Common use of Existing Arrangements Clause in Contracts

Existing Arrangements. The Parties acknowledge that as of the Effective Date, Exelixis; its regulatory agent, TMC Pharma Services (“TMC”); and its authorized distributor, Swedish Orphan Biovitrum AB (“Sobi”), hold certain Regulatory Filings, licenses, and MAA Approvals related to Cometriq for MTC in the EU. Exelixis, and Exelixis on behalf of TMC and Sobi, will ensure that Exelixis, TMC and Sobi will transfer Regulatory Filings, licenses, and MAA Approvals for Cometriq for MTC to Licensee in accordance with Article 8. In addition, Exelixis holds certain EMA Regulatory Filings, including the EMA MAA filing, for the Product in RCC. As set forth in Section 5.1(b), the Parties shall cooperate to be ready to transfer and assign these EMA Regulatory Filings to Licensee and Exelixis shall notify the EMA promptly after the Effective Date that Licensee shall be the Marketing Authorization Holder as from the date of the transfer of the MAA. The Parties agree to work toward the transfer of MAA holder status to Licensee by [ * ]. Until the MAA transfer is accepted by the EMA, Exelixis shall be responsible for preparing and filing the MAA for the Product in RCC.

Existing Arrangements. The Parties acknowledge that as of the Effective Date, Exelixis; its regulatory agent, TMC Pharma Services (“TMC”); and its authorized distributor, Swedish Orphan Biovitrum AB (“Sobi”), hold certain Regulatory Filings, licenses, and MAA Approvals related to Cometriq for MTC in the EU. Exelixis, and Exelixis on behalf of TMC and Sobi, will ensure that Exelixis, TMC and Sobi will transfer Regulatory Filings, licenses, and MAA Approvals for Cometriq for MTC to Licensee in accordance with Article 8. In addition, [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Exelixis holds certain EMA Regulatory Filings, including the EMA MAA filing, for the Product in RCC. As set forth in Section 5.1(b), the Parties shall cooperate to be ready to transfer and assign these EMA Regulatory Filings to Licensee and Exelixis shall notify the EMA promptly after the Effective Date that Licensee shall be the Marketing Authorization Holder as from the date of the transfer of the MAA. The Parties agree to work toward the transfer of MAA holder status to Licensee by [ * ]. Until the MAA transfer is accepted by the EMA, Exelixis shall be responsible for preparing and filing the MAA for the Product in RCC.