definiens: means the manufacturing and product specifications for the applicable Product, which, with respect to Products supplied for use in clinical trials, shall be established in good faith by the Parties promptly following the execution of this Agreement and, upon mutual agreement with respect thereto by the Parties, attached as an amendment hereto as Exhibit B-1, attached hereto and incorporated herein by reference, as it may be amended or augmented from time to time as mutually agreed upon by the Parties, and which, with respect to Products supplied for commercial use or sale following initial approval of the first Governmental Approval in the Territory, 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 Licensed Product and labeling therefor approved in the initial Governmental Approval approved in the Territory and the relevant terms of the License Agreement . If and as the Product Specifications for Products for use in clinical trials are amended pursuant to the foregoing, the existing Exhibit B-1 shall be amended to reflect such changes, and such amended Exhibit B-1 shall be provided to the Parties and deemed to be part of this Agreement . Upon the establishment of Product Specifications for Products for commercial use or sale by the Parties consistent with the foregoing, such Product Specifications shall be attached to this Agreement as Exhibit B-2 and incorporated herein by this reference, and such specifications may be amended or augmented from time to time as mutually agreed upon by the Parties . If and as such Product Specifications for Products for commercial use or sale are amended consistent with this Section 1.11, the existing Exhibit B-2 shall be amended to reflect such changes, and such amended Exhibit B-2 shall be provided to the Parties and deemed to be part of this Agreement