Manufacturing Matters; Inability to Supply. (a) Depomed shall promptly inform Santarus in the event that Depomed becomes aware of any matters which might reasonably be expected to: (i) result in a breach of Section 6.2 hereof; or (ii) have an adverse impact on the ability to supply trade Products or Samples in a timely manner. In each such event, Depomed shall provide Santarus with a reasonable opportunity to participate directly in discussions with Depomed’s Third Party manufacturers of Products concerning the investigation and resolution of such matters. Notwithstanding the generality of the foregoing, Depomed agrees to notify Santarus within twenty-four (24) hours after Depomed has become aware of any event or circumstance related to the manufacture of the Product that might reasonably be expected to impact the safety or efficacy of Product that has been released by Depomed or that might reasonably be expected to cause such released Product to be adulterated or misbranded within the meaning of the Act. (b) In the event that a Depomed Supply Failure occurs, notwithstanding its compliance with its obligations under Section 6.1, Depomed shall diligently exercise its back-up manufacturing rights. In the event that Depomed is not diligently exercising its back-up manufacturing rights, upon written notice to Depomed (a “Santarus Manufacturing Notice”), Santarus shall have, and Depomed hereby grants Santarus, exercisable only in accordance with the provisions hereof, the right, but not the obligation, to manufacture, or have manufactured, the Product on behalf of Depomed, at Depomed’s expense, including expenses related to the technical transfer of the Product, and Depomed will provide reasonable assistance to Santarus in connection therewith, including by transferring or licensing to Santarus all Technology necessary or useful to give Santarus the capability of manufacturing the Product so that Santarus can undertake manufacture of the Product. Any such Product manufactured by Santarus will be sold by Depomed in accordance with this Agreement. [***].
Appears in 2 contracts
Samples: Promotion Agreement (Santarus Inc), Promotion Agreement (Depomed Inc)
Manufacturing Matters; Inability to Supply. (a) Depomed Zogenix shall promptly inform Santarus Astellas in the event that Depomed Zogenix becomes aware of any matters which might reasonably be expected to: to (i) result in a breach of failure to supply Product or Samples in accordance with Section 6.2 6.1(b) hereof; , or (ii) otherwise have an adverse impact on the ability to supply trade Products Product or Samples in a timely manner. In ; including, in each case, ((i) and (ii)), any such event, Depomed shall provide Santarus with a reasonable opportunity matters relating to participate directly in discussions with Depomed’s Third Party manufacturers the availability or production of Products concerning the investigation and resolution of such matters. Components.
(b) Notwithstanding the generality of the foregoing, Depomed Zogenix agrees to notify Santarus Astellas within twenty-four (24) hours [***] after Depomed Zogenix has become aware of any event or circumstance related to the manufacture of the Product that might reasonably be expected to impact the safety or efficacy of Product that has been released by Depomed Zogenix or that might reasonably be expected to cause such released Product to be adulterated or misbranded within the meaning of the Act.
(bc) In Without limitation of any other remedy available to Astellas, in the event that a Depomed Supply Failure occursin any Agreement Month Zogenix and its Affiliates have insufficient inventory of Product to satisfy Trade Demand in the Territory and trade demand outside of the Territory during such month: (i) Zogenix shall notify Astellas of the shortage as soon as possible; (ii) Zogenix shall allocate for sale in the Territory, notwithstanding its compliance with its obligations under Section 6.1an amount of Product no less than [***], Depomed divided by [***]; and (iii) Zogenix shall diligently exercise its back-up manufacturing rights. In distribute Product in the event that Depomed is not diligently exercising its back-up manufacturing rights, upon written notice to Depomed (a “Santarus Manufacturing Notice”), Santarus shall have, and Depomed hereby grants Santarus, exercisable only Territory by allocating such Product in accordance with the provisions hereof, the right, but not the obligation, to manufacture, or have manufactured, the Product on behalf of Depomed, at Depomed’s expense, including expenses related to the technical transfer of the Product, and Depomed will provide reasonable assistance to Santarus in connection therewith, including by transferring or licensing to Santarus all Technology necessary or useful to give Santarus the capability of manufacturing the Product so that Santarus can undertake manufacture of the Product. Any such Product manufactured by Santarus will be sold by Depomed in accordance with this Agreement. [***].
(d) Without limitation of any other remedy available to Astellas, in the event that in any Agreement Month Zogenix has insufficient inventory of Samples to fulfill its delivery requirements for such month pursuant to Sample Orders submitted by Astellas in accordance with Section 6.5(b): (i) Zogenix shall notify Astellas of the shortage as soon as possible; and (ii) Zogenix shall allocate for distribution as Samples to Astellas a quantity of Sample units no less than [***], divided by [***].
Appears in 2 contracts
Samples: Co Promotion Agreement (Zogenix, Inc.), Co Promotion Agreement (Zogenix, Inc.)