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 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. 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. 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.
16.3.2 Each Party shall notify the other within twenty-four (24) hours upon notification by any Regulatory Authority of any intended inspection of AMGEN’s facilities or records relating to the manufacturing, testing, and storage of the supplied Product.
16.3.3 AMGEN will be solely responsible for hosting and managing regulatory inspections at its facilities.
16.3.3.1 Not more than one (1) AKERO representative may be present at such inspections upon approval by AMGEN, given that such approval may not be unreasonably withheld.
16.3.4 Each Party shall inform the other Party of any critical and major regulatory inspection observations by other Government Authorities that are related to the Product and/or Territory.
16.3.5 Responses to regulatory inspections
16.3.5.1 For inspections occurring at AMGEN sites, AMGEN shall be the first to receive the inspection report, unless restricted by regulatory requirements.
16.3.5.2 The Party who received the inspection report shall provide the report to the other Party within twenty-four (24) hours of receipt, and shall be responsible for translation, if required.
16.3.5.3 The Party whose facility was audited shall be responsible for authoring and providing responses to the Regulatory Authority.
16.3.5.4 The non-authoring party shall have a right to review and comment on proposed responses. The final response shall be provided to each party.
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. Nordmark shall permit access to Regulatory Authorities to Xxxxxxxx’x premises. Nordmark shall inform Xxxxxxx of any announced regulatory inspection that solely involves any Contracted Product within forty-eight (48) hours of the notification to Nordmark of such inspection related to any Contracted Product. Nordmark shall immediately inform Xxxxxxx of any unannounced regulatory inspection that solely involves any Contracted Product. Upon Xxxxxxx’x request, such notice shall include without limitation the name of the agency, the number and names of inspectors and the scope of audit, related to any Contracted Product. Nordmark shall permit Xxxxxxx representatives to be present at the Facility for inspection that directly involves any Contracted Product. Xxxxxxx shall participate directly in the inspection at the sole discretion of Nordmark. Nordmark shall inform Xxxxxxx of the result of any regulatory inspection which directly affects the Manufacturing of a Contracted Product, including any notice of violation or other similar notice received by Nordmark affecting Manufacturing, the Facility, testing, storage or handling of a Contracted Product. In the event that there are Inspectional Observations (i.e. FDA Form 483) or other similar regulatory communication, specifically related to the Contracted Product, Xxxxxxx shall be informed immediately and shall have the opportunity to review and provide Nordmark with comments to Xxxxxxxx’x draft responses and corrective actions. Xxxxxxx shall provide its comments to the draft responses and corrective actions within twenty-four (24) hours or other timeframe as agreed upon by the Parties to meet regulatory commitments. Nordmark shall retain the final authority for the content of the responses to the Regulatory Authority. Nordmark shall forward to Xxxxxxx any observations and responses from a routine regulatory inspection by the FDA, Health Canada or the German competent authorities relating to the Facility where the Contracted Products are Manufactured and stored. Nordmark shall also supply Xxxxxxx a complete copy of any Form 483, letter or communication issued by the FDA, Health Canada or the German competent authorities which is directly related to the Manufacturing of the Contracted Products. Nordmark reserves the right to appropriately redact any of the foregoing documentation provided to preserve any Third Party Confidential Information.
Regulatory Authority Inspections. 4.3 Kontroly ze strany regulačních orgánů
Regulatory Authority Inspections. CHOP will be responsible for inspections of its facility by Regulatory Authorities, and will, within [**] of receipt of notice from a Regulatory Authority, when not otherwise prohibited, notify AAVT if such inspections are directly related to the manufacture of Product or if the results of a non-related inspection could materially impair the ability of CHOP to perform in accordance with this Agreement. With respect to inspections directly related to the manufacture of Product, CHOP will, when not otherwise prohibited, (a) provide AAVT with copies of all documents, reports or communications received from or given to any Regulatory Authority associated therewith; (b) permit AAVT’s representatives to be on site in an adjacent area to answer questions or requests specific to AAVT or Product and, to the extent practicable, keep AAVT apprised of the progress of such inspections and consult with AAVT regarding the same; and (c) allow AAVT the opportunity and sufficient time (at least [**] where possible) to review and provide comments to CHOP with respect to matters related to the manufacture of Product, and CHOP will draft and control any such correspondence to Regulatory Authorities, subject to CHOP reasonably taking into account AAVT’s comments.
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.
