Definitions. In this Agreement the following words and expressions shall have the following meanings: "Affiliate" means any company, corporation, firm, individual, trust or other entity which controls, is controlled by or is under common control with a party to this Agreement, and for the purpose of this definition the term "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such firm, person, trust or 2 ... company, whether through the ownership of voting securities, by contract or otherwise, or the ownership either directly or indirectly, including the ownership by trusts with substantially the same beneficial interests, of 50% or more of the voting securities (or, in relation to any country where ownership of more than 50% of the voting securities is prohibited by law, the maximum percentage permitted, provided such percentage is no less than 30%) of such company, corporation, firm, individual, trust ox other entity; "Approved Facilities" means the approved facilities located at 10450 Science Center Dr, San Diego, CA 92121, USA ("Manufacturing Facility") and Zone Industrielle Chesnes Ouest, 55, rue de Montmurier, BP. 45, F 38291 Saint Quentin-Fallavier, France ("Packaging Facility") or as may be changed pursuant to this Agreement comprising buildings and Equipment where Skye shall Manufacture and Quality Control and store or have Manufactured, Quality Controlled and stored the Product; "Certificate of Analysis" means a document setting out the results of analysis of a batch of Product together with the Specification and methods by which, the tests were performed; "Certificate of Conformance" means a document stating and confirming that the Product has been Manufactured and Quality Controlled in accordance with, and in all respects complies with, cGMP and the Marketing Authorisation; "cGMP" means current Good Manufacturing Practice as set out in European Directive 91/356/EEC or its local equivalent as amended from time to time; "Confidential Information" means all confidential information, data and materials 3 in whatever form disclosed by one party to the other or received in connection with this Agreement including, without limitation, the terms of this Agreement, but excluding information: (a) which, at the time of disclosure by one party to the other, is in the public domain; (b) which, after disclosure by one party to the other, becomes part of the public domain by publication, except by breach of any obligation of confidentiality; (c) which the receiving party can establish by competent proof was already in its possession at the time of its receipt and was not acquired directly or indirectly from the other party; (d) which, after disclosure by one party to the other, was developed independently of the information received; or (e) received from third parties who were lawfully entitled to disclose such information; "Delivery" means Skye making available at the Packaging Facility the Product for collection by Mundipharma or its nominated carrier, "Delivery Date" means that date upon which the Product is available for collection from the Packaging Facility; "Distribution Agreement" means the distribution agreement in relation to the Product between Skye and Mundipharma International Holdings Limited; "EMEA" means the European Medicines Evaluation Agency or any successors thereto; 4 "Equipment" means the equipment used in the Manufacture, assembly, Packaging, analysis and testing of the Product; "Finished Product" means Product presented in Vials, packaged and labelled for sale to end users; "Intellectual Property" means patents, trade marks, service marks, logos, trade names, rights in designs, copyright, utility models, rights in Know-How and other intellectual property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world; "Manufacture" means all methods, processes, data and documentation used by Skye or its Third Party Manufacturer in relation to the manufacture Packaging and Quality Control of the Product and "Manufacturer" shall be construed accordingly; "Manufacturing Approval" means all necessary or appropriate approvals, licences, permits, registrations and authorisations in respect of the Manufacture and Quality Control of the Product; "Manufacturing Licence" means any licence as granted by the Regulatory Authority to Skye or the Third Party Manufacturer in the applicable territory to Manufacture the Product; "Manufacturing Technology" means all methods, processes, designs, data, procedures and other information relating to the Manufacture of the Product, including without limitation final quality assurance procedures, manufacturing procedures, product and raw material specifications, formulation data and other technology related thereto; "Marketing Authorisation" means the approval by the EMEA numbered 5 EU/1/01/187/001 permitting the commercial marketing of the Product in certain of the countries licensed to Mundipharma International Holdings Limited under the Distribution Agreement for the licensed indication; "Net Sales" means total gross sales of Finished Product invoiced by Mundipharma International Holdings limited, its Affiliates, sub-distributors and sub-licensees to Third Parties, less: (a) transport, freight and insurance costs; (b) sales and excise taxes and duties; (c) normal and customary trade, quantity and cash discounts and rebates; (d) amounts repaid, discounted or credited by reason of (i) retroactive price reductions; (ii) discounts; or (iii) rebates which are, in any case, imposed upon Mundipharma International Holdings limited, its Affiliates, sub-licensees or sub-distributors by any governmental or non-governmental body with the authority to impose such price reductions, discounts or rebates; (e) billing errors; and (f) amounts repaid or credited (other than in respect of outdated goods) for rejected, returned or recalled goods; "Packaging" means all operations in the assembly, labelling, packaging and Quality Control of the Finished Product ready for sale or supply to a third party in any country licensed under the Distribution Agreement and "Packaged" shall be construed accordingly; 6 "Product" means the Depofoam formulation of cytarabine (a sustained release formulation of cytarabine (ara-C) a pyrimidine analogue (L01BC01)) made to the Specification; "Product Price" means [**] Euros per Vial of Finished Product; "Qualified Person" means a Qualified Person as defined in European Directive 2001/83/EC; "Quality Control" means the sampling, laboratory testing and inspection at the Approved Facilities of: (a) Raw Materials, in-process materials and Finished Product; and (b) the Finished Product as necessary for Release; "Quarter" means any three month period ending on the last day of March, June, September or December in any calendar year; "Raw Materials" means all raw materials required to produce the Product; "Regulatory Authority" means any competent regulatory authority or other governmental body (for example, but not by way of limitation, the EMEA) responsible for granting Manufacturing Licences and Manufacturing Approvals in any country licensed under the Distribution Agreement; "Release" means release of the Finished Product from the Packaging Facility to Mundipharma for sale; "Specification" means the specification of the Product as set out in the Appendix; 7 "Technical Agreement" means the technical agreement between the parties relating to the Manufacture of the Product to be agreed in good faith; "Term" means the term of this Agreement as set out in Clause 9; "Third Party Manufacturer" means a third party appointed by Skye to Manufacture the Product on its behalf; and "Vial" means a [**] vial containing the Product.View More
Definitions. 1.1 References in the Original Agreement to this "Agreement" shall mean the Original Agreement, as amended by this Amendment. Unless otherwise defined in this Amendment, capitalized terms used herein shall have the meanings ascribed to them in the Original Agreement. 1.2 When used in this Amendment, the following capitalized terms shall have the meanings indicated: "Future Milestone Shares" means any and all "restricted" shares of Parent Common Stock that Parent, in its discretion in... accordance with the provisions of the Original Agreement, elects to issue in payment of any of Milestone #2, Milestone #3, Milestone #4 and Milestone #5. The term "restricted" shares for this purpose and for the purposes of the definition of "Milestone Shares" has the meaning set forth in Rule 144 under the Securities Act. "Milestone Shares" means 1,315,789 "restricted" shares of Parent Common Stock, subject to increase as provided in Section 2.4 of this Amendment; "Payment Date" means February 10, 2012. "Securities Act" means the Securities Act of 1933, as amended.View More
Definitions. Unless otherwise expressly defined herein, all capitalized terms used herein and defined in the Agreement shall be used herein as so defined.
Definitions. "Administrative Agent" means Barclays Capital Inc., as administrative agent under the LLC Credit Agreement and any successors and assignees in accordance with the terms of the LLC Credit Agreement, and Wells Fargo Bank, National Association, as collateral agent under the Senior Secured Notes and any successors and assignees in accordance with the terms of the Senior Secured Notes. "Permitted Transfer" means: (a) by operation of law or otherwise, the direct or indirect change in control,... merger, consolidation or acquisition of all or substantially all of the assets of LLC or Cinemark, as applicable, or the assignment of this Agreement by Cinemark to an Affiliate, (b) with respect to the rights and obligations of LLC under this Agreement, (i) the grant of a security interest by LLC in this Agreement and all rights and obligations of LLC hereunder to the Administrative Agent, on behalf of the Secured Parties, pursuant to the Security Documents, (ii) the assignment or other transfer of such rights and obligations to the Administrative Agent (on behalf of the Secured Parties) or other third party upon the exercise of remedies in accordance with the LLC Credit Agreement and/or the Senior Secured Notes and the Security Documents and (iii) in the event that the Administrative Agent is the initial assignee or transferee under the preceding clause (ii), the subsequent assignment or other transfer of such rights and obligations by the Administrative Agent on behalf of the Secured Parties to a third party, or (c) in the event that LLC becomes a debtor in a case under the Bankruptcy Code, the assumption and/or assignment by LLC of this Agreement under section 365 of the Bankruptcy Code, notwithstanding the provisions of section 365(c) thereof. "Security Documents" means the "Security Documents" as defined in the LLC Credit Agreement and in the purchase agreement or the indenture for the Senior Secured Notes, and any amendment, modification, supplement or replacement of such Security Documents. "Secured Parties" means (i) the "Secured Parties" (or any analogous concept) as defined in the LLC Credit Agreement and (ii) Wells Fargo Bank, National Association (or any successor thereto), in its capacity as Trustee or Collateral Agent, as the case may be, for the Senior Secured Notes, and the holders of the Senior Secured Notes. "Senior Secured Notes" means the senior secured notes issued by LLC in April 2012, due in 2022.View More
Definitions. In this Agreement, unless the context otherwise requires, the capitalized terms used in the English version of this Agreement and the terms in the Chinese version of this Agreement shall have the meanings ascribed to them in Part 1 of Schedule 1 to this Agreement.
Definitions. Section 1(q) of the Agreement shall be deleted in its entirety and replaced with the following: "(q) QUALIFIED PUBLIC OFFERING" means any underwritten initial Public Offering.
Definitions. (a) "Actual EBITDA" is defined as the amount of the Corporation's earnings before interest, taxes, depreciation and amortization for the calendar year, as adjusted by the Committee in its sole discretion for any extraordinary or non-recurring items.
Definitions. A. "Default" under this Assignment shall exist (i) if any representation made by any Assignor in this Assignment is found to have been untrue or misleading in any material respect at the time it was made, (ii) if any Assignor fails to observe any covenant made in this Assignment and (A) fails, upon notice from Assignee advising such Assignor of such failure, to cure the failure within thirty (30) days, (B) ceases to pursue diligently the cure of the failure or (C) repudiates in writing its... obligation to cure the failure, or (iii) if an "Event of Default" exists under the terms of the Mortgage or any other Loan Document.View More
Definitions. In this Agreement: "Effective Date" means 10:00 a.m., London time, on July 24, 2008. 1.2 Incorporation of Defined Terms (a) Unless a contrary indication appears, a term defined in the Senior Bridge Facilities Agreement has the same meaning in this Agreement. (b) The principles of interpretation set out in the Senior Bridge Facilities Agreement shall have effect as if set out in this Agreement. 1.3 Third Party Rights A person who is not party to this Agreement, other than the Obligors and the... Finance Parties, has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement.View More