definiens: as defined by the ComprebensiveBnviroDmental Respons~ Compeusationand Liability Act of 1980, as amended, . which reJatesto CD&A 's ability to manufacture or supply Product . WCHreserves the right to conduct au environmental inspection of ClMA 's faciJity(ies ) . during normal business hours and with reasonable advmcenotice . fot the · PUIpOSe of detennining compHauce witbthis Section 2.12(b),no more frequently than once per year during the teon hereof and under conditions of confidentiatity as provided underAJ1icle VIR Upon . CJMA·8 request ; WCB shaJl share the results of any enVh : onmeDtal inspection . with CIMA . Such ins ~ tiontjf it OCCUI$. does not relieve CIMAof.jts sole Obligation to cmnply with the Laws and - does not constitute a waiver of any right otherwise availabJe to WCH . . 2.t3Bpedflc : atlons AmendDMDts . The Specifications shall be amended or supplemented to cmnplywith OMPs and tocomp)y, with any applicable Agency directive and may alao be amended otsupplemented ( including . without limitation . fOttJie purpose of iDeorpoIating im ~ ts ) ~ time.~~. In the event CIMA intends to amend the Specifications, WCHshaD·RCeiw pronapt advance notice of any such 8IDCncknents . No such amendDient shan be filed ~ any applicable Agency or otherwi.se become effeictive without the pri~ written m ~ al approval ofWCH aadCJMA~ In the event that after the p ~ es have initially agreed upon theSpecifications t WCH mpJe8ts ~at the Specific_oDS be amended, CIMA shall teeeive prompt advanc : e notice of any such ~endment·forthe purpose of ~g what, if any, impact the prQPOSed .xnendment would have on tbemanufactute of .Product fot WCH be.reunder and WCH slulll I8iJnbtuBe CIMA for the actual costs incuned by ClMA ( pnrridedtbat such costs are approved in writing by WCH prior to being incuaed by ClMA)because such amendm«mttequhes cbangesto be made in the processes . equipment, testing proceduses . Olcomponents used to~ Product for WCH heIeundet . Upon WeB 's request, ClMA shalJ.use Comme.ttjally Reasonable Efforts to eliminate animal derived materials from the Product.d WCRsball teimburseClMA for the actual costS jJlCUlled by ClMA ( provided that sucb818 approved in writing byWCH prior to being incum : d by CIMA ) in c ~ on therewith . In eacb case, such costs ."include . without Dmitationj > vatidation of new processes, .~t andfacDities . development Of testingmethodsand.start""llp costs . To the extent that any · costs jn ~ by CJM, Ain implementing an amencknent of the Specifications under this Section have been JeimbnIsed'by WCHsucb costs shall DOt be included in CJMA·s DireCt Manufacturing Cost . ' 2.14 ApQlOval for MallDfadUriDg Changes ; TblrdPIirty Manufacturing . CIMA agree$ that DO changeawiD be madetoariy materia1s, equipment or methods of production or ~g which are specified ill tb~ Specifications or any Regulatory Approval by any Agency for ProduCt without WCH 's prior wrltten'approval . wbich approval shall Dot be unreasonably withheIdADP.roductdoliv_d ~ der shall be manufactured at the Facility . Under no -circumstances win CIMA connet out aU or any part of the manufacturing of Product to a Third Pmy without prior written approval from WCIL 115 rermitted Subcontractors . ClMA shall ensure that the permitted contract ~anufacturetafot the manufacture of Product bavesufficientkIJowledge and expertise to cany out the manufactureofPmductand other subcontracted responsibilities . In addition7 CD4A shall ensure that ( i ) each s\1ch contract manufacturer shall be in compliance withGMPs _ d shan be under the inspection of all " " levant Agencies and audited to be in compliance therewith, and ( ii ) WCli wID have the right to inspec;t and audit each such subcontractor 's facilities andreconJs as provided in Section 2.11 heteof