Adverse Event Reporting. As between the Parties: # Licensee is responsible for the timely reporting of adverse drug reactions/experiences, product quality complaints and safety data relating to Product to the appropriate Regulatory Authorities in the Territory; and # Verrica is responsible for reporting adverse drug reactions/experiences, product quality complaints and product safety data relating to Product to the appropriate Regulatory Authorities in the Verrica Territory; in each case ((i) and (ii)) in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Each Party shall use Commercially Reasonable Efforts to ensure that its Affiliates, licensees and sublicensees comply with such reporting obligations, including the Safety Data Exchange Agreement.
As between the Parties and in accordance with [Section 0]: # Verrica is responsible for the timely reporting to the appropriate Regulatory Authorities of all Adverse Events and any other information concerning the safety of Product in the Licensed Field, and # Lytix is responsible for the timely reporting to the appropriate Regulatory Authorities of all Adverse Events and any other information concerning the safety of Product in the Retained Field. The Party that owns the Regulatory Approval for the applicable Product has the right to make the final decision with respect to any Adverse Event filing with a Regulatory Authority with respect to such Product in the event of a dispute and where a decision must be made in order to comply with applicable time filing requirements.
AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.
And AllDrafts generates clean Word and PDF files from any draft.