MEMORANDUM AND ARTICLES OF ASSOCIATION

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1 MEMORANDUM AND ARTICLES OF ASSOCIATION OF THE ORGANISATION FOR PROFESSIONALS IN REGULATORY AFFAIRS (TOPRA) Ltd (Incorporated the 17th day of November 1978) (amended on 11 March 1981, 28 May 1986, 18 May 1987, 23 May 1994, 8 th September 1999 and 10 th September 2003)

2 CERTIFICATE NO THE COMPANIES ACTS 1985 and 1989 COMPANY LIMITED BY GUARANTEE AND NOT HAVING A SHARE CAPITAL M E M O R A N D U M A N D A R T I C L E S O F A S S O C I A T I O N O F THE ORGANISATION FOR PROFESSIONALS IN REGULATORY AFFAIRS Ltd (TOPRA) (Incorporated the 17th day of November 1978) (amended on 11 March 1981, 28 May 1986, 18 May 1987, 23 May 1994, 8 th September 1999 and 10 th September 2003)

3 THE COMPANIES ACTS 1985 and 1989 COMPANY LIMITED BY GUARANTEE AND NOT HAVING A SHARE CAPITAL MEMORANDUM OF ASSOCIATION OF THE ORGANISATION FOR PROFESSIONALS IN REGULATORY AFFAIRS 1. The name of the company (hereinafter called "the Company") is The Organisation for Professionals in Regulatory Affairs Limited. 2. The registered office of the Company will be situated in England. 3. The objects for which the Company is established are: (i) (ii) (iii) (iv) To establish professional identity and standards for regulatory affairs personnel in the pharmaceutical and related fields. To promote education and science in regulatory affairs, to advance the professional competency of its members and to promote co-operative relations with other allied organisations. To collect and circulate relevant statistics and information of all kinds. In furtherance of which but not otherwise the Company shall have power: (a) (b) (c) (d) To purchase, take on lease or in exchange, hire or otherwise acquire any real and personal estate which may be deemed necessary or convenient for any of the purposes of the Company. To construct, maintain, and alter any houses, buildings, or works necessary or convenient for the purposes of the Company. To take any gift of property, whether subject to any special trust or not, for any one or more of the objects of the Company. To take such steps by personal or written appeals, public meetings, or otherwise as may from time to time be deemed expedient for the purpose of procuring contributions to the funds of the Company in the shape of donations, annual subscriptions, or otherwise.

4 (e) To print and publish any newspapers, periodicals, books, leaflets that the Company may think desirable for the promotion of its objects. (f) (g) (h) (i) (j) (k) (l) (m) (n) (o) To sell, manage, lease, mortgage, dispose of, or otherwise deal with all or any part of the property of the Company. To borrow and raise money in such manner as the Company may think fit. To invest the moneys of the Company not immediately required for its purposes in or upon such investments, securities or property as may be thought fit, subject nevertheless to such conditions (if any) and such consents (if any) as may for the time being be imposed or required by law and subject also as hereinafter provided. To undertake and execute any trusts ir any agency business which may seem directly or indirectly conductive to any of the objects of the Company. To subscribe to any local or other charities, and to grant donations for any public purposes, and to provide a superannuation fund for the servants of the Company, or otherwise to assist any such servants, their widows and children. To establish and support, and to aid in the establishment and support of, any other institutions formed for all or any of the objects of this Company. To amalgamate with any companies, institutions, societies or associations having objects altogether or in part similar to those of this Company. To purchase or otherwise acquire and undertake all or any part of the property, assets, liabilities and engagements of any one or more of the companies, institutions, societies or associations with which this Company is authorised to amalgamate. To transfer all or any part of the property, assets, liabilities and engagements of this Company to any one or more of the companies, institutions, societies or associations with which this Company is authorised to amalgamate. To do all such other lawful things as are incidental or conductive to the attainment of the above objects or any of them. And it is hereby declared that the word "Company" in this clause shall be deemed to include any partnership or other body of persons, whether incorporated or not incorporated and whether domiciled in the United Kingdom or elsewhere, and the intention is that the

5 objects of the Company as specified in each of the foregoing paragraphs of this clause shall, except only if at all where otherwise expressed, be separate and distinct objects and shall not be in anywise limited or restricted by reference to or inference from the terms of any other paragraphs or the name of the Company PROVIDED THAT: (i) (ii) (iii) (iv) In case the Company shall take or hold any property which may be subject to any trusts, the Company shall only deal with or invest the same in such manner as allowed by law, having regard to such trusts. The Company shall not support with its funds any object, or endeavour to impose on or procure to be observed by its members or others, any regulation, restriction or condition which if an object of the Company would make it a trade union. The objects of the Company shall not extend to the regulation of relations between workers and employers or organisations of workers and organisations of employers. In case the Company shall take or hold any property subject to the jurisdiction of the Charity Commissioners for England and Wales, the Company shall not sell, mortgage, charge or lease the same without such authority, approval or consent as may be required by law, and as regards any such property the Board of the Company shall be chargeable for any such property that may come into their hands and shall be answerable and accountable for their own acts, receipts, neglects and defaults, and for the due administration of such property in the same manner and to the same extent as they would as such Board have been if no incorporation had been effected, and the incorporation of the Company shall not diminish or impair any control or authority exercisable by the Chancery Division or the Charity Commissioners over such Board but they shall as regards any such property be subject jointly and separately to such control or authority as if the Company were not incorporated. 4. The income and property of the Company whenceover derived, shall be applied solely towards the promotion of the objects of the Company as set forth in this Memorandum of Association, and no portion thereof shall be paid or transferred directly or indirectly, by way of dividend, bonus, or otherwise howsoever by way of profit, to the members of the Company. PROVIDED that nothing herein shall prevent the payment, in good faith, of reasonable and proper remuneration to any officer or servant of the Company, or to any member of the Company, in return for any services actually rendered to

6 the Company, nor prevent the payment of interest at a rate not exceeding five per cent per annum on money lent, or reasonable and proper rent for premises demised or let by any member to the Company; but so that no member of the Board of the Company shall be appointed to any salaried office of the Company or any office of the Company paid by fees, and that no remuneration or other benefit money or money's worth shall be given by the Company to any member of the Board except repayment of out-of-pocket expenses and interest at the rate aforesaid on money lent, or reasonable and proper rent for premises demised or let to the Company. 5. The liability of the members limited. 6. Every member of the Company undertakes to contribute to the assets of the Company, in the event of the same being wound up while he is a member, or within one year after he ceases to be a member, for payment of the debts and liabilities of the Company contracted before he ceases to be a member, and of the costs, charges, and expenses of winding up, and for the adjustment of the rights of the contributories among themselves, such amount as may be required not exceeding If upon the winding up or Dissolution of the Company there remains, after the satisfaction of all its debts and liabilities, any property whatsoever, the same shall not be paid to or distributed among the members of the Company, but shall be given or transferred to some other institution or institutions, having objects similar to the objects of the Company, and which shall prohibit the distribution of its or their income and property among its or their members to an extent at least as great as is imposed on the Company under or by virtue of clauses 4 hereof, such institution or institutions to be determined by the members of the Company at or before the time of dissolution, and if and so far effect cannot be given to such provision then to some charitable object.

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