MATERIAL SAFETY. CyDex shall provide Company, in writing, from time to time, with (a) relevant information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 4 contracts
Samples: License and Supply Agreement (Aldexa Therapeutics, Inc.), License and Supply Agreement (Aldexa Therapeutics, Inc.), License and Supply Agreement (Aldexa Therapeutics, Inc.)
MATERIAL SAFETY. CyDex shall provide CompanySpectrum, in writing, from time to time, with (a) relevant information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company Spectrum is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 3 contracts
Samples: License Agreement (Spectrum Pharmaceuticals Inc), License Agreement (Spectrum Pharmaceuticals Inc), License Agreement (Ligand Pharmaceuticals Inc)
MATERIAL SAFETY. CyDex shall provide CompanyMDCO, in writing, from time to time, with (a) relevant information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company MDCO is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 3 contracts
Samples: Licensing Agreement, Licensing Agreement, License Agreement (Ligand Pharmaceuticals Inc)
MATERIAL SAFETY. CyDex shall promptly provide Company, in writing, from time to time, with (a) relevant information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 3 contracts
Samples: License and Supply Agreement (Melinta Therapeutics, Inc. /New/), License and Supply Agreement (Rib-X Pharmaceuticals, Inc.), License and Supply Agreement (Rib-X Pharmaceuticals, Inc.)
MATERIAL SAFETY. CyDex shall provide Company, in writing, from time to time, with (a) relevant material information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 2 contracts
Samples: License Agreement (Ligand Pharmaceuticals Inc), License Agreement (MEI Pharma, Inc.)
MATERIAL SAFETY. CyDex shall provide Companyprovide, and promptly update, Seelos, in writing, from time to time, with (a) relevant all material information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol, ; and (b) the then-current material safety data sheet for Captisol®. Notwithstanding the foregoing or anything Except as may be otherwise expressly set forth in this Agreement to the contraryAgreement, Company Seelos is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territoryan equivalent foreign Regulatory Authority, (ii) document control and retentionretention after receipt of such documentation from CyDex, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 2 contracts
Samples: License Agreement (Apricus Biosciences, Inc.), License Agreement (Apricus Biosciences, Inc.)
MATERIAL SAFETY. CyDex shall provide Company, in writing, from time to time, with (a) all relevant material information currently known to it regarding handling precautions, toxicity and hazards with respect to Captisol®, and (b) the then-current material safety data sheet for Captisol®. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely responsible for (ix) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency authority in the Territory, (iiy) document control and retention, and (iiiz) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 1 contract
MATERIAL SAFETY. CyDex shall provide Company, in writing, from time to time, with (a) relevant information currently known to it regarding handling precautions, toxicity and hazards with respect to CaptisolCAPTISOL, and (b) the then-current material safety data sheet for CaptisolCAPTISOL. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory, (ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission.
Appears in 1 contract
Samples: License and Supply Agreement (Critical Therapeutics Inc)