310158--2/28/2007--SCHERING_PLOUGH

related topics

{product, candidate, development}

{property, intellectual, protect}

{financial, litigation, operation}

{product, market, service}

{operation, international, foreign}

{cost, regulation, environmental}

Schering-Plough s success is dependent on the development and marketing of new products, and uncertainties in the regulatory and approval process may result in the failure of products to reach the market. Intellectual property protection for innovation is an important contributor to Schering-Plough s profitability. Generic forms of Schering-Plough s products may be introduced to the market as a result of the expiration of patents covering Schering-Plough s products, a successful challenge to Schering-Plough s patent, or the at-risk launch of a generic version of a Schering-Plough product, which may have a material and negative effect on results of operations. Patent disputes can be costly to prosecute and defend and adverse judgments could result in damage awards, increased royalties and other similar payments and decreased sales. U.S. and foreign regulations, including those establishing Schering-Plough s ability to price products, may negatively affect Schering-Plough s sales and profit margins. There are material pending government investigations against Schering-Plough, which could lead to the commencement of civil and/or criminal proceedings involving the imposition of substantial fines, penalties and injunctive or administrative remedies, including exclusion from government reimbursement programs, and which could give rise to other investigations or litigation by government entities or private parties. There are other legal matters in which adverse outcomes could negatively affect Schering-Plough s business. Schering-Plough is subject to governmental regulations, and the failure to comply with, as well as the costs of compliance of, these regulations may adversely affect Schering-Plough s financial position and results of operations. Developments following regulatory approval may decrease demand for Schering-Plough s products. New products and technological advances developed by Schering-Plough s competitors may negatively affect sales. Competition from third parties may make it difficult for Schering-Plough to acquire or license new products or product candidates (regardless of stage of development) or to enter into such transactions on terms that permit Schering-Plough to generate a positive financial impact. Schering-Plough relies on third-party relationships for its key products, and the conduct and changing circumstances of such third parties may adversely impact the business.

Full 10-K form ▸

310158--2/28/2007--SCHERING_PLOUGH_CORP