Proposed Studies Clause Samples
Proposed Studies. ARIAD US may in its sole discretion commence and conduct the Proposed Studies and the provisions of Sections 5.6 or 5.7.2 shall not apply to the Proposed Studies but otherwise all provisions of this ARTICLE 5 shall apply as appropriate to a Proposed Study. ARIAD US shall submit for discussion by the JSC the draft and final detailed budget, draft and final protocol and overview of the clinical trial design prior to study initiation. ARIAD US shall report the results of each of the Proposed Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within six (6) months of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within fifteen (15) days of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments.
Proposed Studies a. Produce chimeric [***] (human gl) monoclonal antibody
b. Produce chimeric [***]
c. Produce [***]
d. Produce chimeric [***]
e. Produce chimeric [***]
f. Evaluate molecules in human tumor xenografts in mice
g. Evaluate targeted killing of tumor vasculature/inhibition of angiogenesis
Proposed Studies a. Humaneer antibody [***]
b. Express in appropriate host cell and generate a manufacturing cell line
c. Demonstrate efficacy in appropriate xenograft models
Proposed Studies a. Production of antibody to formaldehyde-fixed EphA3 b Immunochemistry survey of human tumor samples
Proposed Studies. Each Party shall notify and confer with the other Party through the JCD/RS in advance of any additional clinical study of a Product that such Party proposes to conduct.
Proposed Studies. Studies Initiated In Year One (2021) Studies Initiated In Year Two (2022)
Proposed Studies a) Epidemiology- with collaborators in the department of biostatistics and division of pulmonary medicine, we have determined that deficiency in AAT comprises a risk factor for FLU infection. In these investigations, we will complete the biostatistical analysis required to show that AAT deficiency in humans constitutes a risk factor for FLU infection. For this project we will recruit the assistance of ▇▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, a qualified biostatistician to conduct the mathematical analyses. ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇ will also participate, as the director of the CU Denver lung transplant program.
b) In vitro- in these studies, we will determine the effect of AAT in reducing FLU virus production in cells that are infected with FLU in the laboratory. •Quantify the effect of AAT as a FLU inhibitor in primary Rhesus monkey kidney cells infected with FLU. A primary cell system (as opposed to immortalized cell lines repeat)/ passaged in the laboratory) is ideal for our work with AAT because other commonly used (in FLU research) cell lines such as MDCK (Madin Darby canine kidney) cells require the addition of trypsin (an AAT substrate) to enable multiple rounds of influenza infection. The Rhesus monkey kidney cell assay is used in clinical hospital microbiology laboratories to diagnose FLU infection in patients. Therefore, this assay is validated and accepted for use in FLU infection studies in vitro. Supernatants will be collected from infected cells and analyzed for influenza A nuclear protein (read as HA units) in an ELISA assay. Higher readings are indicative of greater numbers of influenza virions being released from infected cells. •Semi-quantify the AAT effect in FLU infection in cells in the laboratory using immunohistochemistry analysis. The same monkey kidney cells, plated in a larger format (6-well plates), are stained at various times post-infection, with anti-influenza A fluorescent antibody to compare plaque sizes and degree of intracellular dissemination. •Test various AAT preparations for biological anti-FLU activity. We will also assess AAT serine protease inhibitor activity for relevance in FLU suppression; this will be accomplished by testing heat inactivated AAT, which is devoid of serine protease inhibitor function. We will also repeat FLU infection studies using a standard serine protease inhibitor mimic (Ala-Ala-Pro-Val-CMK). These reagents will be used as tools to dissect AAT serine protease activity from additional (non-serine protease inhibitor) A...