Clinical Samples Sample Clauses

Clinical Samples. LTS shall use its Commercially Reasonable Efforts to manufacture and supply to NuPathe Clinical Samples. It is being understood that NuPathe shall pay no other compensation for the delivery of Clinical Samples, other than the compensation as provided for in Article VI.

Clinical Samples. 5.2.1 All Clinical Samples shall, unless otherwise agreed in writing, be held under the custodianship of OXFORD with any storage and transfer to be always in accordance with all Applicable Requirements. OXFORD shall exercise its rights and duties as custodian of the Clinical Samples in accordance with the relevant Trial Subject Consent Documents, any relevant Ethics Committee Opinion, Applicable Requirements and this Section 5.2. 5.2.2 All use of the Clinical Samples, other than for the purposes of the Clinical Trial, shall be subject to a determination as to the safety and scientific validity of the proposed use of the Clinical Samples (taking into account the quantity of the Clinical Samples available). The final decision in relation to such use shall be taken by OXFORD, as custodian of the Clinical Samples, always in accordance with the Trial Subject Consent Documents and all Applicable Requirements.

Clinical Samples. The Party who sponsors the applicable Clinical Trial of SHP2 Inhibitors shall retain and archive all clinical samples obtained by such Party in the course of such Clinical Trial, and shall provide the other Party reasonable access to such retained clinical samples.

Clinical Samples. In accordance with the Protocol, the Clinical Centre shall send clinical samples to the University (or, in accordance with clause 13.4 below, to a third party nominated by the University) for analysis. These clinical samples may include material, other than gametes, which consists of or includes human cells, but does not include embryos outside the human body, or hair and nail from the body of a living person (“Clinical Samples”). The Clinical Centre warrants that all Clinical Samples have been collected with appropriate informed consent and in accordance with applicable law (including without limitation the Human Tissue Xxx 0000 and the Human Tissue (Scotland) Xxx 0000 as appropriate). The Clinical Centre shall indemnify the University against any claims which may arise from the improper collection and supply of such Clinical Samples. The University shall use the Clinical Samples in accordance with the Protocol and the ethical approval for the Study, and shall ensure that the Clinical Samples are stored in accordance with applicable law, and that any Clinical Samples remaining at the end of the Study are either disposed of in accordance with the Human Tissue Authority guidelines and any applicable law or, if consent has been given for Clinical Samples to be used in further research, shall ensure that the Clinical Samples are transferred either to a licensed bio-repository or to another ethically approved study. The University may also arrange for Clinical Samples to be passed to a third party laboratory for analysis under a suitable agreement. If Clinical Samples are passed to a third party, the University shall ensure that the Clinical Samples are used, stored and disposed of in accordance with applicable law. The University shall indemnify the Clinical Centre against any claims arising from the improper use or storage of such Clinical Samples. This indemnity extends to use or storage by a third party as envisaged under clause 13.4 above.

Clinical Samples. GRÜNENTHAL shall supply ENDO with reasonable quantities of Product for research and/or clinical use as requested by ENDO in writing from time to time, provided that it has made adequate progress pursuant to the Development Plan such that it has developed the capability to make clinical samples. Such clinical samples shall be supplied within *** (***) months after any such request provided that, in case of unexpected events leading to increased requirements of clinical samples, both Parties shall use Commercially Reasonable Efforts to supply such clinical samples as quickly as possible, but in no event longer than *** (***) months to comply with such requirements from the receipt of Compound by GRÜNENTHAL plus the time required to generate corresponding stability. The costs for clinical materials shall be included in the development budget and ENDO shall not incur any additional costs for such clinical trial material. The release of clinical trial materials will require review by the Quality Affairs group of ENDO.

Clinical Samples. Flow chart of methods I. Acquisition and storage of samples

Clinical Samples. A total of 36 measurements of 2-aminobenzoic acid labelled ACPA-IgG, ACPA-IgG Fc and ACPA-IgG Fab glycans were previously prepared, measured using HILIC-ultra high performance liquid chromatography (UHPLC) and exported to .txt format using ThermoFisher Chromeleon (17). The ACPA-IgG and ACPA-IgG Fab measurements were used to assess if HappyTools produces comparable results to the previously used ThermoFisher Chromeleon in a clinical setting. Specifically, Fab glycosylation in IgG has been found to be vastly different between ACPA-IgG and normal IgG, with ACPA-IgG showing on average five times higher levels of Fab glycosylation (17). The observed difference in Fab glycosylation suggests that ACPA-IgG may mediate novel immunological activities (17). The study compared IgG and ACPA-IgG Fab glycosylation (S5 Fig), hereby the glycans of the F(ab’)2 fragments and Fc glycopeptides were compared to the glycan profile of the total antibody and the percentage of Fab glycosylation was calculated. The following formula was used to calculate the percentage Fab-glycosylation: where G2S2 consists of GP21, GP22, GP23 and GP24, G1FTotal consists of GP8 and GP9 and G1FFc is taken from glycopeptide measurements of the original publication (17). The results for both Chromeleon and HappyTools show a higher percentage of Fab-glycosylation in ACPA samples than IgG samples, with the values reported by ThermoFisher Chromeleon and HappyTools showing a significant correlation (Fig 3 and S5-S7 Tables). This result shows that the same clinical finding, namely an increase in Fab-glycosylation in ACPA-IgG samples, can be observed with either ThermoFisher Chromeleon or HappyTools. Finally, the total throughput using HappyTools was far superior than what was achieved during the original study. Specifically, during the original study the processing took around 10 hours while the re-analysis using HappyTools took only 1 hour. High performance liquid chromatography (HPLC) has long been considered the gold standard for quantitation of carbohydrates, specifically when combined with HILIC and 2-aminobenzamide (2-AB)-labelled glycans (28). While the number of samples that is measured by HPLC has been increasing, e.g. a study into the Immunoglobulin G glycome measured 2298 individuals, the data analysis is mostly achieved using a high amount of manual processing using the manufacturers software (3). Therefore, the main goal of HappyTools was to provide a framework independent of the manufacturer t...

Clinical Samples. Subject to the limited liability provisions set forth in this Agreement, LTS represents and warrants that the Clinical Samples delivered to NeurogesX shall be in conformity with the Specifications, shall be manufactured in accordance with Current GMP and the Quality Assurance Agreement, and shall comply with all Regulatory Requirements.

Clinical Samples. 7.1 CLINICAL SAMPLES. Clinical samples or derivatives of clinical samples, including blood, plasma, cell lines, tissues, DNA, and RNA collected in the course of the Research Program by Principal Investigator or his collaborators shall be maintained in the laboratory of Principal Investigator. Principal Investigator shall provide SPONSOR samples of biological or other materials generated in the Research Program in accordance with Paragraph 6.1 of the License Agreement. All such materials shall be deemed to be LICENSED MATERIALS for purposes of the License Agreement.

Clinical Samples