Common use of REGISTRATION OF THE PRODUCTS Clause in Contracts

REGISTRATION OF THE PRODUCTS. 1. During the TERM and the ADDITIONAL TERM, IOMED shall be responsible for filing and prosecuting all NDAs and other applications for regulatory approvals. ELAN shall transfer the INDs held by it in relation to the PRODUCTS. IOMED or its sublicensees shall file the NDAs with the FDA and will use its reasonable efforts in prosecuting said NDA to approval. IOMED shall thereafter maintain at its own cost the NDAs with the FDA for the term of this Agreement. Subject to IOMED's reasonable discretion IOMED hereby agrees to provide to ELAN at ELAN's own cost access to such NDAs as ELAN reasonably requests. ****. For the avoidance of doubt, the parties agree that all information furnished to ELAN pursuant to this Paragraph shall Institute CONFIDENTIAL INFORMATION for the purposes of this Agreement. 17 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement.

REGISTRATION OF THE PRODUCTS. 1. During the TERM and the ADDITIONAL TERM, IOMED shall be responsible for filing and prosecuting all NDAs and other applications for regulatory approvals. ELAN shall transfer the INDs held by it in relation to the PRODUCTS. IOMED or its sublicensees shall file the NDAs with the FDA and will use its reasonable efforts in prosecuting said NDA to approval. IOMED shall thereafter maintain at its own cost the NDAs with the FDA for the term term-of this Agreement. Subject to IOMED's 'S reasonable discretion IOMED hereby agrees to provide to ELAN DDS at ELANDDS's own cost access to such NDAs as ELAN DDS reasonably requests. ****. * For the avoidance of doubt, the parties Parties agree that all information furnished to ELAN DDS pursuant to this Paragraph shall Institute constitute CONFIDENTIAL INFORMATION for the purposes of this Agreement. 17. 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement.

REGISTRATION OF THE PRODUCTS. 1. During the TERM and the ADDITIONAL TERM, IOMED shall be responsible for filing and prosecuting all NDAs and other applications for regulatory approvals. ELAN shall transfer the INDs held by it in relation to the PRODUCTS. IOMED or its sublicensees shall file the NDAs with the FDA and will use its reasonable efforts in prosecuting said NDA to approval. IOMED shall thereafter maintain at its own cost the NDAs with the FDA for the term term-of this Agreement. Subject to IOMED's 'S reasonable discretion IOMED hereby agrees to provide to ELAN DDS at ELANDDS's own cost access to such NDAs as ELAN DDS reasonably requests. ****. For the avoidance of doubt, the parties Parties agree that all information furnished to ELAN DDS pursuant to this Paragraph shall Institute constitute CONFIDENTIAL INFORMATION for the purposes of this Agreement. 17. 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement.

REGISTRATION OF THE PRODUCTS. 1. During the TERM and the ADDITIONAL TERM, IOMED shall be responsible for filing and prosecuting all NDAs and other applications for regulatory approvals. ELAN shall transfer the INDs held by it in relation to the PRODUCTS. IOMED or its sublicensees shall file the NDAs with the FDA and will use its reasonable efforts in prosecuting said NDA to approval. IOMED shall thereafter maintain at its own cost the NDAs with the FDA for the term of this Agreement. Subject to IOMED's reasonable discretion IOMED hereby agrees to provide to ELAN at ELAN's own cost access to such NDAs as ELAN reasonably requests. ****. For the avoidance of doubt, the parties agree that all information furnished to ELAN pursuant to this Paragraph shall Institute CONFIDENTIAL INFORMATION for the purposes of this Agreement. 17. 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement.