Representations and Warranties of IMPAX. 7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products that: (i) the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX; (ii) the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® 12-hour Extended Release Tablets and CLARITIN-D® 24-hour Extended Release Tablets, respectively; (iii) IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests; (iv) to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347; and 5,314,697 and any foreign counterparts thereof; (v) the Facilities conform in all respects to applicable law governing such Facilities; and (vi) neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH. 7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical Information: (i) IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date; (ii) IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2; (iii) IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; and (iv) IMPAX is the sole and exclusive owner of the IMPAX Patents and Technical Information free and clear of all liens, charges, encumbrances and security interests.
Appears in 1 contract
Samples: Development, License and Supply Agreement (Impax Laboratories Inc)
Representations and Warranties of IMPAX. 7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products that:
(i) the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s 's designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX;
(ii) the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® D(R) 12-hour Extended Release Tablets and CLARITIN-D® D(R) 24-hour Extended Release Tablets, respectively;
(iii) IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests;
(iv) to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347++; and 5,314,697 and any foreign counterparts thereof;
(v) the Facilities conform in all respects to applicable law governing such Facilities; and
(vi) neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(lss.335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH.
7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical Information:
(i) IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date;
(ii) IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2;
(iii) IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; and
(iv) IMPAX is the sole and exclusive owner of the IMPAX Patents and Technical Information free and clear of all liens, charges, encumbrances and security interests.
Appears in 1 contract
Samples: Development, License and Supply Agreement (Impax Laboratories Inc)
Representations and Warranties of IMPAX. 7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products that:
(i) the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX;
(ii) the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® 12-hour Extended Release Tablets and CLARITIN-D® 24-hour Extended Release Tablets, respectively;
(iii) IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests;
(iv) to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347XXXXX; and 5,314,697 and any foreign counterparts thereof;
(v) the Facilities conform in all respects to applicable law governing such Facilities; and
(vi) neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH.
7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical Information:
(i) IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date;
(ii) IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2;
(iii) IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; and
(iv) IMPAX is the sole and exclusive owner of the IMPAX Patents and Technical Information free and clear of all liens, charges, encumbrances and security interests.
Appears in 1 contract
Samples: Development, License and Supply Agreement (Impax Laboratories Inc)
Representations and Warranties of IMPAX. 7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products that:
(i) the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s 's designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX;
(ii) the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® D(R) 12-hour Extended Release Tablets and CLARITIN-D® D(R) 24-hour Extended Release Tablets, respectively;
(iii) IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests;
(iv) to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347[XXXXXX]*; and 5,314,697 and any foreign counterparts thereof;
(v) the Facilities conform in all respects to applicable law governing such Facilities; and
(vi) neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(lss.335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH.
7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical Information:
(i) IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date;
(ii) IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2;
(iii) IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; andand * Filed under an application for confidential treatment.
(iv) IMPAX is the sole and exclusive owner of the IMPAX Patents and Technical Information free and clear of all liens, charges, encumbrances and security interests.
Appears in 1 contract
Samples: Development, License and Supply Agreement (Impax Laboratories Inc)