LIMITATIONS ON REVERSE ENGINEERING, DECOMPILATION AND DISASSEMBLY You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.
Forecasts and Purchase Orders (a) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval. (b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery. (c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered. (d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility. (e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient. (g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Rolling Forecasts No later than ten (10) days of the Commencement Date, the Client shall provide Patheon with a written non-binding 18 month forecast of the volume of the Drug Product that the Client then anticipates will be required to be produced and delivered to the Client during each month of that 18 month period. Such forecast will be updated by the Client monthly on a rolling 18 month basis and updated forthwith upon the Client determining that the volumes contemplated in the most recent of such forecasts has changed by more than 20%. The most recent 18 month forecast shall prevail.
Specifications That part of the Contract Documents consisting of written requirements for materials, equipment, systems, standards, and workmanship as applied to the Work, and certain administrative requirements and procedural matters applicable thereto. The term "Specifications" shall also include all written matter in the Project Manual or on the drawings and any Addenda or Change Orders thereto.
Annual Forecasts As soon as available and in any event no later than 90 days after the end of each Fiscal Year, forecasts prepared by management of the Borrower, in form satisfactory to the Administrative Agent, of balance sheets, income statements and cash flow statements on an annual basis for the Fiscal Year following such Fiscal Year.
Schematic Design See Section 2, Part 1, Article 2.1.4, Paragraph 2.1.4.2.
Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.
Testing Procedure Limitations The Asset Representations Reviewer will only be required to perform the testing procedures listed under “Tests” in Schedule A, and will have no obligation to perform additional procedures on any Subject Lease or to provide any information other than a Review Report indicating for each Subject Lease whether there was a Test Pass or a Test Fail for each Test, or whether the Subject Lease was a Test Complete and the related reason. However, the Asset Representations Reviewer may provide additional information about any Subject Lease that it determines in good faith to be material to the Review.
Processes Any employer, employee, trade union or employer’s association may at any point in time apply for an exemption from any of the provisions of this Collective Agreement. The applicant is required to complete and submit in writing with the relevant office of the Council, a fully and properly completed prescribed application for exemption form, accompanied by all relevant supporting documentation.
