Safety Database. BMS shall transfer to Company the safety database for the Licensed Compounds, in a mutually agreeable format, as soon as practicable subsequent to the Effective Date as agreed to by the Parties, and Company shall thereafter perform all responsibilities thereafter with respect to reporting of adverse events and pharmacovigilance relating to the Licensed Compounds.
Safety Database. BMS shall transfer to Eiger the safety database for the Licensed Compounds, in the form in which it is held by BMS, as soon as practicable and in any event within [ * ] after the Effective Date, and Eiger shall perform all responsibilities thereafter with respect to reporting of adverse events relating to the Licensed Compounds.
Safety Database. It is assumed, that there is an existing database platform, the ****, within Omnicare CR for Sponsor. Therefore the present budgets include no Project set-up fees but only monthly database maintenance and date entry costs. The system is fully validated and compliant with all regulatory requirements for electronic storage of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. The pricing structure for the use of **** has been developed to be highly competitive for both **** SAE volume. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Safety Database. Omnicare CR will develop the safety database for the Project. The database platform is the current version of the **** safety surveillance system. The system is fully validated and complaint with all regulatory requirements for electronic storage of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions (‘SUSARs’) to regulatory authorities as mandated by the European Clinical Trials Directive.
Safety Database. The safety information generated pursuant to this Agreement shall be added to the safety database for the Shire Product and shall be held and maintained by Shire and shall be the central repository for all drug safety information received worldwide for the Shire Product.
Safety Database. To the extent collected by Novartis and in the form in which Novartis stores such information for its own purposes, Novartis will provide Akcea with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies) and adverse events related to Products licensed by Novartis under this Agreement within a reasonable period of time (but not later than [***] ([***]) calendar days after Novartis’ receipt of such information). In connection with any reported serious adverse event, Novartis will provide Akcea all serious adverse event reports within a reasonable time period of time but not later than [***] ([***]) calendar days after Novartis’ receipt of such information. In addition, with respect to Products, Novartis will provide Akcea with copies of Annual safety updates filed with each IND (e.g. DSURs or IND annual reports) and the safety sections of any final Clinical Study reports within [***] ([***]) calendar days following the date such information is filed, as applicable. Furthermore, Novartis will provide in a timely manner to Akcea supporting data that Novartis determines to be reasonably related to such safety information provided by Novartis under this Section 6.8(a) and answer in a timely manner any follow-up questions reasonably requested by Akcea or its Affiliates to the extent such data and answers are reasonably available to Novartis. All such information disclosed by Novartis to Akcea will be Novartis Confidential Information and Novartis acknowledges and agrees that Akcea will provide all such information to Ionis to enable Ionis to populate the Ionis Internal ASO Safety Database. In addition, so long as Akcea does not disclose the identity of a Product or Novartis’ identity, Akcea may disclose any such Novartis Confidential Information to (i) Akcea’s other partners pursuant to Section 6.8(c) below if such information is regarding class generic properties of ASOs, (ii) any Third Party (other than a Regulatory Authority) that contributes to the populating of the Ionis Internal ASO Safety Database, or (iii) a Regulatory Authority. Novartis will deliver all such information to Akcea for the Ionis Internal ASO Safety Database to Akcea Therapeutics, Inc., 00 Xxxxxxxxx Xxxxxxx, Xxxxxxxxx, XX 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Akcea). Novartis will also cause its Affiliates and Sublicensees to comply with this Section 6.8(b).
Safety Database. Within forty-five (45) days following the Effective Date, AMGEN and AKERO shall initiate the transfer to AKERO of the global safety database for the Product (the “Safety Database”). AMGEN and AKERO shall jointly work to complete the transfer of such Safety Database within ninety (90) days of the Effective Date. Prior to the completion of the transfer of the Safety Database, AKERO and AMGEN shall reasonably cooperate and use diligent efforts to ensure compliance with safety reporting requirements related to the Product and AMGEN shall provide safety information to AKERO as AKERO might reasonably request or otherwise as necessary to satisfy AKERO’ regulatory or other legal obligations. Following the completion of the transfer of the Safety Database, AKERO shall assume ownership and control of the global Safety Database.
Safety Database. Each Party shall maintain a validated safety database for reporting and safety surveillance activities for the Subject Product in accordance with applicable regulations. Strakan shall maintain a validated global safety database for reporting and safety surveillance activities for the Subject Product worldwide in accordance with applicable regulations.
Safety Database. The Parties shall, within sixty (60) days after the Effective Date, agree upon procedures by which each Party shall report safety data. The Parties acknowledge and agree that a worldwide safety database will be held and maintained by Solvay and that Depomed will transfer Product safety data Controlled by Depomed as of the Effective Date to Solvay for inclusion in such database as described in the Pharmacovigilance Agreement.
Safety Database. Isis maintains a database that includes information regarding the safety and tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Database”).
5.3.1 To the extent OncoGenex and its Affiliates have collected data and information specifically regarding Products, and subject to Applicable Law, including, without limitation, all applicable privacy laws, rules and regulations (such as the Health Insurance Portability Accountability Act), any applicable informed consents, and any obligations or restrictions imposed by Third Party clinical sites relating to dissemination or use of such data and information, in an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, OncoGenex will provide Isis with the following: (a) copies of [***] and [***] summary reports, and [***] final reports, in each case specifically regarding Products, and (b) in connection with any reported [***] (including any follow-up or amended reports) specifically regarding a Product, the following [***] regarding the applicable Product: (i) [***]; (ii) [***] usage; (iii) particulars of [***]; (iv) [***] history [***]; and (v) [***]. All such data and information disclosed by OncoGenex to Isis in connection with this Section 5.3, together with any data and information related to the [***] of each Product and any [***], will be OncoGenex’ Confidential Information. Isis shall use such Confidential Information solely for the purpose of populating the Isis Database, and for no other purpose. Isis shall not disclose any such Confidential Information to any Third Party; provided, however, that Isis may conduct analyses to keep Isis and its partners informed regarding class generic safety and pharmacokinetic properties of ASOs so long as Isis does not disclose to such Third Parties the identity of the applicable Product, Clusterin as the target, OncoGenex or its Affiliates (or any information that would foreseeably reveal the identity of the applicable Product, Clusterin as the gene target, OncoGenex or its Affiliates) or any patient identifying information.
5.3.2 To the extent that [***] OncoGenex under this Agreement collects safety and tolerability data or information specifically regarding a Product, OncoGenex shall use commercially reasonable efforts to obtain from such sublicensee (a) the right to provide to Isis (whether through OncoGenex or its Affiliate, o...
