Deficient Site definition
Deficient Site shall have the meaning set forth in Section 5.7.
Deficient Site has the meaning set forth in Section 5.8.2 (Deficient Sublicensees or Sites and Replacement).
Deficient Site has the meaning set forth in Section 3.4(b) (Clinical Trial Audits).
Examples of Deficient Site in a sentence
If Kissei is unable to mitigate the deficiencies or replace any Deficient Site with a Replacement Site or Deficient Sublicensee with a replacement Sublicensee, as applicable, or, as agreed by the Parties in writing, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the Territory Development Plans, as applicable, [***].
More Definitions of Deficient Site
Deficient Site shall have the meaning set forth in Section 5.9 (Clinical Trial Audits and Compliance).
Deficient Site has the meaning set forth in Section 4.4.2 (Deficient Sublicensees/Subcontractors or Sites and Replacement). 1.49 “Deficient Sublicensee/Subcontractor” has the meaning set forth in Section 4.4.2 (Deficient Sublicensees/Subcontractors or Sites and Replacement). 1.50 “Development” means, with respect to any product, any and all internal and external research, development, and regulatory activities regarding such product, including (a) research, process development, non-clinical testing, toxicology, non-clinical activities, GLP toxicology and other preclinical studies, and Clinical Trials and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of such product (the conduct of Clinical Trials and the conduct of those regulatory activities described in the foregoing clause (b), to the extent related to the conduct of Clinical Trials, “Clinical Development”), but excluding any activities directed to Manufacturing, Medical Affairs, or Commercialization. Development will include research, development, and regulatory activities for additional presentations or indications for a product after receipt of Regulatory Approval of such product, including Clinical Trials commenced following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved indication (such as post-Regulatory Approval studies and observational studies, if required by any Regulatory Authority in Japan to support or maintain Regulatory Approval for a product) in Japan. “Develop,” “Developing,” and “Developed” will be construed pursuant to this section. 1.51 “Development Activities” has the meaning set forth in Section 4.1 (Development Responsibilities). 1.52 “Development Data” has the meaning set forth in Section 4.7 (Licensee Data Disclosure and Use). 1.53 “Development Report” has the meaning set forth in Section 4.6 (Development Reports). 1.54 “Disclosing Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence).
Deficient Site has the meaning set forth in Section 4.4.2 (Deficient Sublicensees/Subcontractors or Sites and Replacement). 1.61 “Deficient Sublicensee/Subcontractor” has the meaning set forth in Section 4.4.2 (Deficient Sublicensees/Subcontractors or Sites and Replacement). 1.62 “Development” means, with respect to any product, any and all internal and external research, development, and regulatory activities regarding such product, including (a) research, process development, non-clinical testing, toxicology, non-clinical activities, GLP toxicology and other preclinical studies, and Clinical Trials and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of such product (the conduct of Clinical Trials and the conduct of those regulatory activities described in the foregoing clause (b), to the extent related to the conduct of