Processing Parameter Evaluation Sample Clauses

Processing Parameter Evaluation. The objective of this evaluation is to protect the product from oxygen via manufacturing process modification with inert environment utilizing barrier technology. In addition, secondary vacuum packaging will be explored. 3. Container Closure Evaluation: Since we are focused on 1ml dental cartridge for the new generation EpiPen(TM) lines, we will evaluate a potentially better rubber closure than the current PH701 rubber. We will evaluate both West 4416/50 and 4405 rubber formulations. All these screening formulation will be placed on short-term (three month) accelerated stability trials. The results will be compared with the current EpiPen(TM) product stability before a final formulation and process is selected. An isolator equipped with oxygen monitoring system will be required to complete these studies and will be acquired at STI's expense. 2275 Research Boulevard Rockville, Maryland 20850 301-926-1800 STX XXXXXXXX XXXXXXXXXX XXX. Xxxx Xxxxxxx Pxxx Xxx PHASE - II: SCALE-UP FOR SUBMISSION PHASE $178,937 for each product (EpiPen(TM) Senior; and Epi:Pen(TM) Junior) After a feasible Epinephrine formulation and filling process is identified, we will move forward to the scale-up phase. During this phase, three formal stability batches will be required for each strength (total of six batches). These batches will be filled at STI's St. Louis manufacturing facility using production equipment. The batch size for these stability batches must be at least 10% of the projected commercial batch size. We will manufacture these stability batches under inert environment using Schubert filling equipment that is enclosed in an isolator. The assumxxxxx xxderlying the above cost proposal is that STI will assure that all validation required to support this production scale-up be performed at STI's expense. Center will be responsible for the actual cost of the six stability/submission batches (three for EpiPen(TM) Junior and three for EpiPen(TM) Senior) and related stability testing. The recommended batch size is 8,000 units. The total cost for both products (EpiPen(TM) Senior and Junior) for Phases I and II amounts to $447,716. There are no costs associated with the development of the new DCA device. The terms of this proposal require Center to pay STI a non-refundable down payment equal to 50% of the proposal cost upon initiation of each phase with the remaining balance to be paid upon completion of said phase. Please be advised that an additional phase, Process Validation, wi...
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Related to Processing Parameter Evaluation

  • USE OF THIRD PARTY SYSTEMS-LEVEL SOFTWARE State Street and the Fund acknowledge that in connection with the Data Access Services provided under this Addendum, the Fund will have access, through the Data Access Services, to Fund Data and to functions of State Street’s proprietary systems; provided, however that in no event will the Fund have direct access to any third party systems-level software that retrieves data for, stores data from, or otherwise supports the System.

  • Measurement and Monitoring Tools As of the Effective date, Vendor and Prudential will mutually agree on the measurements and service level management procedures, pursuant to the governance procedures set forth in Attachment G and performance standards set forth in Attachment E-1 and E-2, to measure Vendor's performance of the Services against the applicable Service Levels. Such measurement and monitoring tools and procedures will (a) for Attachment E-1, be implemented upon the Effective Date; (b) for Attachment E-2, be implemented after successful completion of all testing and written acceptance by Prudential of the Transition Services set forth in Attachment B-1; (c) permit reporting at a level of detail sufficient to verify compliance with the Service Levels; and (d) be subject to audit by Prudential or its designee in accordance with the Agreement, except such audit will not include the installation of any audit software on Vendor's network.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

  • Measurement All quantities of Products received or delivered by or into truck, rail, or marine vessel shall be measured and determined based upon the meter readings at each Terminal, as reflected by delivery tickets or bills of lading, or if such meters are unavailable, by applicable calibration tables. All quantities of Products received and delivered by pipeline shall be measured and determined based upon the meter readings of the pipeline operator, as reflected by delivery tickets, or if such meters are unavailable, by applicable calibration tables. Deliveries to a Terminal rack at Mandan, Salt Lake City or Wilmington from a Tesoro Refinery shall be deemed to be the same as the corresponding volumes delivered contemporaneously from the Terminal rack. Deliveries by book transfer shall be reflected by entries in the books of TLO. All quantities shall be adjusted to net gallons at 60° F in accordance with ASTM D-1250 Petroleum Measurement Tables, or latest revisions thereof. A barrel shall consist of 42 U.S. gallons and a gallon shall contain 231 cubic inches. Meters and temperature probes shall be calibrated according to applicable API standards. Tesoro shall have the right, at its sole expense, and in accordance with rack location procedure, to independently certify said calibration. Storage tank gauging shall be performed by TLO’s personnel. TLO’s gauging shall be deemed accurate unless challenged by an independent certified xxxxxx. Tesoro may perform joint gauging at its sole expense with TLO’s personnel at the time of delivery or receipt of Product, to verify the amount involved. If Tesoro should request an independent xxxxxx, such xxxxxx must be acceptable to TLO, and such gauging shall be at Tesoro’s sole expense.

  • Data Processing System, Program and Information (a) The Investment Company shall not, solely by virtue of this Agreement, obtain any rights, title and interest in and to the computer systems and programs, including all related documentation, employed by FTIS in connection with rendering services hereunder; provided however, that the records prepared, maintained and preserved by FTIS pursuant to this Agreement shall be the property of the Investment Company.

  • Statistical, Demographic or Market-Related Data All statistical, demographic or market-related data included in the Registration Statement, the Disclosure Package or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate and all such data included in the Registration Statement, the Disclosure Package or the Prospectus accurately reflects the materials upon which it is based or from which it was derived.

  • Remittance Processing Services In order to provide a means of collection of the Receivables which will allow the Trustee to receive the proceeds of the Receivables and related security without AmeriCredit or its Affiliates having access to the funds, the parties hereto agree for the benefit of the Trustee that the processing services (the “Service(s)”) of Processor will be used for the collection and the deposit of remittances related to the Receivables and related security.

  • Benchmarking 6.5.1. Not earlier than [***], Company shall have the right, but not the obligation, to conduct a measurement and comparison benchmarking process to compare [***] to ensure that Company is receiving [***], given the nature, volume and type of Services provided by Amdocs hereunder (taking into account the volume of Services, the skill sets and geographical location of the Personnel and other such factors necessary to ensure a like-for-like comparison to the benchmark comparator group) (the “Benchmarking Process”). Upon Amdocs’ receipt of notice of Company’s intent to exercise its benchmarking right, the Parties shall agree on a pool of suitably qualified, experienced and independent benchmarkers generally in the business of conducting such measurements and comparisons. The pool of benchmarkers shall not include any Person that is an Amdocs Competitor. It is the Parties’ intention that they shall jointly select the benchmarker to carry out the Benchmarking Process. However, in the event that the Parties are unable to agree as to the identification of such benchmarker, after escalation of this matter to Company’s Senior Vice President (IT) and Amdocs’ Vice President, then Company may utilize any Third Party benchmarker from the pool to perform the Benchmarking Process (the “Benchmarker”). The Benchmarker will review its benchmarking methodology with Company and Amdocs and the Parties shall agree to the criteria used for selection of the benchmark comparator group prior to commencement of the Benchmarking Process. Amdocs shall have reasonable * Confidential treatment has been requested. The redacted material has been separately filed with the Commission. opportunities to make submissions to the Benchmarker as to the performance of the Services and the related pricing. Company shall pay the fees and expenses charged by the Benchmarker (which fees will not be contingency-based). Amdocs’ cooperation with the Benchmarker shall be conditioned on the Benchmarker’s compliance with Amdocs’ commercially reasonable confidentiality requirements; provided, that, Amdocs shall not be obligated to disclose Confidential Information related to any of Amdocs’ or its Affiliates’ other clients to the Benchmarker. The Benchmarking Process shall be conducted so as not to unreasonably disrupt Amdocs’ operations under this Agreement (including so as not to lead to any material impact on the Service Levels).

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Asset-Level Information On or before the 15th day following each Payment Date, the Servicer will prepare a Form ABS-EE, including an asset data file and asset-related document containing the asset-level information for each Receivable for the prior Collection Period as required by Item 1A of Form 10-D.

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