Assignment of Regulatory Documentation. HPA hereby assigns to Emergent, and shall cause its Affiliates to assign to Emergent, all of HPA’s and its Affiliates’ rights, title and interest in and to all Regulatory Documentation, including, to the extent permitted by Applicable Law, all Regulatory Approvals, Controlled by HPA or its Affiliates as of the Effective Date and from time to time during the term of this Agreement; provided, however, that HPA shall not be required to assign any Regulatory Documentation that it may develop, at its expense, solely in connection with the exercise of the Retained Rights under Section 3.3. HPA shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such agreements, documents and instruments, as may be necessary under, or as Emergent may reasonably request in connection with, or to carry out more effectively, the purposes of this Section 3.2.
Assignment of Regulatory Documentation. Ardelyx hereby assigns to AstraZeneca all of its rights, titles and interests in and to all Regulatory Documentation, including, to the extent permitted by Applicable Laws, all Regulatory Approvals Controlled by Ardelyx as of the Effective Date and from time to time during the Term, provided, however, that (i) Ardelyx shall retain the IBS-C IND until Completion of the IBS-C Study, and (ii) Ardelyx shall retain the Cardio/Renal IND until such time as the Cardio/Renal IND has become effective. Ardelyx shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary to complete such assignment, or as AstraZeneca may reasonably request in connection therewith, or to carry out more effectively the purpose thereof, or to better assure and confirm unto AstraZeneca its rights under this Section 2.13, at AstraZeneca’s cost and expense.
Assignment of Regulatory Documentation. If and to the extent requested by AstraZeneca, and except as otherwise provided on Schedule 8.4, Targacept shall, and hereby does, assign to AstraZeneca all of Targacept’s and its Affiliates’ rights, titles and interests in and to all Regulatory Filings Controlled by Targacept or its Affiliates as of the Effective Date and at any time thereafter during the Term for or relating to any Candidate Drug. Targacept shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary, or as AstraZeneca may reasonably request, to carry out more effectively the purpose of this Section 8.4. If, at any time, AstraZeneca believes that its Development of Ispronicline under the applicable Product Development Plan, including any of the Pre-Phase IIb Program, would be delayed or otherwise impaired as a result of the fact that Targacept has not yet assigned [********] to AstraZeneca, the Parties shall work together in good faith, and in the best interests of the Ispronicline, to permit AstraZeneca to conduct such activities in a timely manner as contemplated by the Product Development Plan.
Assignment of Regulatory Documentation. AstraZeneca hereby assigns to Neoprobe all of its rights, titles and interests in and to all Regulatory Documentation, including, to the extent permitted by Applicable Law, all Health Registration Approvals, Controlled by AstraZeneca as of the Effective Date. Neoprobe shall be responsible for the payment of any fee payable by the transferee on the transfer of such Regulatory Documentation. AstraZeneca further hereby agrees to provide during the first five (5) years after the Effective Date reasonable and necessary assistance to Neoprobe during the filing and review of applications submitted by Neoprobe or its Affiliates for Health Registration Approvals and further maintenance of such Health Registration Approvals during the term of this Agreement. It is acknowledged by Neoprobe that such assistance will be utilised only to an extent absolutely required for the purpose of obtaining Health Registration Approval and in view of this the Parties have agreed that AstraZeneca will not charge Neoprobe for such assistance. It is also recognised that the level of assistance is likely going to gradually decrease over the five years period mentioned
Assignment of Regulatory Documentation. AstraZeneca hereby assigns to Flexion free of charge all of its rights, title and interest in and to all Regulatory Documentation (if any), Controlled by AstraZeneca as of the Effective Date. Flexion shall be responsible for the payment of any fee becoming due after the Effective Date payable by Flexion to Third Parties on the transfer of such Regulatory Documentation.
Assignment of Regulatory Documentation. AstraZeneca hereby assigns to Flexion free of charge all of its rights, title and interest in and to all Regulatory Documentation (if any), Controlled by AstraZeneca as of the Effective Date and will do all further acts and things as needed to perfect such assignment. Flexion shall be responsible for the payment of any fee becoming due after the Effective Date payable by Flexion to Third Parties on the transfer of such Regulatory Documentation. For the avoidance of doubt, such rights assigned pursuant to this Section will be assigned back to AstraZeneca by Flexion in the event of a reversion of rights pursuant to Section 3.6 above.
Assignment of Regulatory Documentation. Within five (5) Business Days of the Effective Date or such later date as may be (i) consistent with the Transition Plan, Study Transfer Plan, or Schedule 3.4.1 or (ii) otherwise necessary to enable Xxxxx and its Affiliates to perform their obligations with respect to the Existing Clinical Studies without violating Applicable Law or the terms of any applicable agreement with any Third Party, Xxxxx shall and hereby does assign to Licensee all of its right, title and interest in and to all Regulatory Documentation (including all INDs) owned by Xxxxx and its Affiliates relating to each Molecule or Product, and Xxxxx shall deliver such Regulatory Documentation to Licensee in the format reasonably requested by Licensee within thirty (30) days after Licensee’s request therefor. The Parties shall execute and file such documentation (including transfer letters) with the applicable Regulatory Authorities as shall be required to effect such transfer and coordinate such execution and filing as appropriate.
Assignment of Regulatory Documentation. CureTech hereby assigns to Medivation all of its right, title and interest in and to all Regulatory Documentation, including, to the extent permitted by Applicable Law, all Regulatory Approvals, owned or Controlled by CureTech or any of its Affiliates as of the Effective Date that pertain to the Licensed Product (such Regulatory Documentation, “CureTech Assigned Regulatory Documentation”). CureTech shall duly execute and deliver, or cause to be duly executed and delivered, in each case at its cost and expense, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under, or as Medivation may reasonably request in connection with, or to carry out more effectively the purpose of, or to better assure and confirm unto Medivation its rights under, this Section 3.2.1.
Assignment of Regulatory Documentation. MedImmune or its nominated Affiliate shall be the lead regulatory party and hold all Regulatory Documentation and Regulatory Approvals relating to Licensed Products. Innate hereby assigns to MedImmune all of its rights, titles and interests in and to all Regulatory Documentation, including, to the extent permitted by Applicable Laws, all INDs and Regulatory Approvals Controlled by Innate or its Affiliates as of the Effective Date and from time to time during the Term that relate to the Licensed Antibodies or Licensed Products. Innate shall duly execute and deliver, or cause to be duly executed and delivered such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary to complete such assignment, or as MedImmune may reasonably request in connection therewith, or to carry out more effectively the purpose thereof, or to better assure and confirm to MedImmune its rights under this Section 3.10, at MedImmune’s cost and expense.
Assignment of Regulatory Documentation. Licensor hereby assigns to Myriad all of its right, title, and interest in and to all Regulatory Documentation Controlled by Licensor. Licensor shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including, without limitation, the filing of such assignments, agreements, documents and instruments as Myriad may reasonably request to confirm Myriad’s rights under this Section 3.2. In the event that Licensor does not have Control of Regulatory Documentation in which Myriad desires any right, title or interest, Licensor shall use its reasonable best efforts to acquire Control of such Regulatory Documentation and to assign all of its right, title, and interest therein and thereto to Myriad. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
