definiens: shall mean a drug delivery devi ce that meets all of the following criteria : ( A ) it has a core within a polymer layer that contains a drug in a fo rm other than a CODRUG ™ and no other active ingredi ent, where the core does not include a CODRUG ™, ( B ) it i s Approved or designed to be Approved ( 1 ) to delive r a corticosteroid and no other active ingredient by i m plantation, injection, or other direct delivery met hod to the posterior portion of the eye, or ( 2 ) to treat DME b y delivering a compound or formulation by implantat ion, injection, or other direct delivery method other th an through an incision smaller than that required f or a 25 gauge needle, ( C ) it does not fall under the definition o f Excluded Product, and ( D ) it is Approved or desig ned to be Approved for a particular indication in a particula r country . For clarification, eye drops or other to pical administration and tablets or other oral administra tion shall not be deemed to be direct delivery to t he posterior portion of the eye . For example, shall sp ecifically include a drug delivery device that meet s all of the following criteria ( such product sometimes referred to as the ): ( 1 ) consists of [ * ] ; ( 2 ) is Approved or designed to be Approved to be administered [ * ] ; ( 3 ) is Approved or designed to be Approved [ * ] ; and ( 4 ) is Approved or designed to be Approved for a particula r indication in a particular country . For clarifica tion, with regard to the same drug delivery device described a bove, each indication in each country shall be a se parate Product . By way of non - limiting examples, with rega rd to a particular drug delivery device X, ( i ) X fo r DME and X for age - related macular degeneration shall be two different Products, and ( ii ) X for DME in the United States and X for DME in Japan shall be two differen t Products . The Parties acknowledge that Medidur FA is a First Product