Common use of MEDICAL REGISTRATION Clause in Contracts

MEDICAL REGISTRATION. 6.1 The Distributor shall take any and all necessary measures in order to obtain and maintain appropriate approvals from the local regulatory authorities which shall include, but not be limited to, a PL and PA and authorization to distribute the Product within the Territory. The Company shall assume all expenses related to MRP in the European Union. Distributor shall take care of local expenses, if any, to get local recognition in countries within the European Union. All costs and expenses associated with obtaining regulatory approval and the necessary permits to sell the Product in those countries within the Territory which are not part of the EU, shall be borne by the Distributor (as described in Exhibit A). License Agreement - Arriani Pharmaceuticals, S.A. Date: May 21, 2003 6.2 If the PL and PA are not obtained within twenty four (24) months from the date of receipt of the complete registration file of the Product required by the regulatory Authorities of each one of the countries in the Territory, the Company shall have the right to terminate the Agreement according to the conditions contained in Article 11 below. The Distributor will initiate registration procedures immediately in the countries outside the European Union. The Company shall assume all expenses related to MRP in the European Union. The Distributor shall pay all regulatory and governmental registration fees, if applicable, according to clause 6.1. The Distributor shall be fully responsible for any cost related to the maintenance of the required license for sale of the product in the Territory. 6.3 In the event the Company is not free to disclose to the Distributor any information required by the responsible regulatory or other authorities, the Company shall be obliged to make such confidential information available to the authorities on the Distributor’s behalf at its own cost and expense. 6.4 The Company shall receive two (2) copies of all registration certificates, documentation for reimbursement and any other data or documentation forthwith upon their issuance. The Distributor specifically agrees to provide the Company with copies of all correspondence with the registration authorities as well as any and all government agencies. Each party shall furnish the other with information on any observed unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical use, studies, investigations or tests of the Product in accordance with Exhibit D, which contains a sub-agreement.

MEDICAL REGISTRATION. 6.1 The Distributor shall take any and all necessary measures in order to obtain and maintain appropriate approvals from the local regulatory authorities which shall include, but not be limited to, a PL and PA and authorization to distribute the Product within the Territory. The Company shall assume all expenses related to MRP in the European Union. Distributor shall take care of local expenses, if any, to get local recognition in countries within the European Union. All costs and expenses associated with obtaining regulatory approval and the necessary permits to sell the Product in those countries within the Territory which are not part of the EU, shall be borne by the Distributor (as described in Exhibit A). License Agreement - Arriani Pharmaceuticals, S.A. Date: May 21, 2003. 6.2 The PL has been approved prior to the execution of this Agreement. Such PL shall be maintained in force by the Distributor. If the PL and PA are not obtained within twenty four (24) months from the date of receipt of the complete registration file of the Product required by the regulatory Authorities of each one of the countries in the Territoryexpires due to causes attributable to Distributor, the Company shall have the right to terminate the Agreement according to the conditions contained in Article 11 below. The Distributor will initiate registration procedures immediately in the countries outside the European Union. The Company shall assume all expenses related to MRP in the European Union. Agreement. 6.3 The Distributor shall pay all regulatory and governmental registration fees, if applicable, according to clause 6.1. The Distributor shall be fully responsible all the annual registration maintenance fees and other fees required for any cost related to the maintenance of the required license for sale of the product in the TerritoryProduct as promulgated by any local, regional or national governmental authority. 6.3 6.4 In the event the Company is not free to disclose to the Distributor any information required by the responsible regulatory or other authorities, the Company shall be obliged to make such confidential secret information available to the authorities on the Distributor’s behalf at its own cost and expense. 6.4 6.5 The Company shall receive two (2) copies of all registration certificates, documentation for reimbursement and any other data or documentation forthwith upon their issuance. The Distributor specifically agrees to provide the Company with copies of all correspondence with the registration authorities as well as any and all government agencies. Each party shall furnish the other with information on any observed unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical use, studies, investigations or tests of the Product in accordance with Exhibit D, which contains a sub-agreement. 6.6 Distributor will at its own cost register the Product in the Territory and the Company will be the owner of the Registration in accordance with the existing rules of the law. Distributor will complete the Registration of the Product in the Territory within six (6) months or earlier from the date in which the Company provides to Distributor the documents mentioned in paragraph 6.7. 6.7 In connection to the activities to be performed by Distributor for the registration of the Product according to this Section 6, the Company acknowledges that the Product was previously registered in the Territory under the name Interferon-Alfanative and in favor of Alfanative AB, a Swedish entity of which the Company is currently its successor and beneficiary. Therefore, the Company shall send and grant to Distributor, all documents and powers of attorney reasonably required by Distributor in order that Distributor is able to request the change of the current PL and Registration of the Product, from the name Interferon-Alfanative to Multiferon.

MEDICAL REGISTRATION. 6.1 The Distributor shall take any and all necessary measures in order to obtain and maintain appropriate approvals from the local regulatory authorities which shall include, but not be limited to, a PL and PA and authorization to distribute the Product within the Territory. The Company shall assume all expenses related to MRP in the European Union. Distributor shall take care of local expenses, if any, to get local recognition in countries within the European Union. All costs and expenses associated with obtaining regulatory approval and the necessary permits to sell the Product in those countries within the Territory which are not part of the EU, shall be borne by the Distributor (as described in Exhibit A). License Agreement - Arriani Pharmaceuticals, S.A. Date: May 21, 2003. 6.2 The PL has been approved prior to the execution of this Agreement. Such PL shall be maintained in force by the Distributor. If the PL and PA are not obtained within twenty four (24) months from the date of receipt of the complete registration file of the Product required by the regulatory Authorities of each one of the countries in the Territoryexpires due to causes attributable to Distributor, the Company shall have the right to terminate the Agreement according to the conditions contained in Article 11 below. The Distributor will initiate registration procedures immediately in the countries outside the European Union. The Company shall assume all expenses related to MRP in the European Union. Agreement. 6.3 The Distributor shall pay all regulatory and governmental registration fees, if applicable, according to clause 6.1. The Distributor shall be fully responsible all the annual registration maintenance fees and other fees required for any cost related to the maintenance of the required license for sale of the product in the TerritoryProduct as promulgated by any local, regional or national governmental authority. 6.3 6.4 In the event the Company is not free to disclose to the Distributor any information required by the responsible regulatory or other authorities, the Company shall be obliged to make such confidential secret information available to the authorities on the Distributor’s behalf at its own cost and expense. 6.4 6.5 The Company shall receive two (2) copies of all registration certificates, documentation for reimbursement and any other data or documentation forthwith upon their issuance. The Distributor specifically agrees to provide the Company with copies of all correspondence with the registration authorities as well as any and all government agencies. Each party shall furnish the other with information on any observed unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical use, studies, investigations or tests of the Product in accordance with Exhibit D, which contains a sub-agreement. 6.6 Distributor will at its own cost register the Product in the Territory and the Company will be the owner of the Registration in accordance with the existing rules of the law. Distributor will complete the Registration of the Product in the Territory within six (6) months or earlier from the date in which the Company provides to Distributor the documents mentioned in paragraph 6.7. 6.7 In connection to the activities to be performed by Distributor for the registration of the Product according to this Section 6, the Company acknowledges that the Product was previously registered in the Territory under the name Interferon-Alfanative and in favor of Alfanative AB, a Swedish entity of which the Company is currently its successor and beneficiary. Therefore, the Company shall send and grant to Distributor, all documents and powers of attorney reasonably required by Distributor 3 of 15 in order that Distributor is able to request the change of the current PL and Registration of the Product, from the name Interferon-Alfanative to Multiferon.