Safety Profile definition

Safety Profile means that:
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Safety Profile means that: (a) there is no risk management program requested by the FDA which demonstrates significant safety concerns; (b) the Product is safe for use by patients for up to one (1) year; (c) there are no unspecified adverse events which result in a material safety warning in the label for the Product; and (d) the incidence of diarrhea and nausea in C-IBS phase III study is not materially higher than incidence shown in Phase II study (SPI/0211SIB-0221). “Secondary Product Detail(s)” shall mean any Product Detail other than Primary Product Detail. “Sucampo AG” or “SAG” shall have the meaning set forth in the Recitals. “SPE” shall mean Sucampo Pharma Europe Ltd., a corporation organized under the laws of the United Kingdom, having a principal place of business at ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, London EC4N6NQ United Kingdom. “SPE Option Fee” shall have the meaning set forth in Section 3.3. “SPE Territory” shall have the meaning set forth in Section 3.3. “SPI Option Fee” shall have the meaning set forth in Section 3.3. “SPI Territory” shall have the meaning set forth in Section 3.3. “SPL” shall mean Sucampo Pharma, Ltd., a corporation organized under the laws of Japan, having a principal place of business at ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇-▇▇▇▇▇▇▇▇, ▇▇, ▇-▇-▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇-▇▇▇▇ ▇▇▇▇▇. “SPL Option Fee” shall have the meaning set forth in Section 3.3. “SPL Territory” shall have the meaning set forth in Section 3.3.
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Examples of Safety Profile in a sentence

  • Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization.

  • The Borrower will use the Subject of Loan only for the purposes of the clinical study entitled “A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy and Safety Profile of PF-06700841 in Participants with Active Systemic Lupus Erythematosus (SLE)” (“Study”) which is sponsored by Pfizer Inc.

  • Safety Profile More than 2000 adult patients with HIV infection have been treated with FTC alone or in combination with other ARVs for periods of 10 days to 200 weeks in Phase I-III clinical trials.

  • Safety Profile The safety of NVP has been assessed in more than 2800 patients in clinical trials.

  • Safety Profile More than 1,200 patients have received TDF 300 mg once daily alone or in combination with other ARVs in phase I‑III clinical trials.