GSK to Theravance. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for the first Collaboration Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is [***], and for the first LABA/ICS Combination Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is [***]: Milestone Amount Initiation of Phase I * U.S.$10 Million Initiation of Phase IIa** U.S.$10 Million Initiation of Phase IIb** U.S.$5 Million [***] [***] Registration [***] [***] Launch [***] [***] Annual Worldwide Net Sales over [***] Collaboration Product [***] Annual Worldwide Net Sales over [***] Combination Product [***] * GSK will make a Phase I milestone payment for both TD-3327 and AMI-15471. The Phase I milestone for TD-3327 is defined as initiation of the methacholine challenge portion of the Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. The Phase I milestone for AMI-15471 is defined as initiation of the first Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. **Phase IIa is defined as initiation of the first single dose study in patients where such study is statistically powered for efficacy based on FEV1. Phase IIb is defined as initiation of the first four (4) week dosing, safety and efficacy study in patients. Other Combination Products that contain a Long-Acting x0 Xxxxxxxxxxxx Agonist that is a Theravance Compound are not subject to milestone payments by GSK only if [***]. The Parties ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. intend that if the collaboration is successful [***] Collaboration Products that contain a Theravance Compound, Theravance be paid the applicable milestones [***]. If GSK, either individually or as a member of the Joint Steering Committee or Joint Project Committee, discontinues the Development of a [***] Collaboration Product that is a Theravance Compound for reasons other than [***], and such compound is the [***], it will [***].

GSK to Theravance. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for the first Collaboration Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is a Theravance Compound, and for the first LABA/ICS Combination Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is a Theravance Compound: Milestone Amount Initiation of Phase I * U.S.$10 Million Initiation of Phase IIa** U.S.$10 Million Initiation of Phase IIb** U.S.$5 Million Initiation of Phase III U.S.$25 Million Milestone Amount Registration U.S. U.S.$30 Million Europe U.S.$15 Million Japan U.S.$10 Million Launch U.S. U.S.$30 Million Europe U.S.$15 Million Japan U.S.$10 Million Annual Worldwide Net Sales over U.S.$500 Million for single agent Collaboration Product U.S.$10 Million per year for first five years for single agent Collaboration Product Annual Worldwide Net Sales over U.S.$500 Million for LABA/ICS Combination Product U.S.$20 Million per year for first five years for LABA/ICS Combination Product * GSK will make a Phase I milestone payment for both TD-3327 and AMI-15471. The Phase I milestone for TD-3327 is defined as initiation of the methacholine challenge portion of the Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. The Phase I milestone for AMI-15471 is defined as initiation of the first Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. **Phase IIa is defined as initiation of the first single dose study in patients where such study is statistically powered for efficacy based on FEV1. Phase IIb is defined as initiation of the first four (4) week dosing, safety and efficacy study in patients. Other Combination Products that contain a Long-Acting x0 Xxxxxxxxxxxx Agonist that is a Theravance Compound are not subject to milestone payments by GSK only if all milestone payments through launch have otherwise been made to Theravance from any Collaboration Product as both a single-agent and as a combination product. The Parties intend that if the collaboration is successful in launching at least two Collaboration Products that contain a Theravance Compound, Theravance be paid the applicable milestones through launch for two products. If GSK, either individually or as a member of the Joint Steering Committee or Joint Project Committee, discontinues the Development of a single agent Collaboration Product that is a Theravance Compound for reasons other than Technical Fail...

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Baxter and Nexell shall cooperate in any action taken by a third party solely involving a nullity action, opposition, reexamination or any other action taken by such third party alleging the invalidity or unenforceability of any Licensed Intellectual Property. Both parties agree to share equally in the cost of the defense of such Licensed Intellectual Property.
Licensee Licensee represents and warrants that:
Sublicensee The term “Sublicensee” shall mean any third party to whom Licensee grants a sublicense or similar rights with respect to the rights conferred upon Licensee under this Agreement, as contemplated by Section 2.3. In addition, “Sublicensee” shall include any and all further third party Sublicensees that may be permitted under Section 2.3.
Sublicensees Licensee shall have the full right (but not the obligation) to sublicense those rights granted to it under Section 2.1 to a Third Party (a “Sublicensee”); provided, however, that, prior to the payment of the first milestone pursuant to Section 7.2, Licensee may not grant any such sublicense to any contract research organization conducting Clinical Trials of Products or any Third Parties conducting contract Manufacturing activities without Licensee’s prior written notice (at least twenty (20) Business Days in advance) to Lilly, which shall include a description of the rights to be granted and the purpose therefor, the identity of the Third Party and the countries involved, and Lilly’s prior written consent, but such consent shall only be required (i) until such time as Licensee is the holder of record for the Regulatory Materials related to Taladegib and (ii) to the extent such organization is not performing services for Licensee as of the Effective Date; and provided further, that Licensee shall remain responsible for the performance by any of its Sublicensees. With respect to any Sublicensee granted a sublicense to any Commercialization rights hereunder, Licensee shall ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder. Each Sublicensee shall also be prohibited from further sublicensing. For the avoidance of doubt, (a) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (b) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.3.1 and 2.5, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee.
Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.
Licensor any Person from whom a Grantor obtains the right to use any Intellectual Property. Lien: any Person’s interest in Property securing an obligation owed to, or a claim by, such Person, whether such interest is based on common law, statute or contract, including liens, security interests, pledges, hypothecations, statutory trusts, reservations, exceptions, encroachments, easements, rights-of-way, covenants, conditions, restrictions, leases, and other title exceptions and encumbrances affecting Property. Lien Waiver: an agreement, in form and substance satisfactory to Collateral Agent, by which (a) for any material Collateral located on leased premises, the lessor waives or subordinates any Lien it may have on the Collateral, and agrees to permit Collateral Agent to enter upon the premises and remove the Collateral or to use the premises to store or dispose of the Collateral; (b) for any Collateral held by a warehouseman, processor, shipper, customs broker or freight forwarder, such Person waives or subordinates any Lien it may have on the Collateral, agrees to hold any Documents in its possession relating to the Collateral as agent for Collateral Agent, and agrees to deliver the Collateral to Collateral Agent upon request; (c) for any Collateral held by a repairman, mechanic or bailee, such Person acknowledges Collateral Agent’s Lien, waives or subordinates any Lien it may have on the Collateral, and agrees to deliver the Collateral to Collateral Agent upon request; and (d) for any Collateral subject to a Licensor’s Intellectual Property rights, the Licensor grants to Collateral Agent the right, vis-à-vis such Licensor, to enforce Collateral Agent’s Liens with respect to the Collateral, including the right to dispose of it with the benefit of the Intellectual Property, whether or not a default exists under any applicable License.
Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)
Sublicense Fees Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter.

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