Regulatory Diligence Sample Clauses

Regulatory Diligence. The completion of healthcare regulatory diligence to the satisfaction of Agent and its counsel.

Regulatory Diligence. Ablynx shall use Commercially Reasonable Efforts in undertaking the Development activities (including Initial Development Activities) for the initial Licensed Product containing or comprising the Lead Compound for the Initial Indications in those countries in the Territory set forth in the Initial Development Plan and Budget. Ablynx acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means the delivery by Ablynx to AbbVie of the (i) RA Complete Data Package by the date set forth in the Initial Development Plan and Budget, and (ii) SLE Complete Data Package by the date set forth in the Initial Development Plan and Budget, in each case, unless otherwise mutually agreed to by the Parties.

Regulatory Diligence. In the event that Licensee determines at any time during the Term that it is not economically feasible to incur the costs necessary to obtain and maintain Regulatory Approval for the Product in a given country of the Territory, Licensee shall promptly notify Lilly in writing of such determination and Lxxxx shall have the right to obtain or maintain Regulatory Approval in such country, and may terminate this Agreement with respect to such Product in such country.

Regulatory Diligence. Following the successful completion by Licensor of the Initial Development Activities in accordance with the Initial Development Plan, Licensee shall file for, prosecute and use Commercially Reasonable Efforts to obtain Regulatory Approvals for the initial Licensed Product for the Renal Indication in each Major Market.

Regulatory Diligence. Galapagos shall use Commercially Reasonable Efforts in undertaking the Development activities for the initial Licensed Product containing or comprising the Lead Compound for the Initial Indication in those countries in the Territory set forth in the Initial Development Plan and Budget. Galapagos acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means that the provision by Galapagos to Xxxxxx of the Complete Data Package is expected by […***…]. If Galapagos does not provide the Complete Data Package by […***…], upon Galapagos’ showing that such delay is due to causes relating to Development or regulatory issues, Xxxxxx hereby agrees to extend such delayed date until such Development or regulatory issues are fully resolved in a reasonable period of time. If Xxxxxx alleges that Galapagos has failed to show that such delay is due to Development or regulatory issues, then Xxxxxx shall have the option either to: (i) assume and complete some or all remaining Initial Development Activities pursuant to Section 3.1.2; or (ii) notify Galapagos of such failure as an alleged material breach, subject to Section 12.2.1.

Regulatory Diligence. Section 3.1.3 of the Agreement is hereby amended by replacing all uses of “[…***…]” with “[…***…].”

Regulatory Diligence. Each Party shall use commercially reasonable efforts to perform its obligations under the Development Plan in a professional and timely manner with respect to regulatory obligations. Lilly shall have a right but not an obligation to audit or review clinical quality systems, clinical study data and clinical research organizations engaged by Zosano in carrying out the Development Plan.

Regulatory Diligence. (a) Unless otherwise provided in the JV contract or required by the applicable Laws, Company shall, at its own expense, obtain and maintain, or shall cause to be obtained and maintained, all Regulatory Approvals for each Distribution Product to enable the import, Marketing, sale and distribution of the Distribution Product in the Territory in accordance with applicable Law, including but not limited to the filing, registration or approval processes before importing, distributing and Marketing any medical device in the Territory. Company shall notify BIONIK each time it submits an application for government registration and marketing approval for a Distribution Product and shall supply the BIONIK with copies of and access to Company’s filings and shall keep the BIONIK fully informed of the progress of each such application. (b) For the avoidance of doubt, such filings pursuant to Section 7.1(a) would grant Regulatory Approval for such Distribution Product in the name of, and all such Regulatory Approvals shall be transferred to, BIONIK unless otherwise required by applicable Laws or agreed by the Parties. (c) Without limiting the foregoing, if Company wishes to Manufacture any of the Distribution Products and BIONIK is agreeable to it, BIONIK shall take all actions needed or advisable to transfer any relevant Regulatory Approval to Company. (d) For clarity, in no event shall the Company have any obligation to Market, sell or distribute any Distribution Product unless and until all the relevant Regulatory Approvals have been obtained by Company and a copy of such Regulatory Approvals has been provided to BIONIK provided that Company shall still have the obligation to Market, sell or distribute any Distribution Product in a limited manner and in full compliance with applicable Law.

Regulatory Diligence. Without limiting the generality of Section 4.5.1, MTPC will, within [***] after the completion of all pre-registration activities for a Product necessary to support the applicable applications for Regulatory Approval, submit the applications for Regulatory Approval for such Product; provided that MTPC shall not be required to do so if MTPC reasonably determines that it would not be in the best interests of Commercialization of such Product in the Territory.

Regulatory Diligence. Subject to Successful Completion of the applicable Lead Indication Trial, Mundipharma shall use Commercially Reasonable Efforts to obtain and maintain Regulatory Approvals for Lead Indication Product for the corresponding Lead Indication in each of the Major Markets; provided that, for clarity, Mundipharma shall not be under any obligation to obtain or maintain any Regulatory Approvals for the Lead Indication Product or the Pediatric Licensed Product in the Prophylaxis Indication in China.