definiens: means the manufacturing and product specifications for the applicable Product, which shall be as mutually agreed upon by the Parties reasonably ( but not later than four months ) in advance of Meda 's placement of an Order for Launch Stocks and in a manner reasonably consistent with the form of Fentanyl Product and labeling therefor approved in the initial Governmental Approval approved in the Territory and the relevant tcnns of the License Agreement . Upon the establishment of Product Specifications for Products by the Pariies consistent with the foregoing, such Product Specifications shall be attached to this Agreement as Exhibit B and incorporated herein by this reference, and such specifications may be amended or augmented f1 : om time to time as mutually agreed upon by the Pariies . If and as such Product Specifications for Products are amended consistent with this Section l.14, the existing Exhibit B shall be amended to reflect such changes, and such amended Exhibit B shall be provided to the Pariies and deemed to be pari of this Agreement