Common use of COLUMBIA OBLIGATIONS Clause in Contracts

COLUMBIA OBLIGATIONS. 4.1 Upon and subject to the terms and conditions of this Agreement, Columbia hereby agrees: 4.1.1 promptly following the Effective Date to supply to Urology Company the MAs, the Specifications, and the SmPC and Patient Information Leaflet for the Product; 4.1.2 to manufacture or have manufactured and to supply to Urology Company such amounts of the Product for Urology Company's Commercialization of the Product in the Territory, as Urology Company may order from time to time on terms and otherwise in accordance with Clause 7 below and to manufacture or have manufactured and supply the Product in the manner specified in the MAs and in accordance with cGMP, the Specifications and the Technical Agreement, and all Applicable Laws; 4.1.3 to ensure that Product is handled and stored by it in accordance with all Applicable Laws and to ensure that it creates and retains manufacturing, analytical and distribution records, testing and releasing materials, undertakes production and quality controls, including, but not limited to, in‑process controls and all necessary stability studies, and analysis relating to the Product all in accordance with the Specification and cGMP; 4.1.4 to have in place a Qualified Person, which Qualified Person shall be responsible for batch release of Product and to supply Product which has been released for sale in the Territory by a Qualified Person in accordance with Applicable Laws; 4.1.5 to put in place and maintain a technical agreement with each of its contract manufacturers from time to time as required by Applicable Laws (and on request provide a copy of any or all such technical agreements to Urology Company if required to enable Urology Company to comply with Applicable Laws); 4.1.6 to procure that Urology Company, or its duly appointed agent, shall have the right to inspect, at Urology Company's sole expense, the premises of Columbia or Columbia's contract manufacturer(s) where the Product is manufactured, Packaged or Labelled, which inspections may take place no more often than once per year upon advance notice at any reasonable time; 4.1.7 to notify Urology Company promptly of any proposed inspections by any Governmental Authority (either in the Territory or outside of the Territory) of the facilities at which Product is manufactured and procure that Urology Company has a right to attend on such occasions if the inspection is by a Governmental Authority in the Territory and in any event Columbia shall inform Urology Company of the outcome; 4.1.8 to keep Urology Company informed in a timely manner of any information brought to Columbia's attention which in Columbia's reasonable judgment could lead to a variation of the MAs, SmPC, Packaging or Labelling (subject to Urology Company's responsibility for pharmacovigilance pursuant to Clause 8.2); 4.1.9 to comply with all obligations and duties as the holder of the Marketing Authorisations under Applicable Laws and to liaise with any Governmental Authority in relation to the MAs including but not limited to answering any questions or issues raised by any Governmental Authority relating to the Product or the MAs. 4.1.10 to provide Urology Company with reasonable assistance (and if required copy technical documents) in relation to any questions or issues received by Urology Company from any Governmental Authority relating to Product or the Regulatory Approvals; 4.1.11 to supply the Product in Packaging as required by Urology Company which incorporates all information (including, but not limited to, the patient information leaflet) that may be required by the MAs, any Governmental Authority or any Applicable Law from time to time; 4.1.12 to retain and archive all documentation relating to the Product including, in particular but not limited to, documentation relating to regulatory matters and to clinical trials of Product; and 4.1.13 to investigate promptly and report to Urology Company all significant customer complaints or reports of incidents relating to the Product affecting quality of which it has knowledge and co-operate with Urology Company in the handling of such complaints and in accordance with Clause 8.1 and to provide a copy of each investigation report under this Clause 4.1.13

COLUMBIA OBLIGATIONS. 4.1 Upon and subject to the terms and conditions of this Agreement, Columbia hereby agreesagrees at its own cost and expense: 4.1.1 to procure that Columbia UK uses commercially reasonable efforts to obtain an MA in the Territory by filing and progressing the European Regulatory Application. In the event that a Governmental Authority in the Territory requests that any further clinical trials, studies or investigations be conducted in the Territory before such Governmental Authority grants an MA, Columbia shall promptly following conduct or have conducted such trials, studies or investigations at Columbia’s cost and expense. 4.1.2 to provide Mipharm with reasonable advance notice of all material meetings or calls with Governmental Authorities in the Effective Date Territory relating to supply the Regulatory Applications and permit a maximum of 2 Mipharm personnel to Urology Company the MAs, the Specifications, attend such meetings or calls as an observer at Mipharm’s sole cost and the SmPC and Patient Information Leaflet for the Productexpense; 4.1.2 4.1.3 to manufacture or have manufactured and to supply to Urology Company Mipharm such amounts of the Finished Product for Urology Company's Mipharm’s Commercialization of the Product in the Territory, as Urology Company Mipharm may order from time to time on terms and otherwise in accordance with Clause 7 9 below and to manufacture or have manufactured and supply the Finished Product in the manner specified in the MAs MA of the Territory and in accordance with cGMP, the Specifications and the Technical Agreement, and all Applicable Laws; 4.1.3 4.1.4 to use commercially reasonable efforts to obtain a manufacturing authorisation for the purposes of manufacturing Finished Product in relation to each and every site at which manufacture (or any part thereof) of Finished Product shall occur, to provide Mipharm with a copy of such manufacturing authorisation(s) and to provide Mipharm with advance written notice of any proposed change to such manufacturing authorisation(s) in order that Mipharm may make any relevant variations to the Regulatory Approval if necessary; 4.1.5 to ensure that Product is handled and stored by it in accordance with all Applicable Laws and to ensure that it creates and retains manufacturing, analytical and distribution records, testing and releasing materials, undertakes production and quality controls, including, but not limited to, in‑process including in-process controls and all necessary stability studies, and analysis relating to the Product all in accordance with the Specification and cGMP; 4.1.4 4.1.6 to have in place a Qualified Person, which Qualified Person shall be responsible for batch release of Product in the Territory and to supply Finished Product which has been released in the Territory for sale in the Territory by a Qualified Person in accordance with Applicable Laws; 4.1.5 4.1.7 to put in place and maintain a technical agreement with each of its contract manufacturers from time to time (including in particular Mipharm) as required by Applicable Laws any Governmental Authority which technical agreement shall be identical to the extent required by any Governmental Authority in the Territory (and on request provide a copy of any or all such technical agreements save as to Urology Company if required the parties) to enable Urology Company the Technical Agreement to comply with Applicable Laws)be agreed pursuant to Clause 10.5; 4.1.6 4.1.8 to procure that Urology CompanyMipharm, or its duly appointed agent, shall have the right to inspect, at Urology Company's sole expense, inspect the premises of Columbia or Columbia's ’s contract manufacturer(s) where the Finished Product is manufactured, Packaged or Labelled, which inspections may take place no more often than once per year upon advance notice at any reasonable time; 4.1.7 4.1.9 to ensure that no changes in chemistry and manufacturing controls specified in the MA for the Finished Product in the Territory are made without Mipharm’s having obtained the prior approval of each applicable Governmental Authority for such changes if such approval is required; 4.1.10 to keep Mipharm informed in a timely manner of any information brought to Columbia’s attention which in Columbia’s reasonable judgment could lead to a variation of the MA, SmPC, Packaging or Labelling (subject to any overriding provisions of the pharmacovigilance procedures agreed pursuant to Clause 10.2); 4.1.11 to provide Mipharm with reasonable assistance in relation to any questions or issues raised by any Governmental Authority relating to Finished Product or the Regulatory Approval, including, but not limited to, the provision of any relevant background data relating to Product in Columbia’s possession or control; 4.1.12 to supply the Finished Product in Packaging as required by Mipharm which incorporates all information (including the patient information leaflet) that may be required by the MA, any Governmental Authority or any Applicable Law from time to time; 4.1.13 to notify Urology Company Mipharm promptly of any proposed inspections by any Governmental Authority (either in the Territory or outside of the Territory) of the facilities at which Finished Product is manufactured and procure that Urology Company Mipharm has a right to attend on such occasions if the inspection is by a Governmental Authority in the Territory and in any event Columbia shall inform Urology Company Mipharm of the outcome; 4.1.8 4.1.14 to keep Urology Company informed in establish and maintain a timely manner of any scientific service for scientific information brought relating to Columbia's attention which in Columbia's reasonable judgment could lead to a variation of the MAs, SmPC, Packaging or Labelling (subject to Urology Company's responsibility for pharmacovigilance pursuant to Clause 8.2); 4.1.9 to comply with all obligations and duties as the holder of the Marketing Authorisations under Applicable Laws Product and to liaise with any Governmental Authority in relation to the MAs including but not limited to answering any questions or issues raised by any Governmental Authority relating to the Product or the MAs. 4.1.10 to provide Urology Company with reasonable assistance (and if required copy technical documents) Mipharm in relation to any questions or issues received by Urology Company from any Governmental Authority relating enquiries made to Product or the Regulatory Approvalssuch service; 4.1.11 to supply the Product in Packaging as required by Urology Company which incorporates all information (including, but not limited to, the patient information leaflet) that may be required by the MAs, any Governmental Authority or any Applicable Law from time to time; 4.1.12 4.1.15 to retain and archive all documentation relating to the Product including, in particular but not limited toparticular, documentation relating to regulatory matters and to clinical trials of Product; and 4.1.13 4.1.16 to investigate promptly and report to Urology Company Mipharm all significant customer complaints or reports of incidents relating to the Finished Product affecting quality of which it has knowledge and co-operate with Urology Company Mipharm in the handling of such complaints and in accordance with Clause 8.1 10.1 and to provide a copy of each investigation report under this Clause 4.1.134.1.16 to Mipharm.

COLUMBIA OBLIGATIONS. 4.1 5.1 Upon and subject to the terms and conditions of this Agreement, Columbia hereby agreesagrees at its own cost and expense: 4.1.1 5.1.1 to procure that Columbia UK uses commercially reasonable efforts to obtain an MA in each Major Market of the Territory by filing and progressing the European Regulatory Application. In the event that any Governmental Authority in a Major Market requests that any further clinical trials, studies or investigations be conducted in the Territory before such Governmental Authority grant an MA, Columbia shall promptly following conduct or have conducted such trials, studies or investigations at Columbia's cost and expense. 5.1.2 to provide Ardana with reasonable advance notice of all material meetings or calls with Governmental Authorities in the Effective Date Territory relating to supply the European Regulatory Applications and permit a maximum of 2 Ardana personnel to Urology Company the MAs, the Specifications, attend such meetings or calls as an observer at Ardana's sole cost and the SmPC and Patient Information Leaflet for the Product;expense; [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4.1.2 5.1.3 to manufacture or have manufactured and to supply to Urology Company Ardana such amounts of the Finished Product for Urology CompanyArdana's Commercialization of the Product in the Territory, as Urology Company Ardana may order from time to time on terms and otherwise in accordance with Clause 7 10 below and to manufacture or have manufactured and supply the Finished Product in the manner specified in the MAs relevant MA of each country of the Territory and in accordance with cGMP, the Specifications and the Technical Agreement, and all Applicable Laws; 4.1.3 5.1.4 to use commercially reasonable efforts to obtain a manufacturing authorisation for the purposes of manufacturing Finished Product in relation to each and every site at which manufacture (or any part thereof) of Finished Product shall occur, to provide Ardana with a copy of such manufacturing authorisation(s) and to provide Ardana with advance written notice of any proposed change to such manufacturing authorisation(s) in order that Ardana may make any relevant variations to the Regulatory Approval(s); 5.1.5 to ensure that Product is handled and stored by it in accordance with all Applicable Laws and to ensure that it creates and retains manufacturing, analytical and distribution records, testing and releasing materials, undertakes production and quality controls, including, but not limited to, in‑process including in-process controls and all necessary stability studies, and analysis relating to the Product all in accordance with the Specification and cGMP; 4.1.4 5.1.6 to have in place a Qualified Person, which Qualified Person shall be responsible for batch release of Product in the Territory and to supply Finished Product which has been released in the Territory for sale in the Territory by a Qualified Person in accordance with Applicable Laws; 4.1.5 5.1.7 to put in place and maintain a technical agreement with each of its contract manufacturers from time to time (including in particular Mipharm) as required by Applicable Laws any Governmental Authority which technical agreement shall be identical to the extent required by any Governmental Authority in the Territory (and on request provide a copy of any or all such technical agreements save as to Urology Company if required the parties) to enable Urology Company the Technical Agreement to comply with Applicable Laws);be agreed pursuant to Clause 11.4; [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4.1.6 5.1.8 to procure that Urology CompanyArdana, or its duly appointed agent, shall have the right to inspect, at Urology Company's sole expense, inspect the premises of Columbia or Columbia's contract manufacturer(s) where the Finished Product is manufactured, Packaged or Labelled, which inspections may take place no more often than once per year upon advance notice at any reasonable time; 4.1.7 5.1.9 to ensure that no changes in chemistry and manufacturing controls specified in the CMC Data in the MA for the Finished Product in the Territory are made without Ardana's having obtained the prior approval of each applicable Governmental Authority for such changes if such approval is required; 5.1.10 to keep Ardana informed in a timely manner of any information brought to Columbia's attention which in Columbia's reasonable judgment could lead to a variation of the MA, SmPC, Packaging or Labelling (subject to any overriding provisions of the pharmacovigilance procedures agreed pursuant to Clause 11.3); 5.1.11 to provide Ardana with reasonable assistance in relation to any questions or issues raised by any Governmental Authority relating to Finished Product or the Regulatory Approvals, including, but not limited to, the provision of any relevant background data relating to Product in Columbia's possession or control; 5.1.12 to supply the Finished Product in Packaging as required by Ardana which incorporates all information (including the patient information leaflet) that may be required by the relevant MA, any Governmental Authority or any Applicable Law from time to time; 5.1.13 to notify Urology Company Ardana promptly of any proposed inspections by any Governmental Authority (either in the Territory or outside of the Territory) of the facilities at which Finished Product is manufactured and procure that Urology Company Ardana has a right to attend on such occasions if the inspection is by a Governmental Authority in the Territory and in any event Columbia shall inform Urology Company Ardana of the outcome;; [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4.1.8 5.1.14 to keep Urology Company informed in establish and maintain a timely manner of any scientific service for scientific information brought relating to Columbia's attention which in Columbia's reasonable judgment could lead to a variation of the MAs, SmPC, Packaging or Labelling (subject to Urology Company's responsibility for pharmacovigilance pursuant to Clause 8.2); 4.1.9 to comply with all obligations and duties as the holder of the Marketing Authorisations under Applicable Laws Product and to liaise with any Governmental Authority in relation to the MAs including but not limited to answering any questions or issues raised by any Governmental Authority relating to the Product or the MAs. 4.1.10 to provide Urology Company with reasonable assistance (and if required copy technical documents) Ardana in relation to any questions or issues received by Urology Company from any Governmental Authority relating enquiries made to Product or the Regulatory Approvalssuch service; 4.1.11 to supply the Product in Packaging as required by Urology Company which incorporates all information (including, but not limited to, the patient information leaflet) that may be required by the MAs, any Governmental Authority or any Applicable Law from time to time; 4.1.12 5.1.15 to retain and archive all documentation relating to the Product including, in particular but not limited toparticular, documentation relating to regulatory matters and to clinical trials of Product; and 4.1.13 5.1.16 to investigate promptly and report to Urology Company Ardana all significant customer complaints or reports of incidents relating to the Finished Product affecting quality of which it has knowledge and co-operate with Urology Company Ardana in the handling of such complaints and in accordance with Clause 8.1 11.2 and to provide a copy of each investigation report under this Clause 4.1.135.1.16