Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection or audit of any facility in which any Development or Manufacturing activities are being carried out under this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutus, then (a) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or audit, and (b) Arbutus shall (i) cooperate with such Regulatory Authority during such inspection or audit, (ii) immediately update Gritstone during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iii) promptly provide to Gritstone the inspection or audit observations of such Regulatory Authority relating to such activities or data; provided that Arbutus shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (iv) prepare the response to any such observations, (v) provide a copy of such planned response to Gritstone to the extent it relates to the Product, shall consult with Gritstone concerning the response of Arbutus to each such communication and, if such response affects the Product specifications or any Marketing Authorization Approval (or Gritstone’s obligations to comply with any legal requirements), such response shall be subject to Gritstone’s approval, and (vi) conform its activities under this Agreement to any commitments made in such a response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws, Arbutus shall permit Gritstone the opportunity to be present on-site during (but not directly participate in) any such inspection.
Regulatory Authority Inspections. ELITE shall permit any Regulatory Authority to inspect the facility used to manufacture the Products and all associated records to the full extent permitted by applicable Law (“Regulatory Inspection”). ELITE shall notify LANNETT within forty-eight (48) hours of becoming aware of any planned or actual Regulatory Inspection. ELITE agrees to reasonably cooperate with the applicable Regulatory Authority in connection with such audits. ELITE shall notify LANNETT prior to the commencement of any meetings with, or inspection activity by, any Regulatory Authority, unless such inspection activity is an unannounced inspection. Further, ELITE shall provide a reasonable description to LANNETT of any such governmental inquiries, notifications or inspections related to Products promptly (but in no event later than five (5) calendar days) after such visit or inquiry. ELITE shall furnish to LANNETT: (i) within five (5) calendar days after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483, establishment inspection report, or warning letter; and (ii) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above prior to the submission of such responses or explanations to any Regulatory Authority by ELITE for comment, which comments shall be taken into consideration by ELITE in good faith. ELITE shall also provide LANNETT with a copy of all final responses.
Regulatory Authority Inspections. At Client’s request, Bxxxxx will authorize Regulatory Authorities to review related applications on Client’s behalf as set forth in the Quality Agreement. Client shall bear the costs of Regulatory Authority Inspections as set forth in the Product Master Plan.
Regulatory Authority Inspections. At Celator’s request, Xxxxxx will authorize Regulatory Authorities to review related applications on Celator’s behalf as set forth in the Quality Agreement. Celator shall bear the costs of non-routine Regulatory Authority Inspection or inspections directly relating to the Product as set forth in the Product Master Plan.
Regulatory Authority Inspections. Hospira also agrees to allow any Regulatory Authority to conduct any inspection of the Facility related to the manufacture of the Product which such Regulatory Authority may require and Hospira agrees to reasonably cooperate with the Regulatory Authority in connection with such inspection. Hospira will provide Theravance with notice of any such inspection as soon as practicable. In the event that a Regulatory Authority other than the FDA, Health Canada and the EMA requests or requires an audit of the Facility related to pre-approval inspection (“PAI”), Hospira shall be entitled to charge a fee of [***]. This fee shall include PAI preparation activities and support of the audit. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Regulatory Authority Inspections. 16.3.1 AKERO shall use commercially reasonable efforts to waive or avoid the need for any inspection by Governmental Authorities (as defined in the License Agreement) of AMGEN’s manufacturing facilities and/or documentation with respect to product and/or placebo.
Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection or GxP Audit of Legend, its Affiliates, [***] relating to [***], Legend shall [***] notify Novartis upon Legend becoming aware thereof. Legend shall permit Regulatory Authorities to conduct inspections or audits of Legend, its Affiliates, or, to the extent Legend or its Affiliates has the right, its or their subcontractors (including CMOs), relating to [***], and shall ensure that such Affiliates and, to the extent Legend or its Affiliates has the right, [***] ensure such subcontractors (including CMOs), permit such inspections and audits. Unless prohibited by Applicable Law, (i) Legend shall permit Novartis to attend and observe the aforementioned inspections or audits (provided that [***]), (ii) Legend shall provide Novartis with a [***] of any findings of a Regulatory Authority following a regulatory audit or inspection that are communicated to Legend by such Regulatory Authority, as a result of the inspection or any submitted document(s) or in a correspondence with such Regulatory Authority (e.g., EIR, 483s, warning letters, EMA or European inspection reports, serious breaches, safety urgency measures, issued on PSURs, DSURs) and corresponding proposed responses, in each case related to [***], and (iii) in the event any such inspection could reasonably be expected to [***], Legend shall, no later than [***] the date of such inspection, provide to Novartis [***] of the relevant inspection report or correspondence provided to Legend by the applicable Regulatory Authority. Legend will [***] cooperate with Novartis in the preparation of any response thereto to Regulatory Authorities and any mutually agreed corrective action plans which could reasonably be expected to affect Legend’s Data Integrity or be considered critical findings regarding any IND, MAA or other Regulatory Materials relevant to [***]. In the event that any Regulatory Authority desires to conduct an inspection or audit of Novartis relating to the Licensed Products or Licensed Technology, such as any pre-approval inspection, Legend shall [***] cooperate with Novartis upon request in responding to such audit or inspection, including attending such audit or inspection if so requested by Novartis.
Regulatory Authority Inspections. EyePoint will be responsible for, and shall participate in, inspections of its Facility by any Regulatory Authorities. EyePoint will notify Alimera of any inspections of its Facility that are related in any material respect to the Manufacture of the Product under this Agreement.
Regulatory Authority Inspections. Hovione will be responsible for inspections of its Facilities by any Regulatory Authorities, and will, to the extent permitted by Applicable Law, within * business days of receipt of notice from a Regulatory Authority, notify Client if such inspections are directly related to the Manufacture of Product or if the results of a non-related inspection could reasonably be expected to impair the ability of Hovione to perform in accordance with this Agreement. With respect to inspections solely related to the Product, Hovione will, to the extent permitted by Applicable Law, (i) provide Client with copies of all documents, reports or communications received from or given to any Regulatory Authority associated therewith; (ii) permit Client’s representatives to be present on site and participate, as appropriate, based on questions or requests specific to Client or Product, and as permitted by Regulatory Authorities, in such inspections and participate in the wrap-up sessions; and (iii) allow Client the opportunity to review and provide comments to Hovione with respect to matters related to the Product, and Hovione will draft any such correspondence to Regulatory Authorities taking into account Client’s comments.
Regulatory Authority Inspections. Spark will be responsible for inspections of its facility by Regulatory Authorities, and will notify Genable within [**] hours of receipt of notice from a Regulatory Authority of any such inspections that are specifically related to the Product or at least [**] days in advance of the scheduled inspection date for other inspections of its facility. Such notifications may be given by telephone, e-mail or other reasonable communications method. With respect to inspections specifically related to the manufacture of Product or if the results of a non-specifically related inspection could potentially impair the ability of Spark to perform the Manufacturing Services, Spark will (a) provide Genable with copies of all documents, reports or communications received from or given to any Regulatory Authority associated therewith; and (b) permit Genable’s representatives to be on site in an adjacent area to answer questions or requests specific to Genable or the Product and, to the extent practicable, keep Genable apprised of the progress of such inspections and consult with Genable regarding the same.
