Observation of Processing. In addition to Client’s audit right pursuant to Section 9.4, Client may send, at its expense, up to […***…] to the Facility to observe Processing […***…], upon at least 10 business days’ prior notice, at reasonable times during regular business hours. Such representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such representatives while on Catalent’s premises. Client’s representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. For avoidance of doubt, Client shall not incur any additional services, Processing or other fees from Catalent in connection with its exercise of the foregoing observation right.
Observation of Processing. In addition to Client’s audit right pursuant to Section 9.4, Client may send up to [**] Representatives to the Facility to observe Processing for a maximum of [**] days per calendar Year following the First Commercial sale of Product. In addition, Catalent understands the Client’s request to be present for the development activities and will allow site visitations limited to the batch processing associated with the media fills, clinical batches, process characterization and process validation batches from the Effective Date through the First Commercial Sale of a Product (unless otherwise agreed by Catalent in writing) upon at least [**] business days’ prior notice, at reasonable times during regular business hours. This will consist of no more than [**] hours per day and requires the prior coordination with project manager. Such Representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action, omission or other negligent or wrongful activity of such Representatives while on Catalent’s premises. Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility.
Observation of Processing. In addition to Palatin’s audit right pursuant to Clause 9.4, Palatin may send [***] Representatives to the Facility to observe Processing for a maximum of [***] (unless otherwise agreed by Catalent in writing), upon at least [***] prior notice, at reasonable times during regular business hours. Such Palatin Representatives shall abide by all Catalent safety rules and other applicable policies and procedures, and Palatin shall be responsible for such compliance. Palatin shall defend, indemnify and hold harmless Catalent for any action, omission or other activity of such Palatin Representatives while on Catalent’s premises. Palatin’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility.
Observation of Processing. In addition to Client’s audit rights pursuant to the Quality Agreement, and upon at least [ * ] ([ * ]) days prior notice, subject to approval of the visit by Catalent, whose approval will not be unreasonably withheld, Client may send up to [ * ] ([ * ]) representatives to the Facility to observe Processing. Such observance of Processing shall be limited to that number of days as is reasonably necessary for Client to monitor the efficiency and effectiveness of the Process (e.g., in terms of meeting Specifications, complying with timelines and optimizing Product yield) and to determine whether modifications or improvements to the Process may be warranted. Client and Catalent shall cooperate with one another in good faith to ensure that such Process observation by Client representatives shall not interfere with Catalent’s day to day operations. Such representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such representatives while on Catalent’s premises except for those actions, omission or other activity of such representative mandated by Catalent personnel or its safety rules and employee policies and procedures. Catalent reserves the right to require such representatives to enter into separate confidentiality agreements directly with Catalent in such persons’ individual capacities on terms substantially similar to those set forth in Article 10. Should the number of calendar man-days per Contract Year exceed [ * ] ([ * ]) days, additional fees, as indicated on Attachment C, may be assessed.
Observation of Processing. In addition to Client’s audit right pursuant to Section 9.4, Client may send up to 2 Representatives to the Facility to observe Processing for a maximum of 10 days per Contract Year (unless otherwise agreed by Catalent in writing), upon at least 10 business days’ prior notice, at reasonable times during regular business hours. The foregoing limitations shall not apply to time spent by Client Representatives on site at the Facility to participate in or witness research and development activities or to witness Processing of validation Batches of Product. Such Representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such Representatives while on Catalent’s premises. Client’s Representatives who are not employees of Client shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility.
Observation of Processing. In addition to Client’s audit right pursuant to Section 9.5, Client may send up to [*] representatives to the Facility to observe Processing for a maximum of [*] days per Contract Year (unless otherwise agreed by Catalent in writing), so long as Client provides Catalent at least [*] days’ advance written notice of the attendance of such Client representatives, including the name and title of each such representative. [*] shall be given access to Catalent’s Facility only upon Catalent’s consent, which consent shall not be unreasonably withheld. Such representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. [*].
Observation of Processing. In addition to Client’s audit right pursuant to Section 9.4, Client may send a reasonable number of representatives to the Facility to observe Processing activities, the Validation Services and the Product Maintenance Services specifically indicated on Attachment D, in each case for a maximum of [**] per Contract Year (unless otherwise agreed by Catalent in writing), upon at least [**] prior notice, at reasonable times during regular business hours. In addition, Client may visit the Facility for process improvement and other activities, in each case as mutually agreed. Such representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures communicated by Catalent to Client, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such representatives in breach of such policies and procedures while on Catalent’s premises. Client’s representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility.
Observation of Processing. 4.9.1 In addition to Client’s audit right pursuant to Section 9.4, Client may (i) send up to [*] Representatives to the Facility to observe Processing of Client’s Product during any period in which Client’s Product is being Processed until and unless the Client and Catalent agree otherwise, and (ii) send up to [*] Representatives to the Facility to audit Client’s inventory of API, Client-supplied Materials, or Product, upon at least [*] prior notice, at reasonable times during regular business hours. Such Representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such Representatives while on Catalent’s premises. Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Client observation of Processing does not relieve Catalent of any obligation, responsibility, representation or warranty under this Agreement.
4.9.2 Client will observe all Product Processing, and Catalent may not process Product without the presence of Client Representatives, unless otherwise authorized by Client in writing. However, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. if the Client Representative is not present when they are scheduled to be present, and such absence solely and directly causes a delay in the commencement of any batch processing or manufacturing campaign, [*]; except that [*] if [*].
Observation of Processing. In addition to Iroko's audit right pursuant to Section 9.5, Catalent and Iroko may also agree in writing from time to time to have another Iroko representative observe Processing for a maximum of [****] days per Contract Year at reasonable times during regular business hours excluding Iroko maintenance and repair activities. Such Iroko representatives shall abide by all Catalent safety rules, quality policies and procedures and other applicable employee policies and procedures, and Iroko shall be responsible for such compliance. Iroko shall indemnify and hold harmless Catalent for any action, omission or other activity of its representatives while on Catalent's premises. Iroko's representatives may be required to sign Catalent's standard visitor confidentiality agreement prior to being allowed access to the Facility. [****] Information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed
Observation of Processing. In addition to TXMD’s audit right pursuant to Section 9.5, TXMD may send up to [***] ([***]) Representatives to the Facility to observe Processing. Provided that QPharma has given TXMD adequate notice of commencement of Processing, TXMD shall give QPharma written notice of its intention to observe processing at least [***] ([***]) days prior to the date of its visit. The foregoing limitations shall not apply to time spent by TXMD Representatives on site at the Facility to participate in or witness research and development activities or to witness Processing of validation Batches of Product. Such Representatives shall abide by all QPharma safety rules and other applicable employee policies and procedures, and TXMD shall be responsible for such compliance. TXMD shall indemnify and hold harmless QPharma for any action, omission or other activity of such Representatives while on QPharma’s premises. TXMD’s Representatives who are not employees of TXMD shall be required to sign QPharma’s standard visitor confidentiality agreement prior to being allowed access to the Facility. QPharma shall not be required to accommodate any observation request or activity that would violate GMP or Swedish law. TXMD acknowledges that space constraints at QPharma’s facilities also may limit its ability to observe.
