Common use of General Regulatory Matters Clause in Contracts

General Regulatory Matters. (a) Subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during the period in which it is the IND holder, Strata shall have all regulatory responsibility with respect to and relative to the Product and has the sole right and decision making authority with respect to all such regulatory matters, including without limitation reaching agreement on all regulatory matters with the FDA and/or any other Competent Authority. (b) The Parties acknowledge that Micrologix, as of the Effective Date, owns and holds certain Governmental Approvals in connection with the research and development of the Product, including without limitation the IND listed in Exhibit “D”. Micrologix shall be responsible for the filing and maintenance in good standing of all such Governmental Approvals, with costs and expenses associated therewith to be included in Reimbursable Costs. During the time that Micrologix is the holder of the IND, Micrologix shall comply with all Applicable Laws applicable to the holder of the IND, including, without limitation, process, track and report all IND Safety Reports (as defined by the FDA). Upon Strata’s request, such request to be made as soon as reasonably possible, Micrologix shall transfer to Strata, without any additional consideration, those Governmental Approvals (including without limitation the IND) requested by Strata. (c) During the time that Micrologix is the holder of such Governmental Approvals, Strata shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including without limitation any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time as Micrologix is the holder of such Governmental Approvals, subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during the period of time in which it is the IND holder: (i) Strata has the sole right and decision making authority for all regulatory matters with respect to or relative to the Product. (ii) While it is still the holder of the IND in the United States, Micrologix shall give Strata no less than three (3) business days notice following the scheduling of any such meeting and/or telephone call with the FDA and/or other Competent Authority (or such shorter period of time, if the meeting and/or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Strata shall be able to attend and/or participate in such meeting and/or telephone call). (iii) Micrologix shall provide Strata copies of any materials relating to any regulatory matter prior to their presentation to the FDA or other Competent Authority during the Development, so that Strata shall have an opportunity to review and comment thereon. (iv) The JDMC shall approve all such materials prior to presentation.

General Regulatory Matters. (a) Subject to Micrologix’s 's obligations under Section 6.7(b) and Applicable Laws during the period in which it is the IND holder, Strata shall have all regulatory responsibility with respect to and relative to the Product and has the sole right and decision making authority with respect to all such regulatory matters, including without limitation reaching agreement on all regulatory matters with the FDA and/or any other Competent Authority. (b) . The Parties acknowledge that Micrologix, as of the Effective Date, owns and holds certain Governmental Approvals in connection with the research and development of the Product, including without limitation the IND listed in Exhibit “"D”". Micrologix shall be responsible for the filing and maintenance in good standing of all such Governmental Approvals, with costs and expenses associated therewith to be included in Reimbursable Costs. During the time that Micrologix is the holder of the IND, Micrologix shall comply with all Applicable Laws applicable to the holder of the IND, including, without limitation, process, track and report all IND Safety Reports (as defined by the FDA). Upon Strata’s 's request, such request to be made as soon as reasonably possible, Micrologix shall transfer to Strata, without any additional consideration, those Governmental Approvals (including without limitation the IND) requested by Strata. (c) . During the time that Micrologix is the holder of such Governmental Approvals, Strata shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including without limitation any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time as Micrologix is the holder of such Governmental Approvals, subject to Micrologix’s 's obligations under Section 6.7(b) and Applicable Laws during the period of time in which it is the IND holder: (i) : Strata has the sole right and decision making authority for all regulatory matters with respect to or relative to the Product. (ii) . While it is still the holder of the IND in the United States, Micrologix shall give Strata no less than three (3) business days notice following the scheduling of any such meeting and/or telephone call with the FDA and/or other Competent Authority (or such shorter period of time, if the meeting and/or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Strata shall be able to attend and/or participate in such meeting and/or telephone call). (iii) . Micrologix shall provide Strata copies of any materials relating to any regulatory matter prior to their presentation to the FDA or other Competent Authority during the Development, so that Strata shall have an opportunity to review and comment thereon. (iv) . The JDMC shall approve all such materials prior to presentation.

General Regulatory Matters. (a) Subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during During the period in which it is Development, the IND holder, Strata JDMC shall have all regulatory responsibility with respect to and relative to the Product or RSD1235 in the Field in the Territory and has the sole right and decision making authority with respect to all such regulatory matters, including without limitation reaching agreement on all regulatory matters with the FDA and/or and any other Competent Authority. Subject to the foregoing, from and after the IND Transfer Date, Fujisawa, under the oversight of the JDMC, shall have primary regulatory responsibility for the Indication in the Field in the Territory. From and after Fujisawa's receipt of the applicable Approval Letter from a particular country in the Territory for the Indication, the JDMC shall no longer have any regulatory responsibility or oversight with respect to the Indication in such country. From and after Fujisawa's receipt of any such Approval Letter, Fujisawa shall have sole right and decision making authority with respect to all regulatory matters for the Indication, as well as other indications, in such country. (b) The Parties acknowledge that MicrologixCardiome, as of the Effective Signing Date, owns and holds certain Governmental Approvals in connection with the research and development of the ProductProduct or RSD1235 in the Field, including without limitation the IND listed in Exhibit “D”and the CTA. Micrologix Cardiome shall be responsible for the filing and maintenance in good standing of all such Governmental Approvals, with costs and expenses associated therewith to be included in Reimbursable Development Costs. During the time that Micrologix Cardiome is the holder of the INDIND and CTA, Micrologix Cardiome shall comply with all Applicable Laws applicable to the holder of the IND, including, without limitation, including process, track and report all IND Safety Reports (as defined by the FDAFDA in the U.S and Health Canada in Canada). Upon Strata’s requestNo later than one hundred twenty (120) days prior to the anticipated date of the pre-NDA meeting with the FDA for the Indication, such or earlier upon the JDMC's request to be made as soon as reasonably possible(the "IND Transfer Date"), Micrologix Cardiome shall transfer to StrataFujisawa, without any additional consideration, those all such Governmental Approvals in the Field (including without limitation the INDIND and CTA) requested then owned or held by StrataCardiome. (c) During the time that Micrologix Cardiome is the holder of such Governmental ApprovalsApprovals during the Development, Strata Fujisawa shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including without limitation any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time as Micrologix Cardiome is the holder of such Governmental Approvals, subject to Micrologix’s Cardiome's obligations under Section 6.7(b6.5(b) and Applicable Laws during the period of time in which it is the IND or CTA holder: (i) Strata has the JDMC shall have the sole right and decision making authority for all regulatory matters with respect to or relative to the ProductProduct or RSD1235 in the Field in the Territory. (ii) While it is still the holder of the IND in the United StatesStates or the CTA in Canada, Micrologix Cardiome shall give Strata Fujisawa no less than three (3) business days notice following the scheduling of any such meeting and/or or telephone call with the FDA and/or or other Competent Authority (or such shorter period of time, if the meeting and/or or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Strata Fujisawa shall be able to attend and/or or participate in such meeting and/or or telephone call). (iii) Micrologix Cardiome shall provide Strata Fujisawa copies of any materials relating to any regulatory matter, including telephone logs with the Competent Authorities, no less than three (3) business days prior to their presentation to the FDA or other Competent Authority during the Development, so that Fujisawa shall have an opportunity to review and comment thereon. (d) During the time that Fujisawa is the holder of such Governmental Approvals during the Development, Cardiome shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time, subject to Applicable Laws: (i) the JDMC shall have the sole right and decision making authority for all regulatory matters with respect to or relative to the Product or RSD1235 in the Field in the Territory. (ii) Fujisawa shall give Cardiome no less than three (3) business days notice following the scheduling of any such meeting or telephone call with the FDA or other Competent Authority (or such shorter period of time, if the meeting or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Cardiome shall be able to attend or participate in such meeting or telephone call). (iii) Fujisawa shall provide Cardiome copies of any materials relating to any regulatory matter prior to their presentation to the FDA or other Competent Authority during the Development, so that Strata Cardiome shall have an opportunity to review and comment thereon. (iv) The JDMC shall approve all such materials prior to presentation.

General Regulatory Matters. (a) Subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during During the period in which it is Development, the IND holder, Strata JDMC shall have all regulatory responsibility with respect to and relative to the Product or RSD1235 in the Field in the Territory and has the sole right and decision making authority with respect to all such regulatory matters, including without limitation reaching agreement on all regulatory matters with the FDA and/or and any other Competent Authority. Subject to the foregoing, from and after the IND Transfer Date, Fujisawa, under the oversight of the JDMC, shall have primary regulatory responsibility for the Indication in the Field in the Territory. From and after Fujisawa’s receipt of the applicable Approval Letter from a particular country in the Territory for the Indication, the JDMC shall no longer have any regulatory responsibility or oversight with respect to the Indication in such country. From and after Fujisawa’s receipt of any such Approval Letter, Fujisawa shall have sole right and decision making authority with respect to all regulatory matters for the Indication, as well as other indications, in such country. (b) The Parties acknowledge that MicrologixCardiome, as of the Effective Signing Date, owns and holds certain Governmental Approvals in connection with the research and development of the ProductProduct or RSD1235 in the Field, including without limitation the IND listed in Exhibit “D”and the CTA. Micrologix Cardiome shall be responsible for the filing and maintenance in good standing of all such Governmental Approvals, with costs and expenses associated therewith to be included in Reimbursable Development Costs. During the time that Micrologix Cardiome is the holder of the INDIND and CTA, Micrologix Cardiome shall comply with all Applicable Laws applicable to the holder of the IND, including, without limitation, including process, track and report all IND Safety Reports (as defined by the FDAFDA in the U.S and Health Canada in Canada). Upon StrataNo later than one hundred twenty (120) days prior to the anticipated date of the pre-NDA meeting with the FDA for the Indication, or earlier upon the JDMC’s requestrequest (the “IND Transfer Date”), such request to be made as soon as reasonably possible, Micrologix Cardiome shall transfer to StrataFujisawa, without any additional consideration, those all such Governmental Approvals in the Field (including without limitation the INDIND and CTA) requested then owned or held by StrataCardiome. (c) During the time that Micrologix Cardiome is the holder of such Governmental ApprovalsApprovals during the Development, Strata Fujisawa shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including without limitation any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time as Micrologix Cardiome is the holder of such Governmental Approvals, subject to MicrologixCardiome’s obligations under Section 6.7(b6.5(b) and Applicable Laws during the period of time in which it is the IND or CTA holder: (i) Strata has the JDMC shall have the sole right and decision making authority for all regulatory matters with respect to or relative to the ProductProduct or RSD1235 in the Field in the Territory. (ii) While it is still the holder of the IND in the United StatesStates or the CTA in Canada, Micrologix Cardiome shall give Strata Fujisawa no less than three (3) business days notice following the scheduling of any such meeting and/or or telephone call with the FDA and/or or other Competent Authority (or such shorter period of time, if the meeting and/or or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Strata Fujisawa shall be able to attend and/or or participate in such meeting and/or or telephone call). (iii) Micrologix Cardiome shall provide Strata Fujisawa copies of any materials relating to any regulatory matter, including telephone logs with the Competent Authorities, no less than three (3) business days prior to their presentation to the FDA or other Competent Authority during the Development, so that Fujisawa shall have an opportunity to review and comment thereon. (d) During the time that Fujisawa is the holder of such Governmental Approvals during the Development, Cardiome shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time, subject to Applicable Laws: (i) the JDMC shall have the sole right and decision making authority for all regulatory matters with respect to or relative to the Product or RSD1235 in the Field in the Territory. (ii) Fujisawa shall give Cardiome no less than three (3) business days notice following the scheduling of any such meeting or telephone call with the FDA or other Competent Authority (or such shorter period of time, if the meeting or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Cardiome shall be able to attend or participate in such meeting or telephone call). (iii) Fujisawa shall provide Cardiome copies of any materials relating to any regulatory matter prior to their presentation to the FDA or other Competent Authority during the Development, so that Strata Cardiome shall have an opportunity to review and comment thereon. (iv) The JDMC shall approve all such materials prior to presentation.