definiens: shall mean the first s ale of a LICENSED PRODUCT by COMPANY, its AFFILIATES or SUBLICENSEES to a third party ( i.e., a party that is not an AFFILIATE or a SUBLICENSEE ) in any country following regulatory ap proval of such LICENSED PRODUCT in that country, or if no such regulatory approval or similar market ing approval is required, the date upon which such LICENSED PRODUCT is first commercially launched in any country . For the avoidance of doubt, the follow ing shall not be considered a first commercial sale her eunder : a transfer by COMPANY, or an AFFILIATE or SUBLICENSEE of reasonable amounts of LICENSED PRODU CTS to a third party for purposes of clinical trials, or under compassionate use, patient assista nce, named patient or other similar programs or stu dies where the LICENSED PRODUCT is supplied and/or delivered w ithout charge or any other consideration