PhOSCo General Licence 0 General 0.1. The terms "PhOSCo" and "Pharma Open Source Community" are registered trade marks of Guillemot Design Ltd. Guillemot Design Ltd makes use of Service Partners' trade marks, service marks, trade names or other identifying information ("Third Party Trade marks"), and those Third Party Trade marks remain the sole and exclusive property of the applicable third parties. 0.2. The term "PhOSCo Clinical Trials" is a trade mark of Guillemot Design Ltd and must not be used to endorse or promote products derived from Guillemot Design Ltd's "PhOSCo Clinical Trials" software without the prior written and explicit permission of Guillemot Design Ltd. For written permission, please contact info@phosco.com. 0.3. The "PhOSCo Clinical Trials" software is copyright-protected and all rights are owned by Guillemot Design Ltd. Redistribution of the "PhOSCo Clinical Trials" software with or without Modifications or as part of a Larger Work must reproduce Guillemot's copyright designation and this Licence in the documentation and/or other materials provided with the distribution. Copyright © 1998-2004 Guillemot Design Ltd (http://www.phosco.com/). All Rights Reserved. 0.4. If You transmit Modifications (including feedback, materials, fixes, error corrections enhancements, suggestions and the like) to Guillemot Design Ltd or to the PhOSCo website, you automatically grant Guillemot Design Ltd a world-wide, royalty-free, irrevocable, non-exclusive licence under all intellectual property rights (including copyright) as described under 1.2 without any obligation from Guillemot Design Ltd to pay a distribution fee. Guillemot Design Ltd will make available such Modifications and improvement suggestions from the PhOSCo website under its own name. Any deviation from this procedure needs to be agreed in writing by both parties. 0.5. You agree not to publish any part of the materials governed by this Licence without written prior permission of Guillemot Design Ltd. This does not affect your right to publish or communicate with any person any opinion or evaluation you may wish to. 0.6. GPL Software Extension Licence Notes: PhOSCo software can use a component, the JCalendarBean GPL library, to handle the input of valid dates into Date widgets. JCalendarBean may be linked to the PhOSCo product through a switchable API such that PhOSCo software is not dependent on the JCalendarBean API. According to GPL conditions, you can find JCalendarBean source code at : http://www.toedter.com PhOSCo software can use a component, the Mckoi JDBC Database, to handle the storage of data in a local JDBC compliant datastore. Mckoi may be linked to the PhOSCo product through a switchable API such that PhOSCo software is not dependent on the Mckoi database. According to GPL conditions, you can find Mckoi source code at : http://www.mckoi.com/database 0.7 Government End Users. No special terms or privileges shall be assumed by any government users and such users shall be bound by the normal commercial terms of this licence. 0.8 USE SUBJECT TO JURISDICTION OF THE UNITED STATES OF AMERICA Where any party obtaining or using PhOSCo software is situated in, performs any act, or is in any way subject to, any jurisdiction of the United States of America that party shall indemnify and hold Guillemot Design Limited harmless from any action extra-territorial or otherwise of any third party including but not restricted to government agencies of the United States of America with regard to copyright, copy protection legislation, infringement or other violation of software patent, or other intellectual property restrictions or legislation, and any costs arising from such action. 1 Source Code Licence. 1.1. The Original Developer Grant. The Original Developer hereby grants You a world-wide, non-exclusive licence, subject to third party intellectual property claims: (a) to reproduce, modify, display, run for activities other than Use, sublicence and distribute the Original Program (or portions thereof) with or without Modifications, or as part of a Larger Work subject to the following obligations: i) only redistributing restricted PhOSCo materials to users intending Clinical Research or IT related Services use (other users may obtain restricted PhOSCo materials directly from the Original Developer or via a PhOSCo subscription); ii) binding any recipient by the exact terms of this Licence; iii) notifying the Original Developer in writing about recipients of the Covered Code to which You have distributed or sublicenced it within thirty (30) days; (b) to Use the Original Program (or portions thereof) with or without Modifications, or as part of a Larger work for Clinical Research, Non-profit Research, Personal Use Activities or Other Activities subject to the following obligations: i) paying the Original Developer a fee for the Use of Covered Code according to the Use Type described in the Usage Terms in Exhibit B-2; The Original Developer may decide at its sole discretion if and under which Use Type he will grant You the Licence; that decision may be revised at any time and without explanation. The Original Developer without the obligation for any justification reserves the right not to grant You a Licence. The Original Developer reserves the rights to contract an approved auditor in order to assess Your compliance with the Licence terms. In case a non-compliance situation is found the audit fees will be borne by You besides any other claims arising from such a situation 1.2. Contributor Grant. Each Contributor other than the Original Developer hereby grants You and the Original Developer a world-wide, royalty-free, irrevocable, non-exclusive licence under all intellectual property rights (including copyright) to Use, reproduce, modify, display, run for activities other than Use, sublicence and distribute the Modifications created (including any feedback, materials, fixes, error corrections enhancements, suggestions and the like) and distributed by such Contributor (or portions thereof) either on an unmodified basis, with other Modifications, as Covered Code or as part of a Larger Work Contributor may charge a reasonable fee for the physical act of transferring a copy, and Contributor may at his option offer additional services and/or warranty protection in exchange for a fee. 2 Distribution Obligations 2.1. Application of Licence. The Modifications which You create or to which You contribute are governed by the terms of this License, including without limitation Section 1.2, if said Modifications are made accessible, directly or indirectly, to a third party. The Source Code version of Covered Code may be distributed only under the terms of this Licence or a future version of this Licence released under Section 5., and You must include a copy of this Licence with every copy of the Source Code You distribute. You may not offer or impose any terms on any Source Code version that alters or restricts the applicable version of this Licence or the recipients' rights hereunder. However, You may include an additional document offering the additional rights described in Section 2.5. 2.2. Availability of Source Code. Any Modification which You create or to which You contribute must be made available in Source Code form under the terms of this Licence either on the same media as an Executable version or via an accepted Electronic Distribution Mechanism to anyone to whom you made an Executable version available; and if made available via Electronic Distribution Mechanism, must remain available for at least twelve (12) months after the date it initially became available, or at least six (6) months after a subsequent version of that particular Modification has been made available to such recipients. You are responsible for ensuring that the Source Code version remains available even if the Electronic Distribution Mechanism is maintained by a third party. 2.3. Description of Modifications. You must cause all Covered Code to which you contribute to contain a file documenting the changes You made to create that Covered Code and the date of any change. You must include a prominent statement that the Modification is derived, directly or indirectly, from Original Program provided by the Original Developer and including the name of the Original Developer in (a) the Source Code, and (b) in any notice in an Executable version or related documentation in which You describe the origin or ownership of the Covered Code. 2.4. Intellectual Property Matters If You claim or have knowledge that a party claims an intellectual property right in particular functionality or code (or its use under this Licence), you must include a text file with the source code distribution titled "README-LEGAL" which describes the claim and the party making the claim in sufficient detail that a recipient will know whom to contact. If you obtain such knowledge after You make Your Modification available as described in Section 2.2, You shall promptly modify the README-LEGAL file in all copies You make available thereafter and shall take other steps (such as notifying appropriate mailing lists or newsgroups) reasonably calculated to inform those who received the Covered Code that new knowledge has been obtained. 2.5. Required Notices. You must duplicate the notice in Exhibit B-1 in each file of the Source Code, and this Licence in any documentation for the Source Code, where You describe recipients' rights relating to Covered Code. If You created one or more Modification(s), You may add your name as a Contributor to the notice described in Exhibit B-1. If it is not possible to put such notice in a particular Source Code file due to its structure, then you must include such notice in a location (such as a relevant directory file) where a user would be likely to look for such a notice. You may choose to offer, and to charge a fee for, warranty, support, indemnity or liability obligations to one or more recipients of Covered Code. However, You may do so only on Your own behalf, and not on behalf of the Original Developer or any Contributor. You must make it absolutely clear than any such warranty, support, indemnity or liability obligation is offered by You alone, and You hereby agree to indemnify the Original Developer and every Contributor for any liability incurred by the Original Developer or such Contributor as a result of warranty, support, indemnity or liability terms You offer. 2.6. Distribution of Executable Versions. You may distribute Covered Code in Executable form only if the requirements of Section 2.1-2.5 have been met for that Covered Code, and if You include a notice stating that the Source Code version of the Covered Code is available under the terms of this Licence, including a description of how and where You have fulfilled the obligations of Section 2.2. The notice must be conspicuously included in any notice in an Executable version, related documentation or collateral in which You describe recipients' rights relating to the Covered Code. You may distribute the Executable version of Covered Code under a licence of Your choice, which may contain terms different from this Licence, provided that You are in compliance with the terms of this Licence and that the licence for the Executable version does not attempt to limit or alter the recipient's rights in the Source Code version from the rights set forth in this Licence. If You distribute the Executable version under a different licence You must make it absolutely clear that any terms which differ from this Licence are offered by You alone, not by the Original Developer or any Contributor. You hereby agree to indemnify the Original Developer and every Contributor for any liability incurred by the Original Developer or such Contributor as a result of any such terms You offer. 2.7. Larger Works. You may create a Larger Work by combining Covered Code with other code not governed by the terms of this Licence and distribute the Larger Work as a single product. In such a case, You must make sure the requirements of this Licence are fulfilled for the Covered Code. You may distribute the Larger Work in Executable or Source form only if the requirements of Section 2.1-2.5 have been met for the Covered Code, and if You include a notice stating that the Source Code version of the Covered Code is available under the terms of this Licence, including a description of how and where You have fulfilled the obligations of Section 2.2. 3. Inability to Comply Due to Statute or Regulation If it is impossible for You to comply with any of the terms of this Licence with respect to some or all of the Covered Code due to statute or regulation then You must: (a) comply with the terms of this Licence to the maximum extent possible; and (b) describe the limitations and the code they affect. Such description must be included in the README-LEGAL file described in Section 2.4 and must be included with all distributions of the Source Code. Except to the extent prohibited by statute or regulation, such description must be sufficiently detailed for a recipient of ordinary skill to be able to understand it. 4. Application of this Licence. This Licence applies to code to which the Original Developer has attached the notice in Exhibit B-1, and to related Covered Code. 5. Versions of the Licence. 5.1. New Versions. The Original Developer may publish revised and/or new versions of the Licence from time to time. Each version will be given a distinguishing version number. 5.2. Effect of New Versions. Once Covered Code has been provided to You under a particular version of the Licence, You may always continue to use it under the terms of that version. You may also choose to use such Covered Code under the terms of any subsequent version of the Licence published by the Original Developer. No one other than the Original Developer has the right to modify the terms applicable to Covered Code created under this Licence. 5.3. Derivative Works. If you create or use a modified version of this Licence (which you may only do in order to apply it to code which is not already Covered Code governed by this Licence), you must (a) rename Your licence so that the phrases "PhOSCo", "PhOSCo Clinical Trials", or any confusingly similar phrase do not appear anywhere in your licence, and (b) otherwise make it clear that your version of the licence contains terms which differ from the PhOSCo General Licence. (Filling in the name of the Original Developer, Original Program or Contributor in the notice described in Exhibit B-1 shall not of themselves be deemed to be modifications of this Licence.) 6. DISCLAIMER OF WARRANTY. BECAUSE THE CUSTOMISATION, MODIFICATION, PURPOSE, AND MANNER OF USE OF CODE IS ENTIRELY OUTSIDE THE CONTROL OF GUILLEMOT DESIGN LIMITED, COVERED CODE IS PROVIDED UNDER THIS LICENCE ON AN "AS IS" BASIS, WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES THAT THE COVERED CODE IS FREE OF DEFECTS, MERCHANTABLE, FIT FOR A PARTICULAR PURPOSE, OR NON-INFRINGING. THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE COVERED CODE IS WITH YOU. SHOULD ANY COVERED CODE PROVE DEFECTIVE IN ANY RESPECT, YOU (NOT THE ORIGINAL DEVELOPER OR ANY OTHER CONTRIBUTOR) ASSUME THE COST OF ANY NECESSARY SERVICING, REPAIR, OR CORRECTION. THIS DISCLAIMER OF WARRANTY CONSTITUTES AN ESSENTIAL PART OF THIS LICENCE. NO USE OF ANY COVERED CODE IS AUTHORISED HEREUNDER EXCEPT UNDER THIS DISCLAIMER. 7. Termination. This Licence and the rights granted hereunder will terminate automatically if You fail to comply with terms herein and fail to cure such breach within 30 days of becoming aware of the breach. All sublicences to the Covered Code which are properly granted shall survive any termination of this Licence. Provisions which, by their nature, must remain in effect beyond the termination of this Licence shall survive. 8. LIMITATION OF LIABILITY. UNDER NO CIRCUMSTANCES AND UNDER NO LEGAL THEORY, WHETHER TORT (INCLUDING NEGLIGENCE), CONTRACT, OR OTHERWISE, SHALL THE ORIGINAL DEVELOPER, OR ITS DIRECTORS, OFFICERS, EMPLOYEES, OR AFFILIATES , ANY OTHER CONTRIBUTOR, OR ANY DISTRIBUTOR OF COVERED CODE, OR ANY SUPPLIER OF ANY OF SUCH PARTIES, BE LIABLE TO YOU OR ANY OTHER PERSON FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY CHARACTER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF GOODWILL, WORK STOPPAGE, COMPUTER FAILURE OR MALFUNCTION, OR ANY AND ALL OTHER COMMERCIAL DAMAGES OR LOSSES, EVEN IF SUCH PARTY SHALL HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION OF LIABILITY SHALL NOT APPLY TO LIABILITY FOR DEATH OR PERSONAL INJURY RESULTING FROM SUCH PARTY'S NEGLIGENCE TO THE EXTENT APPLICABLE LAW PROHIBITS SUCH LIMITATION. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THAT EXCLUSION AND LIMITATION MAY NOT APPLY TO YOU. 9. Applicable Law and Jurisdiction. This Licence shall be governed by English law. All disputes arising under this Licence shall be subject to the exclusive jurisdiction of the courts at the registered office of the Original Developer in England. The Original Developer, however, shall remain entitled to bring legal action against You at any other place where jurisdiction is permissible. 10. MISCELLANEOUS This Licence represents the complete agreement concerning subject matter hereof. If any provision of this Licence is held to be unenforceable, such provision shall be reformed only to the extent necessary to make it enforceable.

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