Common use of Regulatory Data Clause in Contracts

Regulatory Data. Within the Field, each Party shall promptly provide to the other Party copies of, or access to all non-clinical and clinical data, and other information, results, and analyses with respect to any development activities that are carried out by on or behalf of or otherwise controlled by such Party or any of its Affiliates, collaborators or licensees (collectively, “Regulatory Data”), when such Regulatory Data becomes available. For the avoidance of doubt, the requirements under this Clause 4.2 shall include that HEMISPHERX shall provide IMPATIENTS with copies of up-to-date versions of (a) the EU GMP certificate of the manufacturing site, (b) if applicable, the Product’s GMP certificate, (c) the Manufacturer’s manufacturing license for the Product, (d) Product stability data and certificate of analysis, together with all other Know How that IMPATIENTS is required to include, or may need to include, in its Early Access Approval applications.