cGMP Documentation Sample Clauses

cGMP Documentation. Supplier shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the API Compound.
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cGMP Documentation. Throughout the Term, each Party shall maintain, in accordance with and for the period required under the NDA, cGMPs, laws and Regulatory Standards, complete and adequate records pertaining to the methods and facilities used for the cGMPs pertaining to the manufacture, processing, testing, packaging, packing, labeling, holding and distribution of the Patches. Corium shall also maintain all records related to its compliance with environmental, health and safety guidelines for such periods of time as are required by the applicable Regulatory Authorities.
cGMP Documentation. Each Party shall maintain, in accordance with and for the period required under the applicable MAA, cGMPs, and Laws, complete and adequate records pertaining to the methods and facilities used for the cGMPs manufacture, processing, testing, packing, labeling, holding and distribution of the Products. Impax shall also maintain all records related to its compliance with its Environmental, Health and Safety Guiding Principles in accordance with Section 5.6.
cGMP Documentation. PII shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Drug Product.
cGMP Documentation. LICENSEE shall not make any changes to Nastech-owned or Nastech-controlled cGMP documentation without the consent of Nastech, in order to insure that all cGMP documentation, which is maintained at Nastech and subject to regulatory review, matches or is consistent with information filed with regulatory authorities. LICENSEE shall be responsible for all costs and penalties incurred if it makes any changes to cGMP documentation without Nastech's consent.
cGMP Documentation. CRL shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Drug Product.
cGMP Documentation. Each Party will maintain, in accordance with and for the period required under the applicable Product Addendum, Specifications, cGMPs and Laws, complete and adequate records pertaining to the methods and facilities used for the cGMPs manufacture, processing, testing, packing, labeling, holding and distribution of the Products. Patheon will keep complete and systematic records related to the Materials purchased, Manufacturing Services performed and any other records generated as a part of this Agreement. These records will include any operational documentation pertaining to Patheon’s Manufacturing Services under this Agreement, including procedures (including records for compliance with Laws) and any other documentation pertaining to Patheon’s obligations under this Agreement. Patheon will preserve these records for the greater of (a) [ * ], or (b) the period agreed upon in writing by the Parties in any Product Addendum. If a legal matter arises requiring preservation of certain records and XenoPort or any Governmental Authority has made a request to preserve records, Patheon will suspend destruction of the records.
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Related to cGMP Documentation

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. Claims can arise, under certain types of insurance contract, long after the expiry of the policy. It is therefore important that you retain and keep safely all documents associated with your policy.

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Project Documentation All documentation provided to the City other than Project drawings shall be furnished on a Microsoft compatible compact disc.

  • Tax Documentation For the purposes of Sections 4(a)(i) and 4(a)(ii) of the Agreement, Counterparty shall provide to Dealer a valid and duly executed U.S. Internal Revenue Service Form W-9, or any successor thereto, completed accurately and in a manner reasonably acceptable to Dealer and, in particular, with the “corporation” box checked on line 3 thereof (i) on or before the date of execution of this Confirmation; (ii) promptly upon reasonable demand by Dealer; and (iii) promptly upon learning that any such tax form previously provided by Counterparty has become inaccurate or incorrect. Additionally, Counterparty shall, promptly upon reasonable request by Dealer, provide, such other tax forms and documents, accurately completed and in a manner reasonably acceptable to Dealer, that may be required or reasonably requested to allow Dealer to make a payment under this Confirmation, including any Credit Support Document, without any deduction or withholding for or on account of any Tax or with such deduction at a reduced rate. For the purposes of Sections 4(a)(i) and 4(a)(ii) of the Agreement, Dealer shall provide to Counterparty a valid and duly executed U.S. Internal Revenue Service Form W-9 or W-8ECI, or any successor thereto, completed accurately and in a manner reasonably acceptable to Counterparty and, in particular, with the “corporation” box checked on line 3 or 4 thereof, (i) on or before the date of execution of this Confirmation; (ii) promptly upon reasonable demand by Counterparty; and (iii) promptly upon learning that any such tax form previously provided by Dealer has become inaccurate or incorrect. Additionally, Dealer shall, promptly upon reasonable request by Counterparty, provide such other tax forms and documents, accurately completed and in a manner reasonably acceptable to Counterparty, that may be required or reasonably requested to allow Counterparty to make a payment under this Confirmation, including any Credit Support Document, without any deduction or withholding for or on account of any Tax or with such deduction at a reduced rate.

  • Source Documentation Accounting records must be supported by such source documentation as canceled checks, bank statements, invoices, paid bills, donor letters, time and attendance records, activity reports, travel reports, contractual and consultant agreements, and subaward documentation. All supporting documentation should be clearly identified with the Award and general ledger accounts which are to be charged or credited. (i) The documentation standards for salary charges to grants are prescribed by 2 CFR 200.430, and in the cost principles applicable to the entity’s organization (Paragraphs 7.4 through 7.7). (ii) If records do not meet the standards in 2 CFR 200.430, then Grantor may notify Grantee in PART TWO, PART THREE or Exhibit G of the requirement to submit Personnel activity reports. See 2 CFR 200.430(i)(8). Personnel activity reports shall account on an after-the-fact basis for one hundred percent (100%) of the employee's actual time, separately indicating the time spent on the grant, other grants or projects, vacation or sick leave, and administrative time, if applicable. The reports must be signed by the employee, approved by the appropriate official, and coincide with a pay period. These time records should be used to record the distribution of salary costs to the appropriate accounts no less frequently than quarterly. (iii) Formal agreements with independent contractors, such as consultants, must include a description of the services to be performed, the period of performance, the fee and method of payment, an itemization of travel and other costs which are chargeable to the agreement, and the signatures of both the contractor and an appropriate official of Grantee. (iv) If third party in-kind (non-cash) contributions are used for Grant purposes, the valuation of these contributions must be supported with adequate documentation.

  • Medical Documentation The teacher must supply a letter from a medical 3 doctor, who treated the patient, stating that in his/her opinion, there is a strong 4 probability that the illness was contracted at school.

  • Closing Documentation (a) At Closing, Seller shall execute and deliver to Buyer the following documents in the forms attached hereto as Exhibits C through H: (i) a special warranty deed (the “Deed”) conveying to Buyer fee simple title to the Land and Improvements, free and clear of all liens, charges and encumbrances, except: (A) ad valorem real property taxes for the calendar year of sale, to the extent not yet due and payable (to be prorated as of the Closing Date), (B) the rights of Buyer as tenant under the Lease (which tenancy shall be deemed merged into Buyer’s fee title), and (C) such other matters as are approved by Buyer, or not objected to in a timely manner under Paragraph 7 (collectively, the “Permitted Encumbrances”); (ii) a xxxx of sale by which Seller transfers to Buyer the FF&E (the “Xxxx of Sale”); (iii) a general assignment of the Contracts, Licenses and Warranties, to the extent the same may be assignable (the “General Assignment”) (provided that Seller shall cooperate with Buyer to obtain the benefit of any Contracts, Licenses and Warranties which are not assignable); (iv) a settlement statement (the “Settlement Statement”) reflecting any applicable adjustments to the Purchase Price and the appropriate receipts and disbursements on behalf of the Parties; (v) an owner’s affidavit in form reasonably acceptable to Buyer and the Title Company (defined in Paragraph 7) affirming that there are no outstanding possessory rights, liens or rights to claim liens against the Property, except for the Permitted Encumbrances, and any other certificates or affidavits reasonably required by the Title Company; (vi) a certificate confirming that Seller is not a “foreign person” within the meaning of the Foreign Investment in Real Property Tax Act, and containing information necessary to complete an IRS Form 1099; (vii) a closing certificate from Seller certifying that all of the representations and warranties contained in Paragraph 12(a) of this Agreement are true and correct as of the Closing Date; and (viii) documents evidencing the due organization and valid existence of Seller and the authority of the designated representative of Seller to execute and deliver the closing documents. (b) At Closing, Buyer shall execute and deliver to Seller: (i) the General Assignment; (ii) the Settlement Statement; (iii) a statement from Buyer certifying that all of the representations and warranties contained in Paragraph 12(b) of this Agreement are true and correct as of the Closing Date; and (iv) documents evidencing the due organization and valid existence of Buyer and the authority of the designated representative of Buyer to execute and deliver the closing documents.

  • Closing Documentation, etc For purposes of determining compliance with the conditions set forth in §12, each Lender that has executed this Credit Agreement shall be deemed to have consented to, approved or accepted, or to be satisfied with, each document and matter either sent, or made available, by any Agent or any Co-Lead Arranger to such Lender for consent, approval, acceptance or satisfaction, or required thereunder to be consented to or approved by or acceptable or satisfactory to such Lender, unless an officer of the Administrative Agent active upon the Borrowers’ account shall have received notice from such Lender prior to the Closing Date specifying such Lender’s objection thereto and such objection shall not have been withdrawn by notice to the Administrative Agent to such effect on or prior to the Closing Date.

  • Supporting Documentation Upon request, the HSP will provide the LHIN with proof of the matters referred to in this Article.

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