Common use of Isis’ Antisense Safety Database Clause in Contracts

Isis’ Antisense Safety Database. (a) Isis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, after Biogen Idec exercises its Option, Biogen Idec will cooperate in connection with populating the Isis Internal ASO Safety Database. To the extent collected by Biogen Idec and in the form in which Biogen Idec uses/stores such information for its own purposes, Biogen Idec will provide Isis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products as soon as practicable following the date such information is available to Biogen Idec (but not later than 30 days after Biogen Idec’s receipt of such information). In connection with any reported serious adverse event, Biogen Idec will provide Isis all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to Products, Biogen Idec will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 days following the date such information is filed or is available to Biogen Idec, as applicable. Furthermore, Biogen Idec will promptly provide Isis with any supporting data and answer any follow-up questions reasonably requested by Isis. All such information disclosed by Biogen Idec to Isis will be Biogen Idec Confidential Information; provided, however, that Isis may disclose any such Biogen Idec Confidential Information to (i) Isis’ 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 Isis does not disclose the identity of a Product or Biogen Idec. Biogen Idec will deliver all such information to Isis for the Isis Internal ASO Safety Database to Isis Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Isis). Biogen Idec will also cause its Affiliates and Sublicensees to comply with this Section 5.2.2(a).

Appears in 2 contracts

Samples: Option and License Agreement (Isis Pharmaceuticals Inc), Development, Option and License Agreement (Isis Pharmaceuticals Inc)

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Isis’ Antisense Safety Database. (a) Isis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, after Biogen Idec exercises its OptionOption exercise, Biogen Idec Roche will cooperate in connection with populating the Isis Internal ASO Safety Database. To the extent collected by Biogen Idec Roche and in the form in which Biogen Idec Roche uses/stores such information for its own purposes, Biogen Idec Roche will provide make available to Isis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products as soon as practicable following the date such information is available to Biogen Idec Roche (but not Roche will make such information available to Isis starting no later than 30 thirty (30) days after Biogen IdecRoche’s receipt of such information). In connection with any reported serious adverse event, Biogen Idec Roche will provide Isis all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to Products, Biogen Idec Roche will provide make available to Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 thirty (30) days following the date such information is filed or is available to Biogen IdecRoche, as applicable. Furthermore, Biogen Idec Roche will promptly provide make available to Isis with any supporting data and answer any follow-up questions reasonably requested by Isis. All such information disclosed by Biogen Idec Roche to Isis will be Biogen Idec Roche Confidential Information; provided, however, that Isis may disclose any such Biogen Idec Roche Confidential Information to (i) Isis’ 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 Isis does not disclose the identity of a Product or Biogen IdecRoche. Biogen Idec Roche will deliver all such information to Isis for the Isis Internal ASO Safety Database to contact Isis’ Chief Medical Officer at Isis Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer 00000 (or to at such other address/contact designated in writing by Isis)) for matters related to the Isis Internal ASO Safety Database. Biogen Idec Roche will also cause its Affiliates and Sublicensees to comply with this Section 5.2.2(a).

Appears in 1 contract

Samples: License Agreement (Isis Pharmaceuticals Inc)

Isis’ Antisense Safety Database. (a) 7.2.1. Isis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, after Biogen Idec exercises its Option, Biogen Idec AstraZeneca will cooperate in connection with populating the Isis Internal ASO Safety Database. To the extent collected by Biogen Idec AstraZeneca and in the form in which Biogen Idec AstraZeneca uses/stores such information for its own purposes, Biogen Idec AstraZeneca will provide Isis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products licensed by AstraZeneca under this Agreement as soon as practicable following the date such information is available to Biogen Idec AstraZeneca (but not later than 30 days after Biogen IdecAstraZeneca’s receipt of such information). In connection with any reported serious adverse event, Biogen Idec AstraZeneca will provide Isis all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to Products, Biogen Idec AstraZeneca will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 days following the date such information is filed or is available to Biogen IdecAstraZeneca, as applicable. Furthermore, Biogen Idec AstraZeneca will promptly provide Isis with any supporting data and answer any follow-up questions reasonably requested by Isis. All such information disclosed by Biogen Idec AstraZeneca to Isis will be Biogen Idec AstraZeneca Confidential Information; provided, however, that so long as Isis does not disclose the identity of a Product or AstraZeneca’s identity, Isis may disclose any such Biogen Idec AstraZeneca Confidential Information to (i) Isis’ other partners pursuant to Section 5.2.2(b) 7.2.2 below if such information is regarding class generic properties of ASOs, or (ii) any Third Party, in each case, so long as Isis does not disclose the identity of a Product or Biogen Idec. Biogen Idec AstraZeneca will deliver all such information to Isis for the Isis Internal ASO Safety Database to Isis Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Isis). Biogen Idec AstraZeneca will also cause its Affiliates and Sublicensees to comply with this Section 5.2.2(a)7.2.1.

Appears in 1 contract

Samples: Collaboration, License and Development Agreement (Isis Pharmaceuticals Inc)

Isis’ Antisense Safety Database. (a) Isis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, after Biogen Idec exercises its Option, Biogen Idec will cooperate in connection with populating the Isis Internal ASO Safety Database. To the extent collected by Biogen Idec and in the form in which Biogen Idec uses/stores such information for its own purposes, Biogen Idec will provide Isis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products Collaboration Product as soon as practicable following the date such information is available to Biogen Idec (but not later than 30 [***] days after Biogen Idec’s receipt of such information). In connection with any reported serious adverse event, Biogen Idec will provide Isis all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to ProductsCollaboration Product, Biogen Idec will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 [***] days following the date such information is filed or is available to Biogen Idec, as applicable. Furthermore, Biogen Idec will promptly provide Isis with any supporting data and answer any follow-up questions reasonably requested by Isis. All such information disclosed by Biogen Idec to Isis will be Biogen Idec Confidential Information; provided, however, that Isis may disclose any such Biogen Idec Confidential Information to (i) Isis’ other partners pursuant to Section 5.2.2(b5.2.7(b) below if such information is regarding class generic properties of ASOs, or (ii) any Third Party, in each case, so long as Isis does not disclose the identity of a Collaboration Product or Biogen Idec. Biogen Idec will deliver all such information to Isis for the Isis Internal ASO Safety Database to Isis Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Isis). Biogen Idec will also cause its Affiliates and Sublicensees to comply with this Section 5.2.2(a5.2.7(a).

Appears in 1 contract

Samples: License Agreement (Isis Pharmaceuticals Inc)

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Isis’ Antisense Safety Database. (a) Isis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Isis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Isis compounds, after Biogen Idec exercises its an Option, Biogen Idec will cooperate in connection with populating the Isis Internal ASO Safety Database. To the extent collected by Biogen Idec and in the form in which Biogen Idec uses/stores such information for its own purposes, Biogen Idec will provide Isis with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to Products as soon as practicable following the date such information is available to Biogen Idec (but not later than 30 days after Biogen Idec’s receipt of such information). In connection with any reported serious adverse event, Biogen Idec will provide Isis all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to Products, Biogen Idec will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 days following the date such information is filed or is available to Biogen Idec, as applicable. Furthermore, Biogen Idec will promptly provide Isis with any supporting data and answer any follow-up questions reasonably requested by Isis. All such information disclosed by Biogen Idec to Isis will be Biogen Idec Confidential Information; provided, however, that Isis may disclose any such Biogen Idec Confidential Information to (i) Isis’ 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 Isis does not disclose the identity of a Product or Biogen Idec. Biogen Idec will deliver all such information to Isis for the Isis Internal ASO Safety Database to Isis Pharmaceuticals, Inc., 0000 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Isis). Biogen Idec will also cause its Affiliates and Sublicensees to comply with this Section 5.2.2(a).

Appears in 1 contract

Samples: License Agreement (Isis Pharmaceuticals Inc)

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