Person in the Plant. As further described in the Quality Agreement, and subject to and in accordance with Althea’s SOPs and other terms jointly agreed regarding access (time and place) to Althea’s Facility, Client shall have the right to designate [***] representatives of Client to be present at any one time in the Xxxxxx Facility during normal business hours and at any other times while active Production is occurring to observe the Production and observe Althea’s performance of Services under this Agreement
Person in the Plant. As further described in the Quality Agreement, Trubion shall have the right to designate up to *** representatives of Trubion to be present at any one time in the Lonza Facility during normal business hours during the Term of this Agreement to observe the Runs and observe Lonza's performance of the Services under this Agreement. While at the Facility, such representative of Trubion shall be restricted to such areas as are directly relevant to the manufacture of the Bulk Product and such other areas as may be otherwise authorized by Lonza, and shall comply with all applicable Lonza policies and procedures and may, at Lonza's option, be escorted by Lonza personnel.
Person in the Plant. During the term of this Agreement, ARC will enable a representative of MacroCure to serve, on Marcocure’s behalf, as a “Person in the Plant” (PIP) at the Approved Facility, who will be allowed to follow and monitor ARC activities in connection with the Services provided hereunder and ARC shall make all the appropriate arrangements to accommodate such PIP. The PIP shall be able to perform real time observation of any stage in the production, testing, packaging, QA release, and shipment and all other related activities. During such inspection, the ARC shall provide access to its manufacturing, quality control and all other relevant documentation and records relating to the Batches and Products and shall cooperate with such representatives in a reasonable manner. The PIP shall be designated by MacroCure from time to time. It is understood that the PIP is present in an observer capacity only and that the PIP shall not directly participate in the manufacturing process in any way. It is understood that any feedback from the PIP shall be routed to ARC through the individuals designated in the Notice provisions of this Agreement. Notwithstanding the foregoing, In case of major or urgent observation/s made by the PIP, the ARC will be notified immediately and shall respond accordingly.
Person in the Plant and/or its Affiliates shall permit Company employees, consultants and/or representatives (excluding agents of third parties which are competitors of ***) to be admitted to the Facility, subject to the safety and security policies of ***, during the Manufacturing of the Excipient and/or Raw Materials for the purposes of (i) observing the manufacturing process and (ii) reviewing all Batch Records and other documents, including, without limitation, all production logs, reagent preparation records, Deviation reports, Raw Materials testing and release data, *** procedures, and the like. Heron employees, consultants and/or representatives shall not be auditing the operations but shall merely observe the Manufacturing activities. All such Company employees, consultants and/or representatives pursuant to this Section 2.3 will be bound by a confidentiality agreement that is at least as stringent as the confidentiality terms set forth herein. *** shall consider, in good faith, any suggestions that Company or its onsite, consultants and/or representatives have regarding the design or operation of the Facility for Manufacturing and will promptly respond to Company regarding such suggestions.
Person in the Plant. CLIENT shall have the right to designate one representative of CLIENT to be present at any time in the XXXXXX facility during normal business hours during the Term of this Agreement to observe the Production of Drug Product. While at the facility, such representative of CLIENT shall be restricted to such areas as are directly relevant to the manufacture of the Drug Product and such other areas as may be otherwise authorized by XXXXXX, and shall comply with all applicable XXXXXX policies and procedures and may, at ALTHEA’s option, be escorted by XXXXXX personnel. † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
Person in the Plant. CLIENT shall have the right to designate one representative of CLIENT to be present at any time in the AXXXXX facility during normal business hours during the Term of this Agreement to observe the Production of Drug Product. While at the facility, such representative of CLIENT shall be restricted to such areas as are directly relevant to the manufacture of the Drug Product and such other areas as may be otherwise authorized by AXXXXX, and shall comply with all applicable AXXXXX policies and procedures and may, at ALTHEA’s option, be escorted by AXXXXX personnel.
Person in the Plant. As further described in the Quality Agreement, Immunex ------------------- shall have the right to designate one employee of Immunex to be present in the Genentech Facility in South San Francisco during normal business hours during the Term of this Agreement to observe the Runs and observe Genentech's performance of its obligations under this Agreement. Such person shall have sufficient technical expertise and delegated corporate authority to, at a minimum, approve change control authorizations and deviations. While at the Facility, such representative of Immunex shall be restricted to such areas as are directly relevant to the manufacture of the Bulk Product, or as otherwise authorized by Genentech, and shall comply with all applicable Genentech policies and procedures and may, at Genentech's option, be escorted by Genentech personnel. Such representative shall have no right to direct or supervise Genentech personnel.
Person in the Plant. During the Term, DENDREON shall be entitled to maintain up to two (2) Persons in the Plant (“PIP”) and any additional PIPs as may be otherwise mutually agreed upon by the Parties, to observe the Process Implementation Phase and the Manufacturing Phase. The responsibilities of the PIP shall include, but not be limited to: (a) acting as liaison for [***] Denotes confidential information omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. DENDREON Quality Assurance and the DENDREON technical transfer team members; (b) performing the functions described in the Quality Agreement required to support technical and quality assurance operations; and (c) participation in Change Control activities, atypical event and deviation resolution meetings related to the Product. GSK shall provide the PIPs reasonable office space within the Suite during regular working hours.
Person in the Plant. Lifecore shall permit Heron employees, consultants and/or representatives to have access to the Facility during the Manufacturing of the Product for the purposes of (i) observing the Manufacturing process and (ii) reviewing all Batch Records and other documents, including, without limitation, all production logs, reagent preparation records, deviation reports, Raw Materials testing and release data, Lifecore Procedures, and the like (individually and collectively, “Access”). Heron employees, consultants and/or representatives shall not be auditing the operations but shall merely observe the Manufacturing activities. All such Heron consultants and/or representatives receiving Access will be bound by a confidentiality agreement that is at least as stringent as the confidentiality terms set forth herein and shall at all times comply with Lifecore rules and regulations. Lifecore shall consider, in good faith, any suggestions that Heron or its onsite, consultants and/or representatives have regarding the design or operation of the Facility for Manufacturing the Product and will promptly respond to Heron regarding such suggestions.
Person in the Plant. SIGMA-TAU shall permit ARADIGM at maximum of two employees, consultants and/or representatives (including from partners) to have access to the Manufacturing Facility during the Processing of the DP or Product for the purposes of (i) observing the manufacturing process and (ii) reviewing all Batch records and other documents, including, without limitation, all production logs, reagent preparation records, column packing [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. records, deviation reports, Materials and components testing and release data, SOPs, and the like (individually and collectively, “Access”). ARADIGM employees, consultants and/or representatives shall not be auditing the operations but shall merely observe the Process activities. All such ARADIGM, consultants and/or representatives receiving Access will be bound by a confidentiality agreement that is at least as stringent as the confidentiality terms set forth herein. SIGMA-TAU shall consider, in good faith, any suggestions that ARADIGM or its onsite, consultants and/or representatives have regarding the design or operation of the Manufacturing Facility and will promptly respond to ARADIGM regarding such suggestions.
