{"id":42334,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/homogeneous-pcr-clinical-services-agreement-roche-molecular.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"homogeneous-pcr-clinical-services-agreement-roche-molecular","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/homogeneous-pcr-clinical-services-agreement-roche-molecular.html","title":{"rendered":"Homogeneous PCR Clinical Services Agreement &#8211; Roche Molecular Systems Inc. and Specialty Laboratories inc."},"content":{"rendered":"<pre>\nCONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF\nTHIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS\nENCLOSED BY BRACKETS AND UNDERLINED. THE CONFIDENTIAL PORTION HAS BEEN FILED\nSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.\n\n\n                   HOMOGENEOUS PCR CLINICAL SERVICES AGREEMENT\n\nThis Agreement is made by and between Roche Molecular Systems, Inc. (\"RMS\"),\nhaving an office at 4300 Hacienda Drive, Pleasanton, California 94588 and\nSpecialty Laboratories, Inc. (\"SLI\"), Santa Monica, California, hereafter\ncollectively referred to as \"The Parties\".\n\n                                   BACKGROUND\n\n         A. RMS owns and has the right to grant immunities from suit to practice\nunder certain United States Patents describing and claiming, INTER ALIA, nucleic\nacid amplification processes referred to as \"homogeneous PCR.\"\n\n         B. SLI has attained substantial expertise in validating, documenting\nand performing sophisticated diagnostic procedures.\n\n         C. SLI desires to obtain an immunity from suit from RMS to practice\nLICENSED TECHNOLOGY to perform certain homogeneous PCR-based human IN-VITRO\nclinical laboratory services in order to augment and extend SLI's PCR Technology\nlicense, entered into previously or on even date herewith, and RMS is willing to\ngrant such an immunity, on the terms and subject to the conditions provided\nexclusively in this Agreement.\n\n         NOW, THEREFORE, for and in consideration of the mutual covenants\ncontained herein, RMS and SLI agree as follows:\n\n1.       DEFINITIONS:\n\n         For the purpose of this Agreement, and solely for that purpose, the\nterms set forth hereinafter shall be defined as follows:\n\n         1.1      \"5' NUCLEASE TECHNOLOGY\" shall mean only the processes defined\nby the method claims of RMS's United States Patent Nos. 5,210,015 and 5,487,972,\nand any reissue or reexamination patents thereof, and reaction mixture claims\n1-12 of United States Patent No. 5,804,375.\n\n         1.2      The term \"AFFILIATE\" of a designated Party to this Agreement \nshall mean:\n\n                  a)       an organization of which fifty percent (50%) or more\n                           of the voting stock is controlled or owned directly\n                           or indirectly by either Party to this Agreement;\n\n                  b)       an organization which directly or indirectly owns or\n                           controls fifty percent (50%) or more of the voting\n                           stock of either Party to this Agreement;\n\n                  c)       an organization, the majority ownership of which is\n                           directly or indirectly common to the majority\n                           ownership of either Party to this Agreement; and\n\n\n                  d)       an organization under (a), (b), or (c) above in which\n                           the amount of said ownership is less than fifty\n                           percent (50%) and that amount is the maximum amount\n                           permitted pursuant to the law governing the ownership\n                           of said organization.\n\n         It is understood and agreed, however, that the term \"AFFILIATE\" shall\nnot include Genentech Inc., a Delaware Corporation.\n\n         1.3      \"EFFECTIVE DATE\" shall mean the date on which the last\nsignatory to this Agreement signs the Agreement.\n\n         1.4      \"HOMOGENEOUS PCR TECHNOLOGY\" shall mean 5' NUCLEASE TECHNOLOGY\nand only the processes defined by the method claims of RMS's United States\nPatent Application Serial No. 07\/695, 201, and any issue, reissue or\nreexamination patents thereof.\n\n         1.5      \"LICENSED CLINICAL SERVICE\" shall mean the performance by SLI\nof an IN VITRO diagnostic procedure utilizing LICENSED TECHNOLOGY on a sample of\nmaterial obtained from a human being solely to detect the presence, absence or\nquantity of a nucleic acid associated with a human disease or condition within\nthe LICENSED FIELD. LICENSED CLINICAL SERVICES include but are not limited to,\nany combination of the steps of collecting a sample for analysis, isolating\nnucleic acid sequences therein, amplifying one or more desired sequences,\nanalyzing the amplified material and reporting the results.\n\n         1.6      \"LICENSED FIELD\" shall mean the field of human IN VITRO\ndiagnostics solely for the detection of genetic diseases, genetic\npre-disposition to disease, agents associated with infectious diseases, cancer;\nand for tissue transplant typing, including testing performed on [***]* disease\nmanagement; and clinical trials.\n\n         1.7      \"LICENSED TECHNOLOGY\" shall mean the HOMOGENEOUS PCR\nTECHNOLOGY and only so much of RT AND RT-PCR TECHNOLOGY and OTHER TECHNOLOGY as\nis necessary for SLI to practice the HOMOGENEOUS PCR TECHNOLOGY in conjunction\nwith SLI's separately licensed PCR Technology. With the exception of the\nreaction mixture claims of United States Patent No. 5,804,375 and United States\nPatent No. 5,476,774, and the plasmid claims of the `774 patent, no rights under\nany substance and\/or kit claims are included in this definition or this\nAgreement.\n\n         1.8      \"NET SERVICE REVENUES\" shall mean gross invoice price for the\nLICENSED CLINICAL SERVICES performed by SLI (or the fair market value for any\nnon-monetary consideration which SLI agrees to receive in exchange for LICENSED\nCLINICAL SERVICES), less the following deductions where they are factually\napplicable and are not already reflected in the gross invoice price:\n\n                  a)       discounts allowed and taken, in amounts customary in\n                           the trade (which shall include the difference between\n                           the dollar amount charged by SLI for a LICENSED\n                           CLINICAL SERVICE and the Medicare and\/or Medicaid\n                           Limits of \n\n------------------------------\n           * PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST \nFOR CONFIDENTIAL TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND \nEXCHANGE COMMISSION.\n\n\n\n                           Allowance and\/or reimbursement limitations of a \n                           THIRD PARTY insurance program); and\n\n                  b)       government imposed sales taxes and other taxes to the\n                           extent they are separately identified on the invoice;\n                           and\n\n                  c)       actual bad debt, up to 2% of gross invoice price for\n                           LICENSED CLINICAL SERVICES, which bad debt SLI can\n                           prove and document that it was reasonable and\n                           diligent in its efforts to collect payment.\n\n         No allowance or deduction shall be made for commissions or collections,\nby whatever name known.\n\n         The NET SERVICE REVENUES of the LICENSED CLINICAL SERVICES that are\nperformed by SLI for any person, firm or corporation controlling, controlled by,\nor under common control with SLI, or enjoying a special course of dealing with\nSLI, shall be determined by reference to the NET SERVICE REVENUES which would be\napplicable under this Section in an arm's length transaction by SLI to a THIRD\nPARTY other than such person, firm or corporation.\n\n         1.9      \"OTHER TECHNOLOGY\" shall mean the method claims of United\nStates Patent Nos. 5,389,512, and claims 1-4 and 15-18 of United States Patent\nNo. 5,476,774, and any reissue or reexamination patents thereof.\n\n         1.10     [***]* shall mean analysis of human genetic material to \nascertain [***]*.\n\n         1.11     \"RT AND RT-PCR TECHNOLOGY\" shall mean the reverse\ntranscription process covered by the method claims of United States Patent Nos.\n5,407,800, 5,322,770 and 5,310,652, and any reissue or reexamination patents\nthereof.\n\n         1.12     \"THIRD PARTY\" shall mean a party other than an AFFILIATE of\nThe Parties to this Agreement.\n\n         1.13     \"VALID CLAIM\" shall mean an unexpired claim of any of the\npatents within LICENSED TECHNOLOGY which has not been held invalid or\nunenforceable by decision of a court or other governmental agency of competent\njurisdiction, such decision being unappealable or unappealed within the time\nallowed for appeal.\n\n         1.14     \"TERRITORY\" shall mean the United States and its possessions \nand the Commonwealth of Puerto Rico.\n\n2.       GRANT:\n\n         2.1      Upon the terms and subject to the conditions of this\nAgreement, RMS hereby grants to SLI, and SLI hereby accepts from RMS, a\nroyalty-bearing, non-exclusive, non-\n\n------------------------------\n           * PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST \nFOR CONFIDENTIAL TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND \nEXCHANGE COMMISSION.\n\n\n\ntransferable immunity from suit under LICENSED TECHNOLOGY solely to perform\nLICENSED CLINICAL SERVICES within the Territory. The Parties understand and\nagree that to the extent that SLI is otherwise licensed by RMS under PCR\nTechnology to perform human IN VITRO diagnostic services (hereinafter referred\nto as a \"PCR Diagnostic Services License\"), the present Homogeneous PCR Clinical\nServices Agreement is independent of the PCR Diagnostic Services License and the\nonly royalties due to RMS for the performance of LICENSED CLINICAL SERVICES\npursuant to the present Agreement shall be in accordance with the present\nAgreement and not the PCR Diagnostic Services License.\n\n         The Parties understand and agree that no rights are hereby granted,\nexpressly or by implication, under United States Patent Nos. B1 4,683,195,\n4,683,202 and 4,965,188, (the `195 and `202 patents covering the polymerase\nchain reaction and the `188 patent, covering the performance of nucleic acid\namplification using a thermostable polymerase) hereinafter \"PCR Technology.\" An\nimmunity from suit under the PCR Technology may be obtained by contacting the\nLicensing Coordinator, Roche Molecular Systems, Inc., 1145 Atlantic Avenue,\nAlameda, CA 94501, Telephone (510) 814-2984, Facsimile (510) 814-2977.\n\n         2.2      The LICENSED TECHNOLOGY hereunder may be practiced solely for\nthe performance of LICENSED CLINICAL SERVICES by SLI and for no other purpose\nwhatsoever and no other right, immunity or license is granted expressly,\nimpliedly or by estoppel.\n\n         2.3      SLI expressly acknowledges and agrees that the immunity from\nsuit pursuant to this Agreement is personal to SLI alone and SLI shall have no\nright to sublicense, assign or otherwise transfer or share its rights under the\nforegoing immunity from suit. SLI further agrees that LICENSED CLINICAL SERVICES\nwill be performed, offered, marketed and sold only by SLI except as provided, in\nArticle 2.3(a) and SLI shall not authorize any other party, including\nAFFILIATES, to practice the LICENSED TECHNOLOGY, nor shall it practice the\nLICENSED TECHNOLOGY in conjunction with any other party.\n\n                  a)       SLI may offer, market and sell LICENSED CLINICAL\n                           SERVICES that are performed by other laboratories\n                           subject to the following conditions:\n\n                           i)       Each laboratory performing LICENSED CLINICAL\n                                    SERVICES for SLI must be separately licensed\n                                    under RMS's Homogeneous PCR Clinical\n                                    Services program.\n\n                           ii)      SLI's report forms must list all LICENSED\n                                    CLINICAL SERVICES marketed and sold by SLI\n                                    which are performed by another laboratory\n                                    even though SLI will not be obligated to pay\n                                    royalties on those LICENSED CLINICAL\n                                    SERVICES.\n\n                           iii)     SLI must contact RMS to verify that a new\n                                    laboratory to which it seeks to send samples\n                                    for performance of LICENSED CLINICAL\n                                    SERVICES is properly licensed by RMS before\n                                    sending samples to that laboratory.\n\n\n                           iv)      Each laboratory performing LICENSED CLINICAL\n                                    SERVICES for SLI must report and pay\n                                    royalties on LICENSED CLINICAL SERVICES\n                                    performed for SLI.\n\n         2.4      RMS hereby grants to SLI the right and SLI accepts and agrees\nto credit RMS as the source of LICENSED TECHNOLOGY rights in SLI's, promotional\nmaterials and any other materials intended for distribution to THIRD PARTIES as\nfollows:\n\n                  \"This test [or assay] is performed pursuant to a license \n                  agreement with Roche Molecular Systems, Inc.\"\n\n3.       ACKNOWLEDGMENT AND AGREEMENT ON DIAGNOSTIC PRODUCTS:\n\n         SLI acknowledges and agrees that the immunity from suit granted\nhereunder is for the performance of LICENSED CLINICAL SERVICES only and does not\ninclude any right to make, have made, import, offer or sell any products,\nincluding but not limited to devices, PCR reagents, reaction mixtures, or kits.\n\n4.       ROYALTIES, RECORDS AND REPORTS:\n\n         4.1      ROYALTIES. For the rights and privileges granted under this\nAgreement, SLI shall pay to RMS an amount equal to the total number of all\nreportable tests (that is, tests the results of which are provided by SLI to any\nparty not a member to this Agreement, including tests the results of which are\nprovided to AFFILIATES of SLI, for diagnostic purposes) performed for each\nLICENSED CLINICAL SERVICE, including tests performed in conjunction with a\nclinical trial, multiplied by (1) [***]* of NET SERVICE REVENUES or (2) [***].*\n\n         4.2      Licensed Services performed under SLI's separately licensed\nPCR Technology and in conjunction with the performance of LICENSED CLINICAL\nSERVICES, are not royalty bearing apart from the royalty due as set forth in\nthis Section 4.\n\n         4.3      SLI shall keep full, true and accurate books of account\ncontaining all particulars which may be necessary for the purpose of showing the\namount payable to RMS by way of royalty or by way of any other provision under\nthis Agreement. Such books and the supporting data shall be open at all\nreasonable times, for three (3) years following the end of the calendar year to\nwhich they pertain (and access shall not be denied thereafter, if reasonably\navailable), to the inspection of RMS or an independent certified public\naccountant retained by RMS for the purpose of verifying SLI's royalty statements\nor SLI's compliance in other respects with this Agreement. It is understood that\nRMS's inspection of SLI's records does not require access to actual patient\nresults. If in dispute, such records shell be kept until the dispute is settled.\nThe inspection of records shall be at RMS's sole cost and expense, unless the\ninspector concludes \n\n------------------------------\n           * PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST \nFOR CONFIDENTIAL TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND \nEXCHANGE COMMISSION.\n\n\n\nthat royalties reported by SLI for the period being audited are understated by\nfive percent (5%) or more from actual royalties, in which case the costs and\nexpenses of such inspection shall be paid by SLI.\n\n         4.4      REPORTS\n\n                  a)       SLI shall within sixty (60) days after the first day\n                           of January and July of each year deliver to RMS a\n                           true and accurate royalty report. Such report shall\n                           cover the preceding six (6) calendar months; and\n                           shall be submitted either (1) on the \"Homogeneous PCR\n                           Clinical Services Royalty Report,\" a copy of which is\n                           attached hereto as Attachment I; or (2) on a form\n                           generated by SLI which duplicates the format of the\n                           Homogeneous PCR Clinical Services Royalty Report; and\n                           shall include at least the following:\n\n                           i)       the name of the LICENSED CLINICAL SERVICE\n                                    and the total number of all reportable\n                                    results obtained for each LICENSED CLINICAL\n                                    SERVICE during the six (6) preceding\n                                    calendar months;\n\n                           ii)      compilation of billing thereon and the\n                                    allowable deductions therefrom;\n\n                           iii)     Net Service Revenues and the calculation of\n                                    the total royalty thereon; and\n\n                           iv)      the calculation of the total royalty due to\n                                    RMS for all such reportable results. If no\n                                    royalties are due, it shall be so reported.\n\n                  b)       The correctness and completeness of each such report\n                           shall be attested to in writing by the responsible\n                           financial officer of SLI's organization or by SLI's\n                           external auditor or by the chair or other head of\n                           SLI's internal audit committee.\n\n                  c)       Simultaneously with the delivery of each such report,\n                           SLI shall pay to RMS the royalty and any other\n                           payments due under this Agreement for the period\n                           covered by such report. All payments due RMS\n                           hereunder shall be paid in United States currency and\n                           sent, by the due date, together with a copy of the\n                           royalty report to the following address:\n\n                                    Roche Molecular Systems, Inc.\n                                    P.O. Box 18139\n                                    Newark; New Jersey 07191\n\n                           or to any address that RMS may advise in writing..\n\n\n                  d)       If, during any reporting period, SLI performs tests,\n                           all of which tests are LICENSED CLINICAL SERVICES\n                           under the present Homogeneous PCR Clinical Services\n                           Agreement, such Licensed Clinical Services shall be\n                           reported in \n\n\n\n                           accordance with the reporting provisions contained \n                           herein, and a separate Summary Royalty Report \n                           pursuant to Section 4.3 of the underlying PCR \n                           Diagnostic Service License is not required.\n\n                  e)       If, during any reporting period, SLI performs tests\n                           which are Licensed Services, pursuant to their PCR\n                           Diagnostic Services License, but are not LICENSED\n                           CLINICAL SERVICES under the present Homogeneous PCR\n                           Clinical Services Agreement, such Licensed Services\n                           shall be reported in accordance with the underlying\n                           PCR Diagnostic Services License. .\n\n                  f)       In the event that, during any reporting period, SLI\n                           performs no tests which are either Licensed Services\n                           or LICENSED CLINICAL SERVICES, SLI shall so indicate\n                           on SLI's Homogeneous PCR Clinical Services Royalty\n                           Report, by checking the appropriate box regarding\n                           both LICENSED CLINICAL SERVICES and Licensed\n                           Services, with no obligation to provide a separate\n                           Summary Royalty Report under the PCR Diagnostic\n                           Service License.\n\n                  g)       In any given reporting period, no single Licensed\n                           Service or LICENSED CLINICAL SERVICE shall be\n                           reported on more than one Royalty Report.\n\n         4.5      LICENSED CLINICAL SERVICES performed by SLI prior to execution\nof this Agreement shall be royalty bearing and reported to RMS together with the\nfirst royalty report due hereunder.\n\n         4.6      SLI's obligation to pay royalties pursuant to this Agreement\nshall continue only for as long as SLI operates under the licenses granted\npursuant to Article 2 herein, and shall terminate when there are no longer any\nVALID CLAIMS in any of patents identified in LICENSED TECHNOLOGY, Section 1.7,\nSUPRA.\n\n         4.7      If SLI shall fail to pay any amount specified under this\nAgreement after the due date thereof, the amount owed shall bear interest of\n1.5% per month from the due date until paid, provided, however, that if this\ninterest rate is held to be unenforceable for any reason, the interest rate\nshall be the maximum rate allowed by law at the time the payment is due.\n\n5.       TECHNOLOGY NOTIFICATION:\n\n         5.1      With respect to any invention, improvement or discovery\n(hereinafter referred to as \"Discoveries\" in this Article) of SLI made after\nentering into this Agreement, resulting from work conducted under this Agreement\nand being applicable to HOMOGENEOUS PCR TECHNOLOGY, RT AND RT-PCR TECHNOLOGY and\nOTHER TECHNOLOGY, if SLI decides to license said Discoveries to THIRD PARTIES,\nthen SLI agrees to provide to RMS, unless not possible due to SLI's pre-existing\ncommitments to THIRD PARTIES relating to said Discoveries, a reasonable\nopportunity to negotiate a license to use said Discoveries. Such Discoveries\ninclude, but are not limited to, improvements of the homogeneous PCR processes\nor in the performance of LICENSED CLINICAL SERVICES, modifications to or new\nmethods of performing the LICENSED CLINICAL \n\n\n\nSERVICES, including the automation of the homogeneous PCR processes or of the\nLICENSED CLINICAL SERVICES.\n\n         5.2      Any agreement reached between The Parries as a result of SLI\nnotification to RMS of a Discovery pursuant to Section 5.1 hereto shall be upon\nthe terms and conditions negotiated in good faith by The Parties.\n\n6.       MOST FAVORED LICENSEE:\n\n         If after the EFFECTIVE DATE of this Agreement, RMS grants to a THIRD\nPARTY a license of substantially the same scope as is granted to SLI but having\nmore favorable royalties in the TERRITORY for LICENSED CLINICAL SERVICES than\nthose set forth herein, RMS shall promptly notify SLI of said more favorable\nroyalties, and SLI shall have the right and option to substitute such more\nfavorable royalties for the royalties contained herein. SLI's right to elect\nsaid more favorable royalties shall extend only for the time period such more\nfavorable royalties shall be available to such other THIRD PARTY and shall be\nconditioned on SLI's acceptance of all the same conditions, favorable or\nunfavorable, under which such more favorable royalties are made available to\nsuch other THIRD PARTY. Upon SLI's acceptance of all such terms of said THIRD\nPARTY agreement, the more favorable royalties shall be effective as to SLI as of\nthe effective date of such other THIRD PARTY license agreement. Notwithstanding\nthe foregoing, in the event that RMS shall receive substantial other\nnon-monetary consideration, for example, such as intellectual property rights,\nas a part of the consideration for its granting of such license to a THIRD\nPARTY, then this Article 6 shall not apply. Furthermore if the \"more favorable\nroyalty\" granted to a THIRD PARTY applies only to LICENSED CLINICAL SERVICES\nperformed in conjunction with a clinical study or clinical trial, then SLI shall\nbe entitled to the same fee for the same tests)\/services performed in\nconjunction with a similar clinical study or trial. However, there shall be no\nreduction in the fee for those LICENSED CLINICAL SERVICES, even if for the same\nanalyte, which are not performed in conjunction with a clinical study or trial.\n\n7.       TERM AND TERMINATION:\n\n         7.1      The immunity from suit granted to SLI herein shall commence on\nthe EFFECTIVE DATE and terminate on the earlier of (1) Dec. 31st of the year in\nwhich the fifth anniversary of the EFFECTIVE DATE is observed or (2) the date of\nexpiration of the last to expire of the patents included within the LICENSED\nTECHNOLOGY, which patent contains at least one VALID CLAIM covering the\nperformance of LICENSED CLINICAL SERVICES.\n\n         7.2      Notwithstanding any other Section of this Agreement, SLI may \nterminate this Agreement for any reason on thirty (30) days' written notice to \nRMS.\n\n         7.3      The immunity from suit granted hereunder to SLI shall\nautomatically terminate upon (a) an adjudication of SLI as bankrupt or\ninsolvent, or SLI's admission in writing of its inability to pay its obligations\nas they mature; or (b) an assignment by SLI for the benefit of creditors; or (c)\nSLI's applying for or consenting to the appointment of a receiver, trustee or\nsimilar officer for any substantial part of its property; or such receiver,\ntrustee or \n\n\n\nsimilar officer's appointment without the application or consent of SLI, if such\nappointment shall continue undischarged for a period of ninety (90) days; or (d)\nSLI's instituting (by petition, application, answer, consent or otherwise) any\nbankruptcy, insolvency arrangement, or similar proceeding relating to SLI under\nthe laws of any jurisdiction; or (e) the institution of any such proceeding (by\npetition, application or otherwise) against SLI, if such proceeding shall remain\nundismissed for a period of ninety (90) days or the issuance or levy of any\njudgment, writ, warrant of attachment or execution or similar process against a\nsubstantial part of the property of SLI; if such judgment, writ, or similar\nprocess shall not be released, vacated or fully bonded within ninety (90) days\nafter its issue or levy; or (f) loss of SLI's federal or state licenses permits\nor accreditation necessary for operation of SLI as a health care institution.\n\n         7.4      RMS shall have the right to terminate this Agreement by\nwritten notice to SLI upon any change in the ownership or control of SLI or of\nits assets. Termination under this Section shall be effective immediately upon\nreceipt by SLI of RMS's notice of termination. For such purposes, a \"change in\nownership or control\" shall mean that 30% or more of the voting stock of SLI\nbecome subject to the control of a person or entity, or any related group of\npersons or entities acting in concert, which person(s) or entity(ies) did not\ncontrol such proportion of voting stock as of the EFFECTIVE DATE of the\nAgreement. Analogously, RMS shall have the right to terminate this Agreement\nupon any transfer or sale of 30% or more of the assets of SLI to another party.\n\n         7.5      BREACH. Upon any breach of or default of a material term under\nthis Agreement by SLI, RMS may terminate this Agreement upon thirty (30) days'\nwritten notice to SLI. Said notice shall become effective at the end of the\nthirty-day period, unless during said period SLI fully cures such breach or\ndefault and notifies RMS of such a cure.\n\n         7.6      SLI's obligations to report to RMS and to pay royalties to RMS\nas to the LICENSED CLINICAL SERVICES performed under the Agreement prior to \ntermination or expiration of the Agreement shall survive such termination or \nexpiration.\n\n8.       CONFIDENTIALITY-PUBLICITY:\n\n         8.1      SLI agrees to obtain RMS's approval before distributing any\nwritten information, such as Press Releases, to THIRD PARTIES referring to RMS\nor this Agreement. RMS's approval shall not be unreasonably withheld or delayed\nand, in any event, RMS's decision shall be rendered within three (3) weeks of\nreceipt of the written information. Once approved, such materials, or abstracts\nof such materials, which do not materially alter the context of the material\noriginally approved may be reprinted during the tern of the Agreement without\nfurther approval by RMS unless RMS has notified SLI in writing of its decision\nto withdraw permission for such use.\n\n         8.2      Each Party agrees that any financial, legal or business\ninformation or any technical information disclosed to it (the \"Receiving Parry\")\nby the other (the \"Disclosing Party\") in connection with this Agreement shall be\nconsidered confidential and proprietary and \n\n\n\nthe Receiving Party shall not disclose same to any THIRD PARTY and shall hold it\nin confidence for a period of five (5) years and will not use it other than as\npermitted under this Agreement provided, however, that any information, know-how\nor data which is orally disclosed to the Receiving Party shall not be considered\nconfidential and proprietary unless such oral disclosure is reduced to writing\nand given to the Receiving Party in written form within thirty (30) days after\noral disclosure thereof. Such confidential and proprietary information shall\ninclude, without limitation, marketing and sales information, commercialization\nplans and strategies, research and development work plans, and technical\ninformation such as patent applications, inventions, trade secrets, systems,\nmethods, apparatus, designs, tangible material, organisms and products and\nderivatives thereof.\n\n         8.3      The above obligations of confidentiality shall not be \napplicable to the extent:\n\n                  a)       such information is general public knowledge or,\n                           after disclosure hereunder, becomes general or public\n                           knowledge through no fault of the Receiving Party; or\n\n                  b)       such information can be shown by the Receiving Party\n                           by its written records to have been in its possession\n                           prior to receipt thereof hereunder; or\n\n                  c)       such information is received by the Receiving Party\n                           from any THIRD PARTY for use or disclosure by the\n                           Receiving Party without any obligation to the\n                           Disclosing Party provided, however, that information\n                           received by the Receiving Party from any THIRD PARTY\n                           funded by the Disclosing Party (e.g. consultants,\n                           subcontractors, etc.) shall not be released from\n                           confidentiality under this exception; or\n\n                  d)       the disclosure of such information is required or\n                           desirable to comply with or fulfill governmental\n                           requirements, submissions to governmental bodies, or\n                           the securing of regulatory approvals.\n\n         8.4      Each Party shall, to the extent reasonably practicable,\nmaintain the confidentiality of the provisions of this Agreement and shall\nrefrain from making any public announcement or disclosure of the terms of this\nAgreement without the prior consent of the other Party, except to the extent a\nParty concludes in good faith that such disclosure is required under applicable\nlaw or regulations, in which case the other Party shall be notified in advance.\n\n9.       COMPLIANCE:\n\n         In exercising any and all rights and in performing its obligations\nhereunder, SLI shall comply fully with any and all applicable laws, regulations\nand ordinances and shall obtain and keep in effect licenses, permits and other\ngovernmental approvals, whether at the federal, state or local levels, necessary\nor appropriate to carry on its activities hereunder. SLI further agrees to\nrefrain from any activities that would have an adverse effect on the business\nreputation of RMS. RMS will advise SLI of any such activities and SLI will have\nthirty (30) days to correct such activity.\n\n\n\n10.      ASSIGNMENT:\n\n         This Agreement shall not be assigned or transferred by SLI (including\nwithout limitation any purported assignment or transfer that would arise from a\nsale or transfer of SLI's business), without the express written consent of RMS.\nRMS may assign all or any part of its rights and obligations under this\nAgreement at any time without the consent of SLI. SLI agrees to execute such\nfurther acknowledgments or other instruments as RMS may reasonably request in\nconnection with such assignment.\n\n11.      NEGATION OF WARRANTIES AND INDEMNITY:\n\n         11.1     Nothing in this Agreement shall be construed as:\n\n                  a)       a warranty or representation by RMS as to the\n                           validity or scope of any patent included within\n                           LICENSED TECHNOLOGY;\n\n                  b)       a warranty or representation that the practice of the\n                           LICENSED TECHNOLOGY and\/or the performance of\n                           LICENSED CLINICAL SERVICES are or will be free from\n                           infringement of patents of THIRD PARTIES;\n\n                  c)       an obligation to bring or prosecute actions or suits\n                           against THIRD PARTIES for infringement;\n\n                  d)       except as expressly set forth herein, conferring the\n                           right to use in advertising, publicity or otherwise\n                           any trademark, trade name, or names, or any\n                           contraction, abbreviation, simulation or adaptation\n                           thereof, of RMS;\n\n                  e)       conferring by implication, estoppel or otherwise any\n                           license, right or immunity under any patents or\n                           patent applications of RMS other than those specified\n                           in LICENSED TECHNOLOGY, regardless of whether such\n                           other patents and patent applications are dominant or\n                           subordinate to those in LICENSED TECHNOLOGY;\n\n                  f)       an obligation to furnish any know-how not provided in\n                           LICENSED TECHNOLOGY; or\n\n                  g)       creating any agency, partnership, joint venture or\n                           similar relationship between RIM and SLI.\n\n         11.2     RMS MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY \nOR FITNESS FOR A PARTICULAR PURPOSE.\n\n\n\n         11.3     SLI shall assume full responsibility for its use of the\nLICENSED TECHNOLOGY and shall defend, indemnify and hold RMS harmless from and\nagainst all liability, demands, damages, expenses (including attorneys' fees)\nand losses for death, personal injury, illness, property damage or any other\ninjury or damage, including any damages or expenses arising in connection with\nstate or federal regulatory action (collectively \"Damages\"), resulting from the\nuse by SLI, including its officers, directors, agents and employees, of the\nLICENSED Technology except, and to the extent that such Damages are caused by\nthe negligence or willful misconduct of RMS.\n\n12.      GENERAL:\n\n         12.1     This Agreement constitutes the entire agreement between The\nParties as to the subject matter hereof, and all prior negotiations,\nrepresentations, agreements and understandings are merged into, extinguished by\nand completely expressed by it. This Agreement may be modified or amended only\nby a writing executed by authorized officers of each of The Parties.\n\n         12.2     Any notice required or permitted to be given by this Agreement\nshall be given by postpaid, first class, registered or certified mail, or by\ncourier, properly addressed to the other Party at the respective address as\nshown below:\n\n         If to RMS:             Roche Molecular Systems, Inc.\n                                1145 Atlantic Avenue\n                                Alameda, California 94501\n                                Attn: General Counsel\n         \n         If to SLI:             Specialty Laboratories, Inc.\n                                2211 Michigan Avenue\n                                Santa Monica, CA 90404-3900 .\n                                Attn: Richard Horan, Material Director\n\n         Either Party may change its address by providing notice to the other\nParty. Unless otherwise specified herein, any notice given in accordance with\nthe foregoing shall be deemed given within four (4) full business days after the\nday of mailing, or one full day after the date of delivery to the courier, as\nthe case will be.\n\n         12.3     GOVERNING LAW AND VENUE. This Agreement and its effect are\nsubject to and shall be construed and enforced in accordance with the law of the\nState of California, U.S.A., except as to any issue which by the law of\nCalifornia depends upon the validity, scope or enforceability of any patent\nwithin the HOMOGENEOUS PCR TECHNOLOGY, RT and RT-PCR TECHNOLOGY or OTHER\nTECHNOLOGY, which issue shall be determined in accordance with the applicable\npatent laws of the United States. The Parties agree that the exclusive\njurisdiction and venue for any dispute or controversy arising from this\nAgreement shall be in the United States District Court for the Northern District\nof California if federal jurisdiction exists, and if no federal jurisdiction\nexists, then in the Superior Court of the County of Alameda, California.\n\n\n\n         12.4     ARBITRATION. Notwithstanding the provisions of Section 12.3\nabove, any dispute concerning solely the determination of facts such as, but not\nlimited to, (a) the value of a LICENSED CLINICAL SERVICE pursuant to Section\n1.8; (b) a determination of royalty rate payments owed pursuant to Section 4.1;\nor (c) good faith compliance with Article 6; and which dispute does not involve\na question of law, shall be settled by final and binding arbitration at a\nmutually convenient location in the State of California pursuant to the\ncommercial arbitration rules of the American Arbitration Association, in\naccordance with the following procedural process:\n\n                           i)       The arbitration tribunal shall consist of\n                                    three arbitrators. In the request for\n                                    arbitration and the answer thereto, each\n                                    Party shall nominate one arbitrator and the\n                                    two arbitrators so named will then jointly\n                                    appoint the third arbitrator as chairman of\n                                    the arbitration tribunal.\n\n                           ii)      The decision of the arbitration tribunal\n                                    shall be final and judgment upon such\n                                    decision may be entered in any competent\n                                    court for juridical acceptance of such an\n                                    award and order of enforcement. Each Party\n                                    hereby submits itself to the jurisdiction of\n                                    the courts of the place of arbitration, but\n                                    only for the entry of judgment with respect\n                                    to the decision of the arbitrators\n                                    hereunder.\n\n         12.5     Nothing in this Agreement shall be construed so as to require\nthe commission of any act contrary to law, and wherever there is any conflict\nbetween any provision of this Agreement or concerning the legal right of The\nParties to enter into this contract and any statute, law, ordinance or treaty,\nthe latter shall prevail, but in such event the affected provisions of the\nAgreement shall be curtailed and limited only to the extent necessary to bring\nit within the applicable legal requirements.\n\n         12.6     If any provision of this Agreement is held to be unenforceable\nfor any reason, it shall be adjusted rather than voided, if possible, in order\nto achieve the intent of The Parties to the extent possible. In any event, all\nother provisions of this Agreement shall be deemed valid and enforceable to the\nfull extent possible.\n\n         IN WITNESS WHEREOF, The Parties hereto have set their hands and seals\nand duly executed this Agreement on the date(s) indicated below, to be effective\non Effective Date as defined herein.\n\n\nROCHE MOLECULAR SYSTEMS, INC           SPECIALTY LABORATORIES, INC.\n\nBy:    \/s\/                             By:    \/s\/\n      -------------------------------        -------------------------------\n       Thomas White, Ph.D.                     Bart Thielen\nTitle: Sr. Vice President, R&amp;D         Title:  Vice President of Finance\n\nDate:  Oct. 1, 1999                    Date:  10\/5\/99\n      -------------------------------        -------------------------------\n\n\n\nApprv'd As To Form \nLAW DEPT.\n\nBy:  \/s\/\n\n\n\n\n\n                 RIDER CONCERNING SUPPLEMENTAL PATENT RIGHTS TO\n                   HOMOGENEOUS PCR CLINICAL SERVICES AGREEMENT\n\nThe purpose of this rider is to set forth the agreement of Specialty\nLaboratories, Inc. (\"SLI\") and Roche Molecular Systems, Inc. (\"RMS\") concerning\nthe supplemental rights to additional patents relating to PCR technology which\nRMS offers and The Parties agree to add to the rights granted to SLI by the\nAgreement between The Parties, executed on even date herewith, (the \"Homogeneous\nPCR Clinical Services Agreement\").\n\n1.    It is understood by The Parties that RMS may, from time to time, come into\n      possession or control of additional patents or claims of patents relating\n      to PCR technology rights to which RMS may decide to offer to add to the\n      Homogeneous PCR Clinical Services Agreement and which SLI may desire to\n      accept. Accordingly, appended hereto as APPENDIX A is a list of such\n      additional patents or claims of patents as RMS is currently offering to\n      which SLI, by its authorized representative, has indicated its acceptance\n      thereof in accordance with the rights of use and all other pertinent\n      obligations, restrictions and limitations as set forth in the Homogeneous\n      PCR Clinical Services Agreement.\n\n2.    APPENDIX A may be amended by mutual agreement of The Parties in writing so\n      as to add additional patent rights being offered by RMS. Accordingly, a\n      new APPENDIX A signed and dated by both parties shall supersede any prior\n      APPENDIX A and shall become a part of this rider.\n\n3.    It is expressly understood and agreed by The Parties that the grant of\n      additional patent rights herein does not in any way otherwise modify the\n      Homogeneous PCR Clinical Services Agreement and that all provisions of\n      that Agreement shall remain in full force and effect as originally set\n      forth therein. The term of the Homogeneous PCR Clinical Services Agreement\n      shall control the enjoyment of rights hereunder and is not extended by the\n      rights granted hereby nor shall there be any additional royalty obligation\n      to RMS beyond that set forth in said Agreement.\n\n4.    In consideration of the further rights being granted it hereunder, SLI\n      agrees to remain in good faith compliance with the applicable terms of the\n      Homogeneous PCR Clinical Services Agreement, including reporting and\n      payment of royalties and the limitation on use of PCR technology strictly\n      for the performance of licensed services and not to make products.\n\n5.    In the event that SLI's obligation to pay royalties under the Homogeneous\n      PCR Clinical Services Agreement for its rights to use the PCR technology\n      shall cease for any reason, whether by termination, expiry, invalidation\n      or otherwise, then The Parties agree that this rider shall become null and\n      void and the rights granted hereunder terminated without notice and The\n      Parties shall be free to negotiate a new agreement with respect to the\n      patent rights listed on APPENDIX A.\n\n\n                                       Accepted and Agreed,\nROCHE MOLECULAR SYSTEMS, INC           SPECIALTY LABORATORIES, INC.\n\nBy:    \/s\/                             By:    \/s\/\n      -------------------------------        -------------------------------\n       Thomas White, Ph.D.                     Bart Thielen\nTitle: Sr. Vice President, R&amp;D         Title:  Vice President of Finance\n\nDate:  Oct. 1, 1999                    Date:  10\/5\/99\n      -------------------------------        -------------------------------\n\n\n\nAPPENDIX A TO RIDER\n\nAdditional Patents\n\nUnited States Patent No. 5,561,058\n\nUnited States Patent No. 5,693,517\n\n[ADVANCE \\Y550]\nROCHE MOLECULAR SYSTEMS, INC           SPECIALTY LABORATORIES, INC.\n\nBy:    \/s\/                             By:    \/s\/\n      -------------------------------        -------------------------------\n       Thomas White, Ph.D.                     Bart Thielen\nTitle: Sr. Vice President, R&amp;D         Title:  Vice President of Finance\n\nDate:  Oct. 1, 1999                    Date:  10\/5\/99]\n      -------------------------------        -------------------------------\n\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[8892],"corporate_contracts_industries":[9437],"corporate_contracts_types":[9613,9620],"class_list":["post-42334","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-specialty-laboratories-inc","corporate_contracts_industries-health__labs","corporate_contracts_types-operations","corporate_contracts_types-operations__services"],"acf":[],"_links":{"self":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts\/42334","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts"}],"about":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/types\/corporate_contracts"}],"wp:attachment":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/media?parent=42334"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42334"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42334"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42334"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}