definiens: means a ( a ) clinical trial that is designed to study the safety and efficacy of the Product ( and to help evaluate its overall risks and benefits ) and is intended to fonn the primary basis for Regulatory Approval for Commercia lization of the Product in one or more countries in the Territory, ( b ) clinical trial that Dicerna or its Affiliate expressly refers to in a press release as a trial or study, or ( c ) clinical trial that satisfies either of the following : ( i ) the protocol for that clinical trial shall have been reviewed by the FDA or other relevant Regulatory Authority under its procedures for reaching agreement on the design and size of clinical trials intended to fonn the primary basis of Regulatory Approval for Commerciali zation of the Product, such as the FDA Guidance for Industry : Special Protocol Assessment ( May 2002 ) ( or equivalent guidance issued in the future ), and any comments from the FDA or other relevant Regulatory Authority on that protocol shall have been incorporated in the final protocol for that clinical trial or resolved to the satisfaction of the FDA or other relevant Regulatory Authority as evidenced by further written communications from the FDA or other relevant Regulatory Authority ; or ( ii ) the FDA or other relevant Regulatory Authority has determined in writing that the clinical trial can be considered as the primary basis for Regulatory Approval for Commercialization of the Product . For the avoidance of doubt, a clinical trial satisfying any of the requirement s sufficient to render it a Pivotal Trial under this definition shall be considered a Pivotal Trial even if more than one such trial is required by the FDA or other Regulator y Authority for Regulatory Approval for Commercia lization of the Product . Such a trial shall be considered initiated on the later of : ( I ) the date that it first satisfied the requirements of this definition ; or ( 2 ) the date of the first dosage of a patient in such trial