Examples of IMMU-132 in a sentence
See paragraph A12.3 in section 4 for more detailed discussion of this point).
Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively.
IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease.
The Parties shall negotiate in good faith, and as soon as reasonably practicable, execute and deliver a supply agreement and related quality assurance agreement that governs the responsibilities related to supply of IMMU-132 and quality systems, quality requirements, quality control, testing and manufacturing records, audits, complaints, inspections and release for IMMU-132 (the “Supply/Quality Agreements”).
For clarity, upon the termination of this Agreement in its entirety, IMMU-132 Information shall be deemed to be the Confidential Information of Company alone.
Company shall (or cause its Affiliates to) (a) manufacture (or have manufactured on its behalf) IMMU-132 in accordance with GMP and (b) provide, and shall use Commercially Reasonable Efforts to cause Company’s Third Party manufacturer(s) to provide, all reasonable access, as requested by Licensee, to audit the manufacturing process.
The two tailed p value was 0.020 and by conventional criteria, this difference was found to be statistically significant.McNemar's testDifference0.1632(Unsigned)Two-Tail0.003719One-Tail0.00186 Cohen’s kappa coefficient was calculated toFurther, A McNemar’s test was performed to see if there is a statistical significant difference between Chest ultrasound and Chest x-ray.
The activities of Company’s Affiliates and its permitted Sublicensees shall be attributed to Company for the purposes of evaluating Company’s fulfillment of the obligations set forth in this Section 5.4. Except for Company Development Activities, neither Company nor its Affiliates shall perform any Development of IMMU-132.
Licensee shall use Commercially Reasonable Efforts to market, promote and commercialize IMMU-132 Product (or, if Licensee ceases development of IMMU-132 or IMMU-132 Product, an Other Licensed Product) in any indication for which Regulatory Approval is obtained in a Major Market, subject to any Regulatory Approvals that may be necessary in particular Major Market countries prior to conducting certain commercialization activities.
While at a Facility, such Licensee personnel shall have reasonable access to all areas as are relevant to Company’s performance of its manufacturing obligations hereunder, including areas for the manufacture, storage or quality testing of IMMU-132, and shall comply with all applicable Company policies and procedures.