Common use of Manufacturing Rights Clause in Contracts

Manufacturing Rights. 14.1 Following January 1, 2001, Distributor shall have the right, by sending a written notice to OTI to that effect (the "MANUFACTURING RIGHTS NOTICE"), to manufacture (or subcontract for manufacture) smart cards (for example, the plastic of the multi-card and antennae, if required) ("SMART CARDS") utilising any or all of OTI Intellectual Property, to the extent it relates to such manufacture, for sale of the Smart Cards within the Territory (the "MANUFACTURING Rights"). The Manufacturing Rights shall be subject to the use and embeddment in the Smart Cards of any one or more of OTI's modules supplied by OTI (such as those set out in ANNEX A as the Smart Card Modules). The Manufacturing Rights shall be exclusive to Distributor in the Territory and shall continue during the Term of this Agreement but shall not in any way limit OTI's right to manufacture OTI Products in the Territory which are sold in or imported into areas outside the Territory. For avoidance of doubt, Distributor shall not be entitled at any time to receive Manufacturing Rights of the OTI modules included in the Smart Cards. 14.2 Within thirty (30) days following receipt by OTI of the Manufacturing Rights Notice, OTI will deliver to Distributor such information, which is necessary for Distributor to manufacture the Smart Cards. Subject to the Manufacturing Rights granted to Distributor herein, all right, title and interest in all OTI Intellectual Property in the Smart Cards, including without limitation, the OTI modules embedded in the Smart Cards, shall at all times remain the property of OTI. 14.3 For the purpose of manufacturing the Smart Cards, Distributor shall purchase from OTI, and not from any other third party, modules to be included in the Smart Cards, for the prices of such modules set forth in the Price List. 14.4 In the event that Manufacturing Rights shall be granted hereunder, OTI shall have the right to order at any time from Distributor, or, in the event that Distributor elects to exercise the Manufacturing Rights by a sub-contractor, to order directly from such sub-contractor, Smart Cards for sale by OTI or by its other distributors, while abiding Distributor's exclusive distribution rights in this Agreement, at prices which shall not be higher than the most favorable prices granted by Distributor (or such sub-contractor of the Distributor) to Customers for similar volume of Smart Cards at the time. Distributor shall abide by such OTI orders, subject to reasonable payment terms and delivery schedule to be agreed. 14.5 For grant of the Manufacturing Rights hereunder OTI shall be entitled to such reasonable royalties at such rates not exceeding market rates for similar Smart Cards and as shall be agreed between the parties at the time of grant of the Manufacturing Rights. CHAPTER F- NON COMPETITION & ADDITIONAL UNDERTAKINGS OF DISTRIBUTOR

Manufacturing Rights. 14.1 Following January 5.3.1 If pursuant to the Section 5.2 of this Article V, Lucent invokes this Section 5.3, Lucent may, with respect to a Sourced Product, notify Agere of Lucent's intention to either manufacture the Sourced Product or have the Sourced Product manufactured by a third party ("Second Source"). In the event of a notice of second source manufacture to Agere, Agere may notify Lucent, within fifteen (15) business days, that it wishes to submit the matter for resolution by Lucent's senior purchasing executive and Agere's appropriate senior executive. If the matter is not thus resolved within twenty (20) days, then the matter may be submitted by either party to an expedited binding arbitration to take place in New Jersey, with costs to be shared equally, for a determination of whether the foregoing default has occurred, which is to be completed within twenty (20) business days. The parties agree that by March 1, 2001, Distributor the parties shall have select an arbitrator to adjudicate disputes on a continuing basis under this clause. Upon failure of the rightparties to agree on the selection of an arbitrator by March 1, by sending a written notice to OTI to that effect (the "MANUFACTURING RIGHTS NOTICE"), to manufacture (or subcontract for manufacture) smart cards (for example2001, the plastic American Arbitration Association shall be requested to make the selection. 5.3.2 Upon failure of Agere to submit the matter for resolution by senior executives or upon the conclusion of an arbitration finding an unresolved Trigger Event exists with respect to a Sourced Product, then Lucent shall have, in addition to any rights provided elsewhere in this Agreement, the following rights with respect to such specific Sourced Product: 5.3.2.1 a perpetual, personal, nonexclusive, non-transferable, irrevocable, worldwide, royalty-free right to distribute the Joint Technical Information and Lucent's derivative works thereof to a Second Source and to sublicense such Second Source to make and sell such Sourced Product for third parties, for so long as the Second Source supplies the Sourced Product to Lucent and for three (3) years thereafter. Lucent shall distribute and sublicense the Joint Technical Information under confidentiality terms consistent with those ordinarily used by Lucent in connection with its disclosure of its own proprietary information, and shall require return or destruction of the multi-card and antennae, if required) ("SMART CARDS") utilising any or all of OTI Intellectual Property, Joint Technical Information when the Second Source ceases to the extent it relates to such manufacture, for sale of the Smart Cards within the Territory (the "MANUFACTURING Rights"). The Manufacturing Rights shall be subject to the use and embeddment in the Smart Cards of any one or more of OTI's modules supplied by OTI (such as those set out in ANNEX A as the Smart Card Modules). The Manufacturing Rights shall be exclusive to Distributor in the Territory and shall continue during the Term of this Agreement but shall not in any way limit OTI's right to manufacture OTI Products in the Territory which are sold in or imported into areas outside the Territory. For avoidance of doubt, Distributor shall not be entitled at any time to receive Manufacturing Rights of the OTI modules included in the Smart Cards. 14.2 Within thirty (30) days following receipt by OTI of the Manufacturing Rights Notice, OTI will deliver to Distributor such information, which is necessary for Distributor to manufacture the Smart Cards. Subject to the Manufacturing Rights granted to Distributor herein, all right, title and interest in all OTI Intellectual Property in the Smart Cards, including without limitation, the OTI modules embedded in the Smart Cards, shall at all times remain the property of OTI. 14.3 For the purpose of manufacturing the Smart Cards, Distributor shall purchase from OTI, and not from any other third party, modules to be included in the Smart Cards, for the prices of such modules set forth in the Price List. 14.4 In the event that Manufacturing Rights shall be granted hereunder, OTI shall have the right to order at any time from Distributorsupply the Sourced Product; and 5.3.2.2 a personal, ornonexclusive, in non-transferable, irrevocable, worldwide, royalty-free right to sublicense a Second Source under Agere's Required Patents to make, use and sell the event that Distributor elects Sourced Product to exercise third parties to the Manufacturing Rights by a sub-contractorextent the Second Source uses the Joint Technical Information to manufacture the Sourced Product, for so long as the Second Source supplies the Sourced Product to order directly from such sub-contractor, Smart Cards Lucent and for sale by OTI or by its other distributors, while abiding Distributor's exclusive distribution rights in this Agreement, at prices which shall not be higher than the most favorable prices granted by Distributor three (or such sub-contractor of the Distributor3) to Customers for similar volume of Smart Cards at the time. Distributor shall abide by such OTI orders, subject to reasonable payment terms and delivery schedule to be agreedyears thereafter. 14.5 For grant of the Manufacturing Rights hereunder OTI shall be entitled to such reasonable royalties at such rates not exceeding market rates for similar Smart Cards and as shall be agreed between the parties at the time of grant of the Manufacturing Rights. CHAPTER F- NON COMPETITION & ADDITIONAL UNDERTAKINGS OF DISTRIBUTOR

Manufacturing Rights. 14.1 Following January 1(a) The Licensors hereby agree to manufacture and deliver, 2001and cause and require their third party contractors to manufacture and deliver, Distributor such quantities of the Monolayer Products, including all components thereof and the related fixers and reagents, as may be requested or specified from time to time by IMI. All such manufacturing and delivery (i) shall have be performed and completed in strict conformance with (A) all of IMI's commercially reasonable (in the rightmedical device industry) specifications and requirements, including, without limitation, those related to time of delivery, volume, design, appearance, performance and pricing and (B) the terms and conditions of all applicable IMI purchase orders, and (ii) shall strictly comply with all Good Manufacturing Practices ("GMP") required or promulgated by sending a written notice the FDA from time to OTI time (with all of the foregoing requirements being hereinafter referred to that effect (as the "MANUFACTURING RIGHTS NOTICE"), to manufacture (or subcontract for manufacture) smart cards (for example, the plastic of the multi-card and antennae, if required) ("SMART CARDS") utilising any or all of OTI Intellectual Property, to the extent it relates to such manufacture, for sale of the Smart Cards within the Territory (the "MANUFACTURING RightsManufacturing Requirements"). The Manufacturing Rights shall be subject to the use and embeddment in the Smart Cards of any one or more of OTI's modules supplied by OTI (such as those set out in ANNEX A as the Smart Card Modules). The Manufacturing Rights shall be exclusive to Distributor in the Territory and shall continue during the Term of this Agreement but shall not in any way limit OTI's right to manufacture OTI Products in the Territory which are sold in or imported into areas outside the Territory. For avoidance of doubt, Distributor shall not be entitled at any time to receive Manufacturing Rights of the OTI modules included in the Smart Cards. 14.2 Within thirty (30) days following receipt by OTI of the Manufacturing Rights Notice, OTI will deliver to Distributor such information, which is necessary for Distributor to manufacture the Smart Cards. Subject to the Manufacturing Rights granted to Distributor herein, all right, title and interest in all OTI Intellectual Property in the Smart Cards, including without limitation, the OTI modules embedded in the Smart Cards, IMI shall at all times remain have the property right of OTI. 14.3 For audit, use and access to the purpose manufacturing data (including component supplier contact information), facilities and know-how of the Licensors and their third party manufacturing the Smart Cards, Distributor shall purchase from OTI, and not from any other third party, modules to be included in the Smart Cardscontractors, for the prices sole purpose of such modules set forth in confirming that the Price ListLicensors or their contractors are complying with all Manufacturing Requirements. 14.4 In (b) With respect to the event that Manufacturing Rights shall be granted hereunder, OTI shall have the right to order at any time from Distributor, orMonolayer Products, in the event that Distributor elects the Licensors or their contractors at any time fail to exercise perform their obligations with respect to manufacturing and delivery of any of the Monolayer Products (including, without limitation, failure to fully comply with the Manufacturing Rights by Requirements), then IMI shall have, in addition to all other rights granted to IMI under this Agreement, the right to manufacture or cause to be manufactured such Monolayer Products and all components thereof and the related disposables, fixers and reagents. With respect to the Manifold System, in the event the Licensors abandon their development effort, or in the event the Licensors or their third party contractors fail to produce a subworking prototype ready for beta site --------------- * DENOTES CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. testing within six (6) months of the date of this Agreement, or fail to perform their obligations with respect to manufacturing and delivery of the Manifold System (including without limitation failure to fully comply with the Manufacturing Requirements), then IMI shall have, in addition to all other rights granted to IMI under this Agreement, the right to manufacture or cause to be manufactured the Manifold System and all components thereof and all related disposables. The intent of the parties is that the Licensors shall be responsible for the manufacturing the Monolayer Products, fixers and reagents and the Manifold System, however, the foregoing contingent manufacturing rights are necessary to ensure that IMI shall not be precluded from full exercise of its rights to use and sell the Monolayer Products, fixers and reagents and the Manifold System. In this regard, the Licensors shall, on the date of this Agreement, deliver to IMI copies of all relevant manufacturing data and component supplier and third party manufacturing contractor contact information and know-contractorhow and specifications which would be necessary for IMI's independent exercise of its contingent manufacturing rights, including without limitation such documentation relating to order directly from such sub-contractor, Smart Cards for sale by OTI or by its other distributors, while abiding Distributor's exclusive distribution rights in the Urine Cytology procedure (the "Manufacturing Documentation"). Throughout the term of this Agreement, at prices which shall not be higher than the most favorable prices granted by Distributor (request of IMI or such sub-contractor upon any material change in the Manufacturing Documentation or creation of new Manufacturing Documentation covering any of the Distributor) to Customers for similar volume of Smart Cards at Manifold System or Monolayer Products, fixers or reagents, the time. Distributor Licensors shall abide by such OTI orders, subject to reasonable payment terms and delivery schedule to be agreed. 14.5 For grant promptly deliver any updates or modifications of the Manufacturing Rights hereunder OTI Documentation to IMI. IMI shall be entitled to not use such reasonable royalties at such rates not exceeding market rates for similar Smart Cards and as shall be agreed between Manufacturing Documentation except in connection with the parties at the time exercise of grant of the Manufacturing Rights. CHAPTER F- NON COMPETITION & ADDITIONAL UNDERTAKINGS OF DISTRIBUTORits contingent manufacturing rights.

Manufacturing Rights. 14.1 Following January 1The exclusive license granted to Amylin pursuant to Section 3.1(a)(i)(B) under the Nastech Technology, 2001Nastech Inventions, Distributor Joint Inventions and Joint Patents to make, have made and import Licensed Intranasal Formulations in order to make, have made, use, offer for sale, sell, have sold and import Products (or grant any sublicense of such rights) shall become effective only upon satisfaction of the following requirements: (A) Nastech shall have the rightfirst right to negotiate with Amylin to manufacture and sell to Amylin Licensed Intranasal Formulations. Not less than [***] prior to commencement of the first pivotal clinical trial of the Product (and in any event prior to commencing development of its own manufacturing process for Product or commencing negotiations with a third party with respect to manufacturing Product), Amylin shall deliver to Nastech written notice (the "NEGOTIATION NOTICE") of its intent to commence negotiation of the terms of a supply agreement, which Negotiation Notice shall be accompanied by sending a draft supply agreement. Nastech shall as promptly as practicable (and in any event within [***]) acknowledge receipt of the Negotiation Notice. (B) The parties shall use good faith efforts to negotiate and sign a definitive Supply Agreement. The parties agree that the terms of the definitive supply agreement (the "SUPPLY AGREEMENT") shall provide that Nastech will supply Product at a transfer price equal to [***] from Nastech's facilities at both Bothell Washington and Hauppauge New York, which will be qualified to supply Product as part of the NDA filing. If despite such good faith efforts by each party the Supply Agreement has not been executed within [***] of the Negotiation Notice, then Amylin shall have the right upon delivery of written notice to OTI to that effect Nastech (the "MANUFACTURING RIGHTS NOTICE"), ) either (x) to declare its intent to manufacture Licensed [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH A SERIES OF THREE ASTERISKS IN BRACKETS [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] Intranasal Formulations itself or (y) to negotiate a supply agreement for Licensed Intranasal Formulations with one or subcontract for manufacturemore third parties. (C) smart cards (for exampleIn the event Product is manufactured by any entity other than Nastech or a Nastech Affiliate, the plastic of the multi-card and antennae, if required) ("SMART CARDS") utilising any or all of OTI Intellectual Property, then in addition to the extent it relates royalties on worldwide Net Sales of Product payable under Section 5.2 hereof, Amylin shall pay to such manufacture, for sale of the Smart Cards within the Territory Nastech an additional royalty (the "MANUFACTURING RightsManufacturing Royalty") of [***] on the Net Sales of all units of Product not manufactured by Nastech ("Non-Nastech Product"). . (I) [***] (II) The Manufacturing Rights Royalty shall be subject calculated and paid quarterly together with the royalty payment under Section 5.2 and Amylin shall provide a report specifying the information underlying the calculation. (III) Amylin shall keep, and shall cause its Affiliates and manufacturing sublicensees to keep, complete and accurate records pertaining to the use manufacturing and embeddment shipment or other disposition of Products in sufficient detail to permit Nastech to confirm the Smart Cards accuracy of all Manufacturing Royalty payments. Receipt or acceptance by Nastech of any one report or more other statement furnished pursuant to this Section 3.5(e) or of OTIany sum paid hereunder (or the cashing of any royalty checks paid hereunder) shall not preclude Nastech from questioning the correctness thereof at any time, and the parties shall otherwise comply with the provisions of Section 6.4 with respect to the maintenance and audit of such records and reports. (IV) Notwithstanding the foregoing, if after entering into a mutually agreed-upon Supply Agreement, Nastech is unable or unwilling to manufacture Product which it has agreed to supply in such Supply Agreement, then Amylin's modules supplied by OTI obligation to pay the Manufacturing Royalty on Non-Nastech Product shall cease. (such as those set out in ANNEX A as D) If either (x) Amylin delivers the Smart Card Modules). The Manufacturing Rights shall be exclusive to Distributor in Notice or (y) after execution of a Supply Agreement by the Territory and shall continue parties, Nastech is unable (or has indicated that it does not believe it will have the capacity) during the Term of this Agreement but shall not in any way limit OTI's right specified period to manufacture OTI Products and deliver Product in quantities previously agreed by the Territory which are sold in or imported into areas outside the Territory. For avoidance of doubtparties, Distributor shall not be entitled at any time to receive Manufacturing Rights of the OTI modules included in the Smart Cards.then 14.2 Within thirty (30I) days following receipt by OTI delivery of the Manufacturing Rights NoticeNotice or other written notice by Amylin referring to Nastech's inability to manufacture, OTI will deliver to Distributor such information, which is necessary for Distributor to manufacture Amylin may declare effective the Smart Cards. Subject to the Manufacturing Rights exclusive license granted to Distributor hereinit pursuant to Section 3.1(a)(i)(B) under the Nastech Technology, all rightNastech Inventions, title Joint Inventions and interest Joint Patents to make, have made and import Licensed Intranasal Formulations in all OTI Intellectual Property in the Smart Cardsorder to make, have made, use, offer for sale, sell, have sold and import Products, including without limitation, the OTI modules embedded in the Smart Cards, shall at all times remain the property of OTI. 14.3 For the purpose of manufacturing the Smart Cards, Distributor shall purchase from OTI, and not from any other third party, modules to be included in the Smart Cards, for the prices of such modules set forth in the Price List. 14.4 In the event that Manufacturing Rights shall be granted hereunder, OTI shall have the right to order sublicense such rights as permitted in Section 3.1(a)(ii) and Amylin may immediately, and without further action by Amylin or Nastech, exercise its rights under such license; and (II) Nastech shall, if requested by Amylin, at any time from DistributorNastech's own expense, oruse its good faith efforts to assist and cooperate with Amylin in qualifying alternative manufacturers to manufacture Product. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, in WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH A SERIES OF THREE ASTERISKS IN BRACKETS [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] (E) Notwithstanding anything to the event that Distributor elects to exercise the Manufacturing Rights by a sub-contractor, to order directly from such sub-contractor, Smart Cards for sale by OTI or by its other distributors, while abiding Distributor's exclusive distribution rights contrary in this Agreement, (I) in no event shall Amylin grant any sublicense of manufacturing rights (or in anticipation of or in connection with such grant, at prices which shall not be higher than the most favorable prices disclose any Nastech Confidential Information, Nastech Inventions or Joint Inventions relating to manufacturing of intranasal delivery formulations of pharmaceuticals) to [***]; and (II) no sublicense granted by Distributor (or such sub-contractor of the Distributor) to Customers for similar volume of Smart Cards at the time. Distributor shall abide by such OTI orders, subject to reasonable payment terms and delivery schedule to be agreed. 14.5 For grant of the Manufacturing Rights hereunder OTI Amylin shall be entitled effective unless it contains (A) an agreement by the sublicensee for the benefit of Nastech to maintain the confidentiality of all Nastech Confidential Information, Nastech Inventions and Joint Inventions disclosed to it in connection with the manufacture of Licensed Intranasal Formulations or the Product and to use such reasonable royalties at information solely for the purposes of manufacturing Licensed Intranasal Formulations or the Product and for no other purpose and (B) a provision permitting termination of such rates not exceeding market rates for similar Smart Cards and as shall be agreed between the parties at the time sublicense by Nastech upon termination of grant of the Manufacturing Rights. CHAPTER F- NON COMPETITION & ADDITIONAL UNDERTAKINGS OF DISTRIBUTORthis Agreement by Nastech.

Manufacturing Rights. 14.1 Following January 1, 2001, Distributor shall have (a) The Supplier agrees to provide the right, by sending a written notice to OTI to that effect (Buyer with the "MANUFACTURING RIGHTS NOTICE"), to manufacture (or subcontract for manufacture) smart cards (for example, the plastic most recent copy of the multi-card Product manual, block diagrams and antennaeviewable mechanical model files (i.e. eDrawing) format for use as first level support documentation and Product data sheets, if requiredupon Buyer’s request. (b) ("SMART CARDS") utilising any or all of OTI Intellectual Property, Further design and manufacturing files will be made available to the extent it relates Buyer as part of this Agreement in the following manner: (c) In the event that Buyer decides to such manufacture, for sale have any of the Smart Cards within Products manufactured internally or by a third party after the Territory (the "MANUFACTURING Rights"). The Manufacturing Rights shall be subject relevant Product(s) has been designed and prototypes manufactured and delivered to the use and embeddment in the Smart Cards of any one or more of OTI's modules supplied by OTI (such as those set out in ANNEX A as the Smart Card Modules). The Manufacturing Rights shall be exclusive to Distributor in the Territory and shall continue Buyer, during the Term of this Agreement but and Extension, then Buyer shall not inform Supplier in any way limit OTI's right writing of its decision to manufacture OTI Products do so (“Alternative Manufacturing Notice”) at least six months in advance (or such other period as agreed between the Territory parties), and Buyer and Supplier shall thereafter enter into a manufacturing license agreement (“Manufacturing License Agreement”) which are sold in or imported into areas outside the Territory. For avoidance of doubtshall include, Distributor shall not be entitled at any time to receive Manufacturing Rights of the OTI modules included in the Smart Cards. 14.2 Within thirty (30) days following receipt by OTI of the Manufacturing Rights Notice, OTI will deliver to Distributor such information, which is necessary for Distributor to manufacture the Smart Cards. Subject to the Manufacturing Rights granted to Distributor herein, all right, title and interest in all OTI Intellectual Property in the Smart Cards, including without limitation, the OTI modules embedded following terms and conditions: (i) Supplier shall grant to Buyer all licenses and rights necessary for Buyer to manufacture the Products or to grant the same rights to a third party to manufacture the Products in the Smart Cards, shall at all times remain the property of OTI. 14.3 For the purpose of manufacturing the Smart Cards, Distributor shall purchase from OTI, and not from any other third party, modules to be included in the Smart Cards, consideration for the prices following applicable fees: a. A one-time license fee of such modules set forth in [***], paid upon receipt including any applicable taxes for each “System” Product, if the Price List.Buyer provides Supplier with an Alternative Manufacturing Notice within twenty-four (24) months of the first Production Shipment of the relevant Product to the Buyer; or 14.4 In b. A one-time license fee of [***], paid upon receipt including any applicable taxes for each “System” Product, if the event that Buyer provides Supplier with an Alternative Manufacturing Rights shall be granted hereunderNotice between twenty-four (24) months and forty-eight (48) months of the first Production Shipment of the relevant Product to the Buyer; or c. A one-time license fee of [***], OTI shall have paid upon receipt including any applicable taxes for each “System” Product, if the Buyer provides Supplier with an Alternative Manufacturing Notice more than forty-eight (48) months of the first Production Shipment of the relevant Product to the Buyer; d. A one-time fee of [***] paid upon receipt, including any applicable taxes for each “System” Product, if the Buyer has exercised its right to order at any time from Distributor, or, terminate this agreement in the event that Distributor elects to exercise the Manufacturing Rights by a sub-contractor, to order directly from such sub-contractor, Smart Cards for sale by OTI or by its other distributors, while abiding Distributor's exclusive distribution rights in this Agreement, at prices which shall not be higher than the most favorable prices granted by Distributor accordance with Section C.5.(a) (or such sub-contractor of the Distributor) to Customers for similar volume of Smart Cards at the time. Distributor shall abide by such OTI orders, subject to reasonable payment terms and delivery schedule to be agreed. 14.5 For grant of the Manufacturing Rights hereunder OTI shall be entitled to such reasonable royalties at such rates not exceeding market rates for similar Smart Cards and as shall be agreed between the parties at the time of grant of the Manufacturing Rights. CHAPTER F- NON COMPETITION & ADDITIONAL UNDERTAKINGS OF DISTRIBUTOR