POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, adverse events or other issues arise with respect to the safety or efficacy of the Product which jeopardizes the Product's performance or are deemed by the Parties to potentially limit its approved indications, the Parties shall consult with each other with respect to such events or other issues. If the Parties determine that the situation requires clinical testing after First Commercial Sale in any country in the Territory, modifications to any Marketing Authorization or other communication with any Competent Authority or entity, Atrix shall design and the Parties shall implement any such testing, modifications or communication as shall be agreed upon by the Parties, and the costs shall be borne [**].
POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, adverse events or other issues arise with respect to the safety or efficacy of GADOLITE(R) which jeopardize GADOLITE(R)'s performance or are deemed by the parties to potentially limit its approved indications, the parties shall consult with each other with respect to such events or other issues. If the parties determine that the situation requires clinical testing after First Commercial Sale in any country in the Territory, modifications to any Marketing Authorization or other communication with any Competent Authority or entity, Pharmacyclics shall design and the parties shall implement any such testing, modifications or communication as shall be agreed upon by the parties; provided, however, that E-Z-EM may communicate with any Competent Authority to the extent it deems necessary or appropriate to fulfill its obligations hereunder. * * *
POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, adverse events or other issues arise with respect to the safety or efficacy of a Licensed Product that jeopardize the Licensed Product's performance or are deemed by either party to potentially limit its approved indications, the parties shall consult with each other with respect to such events or other issues. If the parties determine that the situation requires clinical testing after the First Commercial Sale in any country in the Territory, modifications to any Marketing Authorization or other communication with any Competent Authority or entity, MBI and Chugai shall cooperate to design and the parties shall implement any such testing, modifications or communication as shall be agreed upon by the parties; provided, however, that Chugai may communicate with any Competent Authority to the extent it deems necessary or appropriate to fulfill its obligations hereunder. ***
POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If, after the date of First Commercial Sale in any country in the Territory, adverse events or other issues arise with respect to the safety or efficacy of a Product which jeopardize the Product's performance or are deemed by the Parties to potentially limit its approved indications, the Parties shall consult with each other with respect to such events or other issues. If the Parties determine that the situation requires clinical testing after First Commercial Sale in any country in the Territory, modifications to any Marketing Authorization or other communication with any Competent Authority or entity, Atrix shall design and implement any such testing, modifications or communication and the costs of such additional clinical testing shall be borne [**] by Geneva and [**] by Atrix. If the Parties cannot agree on whether such situation requires clinical testing, such dispute shall be resolved in accordance with Article XVII.
