Regulatory Obligations. Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product. As between the Parties, but subject to [...***...], Licensee will be solely responsible for all activities in connection with maintaining Marketing Approvals required for the Commercialization and manufacture of POZEN Products in the Territory, including communicating and preparing and filing all reports (including Adverse Event reports) with the applicable Regulatory Authorities in the Territory.
Regulatory Obligations. Except as otherwise provided in Article 2.2, above, and this Article 6, Xxxxxxxxx shall be responsible for the regulatory strategy, including strategy for filings and label content, in consultation with Lilly, including commercial input. Xxxxxxxxx shall be solely responsible for all regulatory activities in connection with seeking Regulatory Approvals in the Territory, including communicating and preparing and filing all reports with the Regulatory Authorities. [**]
Regulatory Obligations. All obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any Product-related adverse experience reports, quality reports, and complaint reports. HSL shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL shall remain solely responsible, at its expense, for compliance with (A) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce Product; (B) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (C) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMI, unless the Proposal includes such activities. All information, documents and updates with regard to the manufacture of Product which are required by any governmental agency shall be provided by HSL in a timely manner, and HSL shall submit to all inquiries and inspections by any such agencies. All documents directly related to the Product and a summary of all information provided by HSL to any such agency shall be provided to LMI in advance of submission to such agency. LMI shall not file any documents relating to HSL with regulatory authorities without HSL’s prior written consent, which shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days of receipt and in the absence of delivery of such comments LMI may proceed with its filing. Notwithstanding the foregoing, LMI and HSL acknowledge that the regulatory support described in Proposal No. 973-5-11 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any cos...
Regulatory Obligations. Nothing in this Agreement shall require either Party or any of its Subsidiaries to violate or breach any applicable law, including any regulatory obligations binding on such person.
Regulatory Obligations. Each Party shall be solely responsible for all activities in connection with the Regulatory Approvals for their respective Product Line in the Territory, including without limitation communicating and preparing and filing all reports (including without limitation medical device reports) with the FDA. Each Party agrees to cooperate with the other Party as requested, at the requesting Party’s expense, in preparing and filing all such reports. Each Party shall pay all fees associated with obtaining and maintaining the Regulatory Approvals relating to its Product Line including, without limitation, any establishment license fees of such Party or Third Parties which must be paid with respect to facilities used in the manufacture of such Product Line.
Regulatory Obligations. 10.1 Either party will notify the other immediately it becomes aware of any disciplinary action or investigation planned, requested or conducted by any Regulator, relating in any way to itself or any of its representatives, except where such notification would place the notifying party in breach of any applicable law, or where the notifying party would be acting contrary to any Regulatory Rules.
10.2 Each party (the “Indemnifying Party”) hereby covenants and undertakes that it will on written demand indemnify (fully and effectually) and hold harmless the other party against any demands, liabilities and obligations (whether absolute, contingent, actual or future) and all claims, costs and expenses incurred in relation thereto, directly, indirectly or arising out of or in connection with any failure by the Indemnifying Party to comply with any Regulatory Consent.”
10.3 The Introducer shall:
(a) comply with all applicable laws, statutes, regulations relating to anti-bribery and anti- corruption including but not limited to the Xxxxxxx Xxx 0000 (Relevant Requirements);
(b) not engage in any activity, practice or conduct which would constitute an offence under sections 1, 2 or 6 of the Xxxxxxx Xxx 0000 if such activity, practice or conduct had been carried out in the UK;
(c) have and shall maintain in place throughout the term of this agreement its own policies and procedures, including adequate procedures under the Xxxxxxx Xxx 0000, to ensure compliance with the Relevant Requirements, the Relevant Policies and will enforce them where appropriate.
Regulatory Obligations. Customer is responsible for compiling the registration dossiers (with reasonable and necessary assistance from Lonza), filing the marketing applications with the regulatory authorities in the Territory, and maintaining marketing authorizations for the Product and the costs associated with the same. Lonza shall reasonably assist Customer in obtaining and maintaining marketing authorizations for the Product. Customer is responsible for (a) the formulation, use, packaging, labeling, distribution and disposal of Product, including compliance with all Laws related to the same; (b) communicating with any governmental authority concerning the Product (for the avoidance of doubt, Lonza may interact with governmental authorities for the purpose of fulfilling legal obligations); and (c) storing and handling Product in appropriate conditions following its delivery; and (d) determining that the Product is permitted for human use. Customer is responsible for developing all Product labeling, and for labeling content.
Regulatory Obligations. A Party may bring an action to enforce any Regulatory Obligation, once approved as proposed under this Agreement, only to the extent otherwise provided by Applicable Law. Nothing in this Agreement establishes a right to enforce a Regulatory Obligation, or jurisdiction for such enforcement, against a Party if such right or jurisdiction does not otherwise exist under Applicable Law.
Regulatory Obligations. Customer shall be solely responsible for preparation and submission of applications to Agencies regarding the Product. Customer will advise Codexis of document requirements in support of such applications by Customer. Codexis will, at Customer’s expense at Codexis’ then-current rates agreed upon by the Parties, use its commercially reasonable efforts to provide documents and additional information needed for such applications, and to cooperate with and assist Customer in preparation and submission of such applications to the FDA (and other Agencies, as appropriate). All such applications to Agencies and related filings by Customer shall be the sole and exclusive property of Customer, as applicable. Customer shall be solely responsible for all contacts and communications with any Agencies with respect to all matters relating to the Product. At the request of Customer, Codexis shall make appropriate personnel reasonably available for meetings with Agencies related to manufacturing of Codexis Enzymes and the related processing of the Product.
Regulatory Obligations. Nothing in this Agreement shall exclude or restrict any duty or liability of any Indemnified Person which it has under FSMA or under the regulatory system (as defined in the FCA Handbook) to the extent such exclusion or restriction is prohibited by the FCA Handbook. The parties agree that the terms of this Agreement, including this clause 12, are reasonable, honest, fair and professional.
