General terms

A. Expiration. This Quotation is valid for 30 days from the date hereof, and becomes binding if signed and delivered by both parties during that period.
B. Audits. Client may conduct one quality assurance facility audit per year at no cost. Additional audits will be invoiced separately at the current rate for such services.
C. Regulatory Inspections. European Packaging Centre bv will promptly notify Client of any regulatory inspections directly relating to the Product. Client accepts reasonable and documented costs charged by a regulatory authority for such inspections.
D. Price Changes. European Packaging Centre bv may revise the prices provided in this Quotation (i) if Client's requirements or any Client provided information is inaccurate or incomplete; (ii) if Client revises European Packaging Centre bv's responsibilities or the Product specifications, instructions, procedures, assumptions, processes, test protocols, test methods or analytical requirements; or (iii) for such other reasons set forth in this Quotation.
E. Payments. European Packaging Centre bv will invoice Client as set forth in this Quotation. European Packaging Centre bv charges a late payment fee of 2% per month for payments not received by the date specified in this Quotation (or if no date is specified, within 30 days of invoice date). Failure to bill for interest due shall not be a waiver of European Packaging Centre bv's right to charge interest.
F. Taxes. All sales, use, customs, gross receipts, compensating, value added or other taxes, duties, licenses or fees (excluding European Packaging Centre bv 's net income and franchise taxes) assessed by any tax jurisdiction arising from the Product are the responsibility of Client, whether paid by European Packaging Centre bv or Client.
G. Reservation of Ownership. All the materials supplied to client remain properties of European Packaging Centre bv until all the invoices that have been sent to the client have been paid.
H. Hazardous Materials. Client warrants to European Packaging Centre bv that no specific safe handling instructions are applicable to any Client-supplied materials, except as disclosed to European Packaging Centre bv in writing by the Client in sufficient time for review and training by European Packaging Centre bv prior to delivery. Where appropriate or required by law, Client will provide a Material Safety Data Sheet for all Clients supplied materials and finished product.
I. Shipment. Unless otherwise specified in Quotation, all products and other materials shipped by European Packaging Centre bv are delivered EXW (Incoterms 2000) European Packaging Centre bv's facilities and the title shall pass to Client upon such delivery.
J. Limitations of Liability. European Packaging Centre bv's total liability under this quotation shall in no event exceed the total fees paid for the packaging of the applicable defective batch (but excluding fees for procuring comparator drug). European Packaging Centre bv's liability under this quotation for any and all claims for lost, damaged or destroyed API or client-supplied materials, whether or not incorporated into finished product, shall not exceed €5,000,- neither party shall be liable to the other for indirect, incidental, special or consequential damages arising out of performance under this quotation, including without limitation loss of revenues, profits or data, whether in contract or in tort, even if such party has been advised of the possibility of such damages. Nothing in this quotation shall limit the liability of European Packaging Centre bv for death or personal injury arising from the negligence of European Packaging Centre bv or the liability of European Packaging Centre bv for fraudulent misrepresentation.
K. Confidentiality. All information disclosed by a party in connection with this Quotation shall be confidential information, unless such information is (i) already known to the receiving party, as evidenced by written records; (ii) independently developed or discovered by the receiving party without the use of the disclosing party's confidential information, as evidenced by written records; (iii) in the public domain, other than through the fault of the receiving party; (iv) disclosed to the receiving party by a third party not in breach of a duty of confidentiality owed to the disclosing party; or (v) required to be disclosed by law, or court or administrative order; provided, that to the extent legally possible the receiving party first gives prompt notice thereof to the disclosing party. Neither party shall, without the other party's prior written consent, use the confidential information of the other party or disclose such information to anyone other than employees of the receiving party or its affiliated entities who require such information to perform such party's obligations under this Quotation. This undertaking shall survive for 7 years following the date of this Quotation.
L. Intellectual Property. For purposes hereof, "Client IP" means all intellectual property and embodiments thereof owned by or licensed to Client as of the date hereof or developed by Client other than in connection with the Product; "European Packaging Centre bv IP" means all intellectual property and embodiments thereof owned by or licensed to European Packaging Centre bv as of the date hereof or developed by European Packaging Centre bv other than in connection with the Product; "Invention" means any intellectual property developed by either party in connection with the Product; "API Inventions" means any Invention that relates exclusively to the Client IP or Client's patented API; and "Process Inventions" means any Invention, other than an API Invention, that relates exclusively to the European Packaging Centre bv IP or relates to developing, formulating, manufacturing, filling, processing, packaging, analyzing or testing pharmaceutical products generally. All Client IP and API Inventions shall be owned solely by Client and no right therein is granted to European Packaging Centre bv under this quotation except for use in supplying the Product. All European Packaging Centre bv IP and Process Inventions shall be owned solely by European Packaging Centre bv and no right therein is granted to Client under this Quotation. All Inventions to generic API (other than API Inventions and Process Inventions), if any, shall be owned jointly by European Packaging Centre bv and Client. The parties shall cooperate to achieve the

allocation of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection of its intellectual property.
M. Warranties. European Packaging Centre bv will perform the supply of the Product in accordance with the finished Product written specifications and European Union current Good Manufacturing Practices, Good Clinical Practices or current Good Laboratory Practices, as applicable. The warranties set forth in this article are the sole and exclusive warranties made by European Packaging Centre bv to client, and European Packaging Centre bv makes no other representations, warranties or guarantees of any kind whatsoever, including any implied warranties of merchantability, non-infringement or fitness for a particular purpose.
N. Client Obligations. If applicable and unless otherwise agreed to by the parties in writing, Client is solely responsible to (i) provide complete and accurate scientific data regarding the Product; (ii) if applicable, review and approve all in process and finished product test results to ensure conformity of such results with the finished Product specifications, regardless of which party is responsible for finished Product release; (iii) prepare all submissions to regulatory authorities; and (iv) perform such other obligations of Client set forth in this Quotation.
O. Indemnification. Client will indemnify European Packaging Centre bv, its affiliates and their respective directors, officers, employees and agents against any third-party claim arising directly or indirectly from (i) the manufacture, promotion, marketing, distribution or sale of, or use of or exposure to, the Product, API and Client supplied materials that are the subject of the manufacture and supply of the Product; (ii) the negligence or wilful misconduct of Client; (iii) the breach of this Quotation by Client; or (iv) the use of any intellectual property provided by Client to European Packaging Centre bv. European Packaging Centre bv will indemnify Client against any third-party claim arising directly or indirectly from the negligence or wilful misconduct of European Packaging Centre bv or the breach of this Quotation by European Packaging Centre bv.
P. Set-Off. Without limiting European Packaging Centre bv's rights under law or in equity, European Packaging Centre bv and its affiliates, parent or related entities, collectively or individually, may exercise a right of setoff against all amounts due to European Packaging Centre bv from Client. For purposes of this Article, European Packaging Centre bv, its affiliates, parent or related entities, shall be deemed to be a single creditor.
Q. Force Majeure. Neither party will be liable for any failure to perform or for delay in performance resulting from any cause beyond its reasonable control, including without limitation acts of God, fires, floods or weather, strikes or lockouts, factory shutdowns, embargoes, wars, hostilities or riots, or shortages in transportation. If the cause continues unabated for 90 days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Quotation should result from such cause.
R. Use and Disposal. Client represents and warrants to European Packaging Centre bv that Client will hold, use and/or dispose of products and other materials provided by European Packaging Centre bv in accordance with all applicable laws, rules and regulations. Client grants European Packaging Centre bv full authority to use any Client supplied materials for purposes of this Quotation.
S. Record Retention. Unless the parties otherwise agree in writing, European Packaging Centre bv will retain batch, laboratory and other technical records for the minimum period required by applicable law.
T. Independent Contractor. The relationship of the parties is that of independent contractors and not of joint ventures, co-partners, employer/employee or principal/agent.
U. Publicity. Neither party will make any press release or other public disclosure regarding this Quotation or the transactions contemplated hereby without the other party's express prior written consent, except as required by applicable law, by any governmental agency or by the rules of any stock exchange on which the shares of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or public disclosure.
V. Amendment & Precedence. These Standard Terms and Conditions constitute a part of the Pricing Letter or Quotation to which they are attached (collectively, "this Quotation"); provided, that these Standard Terms and Conditions supersede any conflicting terms and conditions set forth in the Pricing Letter or Quotation to which they are attached or any Client purchase order. This Quotation constitutes the entire understanding between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties, with respect to the Product. No term of this Quotation may be amended except upon written agreement of both parties.
W. Governing Law and Dispute Resolution. All agreements that arise between the parties shall be governed by Dutch Law. If a dispute arises between the parties in connection with this Quotation, the respective presidents or Senior Executives of European Packaging Centre bv and Client shall first attempt to resolve the dispute. If such parties cannot resolve the dispute, such dispute shall be subject to the exclusive jurisdiction of the Dutch District Court of Leeuwarden. The application to the United Nations Convention on the Sale of Goods (1980) is excluded.
X. Invalid Clauses. If one or more of these clauses in full or in part appear to be invalid, the other clauses shall remain valid. Parties agree that they replace the invalid clause by a clause that is valid and approaches the intent of European Packaging Centre bv.
Y. Survival. Subject to execution, the rights and obligations of Client and European Packaging Centre bv in Articles J, K, L, O, U, W and X of these Standard Terms and Conditions shall survive termination or expiration of this Quotation.