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7		-Infinity Pharmaceuticals is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity Pharmaceuticals is focusing its efforts on advancing IPI-549, an orally administered, clinical-stage, immuno-oncology product candidate that selectively inhibits the enzyme phosphoinositide-3-kinase-gamma, or PI3K-gamma.
	7	+Infinity Pharmaceuticals (INFI) is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity Pharmaceuticals is focusing its efforts on advancing IPI-549, an orally administered, clinical-stage, immuno-oncology product candidate that selectively inhibits the enzyme phosphoinositide-3-kinase-gamma, or PI3K-gamma.{{footnote}}https://fintel.io/doc/sec-infi-infinity-pharmaceuticals-10k-2018-march-15-17968{{/footnote}}
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9	9	Preclinical research has demonstrated that PI3K-gamma is highly expressed in tumor-associated macrophages and that blockade of PI3K-gamma signaling by treatment with IPI-549 results in a reprogramming of macrophages in the tumor microenvironment from the M2, or pro-tumor, phenotype to the M1, or anti-tumor, phenotype. This shift increased the number and activity of anti-tumor T cells that can attack the tumor and also increased the production of pro-inflammatory cytokines, which can further stimulate an anti-tumor immune response. Preclinical data from multiple solid tumor models demonstrated that IPI-549 was active as a monotherapy and that IPI-549 administered in combination with checkpoint inhibition led to enhanced activity compared to either treatment alone. Additionally, preclinical tumor model data demonstrated that M2 pro-tumor macrophages are associated with resistance to checkpoint inhibition and that treatment with IPI-549 in combination with checkpoint inhibitors is able to overcome this resistance. These preclinical data further elucidate the mechanism of action for IPI-549 by demonstrating that PI3K-gamma plays a key role in the immuno-suppressive tumor microenvironment.
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19	19	Infinity Pharmaceuticals has worldwide development and commercialization rights to IPI-549, subject to certain success-based milestone payment obligations to its licensor, Takeda, as described in more detail under the heading Strategic Alliances - Takeda. Additionally, Infinity Pharmaceuticals is obligated to pay its former strategic collaborators Mundipharma International Corporation Limited, or Mundipharma, and Purdue Pharmaceutical Products L.P., or Purdue, a 4% royalty in the aggregate on worldwide net sales of products that were previously subject to the strategic alliance, including IPI-549, until such time as Mundipharma and Purdue have recovered approximately $260 million in royalty payments from all products that were previously subject to the strategic alliance. After this cost recovery, which represents the funding paid to it for research and development services performed by it under its strategic alliance, its royalty obligations to Mundipharma and Purdue will be reduced to a 1% royalty on net sales in the United States of products that were previously subject to the strategic alliance, including IPI-549.
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21		-**Lease Termination**
	21	+== Lease Termination ==
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23	23	On March 27, 2017, the company and BHX, LLC, as Trustee of 784 Realty Trust, which the company refer to as the Landlord, entered into an amendment to its lease agreement, or Lease, for the lease of approximately 61,000 feet of office space at 784 Memorial Drive, Cambridge, Massachusetts. Under the lease amendment, the company and the Landlord agreed to the early termination of the Lease subject to the satisfaction of specified contingencies, which the company refer to as Lease Termination Contingencies, and a termination payment of a $5.0 million, which the company refer to as the Termination Payment. The Lease amendment was extended by entry into a second lease amendment dated May 1, 2017, and a third lease amendment dated May 31, 2017. The company refer to the Lease amendment and its extensions as the Lease Amendments.
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25	25	The Lease Termination Contingencies were satisfied on June 15, 2017 and the company paid the first installment of the Termination Payment to the Landlord of $4.5 million. The Lease, as amended, will terminate effective August 31, 2017 provided that the company pay the final installment of the Termination Payment of $0.5 million to the Landlord on or before August 31, 2017. The company intend to secure office space with a significantly smaller lease obligation.
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27		-**Strategic Alliances**
	27	+== Strategic Alliances ==
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29	29	Since its inception, corporate alliances have been integral to its strategy. These alliances have provided access to breakthrough science, significant research and development resources, and innovative drug development programs, all intended to help it realize the full potential of its product pipeline. All of its revenues since September 2006 have been generated under research collaborative agreements including its corporate alliances.
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31		-//Takeda//
	31	+=== //Takeda// ===
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33	33	In July 2010, the company entered into a development and license agreement with Intellikine, Inc., or Intellikine, under which the company obtained rights to discover, develop and commercialize pharmaceutical products targeting the gamma and/or delta isoforms of PI3K, including IPI-549 and duvelisib, an oral, dual inhibitor of PI3K delta and gamma. In January 2012, Intellikine was acquired by Takeda Pharmaceuticals Company Limited acting through its Millennium business unit. The company refer to its PI3K inhibitor program licensor as Takeda. In December 2012, the company amended and restated its development and license agreement with Takeda and further amended the agreement in July 2014, September 2016, and July 2017. The company refer to the amended and restated development and license agreement, as amended, as the Takeda Agreement.
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43	43	The Takeda Agreement expires on the later of the expiration of certain patents and the expiration of the royalty payment terms for the products, unless earlier terminated in accordance with its terms. Either party may terminate the Takeda Agreement on 75 days ’ prior written notice if the other party materially breaches the agreement and fails to cure such breach within the applicable notice period, provided that the notice period is reduced to 30 days where the alleged breach is non-payment. Takeda may also terminate the Takeda Agreement if Infinity Pharmaceuticals is not diligent in developing or commercializing the licensed products and do not, within three months after notice from Takeda, demonstrate to Takeda’s reasonable satisfaction that Infinity Pharmaceuticals has not failed to be diligent. The foregoing periods are subject to extension in certain circumstances. Additionally, Takeda may terminate the Takeda Agreement upon 30 days’ prior written notice if the company or a related party bring an action challenging the validity of any of the licensed patents, provided that Infinity Pharmaceuticals has not withdrawn such action before the end of the 30 -day notice period. The company may terminate the agreement at any time upon 180 days ’ prior written notice. The Takeda Agreement also provides for customary reciprocal indemnification obligations of the parties.
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45		-//Verastem//
	45	+=== //Verastem// ===
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47	47	On October 29, 2016, the company and Verastem Inc., or Verastem, entered into a license agreement, which the company and Verastem amended and restated on November 1, 2016, effective as of October 29, 2016. The company refer to the amended and restated license agreement as the Verastem Agreement. Under the Verastem Agreement, the company granted to Verastem an exclusive worldwide license for the research, development, commercialization, and manufacture of duvelisib and products containing duvelisib, which the company refer to as the Licensed Products, in each case in oncology indications. Upon entry into the Verastem Agreement, Verastem assumed financial responsibility for activities that were part of its ongoing duvelisib program, including a randomized, Phase 3 monotherapy clinical study in patients with relapsed/refractory chronic lymphocytic leukemia, which the company refer to as the DUO Study. Verastem is obligated to use diligent efforts, as defined in the Verastem Agreement, to develop and commercialize one Licensed Product. During the term of the Verastem Agreement, Infinity Pharmaceuticals has agreed not to research, develop, manufacture or commercialize duvelisib in any indication in humans or animals.
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59	59	The company and Verastem have made customary representations and warranties and have agreed to certain customary covenants, including confidentiality and indemnification.
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61		-//AbbVie//
	61	+=== //AbbVie// ===
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63	63	On September 2, 2014, the company entered into a collaboration and license agreement with AbbVie Inc., or AbbVie, which the company refer to as the AbbVie Agreement. Under the AbbVie Agreement, the company and AbbVie agreed to develop and commercialize in oncology indications products containing duvelisib. The company refer to products containing duvelisib as Duvelisib Products. IPI-549 was excluded from the collaboration. On June 24, 2016, AbbVie delivered to it a written notice that AbbVie was exercising its right to terminate the AbbVie Agreement unilaterally upon 90 days’ written notice, which the company refer to as the AbbVie Opt-Out. The termination of the AbbVie Agreement was effective on September 23, 2016.
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67	67	On September 23, 2016, the effective date of the AbbVie Agreement termination, the company received all rights to the regulatory filings related to duvelisib, its license to AbbVie terminated, and AbbVie granted it an exclusive, perpetual, irrevocable, royalty-free license, under certain patent rights and know-how controlled by AbbVie, to develop, manufacture and commercialize products containing duvelisib, excluding any compound which is covered by patent rights controlled by AbbVie or its affiliates, in oncology indications worldwide.
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69	69	Neither party has any ongoing financial obligation to the other party under the AbbVie Agreement.
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	71	+= References =
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