Consent Forms. OV shall prepare the patient informed consent form for the mBC Clinical Trial in consultation with R-Pharm. Any changes to such model form that relate to the Product shall be subject to R-Pharm’s written consent, not to be unreasonably withheld, conditioned, or delayed. R-Pharm will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days after receiving OV’s request therefor. OV shall obtain all patient authorizations and consents for the mBC Clinical Trial, and OV shall ensure that all patient authorizations and consents in connection with the mBC Clinical Trial permit, in accordance with HIPAA, the EU Data Protection Directive or any other similar Applicable Law, sharing of mBC Clinical Trial Data with R-Pharm in accordance with this Agreement.
Appears in 2 contracts
Sources: Development, Option and License Agreement (Allarity Therapeutics, Inc.), Development, Option and License Agreement (Allarity Therapeutics, Inc.)