Technology Transfer. (a) Upon the completion of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement. (b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. (c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health. (d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology. (e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.
Appears in 2 contracts
Sources: License and Supply Agreement (Skinmedica Inc), License and Supply Agreement (Skinmedica Inc)
Technology Transfer. (a) Upon the completion of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.
(b) 7.1 If for any reason Cardinal Health EDT is unable to supply any manufacture Product to Purchaser or provide sufficient quantity of Product to meet PurchaserSM’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health EDT from Purchaser SM and an opportunity to cure not to exceed an additional ***, Purchaser SM shall have the right to manufacture, or have manufactured by the Substitute Manufacturerany substitute manufacturer, the Product, in addition to its other rights and privileges under this Agreement. In such event, EDT shall assist SM in qualifying a second source for the active ingredients in Product in a tube presentation(excluding microsponge), provided that providing technical assistance and documentation as necessary, including such right shall not include the right manufacturing technology and know-how so as to permit another entity to manufacture such active ingredients, and EDT agrees to cooperate with SM to facilitate any technology transfer (excluding microsponge) required in furtherance of the Microsponge or DelPouchforegoing. PurchaserSM’s Minimum Purchase Requirements, and payment obligations to Cardinal Health EDT pursuant to this Agreement, shall be temporarily suspended until Cardinal Health EDT or the Contract Manufacturer can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser SM with the substitute manufacturer
7.2 EDT shall provide SM with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to SM by EDT and any other information available to EDT that is necessary for the safe conduct of the manufacturing of the Product by SM or the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health EDT shall have no obligation supply SM with pertinent information regarding health or safety hazards to transfer DelPouch packaging components, equipment or related technology workers relating to any third partymaterials supplied to SM by EDT. EDT shall update all of such information provided to SM as such information becomes available to EDT. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) 7.3 In the event of any transfer of manufacturing responsibilities pursuant to this Article 187, Cardinal Health EDT shall make available to PurchaserSM, and Purchaser SM shall purchase, PurchaserSM’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may bemicrosponge components. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge microsponge components, and, in any event, Cardinal Health EDT shall offer such Microsponge microsponge components to Purchaser SM on terms no less favorable than the price attributable to the Microsponge microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) 7.4 At such time as Purchaser SM shall have the right to manufacture, or have manufactured, any the Product in accordance with this Article 187, Cardinal Health EDT shall be deemed to have granted to Purchaser SM a license license, under all of Cardinal Health’s patents the Patents and related knowKnow-how How (and any improvement in or modification thereof) to make, have made, use, have used, offer for sale, sell and import such the Product for the Field in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties***, other than payments for Microsponge microsponge components in accordance with Section 18(d) 7.3 above.
Appears in 2 contracts
Sources: Manufacturing and Supply Agreement (Skinmedica Inc), Manufacturing and Supply Agreement (Skinmedica Inc)
Technology Transfer. (a) Upon the completion Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer general introduction to the Substitute Manufacturer required in furtherance Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information falls within one or more of the foregoingexceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be deemed to be confidential. The Substitute Manufacturer timing and extent of additional disclosure by ECC to Sublicensee shall be used to produce a Product for sale only in the circumstances as set forth in subparagraph 22(b) hereof.
(b) Upon execution of this Agreement, ECC shall provide Sublicensee with copies of the patents listed in Section 18(b) belowB of Exhibit "B" hereto. For purposes of clarityBeyond that, Cardinal Health ECC shall not be required to transfer technology related to the DelPouch provide additional information concerning, or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transferdisclosure of, the Substitute Manufacturer shall be required Technology to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.
(b) If for any reason Cardinal Health is unable Sublicensee until Sublicensee provides to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and ECC (i) with respect written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescriptiondesignated Product, and (ii) with respect evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the Benzoyl Peroxide Products, only to production of the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(ddesignated Product; and (z) abovea list of known raw materials suppliers and preferred equipment vendors.
Appears in 2 contracts
Sources: Sublicense Agreement (Earthshell Container Corp), Sublicense Agreement (Earthshell Container Corp)
Technology Transfer. (a) Upon the completion Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer general introduction to the Substitute Manufacturer required in furtherance Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information falls within one or more of the foregoingexceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be deemed to be confidential. The Substitute Manufacturer timing and extent of additional disclosure by ECC to Sublicensee shall be used to produce a Product for sale only in the circumstances as set forth in subparagraph 22(b) hereof.
(b) Upon execution of this Agreement, ECC shall provide Sublicensee with copies of the patents listed in Section 18(b) belowB of Exhibit "B" hereto. For purposes of clarityBeyond that, Cardinal Health ECC shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.
(b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufactureinformation concerning, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct disclosure of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards Technology to workers relating Sublicensee until Sublicensee provides to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and ECC (i) with respect written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescriptiondesignated Product, and (ii) with respect evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the Benzoyl Peroxide Products, only to production of the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(ddesignated Product; and (z) abovea list of known raw materials suppliers and preferred equipment vendors.
Appears in 1 contract
Technology Transfer. Prior to the date of termination of this Agreement (a) Upon or as soon as possible after termination under Section 5.2), CELLSCRIPT shall, at the completion request of Development Phase Argos, transfer to Argos or to a designee of Argos the Process for each Production of the Argos Product and Critical Starting Materials for the Argos Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such including all manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarityrelated thereto (“Technology Transfer”), Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as it being understood that set forth in Section 15 of this Agreement.
(b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health CELLSCRIPT shall have no obligation to transfer DelPouch packaging components, equipment any technology or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how that is not owned by Argos (such as, but not limited to, CELLSCRIPT Information and Materials, including proprietary technology or know-how related to Kits, enzymes, RNA [**], or methods of use of any improvement thereof). Technology Transfer shall include at least the following activities:
(a) CELLSCRIPT shall provide all pertinent information necessary or modification thereof) useful to makemanufacture the Argos Product and Critical Starting Materials for the Argos Product and to support regulatory filings for the Argos Product and Critical Starting Materials for the Argos Product, have madeincluding without limitation analytical testing methods, useprotocols, have usedprocess descriptions, offer for salebatch records, manufacturing documentation, and import such Product in the Territoryother process and manufacturing data and documentation, but only for such period of time provided that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreementsaid pertinent information shall not include CELLSCRIPT Information and Materials, CELLSCRIPT’s Technology, or CELLSCRIPT’s Kits, SOPs, analytical testing methods, protocols, process descriptions, batch records, manufacturing documentation, and other process and manufacturing data and documentation that are not specifically for the Argos Product or Critical Starting Materials for the Argos Product;
(ib) CELLSCRIPT shall provide training sessions and reasonable assistance and cooperation at CELLSCRIPT’s site(s) of manufacture, in a manner that does not unreasonably interfere with respect CELLSCRIPT’s other business activities, in order to train Argos or its designee how to manufacture the EpiQuin Products, only Argos Product and Critical Starting Materials for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.Argos Product;
Appears in 1 contract
Sources: Master Process Development and Supply Agreement (Argos Therapeutics Inc)
Technology Transfer. (a) Upon Toshiba shall use all reasonable efforts to develop, and, in exchange for the completion payments made by SanDisk under the Common R&D Agreement, upon successful development of Development Phase for each Product0.21, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser 0.16, 0.13 * micron process technology applicable to the manufacturing and testing of NAND Flash Memory Products (“Substitute Manufacturer”"NAND PROCESS TECHNOLOGY") to manufacture such Products that can be implemented in a tube presentation for Purchasercommercially viable manner, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance Toshiba shall include deliver such manufacturing technology and know-how so as to permit all improvements thereto * developed by Toshiba during the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance term of the foregoingCommon R&D Agreement, to each of the DSC and Yokkaichi foundry facilities and such other manufacturing facilities as may hereafter be agreed upon by the Parents. Timing of the delivery of technology transfers shall be based on, among other things, available capacity and shall be in accordance with the decision to be made from time to time by the Management Committee. The Substitute Manufacturer shall be used to produce a Product for sale only * INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. parties intend that the Yokkaichi and DSC facilities should run the same technologies in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreementsimilar time frames.
(b) If for any reason Cardinal Health Whenever a technology transfer is unable required hereunder, Toshiba shall deliver such level of NAND Process Technology to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured applicable manufacturing facility as would be normal practice by the Substitute Manufacturer, the Product in Toshiba Semiconductor Company whenever it transfers a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions a new manufacturing facility or transfers a new or advanced technology to an existing manufacturing facility in order to achieve successful implementation of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commissionnewly transferred technology.
(c) Cardinal Health A technology transfer hereunder shall provide Purchaser with data on be deemed complete when the chemical transferred technology passes a reasonable qualification procedure to be mutually agreed upon by Toshiba and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal HealthSanDisk.
(d) In Following the event Closing, Toshiba shall use its best efforts to assist DSC in achieving the same productivity in the manufacturing of any transfer of manufacturing responsibilities pursuant Products as achieved at the Yokkaichi facility. However, the parties understand and agree that Toshiba does not warrant that the DSC facility will be able to this Article 18, Cardinal Health shall make available to Purchaser, manufacture the same quality and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with yield as experienced at the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technologyYokkaichi facility.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product The costs of all technology transfers described in accordance with this Article 18, Cardinal Health Section 7.01 shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement borne by Toshiba or modification thereof) to make, have made, use, have used, offer for saleby DSC as set forth in SCHEDULE 7.01, and import such Product expenses to be borne by DSC shall be included in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products Start-Up Costs as defined in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above7.02.
Appears in 1 contract
Sources: Master Agreement (Sandisk Corp)
Technology Transfer. (a) Upon Prior to manufacturing the completion of Development Phase for each Product, Cardinal Health a technology transfer of the manufacturing process will be performed from Purchaser to SWI. Purchaser shall assist Purchaser in qualifying a second source selected by Purchaser disclose (“Substitute Manufacturer”and provide copies, as applicable) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology SWI all information related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 manufacture of this Agreement.
(b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentationPurchaser’s possession, that is required for the manufacture of the Product by SWI (collectively “Manufacturing Technology”); provided that any such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary used solely for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In the event of any transfer purpose of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18Agreement. SWI acknowledges that such Manufacturing Technology is and shall remain the sole property of Purchaser and/or its Affiliates, Cardinal Health and nothing herein shall be deemed to have granted convey to Purchaser a license under all SWI any right therein except as required for the purpose of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such manufacturing the Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement. The steps, planning and obligations of the Parties regarding the transfer of the Manufacturing Technology for such Product are set forth in the technology transfer master plan attached in Exhibit D (i) the “Technology Transfer Master Plan”). Provided that Purchaser supply SWI with the needed amount of Compound at *** to SWI, SWI will manufacture the required number of Batches as outlined in the Technology Transfer Master Plan and a minimum of *** validation Batches of Product. Purchaser shall be responsible for any and all regulatory requirements with respect to the EpiQuin ProductsProduct. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Plan. Upon request, only Purchaser will provide SWI with, assistance or on-site support as may be reasonably required by SWI in connection with the transfer of the manufacturing technology. Such assistance will be provided *** for use a number of days as set forth in the field Technology Transfer Master Plan. Purchaser shall support the one-time costs as described in the Technology Transfer Master Plan and purchase from SWI each validation Batch that meets the Specifications at the Price set forth in Exhibit B. If any of pigmentation disordersthe validation Batches of a Product does not comply with the Specifications, Supplier shall have *** (***) months to re-manufacture and only deliver the number of validation Batch(es) that failed to meet the extent Specifications. If SWI is unable within that *** (***)-month period to manufacture and deliver to Purchaser the validation Batch(es), Section 9.2(c) shall apply. Purchaser will be reimbursed for *** any validation Batches that fail to meet the Specifications, in the event that such Product failure is available by prescriptiondue to SWI’s mistake, and (ii) negligence or failure to follow Purchaser’s instructions. In the event any validation batches fail to meet the Specifications for any other reason, except for Purchaser’s mistake, negligence or failure to provide SWI with respect to any portion of the Benzoyl Peroxide ProductsManufacturing Technology, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) aboveSWI will ***.
Appears in 1 contract
Technology Transfer. 9.1 In addition to any technology transfer contemplated by any Co-Development Plan, following completion of any Co-Development Plan and as part of any Co-Commercialisation Plan, Adaptimmune will:
(a) Upon reasonably assist Bellicum in establishing a […***…] for any Therapy comprising a Bellicum Candidate, and will allow and enable Bellicum to work with […***…] (to the completion of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expenseextent relevant). Such assistance shall will include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.[…***…]; and
(b) If for provide ongoing technical assistance in relation to Bellicum's development and manufacturing of the Bellicum Candidates and Therapies comprising a Bellicum Candidate as reasonably requested from time to time and during the Term. The details of what technical assistance and transfer of technology will be required from Adaptimmune will be agreed upon by the Parties as part of a technology transfer plan to be initially prepared by Bellicum and approved by the JDC. The costs of such technical assistance and transfer shall be considered to be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer obligations and provision of confidential information will be subject to any reason Cardinal Health is unable Third Party restrictions relevant to supply such technology transfer and provision of confidential information.
9.2 In addition to any Product to Purchaser or provide sufficient quantity technology transfer contemplated by any Co-Development Plan, following completion of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreementany Co-Development Plan and as part of any Co-Commercialisation Plan, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional Bellicum will:
(a) reasonably assist Adaptimmune in establishing a […***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements…] for any Therapy comprising an Adaptimmune Candidate, and payment obligations will allow and enable Adaptimmune to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser work with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. […*** Portions of this page have been omitted pursuant *…] (to a request for Confidential Treatment and filed separately with the Commission.extent relevant). Such assistance will include […***…]; and
(cb) Cardinal Health shall provide Purchaser with data on the chemical ongoing technical assistance in relation to Adaptimmune's development and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product Adaptimmune Candidates and Therapies comprising an Adaptimmune Candidate as reasonably requested from time to time and during the Term. The details of what technical assistance and transfer of technology will be required from Bellicum will be agreed upon by Purchaser or the Substitute ManufacturerParties as part of a technology transfer plan to be initially prepared by Adaptimmune and approved by the JDC. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all The costs of such information provided technical assistance and transfer shall be considered to Purchaser as such information becomes available be a Development Cost and subject to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product reimbursement in accordance with this Article 18, Cardinal Health shall 10. Any technology transfer obligations and provision of confidential information will be deemed subject to have granted any Third Party restrictions relevant to Purchaser a license under all such technology transfer and provision of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.confidential information
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Bellicum Pharmaceuticals, Inc)
Technology Transfer. (a) Upon Within ninety (90) days of the completion of Development Phase for each ProductEffective Date, Cardinal Health Cytokinetics shall, and shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessarycause its Affiliates to, at Purchaserits own cost and expense, deliver to (at Bayer’s expense. Such assistance shall include such manufacturing technology direction) Bayer or its designated Affiliate, true and knowcomplete copies of all Cytokinetics Know-how so How that are necessary or reasonably useful (as reasonably determined by Cytokinetics) for Bayer to permit initiate Development of the Substitute Manufacturer to Manufacture such Licensed Product in the tube presentation. Cardinal Health agrees Field in the Licensed Territory pursuant to cooperate with Purchaser to facilitate any the Development Plan as specified in the initial plan for technology transfer attached to this Agreement as Schedule 3.9 (such plan, the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer “Technology Transfer Plan” and such initial technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required “Initial Technology Transfer”). Within three (3) months following such Initial Technology Transfer, Bayer may identify any additional Cytokinetics Know-How that Bayer reasonably believes is missing from such Initial Technology Transfer and is necessary or reasonably useful for Bayer to sign a confidentiality initiate Development of the Licensed Product in the Field in the Licensed Territory pursuant to the Development Plan and, upon such identification by Bayer, Cytokinetics will provide such missing information if it exists and non-use agreement at least as restrictive as that set forth is in Section 15 of this AgreementCytokinetics’ Control.
(b) If Thereafter, on a continuing basis during the Term, Cytokinetics shall, without any additional compensation, and shall cause its Affiliates to, promptly disclose and deliver to Bayer or its designated Affiliate or Sublicensee, as Bayer may reasonably request, true and complete copies of all written, graphic or electronic embodiments of all additional Cytokinetics Technology that are necessary or reasonably useful for any reason Cardinal Health is unable Bayer to supply any Product to Purchaser or provide sufficient quantity initiate Development of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Licensed Product in a tube presentationthe Field in the Licensed Territory (whether existing as of the Effective Date or coming into Cytokinetics’ Control thereafter) that have not been previously provided to Bayer (or its Affiliate or Sublicensee). In particular, provided that such right from time to time during the Term, Cytokinetics shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration notify Bayer of any substitute manufacturing or supply agreement entered new Cytokinetics Technology that come into by Purchaser with Cytokinetics’ Control to the substitute manufacturer. Notwithstanding extent reasonably useful for the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions Development of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the CommissionLicensed Product in the Licensed Territory.
(c) Cardinal Health Upon Bayer’s reasonable request, Cytokinetics shall, without any additional compensation, provide Bayer with up to [*] of technical assistance in connection with such Initial Technology Transfer, including reasonable access to Cytokinetics’ technical personnel involved in the research and Development of the Compound and Licensed Product. If Bayer requests additional technical assistance [*], Cytokinetics shall provide Purchaser with data such technical assistance, provided that Bayer shall reimburse Cytokinetics on a quarterly basis for the documented, reasonable cost incurred by Cytokinetics to provide such additional technical assistance, calculated on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct basis of the manufacturing FTE Rate multiplied by the number of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal HealthCytokinetics FTEs.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.
Appears in 1 contract
Sources: Collaboration and License Agreement (Cytokinetics Inc)
Technology Transfer. 9.1 In addition to any technology transfer contemplated by any Co-Development Plan, following completion of any Co-Development Plan and as part of any Co-Commercialisation Plan, Adaptimmune will:
(a) Upon reasonably assist Bellicum in establishing a *** for any Therapy comprising a Bellicum Candidate, and will allow and enable Bellicum to work with *** (to the completion of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expenseextent relevant). Such assistance shall will include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.*** ; and
(b) If provide ongoing technical assistance in relation to Bellicum’s development and manufacturing of the Bellicum Candidates and Therapies comprising a Bellicum Candidate as reasonably requested from time to time and during the Term. The details of what technical assistance and transfer of technology will be required from Adaptimmune will be agreed upon by the Parties as part of a technology transfer plan to be initially prepared by Bellicum and approved by the JDC. The costs of such technical assistance and transfer shall be considered to be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer obligations and provision of confidential information will be subject to any Third Party restrictions relevant to such technology transfer and provision of confidential information.
9.2 In addition to any technology transfer contemplated by any Co-Development Plan, following completion of any Co-Development Plan and as part of any Co-Commercialisation Plan, Bellicum will:
(a) reasonably assist Adaptimmune in establishing a *** for any reason Cardinal Health is unable Therapy comprising an Adaptimmune Candidate, and will allow and enable Adaptimmune to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional work with *** (to the extent relevant). Such assistance will include *, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. ** *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.. ; and
(cb) Cardinal Health shall provide Purchaser with data on the chemical ongoing technical assistance in relation to Adaptimmune’s development and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product Adaptimmune Candidates and Therapies comprising an Adaptimmune Candidate as reasonably requested from time to time and during the Term. The details of what technical assistance and transfer of technology will be required from Bellicum will be agreed upon by Purchaser or the Substitute ManufacturerParties as part of a technology transfer plan to be initially prepared by Adaptimmune and approved by the JDC. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all The costs of such information provided technical assistance and transfer shall be considered to Purchaser as such information becomes available be a Development Cost and subject to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product reimbursement in accordance with this Article 18, Cardinal Health shall 10. Any technology transfer obligations and provision of confidential information will be deemed subject to have granted any Third Party restrictions relevant to Purchaser a license under all such technology transfer and provision of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.confidential information
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Adaptimmune Therapeutics PLC)
Technology Transfer. (a) Upon Seller shall reasonably cooperate with and shall make its personnel available at all reasonable times to ensure the prompt and complete transfer to Buyer of all Transferred Know-How, up to a maximum combined resource commitment of {*} until a maximum of {*} from Closing Date (the “Tech Transfer Period”). In connection with the foregoing, Seller shall, at its sole cost and expense (except for the payment required pursuant to Section 6.3(b)) during the Tech Transfer Period: (i) {*}, (ii) make introductions to, arrange for site visits with and, as appropriate, audits of any of Seller’s vendors and/or suppliers vending to and supplying the Business, and (iii) undertake such other activities as are necessary to effect the transfer of the Transferred Know-How (collectively, the activities referred to in the first two (2) sentences of this Section 6.3(a) are hereinafter referred to as the “Tech Transfer Process”). Buyer acknowledges that Seller has publicly announced a lay-off, and that Seller has informed Buyer that the layoff includes scientific personnel familiar with the Acquired Assets, who will not be employed by Seller beyond January 2009. While Seller will {*} assist Seller in the completion of Development Phase for each Productany remaining technology transfer {*} and only during an additional {*}, Cardinal Health the parties intend that barring unforeseen circumstances the technology transfer should be completed within Tech Transfer Period. During the Tech Transfer Period, Buyer shall assist Purchaser in qualifying compile a second source selected by Purchaser reasonably detailed written list (the “Substitute ManufacturerTransferred Know-How List”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance of the Know-How that falls within the definition of ‘Transferred Know-How Category’ and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product is either (a) reflected in the tube presentationdocumentation Seller is required to provide to Buyer under this Agreement (or has been provided to Buyer as part of the due diligence process prior to the Closing Date) or (b) provided to Buyer through the Tech Transfer Process. Cardinal Health agrees Buyer shall provide such Transferred Know-How List to cooperate Seller {*}. {*}. The Transferred Know-How List shall not be deemed final until agreed to in writing by Buyer and Seller.
(b) In connection with Purchaser the foregoing, Buyer shall pay to facilitate any Seller an amount equal to {*} of which {*} shall be paid at the Closing and {*} shall be paid on the earlier of: (i) the {*} anniversary of the Closing or (ii) the date that Buyer provides written notice to Seller that it no longer requires the technology transfer to the Substitute Manufacturer required in furtherance services of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances Seller as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement6.3(a).
(b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with Section 18(d) above.
Appears in 1 contract
Technology Transfer. On or promptly after the Effective Date, ViroPharma shall arrange for a complete technology transfer to Schering or its designated Affiliate (a) Upon the completion of Development Phase for each Product, Cardinal Health shall assist Purchaser such data and information in qualifying a second source selected ViroPharma’s possession reasonably requested by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology Schering related to the DelPouch or Microspongeprocesses and procedures for the manufacture, except to testing, handling, storage, formulation and packaging of the extent necessary to fill Microsponge entrapped with bulk active Compound and inactive ingredients into a tube. Prior to such transferthe finished Products, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.
(b) If the specifications and release testing for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s Minimum Purchase Requirements under this Agreementthe Compound and Products, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(c) Cardinal Health shall provide Purchaser with data on complete copies of the chemical and physical properties, toxicityCMC sections for all of ViroPharma’s INDs for the Compound and/or Products, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the safe conduct of the manufacturing of the applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In samples of all available reference standards for the event Compound and Products, including any known impurities and/or metabolites (the “Transfer Materials”). Within seven (7) business days after delivery of any transfer the Transfer Materials by ViroPharma to Schering, Schering shall inform ViroPharma of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaserwhether additional Transfer Materials are required, and Purchaser if so, shall purchase, Purchaser’s minimum requirements of Microsponge components entrapped describe with the appropriate active and inactive ingredients, as the case may beparticularity such additionally required Transfer Materials. The Parties terms of the immediately preceding sentence shall negotiate in good faith with respect also apply to the appropriate price for any later deliveries of Transfer Materials delivered to Schering at their request. If Schering does not provide such Microsponge componentsnotice to ViroPharma within such seven (7) business day period, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, equipment or related technology.
(e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health then Schering shall be deemed to have granted such received such Transfer Materials required for it to Purchaser make the determination regarding the Specifications described in Section 5.2 below. During the [***] period immediately following the Effective Date, ViroPharma shall, upon request, transfer to Schering any additional information described in Section 5.1(a) above not previously provided to Schering, and ViroPharma shall also, upon request by Schering, make reasonably available ViroPharma’s employees to Schering to discuss matters relating to the processes and procedures for the manufacture, testing, handling, storage, formulation and packaging of the bulk active Compound and the finished Products, and shall assist Schering in contacting ViroPharma’s Third Party manufacturing contractors involved with the manufacture of the Compound and/or Product, all as reasonably necessary to [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. advise and assist Schering or its designated Affiliate in the technology transfer, and the start-up and validation of the manufacturing process for the Compound and/or Products. Such access to personnel shall be during normal business hours and Schering shall pay ViroPharma for the reasonable travel costs and other out-of-pocket expenses incurred by such personnel, as well as a license reasonable hourly rate to be agreed to by the Parties for the time of such personnel in excess of two hundred (200) hours during such [***] period, at Schering’s request in providing such advice and assistance. Following the successful completion of the technology transfer provided for under this Section 5.1, Schering (or its designated Affiliate or Third Party contractor) shall be responsible for the manufacture of all of Cardinal HealthSchering’s patents requirements for supplies of the Compound and related know-how (and any improvement or modification thereof) the Product for the Territory in excess of the initial supplies to make, have made, use, have used, offer for sale, and import such Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Product is available be provided by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Microsponge components in accordance with ViroPharma under Section 18(d) above.5.2
Appears in 1 contract
Sources: License Agreement (Viropharma Inc)