Routine Stability Program Sample Clauses

Routine Stability Program. 6.5.1 ORPHAN is responsible for maintaining a Stability Program and will request samples from Drug Product lots to be placed on stability.
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Routine Stability Program. Nastech is responsible for maintaining a stability program on the finished product and will provide a stability report to LICENSEE annually and otherwise as required by LICENSEE. The stability program will be in compliance with the stability specifications specified by the applicable ANDA. Following initial commercial introduction, which requires [***] to be placed on stability testing, at least [***] of the Product, of each strength, and in each package type (largest and smallest) will be placed on stability each year. The stability program will follow ICH guidelines. The stability protocol and/or any subsequent changes will be handled in accordance with the provisions of Section 28.
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Routine Stability Program. 6.5.1 C*P is responsible for maintaining a routine stability testing program for the PRODUCTS and will provide a report to POZEN annually or upon request. The stability program will be in compliance with any approved application commitments as notified by POZEN. At a minimum one lot of each product, of each strength and in each package type (largest and smallest) will be placed on stability each year. The stability program will generally follow ICH guidelines. The stability protocol or any changes must be approved by POZEN in writing.
Sample 1
Routine Stability Program. SkyePharma is responsible for maintaining a routine stability testing program for the PRODUCTS and will provide a formal stability report to Enzon annually and a data summary semi-annually. The stability program will be in compliance with the NDA commitments. At a, minimum, one lot of each product, of each strength and in each package type (largest and smallest) will be placed on stability each year. The stability program will follow ICH guidelines with the exception of humidity control and monitoring for products packaged in glass. SkyePharma will inform Enzon at the time of occurrence, of any material changes to the stability protocol for any PRODUCT. Any confirmed problems that arise as a result of the stability program will be promptly communicated by SkyePharma to Enzon.
Sample 1
Routine Stability Program. 6.5.1 Halozyme is responsible for developing and submitting to Xxxxxx a routine stability-testing program for the Product. Halozyme is responsible for identifying the batch number and quantity of samples for each lot to be placed in the stability program. Xxxxxx is responsible for executing the stability-testing program and providing summary reports and data per the agreed upon stability program.
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Routine Stability Program. 10.6.1.1 ORGANICHEM is responsible for maintaining a routine stability testing program for the API, and will provide a stability report to NEW RIVER annually or on reasonable request intervals. Stability samples will be tested [***] of the target stability pull date or as indicated per the approved stability protocol. Completed testing data will be provided to NEW RIVER [***] of the request.
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Routine Stability Program. 6.4.1 ORPHAN is responsible for maintaining a Stability Program and will request samples from Drug Product lots to be placed on stability as required. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX H
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Related to Routine Stability Program

  • Maintenance Program LESSEE's Maintenance Program

  • Year 2000 Compatibility Borrower shall take all action necessary to assure that Borrower's computer based systems are able to operate and effectively process data including dates on and after January 1, 2000. At the request of Bank, Borrower shall provide Bank assurance acceptable to Bank of Borrower's Year 2000 compatibility.

  • Sprinkler System If there now is or shall be installed in the Building a "sprinkler system", and such system or any of its appliances shall be damaged or injured or not in proper working order by reason of any act or omission of Tenant, Tenant's agents, servants, employees, licensees or visitors, Tenant shall forthwith restore the same to good working condition at its own expense; and if the New York Board of Fire Underwriters or the New York Fire Insurance Rating Organization or any bureau, department or official of the state or city government, shall require or recommend that any changes, modifications, alterations or additional sprinkler heads or other equipment be made or supplied by reason of Tenant's business, or the location of the partitions, trade fixtures, or other contents of the Premises, Tenant shall, at Tenant's expense, promptly make and supply such changes, modifications, alterations, additional sprinkler heads or other equipment.

  • Stability During the Term, Seller shall conduct the commercial stability program pursuant to Regulatory Requirements applicable as of the Effective Date at its own expense. Should additional stability studies be required, the Parties shall agree, in good faith, upon the protocol, and associated charges, based on the then current charge rates for the staff services, with invoicing for such additional services to occur when the lot is placed on stability.

  • Protocol (cc) Part 2(b) of the ISDA Schedule – Payee Representation.

  • Program Management (WBS 1.1) All components of the Project Management Plan as implemented for the Base Contract and Options 1-4 will be reviewed and amended to reflect specific needs for Option 5 and the outcome of continuous process improvement evaluations.

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  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Monitoring System In each case in which the Custodian has exercised delegated authority to place Assets with a Foreign Custodian, the Custodian shall establish a system, to re-assess or re-evaluate selected Foreign Custodians, at least annually in accordance with Rule 17f-5(c)(3).

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