Common use of Regulatory Approval Clause in Contracts

Regulatory Approval. Licensee shall submit a complete file for WHO Prequalification or any SRA approval within thirty-six (36) months after the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among Pfizer, MPP and Licensee for any new formulation of the Licensed Product. Licensee will diligently pursue such applications following submission. Licensee agrees, where applicable and to the extent that it is able, to not seek and waive regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

Regulatory Approval. Licensee shall submit a complete file for WHO Prequalification or any SRA approval within thirty-thirty- six (36) months after the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among PfizerShionogi, MPP and Licensee for any new formulation of the Licensed Product. Licensee will diligently pursue such applications following submission. Licensee agrees, where applicable and to the extent that it is able, to not seek and waive regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

Regulatory Approval. Licensee shall submit a complete file for WHO Prequalification or any SRA approval within thirty-six (36) months after the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among Pfizer, MPP and Licensee for any new formulation of the Licensed Product. Licensee will diligently pursue such applications following submission. Licensee agrees, where applicable and to the extent that it is able, to not seek and waive regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.Territory.‌