Customer declines the transfer.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
2.8 Inspections
-----------
The Customer has the right at any time during the term of this Agreement, upon
reasonable prior notice and during reasonable business hours and without
disruption to INyX's business, to inspect INyX's facility, and to make FDA-type
inspections at its plant to satisfy itself that INyX manufactures and documents
the Product according to current cGMPs, consistent with FDA standards and
requirements. Such inspections may only be made by individuals reasonably
acceptable to INyX. The provisions of this Section 2.8 are subject to the
confidentiality provisions of Article 7. The Customer shall be responsible for
its costs of travel and accommodation for such inspections.
2.9 Changes to Product Specifications
---------------------------------
(a) If the Customer desires any material change to the Product
Specifications or manufacturing process, the Customer shall
deliver, one-hundred and twenty (120) days prior to the
expected date of implementation, written notice to INyX
specifying such change desired by the Customer, and INyX shall
respond to any such notice within thirty (30) days after
INyX's receipt thereof; provided, however, that the Product
Specifications or process shall not be supplemented, modified
or amended in any respect without the prior written agreement
of the Parties. INyX will use Commercially Reasonable Efforts
to implement changes within one-hundred and twenty (120) days.
If the Customer requests a change to a Product Specification,
including the manufacturing process, and INyX agrees that such
change is feasible, such change shall be incorporated within
the Product Specification pursuant to a written amendment to
this Agreement. The Customer shall be responsible for
obtaining any required FDA approval prior to implementation of
such a change at the Customer's cost.
(b) INyX will communicate to the Customer in a timely manner any
change in the Product Specification, including the
manufacturing process, initiated by INyX, and will obtain the
Customer's written approval by way of written amendment of
this Agreement incorporating such change within the Product
Specification prior to implementation of the change. No such
change may be instituted except in compliance with this
Agreement and the Quality Agreement. The Customer shall have
the option of obtaining, or having INyX obtain any required
FDA approval prior to implementation of such a change. INyX
may provide additional services in conjunction with the
manufacture of Products, such as additional formulation,
process development or stability testing, at the request of
the Customer and pursuant to the Customer's purchase order,
and all data and results from such additional services shall
be owned by the Customer and protected as confidential under
this Agreement.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
2.10 Customer Representative at INyX
-------------------------------
The Customer may, at the Customer's expense, place a company representative
on-site at INyX's manufacturing facility during the term of this Agreement.
Subject to the following sentence, such representative shall have full access to
all operations, documents, and records that specifically pertain to the
manufacture of the Products. The Customer Representative shall accept INyX's
procedures regulating external customer relationships (including GMP training,
guarantee of confidentiality, and health procedures), and shall not materially
disrupt INyX's operations.
ARTICLE 3
PLANNING AND SUPPLY
-------------------
3.1 Production
----------
INyX will produce Products to meet the mutually agreed upon forecasts, subject
to the provisions of this Article 3. INyX will keep the Customer informed of all
scheduled production activity for the Products.
3.2 Termination of Obligation
-------------------------
INyX's obligation to supply Product to the Customer shall terminate pursuant to
the provisions of Article 10 below.
3.3 Forecasts
---------
The Customer shall provide INyX with an annual forecast for budgeting and
production planning purposes. The Customer shall also deliver to INyX a monthly
update, including a 90-day rolling forecast setting forth the Customer's
required quantities and delivery dates for each Product. Forecasts shall include
the amounts of each Product to be manufactured and supplied by INyX and the
expected timing for the delivery of each shipment during the forecast period.
The Parties shall discuss each of the forecasts and shall mutually agree in good
faith on the appropriateness of each forecast versus anticipated demand for
Product.
3.4 Purchase Orders
---------------
The Customer will place written purchase orders directly or through its
designated representatives with INyX approximately 10 weeks prior to requested
shipment date, including the following details: number of units, requested
shipping date, shipping instructions and the Customer's order reference number
including the price calculated according to this Agreement. Each purchase order
issued pursuant to this Agreement shall be governed by the terms and conditions
of this Agreement, and shall override any conflicting provisions in any invoice
or packing slip generated by INyX with respect to the details set forth in this
Section 3.4.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
3.5 Receipt and Acceptance by INyX
------------------------------
INyX shall promptly acknowledge its receipt of purchase orders and inform the
Customer of the anticipated dates of manufacture and delivery of each Product
presentation to the Customer. INyX shall respond in writing as to its acceptance
of each firm purchase order within fifteen (15) days of receipt of such order.
Any portion of the order that exceeds the most recent corresponding twelve (12)
month forecast (supplied pursuant to Section 3.3) by more than one hundred ten
percent (110%) will be accepted at INyX's discretion. Once a specified quantity,
form and delivery date terms have been agreed to by the Parties in any purchase
order placed pursuant to this Section 3.5, the purchase order may not be
canceled by either Party except as provided in Section 3.10 or in Section 3.11
below.
3.6 Shipment; Delays
----------------
INyX shall use Commercially Reasonable Efforts to ship Product to the Customer
by the delivery date specified in the accepted purchase order. If INyX believes
there will be a significant delay in shipment of Finished Product beyond the
delivery dates specified in any accepted purchase order, INyX shall promptly
inform the Customer of such expected delay and shall use Commercially Reasonable
Efforts to minimize the delay.
3.7 Change Orders
-------------
The time of delivery and quantities specified in a purchase order accepted by
INyX pursuant to Section 3.5 above shall be binding upon the Parties and may not
be changed or canceled, except as provided in Sections 3.9 and 3.10 below.
3.8 Increased Demand
----------------
INyX will use Commercially Reasonable Efforts to accommodate the Customer's
requests for units in excess of those reserved for the Customer and set forth in
Exhibit B to this Agreement; provided, however, that it shall not be a breach of
this Agreement if INyX, despite its Commercially Reasonable Efforts, is unable
to supply quantities of Product to the Customer in excess of 110% of the annual
forecast supplied pursuant to Section 3.3 for that year.
3.9 Postponement of Manufacturing; Penalties
----------------------------------------
(a) By the Customer. The Customer may postpone a purchase order
for production in accordance with the provisions in this
Section. The Customer may postpone each purchase order one
time. In the event of postponement pursuant to this Section
3.9, INyX shall use Commercially Reasonable Efforts to
reschedule the postponed order to a date agreeable to both
Parties. Regardless of the amount of notice, if the Customer
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
does not reschedule the Date of Manufacture to a date within
forty-five (45) calendar days of the originally scheduled
date, the purchase order shall be deemed cancelled, and shall
accrue the penalties, if any, pursuant to Section 3.10.
(b) By INyX.
(i) INyX shall use Commercially Reasonable Efforts to
meet the terms of a purchase order that it accepts,
taking into account mutually agreed upon forecasts
under Section 3.3, available plant capacity and
timing of its production.
(ii) If INyX fails to meet the deadlines specified in a
purchase order that it has accepted, or specified in
its acceptance of the purchase order, and the failure
is caused by the gross negligence or willful
misconduct of INyX, then the Customer may require
INyX to supply the undelivered Product at the
earliest possible future date (subject to a penalty
of 15% of the cost of such undelivered Product for
each month's delay) unless otherwise agreed by the
Customer, or the Customer may at its option cancel
such portion of the order without penalty.
3.10 Cancellation of Purchase Orders; Penalties
------------------------------------------
The Customer may cancel a purchase order for production in accordance with the
provisions in this Section. The charge for cancellation shall be determined
according to the following schedule:
(a) If the Customer gives at least ninety (90) calendar days
notice prior to the manufacturing date assigned by INyX
pursuant to Section 3.5, there shall be no penalty for
cancellation.
(b) If the Customer gives less than sixty (60) calendar days and
more than twenty-one (21) days notice, INyX may invoice the
Customer for, and the Customer shall be required to pay to
INyX an amount equal to thirty percent (30%) of the amount
owed under the purchase order, calculated in accordance with
Exhibit B; provided, however, that INyX must use Commercially
Reasonable Efforts to reallocate the suite to manufacture
another product of similar value to INyX on the originally
scheduled date, and no charge shall be assessed to the
Customer if such efforts are successful.
(c) If the Customer gives twenty one (21) days or less notice but
more than fourteen (14) days notice INyX may invoice the
Customer for, and the Customer shall be required to pay to
INyX an amount equal to fifty percent (50%) of the amount owed
under the purchase order, calculated in accordance with
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
Exhibit B; provided, however, that INyX must use Commercially
Reasonable Efforts to reallocate the suite to manufacture
another product of similar value to INyX on the originally
scheduled date, and no charge shall be assessed to the
Customer if such efforts are successful.
(d) If the Customer gives less than fourteen (14) days notice of
cancellation, INyX may invoice the Customer for, and the
Customer shall be required to pay, an amount equal to one
hundred (100%) percent of the amount owed under the purchase
order, calculated in accordance with Exhibit B.
3.11 Shipment; Inspection; Rejection
-------------------------------
(a) Shipment of Product. INyX shall ship, or cause to be shipped
at the Customer's expense, the Product to the Customer or such
destination(s) as the Customer may designate in writing.
Delivery of Product to a common carrier authorized by the
Customer shall constitute delivery to the Customer, and risk
of loss shall pass to the Customer at that time. INyX agrees
to provide support to assist the Customer to pursue any
Product related claims it may have against carriers, provided
that the Customer shall reimburse INyX for any out-of-pocket
expenses INyX may incur in providing such support. All
invoices and other shipping documents shall be sent by first
class mail or by fax to the Customer's address for notices
under this Agreement, directed to the attention of Purchasing
Department, ▇▇▇▇▇▇▇ Laboratories, Inc., ▇▇▇▇ ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇, ▇▇ ▇▇▇▇▇.
(b) Non-Conforming Product. The Customer may reject any batch of
Product that does not conform to the Manufacturing Standards,
or that has less than eighteen (18) months remaining before
its expiration date, subject to the terms of this Section and
the Quality Agreement. Within thirty (30) days after INyX's
internal release of Product, the Customer shall inspect the
Product and notify INyX whether it will accept or reject the
Product. No inspection under this Section shall relieve INyX
of its obligations and warranties under this Agreement. If the
Customer rejects all or any part of any shipment of Product,
the procedures to be followed are:
(i) the Customer shall submit to INyX in writing any
claim that the Product does not conform with the
Product Specifications or cGMPs, accompanied by a
report of the Customer's analysis (which analysis
shall be conducted in good faith) and a sample of the
Product at issue, explaining in reasonable detail the
basis on which the allegedly nonconforming Product
does not meet the Product Specifications. Once
nonconformance is confirmed and fault is determined
to belong with INyX, the Customer shall not be
obligated to pay for such nonconforming shipment of
Product. Only those tests listed in the Product
Specifications may be used to demonstrate
nonconformance of Product.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(ii) INyX shall conduct its own analysis of the sample in
good faith within thirty (30) days after the receipt
by INyX of the report and sample from the Customer,
and provide the results to the Customer.
(A) If after INyX's own analysis of the sample
INyX agrees with the claim of nonconformity,
the Customer shall promptly inform INyX if
the Customer wishes to have INyX replace the
nonconforming Product with conforming
Product. If the Customer wishes to receive
such replacement Product, INyX shall provide
such replacement as soon as reasonably
practicable thereafter, in which case the
Customer shall be obligated to pay only for
such replacement Product. The Customer shall
not be obligated to pay for the
nonconforming Product, and INyX shall: (1)
credit the Customer for the amount paid by
the Customer to INyX for the nonconforming
Product if the Customer has already paid for
such nonconforming Product or (2) cancel its
invoice to the Customer for such
nonconforming Product if the Customer has
not yet paid for such nonconforming Product,
and the Customer shall not be obligated to
pay such cancelled invoiced amount.
(B) If, after its own analysis, INyX does not
agree with the claim of nonconformity or
determines that the Customer is responsible
for the nonconformity, such Product shall be
tested for conformance with the applicable
Product Specifications by an independent
third party testing laboratory mutually
acceptable to both Parties. The independent
analysis shall be binding on both Parties
solely for the purpose of determining
whether such Product may be rightfully
rejected.
(iii) After a final determination that the Product shipment
is:
(A) nonconforming, and if INyX is responsible
for the nonconformity, the Customer shall
return or destroy it at INyX's request and
cost in the most cost effective and
environmentally safe and appropriate manner
available, consistent with federal, state
and local laws and regulations;
(B) conforming, the Customer shall forthwith pay
INyX for such Product in accordance with the
terms of this Agreement.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(iv) If conforming Product supplied under this Agreement
becomes nonconforming or unsuitable at no fault of
INyX, the Customer will remain obligated to pay INyX
for such Product. At INyX's request, the Customer
shall return such unsuitable Product to INyX.
Otherwise, the Customer shall destroy it in the most
environmentally safe and appropriate manner
available, consistent with federal, state and local
laws and regulations.
(c) Notwithstanding the other provisions of this Section 3.11, the
Customer shall have no right to reject any Product that fails
to conform with the Manufacturing Standards if the
nonconformance is attributable to (i) events outside of INyX's
control that occurred after delivery to a common carrier, or
(ii) processes, procedures or Product components specified by
the Customer in the Product Specifications, provided that INyX
followed or used such processes, procedures and Product
components materially in accordance with the Product
Specifications.
3.12 Unique Materials
----------------
The Customer shall reimburse INyX for its actual costs expended for the purchase
of "Unique Materials" (i.e., certain raw materials, artwork, printed cans,
labels, cartons and special valves) purchased by INyX expressly to meet its
performance obligations under this Agreement in reliance upon a firm purchase
order pursuant to Section 3.4 and which later are made obsolete, or to the
extent that such Unique Materials remain on hand at the expiration of this
Agreement as provided under Section 10.1. For purposes of this Section, material
is obsolete if it cannot be incorporated into the Product due to changes
mandated by a Regulatory Authority, changes directed by the Customer, or the
Customer-mandated cancellation or postponement. Once material becomes obsolete,
INyX may invoice the Customer for the acquisition costs of such obsolete
material from time to time, which invoices shall identify the material in
question and shall be accompanied by a reasonably detailed statement of the
cause of such obsolescence and a certification that INyX has disposed of such
materials in accordance with the terms of this Agreement.
3.13 Risk of Loss
------------
Risk of loss of Product shall be with INyX until delivery of Product to a common
carrier pursuant to Section 3.11 of this Agreement. Notwithstanding the
forgoing, INyX shall not be liable for loss of Product caused by an event of
force majeure or the Customer's negligence or willful misconduct.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
3.14 Insurance
---------
INyX shall at its own expense obtain and maintain workers' compensation and
comprehensive general liability insurance with respect to performance under this
Agreement, in the amount of Five Million British Pounds Sterling
((pound)5,000,000).
ARTICLE 4
PRICE AND PAYMENT TERMS
-----------------------
4.1 Price for Products
------------------
The Customer shall pay INyX for Products in amounts to be agreed for each
Product and for each size or formulation. The agreed upon price for each Product
shall be set forth in the document attached as Exhibit B to this Agreement,
which Exhibit may be amended from time to time by the mutual written agreement
of the Parties.
4.2 Invoices
--------
INyX shall submit to the Customer an invoice five (5) days after INyX's internal
release of Product. The Customer shall make payment of each invoice within
forty-five (45) days after receipt by the Customer. If within forty-five (45)
days after the delivery of Product and the accompanying Certificate of Analysis
to the Customer, the Customer demonstrates non-conformance under Section 3.11
and INyX agrees with such finding, the Customer shall not be obligated to pay
for such non-conforming shipment.
4.3 Exclusivity
-----------
The Parties agree to deal with each other exclusively with respect to the
manufacture and supply of topical and foam aerosol products used for
dermatological applications (together with ***, the "Dermatological Products")
during the term of this Agreement (the "Exclusivity Period"), including
extensions and renewals thereof. This exclusivity arrangement:
(a) shall not apply to the manufacture and supply of
Dermatological Products in respect of the current customers of
INyX (formerly the customers of *** and its subsidiaries) such
Dermatological Products and customers to be set out in Exhibit
4.3(a). INyX shall be free to continue to supply such
Dermatological Products to such customers; and
(b) may, at the request of INyX, be suspended for the manufacture
of certain Dermatological Products upon obtaining the consent
of the Customer, such consent not to be unreasonably withheld.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
4.4 ***
---
***
4.5 Currency
--------
Amounts due to INyX under this Agreement are payable in U.S. Dollars, based on
the average exchange rate published in the Wall Street Journal from ten (10)
days prior through the date of the Customer's first rolling forecast provided to
INyX pursuant to Section 3.3 above. If the exchange rate published in the Wall
Street Journal from ten (10) days prior through the date of a subsequent six (6)
month rolling forecast differs by more than five percent (5%) from the exchange
rate then prevailing between the Parties, the Party against which such
difference works may, within ten (10) days, request a renegotiation of such
exchange rate with the other Party. The difference in any such renegotiated
exchange rate not to exceed fifty percent (50%) of the difference between said
then-prevailing and published exchange rates.
4.6 Set-Off
-------
The parties acknowledge that, INyX has made a convertible promissory note of
even date in favour of the Customer in the face amount of (pound)2,500,000.00
British Pounds Sterling (the "Promissory Note"). INyX agrees that the Customer
may, from time to time, at its sole discretion, set-off against amounts due
hereunder any overdue interest or principal payments accruing due pursuant to
the Promissory Note, upon providing INyX ten (10) business days notice of the
Customer's intention to set-off such amounts; and to permit INyX to cure any
default under the Promissory Note as provided therein.
ARTICLE 5
WARRANTIES
----------
5.1 Quality
------
Each shipment of Product under this Agreement shall have been manufactured in
accordance with U.S. Current Good Manufacturing Practices in a duly licensed
facility and shall have been subject to a quality control inspection by the
Customer in accordance with the Product Specifications and with the Customer's
then current quality control standards and systems. INyX shall number each
Product shipment with a vendor lot number that is traceable to raw materials
and/or components used to manufacture such Product.
5.2 Representations and Warranties
------------------------------
(a) INyX warrants that Product delivered to the Customer pursuant
to this Agreement shall, at the time of delivery:
(i) have been manufactured, filled, packaged, stored and
shipped in accordance with all applicable laws,
rules, regulations or requirements;
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(ii) have been manufactured, filled, packaged and stored
in accordance with, and will conform to, the Product
Specifications;
(iii) will be free from defects in material, manufacturing
and workmanship for the shelf life of the Product as
set forth in the Product Specifications;
(iv) not be adulterated or misbranded within the meaning
of the Federal Food, Drug and Cosmetic Act (the
"Act") as amended, or within the meaning of any
applicable state or municipal law in which the
definitions of adulteration and misbranding are
substantially the same as those contained in the Act,
as the Act and such laws are constituted and
effective at the time of delivery; and
(v) will not be an article which may not, under the
provisions of Sections 404 and 505 of the Act, be
introduced into interstate commerce.
(b) Licensing. INyX represents and warrants that it has obtained
and will maintain on a current basis and will comply with all
licenses, permits and approvals of applicable governmental
agencies as may be required to manufacture, test and store the
Product pursuant to this Agreement and perform its other
obligations under this Agreement. INyX shall be responsible
for obtaining and maintaining licenses and permits for
manufacture, testing and storage of the Product and ensuring
that its facilities used in the manufacture of the Product
meet cGMPs in all respects.
(c) Compliance with Laws. INyX represents and warrants that it
shall comply with all federal, state, local and foreign laws,
regulations and other requirements applicable to the
manufacture, testing and storage of the Product and the
performance of INyX's obligations under this Agreement. INyX
shall have sole responsibility for adopting and enforcing
safety procedures for the handling and manufacture of the
Product at its facilities and the proper handling and proper
disposal of waste relating to the Product.
5.3 Limitations; Indemnification
----------------------------
(a) Limitations on Warranty. The warranty furnished in this
Article 5 shall not apply to defects caused by accident or
willful damage, abuse, misuse, neglect, improper testing,
handling, storage or use after delivery by INyX of the Product
in question to the Customer.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(b) No Implied Representations; Warranties or Conditions. EXCEPT
AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
INYX NOR THE CUSTOMER MAKES ANY REPRESENTATIONS OR WARRANTIES
AND THERE ARE NO CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO PRODUCT SUPPLIED UNDER THIS
AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY REPRESENTATIONS,
WARRANTIES OR CONDITIONS WITH RESPECT TO NONINFRINGEMENT,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF SUCH
PRODUCT, OR ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE
PRACTICE.
(c) Limitation of Liability. EXCEPT FOR ANY LOSS, LIABILITY,
DAMAGE OR OBLIGATION ARISING OUT OF OR RELATING TO THE
DISCLOSURE OF CONFIDENTIAL INFORMATION PURSUANT TO ARTICLE 7
OR AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO
EVENT SHALL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER PARTY
OR ANY OTHER THIRD PARTY FOR ANY LOST OPPORTUNITY, COSTS OF
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SPECIAL
DAMAGES ARISING OUT OF THIS AGREEMENT, UNDER ANY CAUSE OF
ACTION OR THEORY OF LIABILITY (INCLUDING NEGLIGENCE), AND
WHETHER OR NOT SUCH PARTY TO THIS AGREEMENT HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGE. THESE LIMITATIONS SHALL
APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY
LIMITED REMEDY. INYX'S MAXIMUM LIABILITY UNDER THIS AGREEMENT
SHALL BE LIMITED TO THE INYX'S ACTUAL RECOVERY UNDER ITS
COMPREHENSIVE GENERAL LIABILITY INSURANCE WHICH AS OF THE DATE
HEREOF CARRIES A COVERAGE OF FIVE MILLION BRITISH POUNDS
STERLING.
(d) INyX shall use commercial efforts in pursuing claims under its
comprehensive general liability insurance in order to
reasonably permit the Customer to recover losses, as its
interest may appear, pursuant to this Agreement. Upon the
Customer's request, INyX shall assign to the Customer (to the
extent it can legally do so) its rights to insurance proceeds,
provided the Customer has a valid claim against INyX under
this Agreement that is either unconditionally admitted by INyX
or is otherwise finally confirmed by court action or other
dispute resolution process.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
ARTICLE 6
TECHNOLOGY TRANSFER
-------------------
6.1 Second Source
-------------
INyX shall assist the Customer (at the Customer's cost and expense) in
qualifying a second source for Product, providing technical assistance and
documentation as necessary, including such manufacturing technology and know-how
so as to permit another entity to manufacture Product, and INyX agrees to
cooperate with the Customer to facilitate the technology transfer.
6.2 Reimbursement
-------------
The Customer agrees to reimburse INyX for INyX's expenses in providing the
assistance required in Section 6.1 for any second source other than an Affiliate
of INyX.
6.3 Intellectual Property
---------------------
INyX shall use Commercially Reasonable Efforts to assist the Customer with the
preparation and filing of patent applications in connection with the Products;
provided that, the Customer shall reimburse INyX for all out-of-pocket costs and
expenses incurred by INyX.
For greater clarity, INyX acknowledges that all intellectual property created
specifically in connection with the Products (the "Intellectual Property"),
including formulations, inventions or discoveries (first made or reduced to
practice in the performance of INyX's obligations hereunder) shall be the
property of the Customer. INyX shall, when requested by the Customer, execute
all such assignments, consents and other documents reasonably necessary to
assign to the Customer all right, title and interest in and to all the
Intellectual Property, and shall use best efforts to cause its employees, agents
and subcontractors to execute the necessary documents to give effect to this
provision.
The Customer hereby grants INyX a royalty-free, non-exclusive, worldwide right
and license to make, use and sell products incorporating Intellectual Property,
subject always to INyX's obligations hereunder.
ARTICLE 7
CONFIDENTIALITY
---------------
7.1 Confidentiality
---------------
(a) Confidential Information. The Parties acknowledge that by
reason of their relationship to each other under this
Agreement, each will have access to certain information and
materials concerning the other's business, plans, trade
secrets, customers (including, but not limited to, customer
lists), technology, and/or products that is confidential and
of substantial value to that Party, which value would be
impaired if such information were disclosed to Third Parties
("Confidential Information"). Each Party agrees that it will
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
not use in any way other than expressly authorized or
contemplated under this Agreement, nor disclose to any third
party, any such Confidential Information revealed to it by the
other Party (except that Confidential Information may be
disclosed, as required for the purposes of this Agreement, to
any Regulatory Authority, an Affiliate, assignee, distributor,
consultant or third party contractor or research and
development organization under similar written obligations of
non-disclosure and non-use), and will take every reasonable
precaution to protect the confidentiality of such information
and with no less restrictive precautions than it takes to
protect its own confidential information. If Confidential
Information is required to be disclosed in response to a valid
order by a court, Regulatory Authority or other government
body of competent jurisdiction, or if otherwise required to be
disclosed by law, or if necessary to establish the rights of
either Party under this Agreement, the receiving Party shall
use reasonable efforts to provide the disclosing Party with
advance notice of such required disclosure to give the
disclosing Party sufficient time to seek a protective order or
other protective measures, if any are available, for such
Confidential Information.
(b) Exceptions. For purposes of this Agreement, information shall
be deemed Confidential Information if such information, by its
nature or due to the context within which it is disclosed, is
obviously intended by the disclosing Party to be kept
confidential even if not identified as such in writing or with
legends or other markings. The person disclosing Confidential
Information shall endeavor to confirm verbally disclosed
Information as "CONFIDENTIAL" in writing, given the
understanding that failure to do so does not constitute a
designation of non-confidentiality, particularly when the
confidential nature is apparent from context and subject
matter. Upon request by a Party, the other Party will advise
whether or not it considers any particular information or
materials to be Confidential Information. Confidential
Information does not include information, technical data or
know-how that:
(i) is or becomes publicly available through no fault of
the receiving Party or its individual employees,
agents or members amounting to a breach of this
Agreement;
(ii) is lawfully obtained on a non-confidential basis by
the receiving Party from a third party who is not
obligated to retain such information in confidence;
(iii) the receiving Party can demonstrate, by competent
evidence, was known to it or any of its Affiliates
from a source other than the disclosing Party or any
of its Affiliates prior to the disclosure under this
Agreement;
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(iv) the receiving Party can demonstrate by its written
records is independently developed by employees of
the receiving Party or an Affiliate of the receiving
Party, which employees were neither privy to nor had
access to the Confidential Information and which is
developed without use in any way of the Confidential
Information;
(v) must be disclosed to governmental agencies, provided
that: (A) this exception shall only apply to
disclosure to such agencies, and not to any other
person or entity; and (B) the disclosing Party shall
(1) provide the other Party with prompt notice
(including copies of all written requests or demands)
of any proposed disclosure to any governmental
agency, with an explanation of the Confidential
Information of the other Party to be disclosed; and
(2) cooperate in any lawful effort by the other Party
to prevent, limit or restrict disclosure of its
Confidential Information to such government agency.
7.2 Remedy
------
If either Party breaches any of its obligations with respect to this Article 7,
or if such a breach is likely to occur, the other Party shall be entitled to
seek equitable relief, including specific performance or an injunction, in
addition to any other rights or remedies, including money damages, provided by
law, without posting a bond.
7.3 Agreement Terms
---------------
Subject to Section 15.2 and the exclusions set forth in Section 7.1(b), the
Parties shall treat the terms and conditions of this Agreement as Confidential
Information; provided, however, after written notification to the other Party,
each Party may disclose the existence of this Agreement and the material terms
and conditions of this Agreement under circumstances that reasonably ensure the
confidentiality thereof to: (a) any government or regulatory authorities,
including without limitation the United States Security and Exchange Commission
pursuant to applicable law (excluding, to the extent legally permitted,
disclosure of financial terms in any publicly available versions of information
so disclosed), (b) its legal representatives, advisors and prospective
investors, and (c) to the Customer's licensors to the extent required for
compliance with the Customer's obligations under third party licenses.
7.4 Return of Confidential Information
----------------------------------
Within ten (10) days following the termination of any agreement between the
Parties with respect to the subject matter the receiving Party agrees to
promptly return all tangible items relating to the Confidential Information,
including all written material, photographs, models, compounds, compositions and
the like made available or supplied by the disclosing Party to the receiving
Party, and all copies thereof, upon the request of the disclosing Party, except
such records as may be required to be kept for FDA or other government
regulatory compliance. Recipient further agrees to identify those persons to
whom the Confidential Information that is the subject of this Agreement was
disclosed upon request of the disclosing Party.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
7.5 Inside Information
------------------
INyX understands that Confidential Information may constitute "inside
information" of the Customer for securities purposes and agrees to refrain from
any unlawful disclosure, trading or other improper use of such information.
7.6 ***
---
*** has, to the best of INyX's knowledge (after due enquiry), returned to ***
all Confidential Information of *** under the provisions of the Amended and
Restated Manufacturing and Supply Agreement between *** and *** dated ***.
ARTICLE 8
ASSIGNMENT
----------
8.1 Assignment by INyX
------------------
INyX shall have no right or authority to assign the Agreement or any portion of
the Agreement, to sublet or subcontract in whole or in part, or otherwise
delegate its performance under this Agreement, without the Customer's prior
written consent, such consent not to be unreasonably withheld. Notwithstanding
the foregoing, nothing in this Agreement shall prohibit INyX from assigning this
Agreement to any Affiliate of INyX that may from time to time own or operate the
facility at Runcorn, England. No such assignment shall relieve INyX of primary
liability for the performance of its obligations under this Agreement.
8.2 Assignment by the Customer
--------------------------
The Customer may assign this Agreement. INyX agrees that if this Agreement is
assigned to any third party or Affiliate, all the terms and conditions of this
Agreement shall obtain between such third party or Affiliate and INyX with the
same force and effect as if said Agreement had been made with such third party
or Affiliate in the first instance, provided that no such assignment shall
relieve the Customer of primary liability for the due performance of this
Agreement.
ARTICLE 9
FORCE MAJEURE
-------------
9.1 Force majeure
-------------
Neither Party shall be considered in default of performance of its obligations
under this Agreement, except any obligation under this Agreement to make
payments when due, to the extent that performance of such obligations is delayed
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
by contingencies or causes beyond the reasonable control and not caused by the
negligence or willful misconduct of such Party, including but not limited to
strike, fire, flood, earthquake, windstorm, governmental acts or orders or
restrictions, or force majeure, to the extent that the failure to perform is
beyond the reasonable control of the nonperforming Party, if the Party affected
shall give prompt written notice of any such cause to the other Party. The Party
giving such notice shall thereupon be excused from such of its obligations under
this Agreement for the period of time that it is so disabled.
ARTICLE 10
TERM AND TERMINATION
--------------------
10.1 Term
----
This Agreement shall expire on March 6, 2007 (the "Initial Term"), after which
this Agreement may be renewed for successive periods of one calendar year each,
any such agreement to renew to be confirmed in writing by the Parties. At the
end of the Initial Term, this Agreement shall, at the Customer's option,
automatically renew for successive one-year periods under the same terms and
conditions set forth under this Agreement (or such other terms agreed in writing
by the Parties) until terminated in writing in accordance with the provisions of
this Agreement.
10.2 Termination for Material Breach
-------------------------------
Either Party may terminate this Agreement upon written notice if the other Party
has breached any of its material obligations under this Agreement, and (a) such
breach has not been cured within 60 days after written notice of the breach, or
(b) if a plan, reasonably acceptable to the non-breaching Party, is not
implemented to cure as soon as practicable after notice of the breach
10.3 Termination upon Insolvency
---------------------------
Either Party may, in addition to any other remedies available to it by law or in
equity, terminate this Agreement immediately by written notice to the other
Party upon (i) the filing by the other Party of a voluntary petition in
bankruptcy or seeking reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts or any other relief under
any bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, (ii) the filing against such other
Party of an involuntary petition in bankruptcy which is not dismissed within 60
days, (iii) the appointment of a receiver or trustee of any of such other
Party's property if such appointment is not vacated within 60 days, (iv) the
adjudication of such other Party as insolvent, or (v) the assignment of such
other Party's property for the benefit of its creditors.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
10.4 Termination for Force Majeure
-----------------------------
Either Party may terminate this Agreement upon thirty (30) days written prior
notice in the event of the other Party's inability to substantially perform its
obligations under this Agreement for more than one hundred eighty (180) days due
to an event of force majeure as described in Article 9.
10.5 Termination without Cause
-------------------------
Either Party may terminate this Agreement upon twelve (12) months' written
notice to the other Party.
10.6 Accrued Liabilities
-------------------
The termination of this Agreement for any reason shall not discharge either
Party's liability for obligations incurred under this Agreement and amounts
unpaid at the time of such termination. The Customer shall be liable to pay INyX
for any Product, work in progress and materials purchased by INyX to fulfill its
obligations under this Agreement, provided however that INyX shall make all
Commercially Reasonable Efforts to mitigate its damages under such
circumstances.
10.7 Return and Disposition of Property
----------------------------------
Upon the termination of this Agreement for any reason, each Party shall return
to the other Party or its designee all of such other Party's property,
including, but not limited to, all proprietary information, in its possession.
To the extent required by law or to comply with such Party's continuing
obligations under this Agreement, each Party may keep a single copy of tangible
property belonging to the other Party. INyX shall dispose of all bulk active
ingredients, raw materials, containers, and Labeling not necessary to complete
work in progress at the Customer's expense in accordance with the Customer's
reasonable instructions.
ARTICLE 11
INDEMNIFICATION
---------------
11.1 Indemnification by INyX
-----------------------
INyX shall, subject to Section 5.3, indemnify the Customer, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all suits, losses, actions,
demands, investigations, claims, damages, liabilities, costs and expenses
(including, without limitation, reasonable attorneys' fees and expenses)
(collectively, "Losses") brought by third parties arising from or occurring as a
result of:
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(a) a nonconformity of Product with the warranties under Sections
5.1 and 5.2 except for any damages attributable to the
negligence of the Customer, its employees or agents;
(b) INyX's failure to comply with the Product Specifications;
(c) any willful act or omission or negligence of INyX or its
employees, agents or other contractors in the manufacturing
and testing of the Product; or
(d) INyX's failure to comply with the Act and the regulations
under the Act in the production of Product.
(e) any breach (or alleged breach) by INyX of its representations,
warranties, or obligations under this Agreement;
(f) the manufacture or the storage of the Product prior to the
date of shipment of Product to the Customer by INyX or its
Affiliates,
all except to the extent caused by the negligence or willful misconduct
of the Customer or its officers, agents, employees, Affiliates,
sublicensees or customers.
11.2 Indemnification by the Customer
-------------------------------
The Customer shall, subject to Section 5.3, indemnify INyX, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all Losses brought by third
parties arising from or occurring as a result of:
(a) failure by the Customer to comply with the Food Drug and
Cosmetic Act and the regulations under the Act;
(b) the handling or other use of the Product;
(c) any willful act or omission or negligence of the Customer or
its employees, agents or other contractors
(d) any breach (or alleged breach) by the Customer of its
representations, warranties, or obligations under this
Agreement;
(e) the manufacture by the Customer or third parties contracted by
the Customer, or the storage of Product after the date of
shipment of Product to the Customer by INyX or its Affiliates,
all except to the extent caused by the negligence or willful misconduct of INyX
or its officers, agents, employees, Affiliates, sublicensees or customers.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
11.3 Process
-------
If either Party expects to seek indemnification from the other pursuant to the
provisions of this Article 11, it shall promptly give notice to the indemnifying
Party of any such Claim. The indemnifying Party shall have the right to control
the defense of such Claim and the indemnified Party shall cooperate with the
indemnifying Party in the defense of such Claim. No settlement or compromise of
any Claim shall be binding on a Party hereto without its prior written consent.
11.4 Patent Indemnification
----------------------
The Customer shall indemnify and hold INyX and its employees, servants and
agents harmless from and against any and all claims, demands, actions, suits,
losses, damages, costs, expenses (including reasonable attorney's fees), and
liabilities which INyX may incur, suffer or be required to pay by reason of any
patent infringement suit brought against INyX because of INyX's manufacture of
Product to the extent that the alleged infringement arose out of or related to
INyX's use of processes, compounds or other products the rights to which are
claimed to be owned by the Customer.
ARTICLE 12
AUDIT RIGHTS; INSPECTIONS
-------------------------
12.1 Inspections
-----------
The Customer, upon its own discretion and at its own cost and expense, is
entitled during ordinary business hours and at dates acceptable to INyX to
inspect or to have inspected, INyX's plant and procedures used for manufacture
and storage of the Products.
12.2 Books and Records
-----------------
INyX agrees to maintain and cause its Affiliates to maintain complete and
accurate books and records of account so as to enable the Customer to verify
amounts due and payable under this Agreement. In particular, INyX shall preserve
and maintain all such records and accounts required for audit for a period of
four (4) years after the calendar quarter for which the record applies.
12.3 Audit of INyX's Records
-----------------------
During the term of this Agreement, the Customer shall have the right upon two
(2) weeks notice to INyX to have an independent certified public accountant,
selected by the Customer and reasonably acceptable to INyX, audit INyX's records
during normal business hours; provided, however, that such audit shall not take
place more frequently than once a year and shall not cover records for more than
the preceding four (4) years.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
12.4 Government Inspection
---------------------
INyX agrees to advise the Customer by telephone and facsimile immediately of any
proposed or announced visit or inspection, and as soon as possible but in any
case within twenty-four (24) hours of any unannounced visit or inspection, by
any Regulatory Authority of any facilities used by INyX in the performance of
its obligations under this Agreement. INyX shall provide the Customer with a
reasonable description of each such visit or inspection promptly (but in no
event later than five 5 calendar days) thereafter, and with copies of any
letters, reports or other documents (including Form 483's) issued by any such
authorities that relate to the Products, or such facilities, processes or
procedures. The Customer may review INyX's responses to any such reports and
communications, and if practicable, and, insofar as timely received, the
Customer's reasonable views and requests shall be taken into account prior to
submission of such reports and communications to the relevant Regulatory
Authority.
ARTICLE 13
DISPUTES
--------
13.1 Arbitration
-----------
If the Parties' are unable to settle amicably any claim, dispute, controversy or
difference arising out of or in relation to or in connection with this Agreement
or for breach of this Agreement through consultation and negotiation in good
faith and a spirit of mutual cooperation, then the dispute shall be resolved
through binding arbitration in accordance with the rules of the American
Arbitration Association then in effect. Judgment upon the award rendered by the
arbitrators may be entered in any court having jurisdiction thereof. In any
arbitration pursuant to this section, the award shall be rendered by a majority
of the members of a board of arbitration consisting of three members, one being
appointed by each Party and the third being appointed by mutual agreement of the
two arbitrators appointed by the Parties. The place of arbitration shall be New
York, New York.
13.2 UN Convention Not Applicable
----------------------------
The Parties expressly disclaim application to this Agreement of the United
Nations Convention on Contracts for the International Sale of Goods, and agree
that it shall not govern or apply to this Agreement or its performance or
construction.
13.3 Governing Law
-------------
This Agreement shall be governed, controlled, interpreted and defined by and
under the laws of the State of New York and the United States without regard to
that body of law known as conflicts of law; provided that issues relating to the
validity and enforceability of patents shall be governed by the laws of the
jurisdiction by which such patent was granted.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
ARTICLE 14
NOTICES
-------
14.1 Notice.
-------
Any notice required or permitted by this Agreement shall be in writing and shall
be sent by prepaid registered or certified mail, return receipt requested; by
facsimile; by internationally recognized courier; or by personal delivery, in
each case addressed to the other Party at the address below or at such other
address for which such Party gives notice under this Agreement.
If to the Customer at:
▇▇▇▇▇▇▇ Laboratories, Inc.
Attention: President and Chief Executive Officer
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
If to INyX, at:
INyX Pharma Ltd.
Attention: ▇▇▇▇▇ ▇▇▇▇▇▇▇
▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
Runcorn, Cheshire, UK WA7 1S&
Such notice shall be deemed to have been given when delivered or, if delivery is
not accomplished by some fault of the addressee, when tendered. Either Party may
change its address for notice by delivering a written notice of the new address
in accordance with this Article.
ARTICLE 15
NATURE OF RELATIONSHIP
----------------------
15.1 No Agency; Independent Contractor
---------------------------------
Each Party is and shall be considered to be an independent contractor of the
other Party. Neither Party shall be the legal agent of the other for any purpose
whatsoever and neither Party has any right or authority to make or underwrite
any promise, warranty or representation, to execute any contract or otherwise to
assume any obligation or responsibility in the name of or on behalf of the other
Party. Neither Party shall be bound by or liable to any third persons for any
act or for any obligation or debt incurred by the other toward such third party,
except to the extent specifically agreed to in writing by the Party so to be
bound.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
15.2 Public Statements
-----------------
The Parties shall endeavor to provide courtesy copies of any public
announcements concerning the relationship created by this Agreement. Neither
Party shall make any representations concerning the other without the prior
consent from the other Party. Notwithstanding the foregoing, each Party consents
to references to it in reports or documents or other disclosures sent to
stockholders or filed with or submitted to any governmental authority or stock
exchange. Except for such disclosure as is required by applicable law and/or
stock exchange regulation, neither Party shall make any announcement, news
release, public statement, publication or presentation relating to the existence
of this Agreement or the arrangements referred to in this Agreement without
first notifying the other Party.
ARTICLE 16
ADDITIONAL PROVISIONS
---------------------
16.1 Headings
--------
Article and section headings contained in this Agreement are included for
convenience of reference only and shall not affect in any way the meaning or
interpretation of this Agreement.
16.2 Partial Invalidity
------------------
If any provision of this Agreement is held to be invalid, illegal, or
unenforceable by a court of competent jurisdiction, then: (a) such provision
will be deemed amended to conform to applicable laws of such jurisdiction so as
to be valid and enforceable, or, if it cannot be so amended without materially
altering the intention of the Parties, it will be stricken; (b) the validity,
legality and enforceability of such provision will not in any way be affected or
impaired thereby in any other jurisdiction; and (c) the remaining provisions of
this Agreement will remain in full force and effect.
16.3 Survival
--------
The covenants and agreements set forth in Articles 7, 11 and 13 shall survive
any termination or expiration of this Agreement and remain in full force and
effect regardless of the cause of termination.
16.4 Entire Agreement
----------------
This Agreement, including the attached Exhibits, constitutes the entire
agreement of the Parties with respect to the subject matter, and supersedes all
prior or contemporaneous understandings or agreements, whether written or oral,
between the Customer and INyX with respect to such subject matter. In
particular, (a) in the event of conflict between this Agreement and the terms
and conditions of any purchase order or other form generated in performance of
this Agreement, then the terms and conditions of this Agreement shall control,
and (b) in the event of conflict between this Agreement and the Quality
Agreement (as it may be amended from time to time), the terms of this Agreement
shall govern all aspects of the relationship between the Parties except that the
Quality Agreement shall govern with respect to quality matters.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
16.5 Waivers
-------
No waiver of any term or condition of this Agreement shall be valid or binding
on either Party unless agreed in writing by the Party to be charged. The failure
of either Party to enforce at any time, or for any period of time, any provision
of this Agreement, or the failure to require at any time performance by the
other Party of any provision of this Agreement, shall in no way be construed to
be a present or future waiver of such provisions or of the right of such Party
thereafter to enforce that provision or other provisions of this Agreement.
16.6 Assignment, Binding Effect
--------------------------
Neither Party shall assign this Agreement, by operation of law or otherwise,
except to an Affiliate of such Party, without the prior written consent of the
other Party, which consent shall not be unreasonably withheld, and any such
attempted assignment without such consent shall be void. No assignment shall be
effective until the assignee shall have unconditionally assumed in writing all
of the assignor's obligations under this Agreement and a written notice of such
assignment is given to all the other Parties. When duly assigned in accordance
with the foregoing, this Agreement shall be binding upon and inure to the
benefit of the assignee.
16.7 Amendment
---------
No amendment or modification of this Agreement shall be valid or binding upon
the Parties unless made in writing and signed by the duly authorized
representatives of both Parties.
16.8 Taxes
-----
INyX and the Customer shall cooperate in seeking and/or applying for all
available waivers, exclusions, exemptions, rebates and the like with respect to
potential taxes (e.g., VAT) on the Products.
16.9 Conflicting Terms and Conditions
--------------------------------
All sales under this Agreement shall be subject to the provisions of this
Agreement (including, without limitation, the Product Specifications) and shall
not be subject to the terms and conditions contained on any purchase order of
the Customer or confirmation of INyX, except insofar as any such purchase order
or confirmation establishes:
(a) the quantity and form of any Product ordered;
(b) the shipment date;
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
(c) the shipment routes and destinations; or
(d) the carrier.
16.10 Binding Effect and Assignment
-----------------------------
Each Party agrees that its rights and obligations under this Agreement may not
be transferred or assigned directly or indirectly, except as follows: (a) either
Party may transfer or assign this Agreement to an Affiliate of such Party which
agrees in writing to undertake the obligations under this Agreement, (b) either
Party may transfer or assign this Agreement in connection with the sale of all
or substantially all of the assigning Party's related business, and (c) either
Party may transfer or assign this Agreement to a non-Affiliate third party with
the prior written consent of the other Party, which consent shall not be
unreasonably withheld. Subject to the foregoing, this Agreement shall be binding
upon and inure to, the benefit of the Parties, their successors and assigns. Any
attempted assignment contrary to the provisions of this Section 16.10 shall be
deemed ineffective, and either Party shall have the right to terminate this
Agreement, with the effect described in Section 10.2.
16.11 Counterparts
------------
This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original and all of which together shall constitute one and the
same agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed
by their respective duly authorized officers as of the date first written above.
▇▇▇▇▇▇▇ LABORATORIES, INC. INYX PHARMA LTD.
Per:/S/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Per: /S/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
--------------------- -------------------
Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Vice President, CFO and Treasurer Title: Director
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
LIST OF EXHIBITS
Exhibit 4.3(a) Current Customers and Dermatological Products
Exhibit A ▇▇▇▇▇▇▇ Products
Exhibit B Pricing
Exhibit C Quality Agreement
Exhibit D Forecasts
Exhibit E-1, E-2 etc Development Agreements
Exhibit 4.3(a)
Current Customers and Dermatological Products
---------------------------------------------
See Attachment dated 28th February, 2003
Exhibit A
▇▇▇▇▇▇▇ Products
----------------
Marketed Name NDC Code Size
Exhibit B
Pricing
-------
Name Size Price per Unit* Price per Unit(Free Issue)
*** *** ***
*** *** ***
*** *** ***
*** *** ***
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
Exhibits
Exhibit C
Quality Agreement
-----------------
[See Attachment dated 4.03.03]
Exhibit D
Forecast Format and Timing
--------------------------
With respect to forecasts supplied by the Customer:
-------------------------- ------------------------- ---------------------------
Date Submitted Description Purchase Orders Issued for
Manufacturing Dates During:
-------------------------- ------------------------- ---------------------------
-------------------------- ------------------------- ---------------------------
-------------------------- ------------------------- ---------------------------
Exhibit E
Development Agreements
----------------------
Future development agreements between the Parties with respect to new Product
candidates shall be attached to this Agreement as Exhibits E-1, E-2, E-3, etc.
___________________________
***Confidential material redacted and filed separately with the Commission
CONFIDENTIAL TREATMENT
Exhibits
