Common use of Third Party Manufacturers Clause in Contracts

Third Party Manufacturers. Orexigen may subcontract any or all of its obligations pursuant to this Article 4 to Third Party manufacturers (the “Third Party Manufacturers”) with Takeda’s prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed. Orexigen shall not amend any agreement with a Third Party Manufacturer in any manner that could have a material impact on the Manufacture of Products for Takeda under this Agreement or Takeda’s ability to Commercialize or Develop the Products in the Territory without Takeda’s prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed. Orexigen shall provide Takeda with a copy of each amendment to an agreement with a Third Party Manufacturer promptly after its execution. For purposes of this Section 4.3, the term “manufacturer” is considered to be inclusive of all facilities designated in the corresponding section of the NDA. These include but are not limited to testing laboratories and packaging facilities. Takeda hereby consents to the Manufacture of the Product by the Third Party Manufacturers set forth on Exhibit 4.3. Orexigen acknowledges that it has entered into Manufacturing agreements with the Third Party Manufacturers set forth on Exhibit 4.3, under which such Third Party Manufacturers undertake the Manufacture of Product or active pharmaceutical ingredients contained in the Product covering a period of at least [***] ([***]) years after First Commercial Sale. [***] Orexigen shall be responsible for the day-to-day management of all Third Party Manufacturer relationships.

Third Party Manufacturers. Orexigen may subcontract any or all (a) No later than [* * *] following the JCC’s first adoption of its obligations the Marketing Plan, the JMC, in consultation with the PDC, shall adopt a plan (a “Third Party Manufacturing Plan”) identifying potential Third Parties to be engaged by DURECT, and that are approved in writing ***Material has been omitted pursuant to this Article 4 a request for confidential treatment and such material has been filed separately with the SEC. by Endo (such approval not to Third Party manufacturers be unreasonably withheld or delayed), to perform services or supply facilities or goods in connection with the manufacture, testing and/or packaging of the Product or Implanter (the including all components, sub-assembly, assembly, finish and fill and packaging thereof) by or on behalf of DURECT to ensure continuous supply of Product, Finished Product and Implanters hereunder (“Third Party Manufacturers”) with Takeda’s prior ). Such Third Party Manufacturing Plan shall be subject to written consent, which consent shall approval by Endo (such approval not to be unreasonably withheld, conditioned, withheld or delayed. Orexigen ), following which DURECT shall not amend any agreement with a Third Party Manufacturer in any manner that could have a material impact on the Manufacture of Products for Takeda under this Agreement or Takeda’s ability use all commercially reasonable efforts to Commercialize or Develop the Products in the Territory without Takeda’s prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed. Orexigen shall provide Takeda with a copy of each amendment to an agreement with a Third Party Manufacturer promptly after its execution. For purposes of this Section 4.3, the term “manufacturer” is considered to be inclusive of all facilities designated in the corresponding section of the NDA. These include but are not limited to testing laboratories and packaging facilities. Takeda hereby consents to the Manufacture of the Product by the Third Party Manufacturers set forth on Exhibit 4.3. Orexigen acknowledges that it has entered enter into Manufacturing definitive manufacturing license agreements with the Third Party Manufacturers set forth on Exhibit 4.3, under which such Third Party Manufacturers undertake the Manufacture of Product (each, a “Third Party Manufacturing Agreement”) and use all commercially reasonable efforts to obtain any necessary or active pharmaceutical ingredients contained in the Product covering a period of at least [***] ([***]) years after First Commercial Sale. [***] Orexigen shall be responsible appropriate Regulatory Approval for the day-to-day management of all such Third Party Manufacturer relationshipsto perform in connection with this Agreement. The Third Party Manufacturers shall be required to provide any and all services, facilities and goods necessary for the manufacture of Product, Finished Product and Implanters in the event that DURECT ceases to fulfill its obligations to do so under this Agreement, including as a result of an Inability to Supply, a Bankruptcy Case or Bankruptcy Rejection, Force Majeure, or being a Non-Performing Party or other breach of DURECT’s obligations hereunder.