Ionis Internal Oligonucleotide Safety Database. 16 5.12.1 Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during non-clinical and clinical Development (the “Ionis Internal Oligonucleotide Safety Database”). To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, (a) Ionis will have the right to use any safety-related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) to maintain the Ionis Internal Oligonucleotide Safety Database and (b) Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests in connection with populating the Ionis Internal Oligonucleotide Safety Database, including by providing Ionis with reasonably requested safety-related supporting data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in connection with any information provided under the Pharmacovigilance Agreement, in each case to the extent such data and answers are reasonably available to Otsuka. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plan (if any), Otsuka will provide Ionis with copies of annual safety updates filed with each IND and the safety sections of any final Clinical Trial reports within [***] following the date such information is filed, as applicable. All such information disclosed by Otsuka to Ionis will be Otsuka Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identity, Ionis may disclose any such Otsuka Confidential Information to (i) Ionis’ other partners if such information is regarding class generic properties of oligonucleotides, (ii) any Third Party that contributes to the populating of the Ionis Internal Oligonucleotide Safety Database, or (iii) any Regulatory Authority. Otsuka will also cause its Affiliates and Sublicensees to comply with this Section 5.12 (Ionis Internal Oligonucleotide Safety Database).
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Ionis Internal Oligonucleotide Safety Database. 16 5.12.1 Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during non-clinical and clinical Development (the “Ionis Internal Oligonucleotide Safety Database”). To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, (a) Ionis will have the right to use any safety-related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) to maintain the Ionis Internal Oligonucleotide Safety Database and (b) Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests in connection with populating the Ionis Internal Oligonucleotide Safety Database, including by providing Ionis with reasonably requested safety-related supporting data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in connection with any information provided under the Pharmacovigilance Agreement, in each case to the extent such data and answers are reasonably available to Otsuka. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plan (if any)Plans, Otsuka will provide Ionis with copies of annual safety updates filed with each IND and the safety sections of any final Clinical Trial reports within [***] following the date such information is filed, as applicable. All such information disclosed by Otsuka to Ionis will be Otsuka Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identity, Ionis may disclose any such Otsuka Confidential Information to (i) Ionis’ other partners if such information is regarding class generic properties of oligonucleotides, (ii) any Third Party that contributes to the populating of the Ionis Internal Oligonucleotide Safety Database, or (iii) any Regulatory Authority. Otsuka will also cause its Affiliates and Sublicensees to comply with this Section 5.12 (Ionis Internal Oligonucleotide Safety Database).
5.12.2 From time to time, Xxxxx utilizes the information in the Ionis Internal Oligonucleotide Safety Database to conduct analyses to keep Ionis and its partners informed regarding class generic properties of oligonucleotides, including with respect to safety. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Licensed Product (including any potential class-related toxicity), Ionis will promptly inform Otsuka of such issues and provide the data supporting Ionis’ conclusions.
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Ionis Internal Oligonucleotide Safety Database. 16 5.12.1 3.9.1 Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during nonpre-clinical and clinical Development development (the “Ionis Internal Oligonucleotide Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis Ionis’ compounds, (a) Ionis Akcea will have the right to use any safety-related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) to maintain the Ionis Internal Oligonucleotide Safety Database and (b) Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests reasonably cooperate in connection with populating the Ionis Internal Oligonucleotide Safety Database. To the extent collected by Akcea and in the form in which Akcea uses/stores such information for its own purposes, including by providing Akcea will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events, and other safety information related to a Product reasonably requested safety-related supporting data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in promptly following the date such information is available to Akcea (but not later than 90 days after Akcea’s receipt of such information). In connection with any information provided under the Pharmacovigilance Agreementreported serious adverse event, in each case to the extent such data Akcea will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended, and answers are reasonably available to Otsukafinal reports. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plan (if any)a Product, Otsuka Akcea will provide Ionis with copies of annual safety updates filed with each IND and the safety sections of any final Clinical Trial reports within [***] 90 days following the date on which such information is filedfiled or is available to Akcea, as applicable. Furthermore, Akcea will promptly provide Ionis with reasonable supporting data and answers to follow-up questions requested by Ionis. All such information disclosed by Otsuka Akcea to Ionis will be Otsuka Akcea Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identity, Ionis may disclose any such Otsuka Akcea Confidential Information to (ia) Ionis’ other partners if such information is regarding class generic properties of oligonucleotidesoligonucleotides pursuant to Section 3.5.6, or (iib) any other Third Party that contributes Party, in each case, so long as Ionis does not disclose the identity of a Product or Akcea or any information from which the identity of a Product or Akcea can be derived. Akcea will deliver all such information to the populating of Ionis for the Ionis Internal Oligonucleotide Safety DatabaseDatabase to: Ionis Pharmaceuticals, Inc. 0000 Xxxxxxx Xxxxx Xxxxxxxx, Xxxxxxxxxx 00000 Attention: Head of Drug Safety Monitoring (or (iii) any Regulatory Authorityto such other address/contact designated in writing by Ionis). Otsuka Akcea will also cause require its Affiliates and Sublicensees to comply with this Section 5.12 (3.9.
3.9.2 From time to time, Ionis utilizes the information in the Ionis Internal Oligonucleotide Safety DatabaseDatabase to conduct analyses to keep Ionis and its partners informed regarding class generic properties of oligonucleotides, including with respect to safety, without compromising the confidential information of the contributing partners. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Product (including any potential class-related toxicity), Ionis will promptly inform Akcea of such issues and, if requested, provide the data supporting Ionis’ conclusions.
3.9.3 During the Agreement Term, Akcea may submit written requests to Ionis for Ionis to run queries of the Ionis Internal Oligonucleotide Safety Database relevant to one or more Products, and Ionis will use Commercially Reasonable Efforts to promptly run such queries and deliver to Akcea the results of such queries. Any information disclosed between the Parties under this Section 3.9.3 will be treated as Confidential Information in accordance with ARTICLE 8.
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Ionis Internal Oligonucleotide Safety Database. 16 5.12.1 3.9.1 Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during nonpre-clinical and clinical Development development (the “Ionis Internal Oligonucleotide Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis Ionis’ compounds, (a) Ionis Akcea will have the right to use any safety-related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) to maintain the Ionis Internal Oligonucleotide Safety Database and (b) Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests reasonably cooperate in connection with populating the Ionis Internal Oligonucleotide Safety Database. To the extent collected by Akcea and in the form in which Akcea uses/stores such information for its own purposes, including by providing Akcea will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events, and other safety information related to a Product reasonably requested safety-related supporting data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in promptly following the date such information is available to Akcea (but not later than 90 days after Akcea’s receipt of such information). In connection with any information provided under the Pharmacovigilance Agreementreported serious adverse event, in each case to the extent such data Akcea will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended, and answers are reasonably available to Otsukafinal reports. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plan (if any)a Product, Otsuka Akcea will provide Ionis with copies of annual safety updates filed with each IND and the safety sections of any final Clinical Trial reports within [***] 90 days following the date on which such information is filedfiled or is available to Akcea, as applicable. Furthermore, Akcea will promptly provide Ionis with reasonable supporting data and answers to follow-up questions requested by Ionis. All such information disclosed by Otsuka Akcea to Ionis will be Otsuka Akcea Confidential Information; provided, ,however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identity, Ionis may disclose any such Otsuka Akcea Confidential Information to (ia) Ionis’ other partners if such information is regarding class generic properties of oligonucleotidesoligonucleotides pursuant to Section 3.5.6, or (iib) any other Third Party that contributes Party, in each case, so long as Ionis does not disclose the identity of a Product or Akcea or any information from which the identity of a Product or Akcea can be derived. Akcea will deliver all such information to the populating of Ionis for the Ionis Internal Oligonucleotide Safety DatabaseDatabase to: Ionis Pharmaceuticals, Inc. 2000 Xxxxxxx Xxxxx Xxxxxxxx, Xxxxxxxxxx 00000 Attention: Head of Drug Safety Monitoring (or (iii) any Regulatory Authorityto such other address/contact designated in writing by Ionis). Otsuka Akcea will also cause require its Affiliates and Sublicensees to comply with this Section 5.12 (3.9.
3.9.2 From time to time, Ionis utilizes the information in the Ionis Internal Oligonucleotide Safety DatabaseDatabase to conduct analyses to keep Ionis and its partners informed regarding class generic properties of oligonucleotides, including with respect to safety, without compromising the confidential information of the contributing partners. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Product (including any potential class-related toxicity), Ionis will promptly inform Akcea of such issues and, if requested, provide the data supporting Ionis’ conclusions.
3.9.3 During the Agreement Term, Akcea may submit written requests to Ionis for Ionis to run queries of the Ionis Internal Oligonucleotide Safety Database relevant to one or more Products, and Ionis will use Commercially Reasonable Efforts to promptly run such queries and deliver to Akcea the results of such queries. Any information disclosed between the Parties under this Section 3.9.3 will be treated as Confidential Information in accordance with ARTICLE 8.
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Ionis Internal Oligonucleotide Safety Database. 16 5.12.1 (a) Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during non-clinical and clinical Development development (the “Ionis Internal Oligonucleotide Safety Database”). To maximize understanding of the extent identified and collected by Novartis or its Affiliates, Novartis will [***] promptly provide Ionis with all material information concerning toxicology, pharmacokinetics, safety profile pharmacology study(ies) and pharmacokinetics of Ionis compounds, (a) Ionis will have the right to use any safety-adverse events directly related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) Licensed Products. Novartis may elect to maintain provide such information in the Ionis Internal Oligonucleotide Safety Database and (b) Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests form in connection with populating the Ionis Internal Oligonucleotide Safety Database, including by providing Ionis with reasonably requested safety-related supporting data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in connection with any which Novartis maintains such information provided under the Pharmacovigilance Agreement, in each case to the extent such data and answers are reasonably available to Otsukafor internal purposes. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plan (if any)Products, Otsuka Novartis will provide Ionis with copies of annual Annual safety updates filed with each IND (e.g., DSURs or IND annual reports) and the safety sections of any final Clinical Trial Study reports within [***] following the date such information is filedsubmitted to the applicable Regulatory Authority, as applicable. All Furthermore, Novartis will answer in a timely manner any follow-up questions reasonably requested by Ionis or its Affiliates to the extent such information disclosed by Otsuka data and answers are reasonably available to Ionis will be Otsuka Confidential Information; providedNovartis. In addition, however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identitythe identity of Novartis, its Affiliates or its Sublicensees, Ionis may disclose any such Otsuka Confidential Information information to (i) Ionis’ other partners pursuant to Section 6.6.2(b) (Ionis Internal Oligonucleotide Safety Database) below if such information is regarding class generic properties of oligonucleotidesOligonucleotides, (ii) any other Third Party (other than a Regulatory Authority) that contributes to the populating of the Ionis Internal Oligonucleotide Safety Database, or (iii) any a Regulatory Authority. Otsuka Novartis will also deliver all such information to Ionis for the Ionis Internal Oligonucleotide Safety Database to Ionis at 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Xxxxx). Novartis will [***] cause its Affiliates and Sublicensees to comply with this Section 5.12 6.6.2 (Ionis Internal Oligonucleotide Safety Database). At either Party’s request, the Alliance Managers will use good faith efforts to establish mutually acceptable specific time periods for the provision of information under this Section 6.6.2 (Ionis Internal Oligonucleotide Safety Database).
(b) From time to time, Xxxxx utilizes the information in the Ionis Internal Oligonucleotide Safety Database to conduct analyses to keep Ionis and its partners informed regarding class generic properties of Oligonucleotides, including with respect to safety. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Licensed Product (including any potential class-related toxicity), Ionis will inform Novartis in a timely manner of such issues and, if requested, allow Novartis to review such issues and conclusions and allow Novartis the opportunity to review and align on safety statement and health authority submissions in a timely manner before release.
(c) During the Agreement Term, Novartis may submit written requests to Ionis for Ionis to have queries run of the Ionis Internal Oligonucleotide Safety Database relevant to the Licensed Products, and Ionis will [***] promptly cause such queries to be run and deliver to Novartis the results of such queries. Any information disclosed by a Party to the other Party under this Section 6.6.2 (Ionis Internal Oligonucleotide Safety Database) will be treated as Confidential Information of such Party in accordance with Article 12 (Confidentiality).
(d) To the extent any information required to be disclosed by Novartis to Ionis under this Section 6.6.2 (Ionis Internal Oligonucleotide Safety Database) is disclosed pursuant to a pharmacovigilance agreement entered into pursuant to Section 6.6.1 (Pharmacovigilance Agreement), such disclosure shall be deemed to satisfy the corresponding obligation under this Section 6.6.2 (Ionis Internal Oligonucleotide Safety Database).
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Samples: Collaboration and License Agreement (Ionis Pharmaceuticals Inc)