Common use of Regulatory Review Clause in Contracts

Regulatory Review. (a) Upon Theravance’s request, Hospira shall review those portions of Theravance’s proposed submissions for Regulatory Approval as related to Hospira’s manufacturing, packaging and quality control procedures before the submissions are filed with relevant Regulatory Authorities. Hospira shall complete its review of any English-language submissions within [***] Business Days after receipt. For any non English-language submissions, Theravance shall provide Hospira with a submission translated into English and the parties will agree on a reasonable period of time that Hospira may require for review of such submissions. (b) Upon Theravance’s request, Hospira shall consult with and advise Theravance in responding to questions from Regulatory Authorities regarding Theravance’s regulatory submission(s) for the Products, provided, however, that Theravance shall have the final control over such submissions. In the event that any additional review and consultation is required by a Regulatory Authority (for example, for technical responses to a Regulatory Authority finding of deficiency, should one arise), Hospira shall provide Theravance with cost estimates (which shall include a professional services fee at its customary per/hour, per/person rates relative to the work to be performed, consistent with its charges to other similarly-situated customers). If Theravance approves such costs in writing, Theravance shall reimburse Hospira for such approved costs upon completion of the work and within [***] days of receipt of Hospira’s invoice.

Regulatory Review. (a) Upon TheravanceCempra’s request, Hospira shall review those portions of TheravanceCempra’s proposed regulatory submissions for Regulatory Approval as related relate to Hospira’s manufacturing, packaging and quality control procedures before the submissions are filed with relevant Regulatory AuthoritiesAuthorities and provide advice, comment, and input with respect thereto. Hospira shall complete its review of any English-English language submissions within [***] Business Days days after receipt. For any non Englishnon-English language submissions, Theravance Cempra shall provide Hospira with a submission translated into English and the parties will agree on a reasonable period of time that Hospira may require for review of said submissions, such submissions.agreement not to be unreasonably withheld by either party, and Hospira shall review such submission within such agreed-upon time period. [*] (b) Upon TheravanceCempra’s request, Hospira shall consult with and advise Theravance Cempra in responding to questions from Regulatory Authorities regarding TheravanceCempra’s regulatory submission(s) for the Products, ; provided, however, that Theravance Cempra shall have the final control over such submissions. In Hospira shall provide Cempra with cost estimates (which shall include a professional services rate of at its customary per/hour, per/person rates then in effect relative to the work to be performed, and consistent with its charges to other similarly-situated customers, which shall in no event that be greater than Commercially Reasonable) for any additional review and consultation is as may be required by a by, or reasonably helpful or required for purposes of any response to or correspondence with any, Regulatory Authority Authorities (for example, for technical responses to a Regulatory Authority finding of deficiency, should one arise), Hospira shall provide Theravance with cost estimates (which shall include a professional services fee at its customary per/hour, per/person rates relative to the work to be performed, consistent with its charges to other similarly-situated customers). If Theravance Cempra approves such costs in writing, Theravance Hospira shall perform such services and Cempra shall reimburse Hospira for such approved costs upon completion of the work and within [***] days of receipt of Hospira’s invoiceinvoice therefor.