By GSK. Subject to the provisions of the Pharmacovigilance ------ Agreement, GSK shall not, without the consent of Adolor, correspond or communicate with any Governmental Authority in the United States concerning the Adolor Products, or otherwise take any action with any Governmental Authority in the United States concerning any Investigational Authorization or Marketing Authorization or permission under which the Adolor Products are sold or any application for the same, except as may be required by Law. Furthermore, GSK shall, promptly upon receipt of any material contact with or communication from any Governmental Authority relating to a Collaboration Product, but in no event more than two (2) Business Days after such receipt or contact, forward a copy or description of the same to Adolor and respond to all reasonable inquiries by Adolor relating thereto. GSK shall notify Adolor of any meeting with a Governmental Authority relating to a Collaboration Product and Adolor may elect one person reasonably acceptable to GSK (such approval not to be unreasonably withheld, refused, conditioned or delayed) to participate as an observer (at Adolor's cost and expense) in such meeting. If GSK is advised by its counsel that it must communicate with any Governmental Authority, then GSK shall promptly, but in no event more than two (2) Business Days, advise Adolor of the same and provide Adolor in advance with a copy of any proposed written communication with such Governmental Authority and comply with any and all reasonable requests of Adolor concerning any meeting or written or oral communication with such Governmental Authority.
By GSK. Subject to the provisions of this Article 9, GSK, in ------ the United States, shall have sole authority and responsibility to seek and/or obtain any necessary Governmental Authority approvals of any label, labeling, package inserts or outserts, monographs and packaging, and Promotional Materials that are approved by the Joint Marketing Committee for use in connection with the GI Products, and for determining whether the same requires Governmental Authority approval. Upon request by GSK, Adolor shall use Commercially Reasonable Efforts to assist GSK in its efforts to seek and obtain such Governmental Authority approvals.
By GSK. GSK shall solely own all Collaboration Know-How that solely relates to GSK Materials (“GSK Collaboration Know-How”). To the extent any GSK Collaboration Know-How is made by Liquidia, whether solely or jointly with GSK, then upon GSK’s request Liquidia will transfer and assign and hereby transfers and assigns to GSK, without additional consideration, all of Liquidia’s interest in such GSK Collaboration Know-How, which transfer and assignment GSK hereby accepts. Liquidia shall execute and deliver to GSK a deed(s) of such assignment, in a mutually agreeable form and will take whatever actions reasonably necessary, including the appointment of GSK as its attorney in fact solely to make such assignment, to effect such assignment.
By GSK. GSK may terminate this Agreement in its entirety or with respect to any particular country at any time and for any reason during the Term upon providing Santarus with not less than six (6) months’ prior written notice referencing this Section 13.4.2 and specifying termination of the Agreement in its entirety or the specific country(ies).
By GSK. During the Term, and for a period of two (2) years thereafter or, if GSK exercises its right of termination pursuant to Section 13.4.2 in relation to the Agreement in its entirety or on a country-by-country basis, until the later of (a) the fifth (5th) anniversary of the Effective Date or (b) the second (2nd) anniversary of the effective date of any termination of this Agreement in its entirety or with respect to a given country as the case may be, neither GSK nor any of its Affiliates or Sublicensees will directly or indirectly distribute, market, promote, detail, advertise or sell any PPI Pharmaceutical Product containing one or more PPIs formulated in combination with one or more buffering agents, or which is otherwise formulated to provide, in either case, for immediate release of the PPI (other than Licensed Products pursuant to this Agreement) in or for such country. The foregoing covenants shall not restrict GSK or any Affiliate or Sublicensee from obtaining rights to, or engaging in research and development activities related to, products in such class during the restricted time period, so long as GSK or its Affiliate or Sublicensee does not engage in the activities set forth in the first sentence of this Section 6.1.1.
By GSK. Upon GSK’s exercise of a GSK Program Option for a Candidate Selection Compound, GSK, at its sole discretion, will thereafter have the right and obligation to (a) manufacture all clinical and commercial supplies of such Candidate Selection Compound itself, (b) use the contract manufacturer utilized by OncoMed to produce clinical supplies of such Candidate Selection Compound used by OncoMed in Clinical Trials, or (c) subcontract such manufacture to a Third Party; provided that, to maintain a timely and efficient advancement of such Candidate Selection Compound into Phase III Trials, the transfer of the obligation to manufacture Candidate Selection Compounds from OncoMed to GSK will be made in accordance with the Manufacturing and Supply Transition Plan, and, prior to and after exercise of GSK’s Program Option, the Parties will discuss such matters in meetings of the JMS. Upon GSK’s exercise of a GSK Program Option for a Candidate Selection Compound, GSK will be responsible for paying, or for reimbursing OncoMed for, any amounts associated with the (i) cancellation of any one or more slots for the manufacture of such Candidate Selection Compound for which OncoMed has secured such slot(s) with OncoMed’s contract manufacturer, which have been cancelled due to GSK’s decision not to have such Candidate Selection Compound manufactured by such contract manufacturer, and/or (ii) manufacture and supply of clinical supplies of such Candidate Selection Compound to be used in Clinical Trials after GSK’s exercise of such GSK Program Option. GSK shall manufacture, handle, store, and ship the Products in compliance with all Laws, with all Regulatory Filings, and with its applicable internal specifications and quality control procedures. For clarity, if GSK elects not to exercise a GSK Program Option for a Candidate Selection Compound, and OncoMed continues to develop such Candidate Selection Compound, OncoMed will continue to be responsible for manufacturing clinical supplies of such Candidate Selection Compound.
By GSK. GSK hereby represents and warrants to OncoMed that it is self-insured against liability and other risks associated with its activities and obligations under this Agreement for the activities to be conducted by it under this Agreement.
By GSK. (a) Without limiting Section 5.3.2, promptly after the Effective Date and in any event within six (6) months thereafter, Santarus shall make available to GSK all Regulatory Filings and Santarus Know-How in its Control as of the Effective Date reasonably necessary for GSK to manufacture or have manufactured Licensed Products and obtain and maintain Marketing Authorizations for Licensed Products in accordance with this Agreement. Data provided under this Section 3.3.1(a) shall be provided in editable format.
By GSK. GSK shall solely own all Arising IP that is made solely by or on behalf of GSK and solely related to GSK Background IP (“GSK Arising IP”).
By GSK. At GSK’s reasonable discretion following the Effective Date, GSK shall [*] under this Agreement solely in the Lyell PoC Development Programs (“[*]”), as the same may be updated from time to time, and provide reasonable consultation and assistance for Lyell to understand and implement such [*] of such Products or Compounds.
