Preclinical Development. If the JSC so tasks the JDC, the JDC will develop, and the JSC will review and approve, a preclinical strategy for the Territory and the European Union, which strategy will provide for the roles and responsibilities of the Parties in (a) preparing and reviewing the preclinical sections of all Regulatory Approval Applications and other submissions to any Regulatory Authorities for the Territory and the European Union, and (b) providing pharmacokinetic, pathology, toxicology and bioanalytical support for the clinical program.
Preclinical Development. The studies, tests and preclinical development and clinical trials, if any, conducted by or on behalf of the Company are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable laws and regulations, including the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. parts 50, 54, 56, 58, 312, and 812. The descriptions of, protocols for, and data and other results of, the studies, tests, development and trials conducted by or on behalf of the Company that have been furnished or made available to the Purchaser are accurate and complete. The Company is not aware of any studies, tests, development or trials the results of which reasonably call into question the results of the studies, tests, and the proposed development conducted by or on behalf of the Company, and the Company has not received any notices or correspondence from the FDA or any other Governmental Entity or any Institutional Review Board or comparable authority requiring the termination, suspension or material modification of any studies, tests, preclinical development or clinical trials conducted by or on behalf of the Company.
Preclinical Development. At the discretion of the Steering Committee, the parties may decide to conduct the necessary preclinical development activities to advance one or more GLP Toxicology Candidates to become IND Candidates, as described in the Collaboration Plan. In such event, the Research Committee will update the Research Plan to provide for such activities, subject to approval of the Steering Committee. These preclinical development activities will continue with respect to a GLP Toxicology Candidate until the Research Committee and Steering Committee decide to stop further efforts. The parties anticipate that these preclinical development activities will continue with respect to a GLP Toxicology Candidate until the parties (i) develop an acceptable IND Candidate, (ii) determine that they are unlikely to develop an acceptable IND Candidate, or (iii) decide to seek commercialization of the GLP Toxicology Candidate and the corresponding Committed Target as described below.
Preclinical Development. There is published in vitro data of Aerucin™ demonstrating effective phagocytic killing of both mucoid and non-mucoid isolates of Pa in vitro7. Furthermore, Aerucin demonstrated potent in vitro killing activity against a panel of recent P.aeruginosa clinical isolates, both mucoid and non-mucoid, with varying levels of antibiotic resistance to tobramycin and aztreonam (see figure). The stably transfected CHO cell line obtained from Dr. Pier’s lab exhibited a starting yield of 0.01 - 0.02 mg/mL or ~8 pg/cell/day when grown to exhaustion (~day 8) at a cell density limit of ~2x106 cells/mL in serum free F-12 media. Culture conditions were optimized by evaluating culture time, pH, feeding regime, seeding density, agitation speed and serum-free media. Antibody yields of 77 pg/cell/day at day 8 were observed with a cell density of up to 4.4 x106 cells/mL. This represents approximately a 10-fold antibody yield enhancement from the initial starting point of 8 pg/cell/day. A second cell line expressing F429 mAb was developed to determine if the yields of F429 could be enhanced further. A mouse myeloma cell line NS0 (European Collection of Animal Cell Cultures, ECACC number 85110503) was used as the host cell line to express F429 light and heavy chain variable regions (VL and VH) genes in a single expression vector. NS0 was selected because it can be adapted to grow in protein-free medium and is one of the three most commonly used host cell lines for the production of human and humanized antibodies. A final clinical production cell line, called ‘2H2’, was selected for cell banking, and has been shown to have an initial mAb production yield of ~0.2g/L after 4-6 days without media optimization at 1-3L scale. Antibody produced from suspension cell cultures of these cells, followed by affinity column chromatography purification currently shows a production yield that can support phase 1 and 2 clinical studies. Aridis has a proprietary technology to produce room temperature stable powder containing Aerucin for direct inhalation using commercially available dry powder inhalers. However, while dry powder formulations bring several advantages in convenience and patient compliance, a simple refrigerated stable liquid formulation for systemic delivery will initially be developed. Formulations were tested for stability at 2-8°C and 37°C (accelerated condition) for six months to determine the most stable formulation. The data shown in the accompanying figure demonstrated that a ...
Preclinical Development. If deemed necessary by AEVI, AEVI will develop a preclinical strategy for the Field in the Territory.
Preclinical Development. Ongoing nonclinical studies Planned nonclinical studies
Preclinical Development. If deemed necessary by Medgenics, Medgenics will develop a preclinical strategy for the Territory, which strategy may include each of the Parties (subject to KHK’s consent over activities to be performed by KHK, which may be withheld in KHK’s sole discretion), (a) preparing and reviewing the preclinical sections of all Regulatory Approval Applications and other submissions to any Regulatory Authorities for the Territory, and (b) providing pharmacokinetic, pathology, toxicology and bioanalytical support for the clinical program.
Preclinical Development. The applicable Party shall conduct, or arrange to have conducted, the following studies (and associated [ * ] and [ * ] activities) and activities: • [ * ] and [ * ] in at least one [ * ] ([ * ] or [ * ]), to [ * ] a [ * ] • [ * ] study in a [ * ] • [ * ] and [ * ] studies in a [ * ] (typically [ * ]) and a [ * ] (typically [ * ]) • [ * ] and [ * ] studies in a [ * ] and a [ * ] (usually [ * ]) • [ * ] studies: in vitro [ * ] ([ * ] and [ * ]) [ * ] and in vitro [ * ] studies (typically [ * ]) • [ * ] study [ * ]: [ * ] evaluation in [ * ]; [ * ] function evaluation in [ * ]; [ * ] function evaluation ([ * ]) in a [ * ] [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Preclinical Development. The Parties shall share equally all internal costs (at the FTE Costs) and Third Party costs incurred to conduct (i) preclinical Development under the OTC Preclinical Development Plan and (ii) preclinical Development of Co-Developed Arcturus Products and Co-Developed CureVac Products, provided, however, in each case, that the costs have been included in the respective Development Plan or have otherwise been approved by both Parties; provided, further, that the foregoing does CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT between CUREVAC and ARCTURUS Confidential not include any Manufacturing Costs, which are addressed in Section 6.3 and which shall be balanced in accordance with Section 4.8(b). In addition, Arcturus will be solely responsible for all costs incurred for regulatory activities for the Co-Developed Arcturus Products prior to the Initiation of clinical trials, and CureVac will be solely responsible for all costs incurred for regulatory activities for the Co-Developed CureVac Products prior to the Initiation of clinical trials.
Preclinical Development. In the event the Collaboration produces an acceptable GLP Toxicology Candidate, at the discretion of the Steering Committee, the Parties may decide to initiate preclinical development of such GLP Toxicology Candidate and conduct the necessary preclinical development activities to advance it to the status of an IND Candidate, as described in the Collaboration Plan. In such event, the Research Committee will update the Research Plan to provide for such activities, subject to approval of the Steering Committee. These preclinical
