In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of a Licensed Product utilizing Captisol, the following provisions shall apply:
In Vivo Studies. If Sage wishes to conduct any in vivo study ([…***…], each a “Study”) […***…], then Sage shall notify CyDex of any such Study and of the protocol therefor in writing at least […***…] days before commencing such Study, and the following provisions shall apply:
In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of the Licensed Product utilizing Captisol, then Company shall notify CyDex of any such Study and the name of the protocol therefor in writing at least fourteen (14) days prior to commencing such Study for pre-clinical studies, and at least thirty (30) days prior to commencing such Study for clinical studies, and the following provisions shall apply:
In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of the Licensed Product utilizing Captisol, then Company shall notify CyDex of any such Study and of the protocol therefore in writing at least **** prior to commencing such Study for pre-clinical studies, and at least **** prior to commencing such Study for clinical studies, and the following provisions shall apply:
In Vivo Studies. If Seelos wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of a CEA Licensed Product utilizing Captisol, the following provisions shall apply:
In Vivo Studies. If Sage wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of the Combination Product combined with or formulated using Captisol, then Sage shall notify CyDex of any such Study and of the protocol therefor in writing at least [***] before commencing such Study, and the following provisions shall apply:
In Vivo Studies. If Pilgrim's Pride is using the Material for non-human IN VIVO studies, it will (a) consider alternative IN VITRO approaches, (b) comply with all applicable federal, state and local laws and regulations and (c) provide MMI with copies of the applicable IN VIVO protocols.
In Vivo Studies. The study was performed in accordance with the Declaration of Helsinki (2000). All subjects involved in this study provided written informed consent with study approval from the institutional review board (15/NS/0030). Ten healthy volunteers without a history of heart disease were imaged using 2D MOLLI, 2D XXXXX and 3D SASHA sequences. The same imaging parameters used for the phantom experiment were employed for the in vivo study. The acquisition of the 3D SASHA sequence was performed in free-breathing with a nominal scan duration of 4:14 (min:sec) for a heart rate of 60 bpm and 100% scan efficiency. A 1D diaphragmatic navigator was used for respiratory motion compensation with a gating window of 5 mm and a tracking factor of
In Vivo Studies. Figure 6.6a shows the myocardial T1 maps of three volunteers obtained with the 2D MOLLI, 2D XXXXX and 3D SASHA sequences. The single T1-weighted images acquired for volunteer 2 are shown in Figure 6.6b. For all volunteers there was good agreement between the myocardial T1 values measured with the 2D XXXXX and the 3D SASHA sequences, while the T1 values obtained with 2D MOLLI sequence were considerably lower (Figure 6.7a). A trend of improvement in terms of precision was visible with the proposed imaging technique compared with the 2D XXXXX (Figure 6.7b). The average T1 values of all subjects for the 2D MOLLI, 2D XXXXX and 3D SASHA sequences were 881 ± 32 ms, 1181.2 ± 32 ms and 1153.6 ± 28 ms, respectively.
In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in animals or in humans, each a “Study”) of a Licensed Product, the following provisions shall apply:
