Abbott Warranties. Abbott warrants to ZymoGenetics that Bulk Drug Substance delivered to ZymoGenetics pursuant to Section 6.2 (as “Registration Batches”) or Articles 8 and 9 of this Agreement shall conform with the Bulk Drug Substance Specifications and shall have been manufactured in compliance with this Agreement and all applicable laws and regulations. Abbott warrants to ZymoGenetics that it has, and shall maintain in compliance with applicable laws and regulations during the term of this Agreement, the facilities, equipment, personnel, licenses and patents and expertise necessary to fulfill its obligations hereunder. Abbott also represents and warrants that (a) it is not debarred and has not and will not knowingly use in any capacity the services of any person debarred under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992 as amended or any comparable law of the EMEA or any ICH confirming country, as each may be amended from time to time, and (b) the Bulk Drug Product will not be adulterated or misbranded, within the meaning of the U.S. Food, Drug & Cosmetics Act, or any comparable laws, rules or regulations of any non-U.S. jurisdiction, as a result of any act or omission of Xxxxxx. XXXXXX MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, ARE HEREBY DISCLAIMED BY ABBOTT. IN NO EVENT SHALL ABBOTT OR XXXXXX’X AFFILIATES BE LIABLE FOR INDIRECT, INCIDENTAL, LIQUIDATED OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST REVENUES OR PROFITS. If at any time any representation or warranty to Xxxxxx’x knowledge is no longer accurate, Abbott will promptly notify ZymoGenetics of such fact.
Appears in 2 contracts
Samples: Development and Supply Agreement, Development and Supply Agreement (Zymogenetics Inc)
Abbott Warranties. Abbott warrants to ZymoGenetics Seattle Genetics that Bulk Drug Substance delivered to ZymoGenetics Seattle Genetics pursuant to this Agreement (other than pursuant to Section 6.2 (as “Registration Batches”6.1) or Articles 8 and 9 of this Agreement shall have been manufactured pursuant to cGMPs, the Batch Records shall conform with the Bulk Drug Substance Specifications and Specifications, shall have been manufactured in compliance with this Agreement and all applicable laws and regulationsregulations and shall be free from defects in materials and workmanship. Abbott warrants to ZymoGenetics Seattle Genetics that it has, and shall maintain in compliance with applicable laws and regulations during the term of this AgreementTerm, the facilities, equipment, personnel, licenses and patents and expertise necessary to fulfill its obligations hereunder. Abbott also represents and warrants that (a) it is not debarred and has not and will not knowingly use in any capacity the services of any person debarred under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992 as amended or any comparable law of the EMEA or any ICH confirming country, as each may be amended from time to time, and (b) the Bulk Drug Product will not be adulterated or misbranded, within the meaning of the U.S. Food, Drug & Cosmetics Act, or any comparable laws, rules or regulations of any non-U.S. jurisdiction, as a result of any act or omission of XxxxxxAbbott. XXXXXX In addition, if any Abbott Inventions are incorporated into the manufacturing process of the Bulk Drug Substance, without Abbott obtaining Seattle Genetics’ written consent, Abbott warrants that, to Xxxxxx’x knowledge, Seattle Genetics’ use of such Abbott Inventions shall not infringe or conflict with any patent or other proprietary right of any Third Party and there is no claim or basis therefor that might impair the use of such Abbott Inventions by Seattle Genetics to manufacture Bulk Drug Substance. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, ARE HEREBY DISCLAIMED BY ABBOTT. NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT SHALL ABBOTT OR XXXXXX’X AFFILIATES BE LIABLE FOR INDIRECT, INCIDENTAL, LIQUIDATED OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST REVENUES OR PROFITS. If at any time any representation or warranty to Xxxxxx’x knowledge is no longer accurate, Abbott will promptly notify ZymoGenetics Seattle Genetics of such fact.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Abbott Warranties. Abbott warrants to ZymoGenetics Seattle Genetics that Bulk Drug Substance delivered to ZymoGenetics Seattle Genetics pursuant to this Agreement (other than pursuant to Section 6.2 (as “Registration Batches”6.1) or Articles 8 and 9 of this Agreement shall have been manufactured pursuant to cGMPs, the Batch Records shall conform with the Bulk Drug Substance Specifications and Specifications, shall have been manufactured in compliance with this Agreement and all applicable laws and regulationsregulations and shall be free from defects in materials and workmanship. Abbott warrants to ZymoGenetics Seattle Genetics that it has, and shall maintain in compliance with applicable laws and regulations during the term of this AgreementTerm, the facilities, equipment, personnel, licenses and patents and expertise necessary to fulfill its obligations hereunder. Abbott also represents and warrants that (a) it is not debarred and has not and will not knowingly use in any capacity the services of any person debarred under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992 as amended or any comparable law of the EMEA or any ICH confirming country, as each may be amended from time to time, and (b) the Bulk Drug Product will not be adulterated or misbranded, within the meaning of the U.S. Food, Drug & Cosmetics Act, or any comparable laws, rules or regulations of any non-U.S. jurisdiction, as a result of any act or omission of XxxxxxAbbott. XXXXXX In addition, if any Abbott Inventions are incorporated into the manufacturing process of the Bulk Drug Substance, without Abbott obtaining Seattle Genetics’ written consent, Abbott warrants that, to Xxxxxx’x knowledge, Seattle Genetics’ use of such Abbott Inventions shall not infringe or conflict with any patent or other proprietary right of any Third Party and there is no claim or basis therefor that might impair the use of such Abbott Inventions by Seattle Genetics to manufacture Bulk Drug Substance. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, ARE HEREBY DISCLAIMED BY ABBOTT. NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT EVENT, EXCEPT PURSUANT TO SECTION 14.2, SHALL ABBOTT OR XXXXXX’X AFFILIATES BE LIABLE FOR INDIRECT, INCIDENTAL, LIQUIDATED OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST REVENUES OR PROFITS. If at any time any representation or warranty to Xxxxxx’x knowledge is no longer accurate, Abbott will promptly notify ZymoGenetics Seattle Genetics of such fact.. In addition, (i) except as set forth in Section 14.2, Abbott shall not be liable for any damages arising from claims of Third Parties for injury, death or property damage suffered as a result of the use of the Product, and (ii) in no event shall Abbott be liable for any claims relating to a failure of Abbott to warn, or to adequately warn, against the dangers of the Product, or failure of Abbott to instruct, or to adequately instruct, about the safe and proper use of the Product or any use of the Product with any other product or products. Except as set forth in Section 14.2(i), the maximum liability of Abbott under this Agreement for all claims, whether in connection with a warranty claim, an indemnity claim, a combination thereof, or otherwise and whether arising under contract, warranty, tort (including negligence), strict liability, product liability, a combination thereof, or any other theory of liability or indemnification [***]. Seattle Genetics further acknowledges that, except in cases of Xxxxxx’x wanton, willful, or gross negligence, or pursuant to Section 14.2(i), any [***]
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Abbott Warranties. Abbott warrants to ZymoGenetics Seattle Genetics that Bulk Drug Substance delivered to ZymoGenetics Seattle Genetics pursuant to this Agreement (other than pursuant to Section 6.2 (as “Registration Batches”6.1) or Articles 8 and 9 of this Agreement shall have been manufactured pursuant to cGMPs, the Batch Records shall conform with the Bulk Drug Substance Specifications and Specifications, shall have been manufactured in compliance with this Agreement and all applicable laws and regulationsregulations and shall be free from defects in materials and workmanship. Abbott warrants to ZymoGenetics Seattle Genetics that it has, and shall maintain in compliance with applicable laws and regulations during the term of this AgreementTerm, the facilities, equipment, personnel, licenses and patents and expertise necessary to fulfill its obligations hereunder. Abbott also represents and warrants that (a) it is not debarred and has not and will not knowingly use in any capacity the services of any person debarred under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992 as amended or any comparable law of the EMEA or any ICH confirming country, as each may be amended from time to time, and (b) the Bulk Drug Product will not be adulterated or misbranded, within the meaning of the U.S. Food, Drug & Cosmetics Act, or any comparable laws, rules or regulations of any non-U.S. jurisdiction, as a result of any act or omission of XxxxxxAbbott. XXXXXX In addition, if any Abbott Inventions are incorporated into the manufacturing process of the Bulk Drug Substance, without Abbott obtaining Seattle Genetics’ written consent, Abbott warrants that, to Xxxxxx’x knowledge, Seattle Genetics’ use of such Abbott Inventions shall not infringe or conflict with any patent or other proprietary right of any Third Party and there is no claim or basis therefor that might impair the use of such Abbott Inventions by Seattle Genetics to manufacture Bulk Drug Substance. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, ARE HEREBY [*] Confidential treatment has been requested with respect to the omitted portions. DISCLAIMED BY ABBOTT. NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT SHALL ABBOTT OR XXXXXX’X AFFILIATES BE LIABLE FOR INDIRECT, INCIDENTAL, LIQUIDATED OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST REVENUES OR PROFITS. If at any time any representation or warranty to Xxxxxx’x knowledge is no longer accurate, Abbott will promptly notify ZymoGenetics Seattle Genetics of such fact.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)