FDA Requirements Sample Clauses

FDA Requirements. Except as set forth on Schedule 4.15, the Company and to the knowledge ------------- of the Company, Celtrix are in compliance in all material respects with all applicable FDA requirements. With respect to any Investigational New Drug Application ("IND") filed by the Company, or to the knowledge of the Company, by --- Celtrix with respect to all drugs currently under development neither the Company nor Celtrix has been advised by the FDA that such IND was or may in the future be (i) terminated, or (ii) subject to indefinite clinical hold, nor is the Company aware of the occurrence of any event that would result in such termination or indefinite clinical hold.
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FDA Requirements. I further hereby certify that the Borrower is in compliance with all governmental requirements, rules or regulations applicable to Borrower’s business, including all requirements, rules and regulations imposed on the Borrower by the United States Food and Drug Administration. STAAR SURGICAL COMPANY By: Its Chief Financial Officer Exhibit C to Credit and Security Agreement PREMISES The Premises referred to in the Credit and Security Agreement are legally described as follows: [To be completed by Borrower]
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FDA Requirements. To ensure continued compliance with the U.S. Food and Drug Administration’s (“FDA”) requirements, Purchaser and any DME Distributors to whom Purchaser sells Private Labeled Products shall not, directly or indirectly, supply any Private Labeled Products comprising a PainShield® device to patients without first obtaining an order or prescription from a physician, if applicable FDA rules or regulations so require. Purchaser and any DME Distributors to whom Purchaser sells Private Labeled Products shall be responsible for maintaining records of all such physician prescriptions for orders of Private Labeled Products that include a PainShield® device.
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FDA Requirements. “FDA Requirements” shall mean all applicable Legal Requirements (including, but not limited to, Section 321 et. seq. of Title 21 of the FDCA) administered or issued by the FDA or any applicable, comparable state or foreign Governmental Table of Contents Body having equivalent authority over medical devices, including requirements related to premarket clearance, exemption from premarket clearance, premarket approval, establishment registration and product listing, medical device reporting, corrections and removals, recalls, import and export requirements, product labeling, promotional materials and advertising, supplier qualification, purchasing controls, product testing, quality system regulation, and good manufacturing practices.
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FDA Requirements. The manufacture by any Seller of the TMR Products is being conducted, and to the Knowledge of Sellers the manufacture by any third party contracted by any Seller for the manufacture of such TMR Products is being conducted, in compliance with all applicable Legal Requirements, including the FDA’s current Good Manufacturing Practices (QSR). All complaints about the TMR Products have been timely reviewed, evaluated, and investigated as appropriate, and adequate corrective and preventive action has been or is in the process of being timely implemented, all as required under 21 C.F.R. Sections 820.100, 820.198 and other applicable provisions of the QSR. In addition, each Seller is in compliance with all other applicable FDA requirements, including, but not limited to, registration and listing requirements set forth in 21 U.S.C. Section 460 and 21 C.F.R. Part 207 and all other applicable Legal Requirements. The TMR Products have been commercially distributed by Seller to its distributors in compliance with the conditions of approval set forth by the FDA included in the PMAs. Sellers have complied in all material respects with all such conditions of approval. Sellers have not made any false, misleading, or otherwise inaccurate statements to the FDA or any other Governmental Authority.
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FDA Requirements. Licensee shall, at its sole expense, ensure that the manufacture, marketing and sale of Licensed Product complies with all applicable FDA rules and regulations, including without limitation rules and fees pertaining to marketing eligibility and requirements necessary to maintain the listing for the Licensed Product in the “Orange Book” including, but not limited to, filing NDA Annual Reports and Safety Reports and paying Establishment Fees and Orange Book listing fees, and the Food, Drug and Cosmetic Act as most recently amended.
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Related to FDA Requirements

  • System Requirements Apple Software is supported only on Apple-branded hardware that meets specified system requirements as indicated by Apple.

  • Health Requirements This is an active trip that requires you to make a realistic assessment of your health. To enjoy the trips as intended, a minimum level of fitness is required. All Participants are expected to be in active good health, to be comfortable traveling as part of a group, and to be ready to experience cultural differences with grace. Air Journey will require prior notice if any participant has any physical or other condition or disability that would prevent them from participating in active elements of any trip and/or could create a hazard to him or herself or to other members of the group. Air Journey may require guests to produce a doctor’s certificate certifying that they are fit to participate. Any physical condition requiring special attention, diet, or treatment should be reported in writing when the reservation is made. We will make reasonable efforts to accommodate Participants with special needs; however, we cannot accommodate wheelchairs. . Walking and climbing stairs are required in many hotels and airports, and are part of many excursions. If you require a slower pace, extra assistance, or the use of a cane or walking stick, arrangements will be made for private touring at each destination, if necessary, at the discretion of our Journey staff. Any extra cost for such arrangements will be the responsibility of the Participant. If you would like to forego some of the scheduled sightseeing to rejuvenate and relax, please feel free to do so at any time. Acting reasonably, if Air Journey is unable to properly accommodate the need of the person(s) concerned or believes that health and safety may be compromised, Air Journey reserves the right to refuse participation. Air Journey also reserves the right to remove from the trip, at the participant’s own expense, anyone whose physical condition or conduct negatively impacts the enjoyment of the other guests or disrupts the tour. Malaria and other diseases may be present in some of the countries featured in this itinerary; proof of yellow fever inoculation may be required. For the latest recommendations on specific health precautions for the areas you will visit, consult your physician and the Centers for Disease Control. The participant represents that neither he nor she nor anyone traveling with him or her has any physical or other condition or disability that could create a hazard to himself or herself or other members of the tour. Itinerary Changes The itinerary and Journey leaders are subject to modification and change by Air Journey. Every reasonable effort will be made to operate the Journey as planned; however, should unforeseen world events and conditions require our itinerary to be altered, Air Journey reserves the right to do so for the safety and best interest of the group without prior notification or consultation. The operation of these flights is subject to the foreign governments involved granting landing rights for the flight. If the air carrier cannot obtain these rights for any particular flight leg of the Journey, that flight leg will be canceled and alternative arrangements may be made, at the discretion of Air Journey. Every effort will be made to operate tours as planned but alterations may occur after the final itinerary has been issued.

  • Specific Requirements 7.4.1 Workers’ compensation insurance with statutory limits required by South Dakota law. Coverage B-Employer’s Liability coverage of not less than $500,000 each accident, $500,000 disease-policy limit, and $500,000 disease-each employee.

  • Basic Requirements To be eligible for PayPal’s Seller Protection program, all of the following basic requirements must be met, as well as any applicable additional requirements: • The primary address for your PayPal account must be in the United States. • The item must be a physical, tangible good that can be shipped, except for items subject to the Intangible Goods Additional Requirements. Transactions involving items that you deliver in person in connection with payment made in your physical store, may also be eligible for PayPal’s Seller Protection program so long as the buyer paid for the transaction in person by using a PayPal goods and services QR code. • You must ship the item to the shipping address on the Transaction Details page in your PayPal account for the transaction. If you originally ship the item to the recipient’s shipping address on the Transaction Details page but the item is later redirected to a different address, you will not be eligible for PayPal’s Seller Protection program. We therefore recommend not using a shipping service that is arranged by the buyer, so that you will be able to provide valid proof of shipping and delivery. • The shipping requirement does not apply to eligible transactions involving items that you deliver in person; provided, however, that you agree to provide us with alternative evidence of delivery or such additional documentation or information relating to the transaction that we may request. • You must respond to PayPal’s requests for documentation and other information in a timely manner as requested in our email correspondence with you or in our correspondence with you through the Resolution Center. If you do not respond to PayPal’s request for documentation and other information in the time requested, you may not be eligible for PayPal’s Seller Protection program. • If the sale involves pre-ordered or made-to-order goods, you must ship within the timeframe you specified in the listing. Otherwise, it is recommended that you ship all items within 7 days after receipt of payment. • You provide us with valid proof of shipment or delivery. • The payment must be marked “eligible” or “partially eligible” in the case of Unauthorized Transaction claims, or “eligible” in the case of Item Not Received claims, for PayPal’s Seller Protection program on the Transaction Details page. • In the case of an Unauthorized Transaction claim, you must provide valid proof of shipment or proof of delivery that demonstrates that the item was shipped or provided to the buyer no later than two days after PayPal notified you of the dispute or reversal. For example, if PayPal notifies you of an Unauthorized Transaction claim on September 1, the valid proof of shipment must indicate that the item was shipped to the buyer no later than September 3 to be eligible for PayPal’s Seller Protection program. PayPal determines, in its sole discretion, whether your claim is eligible for PayPal’s Seller Protection program. PayPal will make a decision, in its sole discretion, based on the eligibility requirements, any information or documentation provided during the resolution process, or any other information PayPal deems relevant and appropriate under the circumstances. Item Not Received additional requirements To be eligible for PayPal’s Seller Protection program for a buyer’s Item Not Received claim, you must meet both the basic requirements and the additional requirements listed below: • Where a buyer files a chargeback with the issuer for a card-funded transaction, the payment must be marked “eligible” for PayPal’s Seller Protection on the Transaction Details page. • You must provide proof of delivery as described below.

  • E-Verify Requirements To the extent applicable under ARIZ. REV. STAT. § 41- 4401, the Contractor and its subcontractors warrant compliance with all federal immigration laws and regulations that relate to their employees and their compliance with the E-verify requirements under ARIZ. REV. STAT. § 23-214(A). Contractor’s or its subcontractor’s failure to comply with such warranty shall be deemed a material breach of this Agreement and may result in the termination of this Agreement by the City.

  • ERISA Requirements (a) Borrower will not engage in any transaction which would cause an obligation, or action taken or to be taken under this Loan Agreement (or the exercise by Lender of any of its rights under the Note, this Loan Agreement or any of the other Loan Documents) to be a non-exempt prohibited transaction under ERISA or Section 4975 of the Tax Code.

  • Time Requirements The Independent Contractor will not be required to follow or establish a regular or daily work schedule, but shall devote during the term of this Agreement the time, energy and skill as necessary to perform the services of this engagement and shall, periodically or at any time upon the request of the Company, submit information as to the amount of time worked and scope of work performed.

  • Program Requirements A. The parties shall comply with the Disadvantaged Business Enterprise Program requirements established in 49 CFR Part 26.

  • Data Requirements ‌ • The data referred to in this document are encounter data – a record of health care services, health conditions and products delivered for Massachusetts Medicaid managed care beneficiaries. An encounter is defined as a visit with a unique set of services/procedures performed for an eligible recipient. Each service should be documented on a separate encounter claim detail line completed with all the data elements including date of service, revenue and/or procedure code and/or NDC number, units, and MCE payments/cost of care for a service or product. • All encounter claim information must be for the member identified on the claim by Medicaid ID. Claims must not be submitted with another member’s identification (e.g., xxxxxxx claims must not be submitted under the Mom’s ID). • All claims should reflect the final status of the claim on the date it is pulled from the MCE’s Data Warehouse. • For MassHealth, only the latest version of the claim line submitted to MassHealth is “active”. Previously submitted versions of claim lines get offset (no longer “active” with MassHealth) and payments are not netted. • An encounter is a fully adjudicated service (with all associated claim lines) where the MCE incurred the cost either through direct payment or sub-contracted payment. Generally, at least one line would be adjudicated as “paid”. All adjudicated claims must have a complete set of billing codes. There may also be fully adjudicated claims where the MCE did not incur a cost but would otherwise like to inform MassHealth of covered services provided to Enrollees/Members, such as for quality measure reporting (e.g., CPT category 2 codes for A1c lab tests and care/patient management). • All claim lines should be submitted for each Paid claim, including zero paid claim lines (e.g., bundled services paid at an encounter level and patient copays that exceeded the fee schedule). Denied lines should not be included in the Paid submission. Submit one encounter record/claim line for each service performed (i.e., if a claim consisted of five services or products, each service should have a separate encounter record). Pursuant to contract, an encounter record must be submitted for all covered services provided to all enrollees. Payment amounts must be greater than or equal to zero. There should not be negative payments, including on voided claim lines. • Records/services of the same encounter claim must be submitted with same claim number. There should not be more than one active claim number for the same encounter. All paid claim lines within an encounter must share the same active claim number. If there is a replacement claim with a new version of the claim number, all former claim lines must be replaced by the new claim number or be voided. The claim number, which creates the encounter, and all replacement encounters must retain the same billing provider ID or be completely voided. • Plans are expected to use current MassHealth MCE enrollment assignments to attribute Members to the MassHealth assigned MCE. The integrity of the family of claims should be maintained when submitting claims for multiple MCEs (ACOs/MCO). Entity PIDSL, New Member ID, and the claim number should be consistent across all lines of the same claim. • Data should conform to the Record Layout specified in Section 3.0 of this document. Any deviations from this format will result in claim line or file rejections. Each row in a submitted file should have a unique Claim Number + Suffix combination. • A feed should consist of new (Original) claims, Amendments, Replacements (a.k.a. Adjustments) and/or Voids. The replacements and voids should have a former claim number and former suffix to associate them with the claim + suffix they are voiding or replacing. See Section 2.0, Data Element Clarifications, for more information. • While processing a submission, MassHealth scans the files for the errors. Rejected records are sent back to the MCEs in error reports in a format of the input files with two additional columns to indicate an error code and the field with the error. • Unless otherwise directed or allowed by XxxxXxxxxx, all routine monthly encounter submissions must be successfully loaded to the MH DW on or before the last day of each month with corrected rejections successfully loaded within 5 business days of the subsequent month for that routine monthly encounter submission to be considered timely and included in downstream MassHealth processes. Routine monthly encounter submissions should contain claims with paid/transaction dates through the end of the previous month.

  • Training Requirements Grantee shall:

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