Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy. 5.2 STOCOSIL shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL. 5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy. 5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation. 5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. 5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory. 5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory. 5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall: (a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2; (b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory; (c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and (d) support STOCOSIL in cGMP audits by Regulatory Authorities. 5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall: (a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and (b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory. 5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder. 5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory. 5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 2 contracts
Samples: Product Development, Licence and Commercialization Agreement (Stocosil Inc.), Product Development, Licence and Commercialization Agreement (Stocosil Inc.)
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to (a) Filings. Between the Product Effective Date and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries date Proof of the Territory. NeverthelessConcept is established, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL Achillion shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Marketing AuthorisationDrug Approval Applications, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory thereafter Gilead shall be borne by STOCOSIL.
5.3 DAEWOONG file and own all Drug Approval Applications and shall be responsible for implementing all communications with Regulatory Authorities in relation thereto (to the extent permitted by law).
(i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and all regulatory filings for each communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Product and/or Optional Product outside Effective Date, Achillion shall provide Gilead with copies of the Territory any documents and communications described in its own name this Section 3.4(a)(i) then in Achillion’s possession, and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. provide Gilead with any additional relevant information or assistance that Gilead reasonably requests.
(ii) The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provideshall, as soon as physically possiblepracticable after Proof of Concept is established, access cooperate to STOCOSIL transfer and provide copies of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is necessary)reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in Gilead shall keep Achillion reasonably apprised of the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (progress of all Drug Approval Applications through the progress reports presented to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activitiesCommittee, and which shall be retained by such Party for at least five (5) years will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except their submission to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunderrelevant Regulatory Authority.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 2 contracts
Samples: Research Collaboration and License Agreement (Achillion Pharmaceuticals Inc), Research Collaboration and License Agreement (Achillion Pharmaceuticals Inc)
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. 6.1 Holder of Regulatory Dossiers Approvals and Regulatory Documentation relating to Submissions. NVCR shall initially be the Product holder of Regulatory Approvals and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements Regulatory Submission for Licensed Products in each countries of the Territory. NeverthelessAt Zai’s request during the Term, DAEWOONG(a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, or its affiliates, shall provide STOCOSIL all and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Dossiers, Approvals and Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product Submissions in the TerritoyTerritory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions.
5.2 STOCOSIL 6.2 Zai’s Responsibilities.
(a) Zai shall be responsible [***] for implementing all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory filings for each activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Product and/or Optional Licensed Product in the Territory in its own name and shall be during such time that NVCR is the owner holder of all Marketing Authorisation, Regulatory Dossier Approvals and Regulatory Documentation other than as described in Clause 5.3 below. For Submissions for the avoidance of doubt, registration fee for such filing Licensed Product in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible Territory) as the express, exclusive, and authorized legal agent of record for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory NVCR in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the ownership benefit of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-Zai in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory. Promptly after the Effective Date and from time to time during the Term, the ownership Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the respective Marketing AuthorisationTerritory. Notwithstanding the foregoing, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Licensed Products in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives Zai shall promptly provide to attend meetings NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission.
(c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries Territory related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved Licensed Product in the performance of Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party designee shall have the right, during normal business hours and upon reasonable noticebut not the obligation, to inspect attend and copy any participate in such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, meeting or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicablydiscussion. If there is no resolutionNVCR elects not to attend such meeting or discussion, STOCOSIL will have the final decision making authority Zai shall provide NVCR with respect to the Product and/or Optional Product a written summary thereof in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the TerritoryEnglish promptly following such meeting or discussion.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Zai Lab LTD), License and Collaboration Agreement (NovoCure LTD)
Regulatory. 5.1 The On a Licensed Compound-by-Licensed Compound basis, with respect to any Licensed Product that contains a Licensed Compound, from and after the Effective Date until and unless such Licensed Compound is a Terminated Compound, as between the Parties shall work together to produce high quality regulatory files relating and subject to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination terms of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall Inmagene will have the right, itself or with or through its Affiliates, Sublicensees or other Third Parties, to: (a) prepare and submit to applicable Regulatory Authorities all Regulatory Materials, including INDs, for such Licensed Products in the Field, (b) obtain and maintain all Regulatory Approvals for such Licensed Products in the Field, and (c) conduct communications with the Regulatory Authorities for such Licensed Products in the Field. During the Option Term with respect to a Licensed Compound, Inmagene may request Hutchison assist, [***], in Inmagene’s efforts to prepare and submit any Regulatory Filings to obtain, support, or maintain Regulatory Approvals for any Licensed Product containing such Licensed Compound. For all Licensed Products, Inmagene will keep Hutchison reasonably informed regarding the status and progress of such regulatory activities, including by (a) during normal business hours and upon reasonable noticethe Option Term for a Licensed Compound, to inspect and providing Hutchison with a copy of any written correspondence from a Regulatory Authority involving Regulatory Filings for any such recordsLicensed Product containing such Licensed Compound; (b) notifying Hutchison of any major topic made by oral correspondence from a Regulatory Authority involving Regulatory Filings; (c) providing Hutchison with a copy of each Regulatory Filing (i.e., except IND, orphan drug applications and designations, and their foreign counterparts) to be submitted to the FDA or a Regulatory Authority in any other country in advance of submission to the relevant Regulatory Authority; (d) providing Hutchison with a copy of all final Regulatory Filings promptly after submission to the relevant Regulatory Authority; and (e) promptly informing Hutchison regarding the receipt or denial of Regulatory Approval for such Licensed Product obtained or denied; provided, however, that in all circumstances, to the extent that a Party reasonably determines that permitted under Applicable Law, Inmagene will inform Hutchison of such records contain Confidential Information that is not licensed event prior to the other Party, or to which the other Party does not otherwise have a right public disclosure of access hereundersuch event by Inmagene.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (Ikena Oncology, Inc.)
Regulatory. 5.1 The Parties B.1 At E*TRADE locations, Broadridge shall work together use its commercially reasonable efforts to produce high quality regulatory files relating ensure that Broadridge employees, subcontractors, contractors, consultants or other similar third parties or personnel under the control of Broadridge (collectively, “Broadridge Personnel”), will comply with all E*TRADE policies and procedures, including, but not limited to, security procedures, information security requirements, rules, regulations, policies, holiday and similar schedules (“E*TRADE Policies”) which have been provided to Broadridge and the Product Broadridge Personnel in writing. Such E*TRADE Policies are subject to change at E*TRADE’s sole discretion at anytime, but such change must be communicated in writing to Broadridge and Optional Productthe Broadridge Personnel. Regulatory Dossiers Broadridge shall use its commercially reasonable efforts to minimize any disruption to E*TRADE’s normal business operations in performing the Services.
B.2 Broadridge acknowledges that all Broadridge Personnel will comply with Broadridge’s information security policy (or if applicable, E*TRADE’s information security policy if any Broadridge Personnel is on E*TRADE’s premises, so long as such policy has been provided in writing to such Personnel). Further, Broadridge agrees that certain Broadridge Personnel, as determined by E*TRADE and Regulatory Documentation relating Broadridge jointly, shall complete information security awareness training reasonably acceptable to E*TRADE.
B.3 Broadridge acknowledges and understands that E*TRADE (any of its parent, subsidiaries and Affiliates) is subject to examination and oversight by various federal and state regulators and governmental administrative agencies, including, without limitation, the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries Office of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration Comptroller of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL shall Currency, and that by entering into this Schedule with E*TRADE, Broadridge may be responsible for implementing all regulatory activities subject to examination and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name oversight by such regulators and shall be the owner of all Marketing Authorisationagencies. Broadridge hereby agrees, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (but solely to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (such examination relates to the extent that it is necessary)Services provided by Broadridge to E*TRADE hereunder, STOCOSIL shall:
to submit to and reasonably cooperate in any such examination, at E*TRADE’s expense, and oversight proceeding or in E*TRADE’s efforts to respond to any audit, inquiry or review, whether formal or informal, which may include, but may not be limited to, granting E*TRADE or federal or state regulatory authorities access to Broadridge’s: (ai) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records overviews of its respective Development activities in sufficient detail disaster recovery and in good scientific manner appropriate business continuity plans; (ii) disaster *** Confidential treatment has been requested for Patent the redacted portions. The Confidential Information redacted has been filed separately with the Securities and Regulatory purposesExchange Commission. recovery test results; (iii) an overview of Broadridge’s information security program, which shall be complete (iv) books and accurate records; and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities(v) facilities, systems, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours equipment on supervised visits and upon reasonable notice, without actual access to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunderBroadridge’s systems.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: Global Amendment to the E*trade Agreements (E TRADE FINANCIAL Corp)
Regulatory. 5.1 The Parties shall work together Regulatory Matters with Respect to produce high quality regulatory files relating Licensed Compounds and Licensed Products in the Co-Promotion Territory.
5.1.1 Subject to the Product terms and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so conditions of this Agreement, until such time as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL responsibility for registration of the Product and/or Optional Product regulatory matters in the Territoy.
5.2 STOCOSIL Co-Promotion Territory for Licensed Compounds and Licensed Products are transferred to Bayer pursuant to Sections 5.1.2 and 5.3, in the Co-Promotion Territory, Loxo shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shallfor:
(ai) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority determining, planning and implementing the regulatory plans and strategies for Licensed Compounds and Licensed Products in the Co-Promotion Territory;
(cii) support STOCOSIL either directly or through its Affiliates, making all regulatory filings with respect to Licensed Compounds and Licensed Products in replying to regulatory queries related to CMC the Co-Promotion Territory including NDA/XXXx;
(iii) holding all IND/CTAs and GMPMarketing Authorizations for Licensed Compounds and Licensed Products throughout the Co-Promotion Territory in the name of either itself or its Affiliates until the transfer of such IND/CTAs and Marketing Authorizations as contemplated by Section 5.1.2; and
(div) support STOCOSIL subject to Sections 5.6 and 5.7, handling all interactions with Regulatory Authorities in cGMP audits by Regulatory Authoritiesthe Co-Promotion Territory with respect to Licensed Compounds and Licensed Products, including all submissions, meetings and discussions in all cases.
5.9 Upon DAEWOONG’s request 5.1.2 As soon as practical after receipt of the Marketing Authorization for the Co-Promotion Territory, on a Licensed Product-by-Licensed Product basis but no later than, in the case of a LOXO-101 Product, [***], and at DAEWOONG’s expense (in the case of a LOXO-195 Product, [***] for such LOXO-195 Product for the Co-Promotion Territory, Loxo shall do all things reasonably necessary or useful to transfer, and Bayer shall provide Loxo reasonable assistance in connection thereto, as well as do all things reasonably necessary or useful to assume and take over, any Regulatory Documentation, including, to the extent that it is necessary)permitted by Law, STOCOSIL all IND/CTAs and Marketing Authorizations related to the applicable Licensed Product Controlled by Loxo or any of its Affiliates for the Co-Promotion Territory into the name of Bayer or its designated Affiliate. Loxo shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil , and shall cause its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintainAffiliates to, duly execute and deliver, or cause to be maintained, records of its respective Development activities in sufficient detail duly executed and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate delivered such instruments and shall fully do and properly reflect all work cause to be done such acts and results achieved things, including the filing of such assignments, agreements, documents and instruments as Bayer may reasonably request from time to time in connection with Bayer’s rights under this Section 5.1.2. [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the performance Securities and Exchange Commission pursuant to Rule 406 of its respective Development activitiesthe Securities Act of 1933, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Lawamended. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute treatment has been requested with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant this information.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Loxo Oncology, Inc.)
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating Regulatory Responsibilities of Clearside. Prior to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product XIPERE NDA Approval Date, Clearside shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL shall be solely responsible for implementing all regulatory activities and all regulatory filings for each interactions with Regulatory Authorities necessary to obtain Regulatory Approval of the XIPERE Product and/or Optional in the United States and shall bear all costs and expenses relating thereto, including in connection with the items set out in Exhibit 5.1 (“Additional Clearside Regulatory Matters”). Clearside shall use Commercially Reasonable Efforts to obtain Regulatory Approval for the XIPERE Product in the United States. Clearside shall (a) promptly provide Bausch Health with copies of any communications which Clearside receives from the applicable Regulatory Authority concerning the XIPERE Product, (b) provide Bausch Health with draft copies of all proposed communications from Clearside to the applicable Regulatory Authority with respect to the XIPERE Product (including any Additional Clearside Regulatory Matters ) prior to Clearside’s submission thereof, and (c) permit Bausch Health with a reasonable period of time to review and comment on such communications and Clearside shall consider in good faith any such reasonable comments, provided that Clearside shall not submit any such communications to the Regulatory Authority without the prior consent of Bausch Health, such consent not to be unreasonably withheld (for greater certainty, if Clearside incorporates any and all comments received from Bausch Health into such communications, then Bausch Health shall be deemed to have provided such prior written consent). Clearside shall promptly (and in any event within [***]) inform Bausch Health of any material regulatory developments with respect to the XIPERE Product in the Territory in its own name and shall be that may negatively affect the owner timeline for the First Commercial Sale of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing XIPERE Product in the Territory and shall be borne by STOCOSIL.
5.3 DAEWOONG promptly respond to Bausch Health’s reasonable questions or requests for information relating thereto. In addition, within [***] following the end of each calendar quarter until the XIPERE NDA Approval Date, Clearside shall be responsible for implementing all provide a written report to Bausch Health setting forth in reasonable detail the status of its then-current regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership relation to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional XIPERE Product in the Territory.
5.8 Upon STOCOSIL. Clearside shall promptly respond to Bausch Health’s request and at STOCOSIL’s expense (reasonable questions or requests for information relating to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunderwritten report.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Regulatory. 5.1 The Parties shall work together 1.1.1 As between the Parties, Licensee will have responsibility for and decision-making over regulatory activities for the Licensed Products for the Indications in the Field of Use. As between the Parties, Licensee will have the right to produce high quality conduct all communications with Regulatory Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to Licensed Products for the Indications in the Field of Use. Licensee will lead and have control over preparing and submitting all INDs, BLAs and other material regulatory files relating filings related to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to Licensed Products for the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product Indications in the Territoy.
5.2 STOCOSIL shall be responsible Field of Use, including all applications for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing AuthorisationRegulatory Approval, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG willprovided, however, have rights that, Licensee shall notify Penn in writing of any such application for Regulatory Approval reasonably in advance of filing to access allow for Penn to request and, upon any such request, review such application. Promptly following any such review request from Penn, Licensee shall provide Penn with a copy of such application for Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL willApproval; provided, however, have access that Licensee shall not be obligated to provide any particular application for Regulatory Approval more than once (unless Licensee materially changes such application other than to incorporate any comments provided by Penn). As between the Parties, Licensee will own any and all applications for Regulatory Documentation Approvals (including INDs), Regulatory Approvals, and other regulatory filings related to the extent necessary for STOCOSIL to obtain its Marketing Authorisation Licensed Products for the Product and/or Optional Product Indications in the TerritoryField of Use which will be held in the name of Licensee (or its designees).
5.8 Upon STOCOSIL1.1.2 At Licensee’s reasonable request and at STOCOSIL’s expense expense, Penn (through Xx. Xxxxxx and other Xxxxxx Lab personnel) shall reasonably cooperate with and assist Licensee (or its designee) in connection with interactions with Regulatory Authorities relating to Licensed Products for the extent that it is necessaryIndications in the Field of Use. In addition, Licensee will keep Penn reasonably informed of the progress of such regulatory interactions and, upon request but not more than twice per Calendar Year, Licensee will provide to Xx. Xxxxxx (or another designated Xxxxxx Lab personnel), DAEWOONG shall:
(a) provide appropriate expertise on a confidential basis, a copy of any material regulatory filings or correspondence to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in or from the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, FDA or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute EMA with respect to the content of a Licensed Product for an Indication. Licensee will consider any regulatory filing reasonable comments provided on a timely basis by Xx. Xxxxxx (or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority such Xxxxxx Lab personnel) with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territorysuch regulatory interactions.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating (a) In the event that any change to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared Specifications is required by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL shall be responsible for implementing all applicable regulatory activities and all regulatory filings for each of the Product and/or Optional Product authority in the Territory in its own name and shall be the owner of all Marketing Authorisationfor Supply Product, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 belowTheraclone will ensure that such change is met. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership Such changes to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation Specifications will be implemented as amendments to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the TerritorySpecifications as set forth in Section 3.1.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified ZKC shall provide updates to Theraclone of (i) the progress of clinical development of Supply Product, (ii) the fact of any investigational new drug application or BLA submissions relating to Supply Product, and (iii) copies of the applicable sections of any ZKC regulatory filings which reference Theraclone, the Supply Product or Theraclone activities. The applicable sections of such ZKC regulatory filings shall be delivered to Theraclone prior to submission of such regulatory filings, and Theraclone shall have thirty (30) days to review and comment prior to their submission. ZKC shall also provide to Theraclone reasonable advance notice of any regulatory submission containing information or data provided by Theraclone to ZKC that ZKC intends and is permitted to disclose to regulatory agencies under this Supply Agreement or the License Agreement. Theraclone shall cooperate with ZKC and provide reasonable assistance to make registration filings for Supply Product as set forth in Section 2.10 of the License Agreement.
(c) Each party shall keep the other informed of any formal or informal inquiry by any regulatory agency of any state or national government or supranational authority relating to Supply Product supplied hereunder.
(d) Theraclone shall permit representatives of any regulatory agency having jurisdiction over the manufacture and/or marketing of the Supply Product or of any diagnostic assay or other product in which the Supply Product is incorporated (or that is used in conjunction with Supply Product), to attend meetings inspect its facilities in conjunction with the manufacture, testing, packaging, storage, handling and shipping of the Supply Product. Further, Theraclone shall advise ZKC immediately if Theraclone receives notice of an impending inspection or if an authorized agent of the FDA or other governmental agency visits any of Theraclone’s manufacturing facilities concerning the Supply Product. Theraclone shall furnish to ZKC any report including any FDA Form 483 notices (or comparable notices of other agencies), regulatory letters or similar documents received from such agency and the application of such report to the Supply Product, if any, within seven (7) days of Theraclone’s receipt of such report.
(e) In the case that Theraclone engages a Third Party manufacturer (subject to ZKC’s prior approval as set forth in Section 2.1) in connection with the supply of Supply Product hereunder, then Theraclone will require that such Third Party manufacturer allow inspections by the Japanese and other Territory regulatory authorities (as well as those of the Retained Territory upon whom Japanese or other Territory regulatory authorities rely) of those portions of its facilities where the Supply Products are manufactured, tested, packaged, stored, handled and shipped and where the manufacturing records for the Supply Product are stored, all on terms at least commensurate with those applicable to Theraclone’s manufacturing facilities in Section 4.2(d) above.
(f) The parties agree that within [***] after the Effective Date ZKC shall provide Theraclone a draft quality agreement for further discussion between the parties prior to its finalization as an agreement acceptable to Theraclone, ZKC, and Third Party licensees of the Supply Product. Such quality agreement shall be finalized in any event prior to Regulatory Approval of the Supply Product. Such quality agreement shall be fully consistent with and not change the terms of this Supply Agreement or of the License Agreement, and shall be sufficiently detailed to comply with applicable regulatory requirements. To avoid doubt, any terms of such quality agreement that are required by the Regulatory Authority in the Territory;
(c) support STOCOSIL in replying Territory need not be acceptable to regulatory queries related to CMC Theraclone, ZKC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside Third Party licensees of the Territory.
5.10 Each Party Supply Product (and their consent to such terms as acceptable shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may not be required by Applicable Lawthis Section or it is deemed automatically granted). Each Party The out-of-pocket cost of preparing such quality agreement (including Theraclone’s and Zenyaku’s out-of-pocket, reasonable and documented costs) shall have the right, during normal business hours be equally shared by Theraclone and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunderZKC.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: Development and License Agreement (Pharmathene, Inc)
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL (a) Licensee shall be responsible for implementing all regulatory activities related to the development and all regulatory filings for each commercialization of the Product and/or Optional in the Field in the Territory, at Licensee’s own cost and expense. Licensee shall prepare and file all Regulatory Materials necessary to obtain and maintain the Regulatory Approval of the Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing Field in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG and shall be responsible for implementing all communication and interaction with Regulatory Authorities with respect thereto.
(b) At Licensee’s request and expense, Licensor shall provide Licensee with reasonable assistance in connection with the regulatory activities for the Product in the Field in the Territory. Licensor shall provide Licensee access to all material preclinical and all clinical data, results, communications and other information Controlled by Licensor and relating to or resulting from any of Licensor’s clinical trials or regulatory filings relating to the Licensed Virus in the Field (the “Licensor Data”) for each use by Licensee in obtaining Regulatory Approval for the Product in the Field in the Territory, and Licensee shall have a right of access, a right of reference and a right to use and incorporate all such Licensor Data for purposes of obtaining Regulatory Approval of the Product and/or Optional Product outside of in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Field in the Territory.
5.8 Upon STOCOSIL(c) Licensee shall provide Licensor with drafts of all Regulatory Materials relating to the Product a reasonable time prior to submission for review and comment, and shall consider and implement in good faith any comments received from Licensor. Without limiting the foregoing, upon Licensor’s request request, Licensee shall remove from such Regulatory Materials any information that Licensor reasonably believes would materially and at STOCOSIL’s expense (adversely affect the development or commercialization of any Therapeutic Virus outside the Field, to the extent that it is necessary)allowed by applicable laws and regulations. In addition, DAEWOONG shall:
Licensee shall provide Licensor with copies of any Regulatory Materials relating to the Product submitted to or received from any Regulatory Authority in the Territory within ten (a10) provide appropriate expertise days after submission or receipt, and shall notify Licensor of any other material communication relating to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings the Product with any Regulatory Authority in the Territory;
Territory within ten (c10) support STOCOSIL in replying to regulatory queries related to CMC and GMP; anddays after such communication.
(d) support STOCOSIL If any Regulatory Exclusivity is available for any Product in cGMP audits by any country or jurisdiction, Licensee shall, at its own cost and expense, use Commercially Reasonable Efforts to seek and maintain such Regulatory AuthoritiesExclusivity protection for such Product. If Licensee does not seek or maintain such Regulatory Exclusivity protection, then Licensor shall have the right (but not the obligation) to do so at Licensor’s own cost and expense; provided that if Licensor successfully obtains such Regulatory Exclusivity protection, Licensee shall reimburse Licensor for all cost and expense incurred.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (e) Licensee shall keep Licensor informed with respect to any adverse event or safety issues relating to the extent that it is necessary), STOCOSIL shall:development or commercialization of the Product in the Field in the Territory. The Parties may enter into a pharmacovigilance agreement setting forth the procedures for the reporting of adverse event or safety issues of the Product in order for the Parties to comply with its reporting obligations under applicable Laws.
(af) provide appropriate expertise Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product may be subject to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any recall, corrective action or other regulatory action by any Regulatory Authority outside (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which conducting a Remedial Action. Licensee shall be complete and accurate and shall fully and properly reflect responsible for all work done and results achieved Remedial Actions for the Product in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product Field in the Territory, including the decision to commence such Remedial Action, and DAEWOONG will have shall bear all cost and expense thereof. Licensee shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit Licensee to trace the final decision making authority with respect to distribution, sale and use of the Product and/or Optional Product outside of in the Field in the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: License Agreement (Genelux Corp)
Regulatory. 5.1 The 10.2.1 DSM will provide AMAG with standard regulatory support as identified under the heading “Regulatory Support” in ANNEX 4 attached hereto. DSM shall also make available to AMAG, at AMAG’s request and expense, additional regulatory consulting services as identified under the heading “Regulatory Consulting” in ANNEX 4 attached hereto. Regulatory support services, as identified in ANNEX 4, shall be at no additional charge to AMAG; regulatory consulting services shall be billed at DSM’s standard hourly rates and payable pursuant to Section 7.4 of this Agreement. Additional regulatory services and/or documentation may be provided by DSM, subject to the agreement of the Parties and subject to additional charges.
10.2.2 AMAG shall work together to produce high quality regulatory files provide DSM with all documents reasonably requested by DSM relating to the Product and Optional Product. Regulatory Dossiers and FDA’s pre-approval inspection of the Facility, including, but not limited to, development reports, CMC sections of AMAG’s NDA or other Regulatory Documentation relating and stability data. In addition, AMAG shall provide to DSM a copy of AMAG’s annual report filed with the FDA with respect to the Product manufacture and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries control of the Territory. Nevertheless, DAEWOONG, or its affiliates, Product; and AMAG shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order take into consideration any DSM comments to support STOCOSIL for registration such annual report solely to the extent applicable to the manufacture of the Product and/or Optional Product as performed by DSM. DSM shall provide comments on the Annual Report to AMAG within three (3) business days after receipt. Notwithstanding the foregoing or anything in this Agreement to the Territoy.
5.2 STOCOSIL contrary, AMAG shall be solely responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in Product, including the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all CMC regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide10.2.3 DSM will not change or modify any of the master batch records or manufacturing SOPs, as soon as physically possibleor otherwise make any change in the materials, access equipment, process or procedures used to STOCOSIL of DAEWOONGmanufacture or test any Product in AMAG’s existing Product ownership of all Korean Marketing Authorization, judgment that would require a filing with a Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer Authority and/or that would reasonably be expected to DAEWOONG as soon as possible after its decision or affects DSM’s ability to permanently stop with the Development and/or Commercialization manufacture the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for Specifications or the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination terms of this Agreement, without first obtaining AMAG’s prior written approval. DSM will disclose all proposed changes in such manufacturing and testing materials, equipment, process or for procedure to AMAG at a level that would be sufficient to allow AMAG to understand and reproduce such longer period as may be required by Applicable Lawchanges and comply with regulatory standards. Each Party shall have the right, during normal business hours and upon reasonable notice, If AMAG agrees to inspect and copy allow any such recordschange requiring AMAG’s approval to be implemented, except then the Parties will revise manufacturing SOPs, master batch records and the relevant Specifications in writing accordingly, if applicable.
10.2.4 DSM will keep complete, accurate and authentic accounts, notes, data and records pertaining to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Partymanufacture, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossierprocessing, Regulatory Documentationtesting, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territorystorage, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization delivery/shipment of the Product from the Facility, including without limitation master production and Optional Product within control records in accordance with regulatory standards and with the Territory as well as outside of terms set forth in the TerritoryQuality Agreement. Each Party DSM will retain such documentation in accordance with DSM’s record retention policy and in accordance with the retention schedule specified in the Quality Agreement, which shall promptly notify each other of relevant informationat least be the period required by applicable law. Electronic records will be backed up and stored at a secure offsite storage facility.
Appears in 1 contract
Samples: Pharmaceutical Manufacturing and Supply Agreement (Amag Pharmaceuticals Inc.)
Regulatory. 5.1 The Parties shall work together to produce high quality (a) Novartis will
(i) determine the regulatory files relating plans and strategies for any Licensed Products;
(ii) make all Regulatory Filings with respect to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. NeverthelessLicensed Products, DAEWOONG, either itself or through its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.Affiliates or sublicensees; and
5.2 STOCOSIL shall (iii) be responsible for implementing all regulatory activities obtaining and all regulatory filings for each of maintaining Regulatory Approvals throughout the Product and/or Optional Product world in the Territory in name of Novartis or its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSILAffiliates or sublicensees.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives Cerulean will reasonably cooperate with and provide assistance to attend meetings Novartis in connection with filings to any Regulatory Authority relating to the Licensed Products, including by executing any required documents, providing access to personnel, and providing Novartis with copies of all reasonably required documentation, and will cause its vendors and service providers to transfer any such filings that are in their control. To cooperate and assist pursuant to this Section, Cerulean will provide, at its expense, up to [**] hours of working time by Cerulean employees; Novartis will bear all reasonable costs and expenses associated with any additional hours required from Cerulean employees hereunder, as well as any reasonable costs associated with cooperation or assistance required from Cerulean’s vendors or service providers. Cerulean will have the Territory;right to attend CMC-specific meetings with Regulatory Authorities, provided that this will not prevent the attendance of required Novartis personnel, as determined by Novartis, due to limitations on the number of attendees imposed by such Regulatory Authorities, and to provide comments (which will be reasonably considered by Novartis) on Regulatory Filings and other communications with Regulatory Authorities that are directly related to the Cerulean platform as implemented in a Licensed Product; and provided, further that any such activities conducted at Cerulean’s election (and not at Novartis’ request) shall be at Cerulean’s own cost and expense (and will not be counted toward the [**] hours of assistance described above). Novartis will share any guidance received from Regulatory Authorities that specifically relates to the Cerulean platform. Any information arising from such activities will be deemed to be the Proprietary Information of Novartis.
(c) support STOCOSIL in replying To the extent necessary, Cerulean will grant or cause to regulatory queries related be granted to CMC Novartis and GMP; andits Affiliates or sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Cerulean or its Affiliates with any Regulatory Authority.
(d) support STOCOSIL Novartis will have the right to disclose the existence of, and the results from, any clinical trials conducted under this Agreement in cGMP audits by Regulatory Authoritiesaccordance with its standard policies.
5.9 Upon DAEWOONG’s request (e) When and at DAEWOONG’s expense (to as deemed necessary or appropriate by Novartis, the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon Parties will enter into a commercially reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute pharmacovigilance agreement with respect to the content of any regulatory filing Licensed Product being Developed by Novartis or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territoryits Affiliates.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: Research Collaboration Agreement (Cerulean Pharma Inc.)
Regulatory. 5.1 The Parties 6.1. Zai’s Responsibilities. Zai shall work together use Commercially Reasonable Efforts to produce high quality regulatory files relating to obtain Regulatory Approvals and pricing and reimbursement approvals for Licensed Products in the Product Territory in accordance with the Development Plan and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product Zai shall be prepared by the Parties so as to meet the standards solely responsible for all costs and all Applicable Law requirements expenses incurred in each countries of connection with performing such activities in the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL Zai shall be responsible for implementing all regulatory activities leading up to and all regulatory filings for each including the obtaining of the Regulatory Approvals for a Licensed Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to from the Regulatory Documentation generated by STOCOSILAuthority on a region-by-region basis, unless it is transferred to DAEWOONG in accordance with Clause 5.5at its sole cost and expense. DAEWOONG willZai or its designee shall own, however, have rights to access to such hold and maintain all Regulatory Documentation to the extent necessary Approvals for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional a Licensed Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (; provided however that [***]; provided that in the event [***]. Zai shall keep Deciphera promptly informed of regulatory developments related to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with Licensed Products in the Territory and shall promptly notify Deciphera in writing of any decision by any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory AuthoritiesTerritory regarding a Licensed Product.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Review of Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable LawSubmissions. Each Party shall have provide to Deciphera for review and comment drafts of all Regulatory Submissions in the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except Territory for the Licensed Products no later than [***] prior to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territoryplanned submission. Each Party shall promptly incorporate any comments received from the other Party on such Regulatory Submissions where required under any Applicable Law and shall consider in good faith any other comments received from the other Party on such Regulatory Submissions. In addition, each Party shall notify each the other Party of relevant informationany material Regulatory Submissions for the Licensed Products and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide such other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof. If any such Regulatory Submission, comment, or correspondence is not in English, then, at the other Party’s request and expense, the Party providing such copies shall also provide the other Party with a written English translation within the corresponding timelines as set forth in this ARTICLE 6.
Appears in 1 contract
Samples: License Agreement (Zai Lab LTD)
Regulatory. 5.1 The Parties (i) Admedus shall work together to produce high quality regulatory files relating to maintain throughout the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries Term of the Territory. NeverthelessAgreement all permits, DAEWOONGregistrations, approvals and authorizations (“Maintained Approvals”) as may be required to manufacture, promote, market, distribute, and sell Products in accordance with the terms of this Agreement, except for those approvals that have been transferred in full to LeMaitre by mutual agreement or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of where LeMaitre is approved as the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 belownew legal manufacturer. For the avoidance of doubt, registration fee the Maintained Approvals do not include any trademark registrations for the Products in any jurisdiction. LeMaitre shall timely provide a transfer request for each Maintained Approval such filing that all Maintained Approvals are transferred to LeMaitre by the end of the Term, except for any Maintained Approvals where the parties mutually agree in the Territory shall be borne by STOCOSILwriting that transfer is not appropriate.
5.3 DAEWOONG (ii) During the Extension Period, LeMaitre shall be responsible reimburse Admedus for implementing all regulatory activities time its employees and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil contractors spend towards fulfilling its obligations under Clause 5.2;
this Section 6(a)(i) and all costs associated with the Maintained Approvals to ensure their maintenance throughout the Extension Period. Within ten (b10) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside business days of the Territory.
5.10 Each Party end of each month during the Extension Period, Admedus shall maintainsend LeMaitre an invoice with documentation listing all out-of-pocket costs incurred during such month, or cause to be maintainedwith copies of receipts evidencing payment by Admedus of such costs, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved setting forth the time spent by each Admedus employee in the performance of its respective Development activitiesthese maintenance services, the name, title and function of each such employee, their Hourly Rate (as defined herein), and which any additional costs including delivery fees, notarization or legalization fees, or fees for any contractors engaged by Admedus and utilized in the performance of these maintenance services (“Invoice”) and LeMaitre shall pay such Invoice within thirty (30) days of receipt. “Hourly Rate” for each Admedus employee shall be retained determined, for salaried employees, based on their annual compensation (excluding bonus) divided by such Party their working hours (which for Australia-based full-time employees shall be 1748 and for US-based employees shall be 1864), and for non-salaried employees, based on their hourly wage plus any applicable overtime. If the monthly costs in any given month are known by Admedus to exceed [***], Admedus shall make reasonable efforts to notify LeMaitre at least five (5) years after business days prior to sending the expiration Invoice. Any Hourly Rates communicated under this section are the Confidential Information of Admedus under Section 7 and shall not be used for any other purpose other than payment of the Invoice or termination shared with anyone other than as required to pay the Invoice. LeMaitre is responsible for any fees associated with any contractor or consultant it retains regarding the Maintained Approvals and in the performance of maintenance services regarding these Maintained Approvals during the Extension Period. Any other fees or application costs for the Maintained Approvals during the Extension Period in a territory listed on Schedule 4.1(j) shall either (A) be borne directly by LeMaitre or (B) Admedus shall be reimbursed by LxXxxxxx within thirty (30) days of Axxxxxx’s request for payment and presentation of evidence of Axxxxxx’s payment therefor.
(iii) If during the Term, LeMaitre wishes to market and sell or distribute any Product in a territory not listed on Schedule 4.1(j) of the APA, then LeMaitre shall be responsible for obtaining and maintaining any permits, registrations, approvals and authorizations for such marketing sale or distribution (“New Approvals”). During the Term, Axxxxxx will reasonably cooperate with LeMaitre in obtaining such New Approvals, with the out-of-pocket costs associated with such efforts to be borne directly by LeMaitre. During the Extension Period only, LeMaitre shall reimburse Admedus for time its employees and contractors spend towards fulfilling its obligations under this Section 6(a)(iii). Within ten (10) business days of the end of each month during the Extension Period, Admedus shall send LeMaitre an Invoice as defined in Section 6(a)(ii) for the services provided under this Section 6(a)(iii). Any Hourly Rates communicated under this section are the Confidential Information of Admedus under Section 7 and shall not be used for any other purpose other than payment of the Invoice or shared with anyone other than as required to pay the Invoice.
(iv) Notwithstanding any of the foregoing, Admedus shall remain, and fulfill the corresponding duties of, the “sponsor” of the Products sold under the SAS for as long as necessary during the Term according to Section 3(e) of this Agreement, or ; provided that LeMaitre (A) transmits to Admedus (without request from Admedus) all necessary data for such longer the previous six-month period as may be required by Applicable Law. Each Party shall have ending December 31 and June 30 respectively during each year of the right, during normal business hours and upon reasonable notice, Term in order for Admedus to inspect and copy any such records, except submit the requisite reports to the extent TGA in respect of Product usage under such scheme and provides Admedus with an attestation that a Party reasonably determines that such records contain Confidential Information that the data is not licensed true and correct, in each case by no later than January 15th and July 15th of each year during the Term, (B) promptly responds to any direct or indirect requests from the TGA or other Partyrelevant SAS authority regarding compliance, or to which and (C) complies promptly with all other reasonable and timely requests by Admedus regarding sales of Products under the other Party does not otherwise have a right of access hereunderSAS.
5.11 In the event of (v) LeMaitre may designate a dispute third party (“Regulatory Vendor”) to perform any obligations under this Agreement as if it were LeMaitre, for example with respect to ARTG listings. Except as otherwise mutually agreed in writing, LeMaitre shall be responsible for any out-of-pocket fees and costs billed by the content Regulatory Vendor including any fees incurred by the Regulatory Vendor (and LeMaitre shall be billed directly for said fees). LeMaitre shall be the primary point of contact with the Regulatory Vendor with Admedus providing LeMaitre with any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or required information in accordance with the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, obligations of Admedus under this Agreement and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside as manufacturer of the TerritoryProducts.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.”
Appears in 1 contract
Samples: Transition Services Agreement (Anteris Technologies Global Corp.)
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. 6.1 Holder of Regulatory Dossiers Approvals and Regulatory Documentation relating to Submissions. NVCR shall initially be the Product holder of Regulatory Approvals and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements Regulatory Submission for Licensed Products in each countries of the Territory. NeverthelessAt Zai’s request during the Term, DAEWOONG(a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, or its affiliates, shall provide STOCOSIL all and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Dossiers, Approvals and Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product Submissions in the TerritoyTerritory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 21 Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions.
5.2 STOCOSIL 6.2 Zai’s Responsibilities.
(a) Zai shall be responsible [***] for implementing all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory filings for each activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Product and/or Optional Licensed Product in the Territory in its own name and shall be during such time that NVCR is the owner holder of all Marketing Authorisation, Regulatory Dossier Approvals and Regulatory Documentation other than as described in Clause 5.3 below. For Submissions for the avoidance of doubt, registration fee for such filing Licensed Product in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible Territory) as the express, exclusive, and authorized legal agent of record for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory NVCR in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the ownership benefit of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-Zai in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory. Promptly after the Effective Date and from time to time during the Term, the ownership Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the respective Marketing AuthorisationTerritory. Notwithstanding the foregoing, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Licensed Products in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives Zai shall promptly provide to attend meetings NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission.
(c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries Territory related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved Licensed Product in the performance of Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party designee shall have the right, during normal business hours and upon reasonable noticebut not the obligation, to inspect attend and copy any participate in such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, meeting or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicablydiscussion. If there is no resolutionNVCR elects not to attend such meeting or discussion, STOCOSIL will have the final decision making authority Zai shall provide NVCR with respect to the Product and/or Optional Product a written summary thereof in the TerritoryEnglish promptly following such meeting or discussion. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the TerritoryMARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Each Party shall promptly notify each other of relevant information.22
Appears in 1 contract
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. 6.1 Holder of Regulatory Dossiers Approvals and Regulatory Documentation relating to Submissions. NVCR shall initially be the Product holder of Regulatory Approvals and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements Regulatory Submission for Licensed Products in each countries of the Territory. NeverthelessAt Zai’s request during the Term, DAEWOONG(a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, or its affiliates, shall provide STOCOSIL all and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Dossiers, Approvals and Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product Submissions in the TerritoyTerritory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 21 Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions.
5.2 STOCOSIL 6.2 Zai’s Responsibilities.
(a) Zai shall be responsible [***] for implementing all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory filings for each activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Product and/or Optional Licensed Product in the Territory in its own name and shall be during such time that NVCR is the owner holder of all Marketing Authorisation, Regulatory Dossier Approvals and Regulatory Documentation other than as described in Clause 5.3 below. For Submissions for the avoidance of doubt, registration fee for such filing Licensed Product in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible Territory) as the express, exclusive, and authorized legal agent of record for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory NVCR in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the ownership benefit of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-Zai in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory. Promptly after the Effective Date and from time to time during the Term, the ownership Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the respective Marketing AuthorisationTerritory. Notwithstanding the foregoing, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Licensed Products in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives Zai shall promptly provide to attend meetings NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission.
(c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries Territory related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved Licensed Product in the performance of Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party designee shall have the right, during normal business hours and upon reasonable noticebut not the obligation, to inspect attend and copy any participate in such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, meeting or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicablydiscussion. If there is no resolutionNVCR elects not to attend such meeting or discussion, STOCOSIL will have the final decision making authority Zai shall provide NVCR with respect to the Product and/or Optional Product a written summary thereof in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the TerritoryEnglish promptly following such meeting or discussion. Each Party shall promptly notify each other of relevant information.THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 22
Appears in 1 contract
Regulatory. 5.1 The Parties (a) Zai (either by itself or through its Affiliates and sublicensees) shall work together have the sole right to produce high quality regulatory files relating to the Product apply for and Optional Product. maintain, at its sole discretion and own cost and expense, all Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries Approvals of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product Products in the Territoy.
5.2 STOCOSIL Field in the Territory consistent with the Zai Development Plan. Zai shall be responsible for implementing the preparation of all regulatory activities Regulatory Materials and all regulatory filings for each of the Product and/or Optional Product in the Territory in Zai or its own name and designee shall be the owner holder of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Approvals in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives Xxx shall be responsible for all communications and interactions with Regulatory Authorities with respect to attend meetings the Products in the Field in the Territory, both prior to and subsequent to Regulatory Approval. Unless otherwise required by applicable Law, MediLink shall not, and shall cause its Affiliates and Permitted Subcontractors not to, correspond or communicate with Regulatory Authorities regarding any Compound or Product without Xxx’s prior written consent. If MediLink, its Affiliates, or Permitted Subcontractors receive any correspondence or other communication from a Regulatory Authority regarding a Compound or Product, MediLink shall provide Zai with access to or copies of all such correspondence or communication promptly after its receipt.
(c) Zai shall keep MediLink reasonably informed of regulatory developments related to Products in each jurisdiction in the Territory and will promptly notify MediLink in writing of any major decision by any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; andTerritory regarding any Product.
(d) MediLink shall support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period Zai as may be required requested by Applicable LawXxx from time to time in connection with Xxx’s preparation, submission to Regulatory Authorities and maintenance of Regulatory Materials, including to obtain or maintain IND and Regulatory Approvals, for any Compounds and Products, including attending meetings with Regulatory Authorities regarding any Compound or Product upon Xxx’s request. Each Party shall have Zai will pay MediLink the right, during normal business documented FTE Costs for the FTE hours and upon reasonable notice, to inspect and copy any actually worked by such records, except to FTEs after the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product Effective Date in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside performance of the Territorysupport to Zai for such regulatory affairs. The calculation method of FTE Costs and the payment mechanism as set forth in Section 3.5(b) shall apply mutatis mutandis.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: License Agreement (Zai Lab LTD)
Regulatory. 5.1 (a) The Parties shall work together JDC will approve all regulatory plans and strategies and the schedule for regulatory submissions. Pursuant to produce high quality regulatory files Section 4.1, Licensor will provide Novartis with copies of any correspondence or other documentation it has submitted to, or received from, any Regulatory Authority relating to the Product Compound or Product.
(b) Licensor shall be solely responsible, at its sole expense, for obtaining Regulatory Approvals for Products in the Territory prior to the exercise by Novartis of its Development Rights. Prior to the Novartis Development Commencement Date, all Regulatory Filings submitted in any country in the Territory in connection with obtaining Regulatory Approvals to test or market the Compound or Product, including all IND, NDA and Optional Product. MAA submissions and other Regulatory Dossiers and Regulatory Documentation Filings relating to the Product and Optional Product Compound or Product, shall be prepared owned by, and submitted by and in the Parties so as name of, Licensor or its Affiliates. Licensor will promptly deliver to meet Novartis copies of all relevant regulatory correspondence or other documents received by Licensor or its Affiliates with respect to the standards Compound or Product. Prior to making any Regulatory Filing or submitting any correspondence or other documentation to any Regulatory Authority with respect to the Compound or Product, Licensor shall deliver to Novartis a copy thereof in draft form. Novartis will have the opportunity to review and provide comments thereon and Licensor will reasonably take into account Novartis’ comments. Novartis will have the right to be present at all Applicable Law requirements meetings with Regulatory Authorities.
(c) Within thirty (30) days after Novartis’ exercise of its Development Rights, Licensor or its Affiliates, without additional consideration, will transfer to Novartis or its designated Affiliate all Regulatory Approvals and Regulatory Filings in each countries the Territory and provide complete copies of the Territory. Nevertheless, DAEWOONG, same to Novartis or its affiliatesdesignated Affiliates. Following the Novartis Development Commencement Date, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
5.2 STOCOSIL (i) Novartis shall be responsible solely responsible, at its sole expense (subject to Section 5.3(b)), for implementing all regulatory activities and all regulatory filings obtaining any Regulatory Approvals for each of the Product and/or Optional Product in the Territory and (ii) all Regulatory Filings submitted in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing any country in the Territory in connection with obtaining Regulatory Approvals to test or market the Compound or Product, including all IND, NDA and MAA submissions and other Regulatory Filings relating to the Compound or Product, shall be borne owned by, and submitted by STOCOSILand in the name of, Novartis, its Affiliates or designees.
5.3 DAEWOONG (d) Licensor shall be responsible for implementing all regulatory activities fully cooperate with and all regulatory filings for each of the Product and/or Optional Product outside of provide reasonable assistance to Novartis in connection with Regulatory Filings in the Territory in its own name relating to the Compound or Product, including by executing any required documents, providing access to personnel and shall be the owner providing Novartis with copies of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategyreasonably required documentation.
5.4 DAEWOONG (e) To the extent required, Licensor shall provide, as soon as physically possible, access grant or cause to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, be granted to Novartis and its Affiliates or sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Licensor or its Affiliates with any Regulatory Dossier Authority with respect to the Compound or Product. Licensor also shall use commercially reasonable efforts to assist Novartis and its Affiliates or sublicensees in obtaining cross-reference rights to any relevant drug master files and other filings submitted by Third Parties with any Regulatory Documentation.
5.5 STOCOSIL, under Step-in Authority with respect to the Compound or Product. If Novartis exercises the Development Rights, Novartis shall transfer grant or cause to DAEWOONG as soon as possible after be granted to Licensor and its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under StepAffiliates or sublicensees cross-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership reference rights to the Regulatory Documentation generated portions of any drug master files and other filings submitted by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain Novartis or its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings Affiliates with any Regulatory Authority in regard to the Territory;Compound or Product that specifically relate to Licensor’s polymer technology.
(cf) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party Novartis shall have the rightright to disclose the existence of, during normal business hours and upon reasonable noticethe results from, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute clinical trials conducted under this Agreement in accordance with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicablyits standard policies. If there is no resolution, STOCOSIL will Licensor shall have the final decision making authority with respect right to disclose the Product and/or Optional Product in the Territoryexistence of, and DAEWOONG will have the final decision making authority with respect to results from, any clinical trials conducted under this Agreement upon prior review and approval by the Product and/or Optional Product outside of the TerritoryJDC or as otherwise permitted by Section 17.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: License and Co Development Agreement (Cell Therapeutics Inc)
Regulatory. 5.1 The Parties shall work together 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to produce high quality and contingent on the resolution of any regulatory files considerations relating to such obligations. Neither YouNow nor PeerStream shall be liable or responsible to the Product other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of the Agreement, when and Optional Productto the extent such failure or delay is caused by or results from the application of any law or regulation, a change in any law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. Regulatory Dossiers Further, YouNow and Regulatory Documentation PeerStream will work in good faith to address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform.
7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the PeerStream Apps to comply with applicable law. Notwithstanding any provisions of this Agreement to the contrary, (i) Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (“SEC”), including any such YOUNOW MASTER SERVICES AGREEMENT 7 CONFIDENTIAL filings or submissions relating to the Product and Optional Product shall be prepared by the Parties so as an offering pursuant to meet the standards and all Applicable Law requirements in each countries Regulation A of the Territory. NeverthelessSecurities Act of 1933, DAEWOONGas amended (“Regulation A”), or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents periodic and other related supporting documents it reports required to be filed by YouNow with the SEC and (ii) YouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Platform in any filings or submissions to the SEC, including periodic and other reports required to be filed by PeerStream with the SEC.
7.4.3 Any alterations that YouNow makes to the structuring of the integration of the PeerStream Apps that YouNow deems necessary in order to support STOCOSIL for registration address regulatory considerations that would restrict the integration of the Product and/or Optional Product PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement.
7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the Territoy.
5.2 STOCOSIL shall future, PeerStream acknowledges that this Agreement does not contemplate any payments to PeerStream from the Protocol Rewards Engine. Further, PeerStream and YouNow acknowledge and agree that: (i) No money or other consideration is being solicited in connection with any YouNow offering from the Protocol Rewards Engine, and if sent in response, will not be responsible for implementing all regulatory activities accepted; (ii) No offer to buy Props Tokens can be accepted and all regulatory filings for each no part of any purchase price can be received in connection with any YouNow offering from the Product and/or Optional Product in Protocol Rewards Engine until an offering statement is qualified pursuant to the Territory in its own name and shall be the owner Securities Act of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide1933, as soon as physically possibleamended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, access to STOCOSIL without obligation or commitment of DAEWOONG’s existing Product ownership any kind, at any time before notice of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible its acceptance given after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMPqualification date; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Regulatory. 5.1 The Parties shall work together 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to produce high quality and contingent on the resolution of any regulatory files considerations relating to such obligations. Neither YouNow nor PeerStream shall be liable or responsible to the Product other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of the Agreement, when and Optional Productto the extent such failure or delay is caused by or results from the application of any law or regulation, a change in any law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. Regulatory Dossiers Further, YouNow and Regulatory Documentation PeerStream will work in good faith to address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform.
7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the PeerStream Apps to comply with applicable law. Notwithstanding any provisions of this Agreement to YOUNOW MASTER SERVICES AGREEMENT 6 CONFIDENTIAL the contrary, (i) Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (“SEC”), including any such filings or submissions relating to the Product and Optional Product shall be prepared by the Parties so as an offering pursuant to meet the standards and all Applicable Law requirements in each countries Regulation A of the Territory. NeverthelessSecurities Act of 1933, DAEWOONGas amended (“Regulation A”), or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents periodic and other related supporting documents it reports required to be filed by YouNow with the SEC and (ii) YouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Platform in any filings or submissions to the SEC, including periodic and other reports required to be filed by PeerStream with the SEC.
7.4.3 Any alterations that YouNow makes to the structuring of the integration of the PeerStream Apps that YouNow deems necessary in order to support STOCOSIL for registration address regulatory considerations that would restrict the integration of the Product and/or Optional Product PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement.
7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the Territoy.
5.2 STOCOSIL shall future, PeerStream acknowledges that this Agreement does not contemplate any payments to PeerStream from the Protocol Rewards Engine. Further, PeerStream and YouNow acknowledge and agree that: (i) No money or other consideration is being solicited in connection with any YouNow offering from the Protocol Rewards Engine, and if sent in response, will not be responsible for implementing all regulatory activities accepted; (ii) No offer to buy Props Tokens can be accepted and all regulatory filings for each no part of any purchase price can be received in connection with any YouNow offering from the Product and/or Optional Product in Protocol Rewards Engine until an offering statement is qualified pursuant to the Territory in its own name and shall be the owner Securities Act of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide1933, as soon as physically possibleamended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, access to STOCOSIL without obligation or commitment of DAEWOONG’s existing Product ownership any kind, at any time before notice of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible its acceptance given after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMPqualification date; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Regulatory. 5.1 The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product5. 1Holder of Regulatory Dossiers Approvals and Regulatory Documentation relating to Submissions; Regulatory Responsibilities. A Marinus Affiliate located in the Product European Union, Marinus Pharmaceuticals Emerald Limited, limited liability company formed corporation incorporated and Optional Product shall existing under the laws of Ireland, registration number 688211, having a principal registered address place of business at 00 Xxxxxxxxx Xxxxxxx, Xxxxxx 0, X00 X000, Ireland, or another Marinus Affiliate located in the European Union will be prepared by the Parties so as to meet the standards and initial marketing authorization holder for all Applicable Law requirements Regulatory Approvals of Licensed Products in each countries of the Territory. NeverthelessMarinus shall have the right to transfer the Regulatory Approvals to other Marinus wholly owned subsidiaries located in the Territory for tax or other corporate purposes. Additionally, DAEWOONGshould Marinus be required to hold local Regulatory Approvals within specific countries in the Territory, or its affiliatesMarinus shall set up such local subsidiaries as are required within such countries in the Territory. Marinus will be responsible for the conduct of all regulatory activities with respect to Licensed Products. Marinus shall promptly inform Licensee in writing of any plan to transfer the Regulatory Approvals and the Parties shall discuss in good faith implications of such transfer. Marinus will be responsible for the conduct of all regulatory activities with respect to Licensed Products in the Field and in the Territory, including (i) developing regulatory plans, strategies and interactions with Regulatory Authorities in the Field in the Territory in support of obtaining such Regulatory Approvals, and (ii) preparing, obtaining, submitting, engaging and maintaining Regulatory Submissions for Licensed Products and obtaining and maintaining Regulatory Approvals of Licensed Products in the Field in any country in the Territory and Licensee shall provide STOCOSIL all such information, data and support to Marinus (including information and data with respect to Licensee’s conduct of Post-Regulatory DossiersApproval Studies) as may be reasonably requested by Marinus from time to time, provided, however, that details of such support shall be subject to a separate written agreement by the Parties. Marinus shall promptly inform Licensee about any Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration Approvals of the Product and/or Optional Product Licensed Products in the Territoy.
5.2 STOCOSIL Territory. Notwithstanding the foregoing, as part of its Commercialization activities, Licensee shall be responsible for implementing using Commercially Reasonable Efforts for obtaining all regulatory activities pricing and all regulatory filings reimbursement approvals for each of the Product and/or Optional Product Licensed Products in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
5.3 DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
5.4 DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
5.5 STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
5.6 DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
5.7 STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product Field in the Territory.
5.8 Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
(a) provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
(c) support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
(d) support STOCOSIL in cGMP audits by Regulatory Authorities.
5.9 Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
(a) provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
(b) send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
5.10 Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
5.11 In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
5.12 Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
Appears in 1 contract
Samples: Collaboration Agreement (Marinus Pharmaceuticals Inc)