Notices Regarding Safety of Products Sample Clauses

Notices Regarding Safety of Products. DSM shall provide RELYPSA with prompt notice of any information it receives from any source regarding adverse events associated with the Product. For serious (based upon a good faith evaluation) events, notice must be given by telephone within [***] after receipt of the information, followed by written notice not more than [***] thereafter. RELYPSA will be responsible at its expense for handling all Product safety complaints, including any necessary communications with the FDA or any other Regulatory Authority and filing any reports with the FDA or other Regulatory Authority concerning such safety matters. DSM will cooperate and provide reasonable assistance in responding to any safety-related requests for information, including reviews of retained samples and Manufacturing and test protocols as well as testing the API against the appropriate retained samples, if required. RELYPSA will reimburse DSM for reasonable costs and expenses incurred therewith to the extent that the safety issue is not a result of Nonconforming Bulk Drug in which case DSM shall solely bear all such costs and expenses.
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Notices Regarding Safety of Products. Each Party shall provide ------------------------------------ the other Party with prompt notice of any information either of them receive regarding the safety of the Drug Product, including any confirmed or unconfirmed information on adverse, serious or unexpected events associated with the use of the Drug Product. For serious, unexpected events, notice must be given by telephone within three (3) calendar days after receipt of the information, and followed by written notice not less than two (2) calendar days thereafter. All responsibility and cost for filing any reports with the FDA concerning such reactions (including Drug Experience Reports) caused by the Drug Substance Manufactured for Centocor shall be borne by Centocor. Furthermore, Centocor will be responsible at its cost for handling all Drug Product complaints. CBSI will provide reasonable assistance in responding to any complaints including reviews of retained samples and Batch records as well as testing the Drug Product engendering a complaint against the appropriate retained samples, if required, and Centocor will reimburse CBSI for reasonable out of pocket expenses incurred therewith. The costs of such testing shall be borne by Centocor; however, if it is determined that the Drug Product complaint was directly or indirectly caused by CBSI's Manufacture and if the Drug Product complaint is related to the Drug Substance's failure to Confidential Treatment Requested THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT THE PLACES INDICATED BY (XXXX); AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION conform to any of its Specifications or other requirements under this Agreement and/or the Quality Requirements, CBSI shall reimburse Centocor for the costs of such testing.
Notices Regarding Safety of Products. LANXESS shall provide RELYPSA with reasonably prompt notice of any credible information directed to LANXESS or Saltigo from any source if LANXESS recognizes such information as regarding adverse events associated with the Product. RELYPSA will be responsible at its expense for handling all Product safety complaints, including any necessary communications with the FDA or any other Regulatory Authority and filing any reports with the FDA or other Regulatory Authority concerning such safety matters. LANXESS will cooperate and provide reasonable assistance in responding to any safety-related requests for information, including reviews of retained samples and Manufacturing and test protocols as well as testing the API against the appropriate retained samples, if required. RELYPSA will reimburse LANXESS for reasonable costs and expenses incurred therewith to the extent that the safety issue is not a result of Nonconforming Bulk Drug in which case LANXESS shall solely bear all such costs and expenses. For purposes of clarity, the Parties agree that compliance with Legal Requirements relating to pharmacovigilance of the Product are the sole responsibility of RELYPSA.

Related to Notices Regarding Safety of Products

  • No Safety Notices (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any the Company’s respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s products or services.

  • Regulatory Notices Manager will, within 2 Business Days after its receipt, give Sprint PCS written notice of all oral and written communications it receives from regulatory authorities (including but not limited to the FCC, the FAA, state public service commissions, environmental authorities, and historic preservation authorities) and complaints respecting Manager's construction, operation, and management of the Service Area Network that could result in actions affecting the License as well as written notice of the details respecting such communications and complaints, including a copy of any written material received in connection with such communications and complaints. Manager will cooperate with Sprint PCS in responding to such communications and complaints received by Manager. Sprint PCS has the right to respond to all such communications and complaints, with counsel and consultants of its own choice. If Sprint PCS chooses to respond to such communications and complaints, Manager will not respond to them without the consent of Sprint PCS, and Manager will pay the costs of Sprint PCS' responding to such communications and complaints, including reasonable attorneys' and consultants' fees, investigation costs, and all other reasonable costs and expenses incurred by Sprint PCS.

  • Notices; Reports Company and Company Sub will promptly notify Parent of any event of which Company or Company Sub obtains knowledge which has had or may have a Material Adverse Effect, or in the event that Company or Company Sub determines that it is unable to fulfill, or that any event has occurred which is reasonably likely to prevent the fulfillment of, any of the conditions to the performance of Parent’s obligations hereunder, as set forth in Articles 9 or 11 herein, and Company or Company Sub will furnish Parent (i) as soon as available, and in any event within one Business Day after it is mailed or delivered to the Board of Directors of Company or committees thereof, any report by Company for submission to the Board of Directors of Company or committees thereof, provided, however, that Company need not furnish to Parent communications of Company’s or Company Sub’s legal counsel regarding Company’s or Company Sub’s rights and obligations under this Agreement or the transactions contemplated hereby, or other communication incident to Company’s or Company Sub’s actions pursuant to Section 6.3 hereof (except as required by Section 6.3 or Section 6.9), or books, records and documents covered by confidentiality agreements or the attorney-client privilege, or which are attorneys’ work product, (ii) prior to sending or filing same, all proxy statements, information statements, financial statements, reports, letters and communications sent by Company to its stockholders or other security holders, and all reports filed by Company with the SEC or other Governmental Entities, and (iii) such other existing reports as Parent may reasonably request relating to Company or Company Sub. No notification delivered pursuant to this Section 6.7 shall affect the representations, warranties, covenants or agreements of the parties or the conditions to the obligations of the parties under this Agreement.

  • NOTICES AND CORRESPONDENCE Notices regarding the subject matter of this Agreement or breach or termination thereof shall be in writing and shall be addressed in duplicate to the last known address of each other party, marked respectively to the attention of its President and, if any, its General Counsel.

  • Notices, Reports and Documents The Company agrees that it will deliver to the Depositary, and the Depositary will, promptly after receipt thereof transmit to the record holders of Receipts, in each case at the address recorded in the Depositary’s books, copies of all notices and reports (including financial statements) required by law, by the rules of any national securities exchange or interdealer quotation system upon which the Preferred Stock, the Depositary Shares or the Receipts are listed or quoted or by the Articles of Incorporation and the Articles of Amendment to be furnished by the Company to holders of the deposited Preferred Stock and, if requested by the holder of any Receipt, a copy of this Deposit Agreement, the form of Receipt, the Articles of Amendment and the form of Preferred Stock. Such transmission will be at the Company’s expense and the Company will provide the Depositary with such number of copies of such documents as the Depositary may reasonably request. In addition, the Depositary will transmit to the record holders of Receipts at the Company’s expense such other documents as may be requested by the Company.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • BILLS AND NOTICES 28. Except as otherwise in this lease provided, a bill, xxatement, notice or communication which Owner may desire or be required to give to Tenant, shall be deemed sufficiently given or rendered if, in writing, delivered to Tenant personally or sent by registered or certified mail addressed to Tenant at the building of which the demised premises form a part or at the last known residence address or business address of Tenant or left at any of the aforesaid premises addressed to Tenant, and the time of the rendition of such bill xx statement and of the giving of such notice or communication shall be deemed to be the time when the same is delivered to Tenant, mailed, or left at the premises as herein provided. Any notice by Tenant to Owner must be served by registered or certified mail addressed to Owner at the address first hereinabove given or at such other address as Owner shall designate by written notice.

  • 1Notices Any notices, consents or other communications required to be sent or given hereunder by any of the parties hereto shall in every case be in writing and shall be deemed properly served if and when (a) delivered by hand, (b) transmitted by facsimile or other means of electronic delivery, with confirmation of transmission, or (c) delivered by Federal Express or other express overnight delivery service, or registered or certified mail, return receipt requested, to the parties at the addresses as set forth below or at such other addresses as may be furnished in writing: To the Company: Authentic Brands LLC 0000 Xxxxx 000 Xxxx ​ Xxxx Xxxx Xxxx, Xxxx 00000 Attention: Xxxx Xxxxx Telephone: 000.000.0000 Facsimile: E-mail: xxxx@xxxxxxxxxxxxxxxx.xxx with copies to: New Coffee Holdings, LLC c/o Sterling Partners 000 X. Xxxxxxxx Xxxxxx, 00xx Xxxxx Xxxxxxx, Xxxxxxxx 00000-0000 Attention: Office of the General Counsel Telephone: 000.000.0000 E-mail: xxxxxxxx@xxxxxxxxxxxxxxxx.xxx and: Xxxxx Xxxxxxxxx LLP 000 Xxxxx Xxxxxx Xxxxx Suite 3100 Chicago, Illinois 60606 Attention: Xxxx Xxxxxxx Telephone: 000.000.0000 E-mail: xxxxxxxx@xxxxxxxx.xxx To Recipient: to the address listed on the signature page. or to such other person or address as any party shall specify by notice in writing to the other party. The date of service of such notice shall be deemed to be: (x) the date such notice is delivered by hand, facsimile or other electronic means, (y) one business day following the delivery by express overnight delivery service, or (z) three business days after the date of mailing if sent by certified or registered mail.

  • Communications Regulatory Matters (A) Schedule 5.13(A) sets forth a true and complete list of the following information for each License issued to each Loan Party or its Subsidiaries: the name of the licensee, the type of service, the expiration date and the geographic area covered by such License.

  • Telephone and Telefax Authorization (a) The Bank may honor telephone or telefax instructions for advances or repayments or for the designation of optional interest rates and telefax requests for the issuance of letters of credit given, or purported to be given, by any one of the individuals authorized to sign loan agreements on behalf of the Borrower, or any other individual designated by any one of such authorized signers.

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