Common use of Rights of Reference Clause in Contracts

Rights of Reference. (a) To the extent any Regulatory Filings are Controlled by LifeCycle, and CHRP has been granted such rights by LifeCycle, or to the extent any Regulatory Filings are Controlled by CHRP, and Shore has been granted any such rights by CHRP, CHRP and Shore hereby grant to Santarus and its sublicensees, a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data within the LifeCycle Know-How relating directly to Licensed Products, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause their respective Affiliates to sign, any instruments reasonably requested by Santarus in order to effect such grant, solely for the purposes of conducting such activities as are contemplated by this Agreement. (b) Each of CHRP and Shore hereby grants to Santarus the full right to use and refer to any Drug Master File for the Licensed Product to which it has access and will provide a copy thereof to Santarus upon Santarus’ request solely for the purposes of Developing and seeking Regulatory Approval of the Licensed Products and conducting such other activities as are contemplated by this Agreement. (c) Shore hereby grants to Santarus and its sublicensees, a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data within the Licensed Know-How relating directly to Licensed Products to which it has access, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Santarus in order to effect such grant, solely for the purposes of conducting such activities as are contemplated by this Agreement. (d) Santarus hereby grants to Shore (and at Shore’s written request, shall grant to LifeCycle) the foreign equivalents, in any country or jurisdiction outside the Territory, to a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data relating directly to Licensed Products, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Shore in order to effect any such grant, solely for the purposes of Developing and seeking Regulatory Approval outside the Territory of the Licensed Products. Upon Shore’s reasonable request made from time to time, Santarus shall, or shall cause its Affiliates or sublicensees to, transfer to Shore or LifeCycle a copy of all such Regulatory Filings with respect to the Licensed Products.

Rights of Reference. (a) To the extent any Regulatory Filings are Controlled by LifeCycle, and CHRP has been granted such rights by LifeCycle, or ArQule hereby grants to the extent any Regulatory Filings are Controlled by CHRP, and Shore has been granted any such rights by CHRP, CHRP and Shore hereby grant to Santarus and its sublicensees, Licensee a “Right of Reference or Use” Reference, as that term is defined in 21 C.F.R. § 314.3(b), ) and any foreign counterpart to such regulation (and any current or future Sublicensee of Licensee of the Licensed Compound and/or any Licensed Products) to a right of access to and a right to use and incorporate all Regulatory Filings Documentation and Product the ArQule Development Data within to the LifeCycle Know-How relating directly extent Controlled by ArQule and necessary or useful to Licensed ProductsDevelop, which includes that related to pharmacologyManufacture, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality controlobtain Regulatory Approval of, and agrees Commercialize the Licensed Compound or any Licensed Product in the Territory, in each case, pursuant to sign, the Development Plan or Commercialization Plan and cause their respective Affiliates otherwise subject to sign, any instruments reasonably requested by Santarus in order to effect such grant, solely for the purposes terms and conditions of conducting such activities as are contemplated by this Agreement. ArQule will use commercially reasonable efforts to have its current or future licensees of the Licensed Compound and/or any Licensed Products provide a Right of Reference to, a right of access to and a right to use and incorporate all Regulatory Documentation controlled by such licensee and necessary or useful to obtain Regulatory Approval of the Licensed Compound or any Licensed Product in the Territory. (b) Each of CHRP and Shore Without any additional consideration to Licensee, Licensee hereby grants to Santarus ArQule (and any current or future licensee of ArQule of the full Licensed Compound and/or any Licensed Products) a Right of Reference to, a right of access to and a right to use and refer incorporate all Regulatory Documentation and the Licensee Development Data to any Drug Master File for the extent Controlled by Licensee, its Affiliates and its and their licensors, (sub)licensees and contractors and necessary or useful to (i) Develop and Manufacture the Licensed Product Compound and any Licensed Products inside the Territory in order to which it has access and will provide a copy thereof to Santarus upon Santarus’ request solely for the purposes of Developing and seeking obtain Regulatory Approval of and Commercialize the Licensed Compound and any Licensed Products outside of the Territory, and conducting such other activities as are contemplated by (ii) Develop, Manufacture, obtain Regulatory Approval of, and Commercialize the Licensed Compound and any Licensed Products outside of the Territory, in each case ((i) and (ii)) in accordance with any applicable terms and conditions of this Agreement. (c) Shore hereby grants Each Party will provide a signed statement to Santarus and its sublicenseesthis effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a “request by either Party, for the limited purpose described in this Clause 2.4 (Rights of Reference). For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data of the other Party to which a Right of Reference or Use” as that term is defined granted under this Clause 2.4 (Rights of Reference) except in 21 C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data within the Licensed Know-How relating directly to Licensed Products to which it has access, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Santarus in order to effect such grant, solely for the purposes of conducting such activities as are contemplated by accordance with this Agreement. For clarity, submission of data to a Regulatory Authority shall not be considered publication or public disclosure under the preceding sentence. (d) Santarus hereby grants to Shore (and at Shore’s written request, shall grant to LifeCycle) In the foreign equivalents, event that Licensee discontinues Development of any Licensed Product in any country or jurisdiction outside the Territory, then Licensee shall (i) return all ArQule Development Data to a “Right of Reference or Use” ArQule as that term is defined in 21 C.F.R. § 314.3(b), to well as any and all Regulatory Filings and Product Licensee Development Data relating generated by Licensee related directly to the discontinued Licensed Products, which includes that related Product (ii) transfer to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, ArQule (and/or any instruments reasonably requested by Shore in order to effect any such grant, solely for the purposes current or future licensee of Developing and seeking Regulatory Approval outside the Territory ArQule of the Licensed Compound and/or any Licensed Products. Upon Shore’s reasonable request made from time to time) all of its right, Santarus shall, or shall cause title and interest in all Regulatory Documentation and Regulatory Approvals in the Territory in its Affiliates or sublicensees to, transfer to Shore or LifeCycle a copy of all such Regulatory Filings with respect name applicable to the Licensed Product; (iii) provide ArQule (and/or any current or future licensee of ArQule of the Licensed Compound and/or any Licensed Products) with copies of all correspondence with Regulatory Authorities relating to such Regulatory Documentation and Regulatory Approvals; and (iv) transfer sponsorship and Control to ArQule (and/or any current or future licensee of ArQule of the Licensed Compound and/or any Licensed Products) of all clinical trials of the Licensed Product being conducted as of the effective date of termination.

Rights of Reference. (ai) To Each Party hereby grants to the extent other Party, its Affiliates and Sublicensees a right to cross-reference, file or incorporate by reference any Regulatory Filings are Controlled by LifeCycle, Materials and CHRP has been granted such rights by LifeCycle, or to the extent any Regulatory Filings are Controlled by CHRP, and Shore has been granted any such rights by CHRP, CHRP and Shore hereby grant to Santarus and its sublicensees, a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any Approval for Licensed Products and all Regulatory Filings data and Product Data within the LifeCycle other Know-How relating directly included or referenced therein or filed in support of any such Regulatory Materials or Regulatory Approvals, subject to the scope of the licenses granted under Sections 7.1 and 7.2, including any patient registries (and any data and other Know-How therein) for any Licensed Product, which Regulatory ​ ​ ​ Materials, Regulatory Approval, data and other information is Controlled by such Party or any of its Affiliates, for the purpose of the other Party, its Affiliates or any Sublicensee developing and obtaining or maintaining Regulatory Approvals for Licensed Products in the Territory as permitted under this Agreement and to otherwise enable such Party to fulfill its obligations or exercise its rights hereunder with respect to Licensed Products, which includes that related Products in the Territory. BPM shall provide to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing Roche access to any BPM Know-How to facilitate Roche’s use of the Regulatory Materials and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause their respective Affiliates to sign, any instruments reasonably requested by Santarus Regulatory Approvals as provided in order to effect such grant, solely for the purposes of conducting such activities as are contemplated by this AgreementSection 4.1(d)(i). (bii) Each of CHRP and Shore In addition, Roche hereby grants to Santarus the full BPM, its Affiliates, licensees and Sublicensees a right to use and refer of reference to any Drug Master File Regulatory Materials and Regulatory Approval for Licensed Products in the Roche Territory and all data and other Know-How included or referenced therein in support of any such Regulatory Materials or Regulatory Approvals, including any patient registries (and any data and other Know-How therein) for any Licensed Product, which Regulatory Materials, Regulatory Approval, data and other information is Controlled by Roche or any of its Affiliates, for the purpose of BPM, its Affiliates, licensee or any Sublicensee developing, obtaining or maintaining Regulatory Approvals for Licensed Product Products in the Existing Partner Territory. Roche shall provide to which it has BPM access and will provide a copy thereof to Santarus upon Santarus’ request solely for the purposes of Developing and seeking Regulatory Approval any reasonably required Roche Know-How to facilitate BPM’s use of the Licensed Products Regulatory Materials and conducting such other activities Regulatory Approvals as are contemplated by provided in this AgreementSection 4.1(d)(ii). (ciii) Shore hereby grants Each Party shall duly execute and deliver, or cause to Santarus be duly executed and its sublicenseesdelivered, a “Right of Reference such instruments and shall do and cause to be done such reasonable acts and things, as may be necessary under, or Use” as that term is defined in 21 C.F.R. § 314.3(b)the other Party may reasonably request, to any and all Regulatory Filings and Product Data within effectuate the Licensed Know-How relating directly to Licensed Products to which it has access, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Santarus rights of reference contemplated in order to effect such grant, solely for the purposes of conducting such activities as are contemplated by this AgreementSection 4.1(d). (d) Santarus hereby grants to Shore (and at Shore’s written request, shall grant to LifeCycle) the foreign equivalents, in any country or jurisdiction outside the Territory, to a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data relating directly to Licensed Products, which includes that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Shore in order to effect any such grant, solely for the purposes of Developing and seeking Regulatory Approval outside the Territory of the Licensed Products. Upon Shore’s reasonable request made from time to time, Santarus shall, or shall cause its Affiliates or sublicensees to, transfer to Shore or LifeCycle a copy of all such Regulatory Filings with respect to the Licensed Products.