Regulatory Correspondence Requiring a Lonza Response Sample Clauses

Regulatory Correspondence Requiring a Lonza Response. In the event that Lonza receives any regulatory letter or comments from any federal, state, local, or foreign regulatory authority directed to its manufacture of Bulk Drug requiring a response or action by Lonza, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Trubion promptly will provide Lonza with any data or information required by Lonza in preparing any response relating to Lonza's manufacture of Bulk Drug, and will cooperate fully with Lonza in preparing such response. Except to the extent prohibited by Legal Requirements, Lonza shall provide Trubion with a copy of each such response for Trubion's review and comment prior to Lonza's submission of its detailed written response. Lonza shall give all due consideration to any Trubion comments to each such proposed Lonza response, provided Trubion timely responds. Likewise, in the event Trubion receives any regulatory letter or comments from any federal, state or local regulatory authority directed to the manufacture of Bulk Drug at the Lonza Facility requiring a response or action by Trubion, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Lonza will promptly provide Trubion with relevant data or information sufficient for Trubion to prepare any response related to the manufacture of Bulk Drug and will cooperate fully with Trubion in preparing such response. Except to the extent prohibited by Legal Requirements, Trubion shall provide Lonza with a copy of each such response for Lonza's review and comment prior to Trubion's submission of its detailed written response. Trubion shall give all due consideration to any Lonza comments to each such proposed Trubion response, provided Lonza timely responds.
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Related to Regulatory Correspondence Requiring a Lonza Response

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

  • Certification Regarding Debarment Party certifies under pains and penalties of perjury that, as of the date that this Agreement is signed, neither Party nor Party’s principals (officers, directors, owners, or partners) are presently debarred, suspended, proposed for debarment, declared ineligible or excluded from participation in Federal programs, or programs supported in whole or in part by Federal funds.

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Workplace Violence Prevention and Crisis Response (applicable to any Party and any subcontractors and sub-grantees whose employees or other service providers deliver social or mental health services directly to individual recipients of such services): Party shall establish a written workplace violence prevention and crisis response policy meeting the requirements of Act 109 (2016), 33 VSA §8201(b), for the benefit of employees delivering direct social or mental health services. Party shall, in preparing its policy, consult with the guidelines promulgated by the U.S. Occupational Safety and Health Administration for Preventing Workplace Violence for Healthcare and Social Services Workers, as those guidelines may from time to time be amended. Party, through its violence protection and crisis response committee, shall evaluate the efficacy of its policy, and update the policy as appropriate, at least annually. The policy and any written evaluations thereof shall be provided to employees delivering direct social or mental health services. Party will ensure that any subcontractor and sub-grantee who hires employees (or contracts with service providers) who deliver social or mental health services directly to individual recipients of such services, complies with all requirements of this Section.

  • REQUIRED PRICE PROPOSAL RESPONSE All pricing must be fixed cost, inclusive of all expenses and fees if this Statement of Work proposal is for a fixed price agreement. (Remove if Time and Materials agreement) For Time and Materials the pricing proposal must include estimated effort hours, hourly rate for proposed personnel, projected timeline, including timing expectations for the State functional and technical resources and be submitted as a separate document from the rest of the proposal. (Remove if not Time and Materials)

  • Lobbying Activities - Standard Form - LLL No response Do not upload this form unless Vendor has reportable lobbying activities. There are Attributes entitled, “2 CFR Part 200 or Federal Provision - Xxxx Anti-Lobbying Amendment – Continued.” Properly respond to those Attributes and only upload this form if applicable/instructed. If upload is required based on your response to those Attributes, the Disclosure of Lobbying Activities – Standard Form - LLL must be downloaded from the “Attachments” section of the IonWave eBid System, reviewed, properly completed, and uploaded to this location.

  • EDD Independent Subrecipient Reporting Requirements Effective January 1, 2001, the County of Orange is required to file in accordance with subdivision (a) of Section 6041A of the Internal Revenue Code for services received from a “service provider” to whom the County pays $600 or more or with whom the County enters into a contract for $600 or more within a single calendar year. The purpose of this reporting requirement is to increase child support collection by helping to locate parents who are delinquent in their child support obligations. The term “service provider” is defined in California Unemployment Insurance Code Section 1088.8, Subparagraph B.2 as “an individual who is not an employee of the service recipient for California purposes and who received compensation or executes a contract for services performed for that service recipient within or without the State.” The term is further defined by the California Employment Development Department to refer specifically to independent Subrecipients. An independent Subrecipient is defined as “an individual who is not an employee of the ... government entity for California purposes and who receives compensation or executes a contract for services performed for that ... government entity either in or outside of California.” The reporting requirement does not apply to corporations, general partnerships, limited liability partnerships, and limited liability companies. Additional information on this reporting requirement can be found at the California Employment Development Department web site located at xxxx://xxx.xxx.xx.xxx/Employer_Services.htm

  • Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.

  • Vendor Logo (Supplemental Vendor Information Only) No response Optional. If Vendor desires that their logo be displayed on their public TIPS profile for TIPS and TIPS Member viewing, Vendor may upload that logo at this location. These supplemental documents shall not be considered part of the TIPS Contract. Rather, they are Vendor Supplemental Information for marketing and informational purposes only. Some participating public entities are required to seek Disadvantaged/Minority/Women Business & Federal HUBZone ("D/M/WBE/Federal HUBZone") vendors. Does Vendor certify that their entity is a D/M/WBE/Federal HUBZone vendor? If you respond "Yes," you must upload current certification proof in the appropriate "Response Attachments" location. NO Some participating public entities are required to seek Historically Underutilized Business (HUB) vendors as defined by the Texas Comptroller of Public Accounts Statewide HUB Program. Does Vendor certify that their entity is a HUB vendor? If you respond "Yes," you must upload current certification proof in the appropriate "Response Attachments" location. No Can the Vendor provide its proposed goods and services to all 50 US States? Yes

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