Common use of Ionis’ Antisense Safety Database Clause in Contracts

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical and clinical development (the “Ionis Internal ASO Safety Database”). To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis and in the form in which Praxis uses/stores such information for its own purposes, Praxis will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly following the date such information is available to Praxis (but not later than [***] after Praxis’ receipt of such information). For any reported serious adverse event, Praxis will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended and final reports. In addition, with respect to Products, Praxis 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 or is available to Praxis, as applicable. Furthermore, Praxis will promptly provide Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis to Ionis will be Praxis Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Confidential Information to (a) Ionis’ other partners if such information is regarding class generic properties of ASOs, or (b) any Third Party. Praxis will deliver all such information to Ionis for the Ionis Internal ASO 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 Ionis). Praxis will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a).

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical preclinical and clinical development (the “Ionis Internal ASO Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis Biogen will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis Biogen and in the form in which Praxis Biogen uses/stores such information for its own purposes, Praxis Biogen will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly as soon as practicable following the date such information is available to Praxis Biogen (but not later than [***] after Praxis’ Biogen’s receipt of such information). For In connection with any reported serious adverse event, Praxis Biogen will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended amended, and final reports. In addition, with respect to Products, Praxis Biogen will provide Ionis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] following the date such information is filed or is available to PraxisBiogen, as applicable. Furthermore, Praxis Biogen will promptly provide Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis Biogen to Ionis will be Praxis Biogen Confidential Information; provided, however, that Ionis may disclose any such Biogen Confidential Information to (i) Ionis’ other partners pursuant to Section 5.3.2(b) below if such information is regarding class generic properties of ASOs, or (ii) any Third Party, in each case, so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Confidential Information to (a) Ionis’ other partners if such information is regarding class generic properties of ASOs, or (b) any Third PartyBiogen. Praxis Biogen will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Ionis). Praxis Biogen will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a5.3.2(a).

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical preclinical and clinical development (the “Ionis Internal ASO Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis Biogen will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis Biogen and in the form in which Praxis Biogen uses/stores such information for its own purposes, Praxis Biogen will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly as soon as practicable following the date such information is available to Praxis Biogen (but not later than [***] days after Praxis’ Biogen’s receipt of such information). For In connection with any reported serious adverse event, Praxis Biogen will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended amended, and final reports. In addition, with respect to Products, Praxis Biogen will provide Ionis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] days following the date such information is filed or is available to PraxisBiogen, as applicable. Furthermore, Praxis Biogen will promptly provide Ionis with any reasonable additional supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis Biogen to Ionis will be Praxis Biogen Confidential Information; provided, however, that Ionis may disclose any such Biogen Confidential Information to (i) Ionis’ other partners in accordance with Section 5.4.2(b) below if such information is regarding class generic properties of ASOs or (ii) any Third Party, in each case, so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Confidential Information to (a) Ionis’ other partners if such information is regarding class generic properties of ASOs, or (b) any Third PartyBiogen. Praxis Biogen will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Ionis). Praxis Biogen will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a5.4.2(a).

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical non-clinical and clinical development and commercialization (the “Ionis Internal ASO Safety Database”). The Ionis Internal ASO Safety Database is an internal database owned and maintained by Ionis to maximize Ionis’ and its partners’ understanding of Ionis’ compounds, and it is separate from, and not a substitute for, the global safety database for which Roche will be responsible under Section 8.2.1 above. To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis after Option exercise, Roche will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis Roche and in the form in which Praxis Roche uses/stores such information for its own purposes, Praxis Roche will provide make available to Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly as soon as practicable following the date such information is available to Praxis Roche (but not Roche will make such information available to Ionis starting no later than [***] thirty (30) days after Praxis’ Roche’s receipt of such information). For In connection with any reported serious adverse eventevent for a Product, Praxis Roche will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended amended, and final reports. In addition, with respect to Products, Praxis Roche will provide make available to Ionis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] thirty (30) days following the date such information is filed or is available to PraxisRoche, as applicable. Furthermore, Praxis Roche will promptly provide make available to Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis Roche to Ionis will be Praxis Roche Confidential Information; provided, however, that Ionis may disclose any such Roche Confidential Information to (i) Ionis’ other partners pursuant to Section 8.2.2(b) below if such information is regarding class generic properties of ASOs, or (ii) any Third Party, in each case, so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Confidential Information to (a) Roche. Roche will contact Ionis’ other partners if such information is regarding class generic properties of ASOsChief Medical Officer at Ionis Pharmaceuticals, or (b) any Third Party. Praxis will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer 00000 (or to at such other address/contact designated in writing by Ionis)) for matters related to the Ionis Internal ASO Safety Database. Praxis Roche will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a8.2.2(a).

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical pre-clinical and clinical development (the “Ionis Internal ASO Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis after the License Effective Date with respect to a Collaboration Program, Biogen will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis Biogen and in the form in which Praxis Biogen uses/stores such information for its own purposes, Praxis Biogen will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly as soon as practicable following the date such information is available to Praxis Biogen (but not later than [***] days after Praxis’ Biogen’s receipt of such information). For In connection with any reported serious adverse event, Praxis Biogen will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended amended, and final reports. In addition, with respect to Products, Praxis Biogen will provide Ionis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] days following the date such information is filed or is available to PraxisBiogen, as applicable. Furthermore, Praxis Biogen will promptly provide Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis Biogen to Ionis will be Praxis Biogen Confidential Information; provided, however, that Ionis may disclose any such Biogen Confidential Information to (i) Ionis’ other partners pursuant to Section 5.2.2(b) below if such information is regarding class generic properties of ASOs, or (ii) any Third Party, in each case, so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Confidential Information to (a) Ionis’ other partners if such information is regarding class generic properties of ASOs, or (b) any Third PartyBiogen. Praxis Biogen will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Ionis). Praxis Biogen will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a5.2.2(a).

Ionis’ Antisense Safety Database. (a) Ionis 2.11.1Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical non-clinical and clinical development (the “Ionis Internal ASO Safety Database”). To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis ProQR will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis and in the form in which Praxis uses/stores such information for its own purposes, Praxis will ProQR shall provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other copies of all clinical safety information related to Products licensed by Praxis under this Agreement reasonably Ionis that ProQR is required to report to the FDA upon or promptly following submission to the date such information is available to Praxis (but not later than [***] after Praxis’ receipt of such information)FDA. For In connection with any reported serious adverse eventevent related or potentially related to a Licensed Product, Praxis ProQR will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended and final reports. In addition, with respect to Licensed Products, Praxis ProQR will provide Ionis with copies of Annual annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] following the date such information is filed or is available to PraxisProQR, as applicable. Furthermore, Praxis ProQR will promptly provide Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis ProQR to Ionis will be Praxis ProQR Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Licensed Product or Praxis’ ProQR’s identity, Ionis may disclose any such Praxis ProQR Confidential Information to (ai) Ionis’ other partners pursuant to Section 2.11.2 below if such information is regarding class generic properties of ASOsantisense oligonucleotides, or (bii) any Third Party. Praxis ProQR will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Ionis). Praxis ProQR will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a)2.11.1.

Ionis’ Antisense Safety Database. (a) Ionis maintains an internal database that includes information regarding the tolerability of its ASO drug compounds, individually and as a class, including information discovered during nonclinical pre-clinical and clinical development (the “Ionis Internal ASO Safety Database”). To In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, Praxis Biogen will cooperate in connection with populating the Ionis CONFIDENTIAL Internal ASO Safety Database. To the extent collected by Praxis Biogen and in the form in which Praxis Biogen uses/stores such information for its own purposes, Praxis Biogen will provide Ionis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by Praxis under this Agreement reasonably promptly Collaboration Product as soon as practicable following the date such information is available to Praxis Biogen (but not later than [***] days after Praxis’ Biogen’s receipt of such information). For In connection with any reported serious adverse event, Praxis Biogen will provide Ionis all serious adverse event reports, including initial, interim, follow-up, amended amended, and final reports. In addition, with respect to ProductsCollaboration Product, Praxis Biogen will provide Ionis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Trial Study reports within [***] days following the date such information is filed or is available to PraxisBiogen, as applicable. Furthermore, Praxis Biogen will promptly provide Ionis with any supporting data and answer any follow-up questions reasonably requested by Ionis. All such information disclosed by Praxis Biogen to Ionis will be Praxis Biogen Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Product or Praxis’ identity, Ionis may disclose any such Praxis Biogen Confidential Information to (ai) Ionis’ other partners pursuant to Section 5.2.7(b) below if such information is regarding class generic properties of ASOs, or (bii) any Third Party, in each case, so long as Ionis does not disclose the identity of a Collaboration Product or Biogen. Praxis Biogen will deliver all such information to Ionis for the Ionis Internal ASO Safety Database to Ionis at Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Ionis). Praxis Biogen will also cause its Affiliates and use reasonable efforts to cause its Sublicensees to comply with this Section 8.4.7(a5.2.7(a). (b) From time to time, Ionis utilizes the information in the Ionis Internal ASO Safety Database to conduct analyses to keep Ionis and its partners informed regarding class generic properties of ASOs, including with respect to safety. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Collaboration Product (including any potential class-related toxicity), Ionis will promptly (and in no event later than five Business Days following identification by Ionis) inform Biogen of such issues and, if requested, provide the data supporting Ionis’ conclusions.