Common use of Transfer of Regulatory Filings Clause in Contracts

Transfer of Regulatory Filings. Except as set forth in Section 5.2, Exelixis shall, in each case as may be required to enable Licensee to submit and file Regulatory Filings and obtain MAA Approvals for Products in the Licensee Territory: (i) transfer to Licensee all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, other than INDs relating to Clinical Trials conducted and sponsored by Exelixis pursuant to the GDP; (ii) to the extent that such transfer is not permitted under Applicable Laws, Exelixis shall provide to Licensee a right of reference or use to such Regulatory Approvals and Regulatory Filings. Exelixis shall provide appropriate notification of Licensee’s access and reference rights to the applicable Regulatory Authorities (including, to the extent applicable, an informed consent letter under Article 10c of Directive 2001/83/EC as amended), at the expense of Licensee seeking such right of reference. For the purposes of this Agreement, “right of reference” shall mean the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any equivalent regulation outside the US, including Article 10c of Directive 2001/83/EC, as each may be amended from time to time; (iii) provide to Licensee copies in electronic form of all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory including those related to CMC, manufacturing and product development, validation and manufacturing for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, regulatory dossiers in Exelixis’ possession or Control, and the Drug Master File; and (iv) to the extent any variations to the chemistry, manufacturing, and controls (“CMC”) section of the Regulatory Filing are required to conform with a variation that is initiated by Exelixis at its sole discretion, Exelixis shall reimburse Licensee for all associated fees that are paid by Licensee in filing such variations; provided that, for variations required to comply with Applicable Laws or any requirement of a Regulatory Authority, (a) Exelixis shall remain responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Exelixis Territory, and (b) Licensee shall be responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Licensee Territory.

Transfer of Regulatory Filings. Except as set forth in Section 5.2, Exelixis shall, in each case as may be required to enable Licensee to submit and file Regulatory Filings and obtain MAA Approvals for Products in the Licensee Territory: (i) transfer to Licensee all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, other than INDs relating to Clinical Trials conducted and sponsored by Exelixis pursuant to the GDP; (ii) to the extent that such transfer is not permitted under Applicable Laws, Exelixis shall provide to Licensee a right of reference or use to such Regulatory Approvals and Regulatory Filings. Exelixis shall provide appropriate notification of Licensee’s access and reference rights to the applicable Regulatory Authorities (including, to the extent applicable, an informed consent letter under Article 10c of Directive 2001/83/EC as amended), at the expense of Licensee seeking such right of reference. For the purposes of this Agreement, “right of reference” shall mean the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any equivalent regulation outside the US, including Article 10c of Directive 2001/83/EC, as each may be amended from time to time; (iii) provide to Licensee copies in electronic form of all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory including those related to CMC, manufacturing and product development, validation and manufacturing for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, regulatory dossiers in Exelixis’ possession or Control, and the Drug Master File; and (iv) to the extent any variations to the chemistry, manufacturing, and controls (“CMC”) section of the Regulatory Filing are required to conform with a variation that is initiated by Exelixis at its sole discretion, Exelixis shall reimburse Licensee for all associated fees that are paid by Licensee in filing such variations; provided that, for variations required to comply with Applicable Laws or any requirement of a Regulatory Authority, (a) Exelixis shall remain responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Exelixis Territory, and (b) Licensee shall be [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Licensee Territory.

Transfer of Regulatory Filings. Except as set forth in Section 5.2, Exelixis shall, in each case as may be required to enable Licensee to submit and file Regulatory Filings and obtain MAA Approvals for Products in the Licensee Territory: : (i) transfer to Licensee all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, other than INDs relating to Clinical Trials conducted and sponsored by Exelixis pursuant to the GDP; ; (ii) to the extent that such transfer is not permitted under Applicable Laws, Exelixis shall provide to Licensee a right of reference or use to such Regulatory Approvals and Regulatory Filings. Exelixis shall provide appropriate notification of Licensee’s access and reference rights to the applicable Regulatory Authorities (including, to the extent applicable, an informed consent letter under Article 10c of Directive 2001/83/EC as amended), at the expense of Licensee seeking such right of reference. For the purposes of this Agreement, “right of reference” shall mean the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any equivalent regulation outside the US, including Article 10c of Directive 2001/83/EC, as each may be amended from time to time; ; (iii) provide to Licensee copies in electronic form of all Regulatory Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee Territory including those related to CMC, manufacturing and product development, validation and manufacturing for the Compound and Products that are in Exelixis’ name and Controlled by Exelixis, regulatory dossiers in Exelixis’ possession or Control, and the Drug Master File; and and (iv) to the extent any variations to the chemistry, manufacturing, and controls (“CMC”) section of the Regulatory Filing are required to conform with a variation that is initiated by Exelixis at its sole discretion, Exelixis shall reimburse Licensee for all associated fees that are paid by Licensee in filing such variations; provided that, for variations required to comply with Applicable Laws or any requirement of a Regulatory Authority, (a) Exelixis shall remain responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Exelixis Territory, and (b) Licensee shall be [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. responsible for submissions and associated fees for all CMC variations originally attributable to a Regulatory Authority in the Licensee Territory.