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Prospectuses and communications, business combinations

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Filed by Shire plc

pursuant to Rule 425 under the Securities Act

of 1933 and deemed filed pursu ant to

Rule 14a-12 of the Securities Exchange

Act of 1934

Subject Company: Baxalta Incorporated

Commission File No. 001-36782

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning our proposed business combination with Baxalta Incorporated (Baxalta) and the timing and financial and strategic benefits thereof, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other targets for future financial results, capital structure, performance and sustainability of the combined company, the combined companys future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products 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, Shires results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

· the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions, including any shareholder or regulatory approvals or the receipt of applicable tax opinions;

· disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;

· the combined company may not achieve some or all of the anticipated benefits of Baxaltas spin-off from Baxter International, Inc. (Baxter) and the proposed transaction may have an adverse impact on Baxaltas existing arrangements with Baxter, including those related to transition, manufacturing and supply services and tax matters;

· the failure to achieve the strategic objectives with respect to the proposed combination with Baxalta may adversely affect the combined companys financial condition and results of operations;

· products and product candidates may not achieve commercial success;

· product sales from ADDERALL XR and INTUNIV are subject to generic competition;

· the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the combined companys products may affect future revenues, financial condition and results of operations, particularly if there is pressure on pricing of products to treat rare diseases;

· supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors; regulatory actions associated with product approvals or changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;

· the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;

· the actions of certain customers could affect the combined companys ability to sell or market products profitably, and fluctuations in buying or...


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