By Biogen Idec Clause Samples
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By Biogen Idec. Except as specifically set forth in Schedule 7.3 (the “Biogen Idec Disclosure Schedule”), Biogen Idec hereby represents and warrants to Elan as follows:
(a) All pre-clinical and clinical trials conducted by or for Biogen Idec with regard to the Alpha-4 Integrin Products and JCV Assays have been conducted in compliance in all material respects with (i) applicable protocols, procedures and controls and (ii) all applicable laws promulgated by the FDA relating thereto, including the FDCA, and its applicable implementing regulations. No Clinical Trial Application filed by or on behalf of Biogen Idec with the FDA regarding any Alpha-4 Integrin Product or JCV Assay has been terminated or suspended by the FDA, and the FDA has not commenced, or, to the knowledge of Biogen Idec, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Biogen Idec involving any Alpha-4 Integrin Product or JCV Assay.
(b) To the knowledge of Biogen Idec, since November 1, 2004, Biogen Idec has complied in all material respects with all applicable laws relating to the Development, marketing, Promotion, distribution and Commercialization of TYSABRI in the Territory. Biogen Idec has not received any written notice of a material violation of material applicable law from any governmental entity relating to TYSABRI since November 1, 2004.
(c) Biogen Idec is a resident only of Bermuda.
(d) Biogen Idec has no place of business or employees or “establishment” (as defined in the Value-Added Tax Consolidation Act 2010) in Ireland, or in any other EU Member State, and is not registered or required to be registered for any taxes in Ireland or in any other EU Member State.
(e) To the knowledge of Biogen Idec as of the Execution Date, and based in part on Elan’s representations and covenants, including in Sections 7.2(a), 7.2(dd), 7.2(ee) and 7.2(ff), Biogen Idec is not required to withhold or deduct from the Upfront Payment under the laws of any jurisdiction. As of the Execution Date, and based in part on Elan’s representations and covenants, including in Sections 7.2(a), 7.2(dd), 7.2(ee) and 7.2(ff), Biogen Idec does not intend to withhold or deduct from the Upfront Payment with respect to withholding taxes under the laws of any jurisdiction.
By Biogen Idec. If ▇▇▇▇▇▇▇ determines not to prosecute any claim or Patent within the Biogen Idec Patents (other than prosecution of the Core Claims in the Required Countries, for which, for the avoidance of doubt, ▇▇▇▇▇▇▇ has the obligation of prosecution), then ▇▇▇▇▇▇▇ shall provide Biogen Idec with written notice of such decision at least [***] ([***]) calendar days prior to the deadline for filing any such prosecution action for any claim or Patent or the date on which the abandonment of any such claim or Patent would become effective. In such event, Biogen Idec shall have the right, but not the obligation, at its option and expense, to control the preparation, filing, prosecution and maintenance of such claim or Patent. If ▇▇▇▇▇▇▇ or any of its Affiliates or Sublicensees subsequently uses, makes, offers for sale, sells or imports a Product in any jurisdiction in which Biogen Idec has assumed patent prosecution under this Section 11.2(b), ▇▇▇▇▇▇▇ shall, at the time of First Commercial Sale in such jurisdiction, reimburse Biogen Idec for the out-of-pocket costs of such patent prosecution actually incurred, which costs shall not be offset against any other amounts due under this Agreement. For the avoidance of doubt, Biogen Idec shall, at all times, have exclusive control over the prosecution of the Reserved Prosecution Patents, including enforcement rights, at its own expense.
By Biogen Idec. Biogen Idec shall not disclose to any Third Party the existence or terms or any other matter of fact regarding this Agreement without the prior written consent of Amorfix; provided, however, that Biogen Idec may make such a disclosure (a) to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which Biogen Idec has its securities listed or traded, or (b) to any acquirers, potential acquirers, investors, prospective investors, lenders and other potential financing sources who are obligated to keep such information confidential. In the event that Biogen Idec is required or wishes to make a disclosure that is subject to Section 5.3.1, Biogen Idec shall make reasonable efforts to provide Amorfix with notice beforehand and to coordinate with Amorfix with respect to the wording and timing of any such disclosure. Once any press release or any other written statement is approved for disclosure by Amorfix, Biogen Idec may make subsequent public disclosure of the contents of such statement without the further approval of Amorfix.