Common use of PERMITS; COMPANY PRODUCTS; REGULATION Clause in Contracts

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Coulxxx xxx each Subsidiary of Coulxxx xx in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders necessary for Coulxxx xx that Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Coulxxx Xxxhorizations"), and no suspension or cancellation of any Coulxxx Xxxhorization is pending or, to the knowledge of Coulxxx, xxreatened. Neither Coulxxx xxx any Subsidiary of Coulxxx xx in material default or material violation of, (i) any laws applicable to Coulxxx xx any Subsidiary of Coulxxx xx by which any material property or asset of Coulxxx xx any Subsidiary of Coulxxx xx bound or affected, or (ii) any Coulxxx Xxxhorization. (b) Except as disclosed in the Coulxxx XXX Reports filed prior to the date of this Agreement, since January 1, 1998, Coulxxx xxx not received any written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Coulxxx (xxe "Products") is defective or fails to meet any applicable standards promulgated by any such governmental or regulatory body. Coulxxx xxx each Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Products and the operation of manufacturing facilities promulgated by the Food and Drug Administration (the "FDA"). Since January 1, 1998, there have been no recalls, field notifications or seizures ordered or, to the knowledge of Coulxxx, xxreatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Coulxxx XXX Reports filed prior to the date of this Agreement, since January 1, 1998, neither Coulxxx xxx any Subsidiary of Coulxxx xxx received a warning letter or Section 305 notice from the FDA. (c) Coulxxx xxx obtained, in all countries where either Coulxxx xx a Subsidiary of Coulxxx xx any corporate partner thereof is marketing the Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Products currently marketed by Coulxxx xx any Subsidiary of Coulxxx xx any corporate partner thereof in such countries. Coulxxx xxx made available for examination by Corixa all material information relating to regulation of the Products, including material licenses, registrations, approvals, permits, device listings, inspections, recalls and product actions, audits and ongoing clinical studies. (d) To the knowledge of Coulxxx, xxere have been no adverse events in any clinical trials conducted by or on behalf of Coulxxx xx such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority.

PERMITS; COMPANY PRODUCTS; REGULATION. (a) Each of Coulxxx xxx each Subsidiary of Coulxxx xx Acquiror and its Subsidiaries is in possession of all material franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals (including, without limitation, FDA approvals, licenses and permits, and any rights to use radio, television and other medium frequencies on a licensed or unlicensed basis) and orders necessary for Coulxxx xx that Subsidiary Acquiror or such Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted (the "Coulxxx XxxhorizationsAcquiror Authorizations"), and no suspension suspension, cancellation or cancellation substantial ----------------------- modification of any Coulxxx Xxxhorization Acquiror Authorization is pending or, to the knowledge of CoulxxxAcquiror , xxreatenedthreatened. Neither Coulxxx xxx Acquiror nor any Subsidiary of Coulxxx xx its Subsidiaries is in material conflict with, or in default or material violation of, (i) any laws applicable to Coulxxx xx Acquiror or any Subsidiary of Coulxxx xx its Subsidiaries or by which any material property or asset of Coulxxx xx Acquiror or any Subsidiary of Coulxxx xx its Subsidiaries is bound or affected, or (ii) any Coulxxx XxxhorizationAcquiror Authorization or (iii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Acquiror or any of its Subsidiaries is a party or by which Acquiror or any of its Subsidiaries or any property or asset of Acquiror or any of its Subsidiaries is bound or affected, except solely with respect to clauses (i) and (ii) to the extent that any such conflict, default or violation would not have a Material Adverse Effect on Acquiror. (b) Except as disclosed in the Coulxxx XXX Acquiror SEC Reports filed prior to the date of this AgreementFebruary 8, 2001, since January 1, 1998, Coulxxx xxx Acquiror has not received any written notices, citations or decisions by any governmental or regulatory body that any material product developed, produced, manufactured, marketed or distributed at any time by Coulxxx Acquiror or any Subsidiary (xxe the "Acquiror Products") ----------------- is defective or fails to meet any applicable standards promulgated by any such governmental or regulatory body. Coulxxx xxx Acquiror and each Subsidiary has complied in all material respects with the laws, regulations, policies, procedures and specifications with respect to the development, design, manufacture, labeling, testing and inspection of the Acquiror Products and the operation of manufacturing facilities promulgated by the Food and Drug Administration (FDA. None of the "FDA"). Since January 1Acquiror Products is the subject of any pending, 1998or to Acquiror's knowledge, there have been no recallsthreatened recall, field notifications or seizures ordered or, to the knowledge of Coulxxx, xxreatened by any such governmental or regulatory body with respect to any of the Products. Except as disclosed in the Coulxxx XXX Reports filed prior to the date of this Agreement, since January 1, 1998, neither Coulxxx xxx any Subsidiary of Coulxxx xxx received a warning letter or Section 305 notice from the FDA. (c) Coulxxx xxx Acquiror has obtained, in all countries where either Coulxxx xx Acquiror or a Subsidiary of Coulxxx xx or any corporate alliance partner thereof is manufacturing or marketing the Acquiror Products, all applicable licenses, registrations, approvals, clearances and authorizations required by local, state or federal agencies (including the FDA) in such countries regulating the safety, effectiveness and market clearance of the Acquiror Products currently manufactured or marketed by Coulxxx xx Acquiror or any Subsidiary of Coulxxx xx or any corporate partner or sublicensee thereof in such countries. Coulxxx xxx Acquiror has made available for examination by Corixa Target all material information relating to regulation of the Acquiror Products, including material licenses, registrations, approvals, permits, device listings, inspections, recalls and product Acquiror Product actions, audits and ongoing field tests and clinical studies. (d) To the knowledge of CoulxxxAcquiror, xxere there have been no adverse events in any field tests or clinical trials conducted by or on behalf of Coulxxx xx Acquiror, any Subsidiary or, with respect to Acquiror Products, any alliance partner or sublicensee of any of them, of such a nature that would be required to be reported to any applicable regulatory authority that have not been so reported to such authority. (e) There is no judgment, injunction, pronouncement, order or decree which has or could reasonably be expected to have the effect of prohibiting or materially impairing any current or future business practice of Acquiror or any Subsidiary, any acquisition of property by Acquiror or any Subsidiary or the overall conduct of business by Acquiror or any Subsidiary as currently conducted or as proposed to be conducted by Acquiror or by any Subsidiary. Neither Acquiror nor any Subsidiary has entered into any agreement under which Acquiror or any Subsidiary is restricted from selling, licensing or otherwise distributing any of its products to any class of customers, in any geographic area, during any period of time or in any segment of the market. (f) Neither Acquiror nor any Subsidiary has made any sales to customers that are contingent upon (x) providing future enhancements of existing products, (y) adding features not presently available on existing Acquiror Products or (z) otherwise enhancing the performance of its existing Acquiror Products (other than beta or similar arrangements pursuant to which Acquiror's customers from time to time test or evaluate products). The Acquiror Products that Acquiror and each Subsidiary have delivered to customers substantially comply with published specifications for such products and neither Acquiror nor any Subsidiary has received material complaints from customers about its products that remain unresolved.