Common use of INTERNATIONAL REGULATORY APPROVAL Clause in Contracts

INTERNATIONAL REGULATORY APPROVAL. (a) SuperGen shall provide Xxxxxx, at SuperGen's expense, with the dossier SuperGen uses for obtaining U.S. Regulatory Approval, along with any and all other data, information and materials reasonably requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for the Product. Xxxxxx shall exercise its reasonable efforts to file, obtain and maintain Regulatory Approval for the Products in the International Territory, and shall bear the full cost and expense thereof, provided that if the EMEA requests or requires additional clinical data beyond that provided to Xxxxxx by SuperGen, or Xxxxxx in its reasonable commercial judgement deems such additional clinical data to be necessary for such Regulatory Approval, then SuperGen shall reimburse Xxxxxx for Xxxxxx'x costs and expenses for such additional clinical studies. Xxxxxx shall keep SuperGen fully apprised with respect to its regulatory activity in the International Territory. Specifically, Xxxxxx shall (i) promptly provide SuperGen with a copy of all filings, documents, and material correspondence with the relevant governmental authorities (without an obligation to translate into English, CONFIDENTIAL TREATMENT REQUESTED unless otherwise available), and (ii) provide SuperGen with advance notice of meetings with such authorities and consider, at Xxxxxx'x sole discretion, SuperGen's request to attend or participate in any such meeting or to obtain a written right of reference to Xxxxxx'x regulatory filings for the Product in the International Territory. (b) Xxxxxx shall use its reasonable efforts to obtain Regulatory Approval in at least three (3) of the following countries within five (5) years of SuperGen's receipt of U.S. Regulatory Approval: Mexico, Canada, Japan, the United Kingdom, France, Italy, Germany, and Spain. If Xxxxxx fails to obtain Regulatory Approval pursuant to this Section 3.3(b) within such time frame, SuperGen shall have the right to take over Xxxxxx'x Regulatory Approval efforts in these countries. In such event, Xxxxxx shall transfer to SuperGen all of the filing materials or information then in Xxxxxx'x possession or control necessary for SuperGen to file for the Regulatory Approval, or to continue the filing if Xxxxxx has commenced the filing process, in these countries.

INTERNATIONAL REGULATORY APPROVAL. (a) SuperGen shall provide XxxxxxAbbott, at SuperGen's expense, with the dossier SuperGen uses for obtaining U.S. Regulatory Approval, along with any and all other data, information and materials reasonably requested by Xxxxxx Abbott for obtaining Regulatory Approval from the EMEA for the Product. Xxxxxx Abbott shall exercise its reasonable efforts to file, obtain and maintain Regulatory Approval for the Products in the International Territory, and shall bear the full cost and expense thereof, provided that if the EMEA requests or requires additional clinical data beyond that provided to Xxxxxx Abbott by SuperGen, or Xxxxxx Abbott in its reasonable commercial judgement deems such additional clinical data to be necessary for such Regulatory Approval, then SuperGen shall reimburse Xxxxxx for Xxxxxx'x costs and expenses for such additional clinical studies. Xxxxxx shall keep SuperGen fully apprised with respect to its regulatory activity in the International Territory. Specifically, Xxxxxx shall (i) promptly provide SuperGen with a copy of all filings, documents, and material correspondence with the relevant governmental authorities (without an obligation to translate into English, CONFIDENTIAL TREATMENT REQUESTED unless otherwise available), and (ii) provide SuperGen with advance notice of meetings with such authorities and consider, at Xxxxxx'x sole discretion, SuperGen's request to attend or participate in any such meeting or to obtain a written right of reference to Xxxxxx'x regulatory filings for the Product in the International Territory. (b) Xxxxxx shall use its reasonable efforts to obtain Regulatory Approval in at least three (3) of the following countries within five (5) years of SuperGen's receipt of U.S. Regulatory Approval: Mexico, Canada, Japan, the United Kingdom, France, Italy, Germany, and Spain[________________________]. If Xxxxxx fails to obtain Regulatory Approval pursuant to this Section 3.3(b) within such time frame, SuperGen shall have the right to take over Xxxxxx'x Regulatory Approval efforts in these countries. In such event, Xxxxxx shall transfer to SuperGen all of the filing materials or information then in Xxxxxx'x possession or control necessary for SuperGen to file for the Regulatory Approval, or to continue the filing if Xxxxxx has commenced the filing process, in these countries.

INTERNATIONAL REGULATORY APPROVAL. (a) SuperGen shall provide Xxxxxx, at SuperGen's expense, with the dossier SuperGen uses for obtaining U.S. Regulatory Approval, along with any and all other data, information and materials reasonably requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for the Product. Xxxxxx shall exercise its reasonable efforts to file, obtain and maintain Regulatory Approval for the Products in the International Territory, and shall bear the full cost and expense thereof, provided that if the EMEA requests or requires additional clinical data beyond that provided to Xxxxxx by SuperGen, or Xxxxxx in its reasonable commercial judgement deems such additional clinical data to be necessary for such Regulatory Approval, then SuperGen shall reimburse Xxxxxx for Xxxxxx'x costs and expenses for such additional clinical studies. Xxxxxx shall keep SuperGen fully apprised with respect to its regulatory activity in the International Territory. Specifically, Xxxxxx shall (i) promptly provide SuperGen with a copy of all filings, documents, and material correspondence with the relevant governmental authorities (without an obligation to translate into English, 13 <PAGE> CONFIDENTIAL TREATMENT REQUESTED unless otherwise available), and (ii) provide SuperGen with advance notice of meetings with such authorities and consider, at Xxxxxx'x sole discretion, SuperGen's request to attend or participate in any such meeting or to obtain a written right of reference to Xxxxxx'x regulatory filings for the Product in the International Territory. (b) Xxxxxx shall use its reasonable efforts to obtain Regulatory Approval in at least three (3) of the following countries within five (5) years of SuperGen's receipt of U.S. Regulatory Approval: Mexico, Canada, Japan, the United Kingdom, France, Italy, Germany, and Spain. If Xxxxxx fails to obtain Regulatory Approval pursuant to this Section 3.3(b) within such time frame, SuperGen shall have the right to take over Xxxxxx'x Regulatory Approval efforts in these countries. In such event, Xxxxxx shall transfer to SuperGen all of the filing materials or information then in Xxxxxx'x possession or control necessary for SuperGen to file for the Regulatory Approval, or to continue the filing if Xxxxxx has commenced the filing process, in these countries.