: plc



03-03-2009, 01:38 AM
Feb 09, 2009 (PR Newswire Europe via COMTEX) -- | -- Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan 09 February 2009- Shire plc (LSE: SHP, NASDAQ: SHPGY), announces that it has received Paragraph IV Notice letters from Barr Laboratories, Inc. ("Barr) and Mylan, Inc. ("Mylan) dated 2 and 4 February 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of 500mg, 750mg and 1gm FOSRENOL(R), (lanthanum carbonate). FOSRENOL is protected by three FDA Orange Book listed patents: U.S. patent No. 5,968,976, Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates; U.S. patent No. 7,381,428, Stabilized Lanthanum Carbonate Compositions; and U.S. patent No. 7,465,465, Pharmaceutical Formulation Comprising Lanthanum Compounds which expire in 2018, 2024 and 2024 respectively. Shire believes these patents provide a robust and sustainable proprietary position for FOSRENOL under U.S. patent laws. Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act, has 45 days from the date of each notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Barr's and Mylan's ANDA, which will commence on 26 October 2009. For further information please contact: Investor Relations Clea Rosenfeld (Rest of the World) +44 1256 894 160 Eric Rojas (North America) +1 617 551 9715 Media Matthew Cabrey (North America) +1 484 595 8248 Notes to editors SHIRE PLC Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results. For further information on Shire, please visit the Company's website: Shire (http://www.shire.com). THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission. 2 Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX Press Release


The Northern Rock plc Compensation Scheme Order 2008
Made
12th March 2008
PART 1 General provisions .
Citation
1. This Scheme may be cited as the Northern Rock plc Compensation Scheme.
Interpretation
2. In this Scheme
assessment notice has the meaning given by paragraph 11;
Northern Rock means Northern Rock plc, company registered number 3273685;
revised assessment notice has the meaning given by paragraph 12;
shares in Northern Rock means the ordinary shares, foundation shares and preference shares issued by Northern Rock;
the Act means the Banking (Special Provisions) Act 2008;
The Transfer Order means the Northern Rock plc Transfer Order 2008:
The transfer time means the beginning of 22nd February 2008;
the Tribunal means the Financial Services and Markets Tribunal;
Valuer means the independent valuer appointed by the Treasury in accordance with paragraph 7.
PART 2 Determination of amount of compensation
Transfer of Northern Rock shares
3.(1) The amount of any compensation payable by the Treasury to persons who held shares in Northern Rock immediately before they were transferred by the Transfer Order shall be determined in accordance with this paragraph.
(2) The amount of compensation payable to a person shall be an amount equal to the value immediately before the transfer time of all shares in Northern Rock held immediately before the transfer time by that person.
(3) For the purposes of this Scheme, the holders of shares in Northern Rock, and the class and number of shares held by them, shall be identified by reference to
(a) the Operator register of members of Northern Rock; and
(b) the issuer register of members of Northern Rock,
following the reconciliation required by article 3(4) of the Transfer Order.
(4) In sub-paragraph (3) issuer register of members and Operator register of members have the meanings given in the Uncertificated Securities Regulations 2001.
Valuation assumptions
6. In determining the amount of any compensation payable by the Treasury to any person in accordance with paragraphs 3 to 5, it must be assumed (in addition to the assumptions required to be made by section 5(4) of the Act (compensation etc. for securities transferred etc.)) that Northern Rock
(a) is unable to continue as a going concern; and
(b) is in administration.
PART 3 Independent valuer
Appointment of independent valuer
7.(1) The Treasury shall appoint an independent valuer for the purposes of this Scheme.
(2) The valuer so appointed shall determine the amount of any compensation payable by the Treasury in accordance with Part 2 of this Scheme.
(3) The valuer is to hold and vacate office in accordance with the terms of his appointment.
(4) The Treasury may remove the valuer only on the ground of incapacity or serious misbehaviour.
(5) Before making any appointment under sub-paragraph (1) the Treasury must consult the Institute of Chartered Accountants in England and Wales.
Remuneration
8. The valuer shall be
(a) paid such remuneration; and
(b) reimbursed such expenses;
as the Treasury may determine.
Appointment of staff
9.(1) The valuer may appoint such staff as he or she may determine.
(2) The valuer shall determine the remuneration and other conditions of service of the persons appointed under this paragraph.
(3) The valuer may pay such pensions, allowances or gratuities to or in respect of the persons appointed under this paragraph as he or she may determine.
(4) The references in sub-paragraph (3) to pensions, allowances or gratuities to or in respect of the persons appointed under this paragraph include reference to pensions, allowances or gratuities by way of compensation in respect of any of those persons who suffer loss of employment.
(5) Any determination under sub-paragraphs (2) to (4) shall require the approval of the Treasury.

03-03-2009, 01:45 AM



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