Analytical and Validation Methodology. Any analytical and validation methodology supplied by Barrier and required for use by DSM in the production of Product hereunder (i) must be certified by Barrier to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic recertification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Barrier, or not previously developed by DSM for Barrier, will be developed by DSM at Barrier’s expense according to DSM’s standard rates.
Analytical and Validation Methodology. Any analytical and validation methodology supplied by AMAG and required for use by DSM in the production of Product hereunder (i) must be certified by AMAG to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by AMAG (or not previously developed by DSM for AMAG) will be developed by DSM, at AMAG’s expense, according to DSM’s standard rates for development.
Analytical and Validation Methodology. Any analytical and validation methodology supplied by Discovery Labs and required for use by DSM in the production of Product hereunder (i) must be certified by Discovery Labs to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Discovery Labs (or not previously developed by DSM for Discovery Labs) will be developed by DSM, at Discovery Labs expense, according to DSM’s standard rates for development.
Analytical and Validation Methodology. Any analytical and validation methodology supplied by OMEROS and required for use by DSM in the Manufacture of Product under this Agreement (a) shall be certified by OMEROS to the best of its knowledge to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (b) shall be validated per current regulatory guidelines, and (c) shall be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION with Applicable Pharmaceutical Law. Required analytical and validation methodology that is not supplied by OMEROS (or not previously developed by DSM for OMEROS) shall be developed by DSM, at OMEROS’ expense, according to DSM’s standard rates for development.
Analytical and Validation Methodology. Any analytical and validation methodology supplied by Onyx and required for use by DSM in the production of Product hereunder (i) must be certified by Onyx to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM Facility. Periodic re-certification of methods [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Onyx (or not previously developed by DSM for Onyx) will be developed by DSM, at Onyx’s expense, according to DSM’s standard rates for development.
