EU Compliance. (A) To the extent requested by NEW ALPHA, GENERICO shall cooperate reasonably and in good faith in connection with NEW ALPHA’s preparation of a plan to obtain necessary Regulatory Approvals from the EMEA with respect to the Melrose Park Facility (the “Melrose Park EU Plan”). All costs and expenses contemplated by the Melrose Park EU Plan shall be borne by NEW ALPHA (unless GENERICO initiates plans to commercialize its products or product candidates in Europe, in which case the Parties shall allocate the costs and expenses contemplated by the Melrose Park EU Plan between them equitably in good faith). Subject to Section 14.2(B) below, the scope and timing of implementation of, and expenditures under, the Melrose Park EU Plan shall be in the sole discretion of NEW ALPHA.
EU Compliance. SANOVO TECHNOLOGY Group is in compliance with the following regulations in regard to materials in contact with food: Regulation (EC) No. 1935/2004 on Materials and Articles intended to come into contact with Food. Regulation (EC) No. 2023/2006 on Good Manufacturing Practice for Materials and Articles intended to come into contact with food.
EU Compliance. Diamond Scientific may prior to January 1, 1996, for the sole purpose of European Unity compliance, initiate procedures that would enable a third party to manufacture Bovine Products on behalf of Diamond Scientific on or after January 1, 1996, subject to the provisions of Section 2.5.
EU Compliance. Section 2.8 of the Agreement is amended by changing the date of January 1, 1996 to January 1, 1997 in both instances where it appears.
