exv10w34w3



 






Exhibit 10.34.3




EXECUTION
VERSION




MANUFACTURING AND SUPPLY AGREEMENT




     THIS MANUFACTURING AND SUPPLY AGREEMENT (the “Agreement”) is made and entered into as
of March 31st, 2005 (the “Effective Date”) by and between AVENTIS
PHARMACEUTICALS, INC., a Delaware corporation (“Aventis”), and INYX USA, LTD., an Isle of
Man limited corporation (“Inyx”).



RECITALS




     WHEREAS, Aventis desires to engage Inyx, and Inyx is willing to be engaged by Aventis,
effective as of the Effective Date, to perform certain services for Aventis, as more specifically
set forth herein, in connection with the manufacturing, labeling, packaging and supply of certain
finished products to Aventis’ Affiliate, Aventis; and



     WHEREAS, the Parties hereto are also parties to that certain Asset Purchase Agreement, dated
as of December 15, 2004 (the “Asset Purchase Agreement”).



COVENANTS




     NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, the Parties hereto hereby agree as follows:



ARTICLE 1

DEFINITIONS




     The following terms, whether used in the singular or plural, shall have the meanings assigned
to them below for purposes of this Agreement:



     1.1 “Acquisition Cost” shall mean the actual invoiced price paid by Inyx to any Third
Party for acquiring Components required hereunder, including, but not limited to, shipping and
handling costs, customs duties and taxes (other than taxes for which Inyx receives a corresponding
benefit or credit) incurred and paid by Inyx to any Third Party in connection with the acquisition
of Components, as the case may be.



     1.2 “Active Ingredient” shall mean, with respect to each Aventis product, the active
ingredient(s) for such Aventis Product identified on Exhibit A hereto.



     1.3 “Affiliate” means, as to any Person, any other Person or group acting in concert
in respect of the Person that, directly or indirectly through one or more intermediaries, controls,
is controlled by, or is under common control with that Person. For purposes of this definition,
“control” (including, with correlative meanings, the terms “controlled by” and “under common
control with”), as used with respect to any Person or group of Persons, means possession, directly
or indirectly, of the power to direct or cause the direction of the management and policies of the
Person, whether through the ownership of voting securities, by contract, or otherwise.



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     1.4 “Agreement” shall mean this Manufacturing and Supply Agreement, as it may
hereafter be amended or supplemented from time to time pursuant to Section 24.4 hereof.



     1.5 “Aventis Products” shall mean the pharmaceutical products specified in Exhibit
A hereto supplied to Aventis, Aventis Affiliates and/or their permitted assigns.



     1.6 “Aventis Required Purchases” shall have the meaning specified in Section 2.2
hereof.



     1.7 “Batch” shall mean a production batch as reflected in the master batch record(s)
contemplated by the Technical Agreement.



     1.8 “Business Day” means a day other than a Saturday, Sunday or a day that is a
statutory holiday in the Commonwealth of Puerto Rico.



     1.9 “cGMPs” shall mean current good manufacturing practices as required by any
applicable regulatory authority, including without limitation pursuant to Parts 210 and 211 of
Title 21 of the United States Code of Federal Regulations, together with the latest FDA and other
applicable guidance documents pertaining to manufacturing and quality control practice, all as
updated, amended and revised from time to time.



     1.10 “Calendar Day” means a 24-hour day of the calendar, including Saturday, Sunday or
a day that is a statutory holiday in the Commonwealth of Puerto Rico.



     1.11. “Category A Complaint (Critical)”: Any complaint about a potential or alleged
failure of a drug to meet any of its quality specifications that represents a potential risk to the
customer/patient.



     1.12 “Category B Complaint”: Any complaint about a potential or alleged failure of a
drug to meet any of its quality specifications that does not represent a potential risk to the
customer/patient.



     1.13 “Claims” shall have the meaning set forth in Section 14.1 hereof.



     1.14 “Components” shall mean all materials, other than Active Ingredients, required to
produce and ship the Aventis Products in accordance with the Specifications, including without
limitation all shipping materials, packaging components, labels, product inserts, other labeling,
raw materials and ingredients.



     1.15 “Confidential Information” shall mean all information, data, know-how and all
other business, technical and financial data disclosed hereunder by one Party or any of its
Affiliates to the other Party or any of its Affiliates, except any portion thereof which:



          (a) at the time of disclosure, is in the public knowledge;




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          (b) after disclosure, becomes part of the public knowledge by publication or otherwise, except
by breach of this Agreement by the recipient;




          (c) the recipient can demonstrate by its written records was in the recipient’s possession at
the time of such disclosure, and which was not acquired, directly or indirectly, from the
disclosing Party;




          (d) is lawfully disclosed to the recipient on a non-confidential basis by a Third Party who is
not obligated to the disclosing Party or any other Third Party to retain it in confidence;




          (e) results from research and development by the recipient independent of such disclosure and
can be so documented in writing; or




          (f) is required to be disclosed by legal process; provided, however, that in
each such case the Party so disclosing information timely informs the other Party and uses its
reasonable good faith efforts to limit the disclosure and maintain confidentiality to the extent
possible and permits the other Party to attempt by appropriate legal means to limit such
disclosure.




     1.16 “Contract Year” shall mean a period of twelve (12) months beginning with the
Effective Date or the anniversary of the Effective Date and ending on the next anniversary of the
Effective Date.



     1.17 “Coordinators” shall have the meaning set forth in Section 3.1 hereof.



     1.18 “Delivery Date” shall mean a date for which delivery of Aventis Products is
stated in a purchase order.



     1.19 “Facility” shall mean Inyx’s plant in Manatí, Puerto Rico which was acquired by
Inyx from Aventis pursuant to the Asset Purchase Agreement.



     1.20 “FDA” shall mean the United States Food and Drug Administration or any successor
entity thereto.



     1.21 “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as
amended from time to time.



     1.22 “Force Majeure Event” shall have the meaning set forth in Section 21.1 hereof.



     1.23 “Intellectual Property” includes, without limitation, rights in patents, patent
applications, formulae, trade-marks, trade-mark applications, trade-names, confidential
information, trade secrets, inventions, copyright, industrial designs, know-how.



     1.24 “Initial Term” shall have the meaning set forth in Section 12.1 hereof.



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     1.25 “Invention” shall mean information relating to any innovation, improvement,
development, discovery, computer program, device, trade secret, method, know-how, process,
technique or the like, whether or not written or otherwise fixed in any form or medium, regardless
of the media on which contained and whether or not patentable or copyrightable.



     1.26 “Inventory” means all inventories of Components, Active Ingredients and
work-in-process produced or held by Inyx in connection with the manufacture of the Aventis
Products.



     1.27 “KPIs” shall have the meaning set forth in Section 3.2(a) hereof.



     1.28 “Packaging Specifications” shall mean the packaging and labeling specifications
for the Aventis Products in effect as of the date hereof, as such specifications may be amended
pursuant to Article 5 hereof.



     1.29 “Party” means Aventis or Inyx.



     1.30 “Products Specifications” shall mean the specifications for the Aventis Products
in effect as of the date hereof, as determined in accordance with the analytical methodology set
forth therein, as such specifications may be amended pursuant to Article 5 hereof.



     1.31 “Recall” shall have the meaning set forth in Section 13.2(a) hereof.



     1.32 “Regulatory Change” shall have the meaning set forth in Section 21.2 hereof.



     1.33 “Renewal Terms” shall have the meaning set forth in Section 12.1 hereof.



     1.34 “Specifications” shall mean the Products Specifications and the Packaging
Specifications.



     1.35 “Technical Agreement” shall mean the Technical Agreement in the form attached
hereto as Exhibit B and made a part hereof, as may be amended from time to time.



     1.36 “Term” shall have the meaning set forth in Section 12.1 hereof.



     1.37 “Third Party” shall mean any person or entity other than Aventis, Aventis
Affiliates, Inyx or Inyx Affiliates.



     1.38 “Third Party Rights” means the Intellectual Property of any Third Party.



     1.39 “Unit Prices” shall have the meaning set forth in Section 9.1 hereof.



     1.40 Exhibits. The following Exhibits are attached to, incorporated in and form part
of this Agreement:



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	Exhibit A

	 	The Aventis Products, Active Ingredients, and Initial Estimated Unit
Prices.
	Exhibit B

	 	Form of Technical Agreement
	Exhibit C

	 	Initial Coordinators
	Exhibit D

	 	Technical Dispute Resolution Procedure
	Exhibit E

	 	KPIs






ARTICLE 2

MANUFACTURE, SALE AND PURCHASE OF PRODUCTS




     2.1 Generally. Subject to the terms and conditions of this Agreement, Inyx shall
manufacture at the Facility and supply to Aventis and/or one or more of its Affiliates, and Aventis
and/or one or more of its Affiliates shall purchase from Inyx, the Aventis Products.



     2.2 Aventis Required Purchases. During each Contract Year during the Initial Term (and
not any Renewal Term), but subject to Sections 12.3 and 21.4 hereof, Aventis and its Affiliates
shall place purchase orders with Inyx for all quantities of the Aventis Products required by
Aventis or its Affiliates, as Aventis may determine in its sole discretion from time to time (the
“Aventis Required Purchases”). For the avoidance of doubt, the Aventis Required Purchases
shall not be construed or deemed to be a minimum purchase requirement or a guarantee of volumes on
the part of Aventis or its Affiliates.



     2.3 Technical Agreement. Inyx shall, in manufacturing the Aventis Products and
performing the other services contemplated hereby, comply in all respects with the terms set forth
in the Technical Agreement.



     2.4 Purchase of Klaron and Klaron Samples. Subject to the terms of Articles 6 and
Article 8, Inyx shall be a non-exclusive supplier of Klaron and Klaron Samples and Aventis may
allocate any portion from 100% to 0% of the total Klaron and Klaron Samples demand to Inyx.



ARTICLE 3

COORDINATORS AND CONTINUOUS IMPROVEMENT




     3.1 Coordinators. During the Term, Aventis and Inyx shall each appoint one or more
authorized representatives (“Coordinators”) for the exchange of all communications, other
than formal notices hereunder, related to the manufacturing, labeling and packaging of the Aventis
Products. Each Party shall provide notice to the other Party as to the name and title of the
individuals so appointed. Exhibit C hereto specifies the initial Coordinators for each
Party. Each Party may replace its Coordinators at any time for any reason by providing written
notice to the other Party in accordance with Section 24.1 hereof. The Coordinators shall meet at
least once in each Contract Year to review each Party’s past and future performance hereunder.



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     3.2 Continuous Improvement.



          (a) KPIs. For each Contract Year during the Term, Inyx shall meet or exceed the key
performance indicators established in good faith by the Coordinators for such Contract Year
pursuant to this Section 3.2, including without limitation with respect to (i) customer service
(including without limitation “on time delivery”), (ii) yield, (iii) costs, and (iv) quality, as
such enumerated items are specified in Exhibit E hereto (collectively, as established with
respect to the applicable Contract Year, the “KPIs”). If the Coordinators cannot agree
upon the KPIs for a particular Contract Year, then (y) the KPIs for the first Contract Year shall
be at least as beneficial to Aventis as the key performance indicators specified in Exhibit
E hereto, which are the KPIs achieved by Aventis immediately prior to the Effective Date, and
(z) for each subsequent Contract Year after the first Contract Year, the KPIs shall be at least as
beneficial to Aventis as the KPIs for the previous Contract Year. The Parties agree that Inyx
shall not be required to invest capital to improve standards for the KPIs unless the Parties
mutually agree in writing as to the capital to be invested and the allocation of costs savings
resulting from such investment, subject to Section 3.2(b) hereof with respect to any remediation
requirements for Inyx’s failure to achieve current KPIs.




          (b) Review of KPIs. The Coordinators shall review at least once for each Contract
Year Inyx’s performance hereunder with respect to the KPIs for that Contract Year. Such reviews
shall include both operational and financial matters. The Coordinators shall jointly develop a
remediation plan to address any failure of Inyx to achieve the KPIs for any Contract Year, and Inyx
at its cost shall comply with such plan, subject to section 3.2(a).




          (c) Sharing of Benefits. Clearly identified and mutually agreed cost reductions
resulting from improvements in the KPIs shall be shared equally between the Parties. For greater
certainty, (i) reductions in Inyx’s costs of performing hereunder which are the result of increased
production volumes at the Facility shall be solely for the benefit of Inyx, and (ii) reductions in
the costs of Components shall be solely for the benefit of Aventis.




          (d) Active Ingredients. The Coordinators shall similarly at least once in each
Contract Year review Inyx’s performance hereunder with respect to the use of Active Ingredients in
the manufacture of the Aventis Products. Such review shall include key performance indicators
related to customer service and quality, but need not include key performance indicators related to
yield and costs.




ARTICLE 4

ARTWORK




     Inyx shall initially utilize the artwork for the Aventis Products utilized by Aventis
immediately prior to the Effective Date. At least forty five (45) days prior to any modification to
the artwork for the Aventis Products, as applicable, and from time to time thereafter with respect
to the Aventis Products, as needed, Aventis shall provide, at no cost to Inyx, artwork meeting the
Packaging Specifications for all packaging components to be used in the manufacture of the



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Aventis Products. Aventis shall be responsible to ensure that all such artwork complies with all
applicable laws, regulations and cGMPs.




ARTICLE 5

SPECIFICATION CHANGES




     Aventis, in its sole discretion, shall have the sole right and authority to make and approve
changes in the Specifications. Upon any change in the Specifications (whether initiated by Aventis
or made in response to a request by Inyx that is agreed to by Aventis), Aventis shall promptly
advise Inyx in writing of such changes, and Inyx shall promptly advise Aventis as to any scheduling
and/or price adjustments which may result from such changes. Prior to implementation of such
changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new
price for any Aventis Products manufactured hereunder by Inyx which embodies such changes, (b) any
amounts to be reimbursed by Aventis to Inyx as described in the next sentence of this Article 5,
and (c) any other amendments to this Agreement which may be necessitated by such changes
(i.e., an adjustment to the lead time for purchase orders). Aventis shall reimburse Inyx
for the mutually agreed upon reasonable expenses incurred by Inyx as a result of such changes,
including, but not limited to, reimbursing Inyx for capital expenditure costs and costs for any
packaging components or other materials rendered unusable as a result of such changes. Validation
and development costs shall be the subject of separate proposals and written agreements between the
Parties. If during the Term, Aventis amends the Specifications (whether voluntarily or as required
by law, regulation or cGMPs) so as to render obsolete quantities of the Active Ingredient and/or
Components for the Aventis Products on hand at Inyx, then Aventis shall (i) accept the return of
all such obsolete Active Ingredient and/or Components and (ii) purchase from Inyx, at Inyx’s
Acquisition Cost, all such obsolete Components obtained by Inyx pursuant to its normal procurement
policies to manufacture quantities of the Aventis Products pursuant to Aventis’ forecasts under
Article 6. Inyx’s normal procurement policies for purposes of the preceding sentence of this
Article 5 shall be considered to be a three-month’s supply or three Batches, whichever is less, for
printed packaging components and a three-month’s supply or three Batches, whichever is less, for
all other Components, such amounts being determined in accordance with the forecast provided in
Article 6 unless, in respect of one or more Components, Aventis has agreed in writing to a
different supply arrangement. Any dispute arising in connection with this Article 5 shall be
resolved in accordance with the Technical Dispute Resolution Procedure set out in Exhibit D
hereto.



ARTICLE 6

FORECASTS




     Within fifteen (15) days after the first day of each calendar month during the Term, Aventis
will provide Inyx with a written twelve (12) month rolling forecast of its anticipated purchase
orders for the Aventis Products, except that for Klaron and Klaron Samples, in accordance with
Section 2.4 of this Agreement, Aventis shall not be required to provide such forecasts nor be
subject to any requirements under this Article 6. Only one hundred percent (100%) of those
quantities specified for the first three months of each such forecast and fifty percent (50%) of
those quantities specified for the second three months of each such forecast



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shall constitute firm commitments to purchase, and Aventis shall confirm such quantities by
purchase orders issued to Inyx pursuant to Section 8.1. By September 1st of each Contract Year,
Aventis will provide Inyx with a written three (3) year rolling forecast. Such three-year
forecasts shall represent the most current estimates for planning purposes only, and shall not be
considered to be purchase commitments. All such forecasts and updates thereof shall be for the sole
purpose of assisting Inyx in its planning and, except as otherwise expressly set forth in the
second sentence of this Article 6, shall not constitute an obligation of Aventis to purchase the
quantities of Aventis Products indicated.




ARTICLE 7

USE OF ACTIVE INGREDIENTS & BPO




     7.1 Generally. Except as specified in Exhibit A hereto, Inyx and/or its
Affiliates shall use all their bulk quantities of the Active Ingredients necessary to manufacture
the Aventis Products as contemplated under this Agreement.



     7.2 Purchase of Benzoyl Peroxide. Inyx and/or its Affiliates shall purchase from
Aventis and/or its Affiliates at Aventis’ Acquisition Costs all of the bulk quantities of Benzoyl
Peroxide (BPO) that are necessary to manufacture the Aventis Products as contemplated under this
Agreement.



     7.3 Purchase of K Kleen. For the Term of this Agreement, Inyx shall use K Kleen as
detergent in the manufacturing of the Aventis Products in the Facility. Aventis will authorize DPT
Laboratories, Ltd. to supply to Inyx K Kleen, and Inyx shall purchase K Kleen from DPT
Laboratories, Ltd. Inyx may not use any other detergent except with the prior approval of Aventis.



     7.4 Inyx’ Warranties. Inyx warrants that all the Active Ingredients used in connection
with the production of the Aventis Products shall meet the Specifications therefor and shall be
suitable for use in the manufacture of the Aventis Products. Active Ingredients used by Inyx which
do not meet Specifications shall be removed and disposed of by Inyx, at its cost and expense, as
soon as practicable after the determination of non-compliance; provided that any such
non-compliance is not the direct result of Aventis’ negligence or a breach of this Agreement.



ARTICLE 8

PURCHASE OF PRODUCTS; DELIVERIES; INSPECTIONS




     8.1 Purchase Orders. Except to the extent the Parties may otherwise agree in writing
with respect to a particular shipment, Aventis or its Affiliates shall order the Aventis Products
pursuant to written purchase orders, which shall be sent to Inyx with not less than ninety (90)
days lead time prior to the Delivery Dates specified in such purchase orders. Inyx shall accept
all such purchase orders which do not exceed two hundred percent (200%) of the most recent forecast
delivered by Aventis pursuant to Article 6 hereof and shall make at the Facility and shall supply
all quantities of the Aventis Products so ordered (subject to any variances permitted



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hereunder) to Aventis within five days early or zero days late of the Delivery Date(s) specified in
each such purchase order. Inyx shall use commercially reasonable efforts to supply Aventis with
quantities of the Aventis Products exceeding Aventis’ forecasted quantities for such periods. Inyx
shall advise and maintain regular communication with Aventis regarding delays and progress on
issued purchase orders.




     8.2 Purchase Quantities. Aventis shall order the Aventis Products in Batch sizes or
whole multiples thereof. Each purchase order shall specify the quantity of Aventis Products being
ordered. Quantities actually shipped pursuant to a given purchase order may vary from the
quantities reflected in such purchase order in an aggregate range of 10 percent (10%) above or 10
percent (10%) below the quantity ordered and still be deemed to be in compliance with such purchase
order; provided, however, Aventis shall only be invoiced and required to pay for
the quantities of Aventis Products which Inyx actually ships to carrier pursuant to Section 8.3;
and provided further, that Aventis shall only be required to pay for such
quantities of Aventis Products if a certificate of analysis with respect to such Aventis Products
accompanies such invoice and indicates that such Aventis Products to be shipped to Aventis meet the
Specifications.



     8.3 Product Discontinuance. Aventis may at its sole discretion request that Inyx
discontinue the manufacture of any of the Aventis Products or of any quantities specified in a
purchase order, without incurring any obligations to Inyx, except that Aventis shall fulfill its
firm commitments to purchase pursuant to Article 6 of this Agreement.



     8.4 Delivery Terms. The terms of delivery for the Aventis Products shall be FCA
(INCOTERMS 2000) the Facility. All shipments of the Aventis Products to Aventis shall be made via
such carrier(s) as Aventis may direct. Title to the Aventis Products shall at all times remain
with Aventis. Risk of loss shall pass to Aventis upon delivery to the carrier. Freight charges
shall be billed ship collect.



     8.5 Inconsistencies. In the event of any inconsistencies between the terms of this
Agreement and any purchase order issued by Aventis hereunder or any acceptance thereof by Inyx, the
terms of this Agreement shall govern.



ARTICLE 9

COMPENSATION AND PAYMENT TERMS




     9.1 Price. Unit prices of the Aventis Products (“Unit Prices”) for the Initial
Term shall be Aventis’ 2005 standard costs of production specified for each Aventis Product in
Exhibit A.



     9.2 Price adjustments. Such Unit Prices with respect to Section 9.1 will be adjusted
on an annual basis (at the beginning of each Contract Year) in the event Inyx’s combined costs for
components or raw materials increases or decreases by more than five percent (5%) within a year, in
which case the prices shall be adjusted to reflect a dollar for dollar increase or decrease and
such prices shall become the new benchmark for the remaining Term of the Agreement. The parties
expressly agree that no other price adjustments will be applicable including any changes



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in the Producer Price Index or the Consumer Price Index. For purposes of example only, if the
combined aggregate cost of raw materials and components is $10 per unit and the combined aggregate
cost increases 6% (i.e., $.60) per unit, then the price would be adjusted by $.60 in connection
with the increase of such aggregate cost of raw materials and components.




     9.3 Payment Terms. Inyx shall invoice Aventis for the Unit Prices of all quantities of
the Aventis Products purchased hereunder, together with applicable taxes if any, concurrently with
Inyx’s shipment thereof to Aventis. All amounts properly invoiced by Inyx or Aventis hereunder
shall be due and payable within forty-five (45) days from the date of the other Party’s invoices.
Payment may be made by corporate check or by wire transfer of funds to such account as Inyx and
Aventis may designate by notice to the other Party.



     9.4 Disputes. In the event of any dispute between the Parties under this Article 9,
Inyx’s Executive Vice President – Operations and Aventis’ Head of Contract Manufacturing for North
America (or such other senior officers as the parties may from time to time designate to the other
in writing) shall meet, within (15) Business Days of written notice of the dispute being given by
one of the Parties to the other, and attempt to resolve the dispute in good faith negotiations. If
any such dispute has not been resolved by such representatives of the Parties in good faith
negotiations within a period of ten (10) Business Days after the end of the such fifteen (15)
Business Day period, then the dispute shall be resolved in accordance with the Technical Dispute
Procedures set out in Exhibit D hereto.



ARTICLE 10

REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE PARTIES




     10.1 Inyx. Inyx represents, warrants and covenants to Aventis as follows:



          (a) Aventis Products. The Aventis Products, at the time of sale and shipment to
carrier pursuant to Section 8.4 by Inyx, (i) will conform to the Specifications, as then in effect
and which had been delivered to Inyx, (ii) will have been manufactured in accordance with cGMPs,
(iii) will not be adulterated or misbranded by Inyx within the meaning of the FD&C Act, and (iv)
will not be subject to any liens, security interests or any other encumbrances.




          (b) Adherence to Specifications. Inyx shall produce the Aventis Products strictly in
accordance with the Specifications and written instructions given by Aventis and accepted by Inyx
hereunder.




          (c) Compliance with Applicable Laws. Inyx in performing all services hereunder shall
fully comply with (i) all applicable federal, state and local laws, and (ii) health and safety
guidelines and cGMPs whenever applicable.




          (d) Qualified Personnel. Inyx shall not in the performance of its obligations under
this Agreement use the services of any person within its organization who has been debarred or
suspended under the FD&C Act. Inyx does not as of the Effective Date have, and covenants that it
will not during the Term hire, as an officer or an employee, any person who has





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been convicted of a felony or misdemeanor under the laws of the United States for conduct relating
to the regulation of any drug product under the FD&C Act.




     10.2 Aventis. Aventis covenants, represents and warrants that:



          (a) the Specifications for each of the Aventis Products are its or its Affiliate’s property
and that Aventis may lawfully disclose the Specifications to Inyx;




          (b) as of the Effective Date there are no actions or other legal proceedings, the subject of
which is the infringement of Third Party Rights related to any of the Specifications, or any of the
Active Ingredients, or the sale, use or other disposition of any Aventis Product made in accordance
with the Specifications;




          (c) the Specifications for all Aventis Products conform to all applicable cGMPs, laws and
regulations;




          (d) Aventis, in connection with its performance under this Agreement, shall fully comply with
all applicable federal, state and local laws; and




          (e) the Aventis Products, if manufactured, labeled and packaged in accordance with the
Specifications and in compliance with applicable cGMPs, may be lawfully sold and distributed in
every jurisdiction in which Aventis markets such Aventis Products.




     10.3 Permits. Aventis shall be solely responsible for obtaining or maintaining any
permits or other regulatory approvals in respect of the Aventis Products or the Specifications,
including, without limitation, all marketing and post-marketing approvals. Inyx shall be solely
responsible for obtaining or maintaining any permits or other regulatory approvals in respect of
the Facility.



     10.4 License of Documentation. Aventis hereby grants to Inyx a non-exclusive,
non-transferable, royalty-free license during the Term, without the right to sub-license, to use
the Documentation (as such term is defined in the Asset Purchase Agreement) as necessary and solely
to manufacture the Aventis Products for exclusive supply to Aventis hereunder. All such
Documentation shall be deemed to be the Confidential Information of Aventis and its Affiliates.



ARTICLE 11

GENERAL REPRESENTATIONS AND WARRANTIES




     Each Party represents and warrants to the other as follows:



     11.1 Power and Authorization. It has all requisite power and authority (corporate and
otherwise) to enter into this Agreement and has duly authorized by all necessary action the
execution and delivery hereof by the officer or individual whose name is signed on its behalf
below.



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     11.2 No Conflict. Its execution and delivery of this Agreement and the performance of
its obligations hereunder do not and will not conflict with or result in a breach of or a default
under its organizational instruments or any other agreement, instrument, order, law or regulation
applicable to it or by which it may be bound.



     11.3 Enforceability. This Agreement has been duly and validly executed and delivered
by it and constitutes its valid and legally binding obligation, enforceable in accordance with its
terms, except as enforcement may be limited by bankruptcy, insolvency or other laws of general
application relating to or affecting the enforcement of creditors’ rights and except as enforcement
is subject to general equitable principles.



ARTICLE 12

TERM; TERMINATION




     12.1 Term.



          (a) Initial Term. Unless sooner terminated pursuant to the terms hereof, the term of
this Agreement shall commence on the Effective Date and shall expire on the third (3rd) anniversary
of the Effective Date (the “Initial Term”).




          (b) First Renewal Term. This Agreement shall automatically renew on the third (3rd)
anniversary of the Effective Date for a period commencing on the date of the third (3rd)
anniversary of the Effective Date and expiring on the fourth (4th) anniversary of the Effective
Date (the “First Renewal Term”), unless notice of termination is provided by Aventis to Inyx not
less than six months prior to the date of the third anniversary of the Effective Date.




          (c) Second Renewal Term: If this Agreement automatically renews for the First Renewal
Period, this Agreement shall automatically renew on the fourth (4th) anniversary of the Effective
Date for a period commencing on the date of the fourth (4th) anniversary of the Effective Date and
expiring on the fifth (5th) anniversary of the Effective Date (the “Second Renewal Term”), unless
notice of termination is provided by Aventis to Inyx not less than six months prior to the date of
the fourth anniversary of the Effective Date.




          (d) The First Renewal Term and the Second Renewal Term shall be collectively referred to as
the “Renewal Terms”. The Initial Term and the Renewal Terms are collectively referred to herein as
the “Term”.




     12.2 Termination by Mutual Agreement. The Parties may terminate this Agreement at any
time by mutual written agreement.



     12.3 Termination for Cause. Subject to 12.1, either Party may terminate this
Agreement upon immediate written notice if the other Party is in breach or default with respect to
any material term or provision hereof and fails to cure the same within ninety (90) calendar days
of receipt of notice of said breach or default. Upon a breach or default of this Agreement by
Inyx, Aventis shall additionally have the right, exercisable by notice to Inyx, to require Inyx to



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waive the requirements of Section 2.2 hereof for Aventis Required Purchases of Aventis Products (on
a product-by-product basis, for all SKUs for a particular Aventis Product) if Inyx is in breach or
default with respect to any material term or provision hereof in respect of such Aventis Product
and fails to cure the same within ninety (90) calendar days of receipt of notice of said breach
or default.




     12.4 Termination for Bankruptcy. Either Party may terminate this Agreement upon
immediate written notice if the other Party ceases for any reason to carry on business (but not as
the result of a merger, acquisition or reorganization with one or more entities whether in a single
transaction or a series of transactions) or convenes a meeting of its creditors or has a receiver
or manager appointed in respect of all or substantially all of its assets or is the subject of an
application for an administration order or of any proposal for a voluntary arrangement or enters
into liquidation (whether compulsorily or voluntarily) or undergoes any analogous act or
proceedings under foreign law.



     12.5 Termination for Debarment. Aventis may terminate this Agreement effective
immediately upon notice if at any time during the Term, Inyx becomes debarred or receives notice of
action or threat of action with respect to its debarment. Inyx shall notify Aventis immediately if
at any time during the Term, Inyx or any of its officers or employees becomes debarred, or receives
notice of action or threat of action with respect to its, his, or her debarment.



     12.6 Rights and Duties Upon Termination.



          (a) Ordered Aventis Products. Unless otherwise mutually agreed by the Parties, Inyx
shall manufacture and ship, and Aventis shall purchase in accordance with the provisions hereof,
all quantities of Aventis Products ordered by Aventis hereunder prior to the date of expiration or
termination.




          (b) Inventory. In the event that (i) Inyx terminates this Agreement pursuant to
Sections 12.3 or 12.4, then (in addition to any other remedies Inyx may have in the event of
default by Aventis) Aventis shall, or (ii) this Agreement expires, then Aventis
shall, or (iii) Aventis terminates this Agreement pursuant to Sections 12.3, 12.4 or 12.5,
then (in addition to any other remedies Aventis may have in the event of default by Inyx) Aventis
may at its option:





               (1) purchase from Inyx, at Inyx’s Acquisition Cost, the Inventory applicable to the
Aventis Products which was purchased, produced or maintained by Inyx pursuant to its normal
procurement policies to manufacture quantities of the Aventis Products pursuant to Aventis’
firm commitments under Article 6 (if applicable prior to notice of termination being given);
and



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               (2) satisfy the purchase price payable pursuant to Inyx’s orders with suppliers of
Components, provided such orders were made by Inyx pursuant to its normal procurement
policies to manufacture quantities of the Aventis Products pursuant to Aventis’ firm
commitments under Article 6 (if applicable prior to notice of termination being given) (to
the extent that Inyx is not compensated therefor by clause 12.6(b)(1) hereof).


Inyx’s “normal procurement policies” for purposes of this Section 12.6(b) shall be considered to be
a three-month’s supply or three Batches, whichever is less, for printed packaging components and a
three-month’s supply for all other Components, such amounts being determined in accordance with the
forecast provided in Article 6 unless, in respect of one or more Components, Aventis has agreed in
writing to a different supply arrangement. The Parties shall cooperate during the Term to minimize
quantities of Inventory and Components which may be the subject of this Section 12.6(b).




ARTICLE 13

CLAIMS; RECALLS




     13.1 Claims. Aventis may reject any quantity of the Aventis Products which fails to
conform to any applicable purchase order or the warranties granted by Inyx pursuant to Section 10.1
(Inyx’s Representations, Warranties and Covenants) hereof upon written notice to Inyx describing
such nonconformity given within thirty (30) days after Aventis’ receipt thereof (or, in the case of
any defects not reasonably susceptible of discovery upon receipt of such goods, within thirty (30)
days after discovery thereof by Aventis but in no event after the expiration date of the Aventis
Product). Upon receipt of a deficiency notice, Inyx shall have ten (10) days to advise Aventis by
notice in writing that it disagrees with the contents of such deficiency notice. If Aventis and
Inyx fail to agree within ten (10) days after Inyx’s notice to Aventis, then the Parties shall
mutually select an independent laboratory to evaluate if the Aventis Products are defective as a
result of defective manufacture, storage or handling which would constitute a breach by Inyx of
Section 10.1 hereof. Such evaluation shall be binding on the Parties, and if such evaluation
certifies that any Aventis Products are defective, Aventis may reject those Aventis Products and
Inyx shall promptly credit Aventis’ account for Inyx’s invoice price to Aventis of such defective
Aventis Products. If Aventis shall have previously paid for such nonconforming Aventis Products,
Inyx shall promptly, at Aventis’ election, either (i) refund the invoice price therefor, (ii)
offset the amount thereof against other amounts then due Inyx hereunder, or (iii) replace such
nonconforming Aventis Products with conforming Aventis Products without Aventis being liable for
payment therefor under Section 9.1 hereof. If such evaluation does not so certify in respect of
any such Aventis Products, then Aventis shall be deemed to have accepted delivery of such Aventis
Products on the fortieth day after delivery.



     13.2 Recalls.



          (a) Each Party shall promptly notify the other of any information, whether received directly
or indirectly, which might affect the marketability, safety or effectiveness of the Aventis
Products and/or which might result in the Recall or seizure of the Aventis Products. For





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purposes of this Agreement, a “Recall” shall mean any action: (i) by Aventis to recover
title to or possession of quantities of the Aventis Products sold or shipped to Third Parties
(including, without limitation, the voluntary withdrawal of the Aventis Products from the market)
or (ii) by any regulatory authorities to detain or destroy any of the Aventis Products.
“Recall” shall also include the election by either Party to refrain from selling or
shipping quantities of the Aventis Products to Third Parties which would have been subject to a
Recall if sold or shipped.




          (b) In the event (i) any governmental or regulatory authority issues a directive, order or,
following the issuance of a safety warning or alert with respect to an Aventis Product, a written
request that any Aventis Product be Recalled, (ii) a court of competent jurisdiction orders such a
Recall, or (iii) Aventis determines that any Aventis Product should be Recalled or that a “dear
doctor” letter is required relating to restrictions on the use of any Aventis Product, the Parties
shall take all appropriate corrective actions, and shall cooperate in the investigations
surrounding the Recall or letter. In the event that Aventis reasonably determines that any Aventis
Product should be Recalled, Aventis shall consult with Inyx prior to taking any corrective actions.
In the event that such Recall results from any cause or event other than that arising from the
defective manufacture, storage or handling which would constitute a breach by Inyx of Section 10.1
(Inyx’s Representations, Warranties and Covenants) hereof of the Recalled Aventis Product, Aventis
shall be responsible for all documented out-of-pocket expenses of such Recall. In the event that
such Recall results from any cause or event arising from the defective manufacture, storage or
handling which would constitute a breach by Inyx of Section 10.1 (Inyx’s Representations,
Warranties and Covenants) hereof, Inyx shall be responsible for all such documented out-of-pocket
expenses. For purposes of this Agreement, the expenses of Recall shall include the expenses of
notification and destruction or return of the Recalled Aventis Product, all other documented
out-of-pocket costs incurred in connection with such Recall and the replacement of the Recalled
Product.




     13.3 Disposition of Nonconforming or Recalled Aventis Products. Aventis shall not
dispose of any damaged, nonconforming or Recalled Aventis Products as to which it intends to assert
a claim against Inyx without Inyx’s written authorization to do so. Alternatively, Inyx may
instruct Aventis to return such Aventis Products to Inyx. Inyx shall bear the cost of disposition
(as well as all applicable shipping costs) with respect to any damaged, nonconforming or Recalled
Aventis Products as to which it bears responsibility under Section 13.1 or 13.2 hereof. Aventis
shall bear the cost of disposition (as well as all applicable shipping costs) with respect to any
damaged, nonconforming or Recalled Aventis Products as to which it bears responsibility under
Section 13.1 or 13.2 hereof.



     13.4 Customer Questions and Complaints. Aventis shall have the sole responsibility
for responding to questions and complaints from customers. Questions or complaints received by
Inyx from customers shall be promptly referred to Aventis. Inyx shall co-operate as reasonably
required to allow Aventis to determine the cause of and resolve any customer questions and
complaints. Such assistance shall include follow-up investigations, including testing.



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     In addition, Inyx shall provide Aventis with all necessary information as follows: (i) if the
complaint is a Category A Complaint (Critical), within one (1) business day from the date that Inyx
receives the customer’s complaint, Inyx shall provide Aventis with preliminary investigation
results and within 30 Calendar Days from the same date, Inyx shall present Aventis with the final
investigation results and (ii) if the complaint is a product technical Category B Complaint, within
30 Calendar Days from the date that Inyx receives the customer complaint, Inyx shall provide
Aventis with all necessary information that will enable Aventis to respond properly to questions or
complaints relating to the Aventis Products. If a return sample is not sent to Inyx initially,
Inyx shall perform at a minimum, document review, evaluation of the retention sample, and other
measures to ensure a well-founded investigation. Upon receipt of the return sample, Inyx has an
additional 30 days for product testing.



     Unless it is determined that the cause of any customer complaint resulted from a failure by
Inyx to manufacture the Aventis Products in accordance with the Specifications, all costs incurred
in respect of this Section 13.4 shall be borne by Aventis. The Parties shall comply with the
provisions of Aventis’ standard operating procedures related to questions and complaints notified
by Aventis to Inyx from time to time during the Term.



ARTICLE 14

INDEMNIFICATION




     14.1 By Aventis. Aventis shall defend, indemnify and hold harmless Inyx, its
Affiliates and their respective officers, directors, shareholders, employees, licensees, agents,
successors and assigns from and against any and all liabilities and expenses whatsoever, including,
without limitation, claims, damages, judgments, awards, settlements, investigations, costs,
expenses and attorneys fees and disbursements (including, without limitation, those associated with
a Recall) (collectively, “Claims”) which any of them may incur or become obligated to pay
arising out of or resulting from (a) the use, handling, distribution, marketing or sale of the
Aventis Products by Aventis or any Third Party after delivery to Aventis pursuant to Section 8.3
hereof, (b) the breach by Aventis of any of its representations, warranties, covenants,
obligations, agreements or duties under this Agreement, (c) any claim that the manufacture, use or
sale of the Aventis Products infringes a United States or foreign patent or any Intellectual
Property or any other proprietary rights, (d) liability claims with respect to the Aventis
Products, other than to the extent such liability claims are the result of a breach by Inyx of
Section 10.1 (Inyx’s Representations, Warranties and Covenants) hereof; or (e) any failure by any
Affiliate of Aventis to comply with the applicable provisions of this Agreement; provided,
however, that such obligation to indemnify shall not extend to any Claim to the extent
arising out of or resulting from any negligence, recklessness or wrongful conduct by Inyx or the
breach by Inyx of any of its representations, warranties, covenants, obligations, agreements or
duties under this Agreement.



     14.2 By Inyx. Inyx shall defend, indemnify and hold harmless Aventis, its Affiliates
and their respective officers, directors, shareholders, employees, licensees, agents, successors
and assigns from and against any and all Claims which any of them may incur or become obligated to
pay arising out of or resulting from (a) Inyx’s negligent acts or omissions or willful misconduct
in connection with the performance of the services contemplated by this Agreement, or (b) the



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breach by Inyx of any of its representations, warranties, covenants, obligations, agreements or
duties under this Agreement; provided, however, that such obligation to indemnify
shall not extend to any Claim to the extent arising out of or resulting from any negligence,
recklessness or wrongful conduct by Aventis or the breach by Aventis of any of its representations,
warranties, covenants, obligations, agreements or duties under this Agreement.




     14.3 Procedure. Promptly after learning of the occurrence of any event which may give
rise to its rights under the provisions of this Article 14, each indemnitee hereunder shall give
written notice of such matter to indemnitor. The indemnitee shall cooperate with the indemnitor in
the negotiation, compromise and defense of any such matter. The indemnitor shall be in charge of
and control such negotiations, compromise and defense and shall have the right to select counsel
with respect thereto, provided that (i) the indemnitor shall promptly notify the indemnitee
of all developments in the matter and (ii) the indemnitee shall also have the right to participate
and be represented by legal counsel of the indemnitee’s choice and at the indemnitee’s cost in all
proceedings and negotiations. In no event shall the indemnitee compromise or settle any such
matter without the prior written consent of the indemnitor, who shall not be bound by any such
compromise or settlement absent its prior written consent, which consent shall not be unreasonably
withheld or delayed.



ARTICLE 15

INSURANCE




     15.1 Inyx’s Required Coverages. At all times during the Term, Inyx shall itself or
through its Affiliates procure and maintain the following insurance coverages:




	 	(i)  	General Liability, including products liability covering bodily
injury and property damage liability with a limit of not less than
US$10,000,000 each occurrence;
	 
	 	(ii)  	Workers’ Compensation insurance (or maintenance of a legally
permitted and governmentally approved program of self-insurance) covering
Inyx’s employees and/or agents pursuant to applicable state workers’
compensation laws for work related injuries suffered by employees and/or agents
of Inyx;
	 
	 	(iii)  	Employers Liability insurance with limits of not less than
US$10,000,000 each occurrence; and
	 
	 	(iv)  	Excess Liability insurance or indemnity policies in an amount
not less than US$1,000,000 with an indemnity to principals clause with respect
to the manufacture, storage and handling of the Aventis Products.




All policies shall be issued by financially secure companies and shall be written as primary
coverage and not contributing with or in excess of any coverage that Aventis may carry. At Aventis’
request, Inyx shall furnish to Aventis a certificate of insurance for each of the above-




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mentioned policies. Each policy shall be on a claims made or occurrence (with tail of twelve (12)
months after termination of this Agreement) basis. Inyx shall provide immediate notice to Aventis
of any significant decrease or adverse change in the aforementioned coverage or limits.




     15.2 Aventis’ Required Coverages. Aventis shall maintain commercial general liability
insurance, including blanket contractual liability insurance covering the obligations of Aventis
under this Agreement through the term of this Agreement, which insurance shall afford limits of not
less than US$3,000,000 for each occurrence (and in the aggregate only with respect to personal
injury liability), products liability and property damage liability. If requested Aventis will
provide Inyx with a certificate of insurance evidencing the above and showing the name of the
issuing company, the policy number, the effective date, the expiration date and the limits of
liability. The insurance certificate shall further provide for a minimum of thirty (30) days’
written notice to the insured of a cancellation of, or material change in, the insurance. All
policies shall be issued by financially secure companies and shall be written as primary coverage
and not contributing with or in excess of any coverage that Inyx may carry. At Inyx’s request,
Aventis shall furnish to Inyx a certificate of insurance for each of the above-mentioned policies.
Each policy shall be on a claims made or occurrence (with tail of twelve (12) months after
termination of this Agreement) basis. Aventis shall provide immediate notice to Inyx of any
significant decrease or adverse change in the aforementioned coverage or limits.



ARTICLE 16

LIMITATION OF LIABILITY




     16.1 Disclaimer of Warranties. EXCEPT AS EXPRESSLY PROVIDED HEREIN, EACH OF THE
PARTIES HEREBY DISCLAIMS ALL CONDITIONS, OTHER WARRANTIES AND STATEMENTS IN RESPECT OF THE AVENTIS
PRODUCTS OR THE PROVISION OF SERVICES HEREUNDER, WHETHER EXPRESS OR IMPLIED, BY STATUTE, CUSTOM OF
THE TRADE OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, ANY SUCH CONDITION, WARRANTY OR STATEMENT
RELATING TO THE DESCRIPTION OR QUALITY OF THE PRODUCTS, THEIR MERCHANTABILITY OR THEIR FITNESS FOR
A PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS) AND ANY SUCH CONDITION, WARRANTY OR STATEMENT IS
HEREBY DISCLAIMED BY SUCH PARTY AND EXCLUDED.



     16.2 Damages. IN NO EVENT SHALL ANY PARTY BE LIABLE UNDER OR WITH RESPECT TO THIS
AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND,
INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS (INCLUDING BUT NOT LIMITED TO, DUE TO BREACH OF
WARRANTY, TORT, OR BREACH OR REPUDIATION OF ANY TERM OR CONDITION OF THIS AGREEMENT); PROVIDED,
HOWEVER, THAT THE FOREGOING SHALL NOT LIMIT EITHER PARTY’S LIABILITY IN CONNECTION WITH ITS
INDEMNITY OBLIGATIONS FOR THIRD PARTY CLAIMS PURSUANT TO ARTICLE 14.



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ARTICLE 17

CONFIDENTIALITY




     17.1 Treatment of Confidential Information. Except as otherwise provided in this
Article 17, during the Term and for a period of ten (10) years thereafter:



          (a) Inyx will retain in confidence and use only for the purposes contemplated hereby any
Confidential Information disclosed to it by or on behalf of Aventis in connection with the
performance of this Agreement; and




          (b) Aventis will retain in confidence and use only for the purposes contemplated hereby any
Confidential Information disclosed to it by or on behalf of Inyx in connection with the performance
of this Agreement.




     17.2 Right to Disclose. To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement or any rights which survive
termination or expiration hereof, each Party may disclose Confidential Information to its
Affiliates, sublicensees, consultants, outside contractors, clinical investigators or other Third
Parties on condition that such entities or persons agree (a) to keep the Confidential Information
confidential for the same time periods and to the same extent as each Party is required to keep the
Confidential Information confidential and (b) to use the Confidential Information only for such
purposes as such Party is entitled to use the Confidential Information. Each Party or its
Affiliates or sublicensees may disclose such Confidential Information to government or other
regulatory authorities to the extent that such disclosure (i) is reasonably necessary to obtain
patents or authorizations to conduct clinical trials with and to market commercially the Aventis
Products, provided such Party is otherwise entitled to engage in such activities under this
Agreement or (ii) is otherwise legally required.



ARTICLE 18

OWNERSHIP OF PROPERTY




     18.1 Aventis Materials. Aventis shall own and retain all right, title and interest in
and to all information, documents and tangible and intangible materials which Aventis provides to
Inyx in connection with the performance of services hereunder.



     18.2 Work Products. Subject only to the provisions of Section 18.3 hereof, Aventis
shall have all rights to use all information, documents and tangible and intangible materials which
result from the performance by Inyx of the services contemplated by this Agreement (including,
without limitation, data, test results, measurements, quantitative and qualitative analyses,
processes, samples, and inventions and technology relating directly to the Aventis Products).



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     18.3 Inventions.



          (a) All Inventions relating to the Aventis Products which are conceived, reduced to practice,
or created solely by Inyx and/or its Affiliates or agents in the course of performing services
under this Agreement (including any background or preexisting technology of Inyx which Inyx so
employs), shall be owned by Inyx. Inyx shall and hereby does grant to Aventis and its Affiliates a
perpetual, royalty-free, non-exclusive, worldwide, irrevocable license to use and/or practice all
such Inyx-owned Inventions (which are used by Inyx hereunder to supply Aventis Products to Aventis)
to manufacture the Aventis Products and to use and sell the same, with the right to sub-license to
any Third Party with whom Aventis or an Affiliate contracts to manufacture the Aventis Products
using any such Inyx-owned Invention.




          (b) All Inventions relating to the Aventis Products which are conceived, reduced to practice,
or created solely by Aventis and/or its Affiliates or agents (including any background or
preexisting technology of Aventis which Aventis shares with Inyx hereunder), shall be owned by
Aventis. Aventis shall and hereby does grant to Inyx and its Affiliates a royalty-free,
non-exclusive license during the Term, without the right to sub-license, to use and/or practice all
such Aventis-owned Inventions solely at the Facility to manufacture the Aventis Products hereunder.




          (c) All Inventions relating to the Aventis Products which are conceived, reduced to practice,
or created jointly by (i) Aventis and/or its Affiliates or agents and (ii) Inyx and/or its
Affiliates or agents pursuant to this Agreement shall be owned by Aventis, unless the Parties have
agreed to a different arrangement in another consulting or services agreement which is more
specific to the services provided by Inyx in connection with such Inventions. Aventis shall and
hereby does grant to Inyx and its Affiliates a royalty-free, non-exclusive license during the Term,
without the right to sub-license, to use and/or practice all such Aventis-owned Inventions solely
at the Facility to manufacture the Aventis Products hereunder.




          (d) Each Party shall be solely responsible for the costs of filing, prosecution and
maintenance of patents and patent applications on its own Inventions and shall share equally costs
for jointly-owned Inventions.




          (e) Either Party shall give the other Party written notice, as promptly as practicable, of all
Inventions which can reasonably be deemed to constitute improvements or other modifications to the
Aventis Products or processes or technology owned or otherwise controlled by such Party.




     18.4 Trademarks. Aventis shall retain all right, title and interest arising under the
U.S. Trademark Act and all other applicable laws in the trademarks and trade names related to or
associated with the Aventis Products and in all other trademarks and trade names which may be
adopted with respect to the Aventis Products.



     18.5 Right of First Negotiation. In the event that Aventis desires to license any of
the Aventis Products, then Aventis shall first negotiate with Inyx to enter into a license
agreement. If



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Aventis delivers to Inyx a written notice of its intent to license any of the Aventis Products,
then Aventis shall negotiate in good faith with Inyx during the thirty (30) calendar day period
commencing on the date of such notice (the “Negotiation Period”). If the parties do not execute an
agreement with respect to the licensing of such Aventis Products during the Negotiation Period,
then Aventis may enter into any agreement to license such Aventis Products with any third party.




ARTICLE 19

RETENTION, INSPECTIONS AND ACCESS




     19.1 Retention. Inyx at its cost shall maintain and retain for five (5) years
following the end of the applicable Contract Year (or such longer period as may be required by
applicable laws) (i) true and accurate books and records relating to its performance under this
Agreement, including without limitation its Acquisition Costs and all other costs incurred in
connection herewith and records of the manufacture, testing and shipping of the Aventis Products,
and (ii) samples of such Aventis Products as are necessary to (A) comply with regulatory
requirements applicable to Inyx or Aventis, and (B) assist with resolving product complaints and
other similar investigations.



     19.2 Inspections of Books and Records. Aventis or an independent accounting firm
nominated by Aventis may inspect Inyx’s books and records relating to Aventis’ interests under this
Agreement during normal business hours and with reasonable advance written notice, provided a
representative of Inyx is present during any such inspection. Inyx shall notify Aventis of any
inspections by any governmental agency involving the Aventis Products.



     19.3 Testing of Samples. Aventis or an independent testing laboratory nominated by
Aventis may inspect and test Inyx’s samples relating to the Aventis Products in accordance with
standard industry practice upon reasonable written request.



     19.4 Access. Inyx shall provide Aventis with reasonable access during normal business
hours upon not less than three (3) Business Days prior written notice to its Facility in which the
Aventis Products are manufactured, stored, handled or shipped in order to permit Aventis’
verification of Inyx’s compliance with the terms of this Agreement and with all applicable laws and
regulations.



ARTICLE 20

COOPERATION WITH GOVERNMENTAL REQUIREMENTS




     The Parties shall cooperate with one another as may be reasonably necessary or appropriate to
satisfy all governmental requirements and obtain all needed permits, approvals and licenses with
respect to the development, manufacture, storage, packaging, marketing and sale of the Aventis
Products. Such cooperation shall include, without limitation, communicating with regulatory
authorities and making available as promptly as practicable all information, documents and other
materials which result from the performance by Inyx of its services hereunder which Aventis is
required to submit or which Aventis may otherwise reasonably




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request in connection with governmental filings relating to the Aventis Products. The costs and
expenses of such cooperation, if applicable, shall be subject to the Parties’ mutual agreement.




ARTICLE 21

FORCE MAJEURE




     21.1 Effects of Force Majeure. Neither Party shall be held liable or responsible for
failure or delay in fulfilling or performing any of its obligations under this Agreement (other
than the payment of money owed hereunder) to the extent that such failure or delay results from any
cause beyond its reasonable control, including, without limitation, act of God, fire, flood,
natural disaster, explosion, act of war, hostilities, act of terrorism, riot, embargo, sabotage,
power failure, power shortage, strike, lock-out, work slowdown or stoppage or other labour
disturbance, acts or omissions of carriers, interruption of or delay in transportation, action or
failure to act of any government or governmental or regulatory authority, or failure or delay by
any other person in providing supplies, materials, active ingredients, equipment, labour or
transportation (each, a “Force Majeure Event”). For clarity, the inclusion of an event or
circumstance in the foregoing sentence as an example of a cause which may give rise to a Force
Majeure Event shall not be interpreted to deem any such cause to be beyond the reasonable control
of a party for purposes of this Article 21; any such cause must also be beyond the reasonable
control of a Party to give rise to a Force Majeure Event. Such excuse shall continue as long as
the Force Majeure Event continues, following which such Party shall promptly resume performance
hereunder.



     21.2 Effects of Regulatory Changes. Neither Party shall be held responsible or liable
for failure or delay in fulfilling or performing any of its obligations under this Agreement to the
extent that such failure or delay results from good faith efforts to comply with the enactment or
revision of any law, rule, regulation or regulatory advisory opinion or order applicable to the
manufacturing, marketing, sale, reimbursement and/or pricing of the Aventis Products (a
“Regulatory Change”). Such excuse shall continue as long as performance is prevented by the
affected Party’s good faith efforts to comply with such Regulatory Change, following which such
Party shall promptly resume performance hereunder.



     21.3 Notice; Right to Terminate. The Party affected by a Force Majeure Event or a
Regulatory Change shall notify the other Party thereof as promptly as practicable after its
occurrence. Such notice shall describe the nature of such Force Majeure Event or Regulatory Change
and the extent and expected duration of the affected Party’s inability fully to perform its
obligations hereunder. The affected Party shall use due diligence, where practicable, to minimize
the effects of or end any such event so as to facilitate the resumption of full performance
hereunder and shall notify the other Party when it is again fully able to perform such obligations.
Should the delay resulting from a Force Majeure Event or Regulatory Change exceed six (6) months
(for Regulatory Changes, from the date that the Regulatory Change is first published or becomes
known, whichever is earlier), the non-invoking Party shall have the right to terminate this
Agreement upon thirty (30) days prior written notice.



     21.4 Waiver of Aventis Required Purchases. If Inyx cannot supply an Aventis Product
as a result of a Force Majeure Event for a period of ninety (90) days or more, Aventis shall



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additionally have the rights, exercisable by written notice to Inyx, to require Inyx to (i) waive
the requirements of Section 2.2 hereof for Aventis Required Purchases of such Aventis Product (on a
product-by-product basis, for all SKUs for a particular Aventis Product), and (ii) reasonably
assist Aventis in qualifying and enabling another facility (owned by Aventis or a Third Party as
designated by Aventis for each such Aventis Product) to manufacture such Aventis Product, including
without limitation the transfer of necessary procedures and technology.




ARTICLE 22

INDEPENDENT CONTRACTORS




     The relationship between Aventis and Inyx is that of independent contractors and nothing
herein shall be deemed to constitute the relationship of partners, joint venturers, nor of
principal and agent between Aventis and Inyx. Neither Party shall have any express or implied right
or authority to assume or create any obligations on behalf of or in the name of the other Party or
to bind the other Party to any contract, agreement or undertaking with any Third Party.



ARTICLE 23

FURTHER ACTIONS




     The Parties agree to execute such additional documents and to perform all such other and
further acts as may be necessary or desirable to carry out the purposes and intents of this
Agreement.



ARTICLE 24

MISCELLANEOUS




     24.1 General Notices. Except as otherwise provided in Section 24.2 hereof, all
notices, requests, instructions, consents and other communications to be given pursuant to this
Agreement shall be in writing and shall be deemed received (i) on the same day if delivered in
person, by same-day courier or by facsimile transmission, (ii) on the next day if delivered by
overnight mail or courier, or (iii) on the date indicated on the return receipt, or if there is no
such receipt, on the third calendar day (excluding Sundays) if delivered by certified or registered
mail, postage prepaid, to the Party for whom intended to the following addresses:



If to Aventis:



Aventis Pharmaceuticals, Inc.

c/o Aventis Pharmaceuticals

300 Somerset Corporate, Blvd.

Bridgewater, NJ 08807

Attention: General Counsel

Facsimile: (908) 243-7219



-23-









 





          With a copy to:



McConnell Valdés

270 Muñoz Rivera Avenue

9th Floor, Hato Rey

San Juan, Puerto Rico 00918

Attention: Antonio Escudero-Viera

Facsimile: (787) 759-2710



          Any Notice to be given to Inyx shall be addressed to:



INYX USA, LTD.

604 San José Industrial Zone Cotto Norte

Manatí, Puerto Rico 00674-0345

Attention: Inyx Facility Coordinator

Facsimile: To be provided



          With a copy to:



Fiddler González & Rodríguez, PSC

PO Box 363507

San Juan, PR 00936-3507

Attention: José Julián Alvarez

Facsimile: (787) 759-3123



          and to:



Bennett Jones LLP

1000 ATCO Centre

10035 105th Str

Edmonton, Alberta

Canada T5J 3T2

Attention: Enzo J. Barichello, Q.C.

Facsimile: (780) 421-7951



          and to:



INYX, INC.

825 Third Avenue, 40th Floor

New York, NY 10022

Attention: Dr. Jack Kachkar MD

Chairman & Chief Executive Officer

Facsimile (212) 838-0060



-24-









 





     Each Party may by written notice given to the other in accordance with this Agreement change
the address to which notices to such Party are to be delivered.



     24.2 Special Notices. Each Party shall notify the other by telephone as soon as
practicable (with written confirmation within three (3) Business Days) upon its receipt of any
technical complaint or notice of adverse reaction; provided, however, that
notification of serious, new or unexpected experiences reported with increased frequency shall be
made immediately (but in any event not more than thirty-six (36) hours after the notifying Party
learns of such experiences). All such notices shall be directed to the Parties at the addresses set
forth in Section 4.1 to the attention of the following personnel:



          If to Aventis:



	 	 	 
	Technical complaints:

	 	Quality Assurance Specialist
	Adverse reactions:

	 	Director of Products Surveillance






          If to Inyx:



	 	 	 
	Technical complaints:

	 	Quality Assurance Specialist – Manatí Site
	Adverse reactions:

	 	V.P. Regulatory Compliance






     24.3 Entire Agreement. This Agreement together with the Technical Agreement contain
the entire understanding of the Parties with respect to the subject matter hereof and supersedes
all prior agreements and understandings, whether written or oral, between them with respect to the
subject matter hereof. Each Party has executed this Agreement without reliance upon any promise,
representation or warranty other than those expressly set forth herein.



     24.4 Amendment. This Agreement shall not be amended, modified, varied or supplemented
except in writing signed by duly authorized representatives of the Parties.



     24.5 Waiver of Breach. The failure of either Party at any time to enforce any of the
provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision,
nor in any way to affect the validity of this Agreement or any provisions hereof or the right of
any Party to thereafter enforce each and every provision of this Agreement. Subject to Sections
12.3 and 21.4 hereof, no waiver of any breach of any of the provisions of this Agreement shall be
effective unless set forth in a written instrument executed by the Party against whom or which
enforcement of such waiver is sought; and no waiver of any such breach shall be construed or deemed
to be a waiver of any other or subsequent breach.



     24.6 Assignment. Except as otherwise expressly provided in this Section 24.6, neither
Party may assign this Agreement in whole or in part without the prior written approval of the other
Party (such approval not to be unreasonably withheld or delayed). Notwithstanding the foregoing,
(i) either Party may, without the other Party’s consent, assign this Agreement to any entity with
which it may merge or consolidate, which acquires all or substantially all of its business and
assets, or which otherwise is or becomes an Affiliate of the assigning Party, and



-25-









 




(ii) Aventis may assign this Agreement, without Inyx’s consent, in whole or in part with respect to
each particular Aventis Product(s), in connection with the sale of assets and/or license of rights
related to such particular Aventis Product(s) to a Third Party, provided that no such
permitted assignment shall be deemed effective until the assignee shall have executed and delivered
an instrument in writing reasonably satisfactory in form and substance to the other Party pursuant
to which the assignee assumes all of the obligations of the assigning Party hereunder. Any
purported assignment of this Agreement in violation of this Section 24.6 shall be void. This
Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of
a Party appearing herein shall be deemed to include the names of its successors and permitted
assigns.




     24.7 Third Party Beneficiaries. This Agreement is not intended to confer upon any
non-party rights or remedies hereunder, except as may be received or created as part of a valid
assignment.



     24.8 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the Commonwealth of Puerto Rico, without regard to its conflicts of laws
principles.



     24.9 Dispute Resolution. Any dispute, controversy or claim arising out of or related
to this Agreement and the transactions contemplated hereby shall, after mandatory negotiation
periods as are expressly provided herein and subject to the provisions of Exhibit D, be
exclusively and finally resolved by litigation in the U.S. federal courts (and in the event such
federal courts decline or abstain from jurisdiction, the state courts) with jurisdiction in New
Jersey, USA (the “Agreed Courts”). Each of the parties hereto hereby irrevocably and
unconditionally (i) consents and attorns to the exclusive jurisdiction of the Agreed Courts for any
such litigation, (ii) waives any objection to laying of venue of any such litigation in the Agreed
Courts, and (iii) agrees not to plead or claim that such litigation brought therein has been
brought in an inconvenient forum.



     24.10 Severability. All of the provisions of this Agreement are intended to be
distinct and severable. If any provision of this Agreement is or is declared to be invalid or
unenforceable in any jurisdiction, it shall be ineffective in such jurisdiction only to the extent
of such invalidity or unenforceability. Such invalidity or unenforceability shall not affect
either the balance of such provision, to the extent it is not invalid or unenforceable, or the
remaining provisions hereof, nor render invalid or unenforceable such provision in any other
jurisdiction.



     24.11 Interpretation. The Parties hereto acknowledge and agree that: (i) each Party
and its representatives have reviewed and negotiated the terms and provisions of this Agreement and
have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities
are resolved against the drafting Party shall not be employed in the interpretation of this
Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to
each Party hereto and not in favor of or against either Party regardless of which Party was
generally responsible for the preparation of this Agreement.



-26-









 





     24.12 Publicity. Nothing in this Agreement shall be deemed to give either Party any
rights to use the other Party’s trademarks or trade names without the other Party’s prior specific,
written consent. Inyx shall not publicly refer to Aventis or the existence of this Agreement in any
promotional materials, business plans, investment memoranda, or announcements without Aventis’
prior specific, written consent. Aventis has been advised by Inyx that this Agreement, in
conjunction with the Asset Purchase Agreement, is a material transaction for Inyx and accordingly
Inyx shall be required to disclose the existence (but not the terms) of this Agreement in its
filings with securities regulators and press releases, the text of which shall be approved by
Aventis prior to issuance, which approval shall not be unreasonably withheld or delayed.



     24.13 Survival. Article 10 (Representations, Warranties and Covenants of the Parties),
Article 11 (General Representations and Warranties), Section 12.6 (Rights and Duties Upon
Termination), Article 13 (Claims; Recalls), Article 14 (Indemnification), Article 16 (Limitation on
Liability), Article 17 (Confidentiality), Article 18 (Ownership of Property), Article 19
(Retention, Inspections, Access), Article 20 (Cooperation with Governmental Requirements), Section
23.8 (Governing Law), Section 23.9 (Dispute Resolution), Section 23.12 (Publicity), Section 23.13
(Survival) and Section 23.19 (Aventis Affiliates) shall survive the expiration or termination of
this Agreement.



     24.14 Headings. The headings of Articles and Sections have been included for
convenience only and shall not be considered in interpreting this Agreement.



     24.15 Singular Terms. Except as otherwise expressly provided herein or unless the
context otherwise requires, all references to the singular shall include the plural and vice versa.



     24.16 Incorporation of Exhibits. All Exhibits referenced herein are hereby made a part
of this Agreement.



     24.17 Currency. Unless otherwise indicated, all monetary amounts are expressed in
this Agreement in U.S. Dollars.



     24.18 Counterparts. This Agreement may be executed in one or more counterparts, each
of which shall be deemed to be an original, and all of which together shall constitute one and the
same Agreement. This Agreement may be executed and delivered via electronic facsimile transmission
with the same force and effect as if it were executed and delivered by the Parties simultaneously
in the presence of one another.



     24.19 Aventis Affiliates. With respect to the Affiliates of Aventis purchasing
Aventis Products from Inyx pursuant to this Agreement, Aventis undertakes and agrees to (i) procure
the compliance by such Affiliates with the applicable provisions of this Agreement, and (ii)
irrevocably, absolutely and unconditionally guarantee the financial obligations of such Affiliates
to Inyx pursuant to this Agreement.



[Remainder of this page left blank intentionally]




-27-









 








     IN WITNESS WHEREOF, the Parties hereto have each caused this Agreement to be duly executed as
of the date first above written.



	 	 	 	 	 	 	 
	Aventis:
	 
	 	 
	AVENTIS PHARMACEUTICALS, INC.
	a Delaware corporation
	 
	 	 
	By:
	 	/s/ Jessica Steinhart
	 

	 	 
	 
	 	 
	Name:
	 	 Jessica Steinhart
	

	 	 
	 
	 	 
	Title:
	 	Assistant Secretary
	

	 	 
	 
	 	 
	Inyx:
	 
	 	 
	INYX USA, LTD.
	an Isle of Man corporation
	 
	 	 
	By:
	 	/s/ Jack Kachkar
	

	 	 
	 
	 	 
	Name:
	 	Jack Kachkar
	

	 	 
	 
	 	 
	Title:
	 	Director
	

	 	 






-28-









 






EXHIBIT A

(Per Sections 1.2, 1.5 and 9.1)




THE PRODUCTS AND INITIAL ESTIMATED UNIT PRICES




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	GMID	 	 	DESCRIPTION	 	 	PRICE/UNIT	 	 	 	 	 
	 	 
	 	 	00282500	 	 	Sulfacet lotion R 25	 	 	$2.39 /ea	 	 	 	 	 
	 	 
	 	 	074120	 	 	Sulfacet lotion R 25 gr Canada	 	 	$3.34 /ea	 	 	 	 	 
	 	 
	 	 	90282500	 	 	Sulfacet R Tint free 25 gr	 	 	$2.86 /ea	 	 	 	 	 
	 	 
	 	 	80440401	 	 	Hytone lotion 1%    4 oz	 	 	$7.83/ea	 	 	 	 	 
	 	 
	 	 	00980270	 	 	Hytone lotion 2.5%  2 oz	 	 	$6.86/ea	 	 	 	 	 
	 	 
	 	 	80420100	 	 	Hytone cream 1%   1 oz	 	 	$1.40/ea	 	 	 	 	 
	 	 
	 	 	00950170	 	 	Hytone cream 2.5%  1 oz	 	 	$2.59/ea	 	 	 	 	 
	 	 
	 	 	00950270	 	 	Hytone cream 2.5% 2oz	 	 	$3.85/ea	 	 	 	 	 
	 	 
	 	 	04416000	 	 	Benzagel wash 60g	 	 	$11.60/ea	 	 	 	 	 
	 	 
	 	 	004418	 	 	10 Benzagel 60g Canada	 	 	$4.83/ea	 	 	 	 	 
	 	 
	 	 	04311500	 	 	10 Benzagel 1.5 oz	 	 	$6.10/ea	 	 	 	 	 
	 	 
	 	 	04301500	 	 	5 Benzagel 1.5 oz	 	 	$2.78/ea	 	 	 	 	 
	 	 
	 	 	00510170	 	 	Vytone cream 1%    1 oz	 	 	$1.44/ea	 	 	 	 	 
	 	 
	 	 	50067120	 	 	Klaron lotion 4 oz	 	 	$3.36/ea	 	 	 	 	 
	 	 
	 	 	75001101	 	 	Klaron lotion sample	 	 	$9.36/cs	 	 	 	 	 
	 





 









 






EXHIBIT B




FORM OF TECHNICAL AGREEMENT




Please see attached.




 









 








EXHIBIT C




INITIAL COORDINATORS




For Inyx:




     Account Manager:



     Account Executive:



For Aventis:




     Account Manager:



     Account Executive:



 









 





EXHIBIT D




TECHNICAL DISPUTE RESOLUTION PROCEDURE




     In the event of a dispute between the Parties that is required to be resolved by the Agreement
pursuant to the procedures of this Exhibit D, the Parties shall observe the following
procedure:




	1.  	The Parties shall make all reasonable efforts to resolve the dispute by amicable
negotiations.
	 
	2.  	For factual matters related to the quality of materials, the Parties shall mutually select an
independent laboratory to evaluate the materials. Such evaluation shall be binding on the
Parties only with respect to the factual determinations made in such evaluation.
	 
	3.  	For factual matters related to an accounting matter, the Parties shall mutually select an
independent certified accounting firm of national prominence in the United States of America
to audit the relevant books and records of the Parties related to such matters. Such audit
shall be binding on the Parties only with respect to the factual determinations made in such
audit.
	 
	4.  	The provisions of Section 24.9 hereof shall govern to finally resolve all disputes,
controversies and claims between the Parties hereunder; provided, however,
that the factual determinations made pursuant to Sections 2 and 3 of this Exhibit D
shall be final and binding upon the Parties.
	 
	5.  	No laboratory or accounting firm selected or acting pursuant to this Exhibit D shall
be deemed to be an arbitrator and the provisions of applicable statute (foreign or domestic)
and the law relating to arbitration shall not apply to any such laboratory or accounting firm.
	 
	6.  	Each Party shall bear its own costs in connection with any matter referred to a laboratory or
accounting firm selected or acting pursuant to this Exhibit D and, in the absence of
express provision in the Agreement to the contrary, the costs and expenses of any such
laboratory or accounting firm shall be shared equally by the Parties.




 









 











EXHIBIT E




KPIs







	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	KPI	 	 	 	 	Description	 	 	Whom	 	 	 
	 	 	 	 	 	 	 	 	 	 
	Cost	 	 	•	 	API Inventory

	 	 	Inyx

	 	 	 
	 	 	 	•	 	Variance, MPV on Components	 	 	Inyx	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Yield	 	 	•	 	Quarterly/Yearly API (depending

upon the active	 	 	Inyx	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Customer

Service

	 	 	 	 	•
	 	Internal CS (% batches delivered

on –5d /+3d)
	 	 	Inyx/sanofi aventis	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Quality	 	 	•	 	Number of Complaints

	 	 	Sanofi Aventis

	 	 	 
	 	 	 	•	 	First Time Quality	 	 	Inyx	 	 	 
	 	 	 	•	 	Audit Score	 	 	Sanofi Aventis