Assignment of Regulatory Filings and Marketing Approvals. Within […***…] of the Option Exercise Date, Xencor shall, at Xencor’s expense, assign and cause to be assigned to Amgen all Regulatory Filings for the Compound and each Product in the Territory. Effective upon such assignment, Amgen agrees to, and hereby does, accept all responsibilities with respect to such Regulatory Filings. Prior to such assignment and transfer, Xencor shall maintain such Regulatory Filings at its expense and shall take all reasonable actions to make available to Amgen and/or its designee the benefits of such Regulatory Filings, to the extent required by Amgen in connection with its activities under this Agreement.
Assignment of Regulatory Filings and Marketing Approvals. At Inovio’s option, which shall be exercised by written notice to Apollo, Apollo shall assign or cause to be assigned to Inovio or its designee (or to the extent not so assignable, Apollo shall take all reasonable actions to make available to Inovio or its designee the benefits of) all regulatory filings and registrations (including INDs, XXXx and Marketing Approvals) for all Product in the Territory, including any such regulatory filings and registrations made or owned by Apollo’s Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable law or regulation, the foregoing assignment (or availability) shall be made within thirty (30) days after the effective date of any termination of this Agreement. In addition, Apollo shall promptly provide to Inovio a copy of all Data and Apollo Know-How pertaining to all Products in the Territory to the extent not previously provided to Inovio and Inovio shall have the right to use and disclose all Data and Apollo Know-How pertaining to such Products following termination of this Agreement.
Assignment of Regulatory Filings and Marketing Approvals. At XenoPort's option, which shall be exercised by written notice to Xanodyne, Xanodyne shall assign to XenoPort or its designee (or, to the extent not so assignable, Xanodyne shall take all reasonable actions to make available to XenoPort or its designee the benefits of) all regulatory filings and registrations (including INDs, NDAs and Marketing Approvals by the FDA) for the Compound and XenoPort Products in the Territory. In each case, unless otherwise required by any applicable law or regulation, the foregoing assignment (or availability) shall be effected within [**] after the effective date of any such termination of this Agreement. In addition, Xanodyne shall promptly provide to XenoPort a copy of all Data and Xanodyne Know-How pertaining to the Compound and all XenoPort Products in the Territory, or otherwise relied upon by Xanodyne in association with any IND, NDA or other approval for the Compound or any XenoPort Product in the Territory, to the extent not previously provided to XenoPort, and XenoPort shall have the right to use and disclose all such Data and Xanodyne Know-How following termination of this Agreement.
Assignment of Regulatory Filings and Marketing Approvals. At the Remaining Party’s option, which shall be exercised by written notice to the Eliminated Party, the Eliminated Party shall assign or cause to be assigned to the Remaining Party or its designee (or, to the extent not so assignable, the Eliminated Party shall take all reasonable actions to make available to the Remaining Party or its designee the benefits of) all regulatory filings and registrations (including INDs, XXXx and Marketing Approvals) for all Products within the Territory, including any such regulatory filings and registrations made or owned by the Eliminated Party’s Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable law or regulation, the foregoing assignment (or availability) shall be made within [****].
Assignment of Regulatory Filings and Marketing Approvals. At XenoPort’s option, which shall be exercised by written notice to GSK, and to the extent permitted under Applicable Law, GSK shall assign or cause to be assigned to XenoPort or its designee (or to the * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED extent not so assignable, GSK shall take all reasonable actions to make available to XenoPort or its designee the benefits of) all Regulatory Filings for all Product in the Territory, including any such Regulatory Filings made or owned by GSK’s Affiliates and/or Sublicensees. In each case, unless otherwise required by any Applicable Law, the foregoing assignment (or availability) shall be made [… * …] the effective date of such termination, [… * …]. In addition, GSK shall promptly provide to XenoPort a copy of all Data and GSK Know-How pertaining to all Products in the Territory to the extent not previously provided to XenoPort and XenoPort shall have the right to use and disclose all Data and GSK Know How pertaining to such Products following termination of this Agreement.
Assignment of Regulatory Filings and Marketing Approvals. At Remaining Party’s request, and to the extent permitted under applicable law, the Opt-Out Party shall assign or cause to be assigned to the Remaining Party or its designee (or to the extent not so assignable, the Opt-Out Party shall take all reasonable actions to make available to the Remaining Party or its designee the benefits of) all Regulatory Filings for the Product in the Territory. In each case, unless otherwise required by any applicable law, the foregoing assignment (or availability) shall be made as soon as reasonably practicable after the date an opt-out notice is issued and in any event no later than thirty (30) days after the effective date of such opt-out, or if such assignment cannot legally be made within such thirty-day period, as soon thereafter as such assignment can legally be made.
Assignment of Regulatory Filings and Marketing Approvals. Ono shall assign (or cause to be assigned) to Array or its designee, at Array’s cost, except in case of termination by Array pursuant to Section 13.3 or 13.4 or by Ono pursuant to Section 13.2, in which case the expenses will be borne by Ono, (or to the extent not so assignable, Ono shall take all reasonable actions to make available to Array or its designee the benefits of) all Regulatory Filings for the Product in the Ono Territory, including any such Regulatory Filings made or owned by its Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable Law or regulation or requested by Array, the foregoing assignment (or availability) shall be made within a period of time agreed upon and consistent with Ono’s obligations during the Wind Down Period. In addition, Ono shall promptly provide to Array a copy of all Data and Ono Know-How pertaining to the Product in the Ono Territory to the extent not previously provided to Array and Array shall have a fully-paid-up right to use and disclose all Data and Ono Know-How pertaining to the Product following termination of this Agreement, except in case of termination by Ono pursuant to Section 13.3 or 13.4, in which case the Section 14.2(a)(ix) shall apply. In addition, all such Data and Ono Know-How, to the extent solely related to the Product, shall be deemed Confidential Information of Array and not Confidential Information of Ono (and will not be subject to the exclusions under Sections 10.1(a) or (e) above).
Assignment of Regulatory Filings and Marketing Approvals. At Angionetics’ option, which shall be exercised by written notice to Licensee, Licensee shall, at its expense, assign or cause to be assigned to Angionetics or its designee (or to the extent not so assignable, Licensee shall take all reasonable actions to make available to Angionetics or its designee the benefits of) all regulatory filings and registrations (including INDs, MXXx and Marketing Approvals) for the any Product in mainland China and the Territory, including any such regulatory filings and registrations made or owned by its Affiliates. In each case, unless otherwise required by any Applicable Law or requested by Angionetics, the foregoing assignment (or availability) shall be made within ninety (90) days after the effective date of the termination of this Agreement. In addition, Licensee shall, at its expense, promptly provide to Angionetics (in electronic form, to the extent the same exists in electronic form) a copy of all Data pertaining to the Compound and/or Product, to the extent not previously provided to Angionetics and notwithstanding anything herein to the contrary, Angionetics shall have the right to use (and authorize the use of), and to disclose, and otherwise commercialize all such Data following termination of this Agreement, in any field and for any products.
Assignment of Regulatory Filings and Marketing Approvals. Galderma shall assign or cause to be assigned to ZARS or its designee (or to the extent not so assignable, Galderma shall take all reasonable actions to make available to ZARS or its designee the benefits of) all regulatory filings and registrations (including INDs, MXXx and Marketing Approvals) for each Product in the Galderma Territory, including any such regulatory filings and registrations made or owned by its Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable law or regulation, the foregoing assignment (or availability) shall be made within thirty (30) days after the effective date of any termination of this Agreement. In addition, Galderma shall promptly provide to ZARS a copy of all Data and Galderma Know-How pertaining to any Product in the Galderma Territory to the extent not previously provided to ZARS and ZARS shall have the right to use and disclose all Data and Galderma Know-How pertaining to any such Product.
Assignment of Regulatory Filings and Marketing Approvals. At XenoPort’s [ * ], DRL shall, at its expense, assign or cause to be assigned to XenoPort or its designee [ * ] all regulatory filings and registrations (including INDs, NDAs and Marketing Approvals) for the Compound and/or any Product in the Territory, including any such regulatory filings and registrations made or owned by its Affiliates. In each case, unless otherwise required by any Applicable Law or requested by XenoPort, the foregoing assignment (or availability) shall [ * ] such expiration or termination of this Agreement. In addition, DRL shall, [ * ] provide to XenoPort (in electronic form, to the extent the same exists in electronic form) a copy of all Data and DRL Know-How pertaining to the Compound and/or Product (including all development plans, life cycle management plans, medical education materials and/or commercialization plans), to the extent not previously provided to XenoPort, and XenoPort shall have the right to use (and authorize the use of), and to disclose, all such Data and other DRL Know-How following expiration or termination of this Agreement.
