In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in animals and/or in humans, each a “Study”) of a Licensed Product utilizing Captisol, 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 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 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 Compound 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. On the basis of these optimized protocols for ex vivo imaging of zebrafish, we extended our studies to image living adult zebrafish using μMRI. Although in vivo MRI has become an approved tool in medicine and pharmacologic research, very few studies have used this method to uncover physiology in aquatic organisms (21). Aquatic animals require special setups and several precautions for supporting in vivo imaging. For example, fish need a continuous flow of aerated water to irrigate their gills during the MRI measurements. This requires a special watertight flow- through chamber to support the fish and to prevent any contact of water with the RF coil and gradient insert. The fish needs to be immobilized to prevent motion artifacts, either by restraining or using anesthetic. In addition, imaging artifacts due to the surrounding water flow should be minimized. In vivoMRI studies in a few aquatic animals such as teleosts (e.g., carp), eelpout, and Gadus morhua have been successfully demonstrated (21-24). Due to the small size of zebrafish, additional precautions are needed for in vivo imaging. For example, a high-resolution microimaging magnet, needed to get good resolution with small fish, has limited space for a flow-through chamber. The small flow-through chamber cannot support a high flow of water that would be needed if unwanted signal from surrounding water is to be avoided. It has been shown that unwanted signal from surrounded water
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 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.
