Product Specifications

Example Definitions of "Product Specifications"
Product Specifications. 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 terms of the License Agreement. Upon the establishment of Product Specifications for... Products by the Parties 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 from time to time as mutually agreed upon by the Parties. If and as such Product Specifications for Products are amended consistent with this Section 1.14, the existing Exhibit B shall be amended to reflect such changes, and such amended Exhibit B shall be provided to the Parties and deemed to be part of this Agreement View More
Product Specifications. The Means the manufacturing and product specifications for the applicable Product, which 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 Fentanyl 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 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 1.14, 1.11, the existing Exhibit B B-2 shall be amended to reflect such changes, and such amended Exhibit B B-2 shall be provided to the Parties and deemed to be part of this Agreement Agreement. View More
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Product Specifications. Those specifications and testing to be performed for Product as set forth in documents prepared by Baxter and agreed to in writing by Halozyme in accordance with Section 10 of the Quality Agreement; provided, however, that Baxter shall include in such documents any changes required by the FDA
Product Specifications. Means the product specifications listed under the column Acceptance Criteria as set forth in the Master Batch Records.
Product Specifications. The manufacturing specifications, quality and quality control for the applicable Product, which, with respect to Products supplied for use in clinical trials, shall be agreed upon by the Parties in each case on short notice, and which, with respect to Products supplied for commercial use or sale are described in Exhibit E, attached hereto and incorporated herein by reference, as they may be amended pursuant to this Agreement following qualification and validation, which specifications shall be... reasonably consistent with the form of BEMA Fentanyl Product and labeling therefore approved in the applicable Governmental Approval(s) in the Territory. If and as the Product Specifications for Products for commercial use or sale are amended consistent with this Agreement, the existing Exhibit E shall be amended to reflect such changes, and such amended Exhibit E shall be provided to LTS by BDSI and shall be deemed to be part of this Agreement. View More
Product Specifications. Means the specifications contained in Exhibit D or any later approved specification of the Products by the Competent Authority in the Territory which may also include specifications for packaging material, labeling and product information.
Product Specifications. The specifications for the Products as may be amended, modified or supplemented in accordance with this Agreement. The initial Product Specifications are attached to this Agreement as Exhibit V.
Product Specifications. The Production and Product Specifications set forth in the Master Batch Records for the Product.
Product Specifications. Means the Breast Implant Product Specifications and the Tissue Expander Product Specifications.
Product Specifications. Shall be set forth in Attachment A and may be changed as provided for herein.
Product Specifications. Means the specifications set forth in Attachment 1 for the Products, as such specifications may be modified from time to time by the mutual agreement of the parties acting in accordance with Section 3.11 to reflect (i) the Product Approvals that issue with respect to the Products or (ii) Improvements and the addition of new products to Manufacturer's product line.
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