Presence at Facility. Upon at least [c.i.] prior written notice given by DUSA to NBC, DUSA shall have the right to assign a reasonable number of employees or consultants of DUSA to inspect and audit the Facility at which Light Sources are manufactured in order to verify NBC's compliance with QS and other agreed requirements, provided, however that (i) such employees or consultants shall not unreasonably interfere with other activities being carried out at the Facility, (ii) that such employees or consultants shall observe all rules and regulations applicable to visitors and to individuals employed at the Facility, and (iii) such employees or consultants agree to maintain the Confidential Information of NBC in accordance with Article 11 below.
Presence at Facility. During the term of this Agreement, Thermage shall have the right upon reasonable notice and during normal business hours to have its representatives visit the facilities at which Products are being manufactured, and to inspect such facilities and the records relating to the manufacture of Products to verify Stellartech’s compliance with the terms of this Agreement and the warranties in Article 8 below, including Stellartech’s manufacture of Products in compliance with Good Manufacturing Practices (“GMP”), ISO 9000 requirements, or other applicable rules and regulations.
Presence at Facility. During the first six (6) months during which each Product is commercially manufactured for Symyx and thereafter upon reasonable written notice to Argonaut, Symyx shall have the right to have its representatives visit, from time to time, each facility at which such Product is being manufactured, to verify Argonaut's compliance with the Quality Assurance program outlined in Section 7.1.
Presence at Facility. Upon reasonable notice given by Vivus to Spolana and at reasonable frequency, Vivus shall have the right to assign a reasonable number of employees or consultants of Vivus to inspect and audit the Facility at which Product is manufactured in order to verify Spolana's compliance with the current GMP and other agreed requirements, provided, however that (a) such employees or consultants shall not unreasonably interfere with other activities being carried out at the Facility, and (b) that such employees or consultants shall observe all rules and regulations applicable to visitors and to individuals employed at the Facility. It is understood that as of the Effective Date Vivus has engaged Forum (Holdings) Limited ("Forum") pursuant to that certain agreement dated September 26, 1996 pursuant to which Forum agreed to assist Vivus in ensuring, by aiding Spolana, that Spolana meets and maintains current GMP and requirements necessary for the sale of Product throughout the world.
Presence at Facility. SAVIENT shall have the right, from time to time, to assign a reasonable number of its employees or representatives to visit NOF’s manufacturing facility and any other relevant location (e.g. warehouse) for two (2) days per Year (or such other period as may be agreed by the Parties in the event that any material non-compliance with the terms of this Agreement or in the manufacture of the Activated PEG is discovered) in order to inspect, discuss and review the activities performed by NOF under this Agreement and to verify NOF’s compliance with the warranties in ARTICLE 5 with respect to the Activated PEG. The presence of SAVIENT’s employees or representatives shall in no way relieve NOF of any of its obligations under this Agreement.
Presence at Facility. During the term of this Agreement, Somnus shall -------------------- have the right upon reasonable notice and during normal business hours to have its representatives visit the facilities at which Products are being manufactured, and to inspect such facilities and the records relating to the manufacture of Products to verify Apical's compliance with the terms of this Agreement and the warranties in Article 10 below, including Apical's manufacture of Products in compliance with Good Manufacturing Practices ("GMP"), ISO 9000 requirements or other applicable rules and regulations.
Presence at Facility. CREALTA shall have the right, from time to time, to assign a reasonable number of its employees or representatives to visit NOF’s manufacturing facility and any other relevant location (e.g. warehouse) for […***…] days per Year (or such other period as may be agreed by the Parties in the event that any material non-compliance with the terms of this Agreement or in the manufacture of the Activated PEG is discovered) in order to inspect, discuss and review the activities performed by NOF under this Agreement and to verify NOF’s compliance with the warranties in ARTICLE 5 with respect to the Activated PEG. The presence of CREALTA’s employees or representatives shall in no way relieve NOF of any of its obligations under this Agreement.
Presence at Facility. Upon at least [c.i.] prior written notice given by DUSA to NSP, DUSA shall have the right to assign a reasonable number of employees or consultants of DUSA (not to exceed [c.i.] to inspect and audit the Facility at which Products are manufactured in order to verify NSP's compliance with GMP and other agreed requirements, provided, however that (i) such employees or consultants shall not unreasonably interfere with other activities being carried out at the Facility, and (ii) that such employees or consultants shall observe all rules and regulations applicable to visitors and to individuals employed at the Facility.
Presence at Facility. Upon reasonable notice given by one party to the other and at reasonable frequency (not more than once per calendar year unless the party can demonstrate a reason for more frequent audits), such party will have the right to assign no more than two employees or consultants of such party to inspect and audit the Facility at which a product is manufactured during normal business hours; provided, however that:
8.9.1 such employees or consultants will not unreasonably interfere with other activities being carried out at the Facility;
8.9.2 such employees or consultants will observe all rules and regulations applicable to visitors and to individuals employed at the Facility; and
Presence at Facility. Upon at least fifteen (15) days’ prior written notice given by NeurogesX to CPL, NeurogesX shall have the right to assign a reasonable number of employees or consultants of NeurogesX (not to exceed three (3) persons) to inspect and audit the Facility in order to verify CPL’s compliance with Regulatory Requirements and other agreed requirements. At all times, NeurgoesX personnel or consultants will be accompanied by CPL representatives and access will be limited to areas and documentation applicable to NeurogesX Product or Proposals.
(a) Changes to the Specifications. NeurogesX shall have the sole right to modify the Specifications with respect to all Bulk Products and Finished Products. All modifications shall be in writing and shall be signed by an authorized representative of NeurogesX and CPL, and shall be effective for purchase orders for Product placed after the effective date of the changes. If the modifications result in a change in CPL’s manufacturing costs, the Parties shall agree upon an appropriate adjustment to the price of the Product under this Agreement. If the modifications result in a delay in delivery, there shall be a reasonable extension of the affected lead times. If residual inventory of a raw material or packaging component results from a change to Specifications, NeurogesX shall reimburse CPL at cost plus 15% (to cover CPL’s administrative, finance, and warehousing) for all residual inventory or restocking charges at suppliers, for materials that CPL cannot use elsewhere or returned without charge.
