Healthcare Industry News: Capsule Endoscopy
News Release - April 21, 2008
Given Imaging Announces Patent Litigation SettlementYOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Apr 21, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced that it has signed a term sheet with Olympus Corporation outlining a settlement of the patent litigation between the two companies in the United States concerning their respective Capsule Endoscopy products.
The term sheet includes certain worldwide cross-licenses under which each party receives a royalty-free license under all existing patents of the other party for its respective existing Capsule Endoscopy products. The parties also exchanged covenants not to sue on currently available medical device products and agreed to a release of all past causes of action. The term sheet also includes a cross-license under existing and future patents of each party for future Capsule Endoscopy products, which may include the payment of royalties by either party at a rate to be determined through an agreed upon mechanism. Finally, the term sheet includes a payment to Given Imaging of $2.33 million and an agreement to cooperate in future mutually beneficial joint market development projects.
The settlement will become final upon the signing of a formal written agreement, which is currently being prepared and is expected to be signed as soon as possible. In the interim, the parties have agreed to ask the Court to stay all activity in the pending litigation. Following signing of the formal agreement, the parties will submit to the Court a request for dismissal of the lawsuit.
Under the term sheet, all other terms and conditions are confidential.
The Company plans to update its fiscal year 2008 EPS guidance in conjunction with the release of its first quarter 2008 financial results on May 13, 2008.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 650,000 patients worldwide have benefited from the PillCam Capsule Endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam COLON (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2007. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Source: Given Imaging
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