Termination of Committees and Information Sharing. If Isis materially breaches this Agreement and fails to cure such breach within the time periods provided under Section 11.2.2 (Termination for Material Breach) and Genzyme does not wish to terminate this Agreement in its entirety, then, in addition to any other remedies Genzyme may have under this Agreement or otherwise, Genzyme will have the right to do any or all of the following in Genzyme’s discretion: (a) terminate Isis’ right to participate in the JDC and JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; (b) terminate the participation of Isis in any ongoing research and development programs and Genzyme’s funding obligations associated therewith, (c) make all decisions required to be made by such committees or the Parties collectively under this Agreement in connection with the development and commercialization of the Product, (d) exclude Isis from all discussions with Regulatory Authorities regarding Isis Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely to the development or supply of the Product; (f) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate Genzyme’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) and Section 6.4 (Isis Safety Database)), other than reports required by Section 8.6 (Periodic Reporting and Reconciliation) and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if Isis has not completed the development activities that are its responsibility under this Agreement, then Genzyme may, but will not be obligated to, assume all responsibility for all such development activities that would have otherwise been Isis’ responsibility under the Agreement. Isis will cooperate with the foregoing and provide to Genzyme and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme in assuming complete responsibility for the development and manufacture of the Product in an efficient and orderly manner.
Appears in 2 contracts
Samples: License and Co Development Agreement (Isis Pharmaceuticals Inc), License and Co Development Agreement (Genzyme Corp)
Termination of Committees and Information Sharing. If Isis materially breaches this Agreement and fails to cure such breach within In the time periods provided under Section 11.2.2 (Termination for Material Breach) and Genzyme does not wish to terminate this Agreement in its entirety, then, in addition to any other remedies Genzyme may have under this Agreement or otherwiseevent of a Change of Control of Isis, Genzyme will have the right right, exercisable by written notice to Isis or its successor in interest within ninety (90) days of the public announcement of the completion of such Change of Control, to do any or all of the following in Genzyme’s discretion: (a) terminate Isis’ right to participate in the JDC and JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; (b) terminate the participation of the successor to Isis in any ongoing research and development programs and Genzyme’s funding obligations associated therewith, (c) make all decisions required to be made by such committees or the Parties collectively under this Agreement in connection with the development and commercialization of the Product, (d) exclude Isis or its successor from all discussions with Regulatory Authorities regarding Isis Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely to the development or supply of the Product; (f) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate Genzyme’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) and Section 6.4 (Isis Safety Database)), other than reports required by Section 8.6 (Periodic Reporting and Reconciliation) and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if Isis has not completed the development activities that are its responsibility under this Agreement, then Genzyme may, but will not be obligated to, assume all responsibility for all such development activities and setoff against amounts payable by Genzyme to Isis under this Agreement any expense incurred by Genzyme in connection with such development activities that would have otherwise been Isis’ responsibility under the AgreementAgreement had the Change of Control not occurred. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Isis or its successor will cooperate with the foregoing and provide to Genzyme and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme in assuming complete responsibility for the development and manufacture of the Product in an efficient and orderly manner. For purposes of clarification, all Confidential Information of Genzyme in Isis’ or its successor’s possession following Genzyme’s exercise of its rights under this Section 14.1 (Change of Control of Isis) will continue to be subject to all applicable provisions of this Agreement (including, without limitation, Article 12 (Confidentiality).
Appears in 2 contracts
Samples: License and Co Development Agreement (Genzyme Corp), License and Co Development Agreement (Isis Pharmaceuticals Inc)
Termination of Committees and Information Sharing. If If, after Option exercise, Isis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen Idec does not wish to terminate this Agreement in its entiretyentirety (an “Isis Breach Event”), then, in addition to any other remedies Genzyme Biogen Idec may have under this Agreement or otherwise, Genzyme Biogen Idec will have the right to do any or all of the following in GenzymeBiogen Idec’s discretion: :
(ai) terminate Terminate Isis’ right to participate in the JDC and JDC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Isis’ participation of Isis in any ongoing research and development programs under this Agreement and GenzymeBiogen Idec’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the Product; provided, however, that Biogen Idec will not have the right to create any obligations or incur any liabilities for or on behalf of Isis;
(div) exclude Exclude Isis from all discussions with Regulatory Authorities regarding Isis Products, (e) require Isis except to assign to Genzyme all of the extent Isis’ right, title and interests in any IND participation is required by a Regulatory Authority or other Regulatory Materials then held by Isis pertaining is otherwise reasonably necessary to Products and any agreements comply with Third Parties related solely to the development or supply of the Product; Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen Idec’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (Agreement, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.5 and Section 6.4 (Isis Safety Database))5.2.2, other than reports required by Section 8.6 6.9.1, Section 10.4.3 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if ; and
(vi) If Isis has not completed the development Development activities that are its responsibility under this Agreementthe ISIS-SMNRX Development Plan, then Genzyme Biogen Idec may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been Isis’ responsibility under the this Agreement. Isis will cooperate with the foregoing and provide to Genzyme Biogen Idec and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen Idec in assuming complete responsibility for the development Development and manufacture Manufacture of the Product Products in an efficient and orderly manner.
Appears in 1 contract
Samples: Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Termination of Committees and Information Sharing. If Isis If, after Option exercise, Ionis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach10.2.4(a) or Section 10.2.5(a), and Genzyme Biogen does not wish to terminate this Agreement in its entiretyentirety (an “Ionis Breach Event”), then, in addition to any other remedies Genzyme Biogen may have under this Agreement or otherwise, Genzyme Biogen will have the right to do any or all of the following in GenzymeBiogen’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Ionis Breach Event:
(ai) terminate IsisIonis’ right to participate in the JDC and JPC and any other subcommittees or working groups established pursuant to this AgreementJPC, each of which will be disbanded; disbanded (bexcept to the extent it is performing activities under an Ionis/Biogen Additional Agreement);
(ii) terminate the Ionis’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen’s funding obligations associated therewith, ;
(ciii) solely make all decisions required or permitted to be made by such committees the JPC or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Product; provided, however, that Biogen will not have the right to create any obligations or incur any liabilities for or on behalf of Ionis;
(div) exclude Isis Ionis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely except to the development extent Ionis’ participation is required by a Regulatory Authority or supply of the Product; is otherwise reasonably necessary to comply with Applicable Law;
(f) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (gv) terminate GenzymeBiogen’s obligation to make further disclosures of Know-How or other information to Isis Ionis pursuant to this Agreement (related to the applicable Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.9 and Section 6.4 (Isis Safety Database))5.3.2, other than reports required by Section 8.6 6.9.1, Section 10.4.4 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis Ionis to perform its remaining obligations under this Agreement. In addition, ; provided such remedy will not limit or diminish the scope of any licenses granted by Biogen to Ionis under this Agreement; and
(vi) if Isis Ionis has not completed the development activities that are its responsibility under this Agreementthe Collaboration Programs, then Genzyme Biogen may, but will not be obligated to, assume all responsibility for all such development activities that would have otherwise been IsisIonis’ responsibility under the this Agreement. Isis Ionis will cooperate with the foregoing and provide to Genzyme Biogen and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen in assuming complete responsibility for the development Development and manufacture Manufacture of the Product Products in an efficient and orderly manner.
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement (Ionis Pharmaceuticals Inc)
Termination of Committees and Information Sharing. If Isis If, after Option exercise, Ionis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen does not wish to terminate this Agreement in its entiretyentirety (an “Ionis Breach Event”), then, in addition to any other remedies Genzyme Biogen may have under this Agreement or otherwise, Genzyme Biogen will have the right to do any or all of the following in GenzymeBiogen’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Ionis Breach Event:
(ai) terminate IsisTerminate Xxxxx’ right to participate in the JDC and CSC, Neurology JRC, the applicable Neurology JDC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Xxxxx’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Collaboration Product; provided, however, that Biogen will not have the right to create any obligations or incur any liabilities for or on behalf of Ionis;
(div) exclude Isis Exclude Ionis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely except to the development extent Ionis’ participation is required by a Regulatory Authority or supply of the Product; is otherwise reasonably necessary to comply with Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen’s obligation to make further disclosures of Know-How or other information to Isis Ionis pursuant to this Agreement (related to the applicable Collaboration Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.9 and Section 6.4 (Isis Safety Database))5.2.7, other than reports required by Section 8.6 6.14.1, Section 10.4.4 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis Ionis to perform its remaining obligations under this Agreement. In addition, if Isis ; provided such remedy will not limit or diminish the scope of any licenses granted by Biogen to Ionis under this Agreement; and
(vi) If Ionis has not completed the development Development activities that are its responsibility under this Agreementthe applicable ASO Development Candidate Identification Plan and Initial Development Plan, then Genzyme Biogen may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been IsisIonis’ responsibility under the this Agreement. Isis Ionis will cooperate with the foregoing and provide to Genzyme Biogen and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products in an efficient and orderly manner.
Appears in 1 contract
Termination of Committees and Information Sharing. If Isis If, after the License Effective Date for a particular Collaboration Program, Ionis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen does not wish to terminate this Agreement in its entiretyentirety (an “Ionis Breach Event”), then, in addition to any other remedies Genzyme Biogen may have under this Agreement or otherwise, Genzyme Biogen will have the right to do any or all of the following in GenzymeBiogen’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Ionis Breach Event:
(ai) terminate IsisTerminate Ionis’ right to participate in the JDC and Neurology JSC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Ionis’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Product; provided, however, that Biogen will not have the right to create any obligations or incur any liabilities for or on behalf of Ionis;
(div) exclude Isis Exclude Ionis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely except to the development extent Ionis’ participation is required by a Regulatory Authority or supply of the Product; is otherwise reasonably necessary to comply with Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen’s obligation to make further disclosures of Know-How or other information to Isis Ionis pursuant to this Agreement (related to the applicable Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.8 and Section 6.4 (Isis Safety Database))5.2.2, other than reports required by Section 8.6 6.9.1, Section 10.4.3 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis Ionis to perform its remaining obligations under this Agreement. In addition, if Isis provided such remedy will not limit or diminish the scope of any licenses granted by Biogen to Ionis under this Agreement; and
(vi) If Ionis has not completed the development Development activities that are its responsibility under this Agreementthe applicable Collaboration Program Research Plan and Development Plan, then Genzyme Biogen may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been IsisIonis’ responsibility under the this Agreement. Isis Ionis will cooperate with the foregoing and provide to Genzyme Biogen and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products in an efficient and orderly manner.
Appears in 1 contract
Termination of Committees and Information Sharing. If Isis If, after the License Effective Date with respect to a particular Collaboration Program, Ionis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.3.5(a), and Genzyme Biogen does not wish to terminate this Agreement in its entiretyentirety (an “Ionis Breach Event”), then, in addition to any other remedies Genzyme Biogen may have under this Agreement or otherwise, Genzyme Biogen will have the right to do any or all of the following in GenzymeBiogen’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Ionis Breach Event:
(ai) terminate IsisElect that some or all of the Biogen Reduced Participation and Information Obligations will apply (in each case, solely with respect to the applicable Collaboration Programs that are the subject of the Ionis Breach Event);
(ii) Terminate Ionis’ right to participate in the JDC and JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; (b) terminate the participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen’s funding obligations associated therewith, ; and
(ciii) make all decisions required to be made by such committees or the Parties collectively under this Agreement in connection with the development and commercialization of the Product, (d) exclude Isis from all discussions with Regulatory Authorities regarding Isis Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely to the development or supply of the Product; (f) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate Genzyme’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) and Section 6.4 (Isis Safety Database)), other than reports required by Section 8.6 (Periodic Reporting and Reconciliation) and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if Isis If Ionis has not completed the development activities that are its responsibility for which it is responsible under this Agreementthe applicable Collaboration Program, then Genzyme Biogen may, but will not be obligated to, assume all responsibility for all such development activities that would have otherwise been IsisIonis’ responsibility under the this Agreement. Isis Ionis will cooperate with the foregoing and provide to Genzyme and Biogen or one or more of its Affiliates or Third Party contractors all Know-How, assistance, assignments of relevant Third Party agreements, to the extent freely assignable and only if such agreements are specific to the Manufacture and supply of Products under such assumed Collaboration Program(s), and other support reasonably requested to assist Genzyme Biogen in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products that are the subject of such Collaboration Program in an efficient and orderly manner. If any such relevant Third Party agreements are not freely assignable or are not specific to the Manufacture and supply of Products under such assumed Collaboration Program(s), then Ionis will, and cause its Affiliates to, obtain for Biogen substantially all of the practical benefit and burden under such Third Party agreements, including by (i) entering into appropriate and reasonable alternative arrangements on terms agreeable to each of Ionis and Biogen (or such Affiliate) and (ii) subject to the consent and control of Biogen, enforcing, at Biogen’s cost and expense and for the account of Biogen, any and all rights of Ionis (or such Affiliate) against the other party thereto arising out of the breach or cancellation thereof by such other party or otherwise.
Appears in 1 contract
Termination of Committees and Information Sharing. If If, after Option exercise, Isis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen Idec does not wish to terminate this Agreement in its entiretyentirety (an “Isis Breach Event”), then, in addition to any other remedies Genzyme Biogen Idec may have under this Agreement or otherwise, Genzyme Biogen Idec will have the right to do any or all of the following in GenzymeBiogen Idec’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Isis Breach Event:
(ai) terminate Terminate Isis’ right to participate in the JDC and CSC, Neurology JRC, the applicable Neurology JDC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Isis’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen Idec’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Collaboration Product; provided, however, that Biogen Idec will not have the right to create any obligations or incur any liabilities for or on behalf of Isis;
(div) exclude Exclude Isis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis except to assign to Genzyme all of the extent Isis’ right, title and interests in any IND participation is required by a Regulatory Authority or other Regulatory Materials then held by Isis pertaining is otherwise reasonably necessary to Products and any agreements comply with Third Parties related solely to the development or supply of the Product; Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen Idec’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (related to the applicable Collaboration Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.7 and Section 6.4 (Isis Safety Database))5.2.7, other than reports required by Section 8.6 6.14.1, Section 10.4.4 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if ; provided such remedy will not limit or diminish the scope of any licenses granted by Biogen Idec to Isis under this Agreement; and
(vi) If Isis has not completed the development Development activities that are its responsibility under this Agreementthe applicable ASO Development Candidate Identification Plan and Initial Development Plan, then Genzyme Biogen Idec may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been Isis’ responsibility under the this Agreement. Isis will cooperate with the foregoing and provide to Genzyme Biogen Idec and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen Idec in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products in an efficient and orderly manner.
Appears in 1 contract
Termination of Committees and Information Sharing. If Isis If, after the License Effective Date with respect to a particular Collaboration Program, Ionis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen does not wish to terminate this Agreement in its entiretyentirety (an “Ionis Breach Event”), then, in addition to any other remedies Genzyme Biogen may have under this Agreement or otherwise, Genzyme Biogen will have the right to do any or all of the following in GenzymeBiogen’s discretiondiscretion solely with respect to the Collaboration Programs that are the subject of the Ionis Breach Event: (ai) terminate IsisTerminate Ionis’ right to participate in the JDC and CSC, Neurology JRC, the applicable Neurology JDC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; (bii) terminate the Terminate Ionis’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen’s funding obligations associated therewith, ; 127 (ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Collaboration Product; provided, however, that Biogen will not have the right to create any obligations or incur any liabilities for or on behalf of Ionis; (div) exclude Isis Exclude Ionis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis to assign to Genzyme all of Isis’ right, title and interests in any IND or other Regulatory Materials then held by Isis pertaining to Products and any agreements with Third Parties related solely except to the development extent Ionis’ participation is required by a Regulatory Authority or supply of the Productis otherwise reasonably necessary to comply with Applicable Law; (fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen’s obligation to make further disclosures of Know-How or other information to Isis Ionis pursuant to this Agreement (related to the applicable Collaboration Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.8 and Section 6.4 (Isis Safety Database))5.2.7, other than reports required by Section 8.6 6.14.1, Section 10.4.4 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis Ionis to perform its remaining obligations under this Agreement. In addition, if Isis ; provided such remedy will not limit or diminish the scope of any licenses granted by Biogen to Ionis under this Agreement; and (vi) If Ionis has not completed the development Development activities that are its responsibility under this Agreementthe applicable ASO Development Candidate Identification Plan and Initial Development Plan, then Genzyme Biogen may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been IsisIonis’ responsibility under the this Agreement. Isis Ionis will cooperate with the foregoing and provide to Genzyme Biogen and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products in an efficient and orderly manner.
Appears in 1 contract
Termination of Committees and Information Sharing. If If, after Option exercise, Isis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen Idec does not wish to terminate this Agreement in its entiretyentirety (an “Isis Breach Event”), then, in addition to any other remedies Genzyme Biogen Idec may have under this Agreement or otherwise, Genzyme Biogen Idec will have the right to do any or all of the following in GenzymeBiogen Idec’s discretion: :
(ai) terminate Terminate Isis’ right to participate in the JDC and JSC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Isis’ participation of Isis in any ongoing research and development programs under this Agreement and GenzymeBiogen Idec’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the Product; provided, however, that Biogen Idec will not have the right to create any obligations or incur any liabilities for or on behalf of Isis;
(div) exclude Exclude Isis from all discussions with Regulatory Authorities regarding Isis Products, (e) require Isis except to assign to Genzyme all of the extent Isis’ right, title and interests in any IND participation is required by a Regulatory Authority or other Regulatory Materials then held by Isis pertaining is otherwise reasonably necessary to Products and any agreements comply with Third Parties related solely to the development or supply of the Product; Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen Idec’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (Agreement, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.5 and Section 6.4 (Isis Safety Database))5.2.2, other than reports required by Section 8.6 6.9.1, Section 10.4.3 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if ; and
(vi) If Isis has not completed the development Development activities that are its responsibility under this Agreementthe ISIS-DMPKRx R&D Plan, then Genzyme Biogen Idec may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been Isis’ responsibility under the this Agreement. Isis will cooperate with the foregoing and provide to Genzyme Biogen Idec and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen Idec in assuming complete responsibility for the development Development and manufacture Manufacture of the Product Products in an efficient and orderly manner.
Appears in 1 contract
Samples: DMPK Research, Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Termination of Committees and Information Sharing. If If, after Option exercise, Isis materially breaches this Agreement and fails to cure such breach within the time periods provided set forth under Section 11.2.2 (Termination for Material Breach) 10.2.4(a), and Genzyme Biogen Idec does not wish to terminate this Agreement in its entiretyentirety (an “Isis Breach Event”), then, in addition to any other remedies Genzyme Biogen Idec may have under this Agreement or otherwise, Genzyme Biogen Idec will have the right to do any or all of the following in GenzymeBiogen Idec’s discretion: discretion solely with respect to the Collaboration Programs that are the subject of the Isis Breach Event:
(ai) terminate Terminate Isis’ right to participate in the JDC and Neurology JSC, JPC and any other subcommittees or working groups established pursuant to this Agreement, each of which will be disbanded; ;
(bii) terminate the Terminate Isis’ participation of Isis in any ongoing research and development programs under the applicable Collaboration Program and GenzymeBiogen Idec’s funding obligations associated therewith, ;
(ciii) Solely make all decisions required or permitted to be made by such committees or the Parties collectively under this Agreement in connection with the development Development and commercialization Commercialization of the applicable Product; provided, however, that Biogen Idec will not have the right to create any obligations or incur any liabilities for or on behalf of Isis;
(div) exclude Exclude Isis from all discussions with Regulatory Authorities regarding Isis applicable Products, (e) require Isis except to assign to Genzyme all of the extent Isis’ right, title and interests in any IND participation is required by a Regulatory Authority or other Regulatory Materials then held by Isis pertaining is otherwise reasonably necessary to Products and any agreements comply with Third Parties related solely to the development or supply of the Product; Applicable Law;
(fv) require Isis to enable Genzyme or a Third Party manufacturer to manufacture clinical and initial commercial quantities of the Product in lieu of Isis, with such transition occurring on a commercially reasonable timetable; (g) terminate GenzymeTerminate Biogen Idec’s obligation to make further disclosures of Know-How or other information to Isis pursuant to this Agreement (related to the applicable Products, including pursuant to Section 5.4.2 (Transfer from Genzyme to Isis) 4.5 and Section 6.4 (Isis Safety Database))5.2.2, other than reports required by Section 8.6 6.9.1, Section 10.4.3 (Periodic Reporting and Reconciliation) if applicable), and as reasonably required to permit Isis to perform its remaining obligations under this Agreement. In addition, if ; and
(vi) If Isis has not completed the development Development activities that are its responsibility under this Agreementthe applicable Collaboration Program Research Plan and Development Plan, then Genzyme Biogen Idec may, but will not be obligated to, assume all responsibility for all such development Development activities that would have otherwise been Isis’ responsibility under the this Agreement. Isis will cooperate with the foregoing and provide to Genzyme Biogen Idec and its Third Party contractors all Know-How, assistance, assignments and other support reasonably requested to assist Genzyme Biogen Idec in assuming complete responsibility for the development Development and manufacture Manufacture of the Product applicable Products in an efficient and orderly manner.
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